Federal Register Vol. 81, No.170,

Federal Register Volume 81, Issue 170 (September 1, 2016)

Page Range60235-60579
FR Document

81_FR_170
Current View
Page and SubjectPDF
81 FR 60579 - Continuation of the National Emergency With Respect to Certain Terrorist AttacksPDF
81 FR 60343 - Initiation of Five-Year (“Sunset”) ReviewPDF
81 FR 60352 - Farm Credit Administration Board; Sunshine Act; Regular MeetingPDF
81 FR 60240 - Special Conditions: Bombardier Aerospace Inc. Model BD-700-2A12 and BD-700-2A13 Airplanes; Sidestick ControllersPDF
81 FR 60236 - Special Conditions: Bombardier Inc., Model BD-700-2A12 and BD-700-2A13 Airplanes; Interactions of Systems and StructuresPDF
81 FR 60401 - FAA Approval of Noise Compatibility Program; Boise Air Terminal (Gowen Field) Boise, IdahoPDF
81 FR 60376 - Second Call for Nominations for the Utah Resource Advisory Council, State Agency CategoryPDF
81 FR 60376 - Notice of Extension of Concession ContractPDF
81 FR 60371 - Privacy Act of 1974; Department of Homeland Security/U.S. Customs and Border Protection (DHS/CBP)-022 Electronic Visa Update System (EVUS) System of RecordsPDF
81 FR 60297 - Privacy Act of 1974: Implementation of Exemptions; Department of Homeland Security U.S. Customs and Border Protection (DHS/CBP)-022 Electronic Visa Update System (EVUS) System of RecordsPDF
81 FR 60377 - Change of Jurisdiction-National Park Service Units Within the Commonwealth of KentuckyPDF
81 FR 60341 - Antidumping Duty Investigation of Certain Amorphous Silica Fabric From the People's Republic of China: Affirmative Preliminary Determination of Sales at Less-Than-Fair Value, Preliminary Affirmative Determination of Critical Circumstances, and Postponement of Final DeterminationPDF
81 FR 60407 - Proposed Information Collection; Comment RequestPDF
81 FR 60410 - Proposed Collection; Comment Request for Forms 8282 and 8283PDF
81 FR 60288 - Magnuson-Stevens Act Provisions; Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; 2015-2016 Biennial Specifications and Management Measures; Inseason AdjustmentsPDF
81 FR 60285 - Snapper-Grouper Fishery of the South Atlantic; 2016 Recreational Accountability Measure and Closure for the South Atlantic Other Porgies ComplexPDF
81 FR 60348 - Proposed Collection; Comment RequestPDF
81 FR 60400 - Executive Order 13224 Designation of Abdiqadir Mumin, aka Sheikh Abdikadir Mumin, aka Sheiky Abdulqadir Mumin, aka Sheikh Abdulqadir Mumin, aka Abdul Qadir Mumin, aka Sheikh Abdiqadir Mumin Yusuf, aka Sheikh Abdulkadir Mumin, aka Abdul Nadir Mumin, aka Abdul Qadr Mu'min as a Specially Designated Global TerroristPDF
81 FR 60401 - Delegation of the Authority To Submit Report Pursuant to Section 1247 of Public Law 114-92PDF
81 FR 60338 - Environmental Impact Statement; Grasshopper and Mormon Cricket Suppression ProgramPDF
81 FR 60354 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
81 FR 60241 - Special Conditions: Bombardier Inc. Model BD-700-2A12 and BD-700-2A13 Airplanes; Hydrophobic Coatings in Lieu of Windshield WipersPDF
81 FR 60235 - Special Rights for Transferred Employees Under the Dodd-Frank Act Regarding Federal Employees' Group Life InsurancePDF
81 FR 60349 - Notification of an Open Meeting of the National Defense University Board of Visitors (BOV)PDF
81 FR 60347 - Mid-Atlantic Fishery Management Council (MAFMC); Public MeetingPDF
81 FR 60407 - Buy America Waiver NotificationPDF
81 FR 60345 - Export Trade Certificate of ReviewPDF
81 FR 60351 - Notice of Public Meeting To Summarize Public Input Received on the Design of a Consent-Based Siting Process for Spent Nuclear Fuel and High-Level Radioactive Waste Storage and Disposal FacilitiesPDF
81 FR 60329 - World Trade Center Health Program; Petition 013-Autoimmune Disease; Finding of Insufficient EvidencePDF
81 FR 60347 - Endangered and Threatened Species; Initiation of 5-Year Review for Mediterranean Monk SealPDF
81 FR 60389 - Notice of Lodging of Proposed First Partial Remedial Design/Remedial Action (RD/RA) Consent Decree Under CerclaPDF
81 FR 60286 - Atlantic Highly Migratory Species; Adjustments to 2016 Northern Albacore Tuna and Atlantic Bluefin Tuna QuotasPDF
81 FR 60415 - Proposed Information Collection (NCA Pre-Need Determination of Eligibility for Burial) Activity: Comment RequestPDF
81 FR 60339 - Tehama County Resource Advisory CommitteePDF
81 FR 60410 - Departmental Offices; Proposed Collection; Comment RequestPDF
81 FR 60403 - Notice of Funding Opportunity for Accelerated Innovation Deployment DemonstrationPDF
81 FR 60299 - Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for CommentsPDF
81 FR 60339 - Glenn and Colusa County Resource Advisory CommitteePDF
81 FR 60390 - Report on Countries That Are Candidates for Millennium Challenge Account Eligibility in Fiscal Year 2017 and Countries That Would Be Candidates but for Legal ProhibitionsPDF
81 FR 60393 - Exelon Generation Company, LLC; LaSalle County Station, Units 1 and 2; License RenewalPDF
81 FR 60353 - Agency Information Collection Activities: Submission for OMB Review; Comment Request (3064-0026)PDF
81 FR 60353 - Notice to All Interested Parties of the Termination of the Receivership of 10500-Slavie Federal Savings Bank Bel Air, MarylandPDF
81 FR 60349 - Notice of Intent To Grant Exclusive Patent License; Microsphere Material Solutions, LLC.PDF
81 FR 60347 - Submission for OMB Review; Comment RequestPDF
81 FR 60360 - Office of Public Health Support; Division of Planning, Evaluation & Research; National Native Health Research Training InitiativePDF
81 FR 60368 - Request for Public Comment: 30-Day Proposed Information Collection: Application for Participation in the IHS Scholarship ProgramPDF
81 FR 60356 - Tribal Consultation MeetingsPDF
81 FR 60357 - The Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program; Public WorkshopPDF
81 FR 60358 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsPDF
81 FR 60350 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Study of the Turnaround School Leaders Program (TSLP)PDF
81 FR 60393 - Advisory Committee for Cyberinfrastructure; Notice of MeetingPDF
81 FR 60350 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Study of School Climate Transformation GrantsPDF
81 FR 60356 - Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee, RenewalPDF
81 FR 60359 - Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee, RenewalPDF
81 FR 60355 - Request for Nominations of Candidates To Serve on the Advisory Committee to the Director, Centers for Disease Control and Prevention (ACD, CDC)-Health Disparities Subcommittee (HDS)PDF
81 FR 60356 - Announcement of the Award of Single-Source Grants Under the Wilson-Fish Alternative Program (W-F); Correction; CFDA Number: 93.583PDF
81 FR 60413 - Proposed Information Collection (Application for Reinstatement-Insurance Lapsed More Than 6 Months (29-352) and Application for Reinstatement-Non Medical Comparative Health Statement (29-353)) Activity: Comment RequestPDF
81 FR 60414 - Proposed Information Collection (Application for Supplemental Service Disabled Veterans Insurance, VA Forms 29-0188 and 29-0189) Activity: Comment RequestPDF
81 FR 60414 - Agency Information Collection (Notice of Disagreement (NOD) (Pension, Dependency and Indemnity Compensation (DIC), Burial and Accrued), VA Form 21P-0970) Activity Under OMB ReviewPDF
81 FR 60416 - Agency Information Collection (Principles of Excellence Complaint System Intake) Activity Under OMB ReviewPDF
81 FR 60415 - Agency Information Collection (Medical Expense Report, VA Form 21P-8416) Activity Under OMB ReviewPDF
81 FR 60254 - Updated Statements of Legal Authority for the Export Administration RegulationsPDF
81 FR 60295 - Fisheries of the Economic Exclusive Zone Off Alaska; Deep-Water Species Fishery by Vessels Using Trawl Gear in the Gulf of AlaskaPDF
81 FR 60396 - Notice of Applications for Deregistration Under Section 8(f) of the Investment Company Act of 1940PDF
81 FR 60398 - Joint Industry Plan; Notice of Filing and Immediate Effectiveness of Amendment to the Plan Establishing Procedures Under Rule 605 of Regulation NMS To Add the Investors Exchange LLC as a ParticipantPDF
81 FR 60397 - Joint Industry Plan; Notice of Filing and Immediate Effectiveness of Amendment to the Plan To Address Extraordinary Market Volatility To Add the Investors Exchange LLC as a ParticipantPDF
81 FR 60399 - Joint Industry Plan; Notice of Filing and Immediate Effectiveness of Amendment to the Plan To Implement a Tick Size Pilot Program To Add the Investors Exchange LLC as a ParticipantPDF
81 FR 60394 - Consolidated Tape Association; Notice of Filing and Immediate Effectiveness of Amendment No. 26 to the Second Restatement of the CTA Plan and Amendment No. 19 to the Restated CQ Plan To Add the Investors Exchange LLC as a ParticipantPDF
81 FR 60395 - Joint Industry Plan; Notice of Filing and Immediate Effectiveness of Amendment No. 37 to the Joint Self-Regulatory Organization Plan Governing the Collection, Consolidation and Dissemination of Quotation and Transaction Information for Nasdaq-Listed Securities Traded on Exchanges on an Unlisted Trading Privileges Basis To Add the Investors Exchange LLC as a ParticipantPDF
81 FR 60345 - New England Fishery Management Council; Public MeetingPDF
81 FR 60392 - Notice of Intent To Grant a Partially Exclusive LicensePDF
81 FR 60392 - Notice of Intent To Grant Partially Exclusive LicensePDF
81 FR 60393 - Agency Information Collection Activities: Proposed Collection; Comment Request: Blanket Justification for NEA Funding Application Guidelines and Reporting RequirementsPDF
81 FR 60389 - 183rd Meeting of the Advisory Council on Employee Welfare and Pension Benefit Plans; Notice of Teleconference MeetingPDF
81 FR 60402 - First Meeting of the Drone Advisory Committee (DAC)PDF
81 FR 60274 - Air Plan Approval; Connecticut; Open Burning and Portable Fuel ContainersPDF
81 FR 60329 - Air Plan Approval; Connecticut; Open Burning and Portable Fuel ContainersPDF
81 FR 60355 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
81 FR 60354 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
81 FR 60278 - Notice of Policy on the Implementation of the Phased Increase in Domestic Content Under the Buy America Waiver for Rolling Stock and Notice of Public Interest Waiver of Buy America Domestic Content Requirements for Rolling Stock Procurement in Limited CircumstancesPDF
81 FR 60351 - Public Comment Draft for the Integrated Risk Information System (IRIS) Assessment of Ethyl Tertiary Butyl Ether (ETBE)PDF
81 FR 60381 - Notice of Inventory Completion: Tennessee Valley Authority, Knoxville, TNPDF
81 FR 60380 - Notice of Inventory Completion: Tennessee Valley Authority, Knoxville, TNPDF
81 FR 60377 - Notice of Inventory Completion: Tennessee Valley Authority, Knoxville, TNPDF
81 FR 60354 - Notice of Agreements FiledPDF
81 FR 60340 - Foreign-Trade Zone (FTZ) 279-Terrebonne Parish, Louisiana; Notification of Proposed Production Activity; Gulf Island Shipyards, LLC (Shipbuilding); Houma, LouisianaPDF
81 FR 60246 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 60304 - Requirements for Notification, Evaluation and Reduction of Lead-Based Paint Hazards in Federally Owned Residential Property and Housing Receiving Federal Assistance; Response to Elevated Blood Lead LevelsPDF
81 FR 60257 - Premerger Notification; Reporting and Waiting Period RequirementsPDF
81 FR 60298 - Petition To Amend Statement of Interpretation and Enforcement Policy Regarding Labeling of Household Products Containing Methylene Chloride; Request for CommentsPDF
81 FR 60332 - Update Means of Providing Recall NotificationPDF
81 FR 60411 - Annual Pay Ranges for Physicians and Dentists of the Veterans Health Administration (VHA)PDF
81 FR 60370 - National Institute on Deafness and Other Communication Disorders Draft 2017-2021 Strategic PlanPDF
81 FR 60243 - Airworthiness Directives; PILATUS AIRCRAFT LTD. AirplanesPDF
81 FR 60418 - Form ADV and Investment Advisers Act RulesPDF
81 FR 60252 - Airworthiness Directives; Bombardier, Inc. AirplanesPDF
81 FR 60248 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 60400 - 60-Day Notice of Proposed Information Collection: Medical Clearance UpdatePDF
81 FR 60383 - Carbon and Alloy Seamless Standard, Line, and Pressure Pipe From Japan and Romania; Institution of Five-Year ReviewsPDF
81 FR 60386 - Sulfanilic Acid From China and India; Institution of Five-Year ReviewsPDF
81 FR 60272 - Occupational Exposure to Respirable Crystalline Silica; CorrectionPDF

Issue

81 170 Thursday, September 1, 2016 Contents Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

See

Forest Service

Animal Animal and Plant Health Inspection Service NOTICES Environmental Impact Statements; Availability, etc.: Grasshopper and Mormon Cricket Suppression Program, 60338-60339 2016-21082 Army Army Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 60348-60349 2016-21089 Centers Disease Centers for Disease Control and Prevention NOTICES Request for Nominations: Advisory Committee to the Director, 60355-60356 2016-21039 Children Children and Families Administration NOTICES Meetings: Tribal Consultation, 60356 2016-21047 Single-Source Grants under the Wilson-Fish Alternative Program; Correction, 60356 2016-21038 Commerce Commerce Department See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Consumer Product Consumer Product Safety Commission PROPOSED RULES Statements of Interpretation and Enforcement Policy: Labeling of Household Products Containing Methylene Chloride, 60298-60299 2016-20928 Defense Department Defense Department See

Army Department

See

Navy Department

NOTICES Meetings: National Defense University Board of Visitors, 60349 2016-21075
Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Study of School Climate Transformation Grants, 60350-60351 2016-21042 Study of Turnaround School Leaders Program, 60350 2016-21044 Employee Benefits Employee Benefits Security Administration NOTICES Meetings: Advisory Council on Employee Welfare and Pension Benefit Plans, 60389-60390 2016-21015 Energy Department Energy Department NOTICES Meetings: Consent-Based Siting Process for Spent Nuclear Fuel and High-Level Radioactive Waste Storage and Disposal Facilities, 60351 2016-21071 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Connecticut; Open Burning and Portable Fuel Containers, 60274-60278 2016-21012 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Connecticut; Open Burning and Portable Fuel Containers, 60329 2016-21011 NOTICES Draft Integrated Risk Information System Assessments: Ethyl Tertiary Butyl Ether, 60351-60352 2016-21005 Farm Credit Farm Credit Administration NOTICES Meetings; Sunshine Act, 60352-60353 2016-21197 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Airbus Airplanes, 60246-60248 2016-20991 Bombardier, Inc. Airplanes, 60252-60254 2016-20826 PILATUS AIRCRAFT LTD. Airplanes, 60243-60246 2016-20833 The Boeing Company Airplanes, 60248-60252 2016-20825 Special Conditions: Bombardier Aerospace Inc. Model BD-700-2A12 and BD-700-2A13 Airplanes; Sidestick Controllers, 60240-60241 2016-21123 Bombardier Inc. Model BD-700-2A12 and BD-700-2A13 Airplanes; Hydrophobic Coatings in Lieu of Windshield Wipers, 60241-60243 2016-21079 Bombardier Inc., Model BD-700-2A12 and BD-700-2A13 Airplanes; Interactions of Systems and Structures, 60236-60240 2016-21122 NOTICES Meetings: Drone Advisory Committee, 60402-60403 2016-21013 Noise Compatibility Programs: Boise Air Terminal (Gowen Field) Boise, ID, 60401-60402 2016-21105 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 60353 2016-21054 Terminations of Receiverships: 10500, Slavie Federal Saving Bank, Bel Air, MD, 60353-60354 2016-21053 Federal Highway Federal Highway Administration NOTICES Buy American Waivers, 60407 2016-21073 Funding Opportunities: Accelerated Innovation Deployment Demonstration, 60403-60407 2016-21063 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 60354 2016-20999 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 60354-60355 2016-21009 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 60354-60355 2016-21010 2016-21081 Federal Trade Federal Trade Commission RULES Premerger Notifications; Reporting and Waiting Period Requirements, 60257-60272 2016-20950 Federal Transit Federal Transit Administration RULES Phased Increase in Domestic Content Under the Buy America Waiver for Rolling Stock; Public Interest Waiver of Buy America Domestic Content Requirements for Rolling Stock Procurement in Limited Circumstances, 60278-60285 2016-21007 Food and Drug Food and Drug Administration PROPOSED RULES Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing, 60299-60304 2016-21062 NOTICES Charter Renewals: Cardiovascular and Renal Drugs Advisory Committee, 60356-60357 2016-21041 Endocrinologic and Metabolic Drugs Advisory Committee, 60359-60360 2016-21040 Meetings: Microbiology Devices Panel of the Medical Devices Advisory Committee, 60358-60359 2016-21045 Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program, 60357-60358 2016-21046 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities: Gulf Island Shipyards, LLC (Shipbuilding), Houma, LA; Foreign-Trade Zone 279, Terrebonne Parish, LA, 60340-60341 2016-20995 Forest Forest Service NOTICES Meetings: Glenn and Colusa County Resource Advisory Committee, 60339 2016-21060 Tehama County Resource Advisory Committee, 60339-60340 2016-21065 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Children and Families Administration

See

Food and Drug Administration

See

Indian Health Service

See

National Institutes of Health

PROPOSED RULES Petitions: World Trade Center Health Program; Petition 013—Autoimmune Disease; Finding of Insufficient Evidence, 60329-60332 2016-21070
Homeland Homeland Security Department PROPOSED RULES Privacy Act; Implementation of Exemptions, 60297-60298 2016-21099 NOTICES Privacy Act; Systems of Records, 60371-60376 2016-21100 Housing Housing and Urban Development Department PROPOSED RULES Requirements for Notification, Evaluation and Reduction of Lead-Based Paint Hazards in Federally Owned Residential Property and Housing Receiving Federal Assistance: Response to Elevated Blood Lead Levels, 60304-60329 2016-20955 Indian Health Indian Health Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Participation in IHS Scholarship Program, 60368-60370 2016-21048 Cooperative Research and Development Agreements: National Native Health Research Training Initiative, 60360-60368 2016-21049 Industry Industry and Security Bureau RULES Statements of Legal Authority for the Export Administration Regulations, 60254-60257 2016-21031 Interior Interior Department See

Land Management Bureau

See

National Park Service

Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 60407-60410 2016-21093 2016-21094 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Amorphous Silica Fabric From the People's Republic of China, 60341-60343 2016-21095 Initiation of Five-Year (Sunset) Review, 60343-60345 2016-21209 Export Trade Certificates of Review, 60345 2016-21072 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Carbon and Alloy Seamless Standard, Line, and Pressure Pipe From Japan and Romania, 60383-60386 2016-20659 Sulfanilic Acid from China and India; Five-Year Reviews, 60386-60389 2016-20658 Justice Department Justice Department NOTICES Consent Decrees: CERCLA, 60389 2016-21068 Labor Department Labor Department See

Employee Benefits Security Administration

See

Occupational Safety and Health Administration

Land Land Management Bureau NOTICES Requests for Nominations: Utah Resource Advisory Council, State Agency Category, 60376 2016-21102 Millenium Millennium Challenge Corporation NOTICES Countries That Are Candidates for Millennium Challenge Account Eligibility in Fiscal Year 2017; Countries That Would Be Candidates but for Legal Prohibitions, 60390-60392 2016-21057 NASA National Aeronautics and Space Administration NOTICES Exclusive Licenses, 60392 2016-21018 Intents To Grant Partially Exclusive Licenses, 60392-60393 2016-21017 National Endowment for the Arts National Endowment for the Arts NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 60393 2016-21016 National Foundation National Foundation on the Arts and the Humanities See

National Endowment for the Arts

National Highway National Highway Traffic Safety Administration PROPOSED RULES Means of Providing Recall Notification, 60332-60337 2016-20926 National Institute National Institutes of Health NOTICES National Institute on Deafness and Other Communication Disorders Draft 2017-2021 Strategic Plan, 60370-60371 2016-20905 National Oceanic National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species: Adjustments to 2016 Northern Albacore Tuna and Atlantic Bluefin Tuna Quotas, 60286-60288 2016-21067 Fisheries of the Exclusive Economic Zone Off Alaska: Deep-Water Species Fishery by Vessels Using Trawl Gear in Gulf of Alaska, 60295-60296 2016-21029 Fisheries Off West Coast States: Pacific Coast Groundfish Fishery; 2015-2016 Biennial Specifications and Management Measures; Inseason Adjustments, 60288-60295 2016-21091 Snapper-Grouper Fishery of the South Atlantic: Recreational Accountability Measure and Closure for the South Atlantic Other Porgies Complex, 60285-60286 2016-21090 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 60347 2016-21050 Endangered and Threatened Species: Initiation of 5-Year Review for Mediterranean Monk Seal, 60347-60348 2016-21069 Meetings: Mid-Atlantic Fishery Management Council, 60347 2016-21074 New England Fishery Management Council, 60345-60347 2016-21019 National Park National Park Service NOTICES Change of Jurisdiction: National Park Service Units Within Commonwealth of Kentucky, 60377 2016-21098 Concession Contracts; Extensions, 60376-60377 2016-21101 Inventory Completions: Tennessee Valley Authority, Knoxville, TN, 60377-60383 2016-21002 2016-21003 2016-21004 National Science National Science Foundation NOTICES Meetings: Advisory Committee for Cyberinfrastructure, 60393 2016-21043 Navy Navy Department NOTICES Intents To Grant Exclusive Patent Licenses: Microsphere Material Solutions, LLC, 60349-60350 2016-21051 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Environmental Impact Statements; Availability, etc.: Exelon Generation Co., LLC; License Renewal for LaSalle County Station, Units 1 and 2, 60393-60394 2016-21055 Occupational Safety Health Adm Occupational Safety and Health Administration RULES Occupational Exposure to Respirable Crystalline Silica; Correction, 60272-60274 2016-20442 Personnel Personnel Management Office RULES Federal Employees' Group Life Insurance Program: Special Rights for Transferred Employees, 60235-60236 2016-21077 Presidential Documents Presidential Documents ADMINISTRATIVE ORDERS Terrorist Attacks; Continuation of National Emergency (Notice of August 30, 2016), 60577-60579 2016-21284 Securities Securities and Exchange Commission RULES Form ADV and Investment Advisers Act, 60418-60575 2016-20832 NOTICES Applications for Deregistration, 60396-60397 2016-21026 Joint Industry Plans: Addition of Investors Exchange, LLC, 60394-60400 2016-21021 2016-21022 2016-21023 2016-21024 2016-21025 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Clearance Update, 60400 2016-20679 Delegations of Authority, 60401 2016-21086 Designations as Specially Designated Global Terrorists: Abdiqadir Mumin, aka Sheikh Abdikadir Mumin, aka Sheiky Abdulqadir Mumin, et al., 60400 2016-21088 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Transit Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department See

Internal Revenue Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 60410-60411 2016-21064
Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 60414-60415 2016-21035 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Supplemental Service Disabled Veterans Insurance, 60414 2016-21036 Applications for Reinstatement: Insurance Lapsed More Than 6 Months; Non Medical Comparative Health Statement, 60413-60414 2016-21037 Medical Expense Report, 60415-60416 2016-21032 NCA Pre-Need Determination of Eligibility for Burial, 60415 2016-21066 Principles of Excellence Complaint System Intake, 60416 2016-21034 Annual Pay Ranges for Physicians and Dentists of the Veterans Health Administration, 60411-60413 2016-20910 Separate Parts In This Issue Part II Securities and Exchange Commission, 60418-60575 2016-20832 Part III Presidential Documents, 60577-60579 2016-21284 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.

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81 170 Thursday, September 1, 2016 Rules and Regulations OFFICE OF PERSONNEL MANAGEMENT 5 CFR Part 870 RIN 3206-AM81 Special Rights for Transferred Employees Under the Dodd-Frank Act Regarding Federal Employees' Group Life Insurance AGENCY:

U.S. Office of Personnel Management.

ACTION:

Final rulemaking.

SUMMARY:

The U.S. Office of Personnel Management (OPM) is issuing a Final Rulemaking to implement provisions of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the Act). The Act includes authorization for certain transferred employees to have a special enrollment opportunity and special rights regarding Federal Employees' Group Life Insurance (FEGLI) to ensure their continuity of benefits coverage.

DATES:

Effective September 1, 2016.

FOR FURTHER INFORMATION CONTACT:

Rachel Royster, Senior Policy Analyst, Planning and Policy Analysis, U.S. Office of Personnel Management, 1900 E Street NW., Washington, DC 20415.

SUPPLEMENTARY INFORMATION:

On January 6, 2014, the U.S. Office of Personnel Management (OPM) published a proposed regulation at 79 FR 613. The Administrative Procedures Act requires Federal agencies to publish a final regulation after a notice and comment period. Therefore, OPM is now finalizing this rule. The rule gave special FEGLI rights to the following employees who were carrying employer sponsored life insurance other than FEGLI: Employees from Office of Thrift Supervision (OTS) transferred to Office of the Comptroller of the Currency (OCC) and Federal Deposit Insurance Corporation (FDIC) under the Act (Pub. L. 111-203). The new regulatory provisions include new subparts in part 870 of title 5 of the Code of Federal Regulations.

Authorizing legislation: Section 322 of Public Law 111-203 discusses the transfer of employees and their special FEGLI rights.

Section 322 Transfer of Employees From OTS to OCC or FDIC

The relevant portions of this section states that if, after the 1-year period beginning on the transfer date, the Office of the Comptroller of the Currency or the Corporation determines that the Office of the Comptroller of the Currency or the Corporation will not continue to participate in any dental, vision or life insurance program of an agency from which an employee was transferred, a transferred employee who is a member of the program may, before the decision takes effect and without regard to any regularly scheduled open season, elect to enroll in the Federal Employees' Group Life Insurance Program established under chapter 87 of title 5, United States Code, without regard to any requirement of insurability.

For any transferred employee, enrollment in a life insurance plan administered by the agency from which the employee transferred, immediately before enrollment in a life insurance plan under chapter 87 of title 5, United States Code, shall be considered as enrollment in a life insurance plan under that chapter for the purpose of 8706(b)(1)(A) of title 5, United States Code.

These provisions allow a transferring employee that participated in an OTS life insurance program that is no longer available at OCC or FDIC to have a special enrollment period for FEGLI. OTS maintained the Office of Thrift Supervision Group Life Insurance Program in which OCC and FDIC did not continue to participate. Therefore, at approximately one year after the transfer date, July 21, 2011, OPM held a special enrollment period for transferred employees participating in Office of Thrift Supervision Group Life Insurance Program to enroll in FEGLI. The special enrollment period began on June 1, 2012 and ended July 29, 2012.

Any employee that enrolled in FEGLI during this special enrollment period will have their time in a life insurance plan administered by OTS credited towards their 5 years of continuous enrollment to continue FEGLI coverage into retirement.

There were other provisions in the Dodd-Frank Act relating to FEGLI coverage discussed in the Notice of Proposed Rulemaking. However, these do not require further changes in FEGLI rulemaking. We received no comments on the proposed rule.

Regulatory Impact Analysis: OPM has examined the impact of this proposed rule as required by Executive Order 12866 and Executive Order 13563, which directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public, health, and safety effects, distributive impacts, and equity). A regulatory impact analysis must be prepared for major rules with economically significant effects of $100 million or more in any one year. This rule is not considered a major rule because OPM expects that this rule will not impose costs of more than $100 million in any one year.

Executive Orders 13563 and 12866, Regulatory Review

This rule has been reviewed by the Office of Management and Budget in accordance with Executive Orders 13563 and 12866.

Federalism

We have examined this rule in accordance with Executive Order 13132, “Federalism,” and have determined that this rule will not have any negative impact on the rights, roles and responsibilities of State, local, or tribal governments.

List of Subjects in 5 CFR Part 870

Administrative practice and procedure, Government employees, Life insurance.

U.S. Office of Personnel Management. Beth F. Cobert, Acting Director.

For the reasons set forth in the preamble, the U.S. Office of Personnel Management amends 5 CFR part 870 as follows:

Title 5—Administrative Personnel PART 870—FEDERAL EMPLOYEES' GROUP LIFE INSURANCE PROGRAM 1. The authority citation for part 870 is revised to read as follows: Authority:

5 U.S.C. 8716; Subpart J also issued under section 599C of Pub. L. 101-513, 104 Stat. 2064, as amended; Sec. 870.302(a)(3)(ii) also issued under section 153 of Pub. L. 104-134, 110 Stat. 1321; Sec. 870.302(a)(3) also issued under sections 11202(f), 11232(e), and 11246(b) and (c) of Pub. L. 105-33, 111 Stat. 251, and section 7(e) of Pub. L. 105-274, 112 Stat. 2419; Sec. 870.302(a)(3) also issued under section 145 of Pub. L. 106-522, 114 Stat. 2472; Secs. 870.302(b)(8), 870.601(a), and 870.602(b) also issued under Pub. L. 110-279, 122 Stat. 2604; Subpart E also issued under 5 U.S.C. 8702(c); Sec. 870.601(d)(3) also issued under 5 U.S.C. 8706(d); Sec. 870.703(e)(1) also issued under section 502 of Pub. L. 110-177, 121 Stat. 2542; Sec. 870.705 also issued under 5 U.S.C. 8714b(c) and 8714c(c); Public Law 104-106, 110 Stat. 521.

2. In § 870.701, add paragraph (f) to read as follows:
§ 870.701 Eligibility for life insurance.

(f) An individual's period of coverage in a life insurance plan is credited to the 5 years of service under paragraph (a)(2) of this section if:

(1) He/she participated in the Office of Thrift Supervision (OTS) life insurance plan and transferred to the Office of the Comptroller of the Currency or the Federal Deposit Insurance Corporation under the Dodd-Frank Wall Street Reform and Consumer Protection Act, Public Law 111-203; and

(2) Elected FEGLI coverage during the special enrollment period between June 1, 2012 and July 29, 2012. Evidence of the non-FEGLI period of continuous coverage will be documented in a manner designated by OPM.

[FR Doc. 2016-21077 Filed 8-31-16; 8:45 am] BILLING CODE 6325-63-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2016-4138; Special Conditions No. 25-635-SC] Special Conditions: Bombardier Inc., Model BD-700-2A12 and BD-700-2A13 Airplanes; Interactions of Systems and Structures AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final special conditions; request for comments.

SUMMARY:

These special conditions are issued for the Bombardier Inc. (Bombardier) Model BD-700-2A12 and BD-700-2A13 airplanes. These airplanes will have novel or unusual features when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. These design features include systems that, directly or as a result of failure or malfunction, affect structural performance. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for these design features. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES:

This action is effective on Bombardier on September 1, 2016. We must receive your comments by October 17, 2016.

ADDRESSES:

Send comments identified by docket number FAA-2016-4138 using any of the following methods:

Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending your comments electronically.

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

Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except federal holidays.

Fax: Fax comments to Docket Operations at 202-493-2251.

Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket Web site, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.

Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to the Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except federal holidays.

FOR FURTHER INFORMATION CONTACT:

Mark Freisthler, FAA, Airframe and Cabin Safety Branch, ANM-115, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-1119; facsimile 425-227-1232.

SUPPLEMENTARY INFORMATION: Comments Invited

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive on or before the closing date for comments. We may change these special conditions based on the comments we receive.

Background

On May 30, 2012, Bombardier applied for an amendment to type certificate no. T00003NY to include the new Model BD-700-2A12 and BD-700-2A13 airplanes. These airplanes are derivatives of the Model BD-700 series of airplanes currently approved under type certificate no. T00003NY, and are marketed as the Bombardier Global 7000 (Model BD-700-2A12) and Global 8000 (Model BD-700-2A13). These airplanes are ultra-long-range, executive-interior business jets.

Type Certification Basis

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.101, Bombardier must show that the Model BD-700-2A12 and BD-700-2A13 airplanes meet the applicable provisions of the regulations listed in type certificate no. T00003NY, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the BD-700-2A12 and BD-700-2A13 airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Model BD-700-2A12 and BD-700-2A13 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.101.

Novel or Unusual Design Features

The Model BD-700-2A12 and BD-700-2A13 airplanes will incorporate the following novel or unusual design features:

Systems that affect the airplane's structural performance, either directly or as a result of failure or malfunction. That is, the airplane's systems affect how it responds in maneuver and gust conditions, and thereby affect its structural capability. These systems may also affect the aeroelastic stability of the airplane. Such systems include flight-control systems, autopilots, stability-augmentation systems, load-alleviation systems, and fuel-management systems. These systems represent novel and unusual features when compared to the technology envisioned in the current airworthiness standards.

Discussion

The flight-control system of the Model BD-700-2A12 and BD-700-2A13 airplanes will consist of a full-authority fly-by-wire system with Normal and Direct modes of operation. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards. Special conditions have been applied on past airplane programs, with similar systems, to require consideration of the effects of those systems on structures.

The regulatory authorities and industry developed standardized criteria in the Aviation Rulemaking Advisory Committee (ARAC) forum based on the criteria defined in Advisory Circular (AC) 25.672-1, dated November 11, 1983. The ARAC recommendations have been incorporated in European Aviation Safety Agency (EASA) Certification Specifications (CS) 25.302 and CS-25 Appendix K. FAA rulemaking on this subject is not complete, thus the need for special conditions.

These special conditions are similar to those previously applied to other airplane models and to EASA CS 25.302. Transport Canada Civil Aviation (TCCA) plans to include CS 25.302 in the Model BD-700-2A12 and BD-700-2A13 airplanes' Canadian certification basis. The differences between these FAA special conditions and the current CS 25.302, which the FAA regards as minor, are shown below. Both these special conditions and CS 25.302:

• Specify the design load conditions to be considered. Special conditions 2(a)(i) and 2(b)(ii)(1) of these special conditions clarify that, in some cases, different load conditions are to be considered due to other special conditions or equivalent-level-of-safety findings.

• allow consideration of the probability of being in a dispatched configuration when assessing subsequent failures and potential “continuation of flight” loads (see special condition 2(d), below). These special conditions, however, also allow using probability when assessing failures that induce loads at the “time of occurrence,” whereas CS 25.302 does not. The FAA provision is relieving as compared to CS 25.302.

The FAA chooses to preserve these minor differences and go forward with this version of the special conditions.

Applicability

As discussed above, these special conditions are applicable to the Model BD-700-2A12 and BD-700-2A13 airplanes. Should Bombardier apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to the other model as well.

Conclusion

This action affects only certain novel or unusual design features on two model series of airplanes. It is not a rule of general applicability.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, the FAA has determined that prior public notice and comment are unnecessary, and good cause exists for adopting these special conditions upon publication in the Federal Register. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and recordkeeping requirements.

The authority citation for these special conditions is as follows: Authority:

49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes.

For airplanes equipped with systems that affect structural performance, either directly or as a result of a failure or malfunction, the influence of these systems and their failure conditions must be taken into account when showing compliance with the requirements of 14 CFR part 25, subparts C and D.

The following criteria must be used for showing compliance with these special conditions for airplanes equipped with flight-control systems, autopilots, stability-augmentation systems, load-alleviation systems, flutter-control systems, fuel-management systems, and other systems that either directly, or as a result of failure or malfunction, affect structural performance. If these special conditions are used for other systems, it may be necessary to adapt the criteria to the specific system.

1. The criteria defined herein only address the direct structural consequences of the system responses and performance. They cannot be considered in isolation, but should be included in the overall safety evaluation of the airplane. These criteria may, in some instances, duplicate standards already established for this evaluation. These criteria are only applicable to structure the failure of which could prevent continued safe flight and landing. Specific criteria that define acceptable limits on handling characteristics or stability requirements, when operating in the system-degraded or inoperative mode, are not provided in these special conditions.

2. Depending upon the specific characteristics of the airplane, additional studies that go beyond the criteria provided in these special conditions may be required to demonstrate the airplane's capability to meet other realistic conditions, such as alternative gust or maneuver descriptions for an airplane equipped with a load-alleviation system.

3. The following definitions are applicable to these special conditions.

a. Structural performance: Capability of the airplane to meet the structural requirements of 14 CFR part 25.

b. Flight limitations: Limitations that can be applied to the airplane flight conditions following an in-flight occurrence, and that are included in the airplane flight manual (e.g., speed limitations, avoidance of severe weather conditions, etc.).

c. Operational limitations: Limitations, including flight limitations, that can be applied to the airplane operating conditions before dispatch (e.g., fuel, payload and master minimum-equipment list limitations).

d. Probabilistic terms: Terms such as probable, improbable, and extremely improbable, as used in these special conditions, are the same as those used in § 25.1309.

e. Failure condition: This term is the same as that used in § 25.1309. However, these special conditions apply only to system-failure conditions that affect the structural performance of the airplane (e.g., system-failure conditions that induce loads, change the response of the airplane to inputs such as gusts or pilot actions, or lower flutter margins).

Effects of Systems on Structures

1. General. The following criteria will be used in determining the influence of a system and its failure conditions on the airplane structure.

2. System fully operative. With the system fully operative, the following apply:

a. Limit loads must be derived in all normal operating configurations of the system from all the limit conditions specified in 14 CFR part 25, subpart C (or defined by special conditions or equivalent level of safety in lieu of those specified in subpart C), taking into account any special behavior of such a system or associated functions, or any effect on the structural performance of the airplane that may occur up to the limit loads. In particular, any significant nonlinearity (rate of displacement of control surface, thresholds, or any other system nonlinearities) must be accounted for in a realistic or conservative way when deriving limit loads from limit conditions.

b. The airplane must meet the strength requirements of 14 CFR part 25 (static strength, residual strength), using the specified factors to derive ultimate loads from the limit loads defined above. The effect of nonlinearities must be investigated beyond limit conditions to ensure that the behavior of the system presents no anomaly compared to the behavior below limit conditions. However, conditions beyond limit conditions need not be considered when it can be shown that the airplane has design features that will not allow it to exceed those limit conditions.

c. The airplane must meet the aeroelastic stability requirements of § 25.629.

3. System in the failure condition. For any system-failure condition not shown to be extremely improbable, the following apply:

a. At the time of occurrence. Starting from 1g level flight conditions, a realistic scenario, including pilot corrective actions, must be established to determine the loads occurring at the time of failure and immediately after the failure.

i. For static-strength substantiation, these loads, multiplied by an appropriate factor of safety that is related to the probability of occurrence of the failure, are ultimate loads to be considered for design. The factor of safety is defined in Figure 1, below.

ER01SE16.128

ii. For residual-strength substantiation, the airplane must be able to withstand two thirds of the ultimate loads defined in special condition 3.a.(i). For pressurized cabins, these loads must be combined with the normal operating differential pressure.

iii. Freedom from aeroelastic instability must be shown up to the speeds defined in § 25.629(b)(2). For failure conditions that result in speeds beyond VC/MC, freedom from aeroelastic instability must be shown to increased speeds, so that the margins intended by § 25.629(b)(2) are maintained.

iv. Failures of the system that result in forced structural vibrations (oscillatory failures) must not produce loads that could result in detrimental deformation of primary structure.

b. For the continuation of the flight. For the airplane in the system-failed state, and considering any appropriate reconfiguration and flight limitations, the following apply:

i. THE loads derived from the following conditions (or used in lieu of the following conditions) at speeds up to VC/MC (or the speed limitation prescribed for the remainder of the flight) must be determined:

1. The limit symmetrical maneuvering conditions specified in §§ 25.331 and 25.345.

2. The limit gust and turbulence conditions specified in §§ 25.341 and 25.345.

3. The limit rolling conditions specified in § 25.349, and the limit unsymmetrical conditions specified in §§ 25.367, and 25.427(b) and (c).

4. The limit yaw-maneuvering conditions specified in § 25.351.

5. The limit ground-loading conditions specified in §§ 25.473 and 25.491.

ii. For static-strength substantiation, each part of the structure must be able to withstand the loads in special condition 3.b.(i), multiplied by a factor of safety depending on the probability of being in this failure state. The factor of safety is defined in Figure 2, below.

ER01SE16.129 Qj = (Tj)(Pj) Where: Qj = Probability of being in failure mode j Tj = Average time spent in failure mode j (in hours) Pj = Probability of occurrence of failure mode j (per hour) Note:

If Pj is greater than 10−3 per flight hour, then a 1.5 factor of safety must be applied to all limit load conditions specified in 14 CFR part 25, subpart C.

iii. For residual-strength substantiation, the airplane must be able to withstand two-thirds of the ultimate loads defined in paragraph 3.b.(ii) of these special conditions. For pressurized cabins, these loads must be combined with the normal operating differential pressure.

iv. If the loads induced by the failure condition have a significant effect on fatigue or damage tolerance, then their effects must be taken into account.

v. Freedom from aeroelastic instability must be shown up to a speed determined from Figure 3, below. Flutter clearance speeds V′ and V″ may be based on the speed limitation specified for the remainder of the flight using the margins defined by § 25.629(b).

ER01SE16.130 V′ = Clearance speed as defined by § 25.629(b)(2). V″ = Clearance speed as defined by § 25.629(b)(1). Qj = (Tj)(Pj) Where: Qj = Probability of being in failure mode j Tj = Average time spent in failure mode j (in hours) Pj = Probability of occurrence of failure mode j (per hour) Note:

If Pj is greater than 10−3 per flight hour, then the flutter clearance speed must not be less than V″.

vi. Freedom from aeroelastic instability must also be shown up to V′ in Figure 3, above, for any probable system-failure condition, combined with any damage required or selected for investigation by § 25.571(b).

b. Consideration of certain failure conditions may be required by other sections of 14 CFR part 25 regardless of calculated system reliability. Where analysis shows the probability of these failure conditions to be less than 10−9, criteria other than those specified in this paragraph may be used for structural substantiation to show continued safe flight and landing.

4. Failure indications. For system-failure detection and indication, the following apply:

a. The system must be checked for failure conditions, not extremely improbable, that degrade the structural capability below the level required by 14 CFR part 25, or that significantly reduce the reliability of the remaining system. As far as reasonably practicable, the flightcrew must be made aware of these failures before flight. Certain elements of the control system, such as mechanical and hydraulic components, may use special periodic inspections, and electronic components may use daily checks, in lieu of detection and indication systems, to achieve the objective of this requirement. These certification-maintenance requirements must be limited to components that are not readily detectable by normal detection-and-indication systems, and where service history shows that inspections will provide an adequate level of safety.

b. The existence of any failure condition, not extremely improbable, during flight, that could significantly affect the structural capability of the airplane, and for which the associated reduction in airworthiness can be minimized by suitable flight limitations, must be signaled to the flightcrew. For example, failure conditions that result in a factor of safety between the airplane strength and the loads of 14 CFR part 25, subpart C below 1.25, or flutter margins below V”, must be signaled to the crew during flight.

5. Dispatch with known failure conditions. If the airplane is to be dispatched in a known system-failure condition that affects structural performance, or that affects the reliability of the remaining system to maintain structural performance, then the provisions of these special conditions must be met, including the provisions of special condition 2 for the dispatched condition, and special condition 3 for subsequent failures. Expected operational limitations may be taken into account in establishing Pj as the probability of failure occurrence for determining the safety margin in Figure 1. Flight limitations and expected operational limitations may be taken into account in establishing Qj as the combined probability of being in the dispatched failure condition and the subsequent failure condition for the safety margins in Figures 2 and 3. These limitations must be such that the probability of being in this combined failure state, and then subsequently encountering limit load conditions, is extremely improbable. No reduction in these safety margins is allowed if the subsequent system-failure rate is greater than 10 3 per hour.

Issued in Renton, Washington, on August 23, 2016. John P. Piccola, Jr., Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-21122 Filed 8-31-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2016-4135; Special Conditions No. 25-636-SC] Special Conditions: Bombardier Aerospace Inc. Model BD-700-2A12 and BD-700-2A13 Airplanes; Sidestick Controllers AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final special conditions; request for comments.

SUMMARY:

These special conditions are issued for the Bombardier Aerospace Inc. (Bombardier) Model BD-700-2A12 and BD-700-2A13 airplanes. These airplanes will have a novel or unusual feature when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. This design feature is a sidestick controller, designed to be operated with only one hand, in lieu of the conventional wheel or stick controls. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES:

This action is effective on Bombardier on September 1, 2016. We must receive your comments by October 17, 2016.

ADDRESSES:

Send comments identified by docket number FAA-2016-4135 using any of the following methods:

Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending your comments electronically.

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

Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Fax: Fax comments to Docket Operations at 202-493-2251.

Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket Web site, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.

Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Todd Martin, FAA, Airframe and Cabin Safety Branch, ANM-115, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-1178; facsimile 425-227-1232.

SUPPLEMENTARY INFORMATION:

Comments Invited

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive on or before the closing date for comments. We may change these special conditions based on the comments we receive.

Background

On May 30, 2012, Bombardier applied for an amendment to type certificate no. T00003NY to include the new Model BD-700-2A12 and BD-700-2A13 airplanes. These airplanes are derivatives of the Model BD-700 series of airplanes currently approved under type certificate no. T00003NY, and are marketed as the Bombardier Global 7000 (Model BD-700-2A12) and Global 8000 (Model BD-700-2A13). These airplanes are ultra-long-range, executive-interior business jets.

Type Certification Basis

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.101, Bombardier must show that the Model BD-700-2A12 and BD-700-2A13 airplanes meet the applicable provisions of the regulations listed in type certificate no. T00003NY, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the BD-700-2A12 and BD-700-2A13 airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Model BD-700-2A12 and BD-700-2A13 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.101.

Novel or Unusual Design Features

The Bombardier Inc. Model BD-700-2A12 and BD-700-2A13 airplanes will have a novel or unusual design feature associated with sidestick controllers designed to be operated with only one hand.

Discussion

The Bombardier Aerospace Model BD-700-2A12 and BD-700-2A13 airplanes are equipped with sidestick controllers instead of the conventional wheel or control stick. This controller is designed to be operated using only one hand. The requirements of § 25.397(c), which define limit pilot forces and torques for conventional wheel or stick controls, are not adequate for sidestick controllers because pilot forces are applied to sidestick controllers with only the wrist, not arms. Special conditions are necessary to specify the appropriate loading conditions for sidestick controllers.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

Applicability

As discussed above, these special conditions are applicable to the Model BD-700-2A12 and BD-700-2A13 airplanes. Should Bombardier apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to the other model as well.

Conclusion

This action affects only certain novel or unusual design features on two model series of airplanes. It is not a rule of general applicability.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, the FAA has determined that prior public notice and comment are unnecessary, and good cause exists for adopting these special conditions upon publication in the Federal Register. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and recordkeeping requirements.

The authority citation for these special conditions is as follows: Authority:

49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes.

In lieu of the pilot forces specified in § 25.397(c), for airplanes equipped with sidestick controls designed for force application by one wrist and not arms, the limit pilot forces are as follows:

1. For all components between and including the handle and its control stops.

Pitch Roll Nose up: 200 pounds force (lbf) Nose left: 100 lbf. Nose down: 200 lbf Nose right: 100 lbf.

2. For all other components of the sidestick control assembly, excluding the internal components of the electrical sensor assemblies, to avoid damage as a result of an in-flight jam.

Pitch Roll Nose up: 125 lbf Nose left: 50 lbf. Nose down: 125 lbf Nose right: 50 lbf.
Issued in Renton, Washington, on August 23, 2016. John P. Piccola, Jr., Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-21123 Filed 8-31-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2015-6363; Special Conditions No. 25-637-SC] Special Conditions: Bombardier Inc. Model BD-700-2A12 and BD-700-2A13 Airplanes; Hydrophobic Coatings in Lieu of Windshield Wipers AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final special conditions; request for comments.

SUMMARY:

These special conditions are issued for the Bombardier Inc. (Bombardier) Model BD-700-2A12 and BD-700-2A13 airplanes. These airplanes will have a novel or unusual feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is hydrophobic coatings in lieu of windshield wipers. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for these design features. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES:

This action is effective on Bombardier on September 1, 2016. We must receive your comments by October 17, 2016.

ADDRESSES:

Send comments identified by docket number FAA-2015-6363 using any of the following methods:

Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending your comments electronically.

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

Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Fax: Fax comments to Docket Operations at 202-493-2251.

Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket Web site, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.

Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Bob Hettman, FAA, Propulsion and Mechanical Systems Branch, ANM-112, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington, 98057-3356; telephone 425-227-2683; facsimile 425-227-1232.

SUPPLEMENTARY INFORMATION:

Comments Invited

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive on or before the closing date for comments. We may change these special conditions based on the comments we receive.

Background

On May 30, 2012, Bombardier applied for an amendment to type certificate no. T00003NY to include the new Model BD-700-2A12 and BD-700-2A13 airplanes. These airplanes are derivatives of the Model BD-700 series of airplanes currently approved under type certificate no. T00003NY, and are marketed as the Bombardier Global 7000 (Model BD-700-2A12) and Global 8000 (Model BD-700-2A13). These airplanes are ultra-long-range, executive-interior business jets.

Type Certification Basis

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.101, Bombardier must show that the Model BD-700-2A12 and BD-700-2A13 airplanes meet the applicable provisions of the regulations listed in type certificate no. T00003NY, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the BD-700-2A12 and BD-700-2A13 airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Model BD-700-2A12 and BD-700-2A13 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.101.

Novel or Unusual Design Features

The Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes will have a novel or unusual design feature associated with flightdeck design, which incorporates a hydrophobic windshield coating to provide adequate pilot compartment view in the presence of precipitation. Sole reliance on such a coating, without windshield wipers, constitutes a novel or unusual design feature for which the applicable airworthiness regulations do not contain adequate or appropriate safety standards.

Discussion

14 CFR 25.773(b)(1) requires a means to maintain a sufficiently clear portion of the windshield for both pilots to have an extensive view along the flight path during precipitation conditions. The regulations require this means to maintain such an area during precipitation in heavy rain at speeds up to 1.5 VSR1. Hydrophobic windshield coatings may depend to some degree on airflow to maintain a clear vision area. The heavy rain and high speed conditions specified in the current rule do not necessarily represent the limiting condition for this new technology. For example, airflow over the windshield, which may be necessary to remove moisture from the windshield, may not be adequate to maintain a sufficiently clear area of the windshield in low-speed flight or during surface operations. Alternatively, airflow over the windshield may be disturbed during such critical times as the approach to land, where the airplane is at a higher-than-normal pitch attitude. In these cases, areas of airflow disturbance or separation on the windshield could cause a failure to maintain a clear vision area on the windshield.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

Applicability

As discussed above, these special conditions are applicable to the Model BD-700-2A12 and BD-700-2A13 airplanes. Should Bombardier apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to the other model as well.

Conclusion

This action affects only certain novel or unusual design features on two model series of airplanes. It is not a rule of general applicability.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, the FAA has determined that prior public notice and comment are unnecessary, and good cause exists for adopting these special conditions upon publication in the Federal Register. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and recordkeeping requirements.

The authority citation for these special conditions is as follows: Authority:

49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes.

1. In addition to meeting the requirements of § 25.773(b)(1), the airplane must have a means to maintain a clear portion of the windshield, during precipitation conditions, such that both pilots to have a sufficiently extensive view along the ground or flight path in taxi and flight. This means must be designed to function, without continuous attention on the part of the crew, in conditions from light misting precipitation to heavy rain, at speeds from fully stopped in still air to 1.5 VSR1 with lift and drag devices retracted, and in icing conditions specified in § 25.1419 if certification for flight in icing conditions is requested.

2. The precipitation removal system must comply with § 25.773.

3. Instructions to maintain the precipitation-removal system must comply with § 25.1529.

4. The materials used in the precipitation removal system must comply with § 25.603.

Issued in Renton, Washington, on August 23, 2016. John P. Piccola, Jr., Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-21079 Filed 8-31-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-7048; Directorate Identifier 2016-CE-014-AD; Amendment 39-18635; AD 2016-18-05] RIN 2120-AA64 Airworthiness Directives; PILATUS AIRCRAFT LTD. Airplanes AGENCY:

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

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for PILATUS AIRCRAFT LTD. Models PC-12, PC-12/45, PC-12/47, and PC-12/47E airplanes installed with an affected engine mounting frame assembly. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as longitudinal material separation on the internal surface of the engine mounting frame assembly tubes. We are issuing this AD to detect and correct this condition, which could lead to partial or complete failure of the structural joint and possibly result in in-flight detachment of the engine with consequent loss of control.

DATES:

This AD is effective October 6, 2016.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in the AD as of October 6, 2016.

ADDRESSES:

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-7048; or in person at Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

For service information identified in this AD, contact Pilatus Aircraft Ltd., Customer Support PC-12, CH-6371 Stans, Switzerland; phone: +41 41 619 33 33; fax: +41 41 619 73 11; email: [email protected]; Internet: www.pilatus-aircraft.com. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the Internet at http://www.regulations.gov by searching for Docket No. FAA-2016-7048.

FOR FURTHER INFORMATION CONTACT:

Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4059; fax: (816) 329-4090; email: [email protected]

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to PILATUS AIRCRAFT LTD. Models PC-12, PC-12/45, PC-12/47, and PC-12/47E airplanes installed with an affected engine mounting frame assembly. The NPRM was published in the Federal Register on June 13, 2016 (81 FR 38115). The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states:

The PC-12 Engine Mounting Frame Assembly (hereafter referred to as “EMF” in this AD), Part Number (P/N) 571.20.12.036, is a welded structure including three special tubes, P/N 571.20.12.073, P/N 571.20.12.074 and P/N 571.20.12.107, the ends of which are subject to a special swaging process during manufacturing. Longitudinal material separation on the internal surface of the special tubes was detected on few EMFs on new production aeroplanes. Investigations identified the root cause to be an incorrect accomplishment of the swaging process.

This condition, if not detected and corrected, could lead to growth of the material separation and subsequent partial or complete failure of the structural joint, possibly resulting in in-flight detachment of the engine and consequent reduced control, or loss of control, of the aeroplane.

To address this potential unsafe condition, Pilatus issued Service Bulletin (SB) No. 71-009, now at Revision 2 (hereafter referred to as “the SB” in this AD), to provide inspection instructions for the affected EMF to detect indications of material separation.

For the reason described above, this AD requires identification and inspection of the affected EMF and, depending on the findings, their replacement with serviceable EMF.

The MCAI can be found in the AD docket on the Internet at: https://www.regulations.gov/document?D=FAA-2016-7048-0002.

Comments

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (81 FR 38115, June 13, 2016) or on the determination of the cost to the public.

Conclusion

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

• Are consistent with the intent that was proposed in the NPRM (81 FR 38115, June 13, 2016) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (81 FR 38115, June 13, 2016).

Related Service Information Under 1 CFR Part 51

We reviewed PILATUS AIRCRAFT LTD. PILATUS PC-12 Service Bulletin No: 71-009, Reference No: 345, Modification No: EC-15-0632, Revision 2, dated March 18, 2016; Pilatus Powerplant Mounting Frame, Removal/Installation, Date module/Technical publication 12-A-71-00-05-00A-920A-A, dated February 26, 2010, found in Pilatus Model type-PC-12, PC-12/45, PC-12/47 MSN-101-888 Aircraft Maintenance Manual (AMM), Document No. 02049, 12-A-AM-00-00-00-I; and Pilatus Powerplant Mounting Frame, Removal/Installation, Date module/Technical publication 12-B-71-00-05-00A-920A-A, dated October 4, 2010, found in Pilatus Model type-PC-12/47E MSN-1001-UP Aircraft Maintenance Manual (AMM), Document No. 02300, 12-B-AM-00-00-00-I. The service information describes procedures for determining if an affected engine mounting frame assembly (EMF) is installed, inspecting the EMF, and replacing the EMF with a serviceable EMF. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this AD.

Costs of Compliance

We estimate that this AD will affect 888 products of U.S. registry. We also estimate that it would take about 3 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $226,440, or $255 per product.

In addition, we estimate that any necessary follow-on actions would cost the following amounts. We have no way of determining the number of products that may need these actions.

The visual and eddy current inspections would take about 3 work-hours for a cost of $255 per product.

The replacement of the EMF would take about 90 work-hours and require parts costing $33,336, for a cost of $40,986 per product.

According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

Authority for This Rulemaking

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

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

Regulatory Findings

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

For the reasons discussed above, I certify this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

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

(3) Will not affect intrastate aviation in Alaska, and

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

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-7048; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new AD: 2016-18-05 PILATUS AIRCRAFT LTD.: Amendment 39-18635; Docket No. FAA-2016-7048; Directorate Identifier 2016-CE-014-AD. (a) Effective Date

This airworthiness directive (AD) becomes effective October 6, 2016.

(b) Affected ADs

None.

(c) Applicability

This AD applies to PILATUS AIRCRAFT LTD. Models PC-12, PC-12/45, PC-12/47, and PC-12/47E airplanes, all serial numbers, that are:

(1) Installed with an affected serial number engine mounting frame assembly (EMF), part number (P/N) 571.20.12.036, listed in figure 1 of paragraph (c)(1) of this AD; and

Figure 1 to Paragraph (c)(1) of this AD: EMF P/N 571.20.12.036, Affected Serial Numbers 0001 through 1200 inclusive. 1202 through 1272 inclusive. 1275 through 1323 inclusive. 1325 through 1328 inclusive. 1334 through 1338 inclusive. 1340 and 1342. 1344 through 1346 inclusive. 1348 and 1349. 1358, 1361, and 1365.

(2) Certificated in any category.

(d) Subject

Air Transport Association of America (ATA) Code 71: Power Plant.

(e) Reason

This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as longitudinal material separation on the internal surface of the engine mounting frame assembly tubes (EMF). We are issuing this AD to detect and correct material separation on the internal surface of the engine mounting frame assembly tubes, which could lead to partial or complete failure of the structural joint and possibly result in in-flight detachment of the engine with consequent loss of control.

(f) Actions and Compliance

Do the actions in paragraphs (f)(1) through (7) of this AD. If paragraphs (f)(1) through (6) of this AD have already been done before October 6, 2016 (the effective date of this AD), then only paragraph (f)(7) of this AD applies.

(1) Within the compliance time identified in figure 2 of paragraph (f)(1) of this AD, do an ultrasonic inspection of the swaged engine mounting tube ends of the affected EMF following the instructions of paragraph 3.B.(1) of PILATUS AIRCRAFT LTD PILATUS PC-12 Service Bulletin No: 71-009, Reference No: 345, Modification No: EC-15-0632, Revision 2, dated March 18, 2016.

Figure 2 to Paragraph (f)(1) of This AD: Initial Compliance Time A or B, Whichever Occurs Later A Before the EMF exceeds 11,000 hours time-in-service (TIS) or 13,500 flight cycles (FC), whichever occurs first since first installation of the EMF on an airplane. B Within 1,000 hours TIS or 1,000 FC or 6 months, whichever occurs first after October 6, 2016 (the effective date of this AD).

(2) If an indication with an echo of less than 40 percent full screen height is detected on an EMF during the ultrasonic inspection required in paragraph (f)(1) of this AD, except for paragraph (f)(7), no further actions are required for this AD. Document compliance with this AD in the maintenance records.

(3) If an indication with an echo of 40 percent full screen height or more is detected on an EMF during the ultrasonic inspection required in paragraph (f)(1) of this AD, do the actions in paragraphs (f)(3)(i) through (iii) of this AD, as applicable.

(i) Before further flight and repetitively thereafter at intervals not to exceed 600 hours TIS or 12 months, whichever occurs first, do a visual inspection of the welding and do an eddy current inspection of the tubes at the indication point detected during the ultrasonic inspection. Use the instructions of paragraphs 3.B.(2) and 3.B.(3) of PILATUS AIRCRAFT LTD PILATUS PC-12 Service Bulletin No: 71-009, Reference No: 345, Modification No: EC-15-0632, Revision 2, dated March 18, 2016.

(ii) If any cracks are found during any of the visual inspections or if an indication with a signal of 20 percent or more is detected during any of the eddy current inspections required in paragraph (f)(3)(i) of this AD, before further flight, replace the EMF with a serviceable EMF following the instructions in the service information listed in paragraph (f)(5) of this AD, including all subparagraphs as applicable.

(iii) Unless already done as required by paragraph (f)(3)(ii) of this AD, with>in 1,800 hours TIS or 36 months after the initial visual and eddy current inspections of the affected EMF required by paragraph (f)(3)(i) of this AD, whichever occurs first, replace the EMF with a serviceable EMF following the instructions in the service information listed in paragraph (f)(5) of this AD, including all subparagraphs as applicable.

(4) For the purpose of this AD, a serviceable EMF is defined as any EMF that is not listed in figure 1 of paragraph (c)(1) of this AD or an affected EMF that is listed in figure 1 of paragraph (c)(1) of this AD but has had the ultrasonic inspection required in paragraph (f)(1) of this AD and had an indication with an echo of less than 40 percent full screen height.

(5) For replacement of the EMF, follow the instructions listed in paragraphs (f)(5)(i) and (ii), as applicable.

(i) For Models PC-12, PC-12/45, and PC-12/47, manufacturer serial numbers (MSN) 101-888: Pilatus Powerplant Mounting Frame, Removal/Installation, Date module/Technical publication 12-A-71-00-05-00A-920A-A, dated February 26, 2010, found in Pilatus Model type-PC-12, PC-12/45, PC-12/47 MSN-101-888 Aircraft Maintenance Manual (AMM), Document No. 02049, 12-A-AM-00-00-00-I.

(ii) For Model PC-12/47E, MSN 1001 and up: Pilatus Powerplant Mounting Frame, Removal/Installation, Date module/Technical publication 12-B-71-00-05-00A-920A-A, dated October 4, 2010, found in Pilatus Model type-PC-12/47E MSN-1001-UP Aircraft Maintenance Manual (AMM), Document No. 02300, 12-B-AM-00-00-00-I.

(6) If an EMF has an indication with an echo of 40 percent or more during the ultrasonic inspection required in paragraph (f)(1) of this AD, you may replace the EMF with a serviceable EMF in lieu of the visual or eddy current inspections required in paragraph (f)(3)(i) of this AD. For replacement of the EMF, follow the instructions in the service information listed in paragraph (f)(5) of this AD, including all subparagraphs as applicable.

(7) As of October 6, 2016 (the effective date of this AD), do not install an EMF P/N 571.20.12.036 unless it has been determined to be a serviceable EMF as specified in paragraph (f)(4) of this AD.

(8) Airplanes with an MSN of 1556 or higher are not affected by this AD provided that the EMF has not been replaced since its manufacture. A review of the maintenance records, Airworthiness Approval Tag (FAA Form 8130-3), or other positive form of parts identification such as a shipping ticket, invoice, or direct ship authority letter, can be used to determine the serial number of the EMF.

(g) Other FAA AD Provisions

The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4059; fax: (816) 329-4090; email: [email protected] Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.

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

(h) Related Information

(1) Refer to MCAI European Aviation Safety Agency (EASA) AD No. 2016-0081, dated April 25, 2016, for related information pertaining to this AD. The MCAI can be found in the AD docket on the Internet at: https://www.regulations.gov/document?D=FAA-2016-7048-0002.

(i) Material Incorporated by Reference

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

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

(i) PILATUS PC-12 Service Bulletin No: 71-009, Reference No: 345, Modification No: EC-15-0632, Revision 2, dated March 18, 2016;

(ii) Pilatus Powerplant Mounting Frame, Removal/Installation, Date module/Technical publication 12-A-71-00-05-00A-920A-A, dated February 26, 2010, found in Pilatus Model type-PC-12, PC-12/45, PC-12/47 MSN-101-888 Aircraft Maintenance Manual (AMM), Document No. 02049, 12-A-AM-00-00-00-I; and

(iii) Pilatus Powerplant Mounting Frame, Removal/Installation, Date module/Technical publication 12-B-71-00-05-00A-920A-A, dated October 4, 2010, found in Pilatus Model type- PC-12/47E MSN-1001-UP Aircraft Maintenance Manual (AMM), Document No. 02300, 12-B-AM-00-00-00-I.

(3) For service information identified in this AD, contact Pilatus Aircraft Ltd., Customer Support PC-12, CH-6371 Stans, Switzerland; phone: +41 41 619 33 33; fax: +41 41 619 73 11; email: [email protected]; Internet: www.pilatus-aircraft.com.

(4) You may view this service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. In addition, you can access this service information on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-7048.

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

Issued in Kansas City, Missouri, on August 23, 2016. David R. Showers, Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-20833 Filed 8-31-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5460; Directorate Identifier 2015-NM-188-AD; Amendment 39-18599; AD 2016-16-01] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule; correction.

SUMMARY:

The FAA is correcting an airworthiness directive (AD) that published in the Federal Register. That AD applies to certain Airbus Model A330-200 Freighter, -200, and -300 series airplanes. Paragraphs (i) and (l) of the regulatory text contain typographical errors in the service bulletin number. This document corrects those errors. In all other respects, the original document remains the same.

DATES:

This final rule is effective September 8, 2016.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of September 8, 2016 (81 FR 51325, August 4, 2016).

ADDRESSES:

For service information identified in this final rule, contact Airbus SAS, Airworthiness Office-EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email: [email protected]; Internet: http://www.airbus.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5460.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone: 425-227-1138; fax: 425-227-1149.

SUPPLEMENTARY INFORMATION:

Airworthiness Directive 2016-16-01, Amendment 39-18599 (81 FR 51325, August 4, 2016) (“AD 2016-16-01”), currently requires an inspection of affected structural parts in the cargo and cabin compartments to determine if proper heat treatment has been done, and replacement if necessary, for certain Airbus Model A330-200 Freighter, -200, and -300 series airplanes.

Need for the Correction

As published, paragraphs (i) and (l) of the regulatory text identify the service information by the wrong service bulletin number. Where paragraphs (i) and (l) incorrectly specify Airbus Service Bulletins “A320-53-3227” and “A320-53-3228,” the correct service bulletin numbers are “A330-53-3227” and “A330-53-3228,” respectively.

Related Service Information Under 1 CFR Part 51

Airbus has issued the following service information:

• Airbus Service Bulletin A330-53-3227, dated August 18, 2015. The service information describes procedures to inspect affected structural parts in the cargo compartment to determine if proper heat treatment has been done, and replacement of parts; and

• Airbus Service Bulletin A330-53-3228, dated August 18, 2015. The service information describes procedures to inspect affected structural parts in the cabin compartment to determine if proper heat treatment has been done, and replacement of parts.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Correction of Publication

This document corrects two errors and correctly adds the AD as an amendment to 14 CFR 39.13. Although no other part of the preamble or regulatory information has been corrected, we are publishing the entire rule in the Federal Register.

The effective date of this AD remains September 8, 2016.

Since this action only corrects a typographical error in two locations, it has no adverse economic impact and imposes no additional burden on any person. Therefore, we have determined that notice and public procedures are unnecessary.

List of Subjects in 14 CFR Part 39

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

Adoption of the Correction

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

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

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

§ 39.13 [Corrected]
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2016-16-01 Airbus: Amendment 39-18599; Docket No. FAA-2016-5460; Directorate Identifier 2015-NM-188-AD. (a) Effective Date

This AD becomes effective on September 8, 2016.

(b) Affected ADs

None.

(c) Applicability

This AD applies to the Airbus airplanes identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD, certificated in any category, manufacturer serial numbers 1175, 1180, 1287 through 1475 inclusive, 1478, 1480, 1483, and 1506.

(1) Model A330-223F and -243F airplanes.

(2) Model A330-201, -202, -203, -223, and -243 airplanes.

(3) Model A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.

(d) Subject

Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

This AD was prompted by a report of a manufacturing defect (i.e., improperly heat-treated materials) that affects the durability of affected parts in the cargo and cabin compartments. We are issuing this AD to prevent crack initiation and propagation, which could result in reduced structural integrity of the fuselage.

(f) Compliance

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

(g) Inspection of Affected Structure in the Cargo Compartment

Within 72 months since first flight of the airplane, do an eddy current inspection (i.e., conductivity measurement) of affected structural parts in the cargo compartment to determine if proper heat treatment has been done as identified in, and in accordance with, the Accomplishment Instructions of Airbus Service Bulletin A330-53-3227, dated August 18, 2015.

(h) Replacement of Non-Conforming Parts in the Cargo Compartment

If, during the inspection required by paragraph (g) of this AD, an affected structural part in the cargo compartment is identified to have a measured value greater than 26 megasiemens per meter (MS/m), or greater than 44.8% International Annealed Copper Standard (IACS), before further flight, replace the affected structural part with a serviceable part, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-53-3227, dated August 18, 2015.

(i) Repair of Non-Conforming Parts in the Cargo Compartment

If, during the inspection required by paragraph (g) of this AD, an affected structural part in the cargo compartment is identified to have a measured value other than those specified in Figure A-GFAAA, Sheet 01, “Inspection Flowchart,” of Airbus Service Bulletin A330-53-3227, dated August 18, 2015, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).

(j) Inspection of Affected Structure in the Cabin Compartment

Within 72 months since first flight of the airplane, do an eddy current inspection of affected structural parts in the cabin compartment to determine if proper heat treatment has been done as identified in, and in accordance with, the Accomplishment Instructions of Airbus Service Bulletin A330-53-3228, dated August 18, 2015.

(k) Replacement of Non-Conforming Parts in the Cabin Compartment

If, during the inspection required by paragraph (j) of this AD, an affected structural part in the cabin compartment is identified to have a measured value greater than 26 MS/m or greater than 44.8% IACS, before further flight, replace the affected structural part with a serviceable part, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-53-3228, dated August 18, 2015.

(l) Repair of Non-Conforming Parts in the Cabin Compartment

If, during the inspection required by paragraph (j) of this AD, an affected structural part in the cabin compartment is identified to have a measured value other than those specified in Figure A-GFAAA, Sheet 01, “Inspection Flowchart,” of Airbus Service Bulletin A330-53-3228, dated August 18, 2015, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA; or Airbus's EASA DOA.

(m) Other FAA AD Provisions

The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone: 425-227-1138; fax: 425-227-1149. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

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

(3) Required for Compliance (RC): If any service information contains procedures or tests that are identified as RC, those procedures and tests must be done to comply with this AD; any procedures or tests that are not identified as RC are recommended. Those procedures and tests that are not identified as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the procedures and tests identified as RC can be done and the airplane can be put back in an airworthy condition. Any substitutions or changes to procedures or tests identified as RC require approval of an AMOC.

(n) Related Information

Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2015-0212, dated November 4, 2015, for related information. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5460.

(o) Material Incorporated by Reference

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

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

(3) The following service information was approved for IBR on September 8, 2016 (81 FR 51325, August 4, 2016).

(i) Airbus Service Bulletin A330-53-3227, dated August 18, 2015.

(ii) Airbus Service Bulletin A330-53-3228, dated August 18, 2015.

(4) For service information identified in this AD, contact Airbus SAS, Airworthiness Office-EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email: [email protected]; Internet: http://www.airbus.com.

(5) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

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

Issued in Renton, Washington, on August 24, 2016. John P. Piccola, Jr., Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-20991 Filed 8-31-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-3702; Directorate Identifier 2015-NM-103-AD; Amendment 39-18634; AD 2016-18-04] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

We are superseding Airworthiness Directive (AD) 2013-24-12 for all The Boeing Company Model 747-8 and 747-8F airplanes. AD 2013-24-12 required repetitive ultrasonic or dye penetrant inspections for cracking of the barrel nuts and bolts on each forward engine mount, and related investigative and corrective actions if necessary. This new AD retains the requirements of AD 2013-24-12 and also requires installing new barrel nuts at the forward engine mounts; or identifying the part number of the barrel nuts, inspecting affected barrel nuts for gaps of the strut bulkhead and forward engine mount, and doing related investigative and corrective actions if necessary. This new AD also removes airplanes from the applicability. This new AD also requires revising the maintenance or inspection program, as applicable, to include a new structurally significant item. This AD was prompted by our determination that it is necessary to mandate the installation of new barrel nuts or new inspections to adequately address the unsafe condition. We are issuing this AD to detect and correct cracked barrel nuts on a forward engine mount, which could result in reduced load capacity of the forward engine mount, separation of an engine under power from the airplane, and consequent loss of control of the airplane.

DATES:

This AD is effective October 6, 2016.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of October 6, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of December 17, 2013 (78 FR 71989, December 2, 2013).

ADDRESSES:

For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-3702.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-3702; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Nathan Weigand, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6428; fax: 425-917-6590; email: [email protected]

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2013-24-12, Amendment 39-17686 (78 FR 71989, December 2, 2013) (“AD 2013-24-12”). AD 2013-24-12 applied to all The Boeing Company Model 747-8 and 747-8F airplanes. The NPRM published in the Federal Register on February 25, 2016 (81 FR 9370) (“the NPRM”). The NPRM was prompted by our determination that it is necessary to mandate the installation of new barrel nuts or new inspections to adequately address the unsafe condition. The NPRM proposed to retain the requirements of AD 2013-24-12 and also require installing new barrel nuts at the forward engine mounts; or identifying the part number of the barrel nuts, inspecting affected barrel nuts for gaps of the strut bulkhead and forward engine mount, and doing related investigative and corrective actions if necessary. The NPRM also proposed to remove airplanes from the applicability. The NPRM also proposed to require revising the maintenance or inspection program, as applicable, to include a new structurally significant item. We are issuing this AD to detect and correct cracked barrel nuts on a forward engine mount, which could result in reduced load capacity of the forward engine mount, separation of an engine under power from the airplane, and consequent loss of control of the airplane.

Comments

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

Support for the NPRM

Boeing stated that it supports the NPRM.

Request To Revise Applicability

The Civil Aviation Administration of China (CAAC) requested that we revise the applicability of the proposed AD to ensure that all necessary actions are applied on all applicable airplanes. CAAC explained that it compared the effectivity between Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015, which is referred to in the applicability of the proposed AD, and Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015 (which is referred to as the appropriate source of service information for doing the actions specified in paragraph (k) of the proposed AD). CAAC explained that there are more airplanes in Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015, than in Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015.

We agree to clarify and revise the applicability of this AD. The difference in effectivity between Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015, and Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015, is that there are six additional airplanes in Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015—four of these airplanes are foreign-registered, and the other two airplanes have not been delivered yet. We have revised paragraph (c) of this AD to refer to Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015. We have also revised paragraph (g) of this AD to specify that only airplanes identified in Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015, are affected by that paragraph.

Request for Explanation of Change in Applicability From AD 2013-24-12

The CAAC requested that we explain the change in the applicability paragraph of the proposed AD from that of AD 2013-24-12. The CAAC explained that the applicability paragraph of AD 2013-24-12 applies to all The Boeing Company Model 747-8 and 747-8F series airplanes. The CAAC stated that the NPRM would retain the requirements of AD 2013-24-12, but the applicability paragraph of the proposed AD only applies to The Boeing Company Model 747-8 and 747-8F airplanes identified in Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015.

We agree to clarify. AD 2013-24-12 was issued as an interim action. Boeing developed Boeing Special Attention Service Bulletin 747-71-2332, dated September 27, 2013 (currently at Revision 1, dated May 28, 2015), which contains a newly designed barrel nut. The effectivity in Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015, identifies the airplanes that did not have the newly designed barrel nuts installed upon delivery. Because this AD does not include airplanes that have the newly designed barrel nuts installed during production, the applicability of AD 2013-24-12 was reduced. No changes have been made to this AD in this regard.

Conclusion

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

We reviewed the following service information:

• Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015. The service information describes procedures for inspecting for cracked bolts and barrel nuts on the forward engine mounts, replacing cracked bolts and barrel nuts, and sending the inspection results and cracked parts to Boeing.

• Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015. The service information describes procedures for installing new barrel nuts, inspecting the barrel nuts at the forward engine mount to determine the part number, inspecting for gaps of the strut bulkhead and forward engine mount, and doing applicable related investigative and corrective actions.

• Boeing 747-8/-8F Airworthiness Limitations (AWLs), Document Number D011U721-02-01, dated September 2015, which includes a limitation for Structurally Significant Item (SSI) 54-50-003c. The service information describes procedures for structural inspections.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

We estimate that this AD affects 7 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

Estimated Costs Action Labor cost Parts cost Cost per product Cost on
  • U.S. operators
  • Inspections (retained actions from AD 2013-24-12) Up to 24 work-hours × $85 per hour = $2,040 per inspection cycle $0 Up to $2,040 per inspection cycle Up to $14,280 per inspection cycle. Installation (new action) 17 work-hours × $85 per hour = $1,445 6,384 7,829 Up to $54,803. Inspections (new alternative actions) 4 work-hours × $85 per hour = $340 0 340 Up to $2,380. Maintenance program revision (new requirement) 1 work-hour × $85 per hour = $85 0 85 595.

    We have received no definitive data that would enable us to provide cost estimates for the bootstrap installation specified in this AD. We estimate the following costs to do other necessary related investigative and corrective actions that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need these actions:

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Ultrasonic inspection 5 work-hours × $85 per hour = $425 $0 $425

    According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

    Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

    (1) Is not a “significant regulatory action” under Executive Order 12866,

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

    (3) Will not affect intrastate aviation in Alaska, and

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by removing Airworthiness Directive (AD) 2013-24-12, Amendment 39-17686 (78 FR 71989, December 2, 2013), and adding the following new AD: 2016-18-04 The Boeing Company: Amendment 39-18634; Docket No. FAA-2016-3702; Directorate Identifier 2015-NM-103-AD. (a) Effective Date

    This AD is effective October 6, 2016.

    (b) Affected ADs

    This AD replaces AD 2013-24-12, Amendment 39-17686 (78 FR 71989, December 2, 2013) (“AD 2013-24-12”).

    (c) Applicability

    This AD applies to The Boeing Company Model 747-8 and 747-8F airplanes, certificated in any category, as identified in Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015.

    (d) Subject

    Air Transport Association (ATA) of America Code 71, Powerplant.

    (e) Unsafe Condition

    This AD was prompted by a report of cracked barrel nuts found on a forward engine mount, and by the determination that additional actions are necessary to address the unsafe condition. We are issuing this AD to detect and correct cracked barrel nuts on a forward engine mount, which could result in reduced load capacity of the forward engine mount, separation of an engine under power from the airplane, and consequent loss of control of the airplane.

    (f) Compliance

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

    (g) Retained Repetitive Inspections and Corrective Actions, With Revised Service Information

    This paragraph restates the actions required by paragraph (g) of AD 2013-24-12, with revised service information. For airplanes identified in Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015: Except as required by paragraph (h)(1) of this AD, at the time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-71A2329, dated September 27, 2013, do the inspection specified in paragraph (g)(1) or (g)(2) of this AD, and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-71A2329, dated September 27, 2013; or Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015. Do all applicable related investigative and corrective actions before further flight. Repeat the inspection thereafter at the times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-71A2329, dated September 27, 2013. As of the effective date of this AD, use only Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015.

    (1) Ultrasonic inspection for cracking of the barrel nuts on each forward engine mount, except as required by paragraph (h)(2) of this AD.

    (2) Dye penetrant inspection for cracking of the bolts and barrel nuts. Whenever a dye penetrant inspection is done, all the bolts and barrel nuts on that engine mount must be removed and replaced with new or serviceable parts.

    (h) Retained Exceptions to Service Information Specifications, With Revised Service Information References

    (1) Where Boeing Alert Service Bulletin 747-71A2329, dated September 27, 2013; or Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015; specify a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specified compliance time after December 17, 2013 (the effective date of AD 2013-24-12).

    (2) Where Appendix B of Boeing Alert Service Bulletin 747-71A2329, dated September 27, 2013, and Appendix B of Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015, state that alternate instruments and transducers can be used, this AD requires that only equivalent instruments and transducers can be used.

    (3) Where Appendix A of Boeing Alert Service Bulletin 747-71A2329, dated September 27, 2013, and Appendix A of Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015, state to record flight hours and flight cycles, record the flight hours and flight cycles on the airplane and the flight hours and flight cycles for each engine since change or removal.

    (i) Retained Reporting and Sending Parts, With Revised Service Information

    After any inspection required by paragraph (g) of this AD: Submit a report of the inspection results (both positive and negative), and return all cracked bolts and barrel nuts, at the applicable time specified in paragraph (i)(1) or (i)(2) of this AD. The report must include the information requested in Appendix A of Boeing Alert Service Bulletin 747-71A2329, dated September 27, 2013, or Appendix A of Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015, except as required by paragraph (h)(3) of this AD. Both the report and all cracked bolts and barrel nuts must be sent to the address specified in Appendix A of Boeing Alert Service Bulletin 747-71A2329, dated September 27, 2013, or Appendix A of Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015.

    (1) For airplanes on which an ultrasonic inspection was done and no cracking was found, do the required actions at the time specified in paragraph (i)(1)(i) or (i)(1)(ii) of this AD, as applicable.

    (i) If the inspection was done on or after December 17, 2013 (the effective date of AD 2013-24-12): Submit the report within 10 days after the inspection.

    (ii) If the inspection was done before December 17, 2013 (the effective date of AD 2013-24-12): Submit the report within 10 days after December 17, 2013 (the effective date of AD 2013-24-12).

    (2) For airplanes on which a dye penetrant inspection was done, do the required actions at the time specified in paragraph (i)(2)(i) or (i)(2)(ii) of this AD, as applicable.

    (i) If the inspection was done on or after December 17, 2013 (the effective date of AD 2013-24-12): Submit the report and return all cracked bolts and barrel nuts within 10 days after replacing the bolts and barrel nuts with new or serviceable bolts and barrel nuts in accordance with Part 2 of the Accomplishment Instructions of Boeing Alert Service Bulletin 747-71A2329, dated September 27, 2013; or Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015.

    (ii) If the inspection was done before December 17, 2013 (the effective date of AD 2013-24-12): Submit the report and return all cracked bolts and barrel nuts within 10 days after December 17, 2013 (the effective date of AD 2013-24-12).

    (j) Retained Paperwork Reduction Act Burden Statement, With No Changes

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

    (k) New Installation or Inspections

    At the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015, except as required by paragraph (o)(1) of this AD: Do the actions specified in paragraph (k)(1) or (k)(2) of this AD, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015, except as required by paragraph (o)(2) of this AD.

    (1) Install new barrel nuts using the bootstrap installation method identified in Part 1 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015.

    (2) Do a general visual inspection to determine the part number (P/N) of the barrel nuts at the forward engine mount. If any barrel nut P/N SL4081C14SP1 is installed, before further flight, do a general visual inspection for gaps of the strut bulkhead and forward engine mount to determine if the nut-by-nut method identified in Part 4 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015, can be used, and do all applicable related investigative and corrective actions. Do all applicable related investigative and corrective actions before further flight, including the nut-by-nut replacement identified in Part 4 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015. If the nut-by-nut replacement identified in Part 4 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015, cannot be accomplished, install new nuts, in accordance with paragraph (k)(1) of this AD.

    (l) Maintenance or Inspection Program Revision

    Within 30 days after accomplishment of the actions required by paragraph (k) of this AD, or within 30 days after the effective date of this AD, whichever occurs later: Revise the maintenance or inspection program, as applicable, to incorporate Structurally Significant Item (SSI) 54-50-003c specified in Boeing 747-8/-8F Airworthiness Limitations (AWLs), Document Number D011U721-02-01, dated September 2015.

    (m) Terminating Action

    Accomplishment of the actions required by paragraphs (k) and (l) of this AD terminate the requirements of paragraphs (g) and (i) of this AD.

    (n) Parts Installation Prohibition

    As of the effective date of this AD, no person may install or reinstall any barrel nut P/N SL4081C14SP1 at the forward engine mount assembly on any airplane; and only P/N SL4750NA may be installed.

    (o) New Exceptions to Service Information Specifications

    (1) Where Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015, specifies a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.

    (2) Where Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015, specifies to contact Boeing for appropriate action: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (r) of this AD.

    (p) No Alternative Actions or Intervals

    After the maintenance or inspection program has been revised as required by paragraph (l) of this AD, no alternative actions (e.g., inspections) or intervals may be used unless the actions or intervals are approved as an alternative method of compliance (AMOC) in accordance with the procedures specified in paragraph (r) of this AD.

    (q) Credit for Previous Actions

    This paragraph provides credit for the actions specified in paragraph (k) of this AD, if those actions were performed before the effective date of this AD using Boeing Special Attention Service Bulletin 747-71-2332, dated May 30, 2014, which is not incorporated by reference in this AD.

    (r) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (s)(1) of this AD. Information may be emailed to: [email protected]

    (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.

    (4) AMOCs approved for AD 2013-24-12 are approved as AMOCs for the corresponding provisions of this AD.

    (5) Except as required by paragraph (o)(2) of this AD: For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (r)(5)(i) and (r)(5)(ii) of this AD apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

    (ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

    (s) Related Information

    (1) For more information about this AD, contact Nathan Weigand, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6428; fax: 425-917-6590; email: [email protected]

    (2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (t)(5) and (t)(6) of this AD.

    (t) Material Incorporated by Reference

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

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

    (3) The following service information was approved for IBR on October 6, 2016.

    (i) Boeing Service Bulletin 747-71A2329, Revision 1, dated May 28, 2015.

    (ii) Boeing Special Attention Service Bulletin 747-71-2332, Revision 1, dated May 28, 2015.

    (iii) Boeing 747-8/-8F Airworthiness Limitation (AWL), Document Number D011U721-02-01, dated September 2015.

    (4) The following service information was approved for IBR on December 17, 2013 (78 FR 71989, December 2, 2013).

    (i) Boeing Alert Service Bulletin 747-71A2329, dated September 27, 2013.

    (ii) Reserved.

    (5) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet https://www.myboeingfleet.com.

    (6) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

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

    Issued in Renton, Washington, on August 19, 2016. Dorr M. Anderson, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-20825 Filed 8-31-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-6414; Directorate Identifier 2015-NM-175-AD; Amendment 39-18633; AD 2016-18-03] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc. Airplanes AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. This AD was prompted by two in-service incidents of a loss of all air data information in the flight deck. This AD requires a revision of the airplane flight manual (AFM) emergency procedures section to provide procedures to guide the crew on how to stabilize the airplane airspeed and attitude for continued safe flight when a loss of all air data information has occurred in the flight deck. We are issuing this AD to prevent loss of control when a loss of all air data information has occurred in the flight deck.

    DATES:

    This AD is effective October 6, 2016.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of October 6, 2016.

    ADDRESSES:

    For service information identified in this final rule, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email [email protected]; Internet http://www.bombardier.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6414.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6414; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Assata Dessaline, Aerospace Engineer, Avionics and Services Branch, ANE-172, FAA, New York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7301; fax 516-794-5531.

    SUPPLEMENTARY INFORMATION:

    Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The NPRM published in the Federal Register on May 10, 2016 (81 FR 28764) (“the NPRM”). The NPRM was prompted by two in-service incidents of a loss of all air data information in the flight deck. The NPRM proposed to require a revision of the AFM emergency procedures section to provide procedures to guide the crew on how to stabilize the airplane airspeed and attitude for continued safe flight when a loss of all air data information has occurred in the flight deck. We are issuing this AD to prevent loss of control when a loss of all air data information has occurred in the flight deck.

    Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2015-12, dated June 23, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The MCAI states:

    Two in-service incidents have been reported on CL-600-2C10 aeroplanes regarding a loss of all air data information in the cockpit. The air data information was recovered as the aeroplane descended to lower altitudes. An investigation determined that the root cause in both events was high altitude icing (ice crystal contamination). If not addressed, this condition may affect continued safe flight.

    Due to similarities in the air data systems, such events could happen on all Bombardier CRJ models, CL-600-2B19, CL-600-2C10, CL-600-2D15, CL-600-2D24 and CL-600-2E25. Therefore, the corrective actions for these models will be mandated once their respective Airplane Flight Manual (AFM) revisions become available.

    This [Canadian] AD mandates the incorporation of AFM procedures to guide the crew to stabilize the aeroplane's airspeed and attitude for continued safe flight.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6414.

    Comments

    We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the NPRM and the FAA's response to that comment.

    Request To Determine Root Cause of Unsafe Condition

    The Airline Pilots Association International (ALPA) requested further investigation and system modifications for the ice crystal contamination. ALPA stated that although the NPRM proposed an amendment to the AFM procedures for the crew, it does not believe that this AFM procedure addresses the root cause of the unsafe condition.

    The Air Line Pilots Association stated that the AFM revision will not address the root cause of the high-altitude icing (ice crystal contamination), and requested that further investigation be done for the ice crystal contamination issue and remedies be provided in addition to the AFM amendments.

    We agree that the AFM revision will not address the root cause of the high-altitude icing (ice crystal contamination). The manufacturer is investigating the issue, but there is no timetable for a final resolution. Should the manufacturer develop modifications to prevent this problem, the FAA will consider further rulemaking. The incorporation of the AFM procedures is meant to be used to guide the crew on how to stabilize the airplane airspeed and altitude for continued safe flight in icing conditions. However, further investigation into this matter extends beyond the scope of this AD.

    Conclusion

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

    • Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

    • Do not add any additional burden upon the public than was already proposed in the NPRM.

    Related Service Information Under 1 CFR Part 51

    Bombardier, Inc. has issued Section 03-19, “Unreliable Airspeed,” of Chapter 3, “Emergency Procedures,” in the Bombardier CRJ Series Regional Jet Model CL-600-2B19 Airplane Flight Manual CSP A-012, Revision 64B, dated December 8, 2015. The service information describes procedures to guide the crew to stabilize the airplane's airspeed and attitude for continued safe flight when a loss of all air data information has occurred in the flight deck. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    Costs of Compliance

    We estimate that this AD affects 500 airplanes of U.S. registry.

    We estimate the following costs to comply with this AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S. operators
    Revision 1 work-hour × $85 per hour = $85 $0 $85 $42,500
    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2016-18-03 Bombardier, Inc.: Amendment 39-18633; Docket No. FAA-2016-6414; Directorate Identifier 2015-NM-175-AD. (a) Effective Date

    This AD is effective October 6, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes, certificated in any category, serial numbers 7003 and subsequent.

    (d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

    (e) Reason

    This AD was prompted by two in-service incidents of a loss of all air data information in the flight deck. We are issuing this AD to prevent loss of control when a loss of all air data information has occurred in the flight deck.

    (f) Compliance

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

    (g) Airplane Flight Manual (AFM) Revision

    Within 30 days after the effective date of this AD, revise the emergency procedures section of the AFM by incorporating Section 03-19, “Unreliable Airspeed”, of Chapter 3, “Emergency Procedures,” in the Bombardier CRJ Series Regional Jet Model CL-600-2B19 Airplane Flight Manual CSP A-012, Revision 64B, dated December 8, 2015.

    (h) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New York Aircraft Certification Office (ACO), ANE-170, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the ACO, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; fax 516-794-5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, New York ACO, ANE-170, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If approved by the DAO, the approval must include the DAO-authorized signature.

    (i) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2015-12, dated June 23, 2015, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6414.

    (j) Material Incorporated by Reference

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

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

    (i) Section 03-19, “Unreliable Airspeed,” of Chapter 3, “Emergency Procedures,” in the Bombardier CRJ Series Regional Jet Model CL-600-2B19 Airplane Flight Manual CSP A-012, Revision 64B, dated December 8, 2015.

    (ii) Reserved.

    (3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email [email protected]; Internet http://www.bombardier.com.

    (4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

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

    Issued in Renton, Washington, on August 19, 2016. Dorr M. Anderson, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-20826 Filed 8-31-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Parts 730, 732, 734, 736, 738, 740, 742, 743, 746, 747, 748, 750, 754, 756, 758, 760, 762, 764, 766, 768, 770, 772, and 774 [Docket No. 160808698-6698-01] RIN 0694-AH09 Updated Statements of Legal Authority for the Export Administration Regulations AGENCY:

    Bureau of Industry and Security, Commerce.

    ACTION:

    Final rule.

    SUMMARY:

    This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite the most recent Presidential notice extending an emergency declared pursuant to the International Emergency Economic Powers Act. This is a procedural rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.

    DATES:

    The rule is effective September 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    William Arvin, Regulatory Policy Division, Bureau of Industry and Security, Telephone: (202) 482-2440.

    SUPPLEMENTARY INFORMATION: Background

    Authority for all parts of the EAR other than part 745 rests, in part, on Executive Order 13222 of August 17, 2001—National Emergency with Respect to Export Control Regulations, 66 FR 44025, 3 CFR, 2001 Comp., p. 783 and on annual notices extending the emergency declared in that executive order. This rule revises the authority paragraphs for the affected parts of the EAR to cite the most recent such notice, which the President signed on August 4, 2016.

    This rule is purely procedural and makes no changes other than to revise CFR authority paragraphs for the purpose of making the authority citations current. It does not change the text of any section of the EAR, nor does it alter any right, obligation or prohibition that applies to any person under the EAR.

    Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). This rule does not impose any regulatory burden on the public and is consistent with the goals of Executive Order 13563. This rule has been determined to be not significant for purposes of Executive Order 12866.

    2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This rule does not involve any collection of information.

    3. This rule does not contain policies with Federalism implications as that term is defined under Executive Order 13132.

    4. The Department finds that there is good cause under 5 U.S.C. 553(b)(B) to waive the provisions of the Administrative Procedure Act requiring prior notice and the opportunity for public comment because they are unnecessary. This rule only updates legal authority citations. It clarifies information and is non-discretionary. This rule does not alter any right, obligation or prohibition that applies to any person under the EAR. Because these revisions are not substantive changes, it is unnecessary to provide notice and opportunity for public comment. In addition, the 30-day delay in effectiveness otherwise required by 5 U.S.C. 553(d) is not applicable because this rule is not a substantive rule. Because neither the Administrative Procedure Act nor any other law requires that notice of proposed rulemaking and an opportunity for public comment be given for this rule, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. Accordingly, no Final Regulatory Flexibility Analysis is required and none has been prepared.

    List of Subjects 15 CFR Part 730

    Administrative practice and procedure, Advisory committees, Exports, Reporting and recordkeeping requirements, Strategic and critical materials.

    15 CFR Parts 732, 740, 748, 750, and 758

    Administrative practice and procedure, Exports, Reporting and recordkeeping requirements.

    15 CFR Part 734

    Administrative practice and procedure, Exports, Inventions and patents, Research, Science and technology.

    15 CFR Parts 736, 738, 770, and 772

    Exports.

    15 CFR Part 742

    Exports, Terrorism.

    15 CFR Part 743

    Administrative practice and procedure, Reporting and recordkeeping requirements.

    15 CFR Parts 746 and 774

    Exports, Reporting and recordkeeping requirements.

    15 CFR Part 747

    Administrative practice and procedure, Exports, Foreign trade, Reporting and recordkeeping requirements.

    15 CFR Part 754

    Agricultural commodities, Exports, Forests and forest products, Horses, Petroleum, Reporting and recordkeeping requirements.

    15 CFR Part 756

    Administrative practice and procedure, Exports, Penalties.

    15 CFR Part 760

    Boycotts, Exports, Reporting and recordkeeping requirements.

    15 CFR Part 762

    Administrative practice and procedure, Business and industry, Confidential business information, Exports, Reporting and recordkeeping requirements.

    15 CFR Part 764

    Administrative practice and procedure, Exports, Law enforcement, Penalties.

    15 CFR Part 766

    Administrative practice and procedure, Confidential business information, Exports, Law enforcement, Penalties.

    15 CFR Part 768

    Administrative practice and procedure, Exports, Reporting and recordkeeping requirements, Science and technology.

    Accordingly, parts 730, 732, 734, 736, 738, 740, 742, 743, 746, 747, 748, 750, 754, 756, 758, 760, 762, 764, 766, 768, 770, 772 and 774 of the EAR (15 CFR parts 730-774) are amended as follows:

    PART 730—[AMENDED] 1. The authority citation for 15 CFR part 730 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c; 22 U.S.C. 2151 note; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; ; 15 U.S.C. 1824a; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 11912, 41 FR 15825, 3 CFR, 1976 Comp., p. 114; E.O. 12002, 42 FR 35623, 3 CFR, 1977 Comp., p. 133; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12214, 45 FR 29783, 3 CFR, 1980 Comp., p. 256; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., p. 179; E.O. 12918, 59 FR 28205, 3 CFR, 1994 Comp., p. 899; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 356; E.O. 12981, 60 FR 62981, 3 CFR, 1995 Comp., p. 419; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p 168; E.O. 13637, 78 FR 16129, 3 CFR, 2014 Comp., p. 223; Notice of September 18, 2015, 80 FR 57281 (September 22, 2015); Notice of November 12, 2015, 80 FR 70667 (November 13, 2015); Notice of January 20, 2016, 81 FR 3937 (January 22, 2016); Notice of May 3, 2016, 81 FR 27293 (May 5, 2016); Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 732—[AMENDED] 2. The authority citation for 15 CFR part 732 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 734—[AMENDED] 3. The authority citation for 15 CFR part 734 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13637, 78 FR 16129, 3 CFR, 2014 Comp., p. 223; Notice of November 12, 2015, 80 FR 70667 (November 13, 2015); Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 736—[AMENDED]
    4. The authority citation for 15 CFR part 736 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 2151 note; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p. 168; Notice of November 12, 2015, 80 FR 70667 (November 13, 2015); Notice of May 3, 2016, 81 FR 27293 (May 5, 2016); Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 738—[AMENDED] 5. The authority citation for 15 CFR part 738 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15 U.S.C. 1824a; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 740—[AMENDED] 6. The authority citation for 15 CFR part 740 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 7201 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 742—[AMENDED] 7. The authority citation for 15 CFR part 742 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; Notice of November 12, 2015, 80 FR 70667 (November 13, 2015); Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 743—[AMENDED] 8. The authority citation for 15 CFR part 743 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13637, 78 FR 16129, 3 CFR, 2014 Comp., p. 223; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 746—[AMENDED] 9. The authority citation for 15 CFR part 746 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 287c; Sec 1503, Pub. L. 108-11, 117 Stat. 559; 22 U.S.C. 6004; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., p. 614; E.O. 12918, 59 FR 28205, 3 CFR, 1994 Comp., p. 899; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p 168; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; Presidential Determination 2007-7, 72 FR 1899, 3 CFR, 2006 Comp., p. 325; Notice of May 3, 2016, 81 FR 27293 (May 5, 2016); Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 747—[AMENDED] 10. The authority citation for 15 CFR part 747 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; Sec. 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 12918, 59 FR 28205, 3 CFR, 1994 Comp., p. 899; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 748—[AMENDED] 11. The authority citation for 15 CFR part 748 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 750—[AMENDED] 12. The authority citation for 15 CFR part 750 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; Sec. 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13637, 78 FR 16129, 3 CFR, 2013 Comp., p. 223; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 754—[AMENDED] 13. The authority citation for 15 CFR part 754 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 15 U.S.C. 1824a; E.O. 11912, 41 FR 15825, 3 CFR, 1976 Comp., p. 114; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 756—[AMENDED] 14. The authority citation for 15 CFR part 756 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 758—[AMENDED] 15. The authority citation for 15 CFR part 758 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 760—[AMENDED] 16. The authority citation for 15 CFR part 760 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 762—[AMENDED] 17. The authority citation for 15 CFR part 762 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 764—[AMENDED] 18. The authority citation for 15 CFR part 764 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 766—[AMENDED] 19. The authority citation for 15 CFR part 766 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 768—[AMENDED] 20. The authority citation for 15 CFR part 768 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 770—[AMENDED] 21. The authority citation for 15 CFR part 770 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 772—[AMENDED] 22. The authority citation for 15 CFR part 772 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    PART 774—[AMENDED] 23. The authority citation for 15 CFR part 774 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15 U.S.C. 1824a; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    Dated: August 26, 2016. Kevin J. Wolf, Assistant Secretary for Export Administration.
    [FR Doc. 2016-21031 Filed 8-31-16; 8:45 am] BILLING CODE 3510-33-P
    FEDERAL TRADE COMMISSION 16 CFR Part 803 Premerger Notification; Reporting and Waiting Period Requirements AGENCY:

    Federal Trade Commission.

    ACTION:

    Final rule.

    SUMMARY:

    The Commission is amending the Hart-Scott-Rodino (“HSR”) Premerger Notification Rules (the “Rules”) that require the parties to certain mergers and acquisitions to file reports with the Federal Trade Commission (“the Commission” or “FTC”) and the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice (“the Assistant Attorney General” or “DOJ”) (together the “Antitrust Agencies” or “Agencies”) and to wait a specified period of time before consummating such transactions. These amendments update the Rules to allow for submission of the Premerger Notification and Report Form (“Form”) and accompanying documents (together the “HSR Filing”) on digital video/versatile disc (“DVD”), and clarify the Instructions to the Form.

    DATES:

    Effective September 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Robert L. Jones, Assistant Director, Premerger Notification Office, Bureau of Competition, Room 5301, Federal Trade Commission, 400 7th Street SW., Washington, DC 20024. Telephone: (202) 326-3100, Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Introduction

    Section 7A of the Clayton Act (the “Act”) requires the parties to certain mergers or acquisitions to file with the Commission and DOJ to allow the Agencies to conduct their initial review of a proposed transaction's competitive impact and requires the parties to wait a specified period of time before consummating such transactions. The reporting requirement and the waiting period that it triggers are intended to enable the Antitrust Agencies to determine whether a proposed merger or acquisition may violate the antitrust laws if consummated and, when appropriate, to seek a preliminary injunction in federal court to prevent consummation, pursuant to Section 7 of the Act.

    Section 7A(d)(1) of the Act, 15 U.S.C. 18a(d)(1), directs the Commission, with the concurrence of the Assistant Attorney General, in accordance with the Administrative Procedure Act, 5 U.S.C. 553, to require that premerger notification be in such form and contain such information and documentary material as may be necessary and appropriate to determine whether the proposed transaction may, if consummated, violate the antitrust laws. Section 7A(d)(2) of the Act, 15 U.S.C. 18a(d)(2), grants the Commission, with the concurrence of the Assistant Attorney General, in accordance with 5 U.S.C. 553, the authority to define the terms used in the Act and prescribe such other rules as may be necessary and appropriate to carry out the purposes of Section 7A.

    Pursuant to that authority, the Commission, with the concurrence of the Assistant Attorney General, developed the Rules, codified in 16 CFR parts 801, 802 and 803, and the Form and its associated Instructions, codified at part 803—appendix, to govern the form of premerger notifications to be provided by merging parties.

    HSR Filings provide the Agencies with the information and documentary material necessary for an initial evaluation of the potential anticompetitive impact of significant mergers, acquisitions and certain similar transactions. Currently, all HSR Filings are submitted in paper. Through these amendments to the Rules, the Agencies will allow the submission of HSR Filings digitally on DVD (“DVD filings”). The acceptance of DVD filings requires certain conforming changes to the Instructions to the Form, so the Commission is also taking this opportunity to clarify the Instructions and make them easier to use.

    Statement of Basis and Purpose for the Commission's Revision of Its Premerger Notification Form, Instructions and Rules

    Since the inception of the HSR program, the HSR Form and its attachments have been submitted in paper. In 2006, an electronic filing option was introduced that would allow filers to upload HSR Filings directly to the Agencies but that option failed to gain traction due to the limitations of the underlying technology, and it was soon discontinued. While the Agencies continue to explore an electronic filing option, they have decided to accept the submission of HSR Filings digitally on DVD. Accordingly, the Commission amends part 803 to delete references to the discontinued electronic filing option and revises these sections and the Instructions to the Form found in the appendix to part 803 to allow for DVD filings. Documents submitted by the parties with the filing are typically created and stored in digital format. Allowing parties to submit these digital files on electronic media will be more efficient and cost-effective, providing benefits to filing parties as well as the Agencies:

    —Currently, those submitting HSR Filings must provide five paper copies of their Form, consisting of one original and one copy to the FTC, and three copies to DOJ, as well as one set of Documentary Attachments to each Agency. DVD filing will eliminate the expensive and time-consuming printing and duplication of documents, and allow for a more efficient filing process for filing parties. —DVD filing will ease the physical delivery of voluminous HSR Filings to the Agencies, and facilitate the processing and review of filings within each Agency. —DVD filing will allow for more efficient and less costly storage options for the Agencies

    To provide maximum flexibility, filing parties will still have the traditional option of submitting HSR Filings in paper. Submitting an HSR Filing partially on DVD and partially in paper will not be permitted, however. Additionally, DVD submissions must be accompanied by original hard copies of the cover letter, certification and affidavit. The individual rule amendments associated with DVD filing are described more fully below.

    Additionally, this rulemaking makes minor changes to the Form Instructions, many of which are unrelated to DVD filing, to reduce the burden on filing parties by making it easier to prepare the Form and comply with the HSR Filing requirements. These changes are not substantive in nature, and involve formatting, clarification, and simplification, as well as the deletion of immaterial language, with the goal of eliminating confusion for filing parties, as noted below.

    Section 803.1 Notification and Report Form

    The internet portal established in 2006, www.hsr.gov, to allow the electronic filing of HSR Filings is no longer technologically viable, and references to HSR.gov are removed from all Rules in which they appear and the Instructions.

    Section 803.2 Instructions Applicable to Notification and Report Form

    Section 803.2(e)(1) currently allows filers to forego the physical production of documents responsive to Item 4(b) by incorporating by reference documents previously filed with the Agencies in other transactions. The purpose of the rule was to avoid the costly duplication of responsive documents that were already in the possession of the Agencies. However, given § 803.2(e)(2), which allows parties to cite to an Internet address rather than provide hard copies of responsive documents, and the ease of copying documents onto a DVD without any expensive hard copy duplication, § 803.2 is being amended to delete § 803.2(e)(1). The existing, current, § 803.2(e)(2) will be renumbered to § 803.2(e), and the new § 803.2(e) has been amended for clarity.

    To ensure the submission of compatible and readable electronic files, and to avoid problems and delays in processing HSR Filings, paragraph (f) of § 803.2 has been amended to require the use of specific formatting when submitting an HSR Filing on DVD, and to remove the reference to www.hsr.gov. The filing person is responsible for ensuring that the formatting requirements are observed and is subject to a notice of deficient filing if an unacceptable format is submitted. See http://www.ftc.gov/enforcement/premerger-notification-program for all current DVD Filing format requirements.

    Section 803.3 Statement of Reasons for Noncompliance

    Section 803.3 identifies the specific information that a filing person must provide when not responding to an Item on the Form. Paragraph (d) identifies the specifics of making a claim of privilege. Paragraph (d) is amended to require the titles and/or positions of the author of a document, the addressee, and all recipients of the document being withheld or redacted under a claim of privilege to enable the Agencies to better assess if the privilege applies.

    Section 803.5 Affidavits Required

    Section 803.5 requires an affidavit from the filing person attesting to the good faith intention of the person filing to proceed with the transaction. The affidavit must be attached to the Form at the time of filing. Paragraphs (a)(1), (a)(3), and (b) are amended to address inclusion of the affidavit when using the DVD filing option. If only a scanned version of the signed affidavit is available at the time of filing, it must be submitted on the DVD, and the original signed hard copy should be provided to the FTC as soon as possible.

    Section 803.10 Running of Time

    Persons required by the Act to submit HSR Filings must comply with specified statutory waiting periods before consummating the transaction. Section 803.10(c)(1)(i) is amended to define the “date of receipt and means of delivery” for purposes of determining when the waiting period begins for filings submitted on DVD. Delivery is to be effected by providing a DVD filing directly to the designated agency offices, by either hand or certified or registered mail, FedEx or UPS, during normal business hours.

    References and paragraphs relating exclusively to “electronic” filing, as well as references to www.hsr.gov, have been deleted to avoid confusion, as the submission of filings electronically is not currently available.

    Appendix to Part 803—Notification and Report Form and Instructions

    A number of changes have been made to the Form Instructions, including changes unrelated to DVD filing, that are intended to clarify the Instructions and simplify the process of completing an HSR Form. Many of these changes involve new formatting or the substitution or deletion of a word, sentence or paragraph. The more significant changes entail the following amendments:

    “Filing”

    Accounts for the option of filing using a DVD, including specific formatting and submission requirements.

    “Responses”

    Clarifies that estimated financial information provided in the Form should include an “est.” notation. Also specifies that additional pages should be included within the Form, not with the Documentary Attachments.

    “Amount Paid”

    Eliminates the requirement for an explanatory attachment regarding valuation.

    “Payer Identification” and “Method of Payment”

    Clarifies the process and requirements for submitting HSR filing fees.

    “Item 1(g)”

    Specifies that identification of a second contact person is required.

    “Item 2(d)”

    Clarifies how to respond where a transaction involves a mixed deal including voting securities, and/or non-corporate interests, and/or assets.

    “Item 3(a)”

    Reorganized and reworded for clarity. Clarifies that the description of the transaction should include a brief and simple description of the relevant assets or business operation(s) to be acquired. Deletes requirement for identification of expected dates of major events and deletes paragraph discussing acquisitions “from a holder other than the issuer or unincorporated entity” to reduce confusion.

    “Item 3(b)”

    Clarifies that agreement schedules are not required unless they represent some agreement between the parties (e.g., a non-compete). Specifies that parties filing on a letter of intent may also submit a draft of the definitive agreement, if one exists.

    “Item 4(b)”

    Reorganized and amended to clarify the types of reports that are acceptable (e.g., unaudited reports that are relied upon by the board are permitted), and from which entities reports are required.

    “Items 4(c) and 4(d)”

    Clarifies that document title, date, and author information is required for both 4(c) and 4(d) documents. Additionally amended to clarify the proper labeling convention for these documents, as well as the privilege log requirements outlined in § 803.3(d).

    “Item 5(a)”

    Simplifies the instructions.

    “Item 6(b)”

    Amended to clarify that only shareholders with 5% or more, but less than 50% must be identified.

    “Item 6(c)”

    Clarifies the instructions.

    “Item 7”

    Amended to clarify that all six-digit NAICS industry code overlaps must be reported, regardless of whether there is a ten-digit NAICS overlap.

    “Item 7(b)”

    Amended to clarify which entities should be listed.

    “Item 7(c)”

    Amended to change the order and organization of the NAICS codes for clarity, and renumbered the sub-sections. Amended to clarify that geographic information should be provided by state postal code abbreviations, including identifying the number of states reported, and that a response of “national” is acceptable in certain cases in lieu of listing every state.

    “Item 7(c)(iv)”

    Amended to more clearly state that county and city/town information is required for the specific NAICS codes outlined in this section. Reformatted for readability.

    “Item 8”

    Amended to clarify that Item 8 is related to codes reported in Item 5.

    Administrative Procedure Act

    The Commission finds good cause to adopt these changes without prior public comment. Under the Administrative Procedure Act (“APA”), notice and comment are not required “when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(3)(B).

    The Commission is updating the Rules, Form and Instructions to provide the option of submitting HSR Filings on DVD, and to clarify the Form Instructions. Paper copy submission will remain available. These amendments to the HSR Rules and Form fall within the category of rules covering agency procedure and practice that are exempt from the notice-and-comment requirements of the APA. See 5 U.S.C. 553(b)(A). Because the amendments are not substantive in nature, they are also not subject to the delayed effective date provisions of the APA. See 5 U.S.C. 553(d) (substantive rules may take effect no sooner than 30 days after publication).

    For these reasons, the Commission finds that there is good cause for adopting this final rule as effective on September 1, 2016 without prior public comment.

    Regulatory Flexibility Act

    The Regulatory Flexibility Act, 5 U.S.C. 601-612, requires that the agency conduct an initial and final regulatory analysis of the anticipated economic impact of the proposed amendments on small businesses, except where the agency head certifies that the regulatory action will not have a significant economic impact on a substantial number of small entities. 5 U.S.C. 605. The Regulatory Flexibility Act requirements apply, however, only to rules or amendments that are subject to the notice-and-comment requirements of the APA. See 5 U.S.C. 603, 604. Because these amendments are exempt from those APA requirements, as noted earlier, they are also exempt from the Regulatory Flexibility Act requirements. In any event, because of the size of the transactions necessary to invoke an HSR Filing, the premerger notification rules rarely, if ever, affect small businesses. Indeed, amendments to the Act in 2001 were intended to reduce the burden of the premerger notification program by exempting all transactions valued at less than $50 million (as adjusted annually). Further, none of the proposed rule amendments expands the coverage of the premerger notification rules in a way that would affect small business. Accordingly, to the extent, if any, that the Regulatory Flexibility Act applies, the Commission certifies that these proposed rules will not have a significant economic impact on a substantial number of small entities. This document serves as notice of this certification to the Small Business Administration.

    Paperwork Reduction Act

    These changes do not contain any record maintenance, reporting or disclosure requirements that would constitute agency “collections of information” that would have to be submitted for clearance and approval by the Office of Management and Budget under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.

    List of Subjects in 16 CFR Part 803

    Antitrust.

    For the reasons stated in the preamble, the Federal Trade Commission amends 16 CFR part 803 as set forth below:

    PART 803—TRANSMITTAL RULES 1. The authority citation for part 803 continues to read as follows: Authority:

    15 U.S.C. 18a(d).

    2. Amend § 803.1 by revising paragraph (a) to read as follows:
    § 803.1 Notification and Report Form.

    (a) The notification required by the act shall be the Notification and Report Form set forth in the appendix to this part, as amended from time to time. All acquiring and acquired persons required to file notification by the act and these rules shall do so by completing and filing the Notification and Report Form, in accordance with the instructions thereon and these rules. The current version of the Form can be obtained at http://www.ftc.gov.

    3. Amend § 803.2 by revising paragraphs (e) and (f) to read as follows:
    § 803.2 Instructions applicable to Notification and Report Form.

    (e) For documents required by item 4(b) of the Notification and Report Form, a person filing the notification may, instead of submitting a document, provide a cite to an operative Internet address directly linking to the document, if the linked document is complete and payment is not required to access the document. If an Internet address becomes inoperative during the waiting period, or the document is otherwise rendered inaccessible or incomplete, upon notification by the Commission or Assistant Attorney General, the parties must make the document available to the agencies by either referencing an operative Internet address where the complete document may be accessed or by providing paper copies to the agencies as provided in § 803.10(c)(1) by 5 p.m. on the next regular business day. Failure to make the document available, by the Internet or by providing paper copies, by 5 p.m. on the next regular business day, will result in notice of a deficient filing pursuant to § 803.10(c)(2).

    (f) Filings made via DVD must comply with all format requirements set forth at the Premerger Notification Office pages at http://www.ftc.gov. The use of any format not specified as acceptable, or any other failure to comply with the applicable format requirements, shall render the entire filing deficient within the meaning of § 803.10(c)(2).

    4. Amend § 803.3 by revising paragraph (d) to read as follows:
    § 803.3 Statement of reasons for noncompliance.

    (d) Where noncompliance is based on a claim of privilege, a statement of the claim of privilege and all facts relied on in support thereof, including the identity of each document, its author, the author's title/position, addressee, the addressee's title/position, date, subject matter, all recipients of the original and of any copies, the recipients' titles/positions, the document's present location, and who has control of it.

    5. Amend § 803.5 by revising paragraphs (a)(1) introductory text, (a)(3), and (b) to read as follows:
    § 803.5 Affidavits required.

    (a)(1) Section 801.30 acquisitions. For acquisitions to which § 801.30 applies, the notification required by the act from each acquiring person shall contain an affidavit, attached to the front of the notification, or with the DVD submission, attesting that the issuer whose voting securities are to be acquired has received notice in writing by certified or registered mail, by wire or by hand delivery, at its principal executive offices, of:

    (3) The affidavit required by this paragraph must have attached to it a copy of the written notice received by the acquired person pursuant to paragraph (a)(1) of this section. For DVD filings, the written notice (in a form specified in the instructions) must be included on the DVD.

    (b) Non-section 801.30 acquisitions. For acquisitions to which § 801.30 does not apply, the notification required by the act shall contain an affidavit, attached to the front of the notification, or with the DVD submission, attesting that a contract, agreement in principle or letter of intent to merge or acquire has been executed, and further attesting to the good faith intention of the person filing notification to complete the transaction.

    6. Amend § 803.10 by revising paragraph (c)(1)(i), removing paragraphs (c)(1)(ii) and (iii), and redesignating paragraph (c)(1)(iv) as paragraph (c)(1)(ii) to read as follows:
    § 803.10 Running of time.

    (c)(1) * * *

    (i) For paper copy filings and DVD filings, the date of receipt shall be the date on which delivery is effected to the designated offices (Premerger Notification Office, Federal Trade Commission, Room 5301, 400 7th Street SW., Washington, DC 20024, and Director of Civil Enforcement, Office of Operations, Antitrust Division, Department of Justice, 950 Pennsylvania Avenue NW., Room #3335, Washington, DC 20530) during normal business hours. Delivery should be effected directly to the designated offices, either by hand or by certified or registered mail (including FedEx and UPS). In the event one or both of the delivery sites are unavailable, the FTC and DOJ may designate alternate sites for delivery of the filing. Notification of the alternate delivery sites will normally be made through a press release and, if possible, on the http://www.ftc.gov Web site.

    7. Amend the appendix to part 803 by revising the Instructions to the Form to read as follows: Appendix to Part 803—Notification and Report Form for Certain Mergers and Acquisitions BILLING CODE 6750-01-P ER01SE16.116 ER01SE16.117 ER01SE16.118 ER01SE16.119 ER01SE16.120 ER01SE16.121 ER01SE16.122 ER01SE16.123 ER01SE16.124 ER01SE16.125 ER01SE16.126 Donald S. Clark, Secretary.
    [FR Doc. 2016-20950 Filed 8-31-16; 8:45 am] BILLING CODE 6750-01-C
    DEPARTMENT OF LABOR Occupational Safety and Health Administration 29 CFR Part 1910, 1915, and 1926 [Docket No. OSHA-2010-0034] RIN 1218-AB70 Occupational Exposure to Respirable Crystalline Silica; Correction AGENCY:

    Occupational Safety and Health Administration, Department of Labor.

    ACTION:

    Final rule; correcting amendment.

    SUMMARY:

    OSHA published a final rule on occupational exposure to respirable crystalline silica on March 25, 2016 which became effective on June 23, 2016. This document corrects typographical errors in the final rule by revising these sections.

    DATES:

    Effective September 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Annette Iannucci, Directorate of Standards and Guidance, Room N-3718, OSHA, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-1950; email [email protected]

    SUPPLEMENTARY INFORMATION:

    On March 25, 2016, OSHA published a final rule entitled Occupational Exposure to Respirable Crystalline Silica (81 FR 16285-16890). The final rule retained the preceding permissible exposure limits (PELs) for respirable crystalline silica in general industry (29 CFR 1910.1000, Table Z-3), shipyards (29 CFR 1915.1000, Table Z), and construction (29 CFR 1926.55, appendix A), and added footnotes to make clear that these PELs apply to any sectors or operations where the new PEL of 50 ­μg/m3 is not in effect. The preceding PELs apply to operations that are not covered by the new standards, such as the processing of sorptive clays. The preceding PELs are also applicable during the time between publication of the silica rule and the dates established for compliance with the rule, as well as in the event of regulatory delay, a stay, or partial or full invalidation by the Court.

    This document corrects typographical errors in the formulas for the preceding PELs, so that they will appear as they did prior to publication of the final rule.

    List of Subjects in 29 CFR Parts 1910, 1915, and 1926

    Cancer, Chemicals, Cristobalite, Crystalline silica, Hazardous substances, Health, Lung diseases, Occupational safety and health, Quartz, Reporting and recordkeeping requirements, Silica, Silicosis, Tridymite.

    Authority and Signature

    This document was prepared under the direction of David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health. It is issued under the following authorities: Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); section 107 of the Contract Work Hours and Safety Standards Act (the Construction Safety Act) (40 U.S.C. 3704); section 41 of the Longshore and Harbor Worker's Compensation Act (33 U.S.C. 941); Secretary of Labor's Order 1-2012 (77 FR 3912 (1/25/2012)); and 29 CFR part 1911.

    Signed at Washington, DC, on August 5, 2016. David Michaels, <E T="03">Assistant Secretary of Labor for Occupational Safety and Health.</E>

    Accordingly, for the reasons set forth in the preamble above, the Occupational Safety and Health Administration is amending 29 CFR parts 1910, 1915, and 1926 as follows:

    PART 1910—OCCUPATIONAL SAFETY AND HEALTH STANDARDS 1. The authority citation for part 1910 continues to read as follows: Authority:

    29 U.S.C. 653, 655, 657; Secretary of Labor's Order Numbers 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable.

    Sections 1910.6, 1910.7, 1910.8 and 1910.9 also issued under 29 CFR 1911. Section 1910.7(f) also issued under 31 U.S.C. 9701, 29 U.S.C. 9a, 5 U.S.C. 553; Public Law 106-113 (113 Stat. 1501A-222); Pub. L. 11-8 and 111-317; and OMB Circular A-25 (dated July 8, 1993) (58 FR 38142, July 15, 1993).

    2. In § 1910.1000, in Table Z-3, revise the entries for “Silica: Crystalline Quartz (Respirable)”, “Silica: Crystalline Cristobalite”, and “Silica: Crystalline Tridymite” to read as follows:
    § 1910.1000 Air contaminants. Table Z-3—Mineral Dusts Substance mppcf a mg/m 3 Silica: Crystalline Quartz (Respirable) f 250b 10 mg/m3 e % SiO2 + 5 % SiO2 + 2 Cristobalite: Use 1/2 the value calculated from the count or mass formulae for quartz.f Tridymite: Use 1/2 the value calculated from the formulae for quartz.f *         *         *         *         *         *         *

    a Millions of particles per cubic foot of air, based on impinger samples counted by light-field techniques.

    b The percentage of crystalline silica in the formula is the amount determined from airborne samples, except in those instances in which other methods have been shown to be applicable.

    e Both concentration and percent quartz for the application of this limit are to be determined from the fraction passing a size-selector with the following characteristics:

    Aerodynamic diameter
  • (unit density sphere)
  • Percent
  • passing selector
  • 2 90 2.5 75 3.5 50 5.0 25 10 0

    The measurements under this note refer to the use of an AEC (now NRC) instrument. The respirable fraction of coal dust is determined with an MRE; the figure corresponding to that of 2.4 mg/m3 in the table for coal dust is 4.5 mg/m3K.

    f This standard applies to any operations or sectors for which the respirable crystalline silica standard, 1910.1053, is stayed or is otherwise not in effect.

    PART 1915—OCCUPATIONAL SAFETY AND HEALTH STANDARDS FOR SHIPYARD EMPLOYMENT 3. The authority citation for part 1915 continues to read as follows: Authority:

    Section 41, Longshore and Harbor Workers' Compensation Act (33 U.S.C. 941); Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable; 29 CFR part 1911.

    Sections 1915.120 and 1915.152 of 29 CFR also issued under 29 CFR part 1911.

    4. In § 1915.1000, amend Table Z by: a. Revising the entries for “Silica, crystalline, respirable dust, cristobalite”, “Silica, crystalline, respirable dust, quartz”, “Silica, crystalline, respirable dust, tripoli (as quartz)”, and “Silica, crystalline, respirable dust, tridymite”; and b. Under the “MINERAL DUSTS” heading of the table, revising the entry for “Silica: Crystalline Quartz”.

    The revisions read as follows:

    § 1915.1000 Air contaminants. Table Z—Shipyards Substance CAS No.d ppm a* mg/m3 b* Skin designation *         *         *         *         *         *         * Silica, crystalline, respirable dust Cristobalite; see 1915.1053 14464-46-1 Quartz; see 1915.1053 5 14808-60-7 Tripoli (as quartz); see 1915.1053 5 1317-95-9 Tridymite; see 1915.1053 15468-32-3 *         *         *         *         *         *         * Mineral Dusts Substance mppcf (j) SILICA: Crystalline 250 (k) Quartz. Threshold Limit calculated from the formula (p) % SiO2 + 5 *    *    *    *    *

    5 See Mineral Dusts table for the exposure limit for any operations or sectors where the exposure limit in § 1915.1053 is stayed or is otherwise not in effect.

    * The PELs are 8-hour TWAs unless otherwise noted; a (C) designation denotes a ceiling limit. They are to be determined from breathing-zone air samples.

    a Parts of vapor or gas per million parts of contaminated air by volume at 25 °C and 760 torr.

    b Milligrams of substance per cubic meter of air. When entry is in this column only, the value is exact; when listed with a ppm entry, it is approximate.

    d The CAS number is for information only. Enforcement is based on the substance name. For an entry covering more than one metal compound, measured as the metal, the CAS number for the metal is given—not CAS numbers for the individual compounds.

    p This standard applies to any operations or sectors for which the respirable crystalline silica standard, 1915.1053, is stayed or otherwise is not in effect.

    PART 1926—SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Subpart D—Occupational Health and Environmental Controls 5. The authority citation for part 1926, subpart D, continues to read as follows: Authority:

    Section 107 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 3704); Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); and Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable; and 29 CFR part 1911.

    Sections 1926.58, 1926.59, 1926.60, and 1926.65 also issued under 5 U.S.C. 553 and 29 CFR part 1911.

    Section 1926.61 also issued under 49 U.S.C. 1801-1819 and 6 U.S.C. 553.

    Section 1926.62 also issued under section 1031 of the Housing and Community Development Act of 1992 (42 U.S.C. 4853).

    Section 1926.65 also issued under section 126 of the Superfund Amendments and Reauthorization Act of 1986, as amended (reprinted at 29 U.S.C.A. 655 Note), and 5 U.S.C. 553.

    6. In § 1926.55, in appendix A, in the table titled “Threshold Limit Values of Airborne Contaminants for Construction”: a. Revise the entries for “Silica, crystalline, respirable dust, cristobalite”, “Silica, crystalline, respirable dust, quartz”, “Silica, crystalline, respirable dust, tripoli (as quartz)”, and “Silica, crystalline, respirable dust, tridymite”; b. Under the “MINERAL DUSTS” heading of the table, revise the entry for “Silica: Crystalline Quartz”

    The revisions read as follows:

    § 1926.55 Gases, vapors, fumes, dusts, and mists. Appendix A to § 1926.55—1970 American Conference of Governmental Industrial Hygienists' Threshold Limit Values of Airborne Contaminants Threshold Limit Values of Airborne Contaminants for Construction Substance CAS No.d ppm a* mg/m3 b Skin designation *         *         *         *         *         *         * Silica, crystalline, respirable dust Cristobalite; see 1926.1153 14464-46-1 Quartz; see 1926.1153 5 14808-60-7 Tripoli (as quartz); see 1926.1153 5 1317-95-9 Tridymite; see 1926.1153 15468-32-3 *         *         *         *         *         *         * Mineral Dusts SILICA: Crystalline 250(k) Quartz. Threshold Limit calculated from the formula (p) % SiO2 + 5 *    *    *    *    *

    5 See Mineral Dusts table for the exposure limit for any operations or sectors where the exposure limit in § 1926.1153 is stayed or is otherwise not in effect.

    * The PELs are 8-hour TWAs unless otherwise noted; a (C) designation denotes a ceiling limit.

    a Parts of vapor or gas per million parts of contaminated air by volume at 25 °C and 760 torr.

    b Milligrams of substance per cubic meter of air. When entry is in this column only, the value is exact; when listed with a ppm entry, it is approximate.

    d The CAS number is for information only. Enforcement is based on the substance name. For an entry covering more than one metal compound, measured as the metal, the CAS number for the metal is given—not CAS numbers for the individual compounds.

    p This standard applies to any operations or sectors for which the respirable crystalline silica standard, 1926.1153, is stayed or otherwise is not in effect.

    [FR Doc. 2016-20442 Filed 8-31-16; 8:45 am] BILLING CODE 4510-26-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R01-OAR-2015-0471; A-1-FRL-9943-06-Region 1] Air Plan Approval; Connecticut; Open Burning and Portable Fuel Containers AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Direct final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the State of Connecticut on November 19, 2012. We are approving Connecticut's request to remove two regulations from its SIP that regulate “open burning” and “portable fuel container spillage control.” In place of the open burning regulation, we are approving into the Connecticut SIP a Connecticut statute that controls open burning. We are also approving a definition of “brush,” which was included in a December 14, 2015 SIP submittal by Connecticut to meet infrastructure requirements of the Clean Air Act for the 2012 fine particle (PM2.5) National Ambient Air Quality Standards (NAAQS). The requirements in the Connecticut portable fuel container regulation have been superseded by federal portable fuel container requirements. This action is being taken in accordance with the Clean Air Act.

    DATES:

    This direct final rule will be effective October 31, 2016, unless EPA receives adverse comments by October 3, 2016. If adverse comments are received, EPA will publish a timely withdrawal of the direct final rule in the Federal Register informing the public that the rule will not take effect.

    ADDRESSES:

    Submit your comments, identified by Docket ID Number EPA-R01-OAR-2015-0471 by one of the following methods:

    1. http://www.regulations.gov: Follow the on-line instructions for submitting comments.

    2. Email: [email protected]

    3. Fax: (617) 918-0047.

    4. Mail: “Docket Identification Number EPA-R01-OAR-2015-0471,” Anne Arnold, U.S. Environmental Protection Agency, EPA New England Regional Office, Office of Ecosystem Protection, Air Quality Planning Unit, 5 Post Office Square-Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912.

    5. Hand Delivery or Courier. Deliver your comments to: Anne Arnold, Manager, Air Quality Planning Unit, Office of Ecosystem Protection, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square-Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912. Such deliveries are only accepted during the Regional Office's normal hours of operation. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays.

    Instructions: Direct your comments to Docket ID No. EPA-R01-OAR-2015-0471. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit through http://www.regulations.gov, or email, information that you consider to be CBI or otherwise protected. The http://www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through http://www.regulations.gov your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

    Docket: All documents in the electronic docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available at http://www.regulations.gov or at U.S. Environmental Protection Agency, EPA New England Regional Office, Office of Ecosystem Protection, 5 Post Office Square-Suite 100, Boston, MA. EPA requests that if at all possible, you contact the contact listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays.

    In addition, copies of the state submittal are also available for public inspection during normal business hours, by appointment at the State Air Agency: The Bureau of Air Management, Department of Energy and Environmental Protection, State Office Building, 79 Elm Street, Hartford, CT 06106-1630.

    FOR FURTHER INFORMATION CONTACT:

    Alison C. Simcox, Air Quality Planning Unit, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square-Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912, telephone number (617) 918-1684, fax number (617) 918-0684, email [email protected]

    SUPPLEMENTARY INFORMATION:

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

    Organization of this document. The following outline is provided to aid in locating information in this preamble.

    I. Background and Purpose II. EPA's Evaluation of Connecticut's SIP Revisions III. Final Action IV. Incorporation by Reference V. Statutory and Executive Order Reviews I. Background and Purpose

    On November 19, 2012, the State of Connecticut submitted a formal revision to its State Implementation Plan (SIP). The SIP revision consists of a request to remove two regulations from its SIP that regulate open burning (Regulations of Connecticut State Agencies (RCSA) section 22a-174-17 (formerly section 19-508-17) and “portable fuel container spillage control” (RCSA section 22a-174-43), and to add into the SIP a statute, Connecticut General Statutes (CGS) section 22a-174(f), that regulates open burning.

    Open Burning

    Connecticut adopted regulations to control open burning in 1972. On May 31, 1972, EPA approved RCSA section 19-508-17 “Control of Open Burning” into the Connecticut SIP (37 FR 10842). In 1983, the state re-codified section 19-508-17 as section 22a-174-17 and, subsequently, adopted revisions to CGS section 22a-174(f) to control open burning, effective March 30, 2000. Connecticut intended that the statute supersede the regulation. Although CGS section 22a-174(f) authorizes the Connecticut Department of Energy and Environmental Protection (CT DEEP) to adopt regulations to control open burning, the agency did not adopt a new regulation and, instead, enforces CGS section 22a-174(f) as the state's sole authority for regulation of open burning.

    On September 27, 2011, CT DEEP proposed to repeal RCSA section 22a-174-17 and held a public hearing on November 9, 2011. CT DEEP repealed RCSA section 22a-174-17, effective on September 10, 2012. On November 19, 2012, CT DEEP submitted a SIP revision to EPA to remove RCSA section 19-508-17 “Control of Open Burning” from the Connecticut SIP and to replace it with a Connecticut statute, CGS section 22a-174(f). Because implementation of this statute depends on having a definition of “brush,” Connecticut included a definition of this term in its December 14, 2015 SIP submittal to meet infrastructure requirements of the Clean Air Act for the 2012 fine particle (PM2.5) National Ambient Air Quality Standards (NAAQS).

    Portable Fuel Container Spillage

    Connecticut adopted regulations to control portable fuel container spillage in 2004. On August 31, 2006, EPA approved RCSA section 22a-174-43 “Portable Fuel Container Spillage Control” into the Connecticut SIP (71 FR 51761). In 2007, EPA issued a regulation entitled “Control of Hazardous Air Pollutants from Mobile Sources” (72 FR 8428), which included new federal requirements for portable fuel containers. See 40 CFR part 59, subpart F “Control of Evaporative Emissions from New and In-Use Portable Fuel Containers.”

    On September 27, 2011, the CT DEEP proposed to repeal RCSA section 22a-174-43 “Portable Fuel Container Spillage Control” and held a public hearing on November 9, 2011. CT DEEP repealed RCSA section 22a-174-43, effective on September 10, 2012. On November 19, 2012, CT DEEP submitted a SIP revision to EPA to remove RCSA section 22a-174-43 “Portable Fuel Container Spillage Control” from the Connecticut SIP.

    II. EPA's Evaluation of Connecticut's SIP Revisions Open Burning

    The open burning rule, RCSA section 19-508-17, which is currently in the Connecticut SIP, identifies the types of open fires that are allowed within state boundaries, and the types of fires that require a written certificate from the Commissioner. Open fires that are allowed include barbecues or other outdoor open fires for cooking food; campfires, bonfires, and other fires for ceremonial or recreational purposes; fires to abate a fire hazard as directed by a responsible fire official; fires in devices used by construction or other workers for heating purposes; and small fires needed for activities such as street installation or paving activities and repairing utilities.

    Fires that require a written certificate from the Commissioner include fires for fire-fighting training; fires for preventing or controlling diseases or pests, including agricultural diseases and pests; agricultural burning for vegetation management; fires for the disposal of dangerous materials where no reasonable alternative disposal method is available; and other fires which the Commissioner determines are necessary for protection of public health.

    CGS section 22a-174(f) allows local open-burning officials to issue permits for open burning on residential property and for fire training, insect control, agricultural purposes, natural disaster clean-up, wildlife habitat and vegetative management and ecological sustainability. It also allows officials to issue permits for open burning of brush in municipal landfills, transfer stations and municipal recycling centers. Open burning of brush is not allowed when national or state air quality standards may be exceeded, where it may create a hazardous health condition, when forest fire danger is extreme, where woodland or grass land is within 100 feet of the proposed burn, or where prohibited by municipal ordinance. Burning of leaves, demolition waste or other solid waste in municipal landfills is also prohibited. The statute also establishes a process for certifying local open burning officials.

    Based on a comparison of provisions in SIP-approved RCSA section 19-508-17 and CGS section 22a-174(f), EPA has determined that the statute is at least as stringent as the regulation except in one regard. CGS section 22a-174(f) includes the term “brush,” but does not include a definition of this term. Instead of including the definition of brush in the statute, Connecticut added “brush” to RCSA section 22a-174-1 (definitions), effective February 1, 2010: “Brush” means shrubs, vegetation or prunings, the diameter of which is not greater than three inches at the widest point.” Connecticut included this definition as contained in RCSA section 22a-174-1(19) as part of the state's December 14, 2015 SIP submittal for infrastructure requirements for the 2012 PM2.5 NAAQS. Therefore, EPA has determined that removing RCSA section 19-508-17 from the Connecticut SIP and replacing it with CGS section 22a-174(f) is consistent with the Clean Air Act section 110(l) anti-backsliding requirements. Accordingly, EPA is approving: (1) The removal of RSCA section 19-508-17 from the Connecticut SIP; (2) the addition of CGS section 22a-174(f), submitted on November 19, 2012, into the Connecticut SIP; and (3) the addition of the definition of “brush” in RSCA section 22a-174-1, submitted on December 14, 2015, into the Connecticut SIP.

    Portable Fuel Container Spillage

    The regulation that controls portable fuel container spillage presently in the Connecticut SIP, RCSA section 22a-174-43, was adopted by the state in 2004, and applies to any person who sells, supplies, offers for sale, or manufactures a portable fuel container or spout for use in Connecticut. In 2007, EPA promulgated national evaporative emission standards for portable fuel containers. EPA's regulation prohibits manufacturers or importers from selling, offering for sale, introducing or delivering for introduction into commerce in the United States, or importing, any new portable fuel container that is subject to the emissions standards of the regulation and is manufactured after December 31, 2008, unless it is covered by a valid certificate of conformity, it is labeled as required, and it complies with all of the applicable requirements of the regulation, including compliance with the emissions standards for its useful life. After June 30, 2009, no manufacturer or importer may sell, offer for sale, introduce or deliver into commerce in the United States, or import any new portable fuel container that was manufactured prior to January 1, 2009 unless it meets the requirements of the regulation.

    EPA's regulation also prohibits wholesale distributors from selling, offering for sale, or distributing any portable fuel container in the United States that is subject to the emissions standards of the regulation and is manufactured after December 31, 2008, unless it is covered by a valid certificate of conformity and is labeled as required. After December 31, 2009, no wholesale distributor may sell, offer for sale, or distribute in the United States any portable fuel container that was manufactured prior to January 1, 2009 unless it meets all of the requirements of the regulation. After December 31, 2009, all new portable fuel containers shall be deemed to be manufactured after December 31, 2008 unless they are in retail inventory.

    Even though the applicability date for SIP-approved RCSA section 22a-174-43 is earlier, May 1, 2004, all fuel containers must now (in the year 2016 and beyond) meet the federal regulation, which is as stringent as RCSA section 22a-174-43. Therefore, EPA has determined that removal of RCSA section 22a-174-43 from the Connecticut SIP is consistent with the Clean Air Act section 110(l) anti-backsliding requirements and is approvable.

    IV. Final Action

    EPA is approving Connecticut's request, submitted to EPA on November 19, 2012, to remove from the Connecticut SIP RCSA section 19-508-17 “Control of Open Burning” and section 22a-174-43 “Portable Fuel Container Spillage Control.” We are also incorporating into the Connecticut SIP the following Connecticut statute which was included in the November 19, 2012 submittal: Connecticut General Statute, Title 446c, Section 22a-174 (Formerly Sec. 19-508) “Powers of the commissioner. Regulations. Fees. Exemptions. General permits. Appeal of commissioner's action re permit applications,” (f) “Open Burning,” effective March 30, 2000. In addition, EPA is approving the definition of “brush” as contained in RCSA section 22a-174-1, which was included in Connecticut's December 14, 2015 submittal to meet infrastructure requirements under sections 110(a)(1) and 110(a)(2) of the Clean Air Act for the 2012 PM2.5 NAAQS.

    The EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should relevant adverse comments be filed. This rule will be effective October 31, 2016 without further notice unless the Agency receives relevant adverse comments by October 3, 2016.

    If the EPA receives such comments, then EPA will publish a notice withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on the proposed rule. All parties interested in commenting on the proposed rule should do so at this time. If no such comments are received, the public is advised that this rule will be effective on October 31, 2016 and no further action will be taken on the proposed rule. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

    V. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Connecticut General Statute, Title 446c, Section 22a-174 (Formerly Sec. 19-508) “Powers of the commissioner. Regulations. Fees. Exemptions. General permits. Appeal of commissioner's action re permit applications,” (f) “Open burning,” effective March 30, 2000, as published in the General Statutes of Connecticut, revision of 1958, revised to January 1, 2015, volume 8, described in the amendments to 40 CFR part 52 set forth below. EPA is also finalizing the incorporation by reference of RCSA section 22a-174-1(19) “brush,” effective February 1, 2010, as published in the State of Connecticut General Statutes, revised to January 1, 2015, described in the amendments to 40 CFR part 52 set forth below. Note that the definition for paragraph (19) in the statute that is incorporated by reference is the same as the definition that became effective in Connecticut on February 1, 2010. The EPA has made, and will continue to make, these documents generally available electronically through http://www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

    VI. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

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

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

    Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 31, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

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

    Dated: February 4, 2016. H. Curtis Spalding, Regional Administrator, EPA New England.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:

    PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority:

    42 U.S.C. 7401 et seq.

    Subpart H—Connecticut 2. Section 52.370 is amended by: a. Removing and reserving paragraph (c)(95)(i)(C); and b. Adding paragraph (c)(113).

    The addition reads as follows:

    § 52.370 Identification of plan.

    (c) * * *

    (113) Revisions to the State Implementation Plan submitted by the Connecticut Department of Energy and Environmental Protection on November 19, 2012 and December 14, 2015.

    (i) Incorporation by reference.

    (A) Section 19-508-17, “Control of Open Burning,” which was approved in the March 1972 plan (see paragraph (b)) is removed and replaced with the following:

    (1) Connecticut General Statute, Title 22A “Environmental Protection,” Chapter 446c “Air Pollution Control,” Section 22a-174 “(Formerly Sec. 19-508). Powers of the commissioner. Regulations. Fees. Exemptions. General permits. Appeal of commissioner's action re permit applications,” paragraph (f), effective March 30, 2000, as published in the General Statutes of Connecticut, revision of 1958, revised to January 1, 2015, volume 8.

    (2) Regulations of Connecticut State Agencies (RCSA) section 22a-174-1 entitled “Definitions,” revisions to Section 22a-174-1(19), as published in the Connecticut Law Journal on July 1, 2014.

    (B) [Reserved]

    (ii) Additional materials. [Reserved]

    3. In § 52.385, Table 52.385 is amended by adding entries to existing state citations for 22a-174-1, 22a-174-17, and 22a-174-43; and adding an entry for CGS Section 22a-174(f) to read as follows:
    § 52.385 EPA-approved Connecticut regulations. Table 52.385—EPA-Approved Regulations Connecticut state citation Title/subject Dates Date
  • adopted by
  • state
  • Date
  • approved by
  • EPA
  • Federal
  • Register
  • citation
  • Section 52.370 Comments/description
    *         *         *         *         *         *         * 22a-174-1 Definitions 2/1/10 9/1/16 [Insert Federal Register citation] (c)(113) Approved 22a-174-1(19) definition of “brush” for purposes of Connecticut General Statutes (CGS) Section 22a-174(f); see paragraph (c)(113)(A) of this section. *         *         *         *         *         *         * 22a-174-17 (formerly 19-508-17) Control of Open Burning 4/4/72 9/1/16 [Insert Federal Register citation] (b)(2) DEEP regulation to control open burning. Paragraph (b) was revised 9/1/16 by redesignating paragraph (b) as (b)(1) and adding paragraph (b)(2) to read as follows: This rule, formerly known as Section 19-508-17, which was approved in paragraph (b)(1), is removed from the SIP and replaced by Connecticut General Statute (CGS) section 22a-174(f) and RCSA section 22a-174-1(19); see paragraph (c)(113)(A) of this section. *         *         *         *         *         *         * 22a-174-43 Portable Fuel Container Spillage Control 5/10/04 9/1/16 [Insert Federal Register citation] (c)(95) DEEP regulation to control portable fuel container spillage. Paragraph (c)(95) was revised 9/1/16 by removing and reserving paragraph (c)(95)(i)(C). *         *         *         *         *         *         * Connecticut General Statute, Title 446c, Section 22a-174(f) Powers of the commissioner. Open Burning 3/30/00 9/1/16 [Insert Federal Register citation] (c)(113) Control of open burning; see paragraph (c)(113)(A) of this section.
    [FR Doc. 2016-21012 Filed 8-31-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF TRANSPORTATION Federal Transit Administration 49 CFR Part 661 [Docket Nos. FTA-2016-0019 & FTA-2016-0020] Notice of Policy on the Implementation of the Phased Increase in Domestic Content Under the Buy America Waiver for Rolling Stock and Notice of Public Interest Waiver of Buy America Domestic Content Requirements for Rolling Stock Procurement in Limited Circumstances AGENCY:

    Federal Transit Administration, DOT.

    ACTION:

    Notice of final policy and public interest waiver.

    SUMMARY:

    This final policy consists of the Federal Transit Administration's (FTA) policy statement regarding its implementation of the phased-in increase in domestic content for rolling stock under the FTA's Buy America statute, as amended by the Fixing America's Surface Transportation (FAST) Act. Through this final policy, FTA is providing guidance to transit agencies and transit vehicle manufacturers regarding how they are to implement the FAST Act's statutory amendments. Additionally, FTA is providing notice of public interest waivers of Buy America domestic content requirements for rolling stock procurements in limited circumstances.

    DATES:

    The final policy takes effect on September 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Cecelia Comito, Assistant Chief Counsel, Office of the Chief Counsel, phone: (202) 366-2217, or email, [email protected]

    SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. Proposed Policy Guidance and Public Interest Waiver A. Proposed Policy B. Proposed Public Interest Waiver III. Response to Comments A. What date controls the percentage of domestic content? B. How do the new requirements apply to options, joint procurements, and piggyback procurements? C. Do the increased domestic content requirements extend to subcomponents? D. Do the changes also apply to train control, communication, and traction power systems? E. Does the increase in domestic content requirements apply to remanufactured, overhauled, or rebuilt transit vehicles? F. Do the FAST Act amendments apply to passenger ferry vessels? G. How do the new rules apply to reimported domestic steel and iron? H. Will FTA issue public interest waivers for vehicle procurements underway when the FAST Act was enacted? IV. Final Policy Guidance and Public Interest Waivers A. Final Policy Guidance B. Final Public Interest Waivers I. Introduction

    This Notice provides guidance and clarification to transit agencies and transit vehicle manufacturers regarding FTA's implementation of the FAST Act's amendments to 49 U.S.C. 5323(j)(2)(C).

    Section 3011 of the FAST Act (Pub. L. 114-94, enacted December 4, 2015) amended the rolling stock waiver in 49 U.S.C. 5323(j)(2)(C) to require a two-step increase in the domestic content of rolling stock as follows:

    When procuring rolling stock with FTA financial assistance (including train control, communication, traction power, and rolling stock prototypes), the cost of components and subcomponents produced in the United States for fiscal years 2016 and 2017, is more than 60 percent of the cost of all components of the rolling stock; for fiscal years 2018 and 2019, is more than 65 percent of the cost of all components of the rolling stock; and for fiscal year 2020 and each fiscal year thereafter, is more than 70 percent of the cost of all components of the rolling stock.

    Given the potential effect of the FAST Act changes to vehicle procurements by the statutory use of the term “produced,” transit agencies and transit vehicle manufacturers asked FTA to provide specific guidance on the applicability of the FAST Act's new Buy America provisions to contracts entered into before, on, or after October 1, 2015, the effective date set forth in section 1003 of the FAST Act.

    Under existing law (49 U.S.C. 5325(e)), recipients of FTA financial assistance may enter into rolling stock contracts for up to five years for buses and seven years for railcars. In FTA Circular 4220.1F, “Third Party Contracting Guidance,” FTA permits these five- and seven-year periods to cover the recipient's “material requirements” for rolling stock and replacement needs from the effective date of the contract through the end of the fifth or seventh year. FTA does not require that “the recipient must obtain delivery, acceptance, or even fabrication in five or seven years—instead, it means only that FTA limits a contract to purchasing no more than the recipient's material requirements for rolling stock or replacement parts for five or seven years, based on the effective date of the contract.” See FTA Circular 4220.1F, Chapter IV, page 23. Under this rule, options for vehicles must be exercised within the five- or seven-year contract term, although the vehicles may be produced and delivered after the contract term.

    II. Proposed Policy and Public Interest Waiver A. Proposed Policy Guidance

    The FAST Act identified two points in time: (1) “when procuring rolling stock,” which FTA's proposed policy interpreted as the date the vehicle procurement contract was signed; and (2) “the cost of components and subcomponents produced in the United States for fiscal years . . .”, which FTA interpreted as the delivery date of the vehicle.

    Individual and Joint Procurements. FTA proposed to implement the FAST Act by requiring that if a recipient (or a group of recipients under a joint procurement) enters into a contract for rolling stock after the effective date of the FAST Act, i.e., October 1, 2015, the new FAST Act provisions for domestic content of the rolling stock would apply based on the delivery date of the vehicle. Thus, for vehicles delivered in FY2018 and FY2019, the domestic content would have to be more than 65 percent, and for vehicles delivered in FY2020 and beyond, the domestic content would have to be more than 70 percent. These higher domestic content requirements would apply to all contracts signed after the effective date of the FAST Act unless FTA issues a waiver, which FTA addressed in a separate Federal Register Notice (81 FR 20051, April 6, 2016).

    In its proposed policy statement, FTA proposed that the FAST Act amendments would not apply to a contract entered into before the effective date of the FAST Act, i.e., October 1, 2015, even if the contract provides for the delivery of vehicles after FY2017. In addition, the policy statement proposed to continue to permit options to be exercised for those contracts entered into before October 1, 2015, even if the vehicles would be delivered outside the five- or seven-year contract term, consistent with Circular 4220.1F.

    However, recipients who were not direct parties to a contract executed before October 1, 2015, would not be allowed to exercise options (a/k/a “piggybacking”) on those contracts and thereby could not take advantage of the lower domestic content requirement. Because the assignment of options to a third party results in the third party and the vendor entering into a new contract that would be entered into after the effective date of the FAST Act, FTA proposed to apply the increased domestic content requirements to vehicles scheduled for delivery in FY 2018 and beyond.

    State Purchasing Schedules. In the proposed policy statement, FTA recognized that some recipients and subrecipients purchase rolling stock from a State purchasing schedule (i.e., an arrangement that a State has negotiated with multiple vendors in which those vendors essentially agree to provide an option to the State, as well as subordinate and local governmental entities allowed to participate in the schedule, to acquire specific property or services in the future at established prices). Because the purchasing schedule does not commit the State to procuring a minimum number of vehicles, a “contract” does not exist until a State, recipient, or subrecipient enters into a purchase order with a vendor listed on the schedule.

    Therefore, the proposed policy statement proposed to retain the 60 percent domestic content requirement for purchase orders placed against State purchasing schedules before October 1, 2015, regardless of the ultimate delivery date(s). However, for purchase orders placed against State purchasing schedules on or after October 1, 2015, FTA proposed to adopt the elevated FAST Act content requirements.

    This interpretation is consistent with the language of the statute, follows Congress' intention to increase the domestic content for vehicles produced in FY2018 or later, and adheres to basic principles of statutory construction.

    Calculation of Domestic Content for Components and Subcomponents. In its proposed policy statement, FTA proposed to adjust the calculation for determining whether a component is of domestic origin under 49 CFR 661.11 to mirror the increase in domestic content for FY2018 and beyond. Currently under 49 CFR 661.11(g), “for a component to be of domestic origin, more that 60 percent of the subcomponents of that component, by cost, must be of domestic origin, and the manufacture of the component must take place in the United States. If, under the terms of this part, a component is determined to be of domestic origin, its entire cost may be used in calculating the cost of domestic content of an end product.”

    Thus, for vehicles to be delivered in FY2018 and 2019, FTA proposed that more than 65 percent of the subcomponents of that component, by cost, must be of domestic origin, and for FY2020 and beyond, more than 70 percent of the subcomponents of the component must be of domestic origin. The existing requirement that manufacture of the component take place in the United States would continue to apply, as well as the provision that states that if a component is determined to be of domestic origin, its entire cost may be used in calculating the domestic value of the rolling stock, regardless of the value of its individual subcomponents.

    B. Proposed Public Interest Waiver

    FTA recognized that the FAST Act amendments may produce significant hardship for two categories of recipients and manufacturers: (1) Recipients who entered into contracts or placed purchase orders against State schedules between October 1, 2015 and December 4, 2015 (i.e., the effective date of the Act and its enactment date, respectively); and (2) recipients who entered into contracts after December 4, 2015, as a result of solicitations for bids or requests for proposals that were advertised before December 4, 2015.

    Under 49 U.S.C. 5323(j)(2)(A), the Secretary of Transportation may waive the Buy America requirements if the Secretary finds that applying the Buy America requirements would be “inconsistent with the public interest.” This function has been delegated to the FTA Administrator by 49 CFR 1.91, and section 661.7(b) of FTA's implementing regulation (49 CFR part 661) provides: “In determining whether the conditions exist to grant this public interest waiver, the Administrator will consider all appropriate factors on a case-by-case basis . . . . When granting a public interest waiver, the Administrator shall issue a detailed written statement justifying why the waiver is in the public interest. The Administrator shall publish this justification in the Federal Register, providing the public with a reasonable time for notice and comment of not more than seven calendar days.”

    In a separate Notice accompanying the proposed policy statement (Docket FTA-2016-0020), FTA sought comment on a general public interest waiver for those affected parties (81 FR 20051, April 6, 2016). FTA proposed a public interest waiver for the following categories of contracts: (1) For contracts entered into between the FAST Act's effective date and date of enactment (i.e., from October 1, 2015 through December 4, 2015), the increased domestic content requirements for FY2018 and beyond would not apply, regardless of when the vehicles were delivered; and (2) for contracts entered into after December 4, 2015 as a result of solicitations for bids or requests for proposals that were advertised before December 4, 2015, the increased domestic content requirements for FY2018 and beyond would not apply, regardless of when the vehicles were delivered.

    III. Response to Comments

    FTA received comments from 24 entities in Docket FTA-2016-0019 and comments from 14 entities in Docket FTA-2016-0020 from a broad cross-section of transit agencies, transit vehicle manufacturers, transit industry trade associations, the passenger vessel industry, an alliance of domestic manufacturing interests, compliance auditors, and the general public. The comments and proposals were diverse. The comments and questions can be categorized into the following primary categories:

    A. What date controls the percentage of domestic content?

    Numerous commenters objected to the proposed policy statement's use of the delivery schedule as the determining factor. Some suggested that domestic content should be based on the solicitation date, which establishes the transit agency's domestic content expectations for prospective bidders, and allows suppliers to begin identifying domestic suppliers. They claimed that using the solicitation date of an invitation for bids or a request for proposals provides certainty to transit vehicle manufacturers, as transit agencies and transit vehicle manufacturers cannot forecast when a contract will be signed or when the vehicles will be delivered.

    As an alternative to the solicitation date, a significant number of commenters proposed that FTA apply the domestic content requirements based upon the date a contract was entered into, for three primary reasons—consistency in vehicle components to avoid cardinal changes and increased pricing risks, reduction of administrative burdens, and consistency with the approach Congress used in implementing the last legislative increase in domestic content, which took place in 1987.

    According to transit vehicle manufacturers, their vehicle bid quotes are based on the price of components known at the time the vehicle manufacturer receives the transit agency's solicitation and begins planning its supply chain by contacting potential suppliers. According to commenters, FTA's proposed policy had the potential of requiring three different component calculations based on a multi-year delivery schedule stemming from a single contract—one for vehicles delivered during FYs 2016-2017, another for FYs 2018-2019, and a third for FYs 2020 and beyond. This would require the vehicle manufacturer to identify new and potentially untried domestic suppliers for each successive configuration, integrate those new components in the midst of an ongoing production line, and incur the risk of price increases for those new components, as well as the possibility that the replacement or substitution of components might be characterized by some competitors as a “cardinal change.” Commenters also noted that a vehicle scheduled for delivery during the FY 2018-2019 time frame with a 65 percent domestic content requirement could find itself subject to a 70 percent domestic content requirement if delays and slippages beyond the control of the transit agency and the transit vehicle manufacturer resulted in the vehicle being delivered in FY 2020 or later. They requested a constant domestic content level that would exist for the duration of the production contract.

    In addition, transit agencies expressed concerns regarding the administrative costs and burdens of performing three separate pre-award audits and three separate post-award audits on three potentially different vehicle configurations. As a term and condition of assistance, recipients of FTA funding must conduct a pre-award and post-delivery audit on every rolling stock model they procure. If domestic content was based on the delivery date, a transit agency with a multi-year delivery schedule faced the possibility that their vehicles could have three different levels of domestic content, which they would need to verify and confirm. In addition, unforeseen delays in production could result in a vehicle delivery occurring in a subsequent fiscal year with a higher domestic content obligation.

    Several commenters pointed out that when Congress elevated the domestic content requirement from 50 percent to 60 percent in section 337 of Title III of the Surface Transportation and Urban Relocation Assistance Act of 1987 (Pub. L. 100-17) (STURAA), Congress provided that a vehicle's domestic content percentage would be based on the date the procurement contract was signed. Commenters suggested that FTA follow that approach.

    Finally, one commenter requested clarification on the Notice's use of the term “advertised” when referring to “solicitations for bids or requests for proposals that were advertised before December 4, 2015.” FTA will address this request in the discussion of the public interest waiver, below.

    FTA's Response:

    Basing domestic content standards on the date the solicitation is made available to the public and potential bidders or on the date the contract is executed is contrary to language in the FAST Act. Using the date of solicitation would allow transit agencies to lock in a lower domestic content threshold for a contract that may be signed at a date when the higher domestic content standards are in effect, contrary to the statutory language. FTA believes Congress provided adequate advance notice in the FAST Act regarding the increase in domestic content, such that manufacturers and vendors have sufficient time to amend open solicitations for bids prior to the submission of bid proposals or the execution of a contract, and in fact, FTA is aware of transit agencies that have amended solicitations after they have been published. FTA also is aware that some vehicle manufacturers have indicated through a survey of pre-award audit data that they are already capable of meeting a higher domestic content threshold.

    FTA does not find the request to follow the language used in earlier revisions to domestic content requirements to be persuasive. When Congress enacted STURRA in 1987, it amended the statutory language in the authorizing statute to increase the domestic content requirement from 50 percent to 55 percent effective October 1, 1989, and section 337(a)(1)(B) increased the domestic content from 55 percent to 60 percent effective October 1, 1991. Specifically, section 337(a)(2)(B) provided that the amendments shall not apply with respect to any supplier or contractor or any successor in interest or assignee which qualified under the provisions of section 165(b)(3) of the Surface Transportation Assistance Act of 1982 prior to the date of enactment of this Act under a contract entered into prior to April 1, 1992.

    UMTA (FTA's predecessor agency) quickly published an implementing Notice that stated:

    The Buy America domestic content requirement for buses, rolling stock and associated equipment will be increased from its existing 50 percent to 55 percent at the end of three years, and to 60 percent at the end of five years, except that any company that has met the existing Buy America requirement would be exempted from these increases for all contracts entered into before April 1, 1992. In addition, the rolling stock price differential waiver is increased from its current 10 percent to 25 percent, and the definition of “components” is specifically to include “subcomponents.” UMTA will be revising its Buy America regulation to reflect these changes. (52 FR 15440, April 28, 1987)

    UMTA then published a Notice of Proposed Rulemaking to implement these new provisions (53 FR 32994, August 29, 1988), issuing its Final Rule on January 9, 1991 (56 FR 926). In the Final Rule, UMTA stated that it “believes that Congress intended to apply the increased domestic content requirements on an accelerated basis to firms entering the marketplace after April 2, 1987, and that it intended to grandfather existing firms that had complied with previous Buy America requirements regardless of the number of contracts or the product supplied (e.g., a bus versus a rail car).”

    Although Congress had the precedent of the timing language used in STURAA when it drafted the FAST Act, Congress declined to reintroduce that language.

    However, FTA finds the requests that the domestic content of a vehicle be fixed upon a single date that establishes the domestic content level for the duration of the contract to be persuasive, for the reasons articulated by the commenters. For those reasons, the applicable domestic content percentage will be based on the scheduled delivery date of the first production vehicle (i.e., the first vehicle intended to carry passengers in revenue service), final acceptance notwithstanding. This approach is closest to the FAST Act's statutory language and to Congress' clear direction. If the delivery date slips into a subsequent FY due to unforeseen circumstances, FTA will address those situations on a case-by-case basis. (Note that FTA is basing the domestic content requirement on the delivery date of the first production vehicle, rather than on the delivery date of a prototype unit, for several reasons. First, prototype units are constructed by the manufacturer for the limited purpose of design qualification testing, and may not necessary represent the finalized car design or car content. Second, prototypes are produced for testing purposes, and do not typically enter revenue (i.e., passenger) service in their prototype configuration. Finally, prototype units are delivered several months before the scheduled delivery date of the first production model and may not necessarily represent the final vehicle configuration, although the scheduled delivery date of the first production unit will undoubtedly control the components contained in the prototype unit. Consistent with the FAST Act, however, prototype units must contain an identical percentage of domestic content as the production units.)

    This approach of using the date of first production vehicle delivery best reflects the statutory language of the FAST Act, while providing the consistency in componentry and relieving the need to conduct multiple pre-award and post-delivery audits raised as concerns by numerous commenters. The FAST Act's phased-in approach provides adequate notice to transit agencies and transit vehicle manufacturer suppliers of the domestic content requirements.

    B. How do the new requirements apply to options, joint procurements, and piggyback procurements?

    FTA received numerous comments regarding the effect of the higher domestic content provisions on options, joint procurements, and piggyback procurements. One commenter objected to extending the domestic content percentages throughout the life of a multi-year contract, including the exercise of any options, believing that Congress intended to increase domestic content as soon as possible, and that allowing the exercise of options would lock in a lower domestic content threshold well through FY 2020 and beyond. In contrast, several transit agencies and vehicle manufacturers proposed that the domestic content for rolling stock extend to the exercise of options for additional vehicles of identical manufacture, citing the benefits to rolling stock manufacturers and transit agencies, such as the predictability of pricing, the availability of components, consistency within the supply chain, and facilitating the ongoing manufacturing of rolling stock. They also cited the retroactive effect of such an approach, stating that applying a higher domestic content standard to a pre-existing contract that established a lower threshold was inconsistent with public interest and general principles of contract law.

    One commenter sought clarity regarding the applicability of the proposed policy guidance to joint procurement contracts executed prior to the effective date of the FAST Act.

    Several commenters objected to FTA's proposed guidance that would not allow recipients to piggyback on another agency's contract unless the vehicles being produced under the original contract met the domestic content requirements at the time the optioned vehicles are delivered.

    FTA's Response:

    FTA's proposed policy recognized the differences between the exercise of options by the original parties to a contract or a joint procurement between two or more purchasers and a single vehicle manufacturer, and piggyback procurements by third parties who were not parties to the original contract. With regard to the exercise of options, FTA is persuaded that the predictability of pricing and consistency within the supply chain outweighs any risks that the FAST Act is being circumvented. Therefore, FTA is modifying its final policy guidance to reflect that the date of the delivery of the first production vehicle under the contract controls the domestic content of all vehicles delivered under the contract, including vehicles delivered pursuant to the exercise of options. The exercise of options by the original parties to the contract or joint procurement establishes a predictable contract price for the buyers, and provides a standardized component list for the transit vehicle manufacturer, while at the same time it allows the transit vehicle manufacturer to keep its production line open, ensuring American jobs. However, only the original parties to a contract (including signatories to a joint procurement) are entitled to the benefits of exercising rights under that procurement.

    FTA is not persuaded by the commenters who objected to FTA's limitations on the use of piggyback procurements during this transition period. The right to exercise an option does not create a contractual obligation until that contract is actually signed. Thus, assigning contract options to a third party will result in a new contract between that third party and the transit vehicle manufacturer, negating commenters' concerns that an increase in domestic content might be viewed as a “cardinal change.” Third parties seeking the assignment of procurement options (a/k/a “piggybacking”) have no contractual or statutory right to that option, and FTA considers that procurement to be a “new” contract and therefore subject to the applicable FAST Act standard based upon the scheduled delivery date of the first production vehicle under the new contract.

    C. Do the increased domestic content requirements extend to subcomponents?

    In its April 6 publication, FTA proposed to extend the elevated domestic content requirements to the subcomponents that constitute a component. FTA received relatively little comment on this specific provision. Several commenters proposed that a component's domestic content be based upon the date the component was offered in response to a solicitation, rather than upon the component's actual date of manufacture or the vehicle's intended delivery date. In support of their position, transit vehicle manufacturers said that they solicit bids for vendors for specific vehicle components. The prices submitted by those bidders are based upon quotes received from their suppliers and sub-suppliers, and the transit vehicle manufacturer has limited ability to leverage that bidder to increase the domestic content of its subcomponents. In addition, changing suppliers midway through a production schedule would be disruptive to production schedules, particularly if a manufacturer must switch to an untested supplier solely to meet a gradual increase in domestic content. In contrast, the association supporting domestic manufacturing expressed concerns that maintaining fixed domestic component and subcomponent levels throughout the life of the contract discourages new rolling stock suppliers from entering the market.

    FTA's Response:

    With the exception of components manufactured by the transit vehicle manufacturer itself, the vehicle manufacturer has little influence over the subcomponent content of a given component, and given the prevalence of multi-year vehicle delivery schedules, the effective date for a component's domestic content will be based upon the requirements in the contract. For solicitations advertised after the effective date of this Notice, however, the solicitation must include the appropriate statutory domestic content percentages for both components and subcomponents.

    FTA is sensitive to the position that the elevated domestic content requirements eventually will encourage new entrants into the vehicle supply chain. All contracts signed after the FAST Act's effective date, including piggyback procurements and procurements off a state's procurement schedule, will be subject to the higher domestic content standards, resulting in more domestic suppliers entering the supply chain and the incorporation of more domestic content into vehicles funded with FTA financial assistance.

    D. Do the changes also apply to train control, communication, and traction power systems?

    For purposes of Buy America, rolling stock includes train control, communication, and traction power equipment. 49 U.S.C. 5323(j)(2)(C). See also 49 CFR 661.11(t), (u), and (v). One commenter pointed out that the delivery of components on a construction contract differs from the delivery schedule of a rolling stock contract. Unlike rolling stock procurements where the transit agency is contracting for a fleet of homogenous transit vehicles, a construction contract may encompass a communication system, a traction power system, and a train control system, all of which may have differing construction schedules and varying component lists. Attempting to impose a domestic content based on when components are delivered to a job site, or the completion date of a particular construction segment may force the substitution of materials midway through a construction project, or in a worse-case scenario, may force the removal and replacement of components if delays push the completion of the contract into a subsequent fiscal year. The commenter proposed that the contracting date for the construction project would be a better determinant of the domestic content requirement, rather than one based on the installation date of each component or the completion of a particular portion of a construction contract.

    FTA's Response:

    FTA agrees with the commenter that there are significant differences between procurements for identical units of rolling stock, and a construction contract consisting of multiple deliverables, and therefore, the contracting award dates for train control, communication, and traction power systems will determine the contract's domestic content percentage. If a contract was signed in FY2016 or FY2017, the resulting components must consist of at least 60 percent domestically-manufactured components. If a construction contract is awarded during FY 2018 or FY 2019, the contract must include a domestic content percentage for that project that exceeds the 65 percent threshold. And if a construction contract is awarded in FY 2020 or beyond, the percentage of domestically-manufactured components must exceed 70 percent.

    E. Does the increase in domestic content requirements apply to remanufactured, overhauled, or rebuilt transit vehicles?

    A transit vehicle rebuilder proposed that the FAST Act amendments should not apply to overhauls, rebuilds or remanufacture of any buses procured prior to the effective date of the FAST Act. The commenter also asked that the requirements be applied consistently throughout the duration of a contract so that the resulting vehicles will have consistent Buy America content. The commenter argues that the FAST Act amendments should not be interpreted in any manner that decreases transit agencies' abilities to complete their intended overhauls by forcing a higher standard of American content at the time of overhaul than when the bus was originally manufactured.

    FTA's Response:

    Consistent with the commenter's recommendation, FTA agrees that the domestic content in effect at the time the vehicle was delivered will apply to any future contracts for overhaul, rebuild, or remanufacturing projects, limited to the parties on the original contract.

    F. Do the FAST Act amendments apply to passenger ferry vessels?

    FTA received two comments from the passenger ferry vessel industry and a ferry operator that proposed an implementation process for ferry vessels that based the domestic content requirement on the date of vessel contracting, rather than on the delivery date of the vessel. Commenters argued that it can be hard at the time of the contract's execution to anticipate with specificity exactly when the constructed ferry vessel will be finished, pass required regulatory inspections and sea trials, and be delivered to the customer. For vessels scheduled to be delivered over a multi-year program, they noted the difficulty and inefficiency in maintaining multiple component lists for identical vessels that would be delivered across different fiscal years.

    FTA's Response:

    FTA acknowledges that the long lead times associated with issuing design specifications, obtaining Coast Guard and other regulatory approval, bid solicitations, and construction of a ferry vessel exceed that required for other traditional types of rolling stock. Accordingly, for ferry vessels, the date on which a transit agency signs the procurement contract will govern the domestic content for all vessels delivered under that contract.

    G. How do the new rules apply to reimported domestic steel and iron?

    One commenter asked that FTA address the applicability of section 3011 of the FAST Act, which added 49 U.S.C. 5323(j)(5), allowing the inclusion of steel and iron produced in the United States and incorporated into a rolling stock frame or car shell outside the United States, provided that the frame or car shell is imported back into the United States for final assembly.

    FTA's Response:

    Consistent with the statutory provision, the cost of any domestic steel and iron may be included in the calculation of the transit vehicle's domestic content, provided that the average cost of the vehicle exceeds $300,000, as provided by the FAST Act. Manufacturers may include the cost of domestic steel and iron on vehicles produced after October 1, 2015, the effective date of the FAST Act.

    H. Will FTA issue public interest waivers for vehicle procurements underway when the FAST Act was enacted?

    In a Notice published concurrently with the proposed policy statement (81 FR 20051, April 6, 2016), FTA invited the public to comment on a proposed public interest waiver that would apply the current domestic content standard to rolling stock contracts entered into between October 1, 2015 (the effective date of the FAST Act) and December 4, 2015, (the date on which the Act was enacted), and for contracts entered into after December 4, 2015, as a result of solicitations for bids or requests for proposals that were advertised before December 4, 2015.

    FTA received 14 comments on the proposed waiver from: A transit industry trade association, a passenger vessel trade group, several public transportation agencies, numerous transit vehicle manufacturers and remanufacturers, and Buy America consultants, all of whom supported the proposed waiver. Among the cited benefits of a waiver were the avoidance of additional costs to transit agencies that would have to rewrite and re-advertise existing solicitations to incorporate the new domestic content thresholds, the administrative costs to vehicle manufacturers who would need to identify and solicit new domestic suppliers, and most importantly, predictable delays in the acquisition of new transit vehicles, which would pose a disservice to transit riders.

    The passenger vessel group asked that FTA extend the waiver to ferry vessel procurements for which the vessel design was substantially complete before the enactment of the FAST Act; vehicle remanufacturers asked that the waiver extend to contracts for rebuilds, overhauls, and remanufacturing entered into prior to the enactment date of the FAST Act; and several transit agencies and vehicle manufacturers asked that the waiver extend to contract options assigned to another transit agency if the contract was entered into prior to the FAST Act's enactment date.

    FTA's Response:

    Based on the foregoing discussion of the FAST Act's implementation and input from commenters, FTA believes that a request for a public interest waiver to address contracts signed before the date the FAST Act was enacted is reasonable, and is extending the waiver to contracts for ferry vessels and to contracts for the remanufacturing, rebuilding, and overhaul of a recipient's existing fleet. However, as stated previously, FTA will not extend pre-FAST Act domestic content percentages to options exercised by a third party after the effective date of the Act.

    Further, to avoid the disruption of ongoing contract solicitations and to facilitate the delivery of transit vehicles to the public, FTA is extending the waiver to contract solicitations advertised on or after December 4, 2015, provided the contract is awarded within 60 days after the publication date of this Notice. If a solicitation was advertised (i.e., published or distributed to potential bidders in manner that constitutes constructive notice) on or after the enactment date of the FAST Act and the parties are unable to execute a contract within 60 days of this Notice, the solicitation must be amended to reflect the applicable domestic content standard that will be in effect when the first production vehicle is scheduled to be delivered. If compliance with this requirement would pose an undue hardship, FTA will evaluate requests for a waiver on a case-by-case basis.

    A request for a public interest waiver should set forth the detailed justification for the proposed waiver, including information about the history of the procurement and the burden on the recipient and/or the industry in complying with the FAST Act. Public interest waivers should be narrowly tailored and FTA will not generally look favorably on waivers that provide for contracts that include the exercise of options for vehicles that will be delivered beyond FY2020. FTA will act expeditiously on public interest waiver requests that provide the information requested.

    IV. Final Policy Guidance and Public Interest Waiver A. Final Policy Guidance

    Individual and Joint Procurements of Buses and Railcars. For rolling stock contracts entered into on or after October 1, 2015, i.e., the effective date of the FAST Act, the applicable domestic content percentage under section 5323(j)(2)(C) will be based on the scheduled delivery date of the first production vehicle (i.e., the first vehicle intended to carry passengers in revenue service), final acceptance notwithstanding. Thus, if a recipient or group of recipients as part of a joint procurement enter into a contract for rolling stock on or after October 1, 2015, then the new FAST Act provisions applicable for the date of delivery of the first production vehicle shall apply. Accordingly, if the first production vehicle is delivered in FY2018 or FY2019, the domestic content must be more than 65 percent, and if the first production vehicle is delivered in FY2020 or beyond, the domestic content must be more than 70 percent. These delivery provisions apply to contracts entered into on or after October 1, 2015, unless a waiver is granted. If the delivery date of the first production vehicle is delayed such that it will be delivered in a year with a higher domestic content, FTA will address those situations on a case-by-case basis.

    The FAST Act amendments do not apply to contracts entered into before October 1, 2015, even if the contract provides for the delivery of the first production vehicle after FY2017. For contracts entered into before October 1, 2015, all vehicles delivered under the original contract base order and any properly exercised options by recipients who are direct parties to the contract may contain a domestic content of more than 60 percent, per the pre-FAST Act requirements. Recipients who are not direct parties to a contract executed before October 1, 2015, however, may not exercise assigned options (a/k/a “piggybacking”) on such contracts.

    Procurements of Ferry Vessels. Due to the long lead time in establishing vessel design specifications, obtaining Coast Guard certifications and other regulatory approval, and the bid solicitation and review process that exceeds that required for other traditional types of rolling stock, the date on which a transit agency signs the vessel contract will govern the domestic content for all vessels delivered under that contract. Therefore, for vessel contracts signed during FYs 2016 or 2017, the vessels must contain a minimum of 60 percent domestic content; contracts signed in FYs 2018 or 2019 must require no less than 65 percent domestic content; and contracts signed in FY 2020 or beyond must mandate a domestic content of no less than 70 percent.

    Train Control, Communication and Traction Power Equipment. For purposes of Buy America, rolling stock includes train control, communication, and traction power equipment. 49 U.S.C. 5323(j)(2)(C). See also 49 CFR 661.11(t), (u), and (v). The domestic content requirement in effect on the date a contract was signed for train control, communication, and traction power equipment will control. If the contract is signed in FY2016 or FY2017, the contract shall require an overall domestic content that exceeds 60 percent; if a contract is signed in FYs 2018 or 2019, the contract must include an overall domestic content percentage that exceeds 65 percent; and if a contract is signed in FY2020 or beyond, the domestic content must exceed 70 percent.

    State Purchasing Schedules. Some recipients purchase rolling stock from a State purchasing schedule. A State purchasing schedule is an arrangement that a State has established with multiple vendors in which those vendors agree to provide essentially an option to the State and its subordinate governmental entities and others it might include in its programs, to acquire specific property or services in the future at established prices. Because the purchasing schedule does not commit the State to procuring a minimum number of vehicles, a “contract” does not exist until a State, recipient or subrecipient enters into a purchase order with a vendor listed on the schedule.

    Therefore, for purchase orders placed against State purchasing schedules before October 1, 2015, for the delivery of rolling stock in FY2018 and beyond, the increased domestic content requirements will not apply. For purchase orders placed against State schedules on or after October 1, 2015, for rolling stock that will be delivered in FY 2016 or 2017, the domestic content requirement must exceed 60%. For purchase orders placed against State schedules for rolling stock that will be delivered in FYs 2018 or 2019, the domestic content must exceed 65%, and for purchase orders placed against State schedules for rolling stock that will be delivered in FY 2020 or beyond, the domestic content must exceed 70%.

    Calculation of Domestic Content. FTA will adjust the calculation for determining whether a component is of domestic origin under 49 CFR 661.11 to accommodate the increase in domestic content for FY2018 and beyond. Currently under 49 CFR 661.11(g), “for a component to be of domestic origin, more that 60 percent of the subcomponents of that component, by cost, must be of domestic origin, and the manufacture of the component must take place in the United States. If, under the terms of this part, a component is determined to be of domestic origin, its entire cost may be used in calculating the cost of domestic content of an end product.”

    Thus, for vehicles to be delivered in FY2018 or 2019, for a component to be of domestic content, more than 65 percent of the subcomponents of that component, by cost, must be of domestic origin, and for FY2020 or beyond, more than 70 percent of the subcomponents of the component must be of domestic origin. The requirement that manufacture of the component take place in the United States still applies. Additionally, if a component is determined to be of domestic origin, its entire cost may be used in calculating the cost of content of an end product.

    Cost of Domestic Steel and Iron for Rolling Stock Frame or Car Shell. Section 3011 of the FAST Act, which added 49 U.S.C. 5323(j)(5), allows domestic content to include steel and iron produced in the United States and incorporated into a rolling stock frame or car shell outside the United States, provided that the frame or car shell is imported back into the United States for final assembly. Consistent with the statutory provision, the cost of any domestic steel and iron may be included in the calculation of the transit vehicle's domestic content, provided that the average cost of the vehicles exceeds $300,000, as provided by the FAST Act. Manufacturers may include the cost of domestic steel and iron on vehicles produced after October 1, 2015, the effective date of the FAST Act.

    B. General Public Interest Waivers

    FTA is issuing two general public interest waivers to address two categories of recipients and manufacturers: (1) Recipients who entered into contracts or placed purchase orders against State schedules between October 1, 2015 and December 4, 2015; and (2) recipients who have entered into contracts after December 4, 2015, as a result of solicitations for bids or requests for proposals that were advertised before December 4, 2015. In addition, FTA is issuing a third public interest waiver for recipients who solicited contracts on or after December 4, 2015, provided they enter into a contract within 60 days of publication of this Notice.

    Under 49 U.S.C. 5323(j)(2)(A), the Administrator may waive the Buy America requirements if the Administrator finds that applying the Buy America requirements would be inconsistent with the public interest. “In determining whether the conditions exist to grant a public interest waiver, the Administrator will consider all appropriate factors on a case-by-case basis . . . When granting a public interest waiver, the Administrator shall issue a detailed written statement justifying why the waiver is in the public interest. The Administrator shall publish this justification in the Federal Register, providing the public with a reasonable time for notice and comment of not more than seven calendar days.” 49 CFR 661.7(b).

    Public interest waiver for contracts entered into between October 1, 2015 and December 4, 2015. FTA grants a general public interest waiver for contracts entered into between the FAST Act's effective date and date of enactment (i.e., between October 1, 2015 and December 4, 2015). For these contracts, the increased domestic content requirements for FY2018 and beyond will not apply, regardless of when the first production vehicle is delivered. However, consistent with FTA's policy statement above, parties to the contracts may exercise options under the contract, but recipients will not be permitted to piggyback on the contracts.

    Public interest waiver for contracts entered into after December 4, 2015 as a result of solicitations advertised before December 4, 2015. FTA grants a general public interest waiver for contracts entered into after December 4, 2015 as a result of solicitations for bids or requests for proposals that were advertised (i.e., published or distributed to potential bidders in a manner that constitutes constructive notice) before December 4, 2015. Under these circumstances, the increased domestic content requirements for FY2018 and beyond will not apply, regardless of when the first production vehicle is delivered. However, consistent with FTA's policy statement above, parties to the contracts may exercise options under the contract, but recipients will not be permitted to piggyback on the contracts.

    Public interest waiver for contract solicitations advertised on or after December 4, 2015 and entered into within 60 days of publication of this notice. To avoid the disruption of ongoing contract solicitations and to facilitate the delivery of transit vehicles to the public, FTA is extending the waiver to contract solicitations advertised on or after December 4, 2015, and entered into within 60 days after the publication date of this Notice. If a solicitation was advertised (i.e., published or distributed to potential bidders in a manner that constitutes constructive notice) after the enactment date of the FAST Act and the parties are unable to execute a contract within 60 days of this Notice, the solicitation must be amended to reflect the applicable domestic content standard that will be in effect when the first production vehicle is scheduled to be delivered. If compliance with this requirement would pose an undue hardship, FTA will evaluate requests for a waiver on a case-by-case basis.

    Recipients may apply to FTA for individual public interest waivers for contracts that do not fall within the scope of a general public interest waiver. A request for a public interest waiver should set forth the detailed justification for the proposed waiver, including information about the history of the procurement and the burden on the recipient and/or the industry in complying with the FAST Act. Public interest waivers should be narrowly tailored and FTA will not generally look favorably on waivers that provide for contracts that include the exercise of options for vehicles that will be delivered beyond FY2020. FTA will act expeditiously on public interest waiver requests that provide the information requested.

    V. Effective Date

    Because the statute is self-effectuating, the changes are effective upon the FAST Act's enactment. FTA will be initiating a subsequent rulemaking updating 49 CFR part 661 to reflect these changes; however, today's Policy Statement and Waiver represents FTA's implementation of the FAST Act provisions during this interim period.

    Dated: August 26, 2016. Ellen Partridge, Chief Counsel.
    [FR Doc. 2016-21007 Filed 8-31-16; 8:45 am] BILLING CODE 4910-57-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 120815345-3525-02] RIN 0648-XE831 Snapper-Grouper Fishery of the South Atlantic; 2016 Recreational Accountability Measure and Closure for the South Atlantic Other Porgies Complex AGENCY:

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

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS implements an accountability measure (AM) for the other porgies complex recreational sector in the exclusive economic zone (EEZ) of the South Atlantic for the 2016 fishing year through this temporary rule. In the South Atlantic, the other porgies complex includes jolthead porgy, knobbed porgy, whitebone porgy, scup, and saucereye porgy. NMFS has determined that recreational landings of species in the other porgies complex have reached the recreational annual catch limit (ACL). Therefore, NMFS closes the recreational sector for the other porgies complex in the South Atlantic EEZ on September 3, 2016. This recreational closure is necessary to protect the other porgies complex resource.

    DATES:

    This rule is effective 12:01 a.m., local time, September 3, 2016, until 12:01 a.m., local time, January 1, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Mary Vara, NMFS Southeast Regional Office, telephone: 727-824-5305, or email: [email protected]

    SUPPLEMENTARY INFORMATION:

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

    The recreational ACL for the other porgies complex is 106,914 lb (48,495 kg), round weight. In accordance with regulations at 50 CFR 622.193(w)(2)(i), if the recreational ACL is met, or is projected to be met, the NMFS Assistant Administrator (AA) will file a notification with the Office of the Federal Register to close the recreational sector for the remainder of the fishing year. Recreational landings in 2016 from the Southeast Fisheries Science Center indicate that the recreational ACL has already been harvested. As a result, the recreational sector for the other porgies complex will be closed effective 12:01 a.m., local time, September 3, 2016.

    During the closure, the bag and possession limits for species in the other porgies complex in or from the South Atlantic EEZ are zero. The recreational sector for the other porgies complex will reopen on January 1, 2017, the beginning of the 2017 recreational fishing year.

    Classification

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

    This action is taken under 50 CFR 622.193(w)(2)(i) and is exempt from review under Executive Order 12866. These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment. This action responds to the best scientific information available.

    The AA finds that the need to immediately implement this action to close the recreational sector for the other porgies complex constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule implementing the AM has already been subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because there is a need to immediately implement this action to protect the species in the other porgies complex. Prior notice and opportunity for public comment would require time and would potentially allow the recreational sector to further exceed its ACL.

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

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: August 29, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-21090 Filed 8-29-16; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 635 [Docket No. 160706586-6780-01] RIN 0648-XE726 Atlantic Highly Migratory Species; Adjustments to 2016 Northern Albacore Tuna and Atlantic Bluefin Tuna Quotas AGENCY:

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

    ACTION:

    Temporary final rule; adjustments to 2016 northern albacore quota and 2016 Atlantic bluefin tuna Reserve category quota.

    SUMMARY:

    NMFS adjusts the northern albacore (NALB) annual baseline quota for 2016 with available underharvest of the 2015 adjusted U.S. NALB quota. NMFS also augments the 2016 Atlantic bluefin tuna (BFT) Reserve category quota with available underharvest of the 2015 adjusted U.S. BFT quota. This action is necessary to implement binding recommendations of the International Commission for the Conservation of Atlantic Tunas (ICCAT), as required by the Atlantic Tunas Convention Act (ATCA), and to achieve domestic management objectives under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

    DATES:

    Effective September 1, 2016 through December 31, 2016.

    ADDRESSES:

    Supporting documents such as the Environmental Assessments and Fishery Management Plans and their Amendments described below may be downloaded from the HMS Web site at www.nmfs.noaa.gov/sfa/hms/. These documents also are available upon request from Sarah McLaughlin or Brad McHale at the telephone number below.

    FOR FURTHER INFORMATION CONTACT:

    Sarah McLaughlin or Brad McHale, 978-281-9260.

    SUPPLEMENTARY INFORMATION:

    Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq.) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq.) governing the harvest of NALB and BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27(e) describes the NALB annual quota recommended by ICCAT and the annual NALB quota adjustment process. Section 635.27(a) subdivides the ICCAT-recommended U.S. BFT quota among the various domestic fishing categories, per the allocations established in the 2006 Consolidated Atlantic Highly Migratory Species Fishery Management Plan (2006 Consolidated HMS FMP) (71 FR 58058, October 2, 2006), as amended by Amendment 7 to the 2006 Consolidated HMS FMP (Amendment 7) (79 FR 71510, December 2, 2014), and describes the annual BFT quota adjustment process. NMFS is required under ATCA and the Magnuson-Stevens Act to provide U.S. fishing vessels with a reasonable opportunity to harvest the ICCAT-recommended quotas.

    The NALB quota implementation and quota adjustment processes, along with the BFT quota adjustment process, were previously analyzed in Amendment 7, which included a Final Environmental Impact Statement, Final Regulatory Impact Review, Final Regulatory Flexibility Analysis, and Final Social Impact Statement, published in August 2014. ICCAT conducted another BFT stock assessment update in 2014, and, after considering the scientific advice in the stock assessment, adopted a recommendation regarding western Atlantic bluefin tuna management that increases the U.S. bluefin tuna quota for 2015 and 2016 (ICCAT Recommendation 14-05: “Recommendation by ICCAT Amending the Supplemental Recommendation by ICCAT Concerning the Western Atlantic BFT Rebuilding Program”). NMFS published a final rule to implement that baseline annual U.S. BFT quota on August 28, 2015 (“BFT Quota Rule,” 80 FR 52198), and prepared an Environmental Assessment, Regulatory Impact Review, and Final Regulatory Flexibility Analysis for that action.

    NALB Annual Quota and Adjustment Process

    As described in the final rule implementing Amendment 7, since 1998, ICCAT has adopted recommendations regarding the NALB fishery. A multiyear management measure for northern albacore tuna was first adopted in 2003, setting the Total Allowable Catch (TAC) at 34,500 mt. ICCAT's Standing Committee on Research and Statistics (SCRS) assessed the northern albacore tuna stock in 2009 and concluded that the stock continues to be overfished with overfishing occurring, recommending a level of catch of no more than 28,000 mt to meet ICCAT management objectives by 2020. In response, in 2009, ICCAT established the NALB rebuilding program via Recommendation 09-05, effective for 2010 and 2011, setting a 28,000-mt TAC and including several provisions to limit catches by individual ICCAT Contracting Parties (for major and minor harvesters) and reduce the amount of unharvested quota that could be carried forward from one year to the next, from 50 percent to 25 percent of a Contracting Party's initial catch quota. Subsequent ICCAT NALB Recommendations 11-04 and 13-05 (both entitled “Supplemental Recommendation by ICCAT Concerning the North Atlantic Albacore Rebuilding Program”) maintained the TAC at 28,000 mt for 2012 through 2016 and contained specific recommendations regarding the NALB rebuilding program, including allocation of the annual TAC among the European Union, Chinese Taipei, the United States, and Venezuela. The U.S. quota for 2012 through 2016 has been 527 mt, annually. These recommendations limit Japanese northern albacore tuna catches to 4 percent in weight of its total Atlantic bigeye tuna longline catch, and limits the catches of other ICCAT parties to 200 mt. Recommendation 13-05 also specifies that quota adjustments for a given year's underharvest or overharvest must be made within 2 years from the subject year (i.e., adjustments based on 2015 catches would be made during or before 2017). The maximum underharvest can be carried forward from one year to the next remains at 25 percent of a Contracting Party's initial catch quota.

    The annual U.S. NALB quota of 527 mt is codified at § 635.27(e) and will remain in effect until changed (for instance, if a new ICCAT NALB TAC recommendation is adopted). Because ICCAT adopted TACs for 2014, 2015, and 2016 in Recommendation 13-05, NMFS currently anticipates that these annual base quotas would be in effect through 2016, but they will remain in place unless and until a new NALB TAC and catch limits are adopted by ICCAT.

    Amendment 7 established the process by which NMFS adjusts the U.S. annual NALB quota for any previous year's underharvest. NMFS makes such adjustments consistent with ICCAT limits and when complete catch information for the prior year is available and finalized.

    Adjustment of the 2016 NALB Quota

    Based on NMFS' best available information as of July 21, 2016, the total 2015 NALB catch is 247.70 mt, which is 293.61 mt less than the 2015 adjusted quota (i.e., 527 mt plus 14.31 mt of 2014 underharvest carried forward to 2015, totaling 541.31 mt). Thus, the underharvest for 2015 is 293.61 mt. Per the 2013 ICCAT recommendation, only 25 percent of the total 2015 U.S. quota, or 131.75 mt, of that underharvest may be carried forward to the 2016 fishing year. Consistent with the process established in Amendment 7, the adjusted 2016 NALB quota is 527 mt plus 131.75 mt, totaling 658.75 mt.

    BFT Annual Quota and Adjustment Process

    Pursuant to Amendment 7, NMFS augments the Reserve category quota to the extent that underharvest from the prior year's adjusted U.S. BFT quota is available. NMFS makes such adjustments consistent with ICCAT limits and when complete catch information for the prior year is available and finalized. Consistent with the BFT quota regulations, NMFS may allocate any portion of the Reserve category quota for inseason or annual adjustments to any fishing category quota pursuant to regulatory determination criteria described at § 635.27(a)(8), or for scientific research.

    NMFS implemented ICCAT Recommendation 14-05 in the BFT quota final rule in August 2015 (80 FR 52198, August 28, 2015). That rulemaking implemented Recommendation 14-05, which included a 2,000-mt western BFT TAC of 2,000 mt (for 2015 and 2016) and the recommended annual U.S. baseline quota of 1,058.79 mt. The total annual U.S. quota, including the 25 mt to account for bycatch related to pelagic longline fisheries in the Northeast Distant gear restricted area (NED) is 1,083.79 mt. The maximum underharvest that a Contracting Party may carry forward from one year to the next is 10 percent of its total quota.

    The baseline annual U.S. BFT quota of 1,058.79 mt is codified at § 635.27(a) and will remain in effect until changed (for instance, if a new ICCAT western BFT TAC recommendation is adopted). Because ICCAT adopted TACs for 2015 and 2016 in Recommendation 14-05, NMFS currently anticipates that these annual baseline quotas would be in effect through 2016, but they will remain in place unless and until a new western BFT TAC and catch limits are adopted by ICCAT.

    Adjustment of the 2016 BFT Reserve Category Quota

    Based on NMFS' best available information as of July 21, 2016, the total 2015 BFT catch is 896.30 mt. This total catch includes 876.80 mt of landings and 19.50 mt of dead discards, which includes the best available estimate of 14.60 mt of dead discards for the pelagic longline fishery and the observed dead discards of 4.90 mt for the purse seine fishery. The total catch of 896.30 mt is 282.36 mt less than the quota available for 2015 landings and dead discards (i.e., 1,083.79 mt plus 94.87 mt of 2014 underharvest carried forward to 2015, totaling 1,178.66 mt). Thus, the underharvest for 2015 is 282.36 mt. Per the 2014 ICCAT recommendation, only 10 percent of the total 2015 U.S. quota, or 108.38 mt, of that underharvest may be carried forward to the 2016 fishing year. The codified Reserve category quota is 24.8 mt. Consistent with the process established in Amendment 7, NMFS augments the Reserve category quota with 108.38 mt in this action. Effective January 1, 2016, NMFS adjusted the Reserve category quota for 2016 to 92.2 mt by reallocating 101.4 mt of Purse Seine quota to the Reserve category (based on 2015 catch by Purse Seine category participants and provisions for calculating Purse Seine allocations in Amendment 7) and also transferring 34 mt of Reserve category quota to the Longline category (81 FR 19, January 4, 2016). Thus, as of the effective date of this action (September 1, 2016), the adjusted 2016 Reserve category quota will be 200.58 mt (i.e., 92.2 mt plus 108.38 mt).

    Classification

    The Assistant Administrator for NMFS (AA) has determined that this final rule is consistent with the Magnuson-Stevens Act, the 2006 Consolidated Atlantic HMS FMP and its amendments, ATCA, and other applicable law.

    The AA finds that it would be unnecessary and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:

    NMFS solicited and accepted public comment on the NALB quota implementation and quota adjustment processes, along with the BFT quota adjustment process, as part of the Amendment 7 rulemaking. Comments on these provisions in response to the proposed Amendment 7 rulemaking were generally supportive and were addressed in the Response to Comments section of the Amendment 7 final rule. (See comments 18, 19, and 105 at 79 FR 71530-71531 and 71553). This action applies the formula noticed to the public in the earlier action (Amendment 7), using the best available data regarding 2015 catch and underharvest and calculating allowable underharvest consistent with ICCAT recommendations. The Amendment 7 rulemaking specifically provided prior notice of, and accepted public comment on, these formulaic quota adjustment processes and the manner in which they occur. The application of this formula in this action does not have discretionary aspects requiring additional agency consideration and thus public comment for this action would not and could not result in any changes.

    There is good cause under U.S.C. 553(d)(3) to waive the 30-day delay in effective date and make the rule effective upon publication in the Federal Register. The fisheries for NALB and BFT began on January 1, 2016. NMFS monitors NALB and BFT annual catch against the available quota. Delaying the effective date of these quota adjustments would unnecessarily complicate the management of the NALB and BFT fisheries, which rely on management flexibility to respond quickly to fishery conditions to ensure that fishermen have a reasonable opportunity to catch the available quota. For example, under the NALB fishery closure regulations, NMFS must close the fishery when the annual fishery quota is reached. Closure of the fishery based only on the baseline (codified) quota versus the adjusted NALB quota would preclude the fishery from harvesting NALB that are legally available consistent with the ICCAT recommendations and the 2006 Consolidated HMS FMP, as amended. Adjusting the BFT Reserve category as soon as possible provides NMFS the flexibility to transfer quota from the Reserve to other fishing categories inseason after considering the regulatory determination criteria, including fishery conditions at the time of the transfer. NMFS could not appropriately adjust the annual quotas for 2016 sooner because the data needed to make the determination only became available in late July and additional time was needed for agency analysis and consideration of the data.

    Additionally, to prevent confusion and potential overharvests, these adjustments should be in place as soon as possible to allow the impacted sectors to benefit from any subsequent quota adjustments to the fishing categories, give them a reasonable opportunity to catch available quota, and provide them the opportunity for planning operations accordingly.

    This action is being taken under §§ 635.27(e) and 635.27(a)(10) and is exempt from review under Executive Order 12866.

    This final rule does not contain a collection-of-information requirement for purposes of the Paperwork Reduction Act.

    Because prior notice and opportunity for public comment are not required for this rule by 5 U.S.C. 553, or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are inapplicable.

    Authority:

    16 U.S.C. 971 et seq. and 1801 et seq.

    Dated: August 25, 2016. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.
    [FR Doc. 2016-21067 Filed 8-31-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 660 [Docket No. 140904754-5188-02] RIN 0648-BG27 Magnuson-Stevens Act Provisions; Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; 2015-2016 Biennial Specifications and Management Measures; Inseason Adjustments AGENCY:

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

    ACTION:

    Final rule; inseason adjustments to biennial groundfish management measures.

    SUMMARY:

    This final rule announces inseason changes to management measures in the Pacific Coast groundfish fisheries. This action, which is authorized by the Pacific Coast Groundfish Fishery Management Plan (PCGFMP), is intended to allow fisheries to access more abundant groundfish stocks while protecting overfished and depleted stocks.

    DATES:

    This final rule is effective September 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Benjamin Mann, phone: 206-526-6117, fax: 206-526-6736, or email: [email protected].

    SUPPLEMENTARY INFORMATION: Electronic Access

    This rule is accessible via the Internet at the Office of the Federal Register Web site at https://www.federalregister.gov. Background information and documents are available at the Pacific Fishery Management Council's Web site at http://www.pcouncil.org/. Copies of the final environmental impact statement (FEIS) for the Groundfish Specifications and Management Measures for 2015-2016 and Biennial Periods Thereafter are available from Chuck Tracy, Executive Director, Pacific Fishery Management Council (Council), 7700 NE Ambassador Place, Portland, OR 97220, phone: 503-820-2280.

    Background

    The Pacific Fishery Management Council (Council)—in coordination with Pacific Coast Treaty Indian Tribes and the States of Washington, Oregon, and California—recommended changes to groundfish management measures at its June 21-28, 2016, meeting. Specifically, the Council recommended taking a portion of the Pacific ocean perch (POP) initially deducted from the annual catch limit (ACL) and making it available to the mothership (MS) sector; a trip limit increase for black rockfish in the limited entry fixed gear (LEFG) and open access (OA) fisheries in northern California; and trip limit reductions in the OA sablefish daily trip limit (DTL) fishery north of 36° N. lat.

    Transferring POP to the Mothership Sector

    As part of biennial harvest specifications and management measures, ACLs are set for non-whiting groundfish species, deductions are made “off-the-top” from the ACL to account for various sources of mortality (including scientific research activities) and the remainder, the fishery harvest guideline, is allocated among the various groundfish fisheries. The limited availability of overfished species that can be taken as incidental catch in the Pacific whiting fishery, particularly darkblotched rockfish, POP, and canary rockfish, led NMFS to implement sector-specific allocations for these species to the Pacific whiting fisheries. If the sector-specific allocation for a non-whiting species is reached, NMFS may close one or more of the at-sea sectors automatically, per regulations at § 660.60(d).

    At the June, 2016 meeting, MS and catcher/processor (C/P) sectors requested more POP to accommodate higher than anticipated harvest and prevent closure of the fishery prior to harvesting their allocations of Pacific whiting.

    At the start of 2016, the MS and C/P sectors of the Pacific whiting fishery were allocated 7.2 mt and 10.2 mt of POP respectively, per regulations at § 660.55(c)(1)(i)(B). According to the best fishery information available at the June 2016 meeting, POP bycatch in the MS sector was approximately double 2016 POP bycatch projections. At that time, best available information regarding bycatch rates of POP in the MS sector indicated that if those rates continued, only 53 percent (38,246 mt) of the Pacific whiting allocation would be harvested by the end of the 2016 fishery. Therefore, the Council recommended that NMFS monitor fishery harvest of Pacific whiting and POP relative to their respective at-sea sector allocations, update projections of Pacific whiting allocation attainment based on new, updated POP bycatch rates, and if necessary, transfer some POP that would otherwise go unharvested to either the MS or C/P sectors as needed.

    Current projections by the Northwest Fishery Science Center indicate that approximately 3.7 mt of POP off-the-top deductions for scientific research would remain unharvested through the end of the year. As of August 11, 2016, the C/P sector has only harvested approximately 4.1 percent (0.41 mt) of its 2016 POP allocation indicating the C/P sector has sufficient POP allocation to cover their Pacific whiting harvests. However, approximately 70 percent (5.0 mt) of the total MS sector POP allocation has been harvested and only approximately 47 percent (34,256.46 mt) of the Pacific whiting allocation has been harvested. Using the most recent catch data through August 11, 2016, NMFS projects that at current rates, the MS sector will only harvest approximately 49 percent (35,486.35 mt) of its total Pacific whiting allocation (74,415 mt) before reaching the 7.2 mt POP allocation. Therefore, consistent with the Council's June recommendation to take into account the best estimates of the amount of POP available and the updated bycatch rates in the MS and C/P fisheries, NMFS is transferring 3.0 mt of POP to the at-sea sectors.

    This rule transfers 3.0 mt of POP that is expected to go unharvested from the scientific research off-the-top deduction to the MS sector. This transfer increases the MS sector POP allocation from 7.2 mt to 10.2 mt. The remaining amount in the off-the-top deduction for scientific research is anticipated to go unharvested (0.7 mt) but is not transferred at this time to buffer for uncertainty in the estimates of POP harvest in scientific research. This inseason action increases the POP amount available to the MS sector, and is expected to provide opportunity for the MS sector to obtain their entire Pacific whiting allocation (72,415 mt). Transfer of POP to the MS sector, when combined with projected impacts from all other sources, is not expected to result in greater impacts to POP than the 2016 ACL. This action is also not expected to increase impacts to other overfished species from those originally projected through the end of the year.

    Increase in Trip Limits for the Black Rockfish LEFG and OA Fisheries Between 42° N. Lat. and 40°10′ N. Lat.

    Black rockfish are caught in nearshore commercial and recreational fisheries. Black rockfish is a healthy stock that co-occurs with nearshore overfished rockfish species (e.g. canary rockfish and yelloweye rockfish). Catch of black rockfish is managed, in part, to keep catch of co-occurring overfished species within the management targets for the nearshore fishery and the state of California. In 2016, reduced fishing effort as a result of poor weather and ocean conditions has significantly impacted catch rate of black rockfish in the area between 42° N. lat., and 40°10′ N. lat. for the LEFG and OA black rockfish commercial fisheries. The State of California reported 2016 black rockfish catch to be approximately 5 percent of the total allocation (19.9 mt of the 420 mt allocated). To provide the opportunity to harvest a larger portion of their allocation the Council recommended and NMFS is implementing an increase in the bimonthly trip limits for the LEFG fishery and the OA fishery between 42° N. lat., and 40°10′ N. lat. from “6,000 lbs/2 months which, no more than 1,200 lbs may be species other than black rockfish” to “7,000 lbs/2 months of which, no more than 1,200 lbs may be species other than black rockfish.” The increased trip limits described above will be effective in periods 5 and 6, beginning September 1.

    Reduction in Trip Limits in the OA Sablefish Fishery North of 36° N. Lat.

    Reduced opportunities in other fisheries (e.g. crab and salmon) in 2016 have resulted in higher than normal effort in the open access sablefish fishery north of 36° N. lat. Reports from the PacFIN Quota Species Monitoring (QSM) Best Estimate Report (BER) dated June 18, 2016 indicate actual landings have been approximately double 2016 projections in the fishery. The Council's groundfish advisory panel (GAP) recommended a reduction in trip limits to reduce effort in order to avoid exceeding 2016 sablefish allocations to the fishery. The Council's GMT projected landings at the current rate of effort were 112 percent to 117 percent of the total OA allocation, through the end of the year. At its June 2016 meeting, the Council recommended and NMFS is implementing a trip limit adjustment from “300 lbs/day, or one landing per week of up to 850 lb, not to exceed 1,700 lb/2 months” to “300 lbs/day, or one landing per week of up to 750 lbs, not to exceed 1,500 lbs/2 months.” Model projections through the end of the year with these adjustments show a total landing of 98 percent of the 2016 OA allocation. The reduced trip limits described above will be effective in periods 5 and 6, beginning September 1.

    Classification

    This final rule makes routine inseason adjustments to groundfish fishery management measures, based on the best available information. This document also serves as notice of an automatic action, based on the best available information. Both are consistent with the PCGFMP and its implementing regulations.

    This action is taken under the authority of 50 CFR 660.60(c) and (d) and 660.140(a)(3) and is exempt from review under Executive Order 12866.

    The aggregate data upon which these actions are based are available for public inspection at the Office of the Administrator, West Coast Region, NMFS, during business hours.

    NMFS finds good cause to waive prior public notice and comment on the revisions to groundfish management measures under 5 U.S.C. 553(b) because notice and comment would be impracticable and contrary to the public interest. Also, for the same reasons, NMFS finds good cause to waive the 30-day delay in effectiveness pursuant to 5 U.S.C. 553(d)(3), so that the regulatory changes in this final rule may become effective September 1, 2016.

    At its June 2016 meeting, the Council recommended that NMFS consider a transfer of POP to the MS and C/P sectors, as needed based on the most recent fishery information. The Council recommended that the transfer be implemented as quickly as possible once the amount of POP, that would otherwise go unharvested in scientific research activities, was estimated. Updated catch information from scientific research activities became available in early August. There was not sufficient time after the June 2016 Council meeting or after research catch information was available to undergo proposed and final rulemaking before this action needs to be in effect. For the action implemented in this final rule, affording the time necessary for prior notice and opportunity for public comment would prevent transfer of POP to the MS sector until later in the season, or potentially eliminate the possibility of doing so during the 2016 calendar year entirely, and is therefore impracticable. Failing to transfer POP to the MS sector in a timely manner could result in unnecessary restriction of fisheries if the MS sector exceeded their allocations. Providing the MS sector fishermen an opportunity to harvest their limits of Pacific whiting without interruption and, when combined with harvest from other sectors, without exceeding the POP ACL, allows harvest as intended by the Council, consistent with the best scientific information available. The Pacific whiting fishery contributes a large amount of revenue to the coastal communities of Washington and Oregon and this change allows continued harvest of Pacific whiting while continuing to prevent ACLs of overfished species and the allocations for target species from being exceeded.

    The Council also recommended commercial trip limit changes for black rockfish and sablefish. These changes are based on the best available information, consistent with the PCGFMP and its implementing regulations. At the June Council meeting the Council recommended that increase to black rockfish trip limits be implemented as quickly as possible during the two-month cumulative limit period and that the decrease to sablefish trip limits be implemented as quickly as possible, by the start of the next cumulative limit period. There was not sufficient time after that meeting to draft this document and undergo proposed and final rulemaking before these actions need to be in effect. For the actions to be implemented in this final rule, affording the time necessary for prior notice and opportunity for public comment would prevent NMFS from managing fisheries using the best available science to approach, without exceeding, the ACLs for federally managed species in accordance with the PCGFMP and applicable law. The adjustments to management measures in this document affect commercial fisheries off Washington, Oregon, and California. These increases to trip limits must be implemented as quickly as possible during the two-month cumulative limit period to allow OA fixed gear fishermen an opportunity to harvest higher limits of black rockfish without exceeding the ACL. The decrease to sablefish trip limits must be implemented by the start of the next two-month cumulative limit period, September 1, to prevent exceedance of the ACL and allow year-round fishing opportunities for fishermen. It would be contrary to public interest to delay implementation of these changes until after public notice and comment, because making the regulatory changes by September 1, allows harvest as intended by the Council, consistent with the best scientific information available. The increase to black rockfish trip limits allows additional harvest in fisheries that are important to coastal communities while continuing to prevent the black rockfish ACL from being exceeded. The decrease to sablefish trip limits allows continued harvest in a fishery that is important to coastal communities while continuing to prevent sablefish ACL from being exceeded.

    For the actions to be implemented in this final rule, affording the time necessary for prior notice and opportunity for public comment would prevent NMFS from managing fisheries using the best available science to prevent overfishing in accordance with the PCGFMP and applicable law.

    Delaying these changes would also keep management measures in place that are not based on the best available information. Such delay would impair achievement of the PCGFMP goals and objectives of managing for appropriate harvest levels while providing for year-round fishing and marketing opportunities.

    Accordingly, for the reasons stated above, NMFS finds good cause to waive prior notice and comment and to waive the delay in effectiveness.

    List of Subjects in 50 CFR Part 660

    Fisheries, Fishing, Indian fisheries.

    Dated: August 29, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 660 is amended as follows:

    PART 660—FISHERIES OFF WEST COAST STATES 1. The authority citation for part 660 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq., 16 U.S.C. 773 et seq., and 16 U.S.C. 7001 et seq.

    2. Table 2b to part 660, subpart C, is revised to read as follows: Table 2b to Part 660, Subpart C—2016, and Beyond, Allocations by Species or Species Group [Weight in metric tons] Species Area Fishery HG or ACT Trawl % Mt Non-trawl % Mt BOCACCIO a S of 40°10′ N. lat 353.7 N/A 85.0 N/A 268.7 Canary rockfish a b Coastwide 109.8 N/A 58.5 N/A 51.3 COWCOD a c S of 40°10′ N. lat 4.0 N/A 1.4 N/A 2.6 DARKBLOTCHED ROCKFISH d Coastwide 325.2 95 308.9 5 16.3 Petrale sole a Coastwide 2,673.4 N/A 2,638.4 N/A 35.0 PACIFIC OCEAN PERCH e N of 40°10′ N. lat 149.0 95 141.6 5 7.5 YELLOWEYE ROCKFISH a Coastwide 13.2 N/A 1.1 N/A 12.1 Arrowtooth flounder Coastwide 3,241 95 3,079 5 162 Chilipepper S of 40°10′ N. lat 1,595 75 1,196 25 399 Dover sole Coastwide 48,406 95 45,986 5 2,420 English sole Coastwide 6,991 95 6,642 5 350 Lingcod N of 40°10′ N. lat 2,441 45 1,098 55 1,342 Lingcod S of 40°10′ N. lat 937 45 422 55 515 Longnose skate a Coastwide 1,927 90 1,734 10 193 Longspine thornyhead N of 34°27′ N. lat 2,969 95 2,820 5 148 Pacific cod Coastwide 1,091 95 1,036 5 55 Pacific whiting Coastwide 301,731 100 301,731 0 0 Sablefish N of 36° N. lat 0 See Table 1C Sablefish S of 36° N. lat 1,875 42 788 58 1,088 Shortspine thornyhead N of 34°27′ N. lat 1,667 95 1,583 5 83 Shortspine thornyhead S of 34°27′ N. lat 871 NA 50 NA 821 Splitnose S of 40°10′ N. lat 1,736 95 1,649 5 87 Starry flounder Coastwide 1,529 50 764 50 764 Widow rockfish f Coastwide 1,880 91 1,711 9 169 Yellowtail rockfish N of 40°10′ N. lat 5,314 88 4,677 12 638 Minor Shelf Rockfish complex a N of 40°10′ N. lat 1,880 60.2 1,132 39.8 748 Minor Shelf Rockfish complex a S of 40°10′ N. lat 1,576 12.2 192 87.8 1,384 Minor Slope Rockfish complex N of 40°10′ N. lat 1,642 81 1,330 19 312 Minor Slope Rockfish complex S of 40°10′ N. lat 675 63 425 37 250 Other Flatfish complex Coastwide 7,039 90 6,335 10 704 a Allocations decided through the biennial specification process. b 14.0 mt of the total trawl allocation of canary rockfish is allocated to the at-sea whiting fisheries, as follows: 5.8 mt for the mothership fishery, and 8.2 mt for the catcher/processor fishery. c The cowcod fishery harvest guideline is further reduced to an ACT of 4.0 mt. d Consistent with regulations at § 660.55(c), 9 percent (27.8 mt) of the total trawl allocation for darkblotched rockfish is allocated to the whiting fisheries, as follows: 11.7 mt for the shorebased IFQ fishery, 6.7 mt for the mothership fishery, and 9.4 mt for the catcher/processor fishery. The tonnage calculated here for the whiting portion of the shorebased IFQ fishery contributes to the total shorebased trawl allocation, which is found at 660.140(d)(1)(ii)(D). e Consistent with regulations at § 660.55(c), 30 mt of the total trawl allocation for POP is allocated to the whiting fisheries, as follows: 12.6 mt for the shorebased IFQ fishery, 7.2 mt for the mothership fishery, and 10.2 mt for the catcher/processor fishery. The amount available to the mothership fishery was raised from 7.2 mt to 10.2 mt, by transferring 3.0 mt of the 5.2 mt initially deducted from the ACL to accunt for scientific research mortality, consistent with § 660.60(c)(3)(ii). The tonnage calculated here for the whiting portion of the shorebased IFQ fishery contributes to the total shorebased trawl allocation, which is found at 660.140(d)(1)(ii)(D). f Consistent with regulations at § 660.55(c), 500 mt of the total trawl allocation for widow rockfish is allocated to the whiting fisheries, as follows: 210 mt for the shorebased IFQ fishery, 120 mt for the mothership fishery, and 170 mt for the catcher/processor fishery. The tonnage calculated here for the whiting portion of the shorebased IFQ fishery contributes to the total shorebased trawl allocation, which is found at 660.140(d)(1)(ii)(D). 3. Table 2 (North) to part 660, subpart E, is revised to read as follows: BILLING CODE 3510-22-P ER01SE16.131 4. Tables 3 (North) and 3 (South) to part 660, subpart F, are revised to read as follows: ER01SE16.132 ER01SE16.133 ER01SE16.134 ER01SE16.135
    [FR Doc. 2016-21091 Filed 8-31-16; 8:45 am] BILLING CODE 3510-22-C
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150818742-6210-02] RIN 0648-XE835 Fisheries of the Economic Exclusive Zone Off Alaska; Deep-Water Species Fishery by Vessels Using Trawl Gear in the Gulf of Alaska AGENCY:

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

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS is prohibiting directed fishing for species that comprise the deep-water species fishery by vessels using trawl gear in the Gulf of Alaska (GOA). This action is necessary because the fourth seasonal apportionment of the Pacific halibut bycatch allowance specified for the trawl deep-water species fishery in the GOA has been reached.

    DATES:

    Effective 1200 hours, Alaska local time (A.l.t.), September 1, 2016, through 1200 hours, A.l.t., October 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Josh Keaton, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

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

    The fourth seasonal apportionment of the Pacific halibut bycatch allowance specified for the deep-water species in the GOA has been determined to be 0 metric tons (mt). This apportionment was established by the final 2016 and 2017 harvest specifications for groundfish of the GOA (81 FR 14740, March 18, 2016) and reapportionment (81 FR 45423, July 14, 2016), for the period 1200 hours, A.l.t., September 1, 2016, through 1200 hours, A.l.t., October 1, 2016.

    In accordance with § 679.21(d)(6)(i), the Administrator, Alaska Region, NMFS, has determined that the fourth seasonal apportionment of Pacific halibut bycatch allowance specified for deep-water species by vessels using trawl gear in the GOA has been reached. Consequently, NMFS is prohibiting directed fishing for the deep-water species by vessels using trawl gear in the GOA. The species and species groups that comprise the deep-water species fishery include sablefish, rockfish, deep-water flatfish, rex sole, and arrowtooth flounder. This closure does not apply to fishing by vessels participating in the cooperative fishery in the Rockfish Program for the Central GOA.

    After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of the deep-water species fishery by vessels using trawl gear in the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 25, 2016.

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

    This action is required by § 679.21 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: August 26, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-21029 Filed 8-31-16; 8:45 am] BILLING CODE 3510-22-P
    81 170 Thursday, September 1, 2016 Proposed Rules DEPARTMENT OF HOMELAND SECURITY Office of the Secretary 6 CFR Part 5 [Docket No. DHS-2016-0064] Privacy Act of 1974: Implementation of Exemptions; Department of Homeland Security U.S. Customs and Border Protection (DHS/CBP)-022 Electronic Visa Update System (EVUS) System of Records AGENCY:

    Privacy Office, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Department of Homeland Security is giving concurrent notice of a newly established system of records pursuant to the Privacy Act of 1974 for the “Department of Homeland Security (DHS)/U.S. Customs and Border Protection (CBP)-022 Electronic Visa Update System (EVUS) System of Records” and this proposed rulemaking. In this proposed rulemaking, the Department proposes to exempt portions of the system of records from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.

    DATES:

    Comments must be received on or before October 3, 2016.

    ADDRESSES:

    You may submit comments, identified by docket number DHS-DHS-2016-0064, by one of the following methods:

    Federal e-Rulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Fax: 202-343-4010.

    Mail: Jonathan R. Cantor, Acting Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528.

    Instructions: All submissions received must include the agency name and docket number for this notice. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided.

    Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    For general questions please contact: Debra L. Danisek, (202) 344-1610, Acting CBP Privacy Officer, Privacy and Diversity Office, 1300 Pennsylvania Ave. NW., Washington, DC 20229. For privacy questions, please contact: Jonathan R. Cantor, (202) 343-1717, Acting Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528.

    SUPPLEMENTARY INFORMATION: I. Background

    In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the Department of Homeland Security (DHS) proposes to establish a new DHS system of records titled, “Department of Homeland Security (DHS)/U.S. Customs and Border Protection (CBP)-DHS/CBP-022 Electronic Visa Update System (EVUS) System of Records.” This system of records will allow DHS/CBP to collect and maintain records on nonimmigrant aliens who (1) hold a passport that was issued by an identified country approved for inclusion in the EVUS program and (2) have been issued a U.S. nonimmigrant visa of a designated category seeking to travel to the United States. The system of records will also cover records of other persons, including U.S. citizens and lawful permanent residents, whose name is provided to DHS as part of a nonimmigrant alien's EVUS enrollment. Requiring aliens holding passports of identified countries containing U.S. nonimmigrant visas of a designated category with multiple year validity will allow DHS/CBP to collect updated information. The system is used to ensure visa holder's information remains current. The information is also used to separately determine whether any admissibility issues may need to be addressed outside the EVUS enrollment process by vetting the information against selected security and law enforcement databases at DHS, including the use of CBP's TECS (not an acronym) (DHS/CBP-011 U.S. Customs and Border Protection TECS, December 19, 2008, 73 FR 77778) and the Automated Targeting System (ATS) (DHS/CBP-006 Automated Targeting System, May 22, 2012, 77 FR 30297). In addition, ATS retains a copy of EVUS enrollment data to identify EVUS enrollees who may pose a security risk to the United States. The Automated Targeting System maintains copies of key elements of certain databases in order to minimize the impact of processing searches on the operational systems and to act as a backup for certain operational systems. DHS may also vet EVUS enrollment information against security and law enforcement databases at other federal agencies to enhance DHS's ability to determine whether the enrollee poses a security risk to the United States or, although addressed through a separate process, is admissible to the United States. The results of this vetting may inform DHS's assessment of whether the enrollee's travel poses a law enforcement or security risk and whether the proposed travel should be permitted.

    DHS is issuing this Notice of Proposed Rulemaking to exempt portions of DHS/CBP-022 Electronic Visa Update System (EVUS) System of Records from certain provisions of the Privacy Act. Pursuant to 5 U.S.C. 552a(j)(2), DHS will claim exemption from secs. (c)(3), (e)(8), and (g) of the Privacy Act of 1974, as amended, as is necessary and appropriate to protect this information. Further, DHS will claim exemption from sec. (c)(3) of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(k)(2) as is necessary and appropriate to protect this information.

    II. Privacy Act

    The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which Federal Government agencies collect, maintain, use, and disseminate personally identifiable information. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals when systems of records maintain information on U.S. citizens, lawful permanent residents, and visitors. DHS is claiming exemptions from certain requirements of the Privacy Act for DHS/CBP-022 Electronic Visa Update System (EVUS) System of Records. Some information in DHS/CBP-022 Electronic Visa Update System (EVUS) System of Records relates to official DHS national security, law enforcement, immigration, and intelligence activities. These exemptions are needed to protect information relating to DHS activities from disclosure to subjects or others related to these activities. Specifically, the exemptions are required to preclude subjects of these activities from frustrating these processes. Disclosure of information to the subject of the inquiry could also permit the subject to avoid detection or apprehension.

    In appropriate circumstances, when compliance would not appear to interfere with or adversely affect the law enforcement purposes of this system and the overall law enforcement process, the applicable exemptions may be waived on a case by case basis.

    A notice of system of records for DHS/CBP-022 Electronic Visa Update System (EVUS) System of Records is also published in this issue of the Federal Register.

    List of Subjects in 6 CFR Part 5

    Freedom of information; Privacy.

    For the reasons stated in the preamble, DHS proposes to amend chapter I of title 6, Code of Federal Regulations, as follows:

    PART 5—DISCLOSURE OF RECORDS AND INFORMATION 1. The authority citation for part 5 continues to read as follows: Authority:

    Pub. L. 107-296, 116 Stat. 2135; (6 U.S.C. 101 et seq.); 5 U.S.C. 301. Subpart A also issued under 5 U.S.C. 552. Subpart B also issued under 5 U.S.C. 552a.

    2. In appendix C, add paragraph 74 to read as follows: Appendix C to Part 5—DHS Systems of Records Exempt From the Privacy Act

    74. The DHS/CBP-022 Electronic Visa Update System (EVUS) System of Records consists of electronic and paper records and will be used by DHS and its components. The DHS/CBP-022 Electronic Visa Update System (EVUS) System of Records is a repository of information held by DHS in connection with its several and varied missions and functions, including, but not limited to the enforcement of civil and criminal laws; investigations, inquiries, and proceedings there under; and national security and intelligence activities. The DHS/CBP-022 Electronic Visa Update System (EVUS) System of Records contains information that is collected by, on behalf of, in support of, or in cooperation with DHS and its components and may contain personally identifiable information collected by other Federal, State, local, tribal, foreign, or international government agencies. The Secretary of Homeland Security, pursuant to 5 U.S.C. 552a(j)(2), has exempted this system from the following provisions of the Privacy Act: 5 U.S.C. 552a(c)(3), (e)(8), and (g). Additionally, the Secretary of Homeland Security, pursuant to 5 U.S.C. 552a(k)(2) has exempted this system from the following provisions of the Privacy Act: 5 U.S.C. 552a(c)(3). Exemptions from these particular subsections are justified, on a case-by-case basis to be determined at the time a request is made, for the following reasons:

    (a) From subsection (c)(3) (Accounting for Disclosures) because release of the accounting of disclosures could alert the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of that investigation and reveal investigative interest on the part of DHS as well as the recipient agency. Disclosure of the accounting would therefore present a serious impediment to law enforcement efforts and/or efforts to preserve national security. Disclosure of the accounting would also permit the individual who is the subject of a record to impede the investigation, to tamper with witnesses or evidence, and to avoid detection or apprehension, which would undermine the entire investigative process.

    (b) From subsection (e)(8) (Notice on Individuals) because compliance would interfere with DHS's ability to obtain, serve, and issue subpoenas, warrants, and other law enforcement mechanisms that may be filed under seal and could result in disclosure of investigative techniques, procedures, and evidence.

    (c) From subsection (g) (Civil Remedies) to the extent that the system is exempt from other specific subsections of the Privacy Act.

    Dated: August 29, 2016. Jonathan R. Cantor, Acting Chief Privacy Officer, Department of Homeland Security.
    [FR Doc. 2016-21099 Filed 8-31-16; 8:45 am] BILLING CODE 9111-14-P
    CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Chapter II [Docket No. CPSC-2016-0019] Petition To Amend Statement of Interpretation and Enforcement Policy Regarding Labeling of Household Products Containing Methylene Chloride; Request for Comments AGENCY:

    Consumer Product Safety Commission.

    ACTION:

    Notice of petition.

    SUMMARY:

    The United States Consumer Product Safety Commission (CPSC or Commission) received a petition requesting that the Commission amend the agency's 1987 Statement of Interpretation and Enforcement Policy regarding labeling of household products containing methylene chloride (Policy Statement). The petition asks the Commission to expand the Policy Statement to address acute hazards from inhalation of methylene chloride vapors in addition to the chronic hazards addressed by the current Policy Statement. The Commission invites written comments concerning the petition.

    DATES:

    The Office of the Secretary must receive comments on the petition by October 31, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CPSC-2016-0019, by any of the following methods:

    Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: http://www.regulations.gov. Follow the instructions for submitting comments. The Commission does not accept comments submitted by electronic mail (email), except through www.regulations.gov. The Commission encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above.

    Written Submissions: Submit written submissions by mail/hand delivery/courier to: Office of the Secretary, Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7923.

    Instructions: All submissions received must include the agency name and docket number for this proposed rulemaking. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to: http://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If furnished at all, such information should be submitted in writing.

    Docket: For access to the docket to read background documents or comments received, go to: http://www.regulations.gov, and insert the docket number, CPSC-2016-0019, into the “Search” box, and follow the prompts. A copy of the petition is available at http://www.regulations.gov under Docket No. CPSC-2016-0019, Supporting and Related Materials.

    FOR FURTHER INFORMATION CONTACT:

    Todd Stevenson, Office of the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-6833.

    SUPPLEMENTARY INFORMATION:

    The Commission received a petition from the Halogenated Solvents Industry Alliance, Inc. (Petitioner) requesting that the Commission amend the agency's Statement of Interpretation and Enforcement Policy regarding labeling of household products containing methylene chloride (Policy Statement). The Policy Statement provides the Commission's guidance for labeling of household products containing methylene chloride, focusing particularly on paint strippers. 52 FR 34698 (Sep. 14, 1987). The Policy Statement sets forth general principles and examples for labeling to warn consumers of potential cancer hazards; it does not address acute hazards.

    The Petitioner asks the Commission to expand the Policy Statement to address acute hazards from inhalation of methylene chloride vapors. Petitioner notes that the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH) issued a Hazard Alert identifying at least 14 deaths associated with use of methylene chloride-containing paint strippers by professional bathtub refinishing operations (https://www.osha.gov/dts/hazardalerts/methylene_chloride_hazard_alert.html). Although the Petitioner refers to incidents involving workers, as the Commission's Policy Statement indicates, methylene chloride paint strippers are household products available for consumers to purchase and use. Petitioner asserts that revising the Policy Statement to give specific guidance on labeling for the acute hazard posed by inhalation of methylene chloride vapors, particularly when used in an enclosed space, such as when refinishing bathtubs, would help to prevent future fatalities.

    By this notice, the Commission seeks comments concerning this petition. Interested parties may obtain a copy of the petition from the Commission's Web site: http://www.cpsc.gov/Regulations-Laws--Standards/Rulemaking/Petitions/ or by writing or calling the Office of the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7923. A copy of the petition is also available for viewing under “Supporting and Related Materials” in: www.regulations.gov, under Docket No. CPSC-2016-0019 .

    Dated: August 2, 2016. Todd A. Stevenson, Secretary, U.S. Consumer Product Safety Commission.
    [FR Doc. 2016-20928 Filed 8-31-16; 8:45 am] BILLING CODE 6355-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 [Docket No. FDA-2016-N-1149] Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of public hearing; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing a 2-day public hearing to obtain input on issues related to communications by manufacturers, packers, and distributors, including their representatives (collectively “firms”), regarding FDA-regulated drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively, “medical products”). FDA is engaged in a comprehensive review of its regulations and policies governing firms' communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA's policy development in this area. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.

    DATES:

    The public hearing will be held on November 9 and 10, 2016, from 9 a.m. to 5 p.m. The meeting may be extended or end early depending on the level of public participation. Persons seeking to attend or present at the public hearing must register by October 19, 2016. Electronic or written comments will be accepted after the public hearing until January 9, 2017.

    ADDRESSES:

    The public hearing will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), 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-1149 for “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments.” 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.

    A link to the live Webcast of this public hearing will be available at http://www.fda.gov/CommunicationsPublicMeeting on the day of the public hearing. A video record of the public hearing will be available at http://www.fda.gov/CommunicationsPublicMeeting following the meeting. A video record of the public hearing will be available at the same Web site address for 1 year.

    FOR FURTHER INFORMATION CONTACT:

    Kristin Davis, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4252, Silver Spring, MD 20993, 301-796-0418, email: [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is responsible for regulating medical products (i.e., drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the Public Health Service Act (PHS Act) as well as all relevant implementing regulations (collectively, “FDA Authorities”) to promote and protect the public health by helping to ensure that these products are safe and effective for their intended uses. As we announced in 2014, FDA is currently engaged in a comprehensive review of the regulatory framework related to firms' communications about unapproved uses of approved/cleared medical products 1 —medical products that may be legally introduced into interstate commerce for at least one other intended use.2 The purpose of this review is to help ensure that our implementation of the FDA Authorities (including promulgating and amending regulations, issuing guidance, developing policies, and taking enforcement action) best protects and promotes the public health in view of ongoing developments in science and technology, medicine, health care delivery, and constitutional law.

    1 In this document, the term “unapproved use” encompasses additional intended uses of approved drugs and approved/cleared devices, including devices that are currently marketed pursuant to a 510(k) clearance or exemption.

    2 See FDA response letter, Docket Nos. FDA-2011-P-0512 and FDA-2013-P-1079 (June 6, 2014), available at http://www.regulations.gov.

    Under the FDA Authorities, in general, firms are required to submit data and other information to FDA for premarket review demonstrating a medical product is safe and effective for each of its intended uses before they introduce the product into interstate commerce for those intended uses. During FDA premarket review of medical products, the Agency also generally reviews proposed labeling for the intended use(s) of the product to ensure that the labeling provides adequate information for the safe and effective use of the product. The FDA Authorities also prohibit firms from marketing medical products with false or misleading labeling and similarly restrict certain medical product advertising.

    The premarket review and labeling and advertising provisions of the FDA Authorities address critical public health objectives. The current regulatory framework was developed in response to public health tragedies, particularly those that occurred when firms could distribute drugs and devices without independent, premarket review of scientific evidence of the products' safety and efficacy.3 Medical product firms are required to develop high-quality data to demonstrate that medical products are safe and effective for their intended uses before marketing of the products for those uses. This requirement helps ensure that the use of medical products is based on sound science, not mere anecdotal experience or misleading promotional tactics, and helps prevent direct and indirect patient harm from products and uses that are unsafe and/or ineffective. When using a medical product for its FDA approved/cleared intended use, health care professionals and patients and their caregivers can be assured that the decision to use the product is supported by robust premarket review of scientific data and other appropriate scientific evidence by an independent scientific agency and that the benefits and risks of the use are described in the product's FDA-approved or required labeling. These important assurances are absent for unapproved uses. The premarket review requirements also reflect Congress's determination that exclusive reliance on postmarket remedies, such as enforcement actions for false or misleading labeling, is unacceptable as a public health strategy because it does not prevent harm and injury to patients.

    3 The Federal Food, Drug, and Cosmetic Act of 1938, which introduced the requirement that firms demonstrate a drug product to be safe before being marketed, followed the deaths of approximately 100 people, mostly children, from ingesting “Elixir Sulfanilamide,” in which the lethal substance diethylene glycol was used as a solvent. Prior to 1938, there were no premarket requirements that mandated that the firm test its product's safety. The passage of the 1962 drug amendments was precipitated in part by the distribution of thalidomide, a sedative that caused birth defects when taken by pregnant women. See Wallace F. Janssen, Outline of the History of U.S. Drug Regulation and Labeling, 36 Food Drug-Cosm. L.J. 420 (1981). Significant problems with medical devices likewise preceded the Medical Device Amendments of 1976, including significant defects in cardiac pacemakers that led to 34 voluntary recalls involving 23,000 units, and serious side effects following implantation of intraocular lenses, including serious impairment of vision and the need to remove the eyes of some patients (H.R. Rep. No. 94-853, at 8 (1976)). See also Henry A. Waxman, A History of Adverse Drug Experiences: Congress Had Ample Evidence to Support Restrictions on the Promotion of Prescription Drugs, 58 Food & Drug L.J. 299 (2003); see also Kate Greenwood, The Ban on “Off-Label” Pharmaceutical Promotion: Constitutionally Permissible Prophylaxis Against False and Misleading Commercial Speech?, 37 Am. J. L. and Med. 278, 291-92 (2011) (describing the history of misleading firm claims in promoting unapproved uses).

    Congress also determined that safety and effectiveness must be evaluated for each intended use of a medical product to prevent the harm that occurs when patients are prescribed or use ineffective treatments and to ensure that the benefits of an intended use outweigh its risks. Under the FDA Authorities, FDA evaluates whether a medical product is safe for a particular use by comparing the expected therapeutic benefits against the risk associated with that use. The weighing of benefit and risk for each intended use is necessary as a matter of science to protect the public health: A product considered “safe and effective” for one disease or condition or patient population cannot automatically be considered “safe and effective” for another disease or condition or patient population. For example, a drug with severe adverse effects may be considered safe and effective for treating metastatic lung cancer, but be unlikely to have a positive benefit-risk balance for treating high blood pressure. Similarly, a non-absorbable suture cleared or approved for wound closure on the skin's surface might raise significant new safety and effectiveness concerns if used internally.

    Notwithstanding the importance of the FDA Authorities in protecting public health, health care professionals are generally permitted to prescribe or use approved/cleared medical products for unapproved uses when they judge that the unapproved use is medically appropriate for their individual patients,4 and relevant, truthful, and non-misleading scientific or medical information regarding unapproved uses of approved medical products may help health care professionals make better individual patient decisions. For example, health care professionals may consider prescribing or using approved/cleared medical products for unapproved uses in circumstances where a patient has a disease for which there is no approved treatment or has exhausted all approved treatments. In such a situation, relevant, truthful, and non-misleading scientific or medical information about an unapproved use may help a health care professional to make treatment decisions in the absence of scientific data or information that is capable of satisfying FDA's premarket review requirements.

    4 FDA generally does not seek to interfere with the exercise of the professional judgment of health care providers in prescribing, for unapproved uses for individual patients, most legally marketed medical products. This longstanding position has been codified with respect to devices. See 21 U.S.C. 396. While FDA generally recognizes the professional judgment of veterinarians, certain unapproved uses of drugs in animals are not permitted and result in the drug being deemed unsafe under section 512 of the FD&C Act. See section 512(a)(4) and (5) of the FD&C Act (21 U.S.C. 360b(a)(4) and (5)) and 21 CFR part 530.

    Health care professionals already can access considerable scientific information about unapproved uses, for example, through public sources such as scientific journals, clinical practice guidelines, and compendia or by requesting that information from firms.5 FDA is interested in comment on the extent to which additional communications from firms about unapproved uses can provide access to information that is relevant, scientifically sound, responsibly presented, and provides as full an understanding as possible about the limitations of the available evidence, as well as comment on the extent to which health care professionals currently face impediments to accessing such information, whether from firms or from other sources. FDA is interested in comment and information addressing whether and in what ways firms' communications of unapproved use information are distinct and perhaps provide unique benefits compared to other sources.

    5 See “Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices—Draft Guidance” (December 2011), available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf. FDA has also issued guidance documents to describe some of the circumstances when it would not consider a manufacturer's distribution of reprints, clinical practice guidelines, or reference texts regarding unapproved uses of approved drugs to be evidence of intended use and/or false or misleading. See “Revised Draft Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices” (February 2014), available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM387652.pdf (“Revised Good Reprint Practices Draft Guidance”); and “Guidance for Industry: Good Reprint Practices for Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices” (January 2009), available at http://www.fda.gov/oc/op/goodreprint.html (“Good Reprint Practices Guidance”).

    Not all communications of information about unapproved uses help support public health. For example, communications that emphasize a medical product's claimed benefits, while minimizing the limitations of the supporting evidence, or minimizing the product's known or potential adverse effects, may inappropriately influence prescribing or use decisions in a manner that is not in a patient's best interest. FDA is interested in comment on both the pros and cons for public health associated with firms' communications of unapproved use information and the kinds of limitations or requirements that would be appropriate to protect patients from harm. We are also interested in any supporting data related to these issues. In addition, allowing additional communications about unapproved uses could have other indirect consequences on public health, which are important to understand and anticipate. For example, FDA is interested in information to better understand how increased communications about unapproved uses would impact incentives to conduct biomedical research submitted for FDA review and subjects' willingness to participate in such research.

    The Agency is aware of technological and business changes that are increasingly affecting medical decision making and prescribing. There are a growing number of entities in the health care system with a stake in evaluating evidence to assess the rational and systematic use of medical products. As medical providers have increasingly been consolidated into integrated systems, the use of system measurements of quality and measurements of the appropriate use of medical products has increased, and insurance carriers, health care systems, and similar entities may restrict coverage for medical products based on assessments of value and employ performance measures to monitor appropriate use and outcomes. FDA is interested in understanding whether and how these changes may be able to provide an impetus for the development of additional high-quality data to address the balance of benefits and risks of each use of a medical product and, if so, in what way they would affect incentives for submission of this data to the Agency for marketing authorization.

    II. Purpose and Scope of the Public Hearing

    The purpose of this public hearing is to obtain comments on FDA's regulation of firms' communications about medical products, with a particular focus on firms' communications about unapproved uses of their approved/cleared medical products. FDA is seeking feedback from a broad group of stakeholders, including, but not limited to, health care professionals and professional societies, patients and their caregivers, patient advocates, representatives from regulated industry, health care organizations, payors and insurers, academic institutions, public interest groups, and the general public.

    To facilitate stakeholder feedback, FDA sets forth some questions in this section. These questions are not meant to be exhaustive. We encourage interested stakeholders to address these and/or other issues related to firms' communications about their medical products. In all cases, FDA encourages stakeholders to provide the rationale and basis for their comments, including any available data and information, and to explicitly articulate any underlying assumptions. FDA also encourages commenters to explain the basis for any distinctions they would draw as to audience, vehicle of communication, type of medical product, type and source of information, or any other aspect of communication.

    1. FDA is interested in input from stakeholders on how increased communications from firms about unapproved uses could impact the public health, and on whether the impact would differ across different categories of medical products. For example,

    a. What are the benefits for clinical decision making, research, coverage, reimbursement, or other purposes (please specify) if firms communicate to health care professionals, payors, researchers, and/or patients more information, including preliminary or inconclusive information, about unapproved uses of approved/cleared medical products? What are the drawbacks and risks? Are there safeguards or requirements that would effectively mitigate any drawbacks or risks?

    b. What information or systems exist to help FDA determine how firms' increased communication of information about unapproved uses of approved/cleared medical products could affect prescribing as well as medical product development and research into new uses of approved/cleared products?

    c. How could firms' increased communication of information about unapproved uses of approved/cleared medical products affect patient incentives to enroll in clinical trials? Related to this, FDA is interested in information on how firms' increased communication of this information could impact their incentives to generate robust data to fully assess the risks and benefits of new uses and to apply for FDA marketing authorization for new uses of approved/cleared products.

    d. Do the answers to the previous questions vary for different categories of medical products (e.g., human drugs and biologics, medical devices, animal drugs) or for different disease areas or patient populations?

    2. FDA is aware of changes happening in the health care system that are outside of FDA's role, which may provide an impetus for the development of high-quality data to fully assess the risks and benefits of new uses of medical products.

    a. To what extent do changes occurring in the health care system that give payors and formulary committees more influence on prescribing decisions (including by denying, limiting, or endorsing coverage of unapproved uses of approved medical products) provide incentives for firms to generate the high-quality data needed to demonstrate safety and effectiveness for new uses?

    b. To what extent do these changes affect (to preserve, enhance, or suppress) incentives for firms to seek FDA approval/clearance of new uses?

    3. FDA recognizes that information about medical products, including information about unapproved uses of approved/cleared medical products, is now broadly available from a wide variety of sources (e.g., academic and governmental organizations, scientific journals, professional societies, compendia) in both traditional and new communication vehicles and platforms, particularly electronic communication platforms (e.g., the Internet). What is the impact of the increasing availability of this information on firms' incentives to communicate information about unapproved uses of approved/cleared products? FDA is also interested in input on other factors that firms may consider when making decisions about providing information about unapproved uses of their approved/cleared medical product, including financial considerations.

    4. Given the importance of the scientific integrity of the information that may be relied on in making decisions about the use of medical treatments, FDA is interested in input from stakeholders on the standards that should apply to unapproved use communications to minimize the potential of these communications to be misleading or otherwise cause harm. For example:

    a. Given the wide range of quality of information potentially available to firms on unapproved uses of their approved/cleared medical products, what processes do firms use to evaluate whether such information is scientifically appropriate to communicate to health care professionals and other entities?

    b. What criteria should the Agency consider in determining whether a study or analysis that is the basis of a firm's communication is scientifically appropriate to support the presentations or conclusions in the communication?

    c. What do health care professionals generally understand about the quality and utility of different kinds or levels of scientific evidence related to unapproved uses? Can the same information be misleading to some audiences of health professionals and not others?

    d. What information is most important to health care professionals and other entities in allowing them to judge the validity and utility of firms' communications about unapproved uses, including the level of uncertainty of the evidence, and why? Does the answer to this question differ depending on the recipient's purpose—e.g., making treatment decisions for an individual patient, informing the direction of further research, making formulary or institutional supply chain contracting decisions, or making coverage determinations?

    5. FDA is interested in input from stakeholders on factors that the Agency should consider in evaluating whether firms' communications about unapproved uses of approved/cleared medical products are truthful and non-misleading, including what information firms should disclose in these communications to help ensure audiences are not misled, and on general considerations related to the audience for these communications and on communication vehicles and techniques. For example:

    a. What information should firms communicate to make audiences aware that the medical product is unapproved for the use discussed and to otherwise distinguish between the approved/cleared use(s) of the medical product and the unapproved use? How could the means of communication affect a recipient's ability to distinguish between unapproved and approved/cleared uses or otherwise impede the disclosure of necessary contextual information?

    b. What factors are most relevant to determining whether a firms' communication about a medical product concerns an unapproved use? How do firms evaluate whether or not their communications concern unapproved uses and whether the messages communicated are accurate and non-misleading?

    c. What other information should firms' disclose in these communications to help ensure audiences are not misled (e.g., about the risks of the product, the nature and weight of the evidence supporting the unapproved use, the regulatory history relating to the unapproved use, the financial involvement of firms in the research described, etc.)?

    d. How can disclosures in firms' unapproved use communications be made most effective in conveying material information while minimizing chances of confusion or inattention? How effective are disclosures in ensuring that limitations concerning data about unapproved uses are adequately communicated and comprehended? For example, how could the content and format of disclosures be developed to optimize the usefulness of this information for audiences? FDA is interested in empirical evidence to assess whether health care professionals or other entities follow or disregard different types or formats of disclosures or disclaimers.

    e. To what extent is it appropriate for firms to communicate information about unapproved uses of their approved/cleared medical products to patient and consumer audiences? What disclosures and additional information would be needed to help ensure that a communication to lay audiences is truthful and non-misleading, given consumers' lack of medical training and expertise in critically evaluating this type of information?

    6. Another important consideration in the changing health care environment is transparency, including the growing expectation that data from human studies will be made available for public review. If a firm bases a communication on data that is not publicly available, should information be provided publicly to ensure that the quality and integrity of the supportive scientific information can be adequately evaluated before any prescribing or use decision? If so, how should transparency of this information be monitored?

    7. FDA is interested in public input on how the Agency should monitor firms' communications about unapproved uses of their medical products, and what actions FDA should take with respect to firms' communications that are determined to be false or misleading or that otherwise raise public health issues. For example, what kinds of surveillance and monitoring could be undertaken to measure and assess the public health impacts of unapproved use communications and by whom?

    8. As discussed previously, the Agency is evaluating its regulations and policies governing firms' communications about unapproved uses of approved/cleared medical products and considering whether revisions are appropriate in order to provide greater legal certainty and clarity to regulated entities. As an initial step, in the Federal Register of September 25, 2015 (80 FR 57756), FDA issued a notice of proposed rulemaking that proposed changes to existing regulations at 21 CFR 201.128 and 801.4 to provide clarity for drug and device firms regarding FDA's interpretation and application of its existing intended use regulations.

    a. What additional changes, if any, should FDA consider in its regulations related to firms' communications about medical products, such as the regulations related to what is false or misleading, adequate directions for use, the definition of labeling, or other relevant provisions?

    b. With respect to proposed alternatives to the current regulations, as well as other proposed alternatives suggested in litigation briefs and journal articles, what are the advantages and disadvantages of these approaches as they relate to the public health objectives that the FDA Authorities are designed to advance?

    III. Attendance and Registration

    The FDA Conference Center at the White Oak location is a Federal facility with security procedures and limited seating. Attendance is free and early registration is recommended. Individuals who wish to attend must register on or before October 19, 2016, at http://www.fda.gov/CommunicationsPublicMeeting and provide complete contact information, including name, title, affiliation, email, and phone number. Those without Internet access may register by contacting Kristin Davis at 301-796-0418. FDA may allow onsite registration if space is available. If registration reaches maximum capacity, FDA will post a notice closing registration at http://www.fda.gov/CommunicationsPublicMeeting.

    Individuals who wish to present at the public hearing must register as noted at http://www.fda.gov/CommunicationsPublicMeeting and identify the questions (see section II) they wish to address in their presentation to help FDA organize the presentations. Individuals and organizations with common interests should consolidate or coordinate their presentations and request time for a joint presentation. FDA will do its best to accommodate requests to speak and will determine the amount of time allotted for each oral presentation and the approximate time that each oral presentation is scheduled to begin. FDA will notify registered presenters of their scheduled times and make available an agenda at http://www.fda.gov/CommunicationsPublicMeeting on or before November 2, 2016. Once FDA notifies registered presenters of their scheduled times, presenters must submit an electronic copy of their presentation to [email protected] by October 26, 2016.

    If you need special accommodations because of a disability, please send an email to [email protected] at least 7 days before the meeting.

    A link to the live Webcast of this public hearing will be available at http://www.fda.gov/CommunicationsPublicMeeting on the day of the public hearing. A video record of the public hearing will be available at http://www.fda.gov/CommunicationsPublicMeeting following the meeting. A video record of the public hearing will be available at the same Web site address for 1 year.

    IV. Notice of Public Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The hearing will be conducted by a presiding officer, accompanied by FDA senior management from the Office of the Commissioner and the relevant centers/offices.

    Under § 15.30(f) (21 CFR 15.30(f)), the hearing is informal and the rules of evidence do not apply. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation (§ 15.30(e)). Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (21 CFR part 10, subpart C) (§ 10.203(a)). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b) (see section V). To the extent that the conditions for the hearing as described in this document conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in § 15.30(h).

    V. Transcripts

    Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (see ADDRESSES). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov.

    Dated: August 29, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-21062 Filed 8-31-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 35 [Docket No. FR-5816-P-01] RIN 2501-AD77 Requirements for Notification, Evaluation and Reduction of Lead-Based Paint Hazards in Federally Owned Residential Property and Housing Receiving Federal Assistance; Response to Elevated Blood Lead Levels AGENCY:

    Office of Lead Hazard Control and Healthy Homes, HUD.

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule would amend HUD's lead-based paint regulations on reducing blood lead levels in children under age 6 who reside in federally-owned or -assisted pre-1978 housing and formally adopt the revised definition of “elevated blood lead levels” in children under the age of 6 in accordance with guidance of the Centers for Disease Control and Prevention (CDC), and establish more comprehensive testing and evaluation procedures for the housing where such children reside. In 2012, the CDC issued guidance revising its definition of elevated blood lead level in children under age 6 to be a blood lead level based on the distribution of blood lead levels in the national population. Since CDC's revision of its definition, HUD has applied the revised definition to funds awarded under its Lead-Based Paint Hazard Control grant program and its Lead Hazard Reduction Demonstration grant program, and has updated its Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing to reflect this definition. CDC is continuing to consider, with respect to evolution of scientific and medical understanding, how best to identify childhood blood lead levels for which environmental interventions are recommended. Through this rule, HUD formally adopts through regulation the CDC's approach to the definition of “elevated blood lead levels” in children under the age of 6 and addresses the additional elements of the CDC guidance pertaining to assisted housing.

    DATES:

    Comment Due Date: October 31, 2016.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this proposed rule to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500. Communications must refer to the above docket number and title. There are two methods for submitting public comments. All submissions must refer to the above docket number and title.

    1. Submission of Comments by Mail. Comments may be submitted by mail to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500.

    2. Electronic Submission of Comments. Interested persons may submit comments electronically through the Federal eRulemaking Portal at http://www.regulations.gov. HUD strongly encourages commenters to submit comments electronically. Electronic submission of comments allows the commenter maximum time to prepare and submit a comment, ensures timely receipt by HUD, and enables HUD to make comments immediately available to the public. Comments submitted electronically through the http://www.regulations.gov Web site can be viewed by other commenters and interested members of the public. Commenters should follow the instructions provided on that site to submit comments electronically.

    Note:

    To receive consideration as public comments, comments must be submitted through one of the two methods specified above. It is not acceptable to submit comments by facsimile (fax). Again, all submissions must refer to the docket number and title of the rule.

    Public Inspection of Public Comments. All properly submitted comments and communications submitted to HUD will be available for public inspection and downloading at http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Warren Friedman, Office of Lead Hazard Control and Healthy Homes, Department of Housing and Urban Development, 451 7th Street SW., Room 8236, Washington, DC 20410-3000, telephone number (202) 402-7698 or email your inquiry to [email protected] For legal questions, contact John B. Shumway, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street, Room 9262, Washington, DC 20410-0500; telephone number (202) 402-5190. The above telephone numbers are not toll-free numbers. Hearing and speech-impaired persons may access the above telephone numbers via TTY by calling the toll-free Federal Relay Service at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION:

    I. Background A. HUD's Long-Term and Ongoing Efforts To Reduce Lead Poisoning in Children

    Childhood lead poisoning has long been recognized as causing reduced intelligence, low attention span, reading and learning disabilities, and has been linked to juvenile delinquency, behavioral problems, and many other adverse health effects. Current reviews by the U.S. Department of Health and Human Services (HHS), including by its Agency for Toxic Substances and Disease Registry (ATSDR) and National Institute of Environmental Health Sciences (NIEHS) and by the U.S. Environmental Protection Agency (EPA) Office of Research and Development have described these effects in detail.1 The removal of lead-based gasoline and paint from commerce has drastically reduced the number of children exposed to levels of lead associated with the most significant among these problems. Data from CDC's National Center for Health Statistics show that mean blood lead levels among children ages 1 to 5 dropped from 16.0 μg/dL in 1976-1980 to 2.6 μg/dL in 1991-1994, to 0.97 μg/dL in 2011-2012.2 However, national statistics mask the fact that blood lead monitoring continues to find some children exposed to elevated blood lead levels due to their specific housing environment. As sources of lead paint sources have decreased, focus has increased on other sources of exposures, including legacy water pipes in homes and schools.

    1 See the following: Agency for Toxic Substances and Disease Registry. Toxicological profile for lead. Atlanta: U.S. Department of Health and Human Services (HHS), August 2007. www.atsdr.cdc.gov/toxprofiles/tp13.pdf. HHS, National Institute of Environmental Health Sciences, National Toxicology Program. NTP Monograph on Health Effects of Low-Level Lead. NIH Publication No. 12-5996. June 13, 2012. http://ntp.niehs.nih.gov/pubhealth/hat/noms/lead/index.html. Office of Research and Development. Integrated Science Assessment for Lead. Research Triangle Park, NC. U.S. Environmental Protection Agency (EPA), June 2013. https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=255721. (See esp. pp. lxxxvii-lxxxxviii, and 1-20—1-24. See also Memo Regarding a Study Assessed in the 2013 ISA for Lead—Dated May 9, 2014. http://ofmpub.epa.gov/eims/eimscomm.getfile?p_download_id=518543.)

    2 Porter, K. National Health and Nutrition Examination Survey. 2015 National Conference on Health Statistics, August 24, 2015, www.cdc.gov/nchs/ppt/nchs2015/Porter_Monday_SalonE_A6.pdf. p. 48.

    In 2014, the CDC noted that, “Lead-based paint and lead contaminated dust are the most hazardous sources of lead for U.S. children,” 3 reaffirming their 2005 Statement on preventing lead poisoning in young children that, “lead-based paint is the most important source of lead” exposure for young children.4 Continued progress in lead paint abatement and interim control over the last decade, such as through HUD's lead hazard control grant programs discussed below, and the lead hazard control work required of landlords under settlements HUD has reached in enforcing the Lead Disclosure Statute and that statute's Rule (42 U.S.C. 4852d; 24 CFR 35, subpart A) has meant further significant decreases in lead exposure among children.

    3 Centers for Disease Control and Prevention (CDC). Lead. Prevention Tips. June 19, 2014. Sec. 2, par. 1. www.cdc.gov/nceh/lead/tips.htm.

    4 CDC. Preventing Lead Poisoning in Young Children. A Statement by the Centers for Disease Control and Prevention. August 2005. p. 4. www.cdc.gov/nceh/lead/publications/PrevLeadPoisoning.pdf.

    Even so, there are a considerable number of assisted housing units that have lead-based paint in which children under age 6 reside. As detailed in the regulatory impact assessment accompanying this notice, there are about 4.3 million housing units in the assistance programs covered by this rulemaking (1.1 million public housing, 1.2 million project-based rental assistance, and 2.0 million tenant-based rental assistance units), of which about 450,000 are estimated to have been built before 1978 and have children under age 6 residing (about 110, 130, and 210 thousand units, respectively). Of those units, about 57,000 units are estimated to have lead-based paint hazards (about 14, 16, and 27 thousand, respectively).

    Health concerns have also been documented for adults exposed to high levels of lead from occupational exposures and to some extent from hobbies and other product or environmental sources, such as what might be associated with workers conducting lead hazard control activities; see, e.g., the Occupational Safety and Health Administration's (OSHA's) Lead standards, one for general industry and one for the construction industry (29 CFR 1910.1025 and 1926.62, respectively); see OSHA's Safety and Health Topics Web page on the health effects of high lead exposure in exposed workers; 5 the CDC/National Institute for Occupational Safety and Health (NIOSH) guides on lead for public health officials and researchers,6 and for workers; 7 and the ATSDR Toxicological Profile for lead and the EPA Integrated Science Assessment for Lead cited above (fn. 1).8

    5 OSHA Salt Lake Technical Center. Lead. Health Effects. https://www.osha.gov/SLTC/lead/healtheffects.html.

    6 NIOSH. LEAD. Information for Public Health Officials and Researchers. www.cdc.gov/niosh/topics/lead/publichealth.html.

    7 NIOSH. LEAD. Information for Workers. www.cdc.gov/niosh/topics/lead/health.html.

    8 As discussed below, while the focus of HUD's existing Rule (Lead Safe Housing Rule) (24 CFR 35, subparts B-R) proposed to be amended by this rulemaking is the protection of the health of children under age 6, the currently codified Rule also addresses protection of all occupants in dwelling units covered by the Rule (see, e.g., § 35.1345), and workers conducting lead-related activities in housing covered by the Rule (see, e.g., § 35.145).

    B. Authority for HUD's Lead-Based Paint Regulations

    HUD's Lead-Based Paint regulations designed to reduce lead exposure in federally-owned and federally-assisted housing (sometimes, for brevity, referred to here as “assisted housing”), referred to as the Lead Safe Housing Rule (LSHR), are found in title 24 of the Code of Federal Regulations (CFR) part 35, subparts B through R. The LSHR implements the Residential Lead-Based Paint Hazard Reduction Act of 1992, which is Title X of the Housing and Community Development Act of 1992 (Pub. L. 102-550, approved October 28, 1992), specifically, the LSHR implements sections 1012 and 1013 of Title X (42 U.S.C. 4822). One of the purposes of the LSHR is to ensure, as far as practicable, that federally-owned or federally-assisted housing that may have lead-based paint, which is most housing constructed prior to 1978 (called “target housing”) 9 does not have lead-based paint hazards.

    9 HUD's regulations, at 24 CFR 35.110, based on the Title X definition at 42 U.S.C. 4851b (27), define “target housing” as “any housing constructed prior to 1978, except housing for the elderly or persons with disabilities (unless a child of less than 6 years of age resides or is expected to reside in such housing for the elderly or persons with disabilities) or any zero- bedroom dwelling. In the case of jurisdictions which banned the sale or use of lead-based paint prior to 1978, HUD may designate an earlier date.” (Note that HUD has not made any such designations.)

    As reflected in the LSHR and consistent with Title X, HUD's primary focus is on minimizing childhood lead exposures, rather than on waiting until children have elevated blood lead levels (see section I.B, below) to undertake actions to eliminate the lead-based paint hazards or the lead-based paint. HUD's Office of Lead Hazard Control and Healthy Homes' (OLHCHH's) ongoing efforts in lead poisoning prevention—i.e., acting before children are exposed to lead such that they develop an elevated blood lead level—were recognized in the HUD's Healthy Homes Strategic Plan. 10 As noted in that document, HUD's OLHCHH has administered a successful Lead Hazard Control program since 1993. Through robust grants, enforcement efforts, research, and outreach, this program has been instrumental in the reduction of 84 percent in childhood blood lead levels of 10 μg/dL or more from 1988-1991 to 1999-2004 11 and least an estimated 97 percent through 2014.12 The success of HUD's OLHCHH comes from taking all actions feasible and authorized to reduce lead exposure in children, and these actions include providing conditions of funding through the office's notices of funding availability, updating guidelines and best practices, and working collaboratively with other Federal agencies such as the U.S. Department of Health and Human Services (HHS), particularly its CDC, and the U.S. Environmental Protection Agency (EPA), to name a few.13

    10 HUD. Leading Our Nation to Healthier Homes: The Healthy Homes Strategic Plan. July 9, 2009. http://portal.hud.gov/hudportal/documents/huddoc?id=hhstratplan_7_9_09.pdf.

    11 Dropping from 8.6% to 1.4%. Jones, R., et al. Trends in Blood Lead Levels and Blood Lead Testing Among U.S. Children Aged 1 to 5 Years, 1988-2004. Pediatrics Vol. 123 No. 3 March 2009, pp. E376-E385. http://pediatrics.aappublications.org/content/123/3/e376.

    12 Dropping from 1.4% to an estimated 0.28% or less, based on the 2.5% of children with blood lead levels at or above 5 μg/dL (see section I.B, below) and data collected by CDC's national surveillance program on blood lead testing data, comparing the numbers of children with blood lead levels at or above 5 μg/dL with those at or above 10 μg/dL in CDC. Number of Children Tested and Confirmed BLL's ≥10 μg/dL by State, Year, and BLL Group, Children < 72 Months Old. www.cdc.gov/nceh/lead/data/Web site_StateConfirmedByYear_1997_2014_01112016.xlsx.

    13 See Advancing Healthy Housing, a Strategy for Action at http://portal.hud.gov/hudportal/documents/huddoc?id=stratplan_final_11_13.pdf.

    CDC has recognized that the “HUD Lead Hazard Control Program . . . is the most easily identifiable and largest source of federal funding for lead-hazard remediation.” 14 HUD notes that that program, which implements section 1011 of Title X (42 U.S.C. 4852) does not address all types of housing with which HUD is associated. Specifically, section 1011 prohibits housing that is “federally assisted housing, federally owned housing, or public housing” from being enrolled under the section's grants. Indeed, Congress required lead hazard evaluation and control in precisely those three categories of housing when it enacted sections 1012 and 1013 of Title X, under which the LSHR was issued, so that the lead hazard control grants and the LSHR complement each other in the housing stock they address.

    14 CDC. CDC Response to Advisory Committee on Childhood Lead Poisoning Prevention Recommendations in “Low Level Lead Exposure Harms Children: A Renewed Call of Primary Prevention.” (CDC Response.) Atlanta, June 7, 2012. (Corrected from initial release May 13, 2012) www.cdc.gov/nceh/lead/acclpp/cdc_response_lead_exposure_recs.pdf.

    HUD emphasizes that the scope of its authority under Title X is limited to lead-based paint hazard reduction in housing, and the scope of this rule is further limited to the reduction of those hazards in HUD-assisted housing. HUD is authorized by Title X to control lead-based paint and lead-based paint hazards in certain HUD-assisted target housing. Lead-based paint hazards are lead-based paint and all residential lead-containing dusts and soils regardless of the source of the lead, which, due to their condition and location, would result in adverse human health effects. Title X required the EPA to promulgate standards for lead-based paint hazards, specifically, paint-lead hazards, dust-lead hazards, and soil-lead hazards, which it did through rulemaking.15 HUD has incorporated the EPA's lead-based paint hazard standards in the LSHR.16 Controlling exposures to lead from water is outside of HUD's authority under Title X. The EPA also has responsibilities regarding lead-based paint under Title X, and the EPA administers other laws regulating lead, including the Clean Air Act, Clean Water Act, Safe Drinking Water Act, Resource Conservation and Recovery Act, and Comprehensive Environmental Response, Compensation, and Liability Act, among others.17

    15 15 U.S.C. 2683, implemented by EPA at 40 CFR 745.65 and 745.227(e)(8)(vii).

    16 24 CFR 35.110, 35.1315, 35.1320(b)(2), and 35.1325.

    17 See https://www.epa.gov/lead/lead-laws-and-regulations for more information.

    C. CDC's Revised Guidance on Elevated Blood Lead Levels

    Until 2012, children were identified by CDC as having a blood lead “level of concern” if testing found 10 or more micrograms per deciliter of lead in the blood (10 μg/dL). In 2012, CDC revised its guidance on childhood lead poisoning in response to recommendations by CDC's Advisory Committee on Childhood Lead Poisoning Prevention (ACCLPP), which concluded that a growing number of scientific studies show that even low blood lead levels can cause lifelong health effects. CDC accepted the recommendation of the ACCLPP to eliminate its use of the term and concept of “blood lead level of concern.” 18 CDC is instead using a “reference range value” to identify children who have been exposed to lead and who require case management. CDC uses the phrase, “to identify persons whose exposure to a toxic substance is higher than that of most persons in the population and useful in instances when no clear threshold for effects has been identified,” as is the case for childhood blood lead levels.19

    18 See Advisory Committee on Childhood Lead Poisoning Prevention. Low Level Lead Exposure Harms Children: A Renewed Call for Primary Prevention. Atlanta, January 4, 2012. www.cdc.gov/nceh/lead/acclpp/final_document_030712.pdf. The ACCLPP's charter expired in October 2013. Activities in the Committee's field of interest are now conducted by the Childhood Lead Poisoning Prevention Subcommittee of the CDC's Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH/ATSDR). See, e.g., www.atsdr.cdc.gov/science/docs/BSC_MINUTES_MAY_2014.pdf.

    19 Raymond J., Wheeler W., Brown, M.J. Lead Screening and Prevalence of Blood Lead Levels in Children Aged 1-2 Years—Child Blood Lead Surveillance System, United States, 2002-2010 and National Health and Nutrition Examination Survey, United States, 1999-2010. Morbidity and Mortality Weekly Report. v. 63, n. 2, p. 36-42. September 12, 2014. www.cdc.gov/mmwr/preview/mmwrhtml/su6302a6.htm.

    Consistent with the ACCLPP recommendation II that CDC link lead levels in its guidance to results from CDC's National Health and Nutritional Examination Survey (NHANES),20 the CDC's “reference range value” method for defining elevated blood lead levels (EBLLs) is based on the blood lead level equaled or exceeded by 2.5 percent of U.S. children aged 1-5 years as determined by NHANES. CDC's current reference range level is 5 μg/dL (5 micrograms of lead per deciliter). This level, established in 2012 as part of CDC's response to ACCLPP, is lower than CDC's former blood lead level of concern, established in its 1991 Statement,21 which had been 10 μg/dL, and its level for recommending environmental intervention for children, 20 μg/dL, or 15 μg/dL if that level persists, levels that it reaffirmed in its 2005 Statement.22 This new lower value means that more children will likely be identified as having lead exposure, allowing parents, doctors, public health officials and communities to take action earlier to reduce the child's future exposure. It is important to note that by CDC's tying its reference value to the national distribution of blood lead levels, the reference level will continue to decrease whenever progress is made on reducing childhood lead exposure. For instance, if the 97.5 percentile drops to 2 μg/dL due to reductions in exposure to lead paint exposure, the number of children who have lead exposures above the new reference value would change only slightly, based on the growth of the national population of children under age 6, which would be about 2 percent over CDC's four-year reference range value updating period.23 CDC concurred in principle with the ACCLPP recommendation to adopt a reference range that is tied to the national distribution of blood lead levels (CDC Response to ACCLPP recommendation II.)

    20 CDC National Center for Health Statistics, National Health and Nutrition Examination Survey. Homepage at www.cdc.gov/nchs/nhanes.htm.

    21 CDC. Preventing Lead Poisoning in Young Children. A Statement by the Centers for Disease Control, chap. 8. October 1991. www.cdc.gov/nceh/lead/publications/books/plpyc/contents.htm.

    22 CDC. Preventing Lead Poisoning in Young Children. A Statement by the Centers for Disease Control and Prevention. August 2005. p. 2. www.cdc.gov/nceh/lead/publications/PrevLeadPoisoning.pdf.

    23 Calculated based on Table 1, Population by Sex and Selected Age Groups: 2000 and 2010, in Howden L.M. and Meyer J.A. U.S. Census Bureau. Age and Sex Composition 2010. 2010 Census Briefs. C2010BR-03. May 2011. Page 2. www.census.gov/prod/cen2010/briefs/c2010br-03.pdf.

    HUD's currently codified LSHR, at 24 CFR 35.110 (the definition section), uses the term “environmental intervention blood lead level” (EIBLL). EIBLL is the blood lead level at which an evaluation for lead-based paint hazards and interim controls of such hazards identified (i.e., a type of environmental intervention) are to be conducted in certain housing covered by the LSHR. Specifically, HUD defined EIBLL as “a confirmed concentration of lead in whole blood equal to or greater than 20 μg/dL for a single test or 15-19 μg/dL in two tests taken at least 3 months apart.” HUD's definition is consistent with the guidance issued by CDC in November 1997, i.e., shortly before the LSHR was published on September 15, 1999, at 64 FR 50139-50231. CDC's 1997 guidance was that a blood lead level of 10-14 μg/dL should trigger monitoring, certain parental actions, and perhaps community-wide education, but not lead hazard control in an individual child's home.24 At the time that HUD was developing the LSHR, CDC did not recommend a full home inspection or assessment in response to blood lead levels below 15 μg/dL. CDC's revised guidance uses a reference range value to trigger the identification of conditions in the environment associated with lead-exposure hazards. CDC's revised guidance recommends that children under age 6 should not live or spend significant time in homes with lead-exposure hazards (CDC Response to ACCLPP recommendations II and III).

    24 CDC. Screening Young Children for Lead Poisoning: Guidance for State and Local Public Health Officials. Chapter 4. Role of Child Health-Care Providers in Childhood Lead Poisoning Prevention. Atlanta. November 1997. www.cdc.gov/nceh/lead/publications/screening.htm.

    Although HUD has not yet conformed the LSHR to reflect the CDC's 2012 revised approach for establishing the definition of EBLL, HUD's Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing (HUD Guidelines) second edition (2012), which provide guidance information regarding evaluation and hazard reduction activities described in the LSHR (24 CFR 35.1310(a)), adopted CDC's reference range value method for defining an EBLL.25 In addition, HUD has implemented use of CDC's revised definition in both of its lead hazard control grant programs—the Lead-Based Paint Hazard Control grant program and the Lead Hazard Reduction Demonstration grant program—in the annual notices of funding availability (NOFAs) issued for these programs commencing in fiscal year 2013,26 the first NOFAs issued after CDC revised its guidance, advising the grantees of grants awarded under those NOFAs to use the definition to prioritize enrollment of housing units for lead hazard control work.

    25 See http://portal.hud.gov/hudportal/HUD?src=/program_offices/healthy_homes/lbp/hudguidelines, HUD Guidelines, esp. chapter 16, Investigation and Treatment of Dwellings that House Children with Elevated Blood Lead Levels.

    26 HUD Office of Lead Hazard Control and Healthy Homes. Notice of Funding Availability for HUD's Fiscal Year (FY) 2013 Lead-Based Paint Hazard Control Grant Program and Lead Hazard Reduction Demonstration Grant Program. December 3, 2012. http://portal.hud.gov/huddoc/2013leadcombonofa.pdf. FY 2014 Lead-Based Paint Hazard Control (LBPHC) Grant Program and Lead Hazard Reduction Demonstration (LHRD) Grant Program. May 13, 2014. http://portal.hud.gov/hudportal/documents/huddoc?id=2014leadcombonofa.pdf. FY 2015 Lead-Based Paint Hazard Control (LBPHC) Grant Program. May 7, 2015. http://portal.hud.gov/hudportal/documents/huddoc?id=2015lbphcnofa.pdf. FY 2015 Lead Hazard Reduction Demonstration (LHRD) Grant Program. May 7, 2015. http://portal.hud.gov/hudportal/documents/huddoc?id=2015lhrdnofa.pdf. Lead-Based Paint Hazard Control (LBPHC) Grant Program for FY 2016. http://portal.hud.gov/hudportal/HUD?src=/program_offices/administration/grants/fundsavail/nofa16/lbphc. Lead Hazard Reduction Demonstration (LHRD) Grant Program for FY 2016. http://portal.hud.gov/hudportal/HUD?src=/program_offices/administration/grants/fundsavail/nofa16/lhrd.

    ACCLPP recommendation X was that CDC adopt prevention strategies to reduce environmental lead exposures in soil, dust, paint, and water before children are exposed. As part of its response, CDC noted that it would continue to emphasize the importance of environmental assessment and mitigation of lead hazards before children are exposed (CDC Response to ACCLPP recommendation X).

    ACCLPP recommendation XI was that, “If lead hazards trigger a response in any unit in a multi-family housing complex, the same response action should be applied to all similar untested units in the housing complex, unless a risk assessment demonstrates that no lead hazards are present in the other units.” In response, CDC concurred with the evidence suggesting that a building that houses one child with lead poisoning is an indication that other children in that building are likely at risk (CDC Response to ACCLPP recommendation XI).

    D. Response to CDC Guidance

    HUD has been implementing primary prevention—the strategy of emphasizing preventing exposure rather than responding after the exposure has taken place 27 —since before CDC responded to the ACCLPP recommendations, specifically, implementing most of those recommendations that pertain to HUD.

    27 CDC Response. op. cit.

    Regarding the CDC Response to ACCLPP recommendation II, on using the reference range value, as noted above, HUD issued the second edition of its Guidelines, which included information on environmental interventions based on CDC's revised approach to EBLL,28 and used the revised definition in its NOFAs for its Lead Hazard Control Grant Programs starting with the first NOFA after the CDC Response was published.

    Regarding the CDC Response to ACCLPP recommendation III, on primary prevention, one of the purposes of the LSHR, as noted above, is to ensure, as far as practicable, that federally-owned or federally-assisted target housing does not have lead-based paint hazards. Assisted target housing covered by the rule is assessed for hazards before the assisted occupants move in; controls before occupancy are required when hazards are identified; when the assistance is ongoing, ongoing lead-based paint maintenance is required, periodic re-evaluations for the presence of lead hazards are conducted, and hazards are controlled, and occupants are notified of the results—all of these actions are independent of, and precede, children's blood lead levels increasing as a result of lead-based paint hazards in their housing.

    Regarding the CDC Response to ACCLPP recommendation VI, that clinicians report EBLL cases to local and state health and/or housing departments, the LSHR includes, in the subparts pertaining to ongoing assistance for target housing, the requirement that the owner (or other “designated party” responsible for the assistance under the rule) promptly report the name and address of a child identified as having an EIBLL to the public health department within 5 business days of being so notified by any other medical health care professional.29

    29 24 CFR 35.730(e), 830(d), 1130(e), 1225(e).

    Regarding the CDC Response to ACCLPP recommendation VII, HUD has long been engaged in educating families, service providers, advocates, and public officials on primary prevention of lead exposure in homes, through outreach campaigns, development, publication and distribution of brochures, flyers, manuals, and guidance documents, training of housing sector stakeholders, and supporting the EPA's National Lead Information Center, which provides the general public and professionals with information about lead, lead hazards, and their prevention.30

    30 See, e.g., EPA. Lead Hotline—The National Lead Information Center. https://www.epa.gov/lead/forms/lead-hotline-national-lead-information-center.

    Regarding the CDC Response to ACCLPP recommendation VIII, HUD has long facilitated data-sharing between health and housing agencies, promoted preventive lead-safe housing standards for target housing, identifying financing for lead hazard remediation, and provided families with the information needed to protect their children from hazards in the home. For example, as far back as 1990, in its Interim Guidelines on addressing lead hazards in public and Indian housing, HUD encouraged public housing agencies to collaborate with health departments on, e.g., encouraging blood lead screening and development of outreach materials, sharing data about cases of high blood lead levels in children, then called “lead poisoning” or elevated blood lead level (albeit with the different quantitative meaning at that time), referring children to a lead hazard control program,31 and the Department has continued these efforts since then.

    31 HUD Office of Public and Indian Housing. Lead-Based Paint: lnterim Guidelines for Hazard ldentification and Abatement in Public and Indian Housing. September 1990.

    Regarding the CDC Response to ACCLPP recommendation X, which emphasizes the importance of environmental assessments to identify and mitigate lead hazards as a primary prevention technique, as noted above, the LSHR requires this of all of the assisted housing covered by the rule. Similarly, on the item that CDC adopt prevention strategies to reduce environmental lead exposures in soil, dust, paint, and water before children are exposed, under the LSHR, as noted above, HUD has been implementing the prevention strategy to reduce environmental lead exposures in soil, dust, and paint, the media for which it has authority to do so under Title X. Regarding lead exposures from water, see the EPA Integrated Science Assessment for Lead.32

    32 EPA. Integrated Science Assessment for Lead. See fn. 1.

    Regarding several additional ACCLPP recommendations, HUD has been implementing the CDC response since the issuance of the CDC Response.

    Regarding the recommendation XIII, specifically, the element of the recommendation that has a housing connection, on CDC improving the use of data from screening programs, HUD and CDC collaborated on matching addresses of HUD-assisted residents with national health survey data to develop a method for improving the targeting of lead hazard control efforts and resources.33 HUD will continue seeking ways it can contribute to CDC's efforts in this regard.

    33 The abstract from this research will be published in the conference program for the Epidemiology Congress of the Americas' conference, June 21-24, 2016 (https://epiresearch.org/2016-meeting/). The full abstract citation will be inserted here at that time, and when the article is published, that article's citation will be inserted here.

    II. Regulatory Approach

    Although HUD is already applying the CDC's 2012 revised definition of EBLL in its lead hazard control NOFAs and in its Guidelines, the LSHR has not yet been updated to reflect the CDC's revised definition of EBL. During this time, federal agencies involved with reducing childhood lead exposures, including HUD, CDC, EPA and NIEHS, have continued to explore how best to use scientific and medical information to approach the problem of childhood lead exposures and develop approaches for prioritizing action within the limits of available resources. To keep HUD's criterion for requiring environmental intervention in response to a child having a sufficiently high blood lead level to warrant such action in synchrony with CDC's approach for determining when environmental intervention is recommended, this rule therefore proposes to revise the LSHR to adopt the CDC's approach to establishing a blood lead level for which CDC recommends environmental intervention, i.e., a trigger level for environmental intervention as the definition of EBLL in the LSHR, and apply it to determining when environmental interventions in federally-assisted and federally-owned target housing covered by the rule are to be conducted. In addition, this rule proposes to change the LSHR to reflect other CDC guidance responding to the ACCLPP recommendations, and to make additional improvements based on HUD's experience with implementing the LSHR in order to further strengthen prevention strategies in federally-assisted and federally-owned target housing.

    Specifically, HUD is proposing to revise the LSHR regarding target housing covered by the five subparts of the LSHR that are related to children under age 6 exposed to lead in housing where the Federal Government maintains a continuing financial or ownership relationship. HUD proposes to implement the recommendations of the CDC, within the scope of HUD's authority, and in consideration of available federal resources. The five subparts currently use the EIBLL threshold for undertaking an environmental response.

    HUD is proposing to revise these subparts to use the CDC's approach for determining when a child's blood lead level triggers the environmental response. The following types of federal housing assistance are covered in 24 CFR part 35 subparts for which an environmental intervention may be required:

    D—Project-Based Assistance Provided by a Federal Agency other than HUD H—Project-Based Assistance I—HUD-Owned and Mortgagee-in-Possession Multifamily Property L—Public Housing Programs M—Tenant-Based Rental Assistance

    Provisions proposed to be revised within the individual subparts are described below.

    In regard to housing for which the current rule requires response to EIBLL cases and this proposed rule would require response to EBL cases, the following types of hazard evaluation and reduction activities are required, whether or not a child with an EIBLL resides or is expected to reside in a unit covered by the LSHR:

    Lead-based paint inspection: Subparts I and L. This is a surface-by-surface investigation to determine the presence (including the location) of lead-based paint and providing a report explaining the results of the investigation.

    Hazard Evaluation:

    • Risk Assessment: Subparts D, H (assistance over $5,000 per unit per year), and I. Lead risk assessments involve visual assessment for deteriorated paint, testing of deteriorated paint to determine if it is lead-based paint (and thus, a lead-based paint hazard because of the deterioration), dust wipe sampling of window sills and floors, and sampling of bare soil.

    • Visual assessment for deteriorated paint: Subparts H (assistance up to $5,000 per unit per year), M

    • Reevaluation: Subparts D, H (assistance over $5,000 per unit per year), I and L. Reevaluations involve a visual assessment of painted surfaces and limited dust and soil sampling conducted periodically following lead-based paint hazard reduction where lead-based paint is still present.

    • Periodic inspection for deteriorated paint: Subpart M: These periodic inspections are conducted as part of the inspection of the assisted housing.

    Hazard Reduction:

    • Abatement of LBP hazards: L (during comprehensive modernization). Abatement is set of measures designed to permanently (for an expected design life of at least 20 years) eliminate lead-based paint or lead-based paint hazards Abatement includes: Removing lead-based paint and dust-lead hazards, permanently enclosing or encapsulating lead-based paint, replacing components or fixtures painted with lead-based paint, and removing permanently covering soil-lead hazards; along with all the preparation, cleanup, disposal, and post-abatement reoccupancy clearance testing activities associated with those measures.

    Interim controls of LBP hazards: Subparts D, I, and L (pending abatement during comprehensive modernization). Interim controls are measures designed to reduce temporarily human exposure or likely exposure to lead-based paint hazards. They include, but are not limited to, repairs, painting, temporary containment, specialized cleaning, clearance for tenant reoccupancy after projects that involve paint disturbance larger than the de minimis amounts specified in the rule,34 ongoing lead-based paint maintenance activities, and the establishment and operation of management and resident education programs.

    34 24 CFR 35.1350(d): 20 square feet on exterior surfaces, 2 square feet in any one interior room or space, or 10 percent of the total surface area on an interior or exterior type of component with a small surface area (e.g., window sills, baseboards, and trim).

    Paint stabilization: Subparts H (assistance up to $5,000 per unit per year), M. Paint stabilization involves repairing any physical defect in the substrate of a painted surface that is causing paint deterioration, removing loose paint and other material from the surface to be treated, and applying a new protective coating or paint.

    Lead hazard evaluation and control activities in HUD-assisted and HUD-owned housing are subject to the requirements of the applicable civil rights laws, including the Fair Housing Act as amended (for example, by the Fair Housing Amendments Act), and its prohibition of discrimination on the basis of disability or familial status (including the presence of a child under age of 18, or of a pregnant woman), Title VI of the Civil Rights Act of 1964 (prohibiting discrimination on the basis of race, color, and national origin), Title IX of the Education Amendments of 1972 (prohibiting discrimination on the basis of sex), and section 504 of the Rehabilitation Act of 1973 (prohibiting discrimination on the basis of disability). These laws, and their associated HUD regulations 35 and guidance 36 are incorporated into the LSHR through its § 35.145, Compliance with Federal laws and authorities. The applicability of the fair housing laws, regulations, and guidance to these activities would continue without change by this proposed rule.

    35See 24 CFR parts 100-180, especially parts 135 and 146.

    36See the Office of Fair Housing and Equal Opportunity's FHEO Library at http://portal.hud.gov/hudportal/HUD?src=/program_offices/fair_housing_equal_opp/library#Guidance for links to a set of Policy and Guidance documents. The FHEO Library also contains links to sets of documents on Decrees and Conciliation Agreements, Marketing Materials, Memorandums of Understanding (MOU), Publications, Studies, Voluntary Compliance Agreements, and Annual Reports. The Office's homepage is at http://portal.hud.gov/hudportal/HUD?src=/program_offices/fair_housing_equal_opp.

    A. Response to Young Children With Elevated Blood Lead Levels

    In updating the LSHR to reflect the CDC's approach to defining EBL, within the scope of HUD's authority, HUD is proposing to shift its threshold for environmental intervention from the environmental intervention blood lead level (EIBLL), as described above, to the elevated blood lead level (EBLL) that is identified in CDC's guidance for recommending a childhood blood lead level such that an environmental intervention should be conducted, at any given point in time. In 2012, CDC's guidance used the reference range value, which had the numerical value of 5 μg/dL; HUD would continue to rely on CDC's guidance, whether CDC's approach continued to use the reference range value or used another criterion. In addition, this rule proposes to revise the type of hazard control undertaken when lead-based paint or other hazards are identified and, in the case of housing projects with more than one unit, address lead-based paint hazards in those other units in which children under age 6 reside.

    The approach to implementing the regulatory protocol under this proposed rulemaking is founded on the currently codified LSHR, the CDC guidance on blood lead reference levels, the HUD Guidelines, and HUD's experience implementing the LSHR since its 1999 promulgation. Figure 1 provides an overview of the proposed protocol for addressing elevated blood lead level cases in assisted housing covered by the LSHR; its details are discussed below.

    BILLING CODE 4210-67-P EP01SE16.127 BILLING CODE 4210-67-C

    In broad terms, HUD's proposed protocol for responding to a case of a child under age 6 with an EBLL would include the “designated party” undertaking certain actions. The designated party is the owner or other entity (e.g., federal agency, public housing agency, tribally designated housing entity, sponsor, etc.) designated under the LSHR as responsible for complying with applicable requirements of the LSHR for the residential property or dwelling unit, as applicable (see § 35.110). As described below, the protocol is the same for each of the four applicable HUD subparts (H, I, L, M), and slightly narrower for the other agencies' subpart (D), for which the agencies would decide how to deal with other housing units in multi-unit properties than the unit in which the child with an EBLL resides.

    The protocol would include the designated party:

    • Conducting an environmental investigation 37 of the dwelling unit in which the child lived at the time the blood was last sampled (the “index” unit 38 ) and of common areas servicing the index unit.39 (The procedure for conducting the environmental investigation is described below.)

    37 This rule proposes to defined this term as the process of determining the source of lead exposure for a child under age 6 with an elevated blood lead level, consisting of administration of a questionnaire, comprehensive environmental sampling, case management, and other measures., in accordance with chapter 16 of the HUD Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing (“Guidelines”).

    38 Terminology adapted from the traditional epidemiology term “index case, the case that is first reported to public health authorities.” CDC. Guidelines for the Control of Pertussis Outbreaks. Centers for Disease Control and Prevention: Atlanta, GA, 2000. Chapter 11, Definitions. www.cdc.gov/pertussis/outbreaks/guide/downloads/chapter-11.pdf.

    39 However, if the designated party conducted a risk assessment of the unit and common areas servicing the unit between the time the child's blood was last sampled and when the designated party received notification of the EBLL, the designated party need only conduct the elements of an environmental investigation not already conducted during the risk assessment. See below for the discussion of environmental investigations vs. risk assessments.

    • Conducting interim control 40 of lead-based paint hazards identified in the index unit and, in the unlikely case that the work duration exceeds thresholds in the LSHR 41 (the most applicable threshold, of 5 calendar days, with the worksite contained and it and the area within 10 feet cleaned so that the family can return each day, is not expected to be exceeded), temporarily relocating the family to a suitable, decent, safe, and similarly accessible dwelling unit that does not have lead-based paint hazards.

    40 Interim control refers to actions that reduce temporarily human exposure or likely exposure to lead-based paint hazards including specialized cleaning, repairs, maintenance, painting, temporary containment.

    41 24 CFR 35.1345(a)(2).

    • Controlling other housing-related sources of lead exposure in the building, such as lead-contaminated debris.

    • Being encouraged to gain the collaboration of the occupants in addressing the presence and use of sources of lead exposure that are not housing-related. Non-housing items (such as lead-containing cosmetics, pottery, folk remedies,42 take-home exposures from the workplace, etc.) owned or used by the occupants are outside of the scope of Title X and, as a result, the LSHR.

    42 Lead has been found in some traditional (folk) medicines used by, for example, East Indian, Indian, Middle Eastern, West Asian, and Hispanic cultures. Folk medicines can contain herbs, minerals, metals, or animal products. Lead and other heavy metals are put into certain folk medicines because these metals are thought to be useful in treating some ailments. Sometimes lead accidentally gets into the folk medicine during grinding, during coloring, or from the package. See www.cdc.gov/nceh/lead/tips/folkmedicine.htm.

    The proposed procedure for conducting an environmental investigation, including procedures for investigating sources of lead exposure other than lead-based paint hazards, as presently found is found in Chapter 16 of the HUD Guidelines. 43 The protocol includes:

    43 Chapter 16 of the HUD Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing notes that, “The purpose of the [environmental] investigation is to identify lead hazards in the environment of a child. An ordinary risk assessment attempts to uncover lead-based paint hazards in a dwelling, regardless of whether a child has an EBLL. The investigator is obligated to conduct a comprehensive investigation of all sources of lead in the child's environment, not just those lead exposures directly related to the child's residence. This investigation includes studying less-common sources of lead, such as glazed pottery and folk medicines or remedies, etc., and other dwellings or areas frequented by the child. Some of these sources may be discovered by the results of the questionnaire. The investigator tests deteriorated paint on furniture identified as a potential hazard to the environmental intervention blood lead (EIBLL) child, regardless of who owns the furniture.” (Paragraphs merged.)

    • Reviewing the findings of any previous lead-based paint inspection, risk assessment, environmental investigation, or reevaluation for the property.

    • Conducting a comprehensive interview of the family of the child, based on the CDC EBLL environmental investigation checklist or HUD EBLL questionnaire (both are in the chapter), or a comparable questionnaire (such as one from the public health department).

    • Conducting a risk assessment.44

    44 A risk assessment is (per § 35.110), an on-site investigation to determine the existence, nature, severity, and location of lead-based paint hazards; and the provision of a report by the individual or firm conducting the risk assessment explaining the results of the investigation and options for reducing lead-based paint hazards. As such, it is narrower in scope than an environmental investigation, as described here.

    • Augmenting the risk assessment, in consultation with the public health department managing the child's EBLL case, if that public health department chooses to cooperate with the designated party, to determine what, if any, other possible sources of exposure should be investigated, including, but not limited to:

    ○ Drinking water.

    ○ Glazed pottery or tableware that may contain lead glazes.

    ○ Work clothes or vehicle that may have been contaminated from a parent's or guardian's work place.

    ○ Imported cosmetics, hobbies, folk remedies, and candies. (Hobby contamination involving lead (e.g., hunting, fishing, furniture refinishing, stained glass making, etc.) has been recognized as a lead exposure source in, e.g., CDC guidance and EPA guidance).

    • Providing to the HUD field office documentation that the designated party has conducted the activities above, within 10 business days of the deadline for each activity. In accordance with the Government Paperwork Elimination Act, which encourages electronic submission of information as a substitute for paper,45 the designated party may submit the documentation of compliance with the LSHR regarding the affected units electronically.

    45 44 U.S.C. 3504(a)(1)(B)(vi).

    The designated party or public health department may have conducted an environmental investigation of the index unit and common areas servicing it between the dates the child's blood was last sampled and the designated party received the EBLL notification. If so, the designated party would not need to conduct another environmental investigation. Similarly, if the designated party had conducted a risk assessment of the index unit and common areas servicing the unit during that period, it would not need to conduct another risk assessment, it would need to conduct only the additional elements of an environmental investigation.

    A key part of the response to the case of a child with an elevated blood lead level is the environmental investigation of the unit in which the child resided, i.e., the index unit. The index unit may be in a building or project with other assisted dwelling units covered by the LSHR in which children under age 6 reside or are expected to reside (see the discussion of “expected to reside” in section II.A.2). If so, the protocol would include the designated party either:

    • Providing to the HUD field office 46 documentation that the designated party has complied with required evaluation (with the type of evaluation, i.e., lead-based paint inspection, risk assessment, or visual assessment for deteriorated paint, in accordance with the Rule's subpart regarding the type of assistance), notification, lead disclosure, ongoing lead-based paint maintenance, and lead-based paint management in those units; or,

    46 See the HUD Field Office listing Web page at http://portal.hud.gov/hudportal/HUD?src=/program_offices/field_policy_mgt/localoffices. For Multifamily Housing assistance, designated parties may also contact the respective Regional Center, Regional Satellite Office, Hub or Program Center directly; see the Multifamily Regional Centers and Satellite Offices Web page at http://portal.hud.gov/hudportal/HUD?src=/program_offices/housing/mfh/hsgmfbus/abouthubspcs.

    • If the designated party does not provide such documentation of compliance to date, conducting a risk assessment of the non-compliant other units within the building or project covered by the LSHR and the common areas that service them, and conducting interim controls of lead-based paint hazards identified, or in the case of tenant-based rental assisted units and project-based rental assisted units receiving under $5,000 per unit per year or being single family housing, conducting visual assessment and stabilization of deteriorated paint,47 and providing to the HUD field office documentation that the designated party has conducted the evaluation (i.e., risk assessment or visual assessment, as applicable) and hazard control (i.e., interim controls or paint stabilization, as applicable) within 10 business days of the deadline for the respective activities.48

    47 Paint stabilization is “repairing any physical defect in the substrate of a painted surface that is causing paint deterioration, removing loose paint and other material from the surface to be treated, and applying a new protective coating or paint.” (§ 35.110)

    48 Paint stabilization is “repairing any physical defect in the substrate of a painted surface that is causing paint deterioration, removing loose paint and other material from the surface to be treated, and applying a new protective coating or paint.” (§ 35.110)

    As noted above in regard to the Government Paperwork Elimination Act, the designated party may submit the documentation of compliance with the LSHR regarding the affected units electronically.

    Consistent with CDC's response to the ACCLPP recommendations, chapter 16 of the HUD Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing (HUD Guidelines) 49 recommends control of sources of lead exposure identified during an environmental investigation or risk assessment. These sources of lead exposure include:

    49 HUD. Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing. Washington, 2014. http://portal.hud.gov/hudportal/HUD?src=/program_offices/healthy_homes/lbp/hudguidelines.

    • Lead-based paint hazards (i.e., paint-lead hazards, dust-lead hazards, or soil-lead hazards, as defined and given quantitative measure by EPA at 40 CFR 745.63 and 745.65, respectively), which are identified by a lead risk assessment. A risk assessment is defined in the LSHR at § 35.110 (see footnote 45, above), and given operational meaning for the LSHR incorporation of EPA's Lead-Based Paint Hazards, Lead-Based Paint Activities, and State and Indian Tribal Programs rules (40 CFR part 745, parts D, E, and Q, respectively, by the LSHR at 24 CFR 35.1320, Lead-based paint inspections and risk assessments), and

    • Other housing-related sources of lead exposure that are outside of the scope of lead risk assessments. The procedure for environmental investigations, as provided in chapter 16 of the Guidelines, is summarized above.

    HUD notes that reevaluation is not part of the response to an EBLL. Reevaluations (or, for tenant-based rental assistance, periodic housing quality standard inspections) are already part of the regular ongoing lead-based paint management required in the subparts this proposed rule would amend, so they are not part of this amendment.

    HUD's statutory authority to require controls of lead exposure sources, in contrast to recommending control of them, is limited to housing hazards under the United States Housing Act of 1937 (1937 Act) 42 U.S.C. 1437 et seq., as amended 50 (e.g., on public housing meeting housing quality standards 51 through lease contracts obligating public housing agencies to maintain housing projects in safe condition,52 and on safety requirements for housing assistance programs for lower-income families 53 ). In this context, the controls are limited to lead-based paint hazards, rather than lead exposures from the personal contents of the housing residents and visitors, the public water supply, ambient air levels or industrial emissions.

    50 Public Law 93-383, 88 Stat. 633, approved August 22, 1974. (The codified version can be searched on www.fdsys.gov; the text of the United States Code's subchapter, General Program of Assisted Housing (42 U.S.C. 1437-1437z-8) can be downloaded from www.thefederalregister.org/fdsys/pkg/USCODE-2012-title42/html/USCODE-2012-title42-chap8-subchapI.htm.).

    51 Section 6(f)(2); 42 U.S.C. 1437d(f)(2).

    52 Section 6(l)(3); 42 U.S.C. 1437d(l)(3).

    53 Section 8(c)(4); 42 U.S.C. 1437f(c)(4).

    As seen in numerous HUD regulations from its various program offices,54 HUD can encourage activities even if it does not require them. Accordingly, through this rulemaking, HUD encourages (in §§ 35.730(f)(3)(iv), 35.1130(f)(4), and 35.1225(f)(3)) designated parties to identify and control lead-based paint hazards in locations not covered by the LSHR (i.e., unassisted housing units), and lead exposure sources other than lead-based paint hazards, even if doing so is not required by the LSHR.

    54E.g., 24 CFR 8.28(a)(2), 50.3(a), 51.101(a)(5), 51.106(a)(4), 91.105(a)(2)(i)(ii)(iii), 200.857(g)(4), 570.466, 902.75(f), 964.15, and 984.201(d)(5), etc.

    As described below, across the different subparts of the LSHR, there are some differences in terminology, scoping, and exceptions, based on the specifics of the housing assistance.

    1. Dwelling Unit in Which the Child Resided

    HUD is proposing that, when a child under age 6 residing in target housing where the Federal government maintains a continuing financial or ownership relationship is reported to have an EBLL, the designated party must complete an environmental investigation of the index unit, and of common areas servicing the index unit, within 15 calendar days of the designated party being notified.

    As noted above, several types of federal housing assistance, covered by 24 CFR part 35 subparts D, H, I, L, and M, identified above, have provisions that address lead safety in regard to children under age 6. The subparts apply when the Federal government maintains a continuing financial or ownership relationship to the target housing (vs. the short-term relationship in most rehabilitation projects, which ends when the construction work is completed, if there is no other long-term assistance relationship).

    Similarly to the process under the currently codified rule, if the notification of an EBLL case is received from a person who is not a medical health care provider, the requirement to conduct an environmental investigation would be conditioned on verification of the case information, including the child's blood lead level information with the public health department or other medical health care provider. However, the threshold for such verification would be changed from EIBLL to EBLL as defined under this proposal.

    Under the currently codified rule, the blood lead threshold for conducting the environmental investigation is fixed. Under this proposed rule, the threshold for the EBLL would change when CDC updates its guidance for a childhood blood lead level such that an environmental intervention should be conducted. As of 2012, this was the reference range level for children under age 6 (i.e., the blood lead level at or above which the top 2.5th percentile of U.S. children's blood lead levels are to be found, per CDC's NHANES). CDC announced that it plans to update the reference range value every 4 years (CDC response to ACCLPP Recommendation II).55 Thus, CDC's recommendation on a childhood blood lead level for recommending an environmental intervention would be updated at least that often.

    55 HUD recognizes that, if the EBLL threshold continues to decrease over time, the measurement variability (sampling and analytical variability) will represent a larger fraction of the threshold value. It would therefore, be likely that, at some point, the percentile approach of the reference range value might not be correlated as tightly with determinable lead exposure sources, i.e., a smaller fraction of cases may be attributable to lead-based paint hazards. The environmental investigation will make that determination in individual cases. Should a statistically significant substantial trend toward low fractions of EBLL cases being attributable to lead-based paint hazards be identified, HUD would consider further LSHR rulemaking based on the evidence available at that future point.

    If the proposed rule is adopted, after CDC publishes an update to the EBL guidance, HUD would issue a notice on the applicability of that updated threshold to the LSHR going forward after a preparatory transition period. HUD's notice would, in order to provide regulatory and programmatic clarity, and to avoid unnecessary retroactive program changes, specify that the change would be prospective, not retroactive. Thus, the status of housing of children with blood lead levels based on measurements taken before the transition period ends that are in the range between the earlier and newer reference range values would not be affected by the change. (For example, if the earlier reference range value was 5.0 μg/dL, and a 4-year old child's blood lead level measured before the end of the transition period were 3.7 μg/dL, the child's dwelling unit would not need to be subject to an environmental investigation, even if the updated EBL value published after the child's blood were tested is 3.7 μg/dL or less. If the child continues to reside in federally-owned or -assisted housing covered by the environmental intervention requirement, and the child's blood, as retested after the transition period has ended is at or above the updated EBL value (in this example, at or above 3.7 μg/dL), the environmental intervention would then be required.)

    Similarly, the blood lead level that would prompt notification to the public health department would be an EBLL rather than an EIBLL.

    In order that HUD be able to promptly monitor implementation of the evaluation and hazard control procedures when an EBLL case has occurred in HUD-assisted or HUD-owned target housing, HUD is proposing that the designated party notify within 5 business days of being notified of the EBLL case by a public health department or any other medical health care professional both the HUD field office (as the currently codified rule requires for public housing, under § 35.1130(e)) and HUD's OLHCHH, which has been delegated authority for oversight of the Lead Safe Housing Rule.56 The OLHCHH, which is functioning as a public health authority as defined by the Privacy Rule (45 CFR parts 160 and 164) promulgated under the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191, 110 Stat. 1936, approved August 21, 1996, as amended),57 is developing an electronic portal for submitting the case information, in order to minimize the reporting burden on designated parties, and will announce the availability of the portal and instructions for its use in a Federal Register notice. If, and so long as there is sufficient demand for notifications to be sent by mail or fax, the OLHCHH will make those submittal pathways available. Should it determine that there is insufficient demand; the OLHCHH will post a Federal Register notice to that effect.

    56 HUD. Delegation of Authority for the Office of Healthy Homes and Lead Hazard Control. 76 FR 45592. July 29, 2011. https://federalregister.gov/a/2011-19279.

    57 HUD-CDC memorandum, March 9, 2004. www.hud.gov/offices/lead.

    The 15-day period for conducting environmental investigation would be the same period as the current LSHR requires in EIBLL cases.

    If the investigation identified lead-based paint hazards in these areas, the designated party (or the owner, as applicable) would be required to conduct interim controls of the hazards within 30 calendar days of receiving the report of the investigation, as in the current rule.

    Similarly, as part of this rulemaking, HUD encourages the designated party to address sources of lead exposure other than lead-based paint hazards. If those sources are housing-related, e.g., airborne emissions from housing activities conducted by the designated party (or the owner, as applicable), such as uncontrolled emissions from welding or soldering operations in the property's machine shop, the designated party (or the owner, as applicable) is encouraged by HUD to address the hazards. The public health department may issue an abatement order in regard to those sources; compliance with such an order is a requirement of state, tribal or local law, as applicable. Some or all of the sources of lead exposure may be outside of the scope of Title X and the LSHR because they are not housing-related sources. For example, the sources may be non-housing items, such as lead-containing cosmetics, pottery, folk remedies, etc. owned or used by the occupants that produce exposures, lead contamination on clothing or skin and in vehicles from the workplace, out-of-home hobbies, or in-home hobbies. Chapter 16 of the HUD Guidelines includes a set of links to the CDC lead Web page on such sources.58 That chapter also refers to the CDC lead Web page on at-risk populations (including children who are poor, are members of racial-ethnic minority groups, are recent immigrants, live in older, poorly maintained rental properties, or have parents who are exposed to lead at work; pregnant women; refugee children; and internationally adopted children),59 which is of particular interest when no probable source of lead may be identified. Both of those Web pages have further links to Web pages on specific topics.

    58www.cdc.gov/nceh/lead/tips/sources.htm.

    59www.cdc.gov/nceh/lead/tips/populations.htm.

    Regarding these sources, HUD encourages the designated party to gain the cooperation of the occupants in addressing the presence and use of non-housing-related sources of lead exposures. Similarly, some of these sources may be ambient, such as hazardous waste facility siting, or industrial emissions, regarding which, by this rulemaking, HUD is indicating that it is important that the designated party inform or even engage with local, state, and/or federal public health and/or environmental officials in addressing the problem.

    Hazard reduction would be considered complete when either:

    • Clearance of the unit and common areas servicing the unit is achieved and the clearance report from the risk assessor states that the control measures have been completed; or

    • The public health department certifies that the lead-based paint hazard reduction and the control of other housing-related lead hazards are complete.

    The designated party may have, between the date the child's blood was last sampled and when the designated party received the notification, conducted hazard reduction of the unit and common areas servicing the unit as described above, including passing clearance. If so, it need not redo the hazard reduction.

    2. Other Assisted Dwelling Units in the Building or Project

    ACCLPP's recommendation XI was that, “If lead hazards trigger a response in any unit in a multi-family housing project, the same response action should be applied to all similar untested units in the housing project, unless a risk assessment demonstrates that no lead hazards are present in the other units.”

    HUD is proposing that if, (a) the dwelling unit in which the child under age 6 resided when she or he was reported as having an EBLL, i.e., the index unit, is part of a residential property or project that has other units of housing covered by the LSHR, and (b) the index unit has been confirmed to have lead-based paint hazards, then the occupancy and lead management of other units covered by the LSHR with a child under age 6 residing or expected to reside would be examined to determine whether the designated party must conduct a risk assessment or visual assessment (as described in the bulleted paragraphs above). If so, and if lead-based paint hazards (or deteriorated paint) are found in those other units, then interim controls or paint stabilization,60 as applicable must be conducted, and clearance passed. On the other hand, if the index unit has been found not to have lead-based paint hazards, HUD is proposing that no risk assessment or visual assessment, as applicable, be required in other assisted units in the building or project. This approach is based on the predicate in the CDC response to ACCLPP recommendation XI, namely, that a response in other units is based on having “lead hazards trigger a response in any unit in a multi-family housing complex.” If the index unit does not have lead-based paint hazards, the CDC guidance does not recommend actions in other units.

    60 Paint stabilization refers to repairing any physical defect in a painted surface that is causing paint deterioration, removing loose paint and other material from the surface to be treated, and applying a new protective coating or paint.

    If index unit has any lead-based paint hazards, HUD is proposing that the types of action required depend on whether a child under age 6 resides or is expected to reside in one or more other assisted units in the building or project, and the documented degree of compliance with the LSHR by the designated party in regard to the residential property, as reviewed by HUD if the designated party wishes to use its performance record as demonstrating that no lead-based paint hazards are likely to be present in other units. This prioritization is intended to focus limited federal resources on the situations of the highest risk to children under age 6 in other assisted units in the building or project where exposure to lead hazards may have occurred. HUD has, of course, no jurisdiction under sections 1012 or 1013 of Title X over unassisted units, but it encourages the use of the protocol below in unassisted units, even if it cannot require its application to those units. Similarly, regarding lead safety in situations not covered by the Rule, HUD encourages housing owners (occupant owners and landlords), housing maintenance, management, and renovation firms, and others to be aware of its hazards, and to work safely with lead-containing building materials, for the protection of the health of occupants, visitors and workers, and their families.

    In general, when the index unit has been found to have lead-based paint hazards, and a child under age 6 resides or is expected to reside in one or more other assisted units in the building or project, HUD is proposing certain actions be undertaken, based on the type of assistance. Specifically, the designated party would be required to (with exceptions as noted below):

    • Conduct a risk assessment of those other units in public housing, project-based rental assisted multifamily properties receiving $5,000 or more per unit per year in HUD assistance, or HUD-owned and mortgagee-in-possession multifamily properties with unit selection as described in the statistically valid random sampling protocol in Chapter 7, Section V, Inspections in Multi-family Housing, of the HUD Guidelines (as discussed below), or sample all of those other units.

    • Conduct a visual assessment for deteriorated paint in those other units in tenant-based rental assisted units, project-based rental assisted properties receiving under $5,000 per unit per year in HUD assistance, or project-based rental assisted single family housing in the same project receiving HUD assistance. Again, when there are a sufficient number of those other units, the random sampling protocol in Chapter 7, Section V, of the HUD Guidelines may be used (as discussed below) for unit selection.

    The occupancy of the other assisted units in the building or project would be examined to determine in which of them, if any, children under age 6 resided or were expected to reside as of the date when, regarding the index unit and common areas servicing that unit:

    • If lead-based paint hazards were identified, the date the lead hazard control work passed clearance, that is, the unit (and/or common area) where the work was done is completed, and the residents can move into their unit (and/or pass through the common area) based on a successful visual inspection for completion of the work and cleanliness is passed and, for work that would disturb painted surfaces that total more than a small (“de minimis”) amount (defined for the LSHR in 24 CFR 35.1350(d)), passing a residual dust-lead level test; or

    • If no lead-based paint hazards were identified, the date the environmental investigation in regard to the child in the index unit was completed.

    The “expected to reside” wording is used because it is in the statutory and regulatory definitions of target housing as the exception to the exemption of housing for persons with disabilities or the elderly from target housing. Thus, housing for persons with disabilities or the elderly in which a child under age 6 resides or is expected to reside is covered by the scope of the LSHR.61 As detailed in the definition section (§ 35.110) of the LSHR, as proposed to be amended by this rule:

    61 42 U.S.C. 4822(e)(1), 4851b(27); 24 CFR 35.110, 35.115.

    Expected to reside means there is actual knowledge that a child will reside in a dwelling unit reserved or designated exclusively for the elderly or reserved or designated exclusively for persons with disabilities. If a resident woman is known to be pregnant, there is actual knowledge that a child will reside in the dwelling unit.”

    It is important to note that a “dwelling unit reserved for the elderly,” or a “dwelling unit . . . designated exclusively for persons with disabilities” differs from a unit's happening to be occupied by the elderly or by persons with disabilities. A child may be “expected to reside” in family housing (i.e., housing available for general occupancy, meaning that there are no restrictions on the types of people who may occupy the unit, or, in other words, the unit is available for occupancy in general to all individuals and families and is not designated or reserved for any particular category) even if there is no child living there at a particular time or even if an elderly family or a family with one or more persons with disabilities are the occupants.

    When the designated party has this actual knowledge about another assisted unit in the building or project, that unit would be included among those that are assessed (unless the designated party had documented to HUD's satisfaction, compliance with the LSHR demonstrating that no lead-based paint hazards were likely to be present in other units) and, if lead-based paint hazards or deteriorated paint (as applicable) are identified, treated.

    The date clearance has passed is used in establishing the deadline for conducting the evaluation of the other units and the control of hazards identified, so that the designated party will focus its initial efforts on the index unit and its associated common areas, in order to expedite evaluating and, if necessary, controlling lead-based paint hazards there.

    If a family with a child under age 6 moves in to a unit formerly designated as one in which no children under age 6 were residing or expected to reside, a risk assessment or visual assessment (as applicable, based on the type of assistance) must be conducted in accordance with the current rule. If lead-based paint hazards or deteriorated paint (as applicable) are found, then, under the current rule, lead hazard control will be conducted to protect the child's health.

    If the index unit has been found to have lead-based paint hazards, it is possible that the designated party may not have met the proposed certain performance requirements under the LSHR. Specifically, under the LSHR, the designated party is responsible for conducting and documenting current evaluation, notifications, and disclosure, and, depending on the type of assistance, may be responsible for conducting and documenting ongoing lead-based paint maintenance and management (see Sections II.A.3 and 4, respectively, below).

    If the designated party has not met the applicable performance requirements above, and a child under age 6 with an EBLL resides in a unit covered by the LSHR that has lead-based paint hazards, HUD is proposing that the designated party conduct a risk assessment (or visual assessment, as applicable) in other dwelling units covered by the LSHR in which children under age 6 reside or are expected to reside, and the common areas servicing those units. If lead-based paint hazards or deteriorated paint, as applicable, are found in those other units, then interim controls or paint stabilization, as applicable must be conducted, and clearance passed.

    If the designated party has met the applicable performance requirements above, and a child under age 6 with an EBLL resides in a unit covered by the LSHR, the designated party is encouraged by HUD to conduct a risk assessment (or visual assessment, as applicable) in other dwelling units covered by the LSHR, although it would not be required to do so. When the set of units with children under age 6 has been identified, if a risk assessment is to be conducted, the designated party (in typical practice, through its risk assessment staff or contractor) would select either all of these units (and the common areas that service them) to assess, or, if the number of units is large enough (over 20, in pre-1960 housing, and over 10 in 1960-1977 housing), a random sample of units (and of the common areas that service them) in accordance with the HUD Guidelines, Chapter 7, Section V.B, Selection of Housing Units, Common Areas, and Exterior Site Areas. Random sampling for risk assessments is appropriate in the context of an elevated blood lead level response because it provides “a statistically significant degree of confidence about the existence of lead-based paint hazards,” in multifamily housing, and “avoids questions about the quality of the criteria used for targeting or worst case sample selection,” according to the HUD Guidelines, Chapter 5, Section III.B.1, Targeted, Worst Case, and Random Sampling. This level of programmatic confidence is particularly important in addressing housing in which a child has an EBLL.

    When the set of units with children under age 6 has been identified, if visual assessment is to be conducted, the designated party (in typical practice, through its risk assessment staff or contractor) would select all of these units (and the common areas that service them) to assess. The visual assessment procedure is much faster than the risk assessment procedure, with the trade-off that it provides less information. Accordingly, conducting a random sample of units and of common areas is not appropriate in this context of a child under age 6 with an EBLL in the building or project.

    However, as under the current LSHR, if the designated party were to choose not to evaluate the other units covered by the LSHR for lead-based paint hazards (or deteriorated paint, as applicable), the designated party would have to presume that lead-based paint hazards are present in these other units and common areas. This is allowable because the current LSHR provides, in §§ 35.120(a) and (b), for risk assessments not to be conducted if “the designated party . . . presume[s] that lead-based paint or lead-based paint hazards or both are present throughout the residential property,” and use standard treatments on the painted building components and horizontal surfaces, and HUD is continuing to allow the designated party to use this option. A designated party may, for example, have staff or contracts in place to control presumed lead-based paint hazards, if it does not wish to delay undertaking the control activities.

    For target housing units receiving tenant-based rental assistance in which children under age 6 reside (which are covered by LSHR subpart M), the legislative history of Title X, as described in the preamble to the LSHR (64 FR 50139, at 50146), supports that, “Congress did not intend for HUD to apply the new minimum procedures set out in section 1012(a) of Title X,” in particular, risk assessments. However, HUD does not accept the assumption that “Congress intended to abolish HUD's [then] current procedures” for lead safety evaluation, and those procedures serve as LSHR's basis for requiring a visual assessment for deteriorated paint in this housing. Accordingly, HUD is continuing to allow the approach of using a visual assessment for this housing in the context of assessing units and common areas other than the index unit and common areas servicing the index unit.

    HUD is proposing that if a risk assessment or a visual assessment (as applicable) finds lead-based paint hazards or deteriorated paint (as applicable), or if these hazards or deterioration are presumed to exist in the other dwelling units with children under age 6 residing or expected to reside and the common areas servicing those units, then the approach to controlling them should be the same as for the index unit and common areas servicing the index unit. For all subparts covered by this rulemaking the control approach would be interim controls, except for subpart M on tenant-based rental assistance, and a portion of subpart H on project-based rental assistance (to units receiving under $5,000 per unit per year or being single family housing) for which the approach is paint stabilization. For both, interim controls and paint stabilization, the control measure would be followed by clearance if the amount of deteriorated paint is above the LSHR's de minimis threshold.62

    62 HUD. Lead Safe Housing Rule. 24 CFR 35.1350(d). The de minimis threshold is either: (1) 20 square feet (2 square meters) on exterior surfaces; 2 square feet (0.2 square meters) in any one interior room or space; or 10 percent of the total surface area on an interior or exterior type of component with a small surface area. Examples include window sills, baseboards, and trim.

    As in the current rule, the designated party would be required to implement lead hazard control measures promptly, with the period specified in the applicable subpart of the rule. In housing covered by the LSHR, for index units, the period for interim controls would be 30 calendar days of receiving the report of the investigation. For other units covered by the LSHR with children under age 6 residing or expected to reside, the period would be 30 calendar days for paint stabilization (as in the current rule at §§ 35.720(a)(2) and 35.1215(b)), and a schedule based on the main threshold for multifamily unit sampling in the HUD Guidelines' chapter 7 as a means of characterizing a large hazard control project: 63 Within 30 calendar days, or within 90 calendar days if more than 20 units each require lead hazard control work that would disturb painted surfaces that total more than the de minimis threshold of § 35.1350, Safe work practices, paragraph (d), De minimis levels,64 and, therefore, would require the work to be done using lead safe work practices and certified renovation or abatement firms.65 Basing the schedule on the amount of hazard control work to be done recognizes resource availability limitations when large numbers of units require work. HUD encourages owners to conduct hazard control work expeditiously, especially if there are few other units in which work is to be done.

    63 Formally, the number of units for which random sampling provides 95 percent confidence that fewer than 5 percent of units (or 50 units, for projects of over 1000 units) have lead-based paint, for lead-based paint inspections, or lead-based paint hazards, for risk assessments. For up to 20 units, all units are sampled; for larger numbers of units, only a fraction need be sampled. (For routine inspections and risk assessments, this criterion is applied to pre-1960 housing, but that year-of-construction distinction need not be made in this case, because of the essential difference that the index unit is known to have lead-based paint hazards.) See the Guidelines, chapter 7, section V.B.

    64 “Safe work practices are not required when maintenance or hazard reduction activities do not disturb painted surfaces that total more than: (1) 20 square feet (2 square meters) on exterior surfaces; (2) 2 square feet (0.2 square meters) in any one interior room or space; or (3) 10 percent of the total surface area on an interior or exterior type of component with a small surface area. Examples include window sills, baseboards, and trim.” (Reformatted here.)

    65 The landlord may be a certified firm. For example, EPA's Renovation, Repair and Painting Program: Property Managers page (www.epa.gov/lead/renovation-repair-and-painting-program-property-managers) has the following questions and answers (reformatted here): “How can property managers comply with the RRP rule? Do you or your employees conduct renovation, repair, or painting activities in a pre-1978 residential building? If yes, then you must become a Lead-Safe Certified Firm. If no, then hire only a Lead-Safe Certified firm for building maintenance, repair, or painting activities that could disturb lead-based paint.”

    See the description of the evaluation and lead-based paint hazard control approach in Section II.A.1, above, along with the approach to addressing sources of lead exposure other than lead-based paint hazards.

    3. Documentation of Current Evaluation, Notifications, Disclosure

    The LSHR requires, in the applicable subparts of title 24 CFR part 35, that evaluations be conducted for lead-based paint, deteriorated paint, and/or lead-based paint hazards, i.e., paint-lead, dust-lead and soil-lead hazards, as applicable to the subpart, and that occupants be notified of the results of evaluations and hazard reduction activities.

    This proposed rule would retain the requirement of notification of evaluations and hazard reduction activities in accordance with § 35.125, Notice of evaluation and hazard reduction activities, of the LSHR. That section requires notification within 15 calendar days of when the designated party receives the evaluation report or the hazard reduction activities have been completed, to each occupied dwelling unit affected by the evaluation, presumption, or hazard reduction activity or serviced by common areas in which it took place.

    The implementing provisions in other parts of title 24 CFR incorporate part 35 by reference, including both the LSHR, in subparts B-R, and the Lead Disclosure Rule, in subpart A. Disclosure is required in addition to notification. Note that any lead-based paint hazards identified by a risk assessment or environmental investigation, and the results of any lead hazard control work, must, under the Lead Disclosure Rule, be disclosed to prospective tenants and buyers, and to current tenants before lease renewal. See HUD's Lead Disclosure Rule Web site at www.hud.gov/lead. Note also that HUD's Lead Disclosure Rule is substantively identical to EPA's Lead Disclosure Rule at 40 CFR part 745 subpart F; see EPA's Real Estate Disclosure Web site at http://www2.epa.gov/lead/real-estate-disclosure/.

    HUD is proposing that, if the designated party has not complied with these requirements in the 12 months ending on the date the owner received the environmental investigation report, or if it has not provided the HUD field office documentation demonstrating compliance, the designated party must conduct the evaluation and, if applicable, hazard reduction requirements in the other assisted dwelling units with children under age 6 and common areas serving them, as described in Section II.A.2, above. Note that, under rules pertaining to the type of assistance, HUD may consider taking remedial action under the assistance contract or agreement as a result of the noncompliance.

    4. Documentation of Ongoing Lead-Based Paint Maintenance and Management

    Implementation of ongoing lead-based paint management and maintenance is important in ensuring that, between evaluations, lead-based paint is maintained properly (such as during day-to-day occupancy and, in particular, renovation, repair and painting (RRP) work) and managed properly (such as during rehabilitation and modernization activities) so that lead-based paint hazards are unlikely to occur. Each of the five LSHR subparts covering HUD-assisted housing for which the current rule has an EIBLL requirement also requires ongoing lead-based paint maintenance. Similarly, when rehabilitation, under subpart J, Rehabilitation, is conducted in such housing, appropriate lead hazard control is required, as is the use of properly certified firms and workers in these activities. Specifically, the LSHR requires compliance with Federal laws and authorities for all lead-based paint activities (24 CFR 35.145). This includes the Environmental Protection Agency's lead-based paint regulations at 40 CFR part 745, such as its RRP Rule.66

    66 See, especially, 40 CFR part 745 subpart E, on certified RRP work practices, and renovation firm and renovator certifications; subpart L, including conducting certified lead-based paint inspection, risk assessment and abatement activities, including clearance examinations when required; and subpart Q, on State and Indian Tribal certification programs that complement EPA's certification programs in other parts of the Nation in which EPA implements the certification program.)

    The designated party may have complied with the evaluation, notification and disclosure requirements described in Section II.A.3, above, but not properly maintained and managed lead-based paint, lead in dust, and lead in soil, or not documented compliance. (Proper management in this context includes using lead-certified firms and workers in maintenance and management activities, and achieving successful clearances for such activities conducted in accordance with the LSHR throughout the 12 months ending on the date the owner received the environmental investigation report.) In such a case of inadequate or absent documentation, or the designated party's not having provided the documentation to the HUD field office, HUD is proposing that the designated party must conduct the evaluation and, if applicable, hazard reduction requirements in the other dwelling units with children under age 6 and common areas serving them, as described in Section II.A.3, above.

    B. Effective Date

    HUD is proposing a delayed effective date for these regulations that would be one or more months after the date of publication of the final rule in the Federal Register. In determining an appropriate delayed effective date, HUD considered three options: 1 month, 6 months, and 12 months after publication of the final rule.

    The argument in favor of a 1 month delayed effective date is based on Title X (sections 1012 and 1013) requiring the evaluation and reduction of lead-based paint hazards in housing receiving Federal assistance and residential property owned by the Federal government. Under one line of argumentation, any delay beyond the mandatory 30 day delayed effective date (42 U.S.C. 3535(o)(3)) in implementing requirements based on the guidance of the federal public health agency would pose an undue risk to the health of children. The argument for a longer delayed effective date is that program administrators at all levels of government, as well as property owners and contractors performing lead-based paint activities, would not have adequate education and training time to implement the new criterion and the associated requirements and procedures required under the proposed regulation.

    Further, the Department recognizes that HUD clients conducting ongoing program activities will need time to incorporate the revised requirements for responding to cases of children with elevated blood lead levels into their programs. As a result, HUD is proposing to delay the effective date of the final rule for 6 months after publication of the final rule as a way to allow all parties—lead-based paint professionals, housing agencies, state and local government agencies, and private property owners—time to prepare for proper implementation of the revised requirements. The Department shares the concern of the public health community that delays in implementing these requirements may have young children with EBLLs living in certain HUD-assisted housing where no environmental intervention has taken place spend a longer amount of time in that housing than the time it takes to control the lead-based hazard. At the same time, however, it would be impractical for HUD to establish a 30 day delayed effective date knowing that the organizational infrastructure necessary to carry it out would not be fully in place.

    Because most of the LSHR went into effect 12 months after its publication,67 and this rulemaking would affect only a small fraction of the housing covered by the whole LSHR, HUD is proposing that this rulemaking go into effect sooner than 12 months. More specifically, HUD believes that a 6 month delayed effective date is sufficient for designated parties to be informed of the rule's becoming final and to prepare for taking action if a child residing in the assisted units has an EIBLL. Most designated parties would not need to take any action in response to this proposed rule, if adopted, because they will not have any children under age 6 in programs covered by this rulemaking who have EBLLs, and those that will need to take action will do so on an occurrence basis, rather than in the anticipation of a likely EBLL.

    67 HUD Lead Safe Housing Rule. 24 CFR 35.105 Effective dates.

    HUD welcomes comments on the length of the proposed delayed effective date for this rule.

    C. Subparts

    1. Subpart B—General Lead-Based Paint Requirements and Definitions for All Programs. This subpart sets out general requirements for federally owned residential property and housing receiving Federal assistance.

    a. Definitions. HUD is proposing to add two new terms, delete one term, and revise two terms, in § 35.110, Definitions:

    Elevated blood lead level. In this rule, HUD proposes to replace the EIBLL threshold with the EBLL threshold that is the blood lead level in children under 6 years of age for which CDC guidance says that an environmental intervention should be conducted. The EBLL will be used for determining when environmental interventions are to be taken under the LSHR.

    As discussed in Section I, above, in 2013, CDC revised its guidance to provide an operational definition of EBLL based on data from NHANES, and committed to update that definition every four years. Accordingly, HUD is proposing to add a definition of EBLL so that the term can be used in the program subparts instead of writing out the full wording of the definition in each applicable section.

    Specifically, elevated blood lead level means a confirmed concentration of lead in whole blood of a child under age 6 equal to or greater than the concentration in guidance published by the Department of Health and Human Services for recommending that an environmental intervention be conducted.

    The entity mentioned in the definition is the Department of Health and Human Services, rather than CDC, in order to accommodate the possibility that that Department could choose to have another organizational unit than CDC announce the updated EBL value, without HUD having to amend this Rule to reflect that updated value.

    HUD is proposing to add a definition that elevated blood lead level means a confirmed concentration of lead in whole blood of a child under age 6 equal to or greater than the concentration in the most recent guidance published by the Department of Health and Human Services on recommending that an environmental intervention be conducted.

    ii. Environmental intervention blood lead level. For the reasons discussed above in regard to adding the definition of elevated blood lead level, the term environmental intervention blood lead level is no longer needed in the program subparts of the LSHR, so HUD is proposing to delete the definition of environmental intervention blood lead level. This proposed rule replaces the term environmental intervention blood lead level with the term elevated blood level throughout the LSHR.

    iii. Environmental investigation. For purposes of clarity, brevity, and consistency with CDC's response to ACCLPP, the term environmental investigation is defined in this proposed regulation the way it is defined in the HUD Guidelines. Specifically, an environmental investigation would be defined to mean the process of determining the source of lead exposure for a child under age 6 with an elevated blood lead level, consisting of administration of a questionnaire, comprehensive environmental sampling, case management, and other measures, in accordance with chapter 16 of the HUD Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing (“Guidelines”). With HUD proposing that an environmental investigation in response to EBLL cases be included in the program subparts of the LSHR, HUD proposes to define the term rather than having to write out its substance in each applicable section. Accordingly, HUD is proposing to add a definition that environmental investigation means the process of determining the source of lead exposure for a child under age 6 with an elevated blood lead level, consisting of administration of a questionnaire, comprehensive environmental sampling, case management, and other measures, as all of these elements are conducted in accordance with chapter 16 of the HUD Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing (“Guidelines”). See preamble Section II.A.1, above, for a summary of the environmental investigation protocol.

    iv. Evaluation. In the current LSHR, an evaluation is a risk assessment, a lead hazard screen, a lead-based paint inspection, paint testing, or a combination of these to determine the presence of lead-based paint hazards or lead-based paint. This proposed rule would add the term environmental investigation, as discussed above, to the list of activities that are evaluations. As a result, in accordance with the LSHR, § 35.125(a), Notice of evaluation or presumption, when an environmental investigation is conducted in a housing unit or common area servicing the units, the tenants will be notified of the results. However, a prohibition against posting a notice of environmental investigation in centrally located common areas is added to § 35.125(d) for the protection of the privacy of the child and the child's family or guardians, in accordance with the Health Insurance Portability and Accountability Act (HIPAA).68

    68See the HIPAA in regard to privacy of children and their families regarding individually identifiable health information. See, especially HIPAA § 1171, creating 42 U.S.C. 1320d-6, Wrongful disclosure of individually identifiable health information, with the definition of the term created at 42 U.S.C. 1320d(6).

    v. Expected to reside. For purposes of clarity, the phrases “reserved for” and “designated exclusively for” in the current LSHR are being unified into the single term “reserved or designated exclusively for.” Specifically, “reserved for the elderly” in regard to whether pre-1978 housing is target housing is being revised to “reserved or designated exclusively for the elderly,” and “designated exclusively for persons with disabilities” is being revised to “reserved or designated exclusively for persons with disabilities.” Certain housing laws and HUD regulations use one or the other phrase.69 Using a unified term eliminates possible confusion about the applicability of the exemption based on the statutory or regulatory history of the type of assistance to a property, allowing HUD and designated parties to focus on the current status of the assistance.

    69See, e.g., 42 U.S.C. 1437e, Designated housing for elderly and disabled families, 24 CFR 880.612a(d)(1), which mentions vacant units “reserved for elderly families;” and 24 CFR 945.105, in which “Mixed population project means a public housing project reserved for elderly families and disabled families.”

    2. Subpart D—Project-Based Assistance Provided by a Federal Agency Other Than HUD. This subpart sets out minimum requirements, consistent with section 1012 of Title X, for Federal agencies other than HUD that have housing programs that provide more than $5,000 of project-based assistance per unit per year to a target housing property.

    This subpart currently requires specific actions in response to a child with an environmental intervention blood lead level in § 35.325. In addition to revising this section to refer to an elevated blood lead level, HUD proposes that the change in evaluation method be updated to reflect the change from risk assessment to environmental investigation.

    HUD is proposing that children under age 6 in this housing be covered when they live in other units in the building or project. Specifically, if the environmental investigation of the index unit identifies any lead-based paint hazards, the owner would generally, as described below, conduct a risk assessment for other assisted dwelling units in which a child under age 6 resides or is expected to reside on the date interim controls are complete, and for the common areas serving those units. Risk assessments would be conducted within 30 calendar days after receipt of the environmental investigation report on the index unit if there are 20 or fewer such units, or 60 calendar days for risk assessments if there are more than 20 such units. If the risk assessment were to identify lead-based paint hazards, the owner would have to control the hazards in those units and common areas. The control work would have to be done within 30 calendar days, or within 90 calendar days if more than 20 units have lead-based paint hazards such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d), as discussed in Section I.A.2, above. These requirements for other units would not apply if either the owner conducted a risk assessment and conducted interim controls of identified lead-based paint hazards between the date the child's blood was last sampled and the date the owner received the notification of the elevated blood lead level; or if the owner has documentation of compliance with evaluation, notification, lead disclosure, ongoing lead-based paint maintenance, and lead-based paint management requirements under this part throughout the 12 months preceding the date the owner received the environmental investigation report, Federal agencies other than HUD would be responsible for updating their policies under this subpart and implementing them.

    3. Subpart H—Project-Based Assistance. This subpart establishes procedures to eliminate as far as practicable lead-based paint hazards in residential properties receiving project-based assistance under a HUD program.

    This subpart covers several categories of project-based assistance programs. Section 35.715 covers project-based assistance to multifamily properties receiving more than $5,000 per unit per year, and includes a paragraph (d) on properties that have not yet had a risk assessment conducted in accordance with paragraph (a). Section 35.720 covers multifamily properties receiving up to $5,000 per unit per year, and single family properties. Both sections incorporate the same § 35.730, about a child with an environmental intervention blood lead level, by reference. HUD is proposing that § 35.730, be revised to reflect the protocol for addressing elevated blood level cases as described above.

    Regarding other dwelling units in the property covered by this subpart other than the index unit, HUD is proposing that, if the environmental investigation report on the index unit identifies lead-based paint hazards, then, for units in which a child under age 6 resides:

    • Evaluation (risk assessment (per § 35.715(a)) or visual assessment (per § 35.720(a)(1)), as applicable) would be conducted within 30 calendar days after receipt of the environmental investigation report on the index unit for visual assessments, 30 calendar days for risk assessments if there are 20 or fewer such units, or 60 calendar days for risk assessments if there are more than 20 such units. These periods provide promptness while recognizing that more than one unit may have to be assessed, and the limited availability of certified risk assessors in some jurisdictions, so that the 15-day period used in § 35.730(a) for conducting an evaluation on that one, index, unit may not be sufficient for the owner to arrange for identifying other units where a child under 6 resides or is expected to reside, and having the evaluation of those other units conducted. HUD encourages owners to conduct these evaluations expeditiously, especially if there are a small number of other units to be evaluated.

    • Hazard control work be completed in these other units on a schedule described above: within 30 calendar days, or within 90 calendar days if more than 20 units have lead-based paint hazards such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d). HUD encourages owners to conduct hazard control work expeditiously, especially if there are few other units in which work is to be done.

    As noted above, to enable prompt HUD monitoring of implementation of the evaluation and hazard control procedures under this subpart when an EBLL case has occurred, HUD is proposing that the designated party notify the HUD field office and HUD's OLHCHH within 5 business days of being so notified by the public health department or medical health care professional.

    It should be noted that CDC used the terms “multi-family housing” and “housing complex” in its Response to ACCLPP recommendation XI to refer to a group of buildings, apartments, etc., that are located near each other and used for a particular purpose, as “complex” is commonly defined in the building context. HUD regulations and program documents use several terms to refer to such a similar group of residential buildings, including “complex,” “buildings,” “apartments,” and “project.” For the sake of uniformity, and to provide clarity for HUD stakeholders, the HUD synonym “project” is used in this and other subparts of the LSHR outside of quotations from CDC that use “complex.”

    HUD proposes to make a technical correction to § 35.715, to redesignate paragraph (d)(4), on blood lead level response, which requires the response until a risk assessment of a property is conducted, but does not require a blood lead level response after the risk assessment is done, as paragraph (e). The current paragraph numbering inadvertently makes the requirement for the higher level of assistance in this section less stringent than the requirement for the lower level of assistance covered by § 35.720. As a result of correcting this inconsistency, the redesignation would have the requirement apply to multifamily properties receiving more than $5,000 per unit, whether before or after the risk assessment has been conducted.

    4. Subpart I—HUD-Owned and Mortgagee-in-Possession Multifamily Property. The purpose of this subpart is to establish procedures to eliminate, as far as practicable, lead-based paint hazards in a HUD-owned multifamily residential property or a multifamily residential property for which HUD is identified as mortgagee-in-possession.

    This subpart currently requires specific actions in response to a child with an environmental intervention blood lead level in § 35.830; the requirements are generally the same with respect to risk assessment, verification, hazard reduction, and reporting requirement as those for housing receiving project-based rental assistance in § 35.730, discussed in Section II.C.3. The difference is that, because HUD is the owner of these properties covered by § 35.830, the term “HUD” is used here where the wording “the owner” is used in § 35.730.

    HUD is proposing that § 35.830 be revised to reflect the protocol for addressing EBLL cases as described above, with the difference that, because HUD is the owner of these properties, for specificity, “HUD” would be used in § 35.830 rather than the phrase “the owner” that would be used in § 35.730.

    As noted above, to enable prompt HUD OLHCHH monitoring of implementation of the evaluation and hazard control procedures under this subpart when an EBLL case has occurred, HUD is proposing that the HUD office managing the property notify the HUD field office and the OLHCHH within 5 business days of being so notified by the public health department or medical health care professional.

    5. Subpart L—Public Housing Programs. The purpose of this subpart L is to establish procedures to eliminate, as far as practicable, lead-based paint hazards in public housing. More formally, public housing is residential property assisted under the 1937 Act, excluding housing assisted under section 8 of the 1937 Act. Target housing assisted under section 8 is covered by subparts D, H, and M of the LSHR, rather than this subpart L.

    This subpart currently requires specific actions in response to a child with an environmental intervention blood lead level in § 35.1130, which are generally the same as those for housing receiving project-based rental assistance in § 35.730 of subpart H, discussed in Section II.C.3, with a difference in terminology and some additional requirements.

    Regarding the terminology, because the public housing agency (PHA) carries out the lead-based paint functions of owner of the properties covered by § 35.1130, the term “PHA” is used where the term “owner” is used in § 35.730. Similarly, “public housing development” is used in this section, where “dwelling unit to which this subpart applies” is used in § 35.730.

    HUD is proposing that § 35.1130(e) require that PHAs report each confirmed (previously labelled “known,” and revised to follow CDC terminology more closely) case of a child with an EBLL to the HUD field office; in the currently codified rule such reporting is required for EIBLL cases. As noted above, to enable prompt HUD monitoring of implementation of the evaluation and hazard control procedures under this subpart when an EBLL case has occurred, HUD is proposing that the designated party also notify the OLHCHH within 5 business days of being so notified by the public health department or medical health care professional of an EBLL case.

    The case of the PHA not completing the hazard reduction required by § 35.1130, which was not addressed in the original rule, is addressed here by noting the linkage between the LSHR and the Uniform Physical Condition Standards (UPCS) at § 5.703, which are incorporated by reference into the public housing regulations at 24 CFR part 965. In particular, if the hazard reduction is not completed, the dwelling unit is not free of lead-based paint hazards, so it is in violation of § 5.703(f), which among other things, requires that the housing be free of lead-based paint hazards. The UPCS are incorporated by reference into the public housing physical condition standards at § 965.601. The LSHR, including its subpart L, Public Housing, is also incorporated by reference into the public housing standards at § 965.701.

    Most significantly, current § 35.1130(f) establishes requirements for PHAs regarding other units in the building with the index unit if the risk assessment of the index unit and common areas servicing the index unit identifies lead-based paint hazards but previous evaluations of the building did not identify lead-based paint or lead-based paint hazards. In such a case, the PHA is required to conduct a risk assessment of other units covered by the LSHR in the building, and interim controls of identified hazards.

    HUD is proposing that, generally, if previous evaluations of the building did identify lead-based paint or lead-based paint hazards, and the risk assessment of the index unit and common areas servicing the index unit identifies lead-based paint hazards, then, generally, the PHA would conduct a risk assessment in other dwelling units covered by the LSHR in which a child under age 6 resides or is expected to reside (and the common areas that service those units). The risk assessments would have to be conducted on a schedule described above, within 30 calendar days after receipt of the environmental investigation report if there are 20 or fewer such units, or 60 calendar days if there are more such units. If lead-based paint hazards are found in any of these other units, they would have to be controlled on a schedule described above, within 30 calendar days, or within 90 calendar days if more than 20 units have lead-based paint hazards such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d). However, if the PHA has met the applicable performance requirements in Section II.A.2, above, for conducting current evaluations, notifications, disclosure, and ongoing lead-based paint maintenance and management in the 12 months before receiving the report of a child with EBLL in the index unit, and provides the HUD field office with documentation of its regulatory compliance, HUD would encourage the PHA to conduct a risk assessment in other dwelling units covered by the LSHR in which a child under age 6 resides (and the common areas that service them), although it would not be required to do so.

    HUD is proposing that § 35.1130 be revised to refer to an elevated blood lead level, and that the section be updated to reflect the protocol for addressing EBLL cases as described above, with the differences that, because the PHA is the owner of these properties, for specificity, “PHA” would be used in § 35.1130 rather than the phrase “the owner” that would be used in § 35.730.

    HUD is proposing to make a technical correction to § 35.1130(f). The first sentence (which HUD is proposing to redesignate as § 35.1130(f)(1)) discusses the requirement for the PHA to conduct interim controls of identified hazards in accordance with the schedule provided in, according to the currently codified rule, § 35.1120(c). The pertinent schedule in § 35.1120 is, however, in paragraph (b), not paragraph (c), so HUD proposes to correct the citation.

    6. Subpart M—Tenant-Based Rental Assistance. The purpose of this subpart is to establish procedures to eliminate as far as practicable lead-based paint hazards in housing occupied by families receiving tenant-based rental assistance.

    This subpart currently requires specific actions in response to a child with an environmental intervention blood lead level in § 35.1225, Child with an environmental intervention blood lead level; similar to those for housing receiving project-based rental assistance in § 35.730 of subpart H, discussed in Section II.C.3, with a difference in terminology and some variations in requirements.

    Regarding the terminology, because of the variety of HUD assistance programs covered by this subpart (see § 35.1200(a)), the generic term “designated party” is used where the term “owner” is used in § 35.730 for project-based assisted housing.

    As noted above, to enable prompt HUD monitoring of implementation of the evaluation and hazard control procedures under this subpart when an EBLL case has occurred, HUD is proposing that the designated party notify the HUD field office and the OLHCHH within 5 business days of being so notified by the public health department or medical health care professional.

    Regarding the other tenant-based rental assisted units where a child less than 6 years is residing or expected to reside in a building with a tenant-based rental assisted unit with a child less than 6 years who has an EBLL, as noted in Section II.C.2, above, HUD is proposing that those other units and common areas servicing them receive a visual assessment for deteriorated paint. (As noted above, HUD does not have the discretion to require risk assessments in those other units and common areas servicing those other units.) The visual assessments would have to be conducted within 30 calendar days after receipt of the environmental investigation report. Similarly, the response action, should deteriorated paint be identified, would be paint stabilization, a treatment that does not require the quantitative information about dust-lead and soil-lead levels needed for the full set of interim control activities that a risk assessment provides. If deteriorated paint is found in any of these other units, the paint would have to be stabilized on a schedule described above, within 30 calendar days, or within 90 calendar days if more than 20 units have deteriorated paint such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d). Of course, a designated party may choose to conduct a risk assessment or environmental investigation of those other units and common areas, and conduct interim controls if lead-based paint hazards are identified, and even conduct that evaluation and hazard control in unassisted units with children under age 6, and HUD encourages them to do so.

    For the sake of clarity regarding target housing occupied by families receiving tenant-based rental assistance with children under age 6 in which deteriorated paint has been identified by a visual assessment, HUD proposes to add a sentence to the end of § 35.1215(b). Regarding a subsequent housing assistance payment (HAP) contract for the unit (i.e., after the unit is no longer under the original HAP contract), the added sentence would provide that paint stabilization must be completed for a family with a child under age 6 to occupy that unit. This would reaffirm the first sentence of paragraph (b), that, for units to be occupied by a child under age 6, the owner shall stabilize each deteriorated paint surface before commencement of assisted occupancy. The placement of this sentence will strengthening the protection against children under age 6 being lead poisoned by clarifying the need for paint stabilization before the unit is occupied by a child under age 6 under a HAP contract.

    D. Specific Questions for Comments

    While HUD welcomes comments on all aspects of this proposed rule, HUD is seeking specific comment on the following questions:

    1. To facilitate effective HUD monitoring of responses to a case of an elevated blood lead level, the proposed rule would have designated parties provide documentation to HUD that the response actions have been conducted in the child's unit and in all other assisted units with a child under age 6, or if there are such other units, that the designated party has been complying with the LSHR for the past 12 months, and need not evaluate those other units.

    a. Is this approach sufficient for HUD to effectively monitor response actions in these cases, and why? Are there areas in which reporting and oversight could be strengthened?

    b. Can the approach to monitoring response actions in these cases be streamlined while maintaining its effectiveness, and if so, how?

    2. Regarding the definition of elevated blood lead level in the proposed rule, is the definition appropriately protective of the health of children in assisted housing covered by the rule? Too protective? Not protective enough? Why?

    3. Regarding the set of types of housing assistance covered by the proposed rule (i.e., in the covered subparts D, H, I, L, and M), is this set appropriately protective of the health of children in assisted housing?

    a. If it is too protective, why, and which types of housing assistance should be removed from the proposed rule?

    b. If it is not protective enough, why, which additional type or types of housing assistance should be included, and how would sufficient resources be provided to ensure implementation and monitoring of the rule in that additional assisted housing?

    4. If interim controls or abatement in a housing unit takes longer than 5 calendar days, or if other occupant protection requirements of 24 CFR 35.1345(a)(2) are not met, the occupants of the unit shall be shall be temporarily relocated before and during hazard reduction activities.

    a. HUD is seeking data on the fraction of lead hazard control activities that take longer than 5 calendar days, including the type of activity (e.g., interim control or abatement; the hazard control method used (e.g., if abatement, component removal, paint stripping, enclosure, encapsulation, etc.), the extent of the work, the reason that the activities cannot be completed within 5 calendar days, whether the housing is a single family, duplex, triplex, quad, or multifamily housing, whether it is located in an urban, suburban, or rural area, whether the EPA has authorized the state to administer the applicable lead certification program (i.e., renovation or abatement), and other factors that are causing temporary relocation to be required under the rule.

    b. HUD is seeking information on the costs of temporary relocation, on a per day basis (average amount or day-specific amounts, as is available), including breakouts of expenses for such categories as lodging, transportation, meals, and incidental expense amounts, if the information is available that way, or as lump sum per-day or per relocation period amounts.

    III. Findings and Certifications Regulatory Review—Executive Orders 12866 and 13563

    Under Executive Order 12866 (Regulatory Planning and Review), a determination must be made whether a regulatory action is significant and, therefore, subject to review by the Office of Management and Budget (OMB) in accordance with the requirements of the order. Executive Order 13563 (Improving Regulations and Regulatory Review) directs executive agencies to analyze regulations that are “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned. Executive Order 13563 also directs that, where relevant, feasible, and consistent with regulatory objectives, and to the extent permitted by law, agencies are to identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public.

    OMB reviewed this proposed rule under Executive Order 12866 (entitled “Regulatory Planning and Review”). This rule was determined to be a “significant regulatory action,” as defined in 3(f) of the order. The docket file is available for public inspection electronically at Federal eRulemaking Portal at http://www.regulations.gov under the title and docket number of this rule.

    Regulatory Impact Assessment

    HUD is publishing, concurrently with this proposal, its draft Regulatory Impact Analysis (RIA) that examines the costs and benefits of the proposed regulatory action in conjunction with this proposed rule, organized into three sections: Cost-Benefit Analysis; Sensitivity Analysis; and Economic Impacts. The RIA is available on-line at: http://www.regulations.gov. The major findings in the RIA are presented in this summary.

    The analysis of net benefits reflects costs and benefits associated with the first year of hazard evaluation and reduction activities under the proposed rule. These costs and benefits, however, include the present value of future costs and benefits associated with first year hazard reduction activities. For example, the costs associated with first year activities include the present value of future reevaluation costs. Similarly, the benefits of first year activities include the present value of lifetime earnings benefits for children living in or visiting the affected unit during that first year, and for children living in or visiting that unit during the second and subsequent years after hazard reduction activities.

    In regard to the discount rate used for this regulatory analysis, HUD is using both the 3 percent, and the 7 percent discount rates in accordance with OMB guidance in OMB Circulars A-4 on Regulatory Analysis,70 and A-94 on Guidelines and Discount Rates for Benefit-Cost Analysis of Federal Programs.71 By presenting results using both 3 and 7 percent discount rates, HUD is providing a broad view of costs and benefits.

    70https://www.whitehouse.gov/omb/circulars_a004_a-4/.

    71https://www.whitehouse.gov/omb/circulars_a094.

    Employing a 3 percent discount rate of the lifetime earnings estimates, the RIA concludes that monetized benefits of activities have a present value of $97.91 million; while first-year costs are $22.17 million. Thus the estimated net benefit is $75.74 million using a 3 percent discount rate. If a 7 percent discount rate is used for lifetime earnings benefits, the monetized present value of the benefits of the proposed rule are estimated to be $31.81 million, and estimated first year costs remain at $22.17 .28 million. The proposed rule would therefore be seen as having a net benefit of $9.64 million using the 7 percent discount rate. Further, the monetized benefit estimates represent a lower bound on benefits, as they only account for lifetime earnings resulting from cognitive impacts on children under age six. Reductions in lead exposure would be expected to result in additional health benefits for these children, as well as older children and adults living in or visiting the housing units addressed by the rule. Such additional benefits include avoidance of decreased attention, increased impulsivity, hyperactivity,72 impaired hearing, slowed growth, delayed menarche,73

    72 EPA. Integrated Science Assessment for Lead (see fn. 1, above). 2013. Table ES-1. p. lxxxiii-lxxxvii.

    73 Selevan SG, Rice DC, Hogan KA, Euling SY, Pfahles-Hutchens A, Bethel J. Blood lead concentration and delayed puberty in girls. N Engl J Med. 2003 Apr 17;348(16):1527-36. www.nejm.org/doi/full/10.1056/NEJMoa020880.

    That the benefit-cost calculation giving lower weight to future generations shows a smaller net benefit is not surprising, given that the monetized benefits of the rule pertain to the future earnings of children under age 6, while the costs pertain to the designated parties of the housing in which the young children currently reside. As noted above, the calculation included monetized but not non-monetized quality of life factors associated with children's lower intelligence, fewer skills, and reduced education and job potential, and adults' decreased cognitive function decrements, psychopathological effects (self-reported symptoms of depression and anxiety), hypertension, coronary heart disease, blood system effects (decreased red blood cell survival and function, and altered heme synthesis), male reproductive function decrements, among other effects.74

    74 EPA. Integrated Science Assessment for Lead (see fn. 1, above). 2013. Table ES-1. p. lxxxiii-lxxxvii.

    Paperwork Reduction Act Statement

    The number of housing units that would require evaluation, possible hazard reduction, and/or reporting of EBLL information to HUD would be changed by the proposed rule. Accordingly, HUD is requesting OMB approval for revising its information collection request approval to reflect the change in the burden.

    The information collection requirements contained in this rule have been submitted to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), for incorporation under existing OMB approval number 2539-0009. In accordance with the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection displays a currently valid OMB control number.

    Table 1—Requirements for Notification, Evaluation, and Reduction of Lead-Based Paint Hazards in Federally Owned Residential Property and Housing Receiving Federal Assistance Information collection Number of
  • respondents
  • Frequency of
  • response
  • Total annual
  • responses
  • Burden hours
  • per response
  • Total annual
  • burden hours
  • Total annual
  • cost
  • Notice of Evaluation 6,887 4 27,550 0.175 4,821 $42,819 Notice of Reduction 6,887 3.17 21,833 0.1 2,183 25,707 Summary Reporting 6,887 8 55,100 0.1 5,510 59,404 Recordkeeping 6,887 4 27,550 0.033 909 10,808 EBLL Report 6,887 4 27,550 1 27,550 278,907 Total or Average 6,887 23 159,583 5.95 40,974 417,645

    In accordance with 5 CFR 1320.8(d)(1), HUD is soliciting comments from members of the public and affected agencies concerning the information collection requirements in this interim rule regarding:

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

    (2) The accuracy of the agency's estimate of the burden of the collection of information;

    (3) Whether the collection of information enhances the quality, utility, and clarity of the information to be collected; and

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

    Interested persons are invited to submit comments regarding the information collection requirements in this rule. Under the provisions of 5 CFR part 1320, OMB is required to make a decision concerning this collection of information between 30 and 60 days after the publication date. Therefore, a comment on the information collection requirements is best assured of having its full effect if OMB receives the comment within 30 days of the publication date. This time frame does not affect the deadline for comments to the agency on the interim rule, however. Comments must refer to the interim rule by name and docket number (FR-5816-P-01) and must be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503, Fax number: (202) 395-6947.

    And

    Anna P. Guido, HUD Reports Liaison Officer, Department of Housing and Urban Development, 451 7th Street SW., Room 4186, Washington, DC 20410.

    Interested persons may submit comments regarding the information collection requirements electronically through the Federal eRulemaking Portal at http://www.regulations.gov. HUD strongly encourages commenters to submit comments electronically. Electronic submission of comments allows the commenter maximum time to prepare and submit a comment, ensures timely receipt by HUD, and enables HUD to make them immediately available to the public. Comments submitted electronically through the http://www.regulations.gov Web site can be viewed by other commenters and interested members of the public. Commenters should follow the instructions provided on that site to submit comments electronically.

    The information collection requirements contained in this rule have been submitted to the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). HUD has determined that the following provisions contain information collection requirements: 24 CFR part 35, subparts D, H, I, L, and M.

    Regulatory Flexibility Act

    In accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), HUD has reviewed this proposed rule before publication and by approving it for publication, certifies that the proposed regulatory requirements would not have a significant economic impact on a substantial number of small entities, other than those impacts specifically required to be applied universally by the statute. As discussed below, the requirements of the proposed rule are applicable only to a limited and specifically defined portion of the nation's housing stock. To the extent that the requirements affect small entities, the impact is generally discussed in the economic analysis that accompanies this proposed rule.

    Specifically, the economic analysis estimated the number of index units and other assisted units to be evaluated and, possibly, based on the evaluation, having lead hazard control work done. For each type of assistance and for all types of assistance together, the economic analysis also estimated:

    • The cost per unit of the evaluation (environmental investigation for index units, and risk assessments or visual assessment for other units that are assisted and have a child under age 6 residing, as per the current LSHR);

    • The total cost of the evaluation and hazard control (for index units, other units, and both); and

    • The percentage of units evaluated and possibly, based on the evaluation results, hazard controlled (again, for index units, other units, and both).

    The estimates are summarized in the table below.

    Public
  • housing
  • HUD
  • Project-
  • based
  • Tenant-
  • based
  • USDA
  • Project-
  • based
  • All
  • assistance
  • types
  • Number of index units 1,899 1,494 3,383 112 6,887 Average cost per index unit for environmental investigation and hazard control $2,680 $2,680 $2,680 $2,680 Cost for index units $5,090,047 $4,004,506 $9,066,416 $300,206 $18,461,176 Other assisted units with children under age 6 8,014 3,783 2,855 284 14,935 Average cost per other assisted housing unit for risk assessment (or visual assessment) and hazard control $615 $615 $260 $615 Cost for other assisted units $4,924,470 $2,324,545 $740,829 $174,264 $8,164,108 Total cost $10,014,517 $6,329,051 $9,807,245 $474,471 $26,625,284 Total number of units evaluated and possibly hazard controlled 9,913 5,277 6,237 396 21,822 Total number of assisted units 1,100,000 1,200,000 2,200,000 286,108 4,786,108 Percent of assisted units evaluated and possibly hazard controlled 0.90% 0.44% 0.28% 0.14% 0.46%

    Among the key results are that:

    • About 6,887 housing units would have a child under age 6 with a blood lead level that is elevated but not an environmental intervention blood lead level; these units would be required to have an environmental investigation and have any lead-based paint hazards controlled.

    • About 14,935 other housing units would be evaluated and have any lead-based paint hazards controlled.

    • About 0.46 percent of the assisted housing stock covered by this rulemaking would be evaluated and have any lead-based paint hazards controlled, specifically, 0.90 percent of the public housing stock, 0.44 percent of the HUD project-based rental assisted housing stock, 0.28 percent of the tenant-based rental assisted housing stock, and 0.14 percent of the U.S. Department of Agriculture (USDA) project-based rental assisted housing stock.

    • The total cost of evaluation and control (and the small amount of temporary relocation of occupants) would be $26.63 million, including $10.01 million for public housing, $6.33 million for HUD project-based rental assisted housing, $9.81 million for tenant-based rental assisted housing, and $286,000 for USDA project-based rental assisted housing.

    • Using the 3 percent discount rate, benefits are estimated at $97.91 million, with net benefits (i.e., benefits less the $22.17 million in costs) estimated at $75.74 million. Using the OMB's 7 percent discount rate, benefits are estimated at $31.81 million, with costs remaining at $22.17 million, so the net benefits would be $9.65 million.

    • Regarding index units, for FY 2017, an estimated 1,899 units of public housing, 1,494 units of HUD project-based rental assisted housing, 3,383 units of tenant-based rental assisted housing, and 112 units of USDA project-based rental assisted housing have children under age 6 with EBLLs that are not EIBLLs, that is, children for whom an environmental investigation and possible (i.e., if hazards are found) hazard control of their housing unit and common area servicing it would be newly required under the proposed rule.

    • Regarding other units to have lead hazard control work conducted, for FY 2015, there would be an estimated 8,014 units of public housing, 3,783 units of HUD project-based rental assisted housing, 3,383 units of tenant-based rental assisted housing, and 112 units of USDA project-based rental assisted housing.

    • The conservative (i.e., intentionally high, in this instance) assumption about the properties in which these children reside is that each of them is a different property (vs. there being more than one such child in a property); a similarly conservative assumption about the private entities (i.e., the ones that lease the project-based and the tenant-based assisted units to the families of these children) is that all of them are small entities and all have just one such child (vs. an entity having more than one property with such a child). The economic analysis used the FY 2017 Congressional Justifications of the number of housing units assisted by the several programs: 1,100,000 public housing units, 1,200,000 HUD project-based units, 2,200,000 tenant-based units, and 286,108 USDA project-based units. Regarding units other than the index units, a maximum of approximately 0.73 percent of other public housing units, 0.32 percent of other HUD project-based units, 0.13 percent of other tenant-based units, and 0.10 percent of USDA project-based units (overall, 0.31 percent of units in these assistance programs) would be required to undertake a risk assessment and, possibly, based on the risk assessment, lead hazard control.

    Environmental Impact

    A Finding of No Significant Impact with respect to the environment has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The Finding of No Significant Impact is available for public inspection electronically at Federal eRulemaking Portal at http://www.regulations.gov under the title and docket number of this rule.

    Executive Order 13132, Federalism

    Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on State and local governments or is not required by statute, or the rule preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive Order. This rule will not have federalism implications and would not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive Order.

    Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) establishes requirements for federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments, and on the private sector. This rule does not impose any federal mandates on any State, local, or tribal governments, or on the private sector, within the meaning of UMRA.

    List of Subjects in 24 CFR Part 35

    Grant programs—housing and community development, Lead poisoning, Mortgage insurance, Rent subsidies, Reporting and recordkeeping requirements.

    Accordingly, for the reasons stated in the preamble, HUD amends 24 CFR part 35 to read as follows:

    PART 35—LEAD-BASED PAINT POISONING PREVENTION IN CERTAIN RESIDENTIAL STRUCTURES 1. The authority citation for 24 CFR part 35 continues to read as follows: Authority:

    42 U.S.C. 3535(d), 4821, and 4851.

    2. In § 35.100, add, in alphabetical order the definitions of “Elevated blood lead level”, “Environmental investigations”, revise the definitions of “Evaluation” and “Expected to reside” and delete the definition of “Environmental intervention blood lead level”, to read as follows:
    § 35.110 Definitions.

    Elevated blood lead level means a confirmed concentration of lead in whole blood of a child under age 6 equal to or greater than the concentration in the most recent guidance published by the U.S. Department of Health and Human Services (HHS) on recommending that an environmental intervention be conducted. (When HHS changes the value, HUD will publish a notice in the Federal Register, with the opportunity for public comment, on its intent to apply the changed value to this part, and, after considering comments, publish a notice on its applying the changed value to this part.)

    Environmental investigation means the process of determining the source of lead exposure for a child under age 6 with an elevated blood lead level, consisting of administration of a questionnaire, comprehensive environmental sampling, case management, and other measures, in accordance with chapter 16 of the HUD Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing (“Guidelines”).

    Evaluation means a risk assessment, a lead hazard screen, a lead-based paint inspection, paint testing, or a combination of these to determine the presence of lead-based paint hazards or lead-based paint, or an environmental investigation.

    Expected to reside means there is actual knowledge that a child will reside in a dwelling unit reserved or designated exclusively for the elderly or reserved or designated exclusively for persons with disabilities. If a resident woman is known to be pregnant, there is actual knowledge that a child will reside in the dwelling unit.

    3. Amend § 35.125 by adding paragraph (c)(4)(iii) to read as follows:
    § 35.125 Notice of evaluation and hazard reduction activities.

    (c) * * *

    (4) * * *

    (iii) However, for the protection of the privacy of the child and the child's family or guardians, no notice of environmental investigation shall be posted to any centrally located common area.

    § 35.165 Prior evaluation or hazard reduction.
    4. In § 35.165 amend paragraph (b)(4) by removing the term “environmental intervention blood level” wherever it appears and adding its place the term “elevated blood lead level”. 5. Revise § 35.325 to read as follows:
    § 35.325 Child with an elevated blood lead level.

    (a) If a child less than 6 years of age living in a federally assisted dwelling unit has an elevated blood lead level, the owner shall immediately conduct an environmental investigation. Interim controls of identified lead-based paint hazards shall be conducted in accordance with § 35.1330.

    (b) Other assisted dwelling units in the property. If the environmental investigation conducted under paragraph (a) of this section identifies lead-based paint hazards, the owner shall conduct a risk assessment for other assisted dwelling units covered by this subpart in which a child under age 6 resides or is expected to reside on the date interim controls are complete, and for the common areas serving those units. The risk assessments would be conducted within 30 calendar days after receipt of the environmental investigation report on the index unit if there are 20 or fewer such units, or 60 calendar days for risk assessments if there are more than 20 such units. If the risk assessment identifies lead-based paint hazards, the owner shall control the hazards in those units and common areas within 30 calendar days, or within 90 calendar days if more than 20 units have lead-based paint hazards such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d). The requirements for other assisted dwelling units covered by this subpart do not apply if:

    (1) The owner conducted an environmental investigation and conducted interim controls of identified lead-based paint hazards between the date the child's blood was last sampled and the date the owner received the notification of the elevated blood lead level; or

    (2) The owner provides the Federal agency documentation of compliance with evaluation, notification, lead disclosure, ongoing lead-based paint maintenance, and lead-based paint management requirements under this part throughout the 12 months preceding the date the owner received the environmental investigation report.

    (c) Interim controls are complete when clearance is achieved in accordance with § 35.1340.

    (d) The Federal agency shall establish a timetable for completing environmental investigations and hazard reduction when a child identified as having an elevated blood lead level is identified.

    § 35.715 Multifamily properties receiving more than $5,000 per unit.
    6. Amend § 35.715 by: a. Redesignating paragraph (d)(4) as paragraph (e); and b. Removing the term “environmental intervention blood level” and adding in its place “elevated blood lead level”.
    § 35.720 Multifamily properties receiving up to $5,000 per unit, and single family properties.
    7. In § 35.720 amend paragraph (c) by removing the term “environmental intervention blood level” wherever it appears and adding in its place “elevated blood lead level”. 8. Revise § 35.730 to read as follows:
    § 35.730 Child with an elevated blood lead level.

    (a) Environmental investigation. Within 15 calendar days after being notified by a public health department or other medical health care provider that a child of less than 6 years of age living in a dwelling unit to which this subpart applies has been identified as having an elevated blood lead level, the owner shall complete an environmental investigation of the dwelling unit in which the child lived at the time the blood was last sampled and of common areas servicing the dwelling unit. The requirements of this paragraph apply regardless of whether the child is or is not still living in the unit when the owner receives the notification of the elevated blood lead level. The requirements of this paragraph shall not apply if the owner conducted an environmental investigation of the unit and common areas servicing the unit between the date the child's blood was last sampled and the date when the owner received the notification of the elevated blood lead level. If the owner conducted a risk assessment of the unit and common areas servicing the unit during that period, the owner need not conduct another risk assessment there but shall conduct the elements of an environmental investigation not already conducted during the risk assessment. If a public health department has already conducted an evaluation of the dwelling unit, the requirements of this paragraph (a) of this section shall not apply.

    (b) Verification. After receiving information from a person who is not a medical health care provider that a child of less than 6 years of age living in a dwelling unit covered by this subpart may have an elevated blood lead level, the owner shall immediately verify the information with the public health department or other medical health care provider. If the public health department or provider denies the request, such as because it does not have the capacity to verify that information, the owner shall send documentation of the denial to the HUD rental assistance program manager, who shall make an effort to verify the information. If the public health department or provider verifies that the child has an elevated blood lead level, such verification shall constitute notification, and the owner shall take the action required in paragraphs (a) and (c) of this section.

    (c) Hazard reduction. Within 30 calendar days after receiving the report of the environmental investigation conducted pursuant to paragraph (a) of this section or the evaluation from the public health department, the owner shall complete the reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330. Hazard reduction is considered complete when clearance is achieved in accordance with § 35.1340 and the clearance report states that all lead-based paint hazards identified in the environmental investigation have been treated with interim controls or abatement or the public health department certifies that the lead-based paint hazard reduction is complete. The requirements of this paragraph do not apply if the owner, between the date the child's blood was last sampled and the date the owner received the notification of the elevated blood lead level, already conducted an environmental investigation of the unit and common areas servicing the unit and completed reduction of identified lead-based paint hazards. If the owner conducted a risk assessment of the unit and common areas servicing the unit during that period, the owner is not required to conduct another risk assessment there but shall conduct the elements of an environmental investigation n not already conducted during the risk assessment.

    (d) If an environmental investigation, evaluation or hazard reduction is undertaken, each owner shall provide notice to occupants in accordance with § 35.125.

    (e) Reporting requirement. (1) The owner shall report the name and address of a child identified as having an elevated blood lead level to the public health department within 5 business days of being so notified by any other medical health care professional.

    (2) The owner shall also report each confirmed case of a child with an elevated blood lead level to the HUD field office and HUD Office of Lead Hazard Control and Healthy Homes within 5 business days of being so notified.

    (3) The owner shall provide to the HUD field office documentation that the designated party has conducted the activities of paragraphs (a) through (d) of this section, within 10 business days of the deadline for each activity.

    (f) Other assisted dwelling units in the property. (1) If the environmental investigation conducted pursuant to paragraph (a) of this section identifies lead-based paint hazards, the owner shall, for other assisted dwelling units covered by this part in which a child under age 6 resides or is expected to reside on the date hazard reduction under paragraph (c) of this section is complete, and for the common areas servicing those units, conduct a risk assessment if the unit investigated was covered by § 35.715, within 30 calendar days after receipt of the environmental investigation report if there are 20 or fewer such other units, or 60 calendar days if there are more than 20 such other units; or conduct a visual assessment if the unit investigated was covered by § 35.720, within 30 calendar days of receipt of the environmental investigation report.

    (2) Control measures. (i) If the risk assessment conducted under paragraph (f)(1) of this section identifies lead-based paint hazards, the owner shall complete the reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330 in those units and common areas within 30 calendar days, or within 90 calendar days if more than 20 units have lead-based paint hazards such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d).

    (ii) If the visual assessment conducted under paragraph (f)(1) of this section identifies deteriorated paint, the owner shall stabilize the paint in those units and common areas within 30 calendar days, or within 90 calendar days if more than 20 units have lead-based paint hazards such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d).

    (3) The owner shall provide to the HUD field office documentation that the designated party has conducted the activities of paragraph (f)(1) and (f)(2) of this section, within 10 business days of the deadline for each activity.

    (4) The requirements of this paragraph (f) do not apply if the property meets any of these conditions:

    (i) If the property is covered by § 35.715, the owner conducted a risk assessment and conducted interim controls of identified lead-based paint hazards in accordance with § 35.175(b) between the date the child's blood was last sampled and the date the owner received the notification of the elevated blood lead level;

    (ii) If the property is covered by § 35.720, the owner conducted a visual assessment and stabilized deteriorated paint (unless it was determined not to be lead-based paint) identified in accordance with § 35.720(b)(2) in the other assisted dwelling units and the common areas serving those units, between the date the child's blood was last sampled and the date the owner received the notification of the elevated blood lead level; or

    (iii) The owner has documentation of compliance with evaluation, notification, lead disclosure, ongoing lead-based paint maintenance, and lead-based paint management requirements under this part throughout the 12 months preceding the date the owner received the environmental investigation report pursuant to paragraph (a) of this section; and

    (iv) The owner provides to the HUD field office documentation that it has conducted the activities of paragraphs (f)(4)(i) through (iii) of this section, within 10 business days of the deadline for each activity.

    (g) HUD encourages the owner to evaluate for sources of lead exposure in units other than those covered by this subpart, and to control such sources.

    9. Revise § 35.830 to read as follows:
    § 35.830 Child with an elevated blood lead level.

    (a) Environmental investigation. Within 15 calendar days after being notified by a public health department or other medical health care provider that a child of less than 6 years of age living in a dwelling unit owned by HUD (or where HUD is mortgagee-in-possession) has been identified as having an elevated blood lead level, HUD shall complete an environmental investigation of the dwelling unit in which the child lived at the time the blood was last sampled and of common areas servicing the dwelling unit. The requirements of this paragraph apply regardless of whether the child is or is not still living in the unit when HUD receives the notification of the elevated blood lead level. The requirements of this paragraph shall not apply if HUD conducted an environmental investigation of the unit and common areas servicing the unit between the date the child's blood was last sampled and the date when HUD received the notification of the elevated blood lead level. If HUD conducted a risk assessment of the unit and common areas servicing the unit during that period, HUD is not required to conduct another risk assessment there but it shall conduct the elements of an environmental investigation not already conducted during the risk assessment. If a public health department has already conducted an evaluation of the dwelling unit, the requirements of this paragraph shall not apply.

    (b) Verification. After receiving information from a person who is not a medical health care provider that a child of less than 6 years of age living in a dwelling unit covered by this subpart may have an elevated blood lead level, HUD shall immediately verify the information with the public health department or other medical health care provider. If the public health department or provider denies the request, such as because it does not have the capacity to verify that information, the HUD Realty Specialist assigned to that property shall send documentation of the denial to the HUD Office of Lead Hazard Control and Healthy Homes, which shall make an effort to verify the information. If the public health department or provider verifies that the child has an environmental intervention blood lead level, such verification shall constitute notification, and HUD shall take the action required in paragraphs (a) and (c) of this section.

    (c) Hazard reduction. Within 30 calendar days after receiving the report of the environmental investigation conducted pursuant to paragraph (a) of this section or the evaluation from the public health department, HUD shall complete the reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330. Hazard reduction is considered complete when clearance is achieved in accordance with § 35.1340 and the clearance report states that all lead-based paint hazards identified in the environmental investigation have been treated with interim controls or abatement or the public health department certifies that the lead-based paint hazard reduction is complete. The requirements of this paragraph do not apply if HUD, between the date the child's blood was last sampled and the date HUD received the notification of the elevated blood lead level, already conducted an environmental investigation of the unit and common areas servicing the unit and completed reduction of identified lead-based paint hazards. If HUD conducted a risk assessment of the unit and common areas servicing the unit during that period, it is not required to conduct another risk assessment there but it shall conduct the elements of an environmental investigation not already conducted during the risk assessment.

    (d) Notice. If evaluation or hazard reduction is undertaken, each owner shall provide a notice to occupants in accordance with § 35.125.

    (e) Reporting requirement. (1) HUD shall report the name and address of a child identified as having an elevated blood lead level to the public health department within 5 business days of being so notified by any other medical health care professional.

    (2) HUD shall also report each confirmed case of a child with an elevated blood lead level to the HUD Office of Lead Hazard Control and Healthy Homes within 5 business days of being so notified.

    (3) HUD shall provide to the HUD Office of Lead Hazard Control and Healthy Homes documentation that it has conducted the activities of paragraphs (a) through (d) of this section, within 10 business days of the deadline for each activity.

    (f) Other assisted dwelling units in the property. (1) If the environmental investigation conducted pursuant to paragraph (a) of this section identifies lead-based paint hazards, HUD shall, for other assisted dwelling units covered by this part in which a child under age 6 resides or is expected to reside on the date hazard reduction under paragraph (c) of this section, and the common areas servicing those units, is complete, conduct a risk assessment in accordance with § 35.815 within 30 calendar days after receipt of the environmental investigation report if there are 20 or fewer such other units, or 60 calendar days if there are more than 20 such other units.

    (2) If the risk assessment conducted under paragraph (f)(1) of this section identifies lead-based paint hazards, HUD shall complete the reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330 in those units and common areas within 30 calendar days, or within 90 calendar days if more than 20 units have lead-based paint hazards such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d).

    (3) The requirements of this paragraph (f) do not apply if HUD, between the date the child's blood was last sampled and the date HUD received the notification of the elevated blood lead level, conducted a risk assessment in the other assisted dwelling units and the common areas serving those units, and conducted interim controls of identified lead-based paint hazards in accordance with § 35.820.

    (4) The requirements of this section do not apply if HUD has documentation of compliance with evaluation, notification, lead disclosure, ongoing lead-based paint maintenance, and lead-based paint management requirements under this part throughout the 12 months preceding the date HUD received the environmental investigation report pursuant to paragraph (a) of this section.

    (5) HUD shall provide to the HUD Office of Lead Hazard Control and Healthy Homes documentation that it has conducted the activities of paragraph (f)(1) through (3) of this section, or that it has complied with the requirements in paragraph (f)(4) of this section, within 10 business days of the deadline for each activity.

    (g) Closing. If the closing of a sale is scheduled during the period when HUD is responding to a case of a child with an elevated blood lead level, HUD may arrange for the completion of the procedures required by paragraphs (a) through (d) of this section by the purchaser within a reasonable period of time.

    (h) Extensions. The Assistant Secretary for Housing-Federal Housing Commissioner or designee may consider and approve a request for an extension of deadlines established by this section for lead-based paint inspection, risk assessment, environmental investigation, hazard reduction, and reporting. Such a request may be considered, however, only during the first six months during which HUD is owner or mortgagee-in-possession of a multifamily property.

    10. Revise § 35.1130 to read as follows:
    § 35.1130 Child with an elevated blood lead level.

    (a) Environmental investigation. Within 15 calendar days after being notified by a public health department or other medical health care provider that a child of less than 6 years of age living in a dwelling unit to which this subpart applies has been identified as having an elevated blood lead level, the PHA shall complete an environmental investigation of the dwelling unit in which the child lived at the time the blood was last sampled and of common areas servicing the dwelling unit. The environmental investigation is considered complete when the PHA receives the environmental investigation report. The requirements of this paragraph apply regardless of whether the child is or is not still living in the unit when the PHA receives the notification of the elevated blood lead level. The requirements of this paragraph shall not apply if the PHA conducted an environmental investigation of the unit and common areas servicing the unit between the date the child's blood was last sampled and the date when the PHA received the notification of the elevated blood lead level. If the PHA conducted a risk assessment of the unit and common areas servicing the unit during that period, the PHA need not conduct another risk assessment there but shall conduct the elements of an environmental investigation not already conducted during the risk assessment. If a public health department has already conducted an evaluation of the dwelling unit, the requirements of this paragraph shall not apply.

    (b) Verification. After receiving information from a person who is not a medical health care provider that a child of less than 6 years of age living in a dwelling unit covered by this subpart may have an elevated blood lead level, the PHA shall immediately verify the information with the public health department or other medical health care provider. If that department or provider denies the request, such as because it does not have the capacity to verify that information, the PHA shall send documentation of the denial to its HUD field office, who shall make an effort to verify the information. If that department or provider verifies that the child has an elevated blood lead level, such verification shall constitute notification, and the housing agency shall take the action required in paragraphs (a) and (c) of this section.

    (c) Hazard reduction. Within 30 calendar days after receiving the report of the environmental investigation conducted pursuant to paragraph (a) of this section or the evaluation from the public health department, the PHA shall complete the reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330. Hazard reduction is considered complete when clearance is achieved in accordance with § 35.1340 and the clearance report states that all lead-based paint hazards identified in the environmental investigation have been treated with interim controls or abatement or the local or State health department certifies that the lead-based paint hazard reduction is complete. The requirements of this paragraph do not apply if the PHA, between the date the child's blood was last sampled and the date the PHA received the notification of the elevated blood lead level, already conducted an environmental investigation of the unit and common areas servicing the unit and completed reduction of identified lead-based paint hazards. If the PHA conducted a risk assessment of the unit and common areas servicing the unit during that period, it is not required to conduct another risk assessment there but it shall conduct the elements of an environmental investigation not already conducted during the risk assessment. If the PHA does not complete the hazard reduction required by this section, the dwelling unit is in violation of the standards of 24 CFR 965.601, which incorporates the uniform physical condition standards of § 5.703(f), including that it be free of lead-based paint hazards.

    (d) Notice of evaluation and hazard reduction. The PHA shall notify building residents of any evaluation or hazard reduction activities in accordance with § 35.125.

    (e) Reporting requirement. (1) The PHA shall report the name and address of a child identified as having an elevated blood lead level to the public health department within 5 business days of being so notified by any other medical health care professional.

    (2) The PHA shall report each confirmed case of a child with an elevated blood lead level to the HUD field office and the HUD Office of Lead Hazard Control and Healthy Homes within 5 business days of being so notified.

    (3) The PHA shall provide to the HUD field office documentation that it has conducted the activities of paragraphs (a) through (d) of this section, within 10 business days of the deadline for each activity.

    (f) Other units in the property. (1) If the environmental investigation conducted pursuant to paragraph (a) of this section identifies lead-based paint hazards, the PHA shall conduct a risk assessment of other units of the building covered by this subpart within 30 calendar days after receipt of the environmental investigation report if there are 20 or fewer such other units, or 60 calendar days if there are more than 20 such other units, and shall complete the reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330 within 30 calendar days, or within 90 calendar days if more than 20 units have lead-based paint hazards such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d).

    (2) If the environmental investigation conducted pursuant to paragraph (a) of this section identifies lead-based paint hazards and previous evaluations of the building conducted pursuant to § 35.1320 identified lead-based paint or lead-based paint hazards, the PHA shall, for other dwelling units in the property in which a child under age 6 resides or is expected to reside on the date hazard reduction under paragraph (c) of this section is complete, and the common areas serving those units, conduct a risk assessment within 30 calendar days after receipt of the environmental investigation report if there are 20 or fewer such units, or 60 calendar days if there are more such units.

    (3) Control measures. If the risk assessment conducted under paragraph (f)(2) of this section identifies lead-based paint hazards, the PHA shall control the hazards in those units and common areas within 30 calendar days, or within 90 calendar days if more than 20 units have lead-based paint hazards such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d).

    (4) The PHA shall provide to the HUD field office documentation that it has conducted the activities of paragraphs (f)(1) through (3) of this section, within 10 business days of the deadline for each activity.

    (5) The requirements of this paragraph (f) of this section do not apply if the PHA, between the date the child's blood was last sampled and the date the PHA received the notification of the elevated blood lead level, conducted a risk assessment of the other assisted dwelling units and the common areas serving those units, and conducted interim controls of identified hazards in accordance with § 35.1120(b); or if the PHA has documentation of compliance with evaluation, notification, lead disclosure, ongoing lead-based paint maintenance, and lead-based paint management requirements under this part throughout the 12 months preceding the date the PHA received the environmental investigation report pursuant to paragraph (a) of this section; and, in either case, the PHA provided the HUD field office, within 10 business days after receiving the notification of the elevated blood lead level, documentation that it has conducted the activities described in this paragraph (f)(5) of this section.

    (g) HUD encourages the PHA to evaluate for sources of lead exposure in units other than those covered by this subpart, and to control such sources.

    § 35.1135 Eligible costs.
    11. Amend § 35.1135(d) by removing the term “environmental intervention blood level” and adding in its place the term “elevated blood lead level”. 12. Revise § 35.1215(b) as follows:
    § 35.1215 Activities at initial and periodic inspection.

    (b) * * * For the unit subsequently to come under a HAP contract with the housing agency for occupancy by a family with a child under age 6, paint stabilization must be completed, including clearance being achieved in accordance with Sec. 35.1340.

    13. Revise § 35.1225 to read as follows:
    § 35.1225 Child with an elevated blood lead level.

    (a) Within 15 calendar days after being notified by a public health department or other medical health care provider that a child of less than 6 years of age living in a dwelling unit to which this subpart applies has been identified as having an elevated blood lead level, the designated party shall complete an environmental investigation of the dwelling unit in which the child lived at the time the blood was last sampled and of common areas servicing the dwelling unit. When the environmental investigation is complete, the designated party shall immediately provide the report of the environmental investigation to the owner of the dwelling unit. If the child identified as having an elevated blood lead level is no longer living in the unit when the designated party receives notification from the public health department or other medical health care provider, but another household receiving tenant-based rental assistance is living in the unit or is planning to live there, the requirements of this section apply just as they do if the child still lives in the unit. If a public health department has already conducted an evaluation of the dwelling unit, or the designated party conducted an environmental investigation of the unit and common areas servicing the unit between the date the child's blood was last sampled and the date when the designated party received the notification of the elevated blood lead level, the requirements of this paragraph shall not apply. If the designated party or the owner conducted a risk assessment of the unit and common areas servicing the unit during that period, the designated party need not conduct another risk assessment there but shall conduct the elements of an environmental investigation not already conducted during the risk assessment.

    (b) Verification. After receiving information from a person who is not a medical health care provider that a child of less than 6 years of age living in a dwelling unit covered by this subpart may have an elevated blood lead level, the designated party shall immediately verify the information with the public health department or other medical health care provider. If the public health department or provider denies the request, such as because it does not have the capacity to verify that information, the designated party shall send documentation of the denial to the HUD rental assistance program manager, who shall make an effort to verify the information. If that department or provider verifies that the child has an elevated blood lead level, such verification shall constitute notification, and the designated party shall take the action required in paragraphs (a) and (c) of this section.

    (c) Hazard reduction. Within 30 calendar days after receiving the report of the environmental investigation from the designated party or the evaluation from the public health department, the owner shall complete the reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330. Hazard reduction is considered complete when clearance is achieved in accordance with § 35.1340 and the clearance report states that all lead-based paint hazards identified in the environmental investigation have been treated with interim controls or abatement or the public health department certifies that the lead-based paint hazard reduction is complete. The requirements of this paragraph do not apply if the designated party or the owner, between the date the child's blood was last sampled and the date the designated party received the notification of the elevated blood lead level, already conducted an environmental investigation of the unit and common areas servicing the unit and the owner completed reduction of identified lead-based paint hazards. If the owner does not complete the hazard reduction required by this section, the dwelling unit is in violation of the standards of 24 CFR 982.401.

    (d) Notice of evaluation and hazard reduction. The owner shall notify building residents of any evaluation or hazard reduction activities in accordance with § 35.125.

    (e) Reporting requirement. (1) The owner shall report the name and address of a child identified as having an elevated blood lead level to the public health department within 5 business days of being so notified by any other medical health care professional.

    (2) The owner shall also report each confirmed case of a child with an elevated blood lead level to the HUD field office and the HUD Office of Lead Hazard Control and Healthy Homes within 5 business days of being so notified.

    (3) The owner shall provide to the HUD field office documentation that it has conducted the activities of paragraphs (a) through (d) of this section, within 10 business days of the deadline for each activity.

    (f) Other assisted dwelling units in the property. (1) If the environmental investigation conducted pursuant to paragraph (a) of this section identifies lead-based paint hazards, the designated party or the owner shall, for other assisted dwelling units covered by this part in which a child under age 6 resides or is expected to reside on the date hazard reduction under paragraph (c) of this section is complete, and the common areas serving those units, conduct a visual assessment in accordance with the procedures of § 35.1215(a), within 30 calendar days after receipt of the environmental investigation report if there are 20 or fewer such units, or 60 calendar days if there are more such units.

    (2) If the visual assessment conducted under paragraph (f)(1) of this section identifies deteriorated paint, the owner shall stabilize the paint within 30 calendar days, or within 90 calendar days if more than 20 units have deteriorated paint such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d).

    (3) The requirements of this paragraph (f) of this section do not apply if the designated party or the owner, between the date the child's blood was last sampled and the date the owner received the notification of the elevated blood lead level, conducted a visual assessment or risk assessment in those other assisted dwelling units and the common areas serving those units, and the owner stabilized deteriorated paint (unless it was determined not to be lead-based paint) identified; or if the owner has documentation of compliance with evaluation, notification, lead disclosure, ongoing lead-based paint maintenance, and lead-based paint management requirements under this part throughout the 12 months preceding the date the owner received the environmental investigation report pursuant to paragraph (a) of this section; and, in either case, the owner provided the HUD field office, within 10 business days after receiving the notification of the elevated blood lead level, documentation that it has conducted the activities described in this paragraph (f)(4) of this section.

    (g) HUD encourages the designated party or the owner to evaluate for sources of lead exposure in units other than those covered by this subpart, and to control such sources.

    (h) Data collection and record keeping responsibilities. At least quarterly, the designated party shall attempt to obtain from the public health department(s) with area(s) of jurisdiction similar to that of the designated party the names and/or addresses of children of less than 6 years of age with an identified elevated blood lead level. At least quarterly, the designated party shall also report an updated list of the addresses of units receiving assistance under a tenant-based rental assistance program to the same public health department(s), except that the report(s) to the public health department(s) is not required if the health department states that it does not wish to receive such report. If it obtains names and addresses of elevated blood lead level children from the public health department(s), the designated party shall match information on cases of elevated blood lead levels with the names and addresses of families receiving tenant-based rental assistance, unless the public health department performs such a matching procedure. If a match occurs, the designated party shall carry out the requirements of this section.

    Dated: August 26, 2016. Michelle Miller, Deputy Director, Office of Healthy Homes and Lead Hazard Control.
    [FR Doc. 2016-20955 Filed 8-31-16; 8:45 am] BILLING CODE 4210-67-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R01-OAR-2015-0471; A-1-FRL-9943-04-Region 1] Air Plan Approval; Connecticut; Open Burning and Portable Fuel Containers AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Connecticut on November 19, 2012. We propose to approve Connecticut's request to remove two regulations from its SIP that regulate “open burning” and “portable fuel container spillage control.” In place of the open burning regulation, we propose to approve into the Connecticut SIP a Connecticut statute that controls open burning. We also propose to approve a definition of “brush,” which was included in a December 15, 2015 SIP submittal by Connecticut to meet infrastructure requirements of the Clean Air Act for the 2012 fine particle (PM2.5) National Ambient Air Quality Standards (NAAQS). The requirements in the Connecticut portable fuel container regulation have been superseded by federal portable fuel container requirements. This action is being taken in accordance with the Clean Air Act.

    DATES:

    Written comments must be received on or before October 3, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R01-OAR-2015-0471 by one of the following methods:

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

    2. Email: [email protected]

    3. Mail: “EPA-R01-OAR-2015-0471,” Anne Arnold, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square—Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912.

    4. Hand Delivery or Courier. Deliver your comments to: Anne Arnold, Manager, Air Quality Planning Unit, Office of Ecosystem Protection, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square—Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912. Such deliveries are only accepted during the Regional Office's normal hours of operation. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays.

    Please see the direct final rule which is located in the Rules Section of this Federal Register for detailed instructions on how to submit comments.

    FOR FURTHER INFORMATION CONTACT:

    Alison C. Simcox, Air Quality Planning Unit, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square—Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912, telephone number (617) 918-1684, fax number (617) 918-0684, email [email protected]

    SUPPLEMENTARY INFORMATION:

    In the Final Rules Section of this Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

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

    Dated: February 4, 2016. H. Curtis Spalding, Regional Administrator, EPA New England.
    [FR Doc. 2016-21011 Filed 8-31-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 88 [NIOSH Docket 094] World Trade Center Health Program; Petition 013—Autoimmune Disease; Finding of Insufficient Evidence AGENCY:

    Centers for Disease Control and Prevention, HHS.

    ACTION:

    Denial of petition for addition of a health condition.

    SUMMARY:

    On April 4, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 013) to add “relapsing remitting multiple sclerosis (autoimmune)” to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 013 is not substantially different from Petitions 007, 008, 009, and 011, which also requested the addition of autoimmune diseases, including various subtypes. The Administrator recently published responses to the four previous petitions in the Federal Register and has determined that Petition 013 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases, including multiple sclerosis. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.

    DATES:

    The Administrator of the WTC Health Program is denying this petition for the addition of a health condition as of September 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Rachel Weiss, Program Analyst, 1090 Tusculum Avenue, MS: C-46, Cincinnati, OH 45226; telephone (855) 818-1629 (this is a toll-free number); email [email protected]

    SUPPLEMENTARY INFORMATION: Table of Contents A. WTC Health Program Statutory Authority B. Approval To Submit Document to the Office of the Federal Register C. Petition 013 D. Administrator's Determination on Petition 013 A. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347, as amended by Pub. L. 114-113), added Title XXXIII to the Public Health Service Act (PHS Act),1 establishing the WTC Health Program within the Department of Health and Human Services (HHS). The WTC Health Program provides medical monitoring and treatment benefits to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania (responders), and to eligible persons who were present in the dust or dust cloud on September 11, 2001 or who worked, resided, or attended school, childcare, or adult daycare in the New York City disaster area (survivors).

    1 Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm to 300mm-61. Those portions of the Zadroga Act found in Titles II and III of Public Law 111-347 do not pertain to the WTC Health Program and are codified elsewhere.

    All references to the Administrator of the WTC Health Program (Administrator) in this notice mean the Director of the National Institute for Occupational Safety and Health (NIOSH) or his or her designee.

    Pursuant to section 3312(a)(6)(B) of the PHS Act, interested parties may petition the Administrator to add a health condition to the List in 42 CFR 88.1. Within 90 days after receipt of a petition to add a condition to the List, the Administrator must take one of the following four actions described in section 3312(a)(6)(B) and 42 CFR 88.17: (1) Request a recommendation of the STAC; (2) publish a proposed rule in the Federal Register to add such health condition; (3) publish in the Federal Register the Administrator's determination not to publish such a proposed rule and the basis for such determination; or (4) publish in the Federal Register a determination that insufficient evidence exists to take action under (1) through (3) above. However, in accordance with 42 CFR 88.17(a)(4), the Administrator is required to consider a new petition for a previously-evaluated health condition determined not to qualify for addition to the List only if the new petition presents a new medical basis—evidence not previously reviewed by the Administrator—for the association between 9/11 exposures and the condition to be added.

    B. Approval To Submit Document to the Office of the Federal Register

    The Secretary, HHS, or her designee, the Director, Centers for Disease Control and Prevention (CDC) and Administrator, Agency for Toxic Substances and Disease Registry (ATSDR), authorized the undersigned, the Administrator of the WTC Health Program, to sign and submit the document to the Office of the Federal Register for publication as an official document of the WTC Health Program. Thomas R. Frieden, M.D., M.P.H., Director, CDC, and Administrator, ATSDR, approved this document for publication on August 24, 2016.

    C. Petition 013

    On April 4, 2016, the Administrator received a petition from a responder in the WTC Health Program to add “relapsing remitting multiple sclerosis (autoimmune)” to the List (Petition 013).2 Because the petitioner identified the requested health condition as “the autoimmune disease of multiple sclerosis” in the petition narrative and used a study of autoimmune diseases among WTC responders to provide the medical basis for the petition,3 the Administrator determined that the petitioned health condition is “autoimmune diseases, including multiple sclerosis.”

    2See Petition 013, WTC Health Program: Petitions Received, http://www.cdc.gov/wtc/received.html.

    3Id.

    This is the fifth petition to the Administrator requesting the addition of autoimmune diseases, including various subtypes, to the List; each of the first four autoimmune disease petitions were denied due to insufficient evidence, as described in respective Federal Register notices (FRNs).4 The medical basis for a potential addition to the List may be demonstrated by reference to a peer-reviewed, published, epidemiologic study about the health condition among 9/11-exposed populations or to clinical case reports of health conditions in WTC responders or survivors.5 In accordance with WTC Health Program policy, the Science Team reviews references for relevance, and relevant studies are further reviewed for quality and quantity.6 The current petition, Petition 013, presented five references to support the request to add “relapsing remitting multiple sclerosis (autoimmune)” to the List.

    4 “World Trade Center Health Program; Petition 007—Autoimmune Diseases; Finding of Insufficient Evidence,” 80 FR 32333 (June 8, 2015); “World Trade Center Health Program; Petition 008—Autoimmune Diseases; Finding of Insufficient Evidence,” 80 FR 39720 (July 10, 2015); “World Trade Center Health Program; Petition 009—Autoimmune Diseases; Finding of Insufficient Evidence,” 80 FR 65980 (Oct. 28, 2015); and “World Trade Center Health Program; Petition 011—Autoimmune Diseases; Finding of Insufficient Evidence,” 81 FR 24047 (April 25, 2016).

    5See John Howard, Administrator of the WTC Health Program, Policy and Procedures for Handling Submissions and Petitions to Add a Health Condition to the List of WTC-Related Health Conditions, May 14, 2014, http://www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandlingProcedures14May2014.pdf.

    6 Information is determined to be relevant if it is presented in peer-reviewed, published, epidemiologic studies of the health condition in 9/11-exposed populations. John Howard, Administrator of the WTC Health Program, Policy and Procedures for Adding Non-Cancer Conditions to the List of WTC-Related Health Conditions, May 11, 2016, http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancer_Conditions_Revision_11_May_2016.pdf.

    Petition 013 references 1, 2, and 4 are links to the same newspaper article announcing the online publication of a study published in 2015.7 Petition 013 reference 3 is a different newspaper article announcing the online publication of the same study.8 These four references identify a 2015 study by Webber et al., a peer-reviewed, published epidemiologic study of autoimmune diseases among 9/11-exposed responders and survivors, titled “Nested Case-Control Study of Selected Systemic Autoimmune Diseases in World Trade Center Rescue/Recovery Workers.” 9 The 2015 Webber et al. study has already been evaluated by the Administrator in consideration of the other four autoimmune disease petitions, and is discussed below.

    7 The article, by Amy Norton, is published in reference 1, New Health Worry for 9/11 Recovery Workers, HealthDay, March 19, 2015, in www.cbsnews.com/news/ground-zero-workers-at-risk-of-autoimmune-diseases; reference 2, `Ground Zero' Workers at Risk of Autoimmune Diseases: Study, HealthDay, March 19, 2015, in http://www.medicinenet.com/script/main/art.asp?articlekey=187534; and reference 4, `Ground Zero' Workers at Risk of Autoimmune Diseases: Study, HealthDay, March 19, 2015, https://consumer.healthday.com/senior-citizen-information-31/misc-arthritis-news-41/ground-zero-workers-at-risk-of-autoimmune-diseases-study-697581.html. The study announced in the Norton article is the 2015 study by Webber et al., cited infra note 9.

    8 Nancy Walsh, Autoimmunity Rising in 9/11 Workers, MedPage Today, March 19, 2015, http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/50548.

    9 Mayris Webber, William Moir, Rachel Zeig-Owens, et al., Nested Case-Control Study of Selected Systemic Autoimmune Diseases in World Trade Center Rescue/Recovery Workers, Arthritis Rheumatol 2015;67(5):1369-1376.

    The fifth reference provided in Petition 013 does not specifically identify a peer-reviewed, published epidemiologic study of the health condition among 9/11-exposed populations, nor is it a clinical case report of the health condition in WTC responders or survivors. Petition 013 reference 5 is a link to the proceedings of a research meeting conducted by the WTC Health Program in 2014.10 Two abstracts found in the proceedings address the topic of autoimmune disease among the 9/11 population—“Autoimmune Disease among WTCHR [World Trade Center Health Registry] Registrants: Survey Design and Preliminary Response Rates,” and “Post-9/11 Incidence of Systemic Autoimmune Diseases in the FDNY Cohort.” The former abstract references an unpublished study; because unpublished studies do not meet the Program's standard for relevance, it was not further considered. The latter abstract describes a study that resulted in the 2015 Webber et al. publication discussed in this action and reviewed in full in the April 2016 FRN for Petition 011.

    10 WTC Health Program, Research Meeting Proceedings, June 17-18, 2014, www.cdc.gov/wtc/proceedings.html.

    As discussed in the April 2016 FRN finding of insufficient evidence for Petition 011, the 2015 Webber et al. study looked at the association between 9/11-related exposures and systemic autoimmune diseases. It was found to be a published, peer-reviewed epidemiologic study of autoimmune diseases in the 9/11 population, and therefore deemed relevant. However, the study was found to exhibit substantial limitations, and it was ultimately concluded not to have the potential to form the basis for a decision on whether to propose adding autoimmune diseases to the List of WTC-Related Health Conditions.11

    11 81 FR 24047 at 24049.

    In addition to a review of the studies presented in Petition 013, the WTC Health Program Science Team conducted a review of the scientific literature to determine if the available scientific information has the potential to provide a basis for a decision on whether to add the condition to the List. A previously conducted literature review for autoimmune diseases in response to Petition 007 12 included all of the autoimmune conditions in the 2015 Webber et al. study.13 In reviewing Petition 013, the Science Team conducted a search to update the results of the previous literature review for all of the types of autoimmune diseases identified in the 2015 Webber et al. study, and also conducted a separate search for published, peer-reviewed studies of multiple sclerosis in 9/11 populations.14

    12See 80 FR 32333 at 32334.

    13 Rheumatoid arthritis; spondyloarthritis; inflammatory myositis (polymyositis and dermatomyositis); systemic lupus erythematosus; systemic sclerosis (scleroderma); Sjogren's syndrome; antiphospholipid syndrome; granulomatosis with polyangiitis (Wegener's); and eosinophilic granulomatosis with polyangiitis (Churg-Strauss).

    14 Databases searched include: CINAHL, Embase, NIOSHTIC-2, PsycINFO, PubMed, Scopus, Toxicology Abstracts, and TOXLINE.

    The Science Team identified five additional references to review for relevance. Of the five additional references, only one study, published in 2016 by Webber et al., 15 was found to be a relevant, published, peer-reviewed study of autoimmune diseases in 9/11-exposed populations. No published, peer-reviewed epidemiologic studies of multiple sclerosis in 9/11-exposed populations were identified in the literature search.

    15 Mayris Webber, William Moir, Cynthia Crowson, et al., Post-September 11, 2001, Incidence of Systemic Autoimmune Diseases in World Trade Center-Exposed Firefighters and Emergency Medical Service Workers, Mayo Clin Proc 2016;91(1):23-32.

    The 2016 Webber et al. study is a follow-up to the 2015 Webber et al. study discussed above. The 2016 Webber et al. study looked at the same cohort of FDNY rescue/recovery workers included in the 2015 study to estimate the incidence of systemic autoimmune diseases in the cohort of FDNY rescue/recovery workers and to compare the FDNY incidence rates to demographically similar men and other published rates. This additional reference, the 2016 Webber et al. study, was also identified as relevant in the literature search for Petition 011. As a result, it was further reviewed in the April 2016 FRN for Petition 011 and, along with the 2015 Webber et al. study, evaluated for quantity and quality to provide a sufficient basis for deciding whether to propose an addition to the List. Significant limitations, discussed in the April 2016 FRN for Petition 011, led the WTC Health Program to conclude that the 2015 Webber et al., and the 2016 Webber et al. study together do not have the potential to provide a basis for a decision on whether to propose adding autoimmune diseases to the List.

    All of the references and potential medical bases presented in Petition 013 were previously identified and assessed in Petition 011; as discussed above, these medical bases had significant limitations that prevented them from having the potential to provide a basis to propose adding autoimmune diseases to the List. The Science Team did not find any information during their review of Petition 013 which would alter the assessment of the previously reviewed studies. Moreover, none of the studies identified, including the 2015 and 2016 Webber et al. studies, include multiple sclerosis. Thus, no evidence was found specific to multiple sclerosis which would have the potential to form the basis for a decision on whether to propose adding multiple sclerosis to the List.

    D. Administrator's Determination on Petition 013

    The Administrator has established a policy for evaluating whether to propose the addition of non-cancer health conditions to the List of WTC-Related Health Conditions.16 Petition 013 requested the addition of “relapsing remitting multiple sclerosis (autoimmune)” to the List. The Administrator previously reviewed the category of “autoimmune diseases,” which includes multiple sclerosis, for Petitions 007, 008, 009, and 011. Neither the references included in Petition 013 nor the studies found in the literature review conducted by the Science Team presented evidence of a causal association between 9/11 exposures and autoimmune diseases, including multiple sclerosis.

    16Supra note 6.

    The Administrator initially reviewed the findings presented in the 2015 Webber et al. study in response to Petition 007, which also requested the addition of autoimmune diseases, including rheumatoid arthritis and connective tissue diseases. In that review, due to limitations in the 2015 Webber et al. study, the Administrator determined that insufficient evidence existed to take any of the following actions: Propose the addition of autoimmune diseases to the List (pursuant to PHS Act, sec. 3312(a)(6)(B)(ii) and 42 CFR 88.17(a)(2)(ii)); publish a determination not to publish a proposed rule in the Federal Register (pursuant to PHS Act, sec. 3312(a)(6)(B)(iii) and 42 CFR 88.17(a)(2)(iii)); or request a recommendation from the STAC (pursuant to PHS Act, sec. 3312(a)(6)(B)(i) and 42 CFR 88.17(a)(2)(i)). The 2015 Webber et al. study was also presented as evidence to support the Petition 008 request for autoimmune disorders, specifically encephalitis of the brain, the Petition 009 request for autoimmune disorders, including multiple sclerosis, as well as the Petition 011 request for autoimmune disorders, including lupus and rheumatoid arthritis. The 2016 Webber et al. study was also presented as evidence to support Petition 011. As concluded in the April 2016 FRN for Petition 011, the two Webber et al. studies, taken together, while meeting the relevance threshold of being published, peer-reviewed epidemiologic studies of autoimmune diseases in 9/11-exposed populations, were found to exhibit significant limitations and were thus insufficient to provide a potential basis for a decision on whether to propose adding the requested health conditions to the List.17

    17 81 FR 24047 at 24050.

    Finding no additional relevant studies with regard to Petition 013, the Administrator has accordingly determined that insufficient evidence exists to take further action at this time, including either proposing the addition of autoimmune diseases, including multiple sclerosis, to the List (pursuant to PHS Act, sec. 3312(a)(6)(B)(ii) and 42 CFR 88.17(a)(2)(ii)) or publishing a determination not to publish a proposed rule in the Federal Register (pursuant to PHS Act, sec. 3312(a)(6)(B)(iii) and 42 CFR 88.17(a)(2)(iii)). The Administrator has also determined that requesting a recommendation from the STAC (pursuant to PHS Act, sec. 3312(a)(6)(B)(i) and 42 CFR 88.17(a)(2)(i)) is unwarranted.

    For the reasons discussed above, the request made in Petition 013 to add “relapsing remitting multiple sclerosis (autoimmune)” to the List of WTC-Related Health Conditions is denied.

    The Administrator will continue to monitor the scientific literature for publication of the results of the ongoing WTC Health Registry study discussed above (reference 5 in the petition) and any other studies that address autoimmune diseases among 9/11-exposed populations.

    John Howard, Administrator, World Trade Center Health Program and Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Department of Health and Human Services.
    [FR Doc. 2016-21070 Filed 8-31-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 577 [Docket No. NHTSA-2016-0001] RIN 2127-AL66 Update Means of Providing Recall Notification AGENCY:

    National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    NHTSA proposes to amend the means of recall notification to owners and purchasers required under the Safety Act to be in an electronic manner, in addition to first class mail, in accordance with Section 30130 of the Moving Ahead for Progress in the 21st Century Act (MAP-21) and Section 24104 of the Fixing America's Surface Transportation Act (FAST Act). Through this proposed rule, NHTSA also seeks to improve the efficacy of recalls by requiring manufacturers to send additional notifications of defects or noncompliance with applicable Federal Motor Vehicle Safety Standards (FMVSS) if a second notification by the manufacturer does not result in an adequate number of motor vehicles or replacement equipment being returned for remedy.

    DATES:

    Comments must be received on or before October 31, 2016. In compliance with the Paperwork Reduction Act, NHTSA is also seeking comment on amendments to an information collection. See the Paperwork Reduction Act section under Rulemaking Analyses and Notices below. Please submit all comments relating to the information collection requirements to NHTSA and to the Office of Management and Budget (OMB) at the address listed in the ADDRESSES section on or before October 31, 2016. Comments to OMB are most useful if submitted within 30 days of publication.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Internet: Go to http://www.regulations.gov and follow the online instructions for submitting comments.

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

    Hand Delivery or Courier: U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building, Room W12-140, Washington, DC 20590 between 9 a.m. and 5 p.m. Eastern Time, Monday through Friday, except Federal holidays.

    Facsimile: (202) 493-2251.

    Regardless of how you submit your comments, please include the docket number of this document.

    You may also call the Docket at (202) 366-9322.

    Note that all comments received will be posted without change to http://www.regulations.gov, including any personal information provided. Please see the Privacy Act discussion below.

    Privacy Act: Anyone is able to search the electronic form of all comments name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19476 at 19477-78).

    FOR FURTHER INFORMATION CONTACT:

    For substantive issues: Jennifer Timian, Office of Defects Investigation, National Highway Traffic Safety Administration, at (202) 366-4000. For legal issues: Justine Casselle, Office of the Chief Counsel, National Highway Traffic Safety Administration, at (202) 366-2992.

    SUPPLEMENTARY INFORMATION:

    I. Executive Summary II. Notification Requirements Before and After MAP-21 and FAST Act III. NHTSA's Proposed Amendment To Require Notification to Owners and Purchasers by Electronic Means in Addition to Notification by First Class Mail A. Public Response to NHTSA's ANPRM B. Suggested Approaches for Electronic Notification C. Limitations to Electronic Notification Approaches D. Privacy Considerations and Impacts of Any Existing Laws IV. Proposed Changes to Notification Requirements V. Proposed Changes to Follow-Up Requirements VI. Rulemaking Analyses and Notices A. Adjusted Estimates for Current Information Collections B. Estimates for New Information Collections I. Executive Summary

    In the Moving Ahead for Progress in the 21st Century Act (MAP-21), Congress enacted a provision authorizing NHTSA to amend the means by which a manufacturer of a motor vehicle or motor vehicle equipment provides notification to owners, purchasers, and dealers that a vehicle or equipment contains a defect related to motor vehicle safety or does not comply with an applicable federal motor vehicle safety standard (FMVSS). Public Law 112-141, 31310, 126 Stat. 758 (2012). More recently, Section 24104 of the Fixing America's Surface Transportation Act (FAST Act) expressly provided that NHTSA amend 49 CFR part 577 to require notification to owners and purchasers by electronic means in addition to notification by first class mail. Public Law 114-94, 24104 (2015). MAP-21 further authorized NHTSA to improve recall effectiveness by requiring manufacturers to send additional notifications of defects or noncompliance if a second notification by the manufacturer does not result in an adequate number of motor vehicles or equipment being returned for remedy. Public Law 112-141, 31310, 126 Stat. 758 (2012). NHTSA issued an Advanced Notice of Proposed Rulemaking (ANPRM) soliciting comments and supporting information about what NHTSA might require as to electronic notification. See 81 FR 4007 (January 25, 2016). We asked questions to facilitate comments from stakeholders on what means of notification, based on their experience, have been most effective in providing information to customers and motivating customers to have safety recall remedies performed. As part of implementing the MAP-21 and FAST Act notification provisions, and after consideration of comments received in response to the ANPRM, we now propose to amend Part 577 to require electronic notification means in addition to first class mail notification to owners and purchasers. This proposed update is not intended to change the scope of the existing rule, other than as specifically described in this notice, but is intended to aid in efficiently and effectively improving safety recall completion rates.

    II. Notification Requirements Before and After MAP-21 and FAST Act

    49 U.S.C. 30118(c) requires that, in the event of a defect or noncompliance with an applicable FMVSS in a motor vehicle or replacement equipment, manufacturers notify owners, purchasers, and dealers of the vehicle or equipment pursuant to 49 U.S.C. 30119. The manner by which this required notice is given to owners, purchasers, and dealers of vehicles or equipment is governed by 49 U.S.C. 30119(d). Prior to MAP-21, for vehicle recalls, section 30119(d) required notice to be sent by first class mail to the registered owner or, if the registered owner could not be identified, to the most recent purchaser known to the manufacturer. 49 U.S.C. 30119(d)(1)(A)-(B). For recalls of replacement equipment, the statute required notification by first class mail to the most recent purchaser. Id. Manufacturers were also required to notify dealers under the statute “by certified mail or quicker means if available.” 49 U.S.C. 30119(d)(4).

    Section 31310 of MAP-21 amended the notice provisions in 49 U.S.C. 30119(d) to allow the Secretary of Transportation, and by delegation NHTSA's Administrator, the flexibility to determine the manner by which notifications about safety recalls under 49 U.S.C. 30118 must be sent. The amended statutory language authorized the Agency to engage in a rulemaking to permit notification to owners and purchasers of safety recalls by means other than first class mail. In December 2015, Congress enacted the FAST Act expounding on this authority by expressly requiring the Agency to amend 49 CFR 577.7 to include notification to owners and purchasers by electronic means in addition to notification by first class mail.1

    1 Notification to dealers and distributors is generally required to be sent “by certified mail, verifiable or electronic means such as receipts or logs from electronic mail or satellite distribution system, or other more expeditious and verifiable means.” 49 CFR 577.7(c)(2). Dealers and distributors are not notified by first class mail. Therefore, the FAST Act did not require the Agency to change the means of notification for dealers and distributors, and we are not proposing to do so.

    Section 31310 of MAP-21 aimed to improve the efficacy of recalls not just through updating the means of notification, but also through allowing the Secretary to order additional notifications when necessary. Previously, 49 U.S.C. 30119(e) authorized the Secretary to order a second notification if the Secretary determined that the first notification failed to result in an adequate number of motor vehicles or items of equipment being returned for remedy. The statute was silent, however, as to whether additional notifications beyond a second notification could be required. Section 31310 resolved this question by amending 49 U.S.C. 30119(e), which now, under 49 U.S.C. 30119(e)(2)(A)(i), authorizes the Secretary to order additional notifications if the Secretary determines that a second notification also failed to result in an adequate number of motor vehicles or items of equipment being returned for remedy.

    III. NHTSA's Proposed Amendment To Require Notification to Owners and Purchasers by Electronic Means in Addition to Notification by First Class Mail

    In the ANPRM, NHTSA invited comments and supporting information on how the Agency can best leverage the new flexibilities given under MAP-21 and the FAST Act to update the required means manufacturers use, whether as a first notification or as a follow-up notification, to successfully notify their customers and urge them toward seeking the free remedies offered. The ANRPM posed several questions about the variety of means and methods manufacturers use to communicate with their customers. Additionally, the ANPRM posed several questions about general owner knowledge and behavior, and asked commenters to present any data on owner behavior in the recall context, including whether owners were responsive to incentives and to the currently prescribed content and layout of the notifications.

    A. Public Response to NHTSA's ANPRM

    We received 16 comments in response to the ANPRM regarding our proposed update of Part 577. Comments were submitted by Advocates for Highway Safety; Alliance of Automobile Manufacturers (Alliance); American Automotive Leasing Association; IHS Automotive (IHS); FCA US LLC (FCA); General Motors LLC (GM); Global Automakers (Global); NAFA Fleet Management Association (NAFA); National Automobile Dealers Association (NADA); National Independent Automobile Dealers Association (NIADA); Rubber Manufacturers Association (RMA); Pandora Media, Inc. (Pandora); Tire Industry Association (TIA); Truck and Engine Manufacturers Association (EMA); New Jersey Gasoline, C-Store, and Automotive Association (NJGCA); and Tesla Motors (Tesla).

    Many of the comments addressed general owner knowledge and behavior and proposed potential changes to the specific information provided to owners and the layout of the notifications. Many also proposed that NHTSA should conduct studies on these matters. Although the comments were insightful, NHTSA is not proposing additional or changed requirements as to the specific content and layout of notifications at this time. This NPRM is limited to updating the means of notification by requiring electronic notification.

    B. Suggested Approaches for Electronic Notification

    Most commenters generally supported the use of electronic means and provided suggestions on which types would be best suited for recall notifications. Advocates for Highway Safety stated its belief that email and text message notification should be required, as both methods allow for delivery receipt. It also suggested that newspaper, radio, television, internet, and social media be required methods of notification. Finally, it suggested that manufacturers use direct-to-vehicle communications to notify owners.

    IHS suggested that social media, digital radio broadcasts, and connected car applications are “future looking applications of reaching audiences who may not respond to direct mail or even email notices.” IHS further commented that some manufacturers use a method called Voice Broadcast which is a “notice in advance of the mailing or other communication to alert the consumer to the forthcoming first class mail communication.”

    The Alliance recommended that the Agency permit a multi-tiered approach that allows manufacturers to use a variety of electronic communication methods. The Alliance noted that manufacturers already use multiple electronic communication methods such as “robo-calls, agent-assisted calls, Facebook notifications, and other means,” especially when recall completion rates are low.

    Similar to the Alliance's comments, GM suggested that any changes to Part 577 be flexible, allowing for new technologies as they arise, and further commented that the demographics of the vehicle and the particular recall issue must be better understood as they each play a key role in recall completion rates. GM noted that it has used robo-calls, live calls, in-vehicle calls, and social media to reach out to its owners. The company found social media effective for the purpose of raising awareness, but could not tie it to significant gains in recall completion.

    Tesla provided a contextual example of successful electronic notifications used in a recent recall. As Tesla has every Tesla customer's email address, email notifications were sent to every customer two weeks before the physical mailings were ready to be mailed. Thirty percent of Tesla customers had their vehicle remedied by the time the physical mailings were sent via first class mail. Tesla agrees that electronic notification is instantaneous but, though very effective, should be supplemental to the current first class mail standard.

    NAFA agreed that electronic notification should be added to the existing first class mail notification.

    NIADA suggested that NHTSA move away from a “one-sized fits all approach,” and allow notification means such as email, text messaging, internet, OnStar, Blue Link, and other technologies. NIADA commented broadly that it supports strategies that expand how owners are reminded of recalls.

    Pandora noted that it worked with GM in the past to notify targeted owners with audio notifications about open recalls. Pandora further shared that its notifications are interactive and can connect a user directly to scheduling or to a manufacturer's Web site.

    EMA shared that many fleets and dealers already use a variety of electronic means to connect with owners, such as email, telephone, text messages, direct service database flags, and more.

    TIA and NJGCA provided no data as to the effectiveness of first class mail notifications, but opined that “change-of-address” impacts notifications. TIA further commented that tire manufacturers “could use the Internet and social media to notify owners about safety recalls . . .” but tire manufacturers currently only provide first class mail notifications and sometimes a press release.

    C. Limitations to Electronic Notification Approaches

    Not all commenters supported the use of electronic means during the recall notification process and some commenters highlighted some concerns or limitations with various methods of electronic communications.

    Survey results provided by the Alliance and Global included information about the success of various means of notification. Per the results, neither was able to correlate recall completion rates with a specific outreach method. The Alliance and Global noted that there is no ability to connect social media outreach to particular VINs and no guarantee that owners will not treat emails from manufacturers as SPAM or JUNK, even with a valid delivery receipt.

    GM also recognized some concerns such as the difficulty of obtaining owner email addresses without paying a third-party and social media privacy policies. GM did not recommend that email notification replace first class mail notification, and noted that delivery rates through first class mail can be as high as 96%.

    The American Automotive Leasing Association stated its position that a change to Part 577 should not burden lessors with requirements to send any additional notifications, email or otherwise, to vehicle lessees.

    EMA commented that existing first class mail notification is very effective for commercial vehicle recalls because the owner records are typically better kept amongst the commercial vehicle market. Additionally, EMA does not believe social media notifications will be useful for the commercial vehicle market.

    D. Privacy Considerations and Impacts of Any Existing Laws

    Three (3) commenters, the Alliance, GM, and TIA, commented on specific privacy concerns or existing state and Federal laws that might be impacted by the use of electronic recall communications.

    GM noted that the expertise to market via electronic communications is often housed in the manufacturer's marketing department. While a specific legal restriction was not cited, GM did suggest that owner data from state registrations would need housing in a “safe haven” where the manufacturer could only use that data within legal constraints. GM further mentioned that some social media privacy policies restrict the amount of feedback the vehicle manufacturer can obtain and some publishers do not offer any feedback at all. As such, it would be difficult to measure the effectiveness of some social media recall notifications.

    The Alliance commented that some forms of social media, like Twitter, restrict the amount of content shared to users. For example, a recall communication containing a summary of the recall, safety risk, available remedy, and contact information would be difficult to transmit given Twitter's 140 character limit restriction. Also, the Alliance recommended an additional study needed to ensure new means of notification do not conflict with the Controlling the Assault of Non-Solicited Pornography and Marketing Act (CAN-SPAM Act), the Telephone Consumer Protection Act (TCPA), and the Do-Not-Call Implementation Act as amended.

    TIA cautioned the Agency in requiring additional personal information to be provided back to the tire manufacturers in order to facilitate electronic recall notifications. TIA noted that 49 CFR part 574 prohibits manufacturers from using registration information for marketing purposes; however, TIA claims tire manufacturers have circumvented this prohibition and TIA worries any additional data that tire retailers must collect (such as customer email addresses) may create a competitive disadvantage to independent tire retailers.

    IV. Proposed Changes to Notification Requirements

    After considering the relevant comments provided, we propose to amend 49 CFR 577.7 to require notification by electronic means in addition to first class mail every time a recall notification is required. The proposal gives the recalling manufacturer the flexibility to define and determine the electronic means they feel are most effective to employ in an effort to optimize the recalls completion for a particular recall campaign. As many of the commenters noted, there are a wide variety of electronic means currently available for use by manufacturers and some have chosen to use as a supplementary means of notification with varying degrees of success. A flexible approach values the knowledge and experience of the recalling manufacturers concerning what means are most likely to reach and resonate with their owners and motivate them toward taking steps to have their products remedied.

    Accordingly, we propose defining “electronic means” to include “electronic mail, text messages, radio or television notifications, vehicle infotainment console messages, over-the-air alerts, social media or targeted online campaigns, phone calls, including automated phone calls, or other real time means.” As with any recall communication, the Agency retains the discretion to require other means and additional notifications if the manufacturer's chosen means is impractical, does not feasibly reach all of the purchasers or owners impacted, or the Agency otherwise deems inappropriate. At this time we decline to set any additional and mandatory notification means beyond the electronic means identified here.

    The Agency recognizes that the proposed definition of “electronic means” is broad and that certain proposed means of electronic notification may be difficult to achieve in practice given the current content requirements of 49 CFR part 577. We propose a broad definition of “electronic means” now in anticipation that we may amend the content requirements of 49 CFR part 577 in the future. However, at this time, we propose to require that any electronic notification issued under this paragraph comply with the content requirements of 49 CFR part 577, or provide a hyperlink to a notice that complies with the content requirements of 49 CFR part 577, or a representative copy of such a notice along with instructions on how a vehicle owner can determine whether his or her vehicle is impacted.

    Vehicle safety recalls require inclusion of the owner's VIN in the part 577 notification letter. We recognize that is not always feasible through social media or other electronic means where a notice may be viewed by more than one individual. In that case, a representative copy of a notice may be used, so long as additional information is given as to how an owner could readily determine whether his or her vehicle or equipment is impacted by the recall. For those manufacturers that are currently required to support NHTSA's VIN search tool and offer VIN-based safety recall search tools on their Web sites pursuant to existing regulation, the communication must also direct viewers to NHTSA's VIN search tool 1 and the manufacturer's search tool.

    1 NHTSA's VIN search tool is available at https://vinrcl.safercar.gov/vin/.

    It must be noted that this proposed rule does not alter a manufacturer's requirements under 49 CFR part 573, nor is an amendment to 49 CFR part 573 required at this time. Manufacturers must continue to comply with 49 CFR 573.6 by filing representative copies of “all notices, bulletins, and other communications that relate directly to the defect or noncompliance and are sent to more than one manufacturer, distributor, dealer or purchaser.” Electronic notifications are notices, bulletins, or other communications under 49 CFR 573.6. Currently, manufacturers provide representative copies to NHTSA via the online Recalls Portal. Upon the publishing of the Final Rule, manufacturers will continue to do so, as the online Recalls Portal will be updated to allow for manufacturers to select their choice among one of the allowable electronic means. Representative copies are required even if a manufacturer chooses to issue Part 577-compliant notices via electronic means such as radio or television notifications, vehicle infotainment console messages, over-the-air alerts, telephone calls, or other allowable means. In practice, manufacturers can submit to the online Recalls Portal copies of electronic messages (emails), screenshots of messages or alerts, and scripts of calls or ads, for example.

    We also note that 49 CFR 577.7(c)(2) concerning notifications to dealers and distributers already contains language providing for notification “by certified mail, verifiable electronic means such as receipts or logs from electronic mail or satellite distribution system, or other more expeditious and verifiable means. . . .” At this time, the Agency does not believe a change to the required means of notification to dealers and distributers is warranted.

    In response to concerns expressed about whether the proposed electronic notification requirement will conflict with existing federal laws aimed at protecting consumers and businesses from unwanted electronic messages, the Agency's position is that it will not. Recall notifications are safety-related informational messages. The proposed changes in this rulemaking are not intended to exempt from federal laws, including but not limited to the CAN-SPAM Act, the TCPA, and the Do-Not-Call Implementation Act, conduct that is unlawful under those laws.

    We request comments on this proposal and any alternative approaches that allow for numerous electronic notification means, but at the same time ensure that the notification communicates the long-standing and essential components of traditional Part 577 first class mailings. That is, that the manufacturer had decided there is a safety defect or failure to meet minimum safety standards; that the safety defect or failure to comply increases the risk of a motor vehicle crash, injury and/or fire; a safety recall is being conducted; and a remedy will be provided at no cost. More specifically, we request comment on our proposed approach to permit discretion in the means chosen to meet the requirement of electronic notification. In addition to our request for comments on our proposed definition of “electronic means,” we request comment on whether the terms “social media or targeted online campaigns” need further definition, given that such proposed electronic notification means are fundamentally different from other means targeted at individual owners. Finally, we request comment on our proposal to require inclusion of directions to NHTSA's VIN search tool and the manufacturer's search tool, for social media campaigns, for example, which we believe will allow owners to readily ascertain the application of the safety recall to vehicles and equipment they own.

    V. Proposed Changes to Follow-Up Requirements

    As mentioned above, MAP-21 authorized NHTSA to require manufacturers to send additional notifications of defects or noncompliance if a second notification by the manufacturer does not result in an adequate number of motor vehicles or equipment being returned for remedy. Public Law 112-141, § 31310, 126 Stat. 758 (2012). Although 49 CFR 577.10 currently provides that the Administrator “may authorize the use of other media besides first-class mail for a follow-up notification,” we propose a minor revision to this section for clarity and consistency purposes. Still subject to the Administrator's approval, we propose clarifying that a follow-up notification shall be sent by first class mail and by electronic means in the same manners we propose be included in 49 CFR 577.7 above. We request comment on this proposed clarification.

    VI. Rulemaking Analyses and Notices Executive Orders 12866 and 13563, and DOT Regulatory Policies and Procedures

    This rulemaking document was not reviewed under Executive Order 12866 or Executive Order 13563. NHTSA has considered the impact of this NPRM under the Department of Transportation's regulatory policies and procedures. This action would amend Part 577 to update the procedures by which manufacturers notify owners, purchasers, and dealers of defects and noncompliances in an effort to improve vehicle safety recall completion rates. The rulemaking imposes no new significant burdens on the manufacturers and does not create significant related costs that would require the development of a full cost/benefit evaluation. Since this action also does not change the number of those organizations or individuals subject to this requirement, the impacts of the rule are limited. Therefore, this rulemaking has been determined to be not “significant” under the Department of Transportation's regulatory policies and procedures and the policies of the Office of Management and Budget.

    Regulatory Flexibility Act

    We have also considered the impact of this notice under the Regulatory Flexibility Act. I certify that this rule is not expected to have a significant economic impact on a substantial number of small entities. The following provides the factual basis for this certification under 5 U.S.C. 605(b). The amendments almost entirely affect manufacturers of motor vehicles and motor vehicle equipment.

    SBA uses size standards based on the North American Industry Classification System (“NAICS”), Subsector 336—Transportation Equipment Manufacturing, which provides a small business size standard of 1,000 employees or fewer for automobile manufacturing businesses. Other motor vehicle-related industries have lower size requirements that range between 100 and 750 employees. For example, according to the SBA coding system, businesses that manufacture truck trailers, travel trailers/campers, and vehicular lighting equipment, qualify as small businesses if they employ 500 or fewer employees. Small businesses are subject to the notification requirements and therefore may be affected by the proposed changes in this NPRM. However, the impacts of this rulemaking on small businesses are minimal, as this proposed procedural update does not impose a significant additional burden or additional costs.

    Unfunded Mandates Reform Act of 1995

    The Unfunded Mandates Reform Act of 1995, Public Law 104-4, requires agencies to prepare a written assessment of the cost, benefits and other effects of proposed or final rules that include a federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually. Because this rulemaking would not have a $100 million effect, no Unfunded Mandates assessment will be prepared.

    Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et. seq.), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct, sponsor, or require through regulations. In compliance with the PRA, we announce that NHTSA is seeking comment on a revision of a currently approved collection.

    Agency: National Highway Traffic Safety Administration (NHTSA).

    Title: 49 CFR part 577, Defect and Noncompliance Notification.

    Type of Request: Revision of a currently approved collection.

    OMB Control Number: 2127-0004.

    Form Number: The collection of this information uses no standard form.

    Requested Expiration Date of Approval: Three (3) years from the date of approval.

    Summary of the Collection of Information

    This approved information collection is associated with 49 CFR Part 573 and portions of 49 CFR part 577, and consists of important safety recall information that motor vehicle and motor vehicle equipment manufacturers must submit.

    Description of the Need for the Information and Use of the Information

    The information is needed for NHTSA to better serve the public by effectively monitoring safety recalls and by providing timely recall information to consumers regarding specific vehicles. Owners and purchasers will benefit from the increased ease with which they can ascertain information on recalled vehicles. The public at large will benefit from a decrease in the numbers of defect or noncompliant vehicles on public roads and, concurrently, a decrease in the incident or risk of incident of injuries and fatalities associated with those defects and failures to comply, that we expect to result from increased recalls completion rates stemming from the public's enhanced ability to quickly locate important safety recall information on vehicles they drive.

    Description of the Likely Respondents (Including Estimated Number, and Proposed Frequency of Response to the Collection of Information)

    Should this proposal be made final, we expect that all manufacturers regulated by NHTSA and currently subject to the defect and noncompliance reporting and notification requirements will continue to be subject to the updated requirements.

    Estimate of the Total Annual Reporting and Recordkeeping Burden Resulting From the Collection of Information

    Today's proposed rule requiring manufacturers to notify their affected owners by electronic means in addition to first class mail notifications will add some paperwork burden to the industry. However, electronic methods such as email, social media accounts, over-the-air communications and others are existing technologies and largely free of charge.

    Given the recent increase in the number of safety recalls the Agency administers yearly and the volume of products included in those recalls, this information collection burden hour total is increased from previous estimates. The Agency anticipates that each recall will require 4 burden hours for the manufacturer to plan its strategy for meeting the electronic notification requirement and executing that strategy. With an estimated 854 recalls filed each year, we estimate a new 3,416 burden hours (854 recalls x 4 hours) for this new requirement.

    Comments are invited on:

    • Whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility.

    • Whether the Department's estimate for the burden of the information collection is accurate.

    • Ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.

    A comment to OMB is most effective if OMB receives it within 30 days of publication. Send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attn: NHTSA Desk Officer. PRA comments are due within 30 days following publication of this document in the Federal Register.

    The Agency recognizes that the collection of information contained in today's proposed rule may be subject to revision in response to public comments.

    Regulatory Identifier Number (RIN)

    The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.

    Privacy Act

    Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78).

    List of Subjects in 49 CFR Part 577

    Administrative practice and procedure, Motor vehicles, Motor vehicle safety, Reporting and recordkeeping requirements.

    Proposed Regulatory Text

    For the reasons set forth in the preamble, NHTSA proposes to amend 49 CFR part 577 as follows:

    PART 577—DEFECT AND NONCOMPLIANCE NOTIFICATION 1. The authority citation for part 577 continues to read as follows: Authority:

    49 U.S.C. 30102, 30103, 30116-121, 30166; delegation of authority at 49 CFR 1.95 and 49 CFR 501.8.

    2. Amend § 577.7 by revising paragraph (a)(2)(i) through (iv) and adding paragraphs (a)(2)(v) and (vi) to read as follows:
    § 577.7 Time and manner of notification.

    (a) * * *

    (2) * * *

    (i) In the case of a notification required to be sent by a motor vehicle manufacturer, by first class mail and by electronic means to each person who is registered under State law as the owner of the vehicle and whose name and address are reasonably ascertainable by the manufacturer through State records or other sources available to him. If the owner cannot be reasonably ascertained, the manufacturer shall notify the most recent purchaser known to the manufacturer. The manufacturer shall also provide notification to each lessee of a leased motor vehicle that is covered by an agreement between the manufacturer and a lessor under which the manufacturer is to notify lessees directly of safety-related defects and noncompliances.

    (ii) In the case of a notification required to be sent by a replacement equipment manufacturer—

    (A) By first class mail and by electronic means to the most recent purchaser known to the manufacturer, and

    (B) (Except in the case of a tire) if decided by the Administrator to be required for motor vehicle safety, by public notice in such manner as the Administrator may require after consultation with the manufacturer.

    (iii) In the case of a manufacturer required to provide notification concerning any defective or noncomplying tire, by first class or certified mail and by electronic means.

    (iv) In the case of a notification to be sent by a lessor to a lessee of a leased motor vehicle, by first class mail and by electronic means to the most recent lessee known to the lessor. Such notification shall be sent within ten days of the lessor's receipt of the notification from the vehicle manufacturer.

    (v) Notification by electronic means required by paragraph (a)(2) of this section is defined to include notification by electronic mail, text messages, radio or television notifications, vehicle infotainment console messages, over-the-air alerts, social media or targeted online campaigns, telephone calls, automated or otherwise, or other real time means. No matter the means identified by the manufacturer, the Administrator retains the discretion to require other means and additional notifications if the manufacturer's chosen means is impractical, does not feasibly reach all of the purchasers or owners impacted, or is otherwise deemed inappropriate. Any electronic notification issued under this paragraph must either comply with the content requirements of § 577.5(b) through (g) of this part, provide an internet hyperlink to a notice that complies with the content requirements of § 577.5(b) through (g), or provide an internet hyperlink to a representative copy of a notice that complies with the content requirements of § 577.5(b) through (g) along with instructions on how the purchaser or owner can determine whether his or her vehicle or equipment is impacted.

    (vi) In the case of a notification by electronic means that may be viewed by more than one individual, manufacturers who are currently required to support NHTSA's VIN search tool and offer VIN-based safety recall search tools pursuant to existing regulation under this chapter, such notification must direct viewer to NHTSA's VIN search tool and the manufacturer's search tool.

    3. Amend § 577.10 by revising paragraph (g) to read as follows:
    § 577.10 Follow-up notification.

    (g) A follow-up notification shall be sent by first class mail and by electronic means pursuant to § 577.7(a)(2) of this part. Notwithstanding any other provision of this part, the Administrator may authorize the use of other media besides first class mail and electronic means for a follow-up notification.

    Issued in Washington, DC, on August 25, 2016 under authority delegated pursuant to 49 CFR 1.95. Gregory K. Rea, Associate Administrator for Enforcement.
    [FR Doc. 2016-20926 Filed 8-31-16; 8:45 am] BILLING CODE 4910-59-P
    81 170 Thursday, September 1, 2016 Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2016-0045] Environmental Impact Statement; Grasshopper and Mormon Cricket Suppression Program AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Notice of intent to prepare an environmental impact statement.

    SUMMARY:

    We are advising the public that the Animal and Plant Health Inspection Service plans to prepare an environmental impact statement to analyze the effects of a program to suppress populations of grasshoppers and Mormon cricket from 17 States in the western United States. This notice identifies potential issues and alternatives that will be studied in the environmental impact statement, and requests public comments to further delineate the scope of the alternatives and environmental impacts and issues.

    DATES:

    We will consider all comments that we receive on or before October 17, 2016.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0045.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2016-0045, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.

    Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0045 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

    FOR FURTHER INFORMATION CONTACT:

    For questions related to the Grasshopper and Mormon Cricket Suppression Program, contact Mr. William D. Wesela, APHIS National Grasshopper and Mormon Cricket Program Manager, [email protected], (301) 851-2229. For questions related to the environmental impact statement, contact Dr. Jim Warren, Environmental Protection Specialist, Environmental and Risk Analysis Services, PPD, APHIS, 4700 River Road, Unit 149, Riverdale, MD 20737; [email protected]; (202) 316-3216.

    SUPPLEMENTARY INFORMATION:

    About 400 species of grasshoppers inhabit the 17 western States (Arizona, California, Colorado, Idaho, Kansas, Montana, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington, and Wyoming) involved in the Animal and Plant Health Inspection Service's (APHIS') cooperative grasshopper suppression program, but only a small percentage are considered pest species. APHIS assists Federal land management agencies and State, county, and local governments during rangeland pest outbreaks. Grasshoppers and Mormon crickets (hereafter referred to collectively as grasshoppers) feed on and damage grasses and other vegetation, including some adjacent crops.

    Rangeland in the western United States is a valuable agricultural resource for livestock production. Other economic benefits include energy production sites and recreation uses. Rangelands also provide numerous ecosystem benefits, such as protection of water and soil quality, nutrient cycling and serve as habitat for a variety of wildlife. Grasshoppers are natural components of this ecosystem; however, their populations can reach outbreak levels and cause serious economic losses to rangeland forage, especially when accompanied by a drought. A rapid and effective response is required when a grasshopper outbreak develops and threatens rangeland forage.

    Currently, APHIS conducts surveys for grasshopper populations on rangeland in the western United States, provides technical assistance on grasshopper management to land owners/managers, and cooperatively suppresses grasshoppers when direct intervention is requested by a Federal land management agency or a State agriculture department and deemed necessary.

    Under the provisions of the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C 4321 et seq.), Federal agencies must examine the potential environmental effects of the proposed Federal actions and alternatives. As such, we intend to prepare an environmental impact statement (EIS) to examine the environmental effects of control alternatives available to the agency, including a no action alternative. The EIS will be used for planning and decisionmaking and to inform the public about the environmental effects of APHIS' grasshopper suppression activities. It will also provide an overview of APHIS activities to which we can tier site-specific analyses and environmental assessments if new grasshopper infestations are discovered in the affected States.

    We are requesting public comment to help us identify or confirm potential alternatives and environmental issues that should be examined in the EIS, as well as comments that identify other issues that should be examined in the EIS.

    The EIS will be prepared in accordance with: (1) NEPA, (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

    We have identified three alternatives for further examination in the EIS:

    No action. Under this alternative, APHIS would maintain the program that was described in the 2002 EIS and Record of Decision. APHIS may opt to provide technical assistance, but any suppression program would be implemented by a Federal land management agency, a State agriculture department, a local government, or a private group or individual.

    No suppression program. Under this alternative, APHIS would not fund or participate in any program to suppress grasshopper infestations. APHIS may opt to provide technical assistance, but any suppression program would be implemented by a Federal land management agency, a State agriculture department, a local government, or a private group or individual.

    Insecticide applications at conventional rates or reduced agent area treatments. This alternative would update the information and technologies that were analyzed in the 2002 EIS. The insecticides available for use by APHIS include the U.S. Environmental Protection Agency-registered chemicals carbaryl, diflubenzuron, chlorantraniliprole, and malathion. Carbaryl and malathion are cholinesterase inhibitors which effects the nervous system. Diflubenzuron is an insect growth regulator. Chlorantraniliprole affects the nervous system by activating ryanodine receptors in insects. Only one insecticide would be used at a time, and would be applied at a rate that is normally or conventionally used for grasshopper suppression treatments, or could be applied as a reduced agent area treatment (RAATs). The RAATs strategy uses a reduced rate of insecticide from conventional levels by alternating treatment swaths in a spray block, reduced application rates, or both. The RAATs strategy suppresses grasshoppers within treated swaths, while conserving grasshopper predators and parasites in swaths that are not treated. An adaptive approach of either conventional rates or RAATs will allow the program to make site-specific suppression applications using a range of application rates to ensure adequate suppression.

    We have identified the following potential environmental impacts or issues for further examination in the EIS:

    • Effects on wildlife, including consideration of migratory bird species and changes in native wildlife habitat and populations, and federally listed endangered and threatened species.

    • Effects on soil, air, and water quality.

    • Effects on human health and safety.

    • Effects on cultural and historic resources.

    • Effects on economic resources.

    All comments on this notice will be carefully considered in developing the final scope of the EIS. Upon completion of the draft EIS, a notice announcing its availability and an invitation to comment on it will be published in the Federal Register.

    Done in Washington, DC, this 26th day of August 2016. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2016-21082 Filed 8-31-16; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Forest Service Glenn and Colusa County Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Glenn and Colusa County Resource Advisory Committee (RAC) will meet in Willows, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with title II of the Act. RAC information can be found at the following Web site: http://www.fs.usda.gov/main/pts/specialprojects/racweb.

    DATES:

    The meeting will be held on September 19, 2016, from 1:00 p.m. to 4:00 p.m.

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

    ADDRESSES:

    The meeting will be held at the USDA Mendocino National Forest, Snow Mountain Conference Room, 825 North Humboldt Avenue, Willows, California.

    Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at the USDA Mendocino National Forest, Grindstone Ranger District, 825 North Humboldt Avenue, Willows, California. Please call ahead at 530-934-3316 to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Zachary Rich, Committee Coordinator by phone at 530-934-1259, or via email at [email protected]

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

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to discuss current or completed projects and present new projects for review.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by September 12, 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 or after the meeting. Written comments and requests for time for oral comments must be sent to Zachary Rich, Committee Coordinator, USDA Mendocino National Forest, Grindstone Ranger District, 825 North Humboldt Avenue, Willows, California 95988; or by email to [email protected], or via facsimile to 530-934-7384.

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

    Dated: August 25, 2016. Eduardo Olmedo, District Ranger.
    [FR Doc. 2016-21060 Filed 8-31-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Tehama County Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Tehama County Resource Advisory Committee (RAC) will meet in Red Bluff, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with title II of the Act. RAC information, can be found at the following Web site: http://www.fs.usda.gov/main/pts/specialprojects/racweb.

    DATES:

    The meeting will be held on September 29, 2016, from 9:00 a.m. to 12:00 p.m.

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

    ADDRESSES:

    The meeting will be held at the Tehama County Farm Bureau, 275 Sale Lane, Red Bluff, California.

    Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at the USDA Mendocino National Forest, Grindstone Ranger District, 825 North Humboldt Avenue, Willows, California. Please call ahead at 530-934-3316 to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Randy Jero, Committee Coordinator by phone at 530-934-3316, or via email at [email protected]

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

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to discuss current or completed projects and present new projects for review.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by September 23, 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 or after the meeting. Written comments and requests for time for oral comments must be sent to Randy Jero, Committee Coordinator, USDA Mendocino National Forest, Grindstone Ranger District, 825 North Humboldt Avenue, Willows, California 95988; or by email to [email protected], or via facsimile to 530-934-7384.

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

    Dated: August 25, 2016. Eduardo Olmedo, District Ranger.
    [FR Doc. 2016-21065 Filed 8-31-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-56-2016] Foreign-Trade Zone (FTZ) 279—Terrebonne Parish, Louisiana; Notification of Proposed Production Activity; Gulf Island Shipyards, LLC (Shipbuilding); Houma, Louisiana

    Gulf Island Shipyards, LLC (Gulf Island Shipyards) submitted a notification of proposed production activity to the FTZ Board for its facilities in Houma, Louisiana within FTZ 279. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on August 19, 2016.

    The request indicates that a separate application for site designation at the Gulf Island Shipyards facilities will be submitted pursuant to Section 400.38 of the Board's regulations. The Gulf Island Shipyards facilities are used for the repair, maintenance and fabrication of tugs, barges, dredges, offshore drilling rigs and other vessels. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

    Production under FTZ procedures could exempt Gulf Island Shipyards from customs duty payments on the foreign-status components used in export production. On its domestic sales, Gulf Island Shipyards would be able to choose the duty rate during customs entry procedures that applies to: Cargo vessels; passenger vessels; tankers; refrigerated vessels; offshore service vessels; fishing vessels; tugs and pusher crafts; dredgers; offshore drilling or production platforms; floating docks and similar structures; lifeboats and military vessels; and, hulls (duty-free) for the foreign-status inputs noted below. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.

    The components and materials sourced from abroad include: Floor-bonding coats; epoxy resins; fittings; plastic floor coverings; boxes and crates; handles and knobs; gaskets; life jackets; insulation; plastic tiles; tableware; pipe fittings; flanges; metal elbows; metal sleeves; marine doors; steel wall panels; anchors; small steel drums; steel metadisc fasteners; steel washers; steel fasteners; ladders and raceways; wires; copper fittings; nuts; bolts; washers; screws; nickel fittings; aluminum rods, profiles and fittings; hangers; forgings; lead pipes and pipe fittings; zinc tubes, pipes and fittings; tin tubes, pipes and fittings; metal fittings; flexible tubing; boilers; steam turbines; turbine parts; marine inboard engines; diesel engines and parts; turbine jets; gas turbines; hydrojet engines; fuel oil pumps; cooling pumps; ballast pumps; macerator pumps; hydraulic pumps; bilge, sump and dredge pumps; jet pumps; air and liquid compressors; turbochargers; pumps and compressors; air conditioner units; HVAC units; refrigeration units; fire dampers; heat exchangers; cooling equipment; liquid purifying equipment; fuel filters; air filters; sprayers; winches; derricks; elevators; drilling risers; deck machinery; trash compactors; pressure valves; scupper valves; check valves; relief valves; gate valves; roller bearings; Z-drives; transmission shafts; housed bearings; gearboxes; pulleys; flywheels; clutches; universal joints; acoustic baffles; propellers and blades; AC and DC electric motors up to 746W; electric motors and generators (>750W); single-phase AC electric motors and generators; multi-phase AC electric motors and generators; AC motors and generators (750W-150kW); AC generators; generator sets; electrical ballasts; transformers; rectifiers; power supplies; inductors; starters; heaters; television reception equipment; radar equipment; radio remote control equipment; antennas; tuners; signaling devices; motor starters; switches; connectors; electrical terminals; switching equipment; electrical panels; arc lamps; signal generators; displays; coaxial cables; ignition wiring sets; electric conductors; mirrors; optical instruments; depth-sounding apparatus; micrometers; calipers; thermostats; voltage regulators; marine chronometers; helm chairs; table brackets and plates; seats and accessories; furniture; seat parts; and, searchlights (duty rate ranges from duty-free to 8.5%). The production activity under FTZ procedures would be subject to the “standard shipyard restriction” applicable to foreign origin steel mill products, which requires that Gulf Island Shipyards pay all applicable duties on such items.

    Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is October 11, 2016.

    A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via www.trade.gov/ftz.

    For further information, contact Elizabeth Whiteman at [email protected] or (202) 482-0473.

    Dated: August 25, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-20995 Filed 8-31-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-038] Antidumping Duty Investigation of Certain Amorphous Silica Fabric From the People's Republic of China: Affirmative Preliminary Determination of Sales at Less-Than-Fair Value, Preliminary Affirmative Determination of Critical Circumstances, and Postponement of Final Determination AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that certain amorphous silica fabric (silica fabric) from the People's Republic of China (the PRC) is being, or is likely to be, sold in the United States at less-than-fair value (LTFV). The period of investigation is July 1, 2015, through December 31, 2015. The estimated weighted-average dumping margins are shown in the “Preliminary Determination” section of this notice. We invite interested parties to comment on this preliminary determination.

    DATES:

    Effective September 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Scott Hoefke or Fred Baker, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-4947 and (202) 482-2924, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    The Department published the notice of initiation of this LTFV investigation on February 23, 2016.1 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum that is dated concurrently with this determination and is hereby adopted by this notice.2 A list of topics included in the Preliminary Decision Memorandum is included as Appendix I to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov, and to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be found at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and electronic version of Preliminary Decision Memorandum are identical in content.

    1See Certain Amorphous Silica Fabric From the People's Republic of China: Initiation of Less-Than-Fair-Value Investigation, 81 FR 8913 (February 23, 2016) (Initiation Notice).

    2See Memorandum from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance “Decision Memorandum for the Preliminary Determination in the Antidumping Duty Investigation of Certain Amorphous Silica Fabric From the People's Republic of China,” (Preliminary Decision Memorandum) dated concurrently with this notice.

    Scope of the Investigation

    The product covered by this investigation is silica fabric from the PRC. For a complete description of the scope of this investigation, see Appendix II.

    Scope Comments

    In accordance with the preamble to the Department's regulations,3 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., “scope”).4 We received comments from one interested party on March 13, 2016. However, since these comments were untimely filed, we rejected them from the record. We received no other comments on scope since publication of the Initiation Notice, other than rebuttal comments filed by petitioner on March 17, 2016, with respect to the untimely filed March 7, 2016, comments. The Department is preliminarily not modifying the scope language as it appeared in the Initiation Notice.

    3See Antidumping Duties; Countervailing Duties, 62 FR 27296, 27323 (May 19, 1997).

    4See Initiation Notice, 81 FR at 8913.

    Methodology

    The Department conducted this investigation in accordance with section 731 of the Tariff Act of 1930, as amended (the Act). We calculated constructed export prices in accordance with section 772 of the Act. Because the PRC is a non-market economy within the meaning of section 771(18) of the Act, we calculated normal value (NV) in accordance with section 773(c) of the Act. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum.

    Affirmative Preliminary Determination of Critical Circumstances

    On July 13, 2016, Petitioner filed a timely critical circumstances allegation, pursuant to section 733(e)(1) of the Act and 19 CFR 351.206, alleging that critical circumstances exist with respect to imports of silica fabric from the PRC.5 We preliminarily determine that critical circumstances exist for ACIT (Pinghu) Inc. (ACIT), Nanjing Tianyuan Fiberglass Material Co., Ltd. (Nanjing Tianyuan), and the PRC-wide entity. For a full description of the methodology and results of our analysis, please see the Preliminary Decision Memorandum.

    5See Letter from Auburn Manufacturing, Inc. (Petitioner), dated July 13, 2016.

    Combination Rates

    In the Initiation Notice, the Department stated that it would calculate combination rates for the respondents that are eligible for a separate rate in this investigation.6 Policy Bulletin 05.1 describes this practice.7

    6See Initiation Notice, 81 FR at 8917.

    7See Enforcement and Compliance's Policy Bulletin No. 05.1, regarding, “Separate-Rates Practice and Application of Combination Rates in Antidumping Investigations involving Non-Market Economy Countries,” (April 5, 2005) (Policy Bulletin 05.1), available on the Department's Web site at http://enforcement.trade.gov/policy/bull05-1.pdf.

    Preliminary Determination

    The preliminary weighted-average antidumping margins are as follows:

    Exporter Producer Weighted-
  • average
  • margin
  • (%)
  • ACIT (Pinghu) Inc ACIT (Pinghu) Inc 162.47 Nanjing Tianyuan Fiberglass Material Co., Ltd Nanjing Tianyuan Fiberglass Material Co., Ltd 162.47 PRC-Wide Rate 162.47
    Suspension of Liquidation

    In accordance with section 733(d)(2) of the Act, we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of all entries of silica fabric from the PRC as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register.

    Section 733(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of investigation was published. As described above, we preliminarily find that critical circumstances exist for imports produced or exported by all exporters of subject merchandise from the PRC. Therefore, in accordance with section 733(e)(2)(A) of the Act, the suspension of liquidation shall apply to unliquidated entries of merchandise entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice. Accordingly, for ACIT, Nanjing Tianyuan, and the PRC-wide entity, in accordance with section 733(e)(2)(A) of the Act, the suspension of liquidation shall apply to unliquidated entries of merchandise entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice. We will also instruct CBP, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), to require a cash deposit equal to the margins indicated in the chart above.8 As described in the Preliminary Decision Memorandum, in this preliminary determination, no adjustments pursuant to section 777A(f) and 772(c)(1)(C) of the Act are being made for cash deposit purposes. The suspension of liquidation will remain in effect until further notice.

    8See Modification of Regulations Regarding the Practice of Accepting Bonds During the Provisional Measures Period in Antidumping and Countervailing Duty Investigations, 76 FR 61042 (October 3, 2011).

    Disclosure and Public Comment

    We will disclose to interested parties the calculations performed in this proceeding within five days of the date of announcement of this preliminary determination in accordance with 19 CFR 351.224(b). Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this proceeding.9 Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.10

    9See 19 CFR 351.309(b)(2)(c)(i).

    10See 19 CFR 351.309, see also 19 CFR 351.303 (for general filing requirements).

    Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.11 This summary should be limited to five pages total, including footnotes.

    11See 19 CFR 351.309(c)(2) and (d)(2).

    Interested parties who wish to request a hearing must do so in writing within 30 days after the publication of this preliminary determination in the Federal Register.12 Requests should contain the party's name, address, and telephone number; the number of participants; and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, at a date, time, and location to be determined. Parties will be notified of the date, time, and location of any hearing.

    12See 19 CFR 351.310(c).

    Parties must file their case and rebuttal briefs, and any requests for a hearing, electronically using ACCESS.13 Electronically-filed documents must be received successfully in their entirety by 5:00 p.m. Eastern Time on the due dates established above.14

    13See 19 CFR 351.303(b)(2)(i).

    14See 19 CFR 351.303(b)(1).

    Postponement of Final Determination and Extension of Provisional Measures

    Section 735(a)(2) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination by the Department, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination by the Department, a request for such postponement is made by the petitioner. 19 CFR 351.210(e)(2) requires that requests by respondents for postponement of a final antidumping determination be accompanied by a request for extension of provisional measures from a four-month period to a period not more than six months in duration.

    On August 8, 2016, pursuant to 19 CFR 351.210(b)(2)(ii), Petitioner and ACIT requested that the Department postpone its final determination. On August 9, 2016, Nanjing Tianyuan also requested that the Department postpone its final determination. In their respective requests for postponement, ACIT and Nanjing Tianyuan also requested that the Department extend the application of the provisional measures prescribed under section 733(d) of the Act and 19 CFR 351.210(e)(2), from a four-month period to a period not to exceed six months.

    In accordance with section 735(a)(2)(A) of the Act and 19 CFR 351.210(b)(2)(ii) and (e)(2), because (1) our preliminary determination is affirmative; (2) the requesting exporters account for a significant proportion of exports of the subject merchandise; and (3) no compelling reasons for denial exist, we are postponing the final determination and extending the provisional measures from a four-month period to a period not greater than six months. Accordingly, we will make our final determination no later than 135 days after the date of publication of this preliminary determination, pursuant to section 735(a)(2) of the Act.15

    15See 19 CFR 351.210(e).

    International Trade Commission (ITC) Notification

    In accordance with section 733(f) of the Act, we will notify the International Trade Commission (ITC) of our preliminary determination of sales at LTFV. If our final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after our final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.

    This determination is issued and published in accordance with sections 733(f) and 777(i)(I) of the Act and 19 CFR 351.205(c).

    Dated: August 24, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I—List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Period of Investigation IV. Preliminary Determination of Critical Circumstances V. Scope of the Investigation VI. Discussion of the Methodology A. Non-Market Economy Country B. Surrogate Country and Surrogate Value Comments C. Separate Rates D. The PRC-wide Entity E. Application of Facts Available and Adverse Inferences F. Date of Sale G. Comparisons to Fair Value VII. Currency Conversion VIII. Adjustment Under Section 777A(F) of the Act IX. Adjustment for Countervailable Subsidies X. Disclosure and Public Comment XI. Verification XII. Conclusion Appendix II—Scope of the Investigation

    The product covered by this investigation is woven (whether from yarns or rovings) industrial grade amorphous silica fabric, which contains a minimum of 90 percent silica (SiO2) by nominal weight, and a nominal width in excess of 8 inches. The investigation covers industrial grade amorphous silica fabric regardless of other materials contained in the fabric, regardless of whether in roll form or cut-to-length, regardless of weight, width (except as noted above), or length. The investigation covers industrial grade amorphous silica fabric regardless of whether the product is approved by a standards testing body (such as being Factory Mutual (FM) Approved), or regardless of whether it meets any governmental specification.

    Industrial grade amorphous silica fabric may be produced in various colors. The investigation covers industrial grade amorphous silica fabric regardless of whether the fabric is colored. Industrial grade amorphous silica fabric may be coated or treated with materials that include, but are not limited to, oils, vermiculite, acrylic latex compound, silicone, aluminized polyester (Mylar®) film, pressure-sensitive adhesive, or other coatings and treatments. The investigation covers industrial grade amorphous silica fabric regardless of whether the fabric is coated or treated, and regardless of coating or treatment weight as a percentage of total product weight. Industrial grade amorphous silica fabric may be heat-cleaned. The investigation covers industrial grade amorphous silica fabric regardless of whether the fabric is heat-cleaned.

    Industrial grade amorphous silica fabric may be imported in rolls or may be cut-to-length and then further fabricated to make welding curtains, welding blankets, welding pads, fire blankets, fire pads, or fire screens. Regardless of the name, all industrial grade amorphous silica fabric that has been further cut-to-length or cut-to-width or further finished by finishing the edges and/or adding grommets, is included within the scope of this investigation.

    Subject merchandise also includes (1) any industrial grade amorphous silica fabric that has been converted into industrial grade amorphous silica fabric in China from fiberglass cloth produced in a third country; and (2) any industrial grade amorphous silica fabric that has been further processed in a third country prior to export to the United States, including but not limited to treating, coating, slitting, cutting to length, cutting to width, finishing the edges, adding grommets, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the in-scope industrial grade amorphous silica fabric.

    Excluded from the scope of the investigation is amorphous silica fabric that is subjected to controlled shrinkage, which is also called “pre-shrunk” or “aerospace grade” amorphous silica fabric. In order to be excluded as a pre-shrunk or aerospace grade amorphous silica fabric, the amorphous silica fabric must meet the following exclusion criteria: (l) The amorphous silica fabric must contain a minimum of 98 percent silica (SiO2) by nominal weight; (2) the amorphous silica fabric must have an areal shrinkage of 4 percent or less; (3) the amorphous silica fabric must contain no coatings or treatments; and (4) the amorphous silica fabric must be white in color. For purposes of this scope, “areal shrinkage” refers to the extent to which a specimen of amorphous silica fabric shrinks while subjected to heating at 1800 degrees F for 30 minutes.16

    16 Areal shrinkage is expressed as the following percentage: ((Fired Area, em2−Initial Area, cm2)/Initial Area, cm2) × 100 = Areal Shrinkage, %.

    Also excluded from the scope are amorphous silica fabric rope and tubing (or sleeving). Amorphous silica fabric rope is a knitted or braided product made from amorphous silica yarns. Silica tubing (or sleeving) is braided into a hollow sleeve from amorphous silica yarns.

    The subject imports are normally classified in subheadings 7019.59.4021, 7019.59.4096, 7019.59.9021, and 7019.59.9096 of the Harmonized Tariff Schedule of the United States (HTSUS), but may also enter under HTSUS subheadings 7019.40.4030, 7019.40.4060, 7019.40.9030, 7019.40.9060, 7019.51.9010, 7019.51.9090, 7019.52.9010, 7019.52.9021, 7019.52.9096 and 7019.90.1000. HTSUS subheadings are provided for convenience and customs purposes only; the written description of the scope of this investigation is dispositive.

    [FR Doc. 2016-21095 Filed 8-31-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration Initiation of Five-Year (“Sunset”) Review AGENCY:

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

    SUMMARY:

    In accordance with section 751(c) of the Tariff Act of 1930, as amended (“the Act”), the Department of Commerce (“the Department”) is automatically initiating the five-year review (“Sunset Review”) of the antidumping and countervailing duty (“AD/CVD”) order(s) listed below. The International Trade Commission (“the Commission”) is publishing concurrently with this notice its notice of Institution of Five-Year Review which covers the same order(s).

    DATES:

    Effective Date: September 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    The Department official identified in the Initiation of Review section below at AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230. For information from the Commission contact Mary Messer, Office of Investigations, U.S. International Trade Commission at (202) 205-3193.

    SUPPLEMENTARY INFORMATION:

    Background

    The Department's procedures for the conduct of Sunset Reviews are set forth in its Procedures for Conducting Five-Year (“Sunset”) Reviews of Antidumping and Countervailing Duty Orders, 63 FR 13516 (March 20, 1998) and 70 FR 62061 (October 28, 2005). Guidance on methodological or analytical issues relevant to the Department's conduct of Sunset Reviews is set forth in 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).

    Initiation of Review

    In accordance with 19 CFR 351.218(c), we are initiating Sunset Reviews of the following antidumping and countervailing duty order(s):

    DOC case No. ITC case No. Country Product Department
  • contact
  • A-533-806 731-TA-561 India Sulfanilic Acid (4th Review) David Goldberger 202-482-4136. C-533-807 701-TA-318 India Sulfanilic Acid (4th Review) David Goldberger 202-482-4136. A-570-815 731-TA-538 PRC Sulfanilic Acid (4th Review) David Goldberger (202) 482-4136. A-588-850 731-TA-847 Japan Carbon and Alloy Seamless Standard, Line, and Pressure Pipe (Over 41/2 Inches) (3rd Review) David Goldberger (202) 482-4136. A-588-851 731-TA-847 Japan Carbon and Alloy Seamless Standard, Line, and Pressure Pipe (Under 41/2 Inches) (3rd Review) David Goldberger (202) 482-4136. A-485-805 731-TA-849 Romania Carbon and Alloy Seamless Standard, Line, and Pressure Pipe (Under 41/2 Inches) (3rd Review) David Goldberger (202) 482-4136.
    Filing Information

    As a courtesy, we are making information related to sunset proceedings, including copies of the pertinent statute and Department's regulations, the Department's schedule for Sunset Reviews, a listing of past revocations and continuations, and current service lists, available to the public on the Department's Web site at the following address: “http://enforcement.trade.gov/sunset/.” All submissions in these Sunset Reviews must be filed in accordance with the Department's regulations regarding format, translation, and service of documents. These rules, including electronic filing requirements via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”), can be found at 19 CFR 351.303.1

    1See also Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures, 76 FR 39263 (July 6, 2011).

    This notice serves as a reminder that any party submitting factual information in an AD/CVD proceeding must certify to the accuracy and completeness of that information.2 Parties are hereby reminded that revised certification requirements are in effect for company/government officials as well as their representatives in these segments.3 The formats for the revised certifications are provided at the end of the Final Rule. The Department intends to reject factual submissions if the submitting party does not comply with the revised certification requirements.

    2See section 782(b) of the Act.

    3See Certification of Factual Information To Import Administration During Antidumping and Countervailing Duty Proceedings, 78 FR 42678 (July 17, 2013) (“Final Rule”) (amending 19 CFR 351.303(g)).

    On April 10, 2013, the Department modified two regulations related to AD/CVD proceedings: The definition of factual information (19 CFR 351.102(b)(21)), and the time limits for the submission of factual information (19 CFR 351.301).4 Parties are advised to review the final rule, available at http://enforcement.trade.gov/frn/2013/1304frn/2013-08227.txt, prior to submitting factual information in these segments. To the extent that other regulations govern the submission of factual information in a segment (such as 19 CFR 351.218), these time limits will continue to be applied. Parties are also advised to review the final rule concerning the extension of time limits for submissions in AD/CVD proceedings, available at http://enforcement.trade.gov/frn/2013/1309frn/2013-22853.txt, prior to submitting factual information in these segments.5

    4See Definition of Factual Information and Time Limits for Submission of Factual Information: Final Rule, 78 FR 21246 (April 10, 2013).

    5See Extension of Time Limits, 78 FR 57790 (September 20, 2013).

    Letters of Appearance and Administrative Protective Orders

    Pursuant to 19 CFR 351.103(d), the Department will maintain and make available a public service list for these proceedings. Parties wishing to participate in any of these five-year reviews must file letters of appearance as discussed at 19 CFR 351.103(d)). To facilitate the timely preparation of the public service list, it is requested that those seeking recognition as interested parties to a proceeding submit an entry of appearance within 10 days of the publication of the Notice of Initiation.

    Because deadlines in Sunset Reviews can be very short, we urge interested parties who want access to proprietary information under administrative protective order (“APO”) to file an APO application immediately following publication in the Federal Register of this notice of initiation. The Department's regulations on submission of proprietary information and eligibility to receive access to business proprietary information under APO can be found at 19 CFR 351.304-306.

    Information Required From Interested Parties

    Domestic interested parties, as defined in section 771(9)(C), (D), (E), (F), and (G) of the Act and 19 CFR 351.102(b), wishing to participate in a Sunset Review must respond not later than 15 days after the date of publication in the Federal Register of this notice of initiation by filing a notice of intent to participate. The required contents of the notice of intent to participate are set forth at 19 CFR 351.218(d)(1)(ii). In accordance with the Department's regulations, if we do not receive a notice of intent to participate from at least one domestic interested party by the 15-day deadline, the Department will automatically revoke the order without further review.6

    6See 19 CFR 351.218(d)(1)(iii).

    If we receive an order-specific notice of intent to participate from a domestic interested party, the Department's regulations provide that all parties wishing to participate in a Sunset Review must file complete substantive responses not later than 30 days after the date of publication in the Federal Register of this notice of initiation. The required contents of a substantive response, on an order-specific basis, are set forth at 19 CFR 351.218(d)(3). Note that certain information requirements differ for respondent and domestic parties. Also, note that the Department's information requirements are distinct from the Commission's information requirements. Consult the Department's regulations for information regarding the Department's conduct of Sunset Reviews. Consult the Department's regulations at 19 CFR part 351 for definitions of terms and for other general information concerning antidumping and countervailing duty proceedings at the Department.

    This notice of initiation is being published in accordance with section 751(c) of the Act and 19 CFR 351.218(c).

    Dated: August 25, 2016. Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2016-21209 Filed 8-31-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [Application No. 14-3A004] Export Trade Certificate of Review ACTION:

    Notice of Issuance of an amended Export Trade Certificate of Review to DFA of California (“DFA”), Application No. 14-3A004.

    SUMMARY:

    The Secretary of Commerce, through the Office of Trade and Economic Analysis (“OTEA”), issued an amended Export Trade Certificate of Review to DFA of California (“DFA”) on August 8, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Joseph E. Flynn, Director, Office of Trade and Economic Analysis, International Trade Administration, by telephone at (202) 482-5131 (this is not a toll-free number) or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Title III of the Export Trading Company Act of 1982 (15 U.S.C. Sections 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. The regulations implementing Title III are found at 15 CFR part 325 (2016).

    OTEA is issuing this notice pursuant to 15 CFR 325.6(b), which requires the Secretary of Commerce to publish a summary of the certification in the Federal Register. Under Section 305(a) of the Act and 15 CFR 325.11(a), any person aggrieved by the Secretary's determination may, within 30 days of the date of this notice, bring an action in any appropriate district court of the United States to set aside the determination on the ground that the determination is erroneous.

    Description of Amended Certificate

    DFA's Export Trade Certificate of Review has been amended to make the following changes to the list of Members covered by the Certificate:

    Proposed Amendment:

    1. Change the name of existing Member Diamond Foods, Inc. to Diamond Foods, LLC.

    The Members covered by the amended Export Trade Certificate of Review are listed below:

    1. Alpine Pacific Nut Company, Hughson, CA 2. Andersen & Sons Shelling, Vina, CA 3. Avanti Nut Company, Inc., Stockton, CA 4. Berberian Nut Company, LLC, Chico, CA 5. Carriere Family Farms, Inc., Glenn, CA 6. California Almond Packers and Exporters (CAPEX), Corning CA 7. California Walnut Company, Inc., Los Molinos, CA 8. Chico Nut Company, Chico, CA 9. Continente Nut LLC, Oakley, CA 10. C. R. Crain & Sons, Inc., Los Molinos, CA 11. Crain Walnut Shelling, Inc., Los Molinos, CA 12. Crisp California Walnuts, Stratford, CA 13. Diamond Foods, LLC, Stockton, CA 14. Empire Nut Company, Colusa, CA 15. Fig Garden Packing, Inc., Fresno, CA 16. Gold River Orchards, Inc., Escalon, CA 17. Grower Direct Nut Company, Hughson, CA 18. GSF Nut Company, Orosi, CA 19. Guerra Nut Shelling Company, Hollister, CA 20. Hill View Packing Company Inc., Gustine, CA 21. Mariani Nut Company, Winters, CA 22. Mariani Packing Company, Inc., Vacaville, CA 23. Mid Valley Nut Company Inc., Hughson, CA 24. Morada Nut Company, LP, Stockton, CA 25. National Raisin Company, Fowler, CA 26. O-G Nut Company, Stockton, CA 27. Omega Walnut, Inc., Orland, CA 28. Pearl Crop, Inc., Stockton, CA 29. Poindexter Nut Company, Selma, CA 30. Prima Noce Packing, Linden, CA 31. RPC Packing Inc., Porterville, CA 32. Sacramento Packing, Inc., Yuba City, CA 33. Sacramento Valley Walnut Growers, Inc., Yuba City, CA 34. San Joaquin Figs, Inc., Fresno, CA 35. Shoei Foods USA, Inc., Olivehurst, CA 36. Stapleton-Spence Packing, Gridley, CA 37. Sun-Maid Growers of California, Kingsburg, CA 38. Sunsweet Growers Inc., Yuba City, CA 39. Taylor Brothers Farms, Inc., Yuba City, CA 40. T.M. Duche Nut Company, Inc., Orland, CA 41. Wilbur Packing Company, Inc., Live Oak, CA 42. Valley Fig Growers, Fresno, CA

    No change has been made regarding the Export Trade, Export Trade Activities or Methods of Operation covered by the Certificate.

    The amended Certificate of Review is effective from May 9, 2016, the date on which the application for an amendment was deemed submitted.

    Dated: August 26, 2016. Emily Kilcrease, Office of Trade and Economic Analysis, International Trade Administration.
    [FR Doc. 2016-21072 Filed 8-31-16; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE849 New England Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of public meeting.

    SUMMARY:

    The New England Fishery Management Council (Council, NEFMC) will hold a three-day meeting to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).

    DATES:

    The meeting will be held on Tuesday, Wednesday, and Thursday, September 20, 21, and 22, 2016. It will start at 9 a.m. on September 20; 8:30 a.m. on September 21; and at 8:30 a.m. on September 22, 2016.

    ADDRESSES:

    The meeting will be held at the DoubleTree by Hilton Hotel, 50 Ferncroft Road, Danvers, MA 01923; telephone: (978) 777-2500; online at http://doubletree3.hilton.com/en/hotels/massachusetts/doubletree-by-hilton-hotel-boston-north-shore-BOSNSDT/index.html.

    Council address: New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950; telephone: (978) 465-0492; www.nefmc.org.

    FOR FURTHER INFORMATION CONTACT:

    Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492, ext. 113.

    SUPPLEMENTARY INFORMATION: Agenda Tuesday, September 20, 2016

    After introductions and brief announcements, the meeting will begin with the swearing-in of new and reappointed Council members, followed by the annual election of officers. Next, the Council will receive reports from its Chairman and Executive Director, NMFS's Regional Administrator for the Greater Atlantic Regional Office (GARFO), liaisons from the Northeast Fisheries Science Center and Mid-Atlantic Fishery Management Council, representatives from NOAA General Counsel and the Office of Law Enforcement, and staff from the Atlantic States Marine Fisheries Commission and the U.S Coast Guard. Following these reports, the Council will receive a presentation from the NMFS Highly Migratory Species (HMS) staff on Draft Amendment 10 to the Consolidated HMS Fishery Management Plan (FMP), which addresses habitat revisions.

    After a lunch break, members of the public will be able to speak during an open comment period on issues that relate to Council business but are not included on the published agenda for this meeting. Next, the Whiting Plan Development Team (PDT) will present the 2015 Annual Monitoring Report for the small-mesh multispecies fishery, which includes red, silver, and offshore hakes. Based on the contents of this report, the Council may, if necessary, initiate a framework adjustment to modify accountability measures (AMs) in the fishery. The Council then will receive an update from its Atlantic Herring Committee about two actions that are under development: (1) Amendment 8 to the Atlantic Herring FMP, which is considering acceptable biological catch (ABC) control rules for the fishery under a management strategy evaluation (MSE) process and measures to address localized depletion; and (2) Framework Adjustment 5 to potentially modify haddock bycatch AMs in the herring midwater trawl fishery. The Council will close out the day with a report from the GARFO staff about its electronic monitoring (EM) pilot project on Atlantic herring and mackerel midwater trawl vessels to test the utility of EM for future programs.

    Wednesday, September 21, 2016

    The second day of the meeting will begin with a report from the Transboundary Resource Assessment Committee (TRAC) with results from the 2016 stock assessments for Eastern Georges Bank cod, Eastern Georges Bank haddock, and Georges Bank yellowtail flounder. The Scientific and Statistical Committee (SSC) will report next with ABC recommendations for Georges Bank yellowtail flounder, monkfish, and deep-sea red crab. Following the SSC report, the Council will hear from U.S. representatives to the Transboundary Management Guidance Committee (TMGC) and potentially approve TMGC recommendations for 2017 total allowable catches (TACs) for U.S./Canada shared stocks on Georges Bank. Next, the Council will go into its Groundfish Committee report, where it is scheduled to approve a range of alternatives for Framework Adjustment 56, including: (1) 2017 U.S./Canada specifications; (2) 2017-19 witch flounder specifications; and (3) commercial and recreational management measures for groundfish. More specifically, the management measures under consideration include: (a) Establishment of a sub-annual catch limit (sub-ACL) for northern windowpane flounder for the scallop fishery; (b) a potential increase to the sub-ACL for Georges Bank haddock for the Atlantic herring midwater trawl fishery; (c) revisions to the process for determining recreational management measures; and (d) potential modifications to Atlantic halibut measures. Finally, the Council will receive a briefing on the PDT's Groundfish Monitoring White Paper.

    The Council will take a lunch break and, if necessary, conclude any unfinished groundfish business immediately following lunch. Then it will receive a report from its Monkfish Committee, which will include an update on fishing year 2017-19 specifications and potentially lead to the initiation of a framework adjustment if the Council determines that additional management measures are warranted. Closing out the day, the Council will receive an Atlantic deep-sea red crab report and take final action on 2017-19 specifications for the fishery.

    Thursday, September 22, 2016

    The final meeting day will begin with a preliminary discussion of 2017 Council priorities. Here, the Council will review and discuss a draft list of possible actions and tasks for further development in 2017 covering all committees. The Council will not take final action on priorities until its November meeting. Next, the Council will receive an update from its Habitat Committee on the development of two actions: (1) The Omnibus Deep-Sea Coral Amendment; and (2) a Clam Dredge Framework Adjustment. The Council will hear about ongoing analyses for both actions and provide recommendations for further work. It also will review and possibly approve minor adjustments to the range of alternatives in the coral amendment. The Scallop Committee will report next with an update on Framework Adjustment 28 to the Atlantic Sea Scallop FMP. The framework includes: (1) Specifications for fishing year 2017 with default measures for 2018; (2) a measure to potentially restrict the possession of shell stock inshore of the days-at-sea demarcation line north of 42°20′ N.; (3) modifications to the process for setting scallop fishery annual catch limits; and (4) modifications to the Closed Area I Scallop Access Area boundary to be consistent with potential changes to habitat and groundfish mortality closed areas. More specifically, the 2017 specifications and 2018 default measures include: (a) Setting ABCs, ACLs, days-at-sea, and access-area allocations for both limited access (LA) and limited access general category (LAGC) vessels; (b) determining the hard TAC for the Northern Gulf of Maine Management Area; (c) setting the target TAC for the LAGC incidental catch; and (d) specifying set-aside amounts for the scallop observer and research set-aside programs.

    Following a lunch break, the Scallop Committee discussion may resume to conclude any unfinished business before the Council begins its Ecosystem-Based Fishery Management (EBFM) session. Here, the Council will receive a draft report from the EBFM PDT on a Georges Bank operating model to support the development of an example Fishery Ecosystem Plan and Management Strategy Evaluation. The Council will provide further guidance to the PDT and the EBFM Committee for additional work. Next, the Council will develop comments for NMFS on its EBFM road map. Finally, the meeting will conclude with a discussion of items under “other business.”

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

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies (see ADDRESSES) at least 5 days prior to the meeting date.

    Dated: August 26, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-21019 Filed 8-31-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE850 Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting AGENCY:

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

    ACTION:

    Notice; public meeting.

    SUMMARY:

    The Mid-Atlantic Fishery Management Council's Spiny Dogfish Monitoring Committee will hold a public meeting.

    DATES:

    The meeting will be held Friday, September 16, 2016, from 9 a.m. to 11 a.m.

    ADDRESSES:

    The meeting will be held via webinar: http://mafmc.adobeconnect.com/spinydogmc-2016/. Call-in information is provided upon logging onto the webinar.

    Council address: Mid-Atlantic Fishery Management Council, 800 N. State St., Suite 201, Dover, DE 19901; telephone: (302) 674-2331.

    FOR FURTHER INFORMATION CONTACT:

    Christopher M. Moore, Ph.D. Executive Director, Mid-Atlantic Fishery Management Council; telephone: (302) 526-5255. The Council's Web site, www.mafmc.org will also have details on the proposed agenda and briefing materials.

    SUPPLEMENTARY INFORMATION:

    The MAFMC's Spiny Dogfish Monitoring Committee will hold a public meeting to review 2017 specifications and management measures and make any appropriate recommendations. Spiny dogfish is in multi-year specifications for 2016-18 but the specifications are reviewed annually. Public comment will be taken.

    Special Accommodations

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

    Dated: August 29, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-21074 Filed 8-31-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

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

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: Alaska Saltwater Sport Fishing Economic Survey.

    OMB Control Number: 0648-0639.

    Form Number(s): None.

    Type of Request: Regular (reinstatement without change).

    Number of Respondents: 2,902.

    Average Hours per Response: Survey, 30 minutes; follow-up telephone interview, 6 minutes.

    Burden Hours: 1,374.

    Needs and Uses: This request is for a reinstatement, with changes, without change, of a previously approved information collection.

    The National Marine Fisheries Service (NMFS) previously collected survey data in 2007 and 2012 for conducting economic analyses of marine sport fishing in Alaska. These surveys were necessary to understand the factors that affect the economic value of marine recreational fishing trips and improve estimates of fishing trip values that can aid fishery managers evaluate management options pertaining to sport fisheries. The proposed survey is an update of the previously conducted surveys and is needed to improve estimates of fishing trip values potentially affected by recent changes in federal recreational fisheries off Alaska, most notably the Halibut Catch Sharing Plan (76 FR 44156) which went into effect in 2014 for the Pacific halibut fishery. Several questions in the survey have been updated to better reflect these recent fishery management changes.

    The Federal Government is responsible for the management of the Pacific halibut sport fishery off Alaska, while the State of Alaska manages the salmon sport fisheries (Chinook, coho, sockeye, chum, and pink), as well as several other saltwater sport fisheries. The updated survey's scope covers marine sport fishing for Pacific halibut, salmon, and other popular marine sport species in Alaska (e.g., lingcod and rockfish). The data collected from the survey will be used to update estimates of the demand for and value of marine fishing to anglers and to analyze how the type of fish caught, fishery regulations, and other factors affect fishing values and anglers' decisions to participate in Alaska marine fishing activities. The economic information provided from the survey will help inform fishery managers about the economic values of Alaska marine sport fisheries and the changes to participation in these fisheries with proposed regulations.

    Affected Public: Individuals or households.

    Frequency: One time.

    Respondent's Obligation: Voluntary.

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

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

    Dated: August 29, 2016. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2016-21050 Filed 8-31-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE796 Endangered and Threatened Species; Initiation of 5-Year Review for Mediterranean Monk Seal AGENCY:

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

    ACTION:

    Notice of initiation of 5-year review; request for information.

    SUMMARY:

    We, NMFS, announce a 5-year review of the Mediterranean monk seal (Monachus monachus) under the Endangered Species Act of 1973, as amended (ESA), to ensure that the listing classification of the species is accurate. The 5-year review will be based on the best scientific and commercial data available at the time of the review. Therefore, we request submission of any such information on Mediterranean monk seals that has become available since their original listing as endangered in June 1970. Based on the results of this 5-year review, we will make the requisite determination under the ESA.

    DATES:

    To allow us adequate time to conduct this review, we must receive your information no later than October 31, 2016. However, we will continue to accept new information about any listed species at any time.

    ADDRESSES:

    You may submit information on this document identified by NOAA-NMFS-2016-0104 by either of the following methods:

    Electronic submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2016-0104, click on the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    • Mail or hand-deliver written comments to Brendan Newell, NMFS Office of Protected Resources, 1315 East-West Highway, Silver Spring, MD 20910.

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

    FOR FURTHER INFORMATION CONTACT:

    Brendan Newell, NMFS Office of Protected Resources, 301-427-7710.

    SUPPLEMENTARY INFORMATION:

    Under the ESA, the U.S. Fish and Wildlife Service maintains a list of endangered and threatened wildlife and plant species at 50 CFR 17.11 (for animals) and § 17.12 (for plants). Section 4(c)(2)(A) of the ESA requires that we conduct a review of listed species at least once every five years. On the basis of such reviews under section 4(c)(2)(B), we determine whether or not any species should be delisted or reclassified from endangered to threatened or from threatened to endangered. Delisting a species must be supported by the best scientific and commercial data available and only considered if such data substantiates that the species is neither endangered nor threatened for one or more of the following reasons: (1) The species is considered extinct; (2) the species is considered to be recovered; and/or (3) the original data available when the species was listed, or the interpretation of such data, were in error. Any change in Federal classification would require a separate rulemaking process. The regulations in 50 CFR 424.21 require that we publish a notice in the Federal Register announcing those species currently under active review. This notice announces our active review of the Mediterranean monk seal currently listed as endangered (56 FR 1463; January 14, 1991).

    Background information on Mediterranean monk seals including the endangered listing is available on the NMFS Office of Protected Species Web site at: http://www.fisheries.noaa.gov/pr/species/mammals/seals/mediterranean-monk-seal.html.

    Determining if a Species Is Threatened or Endangered

    Section 4(a)(1) of the ESA requires that we determine whether a species is endangered or threatened based on one or more of the five following factors: (1) The present or threatened destruction, modification, or curtailment of its habitat or range; (2) overutilization for commercial, recreational, scientific, or educational purposes; (3) disease or predation; (4) the inadequacy of existing regulatory mechanisms; or (5) other natural or manmade factors affecting its continued existence. Section 4(b) also requires that our determination be made on the basis of the best scientific and commercial data available after taking into account those efforts, if any, being made by any State or foreign nation, to protect such species.

    Public Solicitation of New Information

    To ensure that the 5-year review is complete and based on the best available scientific and commercial information, we are soliciting new information from the public, governmental agencies, Tribes, the scientific community, industry, environmental entities, and any other interested parties concerning the status of Mediterranean monk seals. The 5-year review considers the best scientific and commercial data and all new information that has become available since the listing determination or most recent status review. Categories of requested information include: (1) Species biology including, but not limited to, population trends, distribution, abundance, demographics, and genetics; (2) habitat conditions including, but not limited to, amount, distribution, and important features for conservation; (3) status and trends of threats; (4) conservation measures that have been implemented that benefit the species, including monitoring data demonstrating effectiveness of such measures; (5) need for additional conservation measures; and (6) other new information, data, or corrections including, but not limited to, taxonomic or nomenclatural changes, identification of erroneous information contained in the list of endangered and threatened species, and improved analytical methods for evaluating extinction risk.

    If you wish to provide information for this 5-year review, you may submit your information and materials electronically or via mail (see ADDRESSES section). We request that all information be accompanied by supporting documentation such as maps, bibliographic references, or reprints of pertinent publications. We also would appreciate the submitter's name, address, and any association, institution, or business that the person represents; however, anonymous submissions will also be accepted.

    Authority:

    16 U.S.C. 1531 et seq.

    Dated: August 29, 2016. Angela Somma, Chief, Endangered Species Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-21069 Filed 8-31-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF DEFENSE Department of the Army [Docket ID: USA-2015-0018] Proposed Collection; Comment Request AGENCY:

    U.S. Army Corps of Engineers, DoD.

    ACTION:

    Notice.

    SUMMARY:

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

    DATES:

    Consideration will be given to all comments received by October 31, 2016.

    ADDRESSES:

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

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

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24, Alexandria, VA 22350-1700.

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

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

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the US Army Corps of Engineers, Institute for Water Resources, Casey Building, 8801 Telegraph Road, Alexandria VA 22315, ATTN Meredith Bridgers or call 703-428-8458.

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Recreation Use and Expenditure Survey; OMB Control Number 0710-XXXX.

    Needs and Uses: The information collection requirement is necessary to produce recreation visitation and local expenditure estimates at US Army Corps of Engineers Water Resource Projects.

    Affected Public: Individuals or households, business or other for-profit, and not-for-profit institutions.

    Annual Burden Hours: 2,115 hours.

    Number of Respondents: 19,050.

    Responses per Respondent: 1.11.

    Annual Responses: 21,146.

    Average Burden per Response: 6 minutes (0.1 hours).

    Recreation Use Survey—5 min per response. Abbreviated Bus/Bike Survey—2 minutes per response. Web-Based Follow-up Economic Survey—11 minutes per response.

    Frequency: On occasion.

    Respondents are public visitors to US Army Corps of Engineers Recreation Areas. Visitors exiting the recreation area by vehicle are stopped as potential respondents. Participation is voluntary. Respondents are asked questions in the following categories; characteristics of visit, quantity of people in the vehicle, description of overnight stay, activity participation, demographics, willingness to participate in follow-up web survey. The follow-up web survey asks questions in the following categories; total party size, trip frequency, activity equipment characteristics. Appropriate disclosures (Privacy Act Statement) may be provided to the respondent visually (in writing on paper) or orally (in spoken word by a USACE employee or representative).

    Dated: August 29, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-21089 Filed 8-31-16; 8:45 am] BILLING CODE 3710-08-P
    DEPARTMENT OF DEFENSE Office of the Secretary Notification of an Open Meeting of the National Defense University Board of Visitors (BOV) AGENCY:

    National Defense University, DoD.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    The Department of Defense is publishing this notice to announce that the following Federal Advisory Committee meeting of the National Defense University Board of Visitors (BOV) will take place.

    DATES:

    The meeting will be held on Thursday, September 29, 2016 from 12:00 p.m. to 4:00 p.m. and will continue on Friday, September 30, 2016, from 8:30 a.m. to 12:00 p.m.

    ADDRESSES:

    The Board of Visitors meeting will be held at Marshall Hall, Building 62, Room 155B, the National Defense University, 300 5th Avenue SW., Fort McNair, Washington, DC 20319-5066.

    FOR FURTHER INFORMATION CONTACT:

    The point of contact for this notice of open meeting is Ms. Joycelyn Stevens at (202) 685-0079, Fax (202) 685-3920 or [email protected]

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150. Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. The future agenda will include discussion on accreditation compliance, organizational management, strategic planning, resource management, and other matters of interest to the National Defense University. Limited space made available for observers will be allocated on a first come, first served basis. Pursuant to 41 CFR 102-3.105(j) and 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, written statements to the committee may be submitted to the committee at any time or in response to a stated planned meeting agenda by FAX or email to the point of contact person listed in FOR FURTHER INFORMATION CONTACT. (Subject Line: Comment/Statement to the NDU BOV).

    Dated: August 29, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-21075 Filed 8-31-16; 8:45 a.m.] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Navy Notice of Intent To Grant Exclusive Patent License; Microsphere Material Solutions, LLC. AGENCY:

    Department of the Navy, DoD.

    ACTION:

    Notice.

    SUMMARY:

    The invention listed below is assigned to the United States Government as represented by the Secretary of the Navy. The Department of the Navy hereby gives notice of its intent to grant to Microsphere Material Solutions, LLC., a revocable, nonassignable, exclusive license to practice in the United States, the Government-owned invention described below:

    U.S. PATENT 9,102,087 (Navy Case 103037): Issued August 11, 2015, entitled “FOAMS MADE OF AMORPHOUS HOLLOW SPHERES AND THE MANUFACTURE THEREOF”.

    DATES:

    Anyone wishing to object to the grant of this must file written objections along with supporting evidence, if any, not later than September 16, 2016.

    ADDRESSES:

    Written objections are to be filed with Naval Surface Warfare Center, Crane Div, Code OOL, Bldg. 2, 300 Highway 361, Crane, IN 47522-5001.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Christopher Monsey, Naval Surface Warfare Center, Crane Div, Code OOL, Bldg 2, 300 Highway 361, Crane, IN 47522-5001, telephone 812-854-4100.

    Authority:

    35 U.S.C. 207, 37 CFR part 404.

    Dated: August 24, 2016. N.A. Hagerty-Ford, Commander, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer.
    [FR Doc. 2016-21051 Filed 8-31-16; 8:45 am] BILLING CODE 3810-FF-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0065] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Study of the Turnaround School Leaders Program (TSLP) AGENCY:

    Department of Education (ED), Office of Planning, Evaluation and Policy Development (OPEPD).

    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 October 3, 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-0065. 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-347, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Ivy Morgan, 202-401-7767.

    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: Study of the Turnaround School Leaders Program (TSLP).

    OMB Control Number: 1875-NEW.

    Type of Review: A new information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 62.

    Total Estimated Number of Annual Burden Hours: 63.

    Abstract: The study will examine the implementation of the Turnaround School Leaders Program (TSLP) and provide information on how grantees (1) identify, develop, and support leaders and aspiring leaders of low-performing schools; (2) adjust their project plans, (3) use data to examine progress, and (4) work with project partners to meet goals. The ultimate purpose of the study is to glean specific lessons learned for turnaround leadership development (for the field), program improvement (for program staff), and program design (for policy makers). The study will include surveys of all (12) Cohort 1 grantees; case studies of seven Cohort 1 grantees, including each grantees' partners; and an analysis of extant data, including grantee applications, early outcomes data, and other relevant project-specific data.

    Dated: August 29, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-21044 Filed 8-31-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0062] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Study of School Climate Transformation Grants AGENCY:

    Department of Education (ED), Office of Planning, Evaluation and Policy Development (OPEPD)

    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 October 3, 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-0062. 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-347, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Joanne Bogart, 202-205-7855.

    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: Study of School Climate Transformation Grants.

    OMB Control Number: 1875-NEW.

    Type of Review: A new information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 89.

    Total Estimated Number of Annual Burden Hours: 127.

    Abstract: This study examines how state departments of education and school districts that have received multiple federal grants coordinate the activities across those grants. U.S. Department of Education-funded School Climate Transformation Grants aim to improve school safety by supporting schools in the implementation of an evidence-based, multi-tiered system of behavioral support. Department of Health and Human Services-supported Project AWARE grants aim to increase access to mental health services by training adults to notice signs of behavioral health distress and intervene appropriately. Department of Justice-funded School Justice Collaboration Program grants supports courts' collaboration with schools to implement diversion and similar programs to minimize juvenile detention. The study will explore the nature of coordination across grants, the perceived value of coordination, and challenges and lessons learned.

    Dated: August 29, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-21042 Filed 8-31-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Notice of Public Meeting To Summarize Public Input Received on the Design of a Consent-Based Siting Process for Spent Nuclear Fuel and High-Level Radioactive Waste Storage and Disposal Facilities AGENCY:

    Fuel Cycle Technologies, Office of Nuclear Energy, Department of Energy.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    The U.S. Department of Energy (DOE) is designing a consent-based process for siting facilities that will be a part of an integrated waste management system to transport, store, and dispose of spent nuclear fuel and high-level radioactive waste. As part of this process, the Department issued an Invitation for Public Comment in the Federal Register on December 23, 2015 and hosted eight public meetings across the United States in 2016 to get public input on the elements that should be considered in the development of a consent-based siting process. At the September 15, 2016 meeting, the Department will summarize the comments received and discuss next steps in designing a consent-based siting process. The entire meeting will be broadcast live via webstream at http://consentbasedsitingwebcast.azureWebsites.net.

    DATES:

    The meeting will take place on Thursday September 15, 2016 from 2:00-4:00 p.m. Eastern Daylight Time. Department officials will be available to discuss consent-based siting during an informal open house 30 minutes before and after the formal meeting.

    ADDRESSES:

    The meeting will be held at the Embassy Suites by Hilton Washington DC Convention Center, 900 10th St NW., Washington, DC 20001. To register for this meeting and to review the agenda for this meeting, please visit energy.gov/consentbasedsiting.

    FOR FURTHER INFORMATION CONTACT:

    Requests for further information should be sent to [email protected] or to Michael Reim at 202-586-2981. Updated information including registration links and meeting information will be posted at energy.gov/consentbasedsiting.

    Privacy Act/Publishing of Personally Identifiable Information: Data collected via the mechanisms listed above will not be protected from the public view in any way. Individual commentors' names and addresses (including email addresses) received as part of oral presentations at the public meeting will be included in the transcript of the public meeting will be published at energy.gov/consentbasedsiting.

    Issued in Washington, DC on August 23, 2016. Andrew Griffith, Associate Deputy Assistant Secretary for Fuel Cycle Technologies, Office of Nuclear Energy, Department of Energy.
    [FR Doc. 2016-21071 Filed 8-31-16; 8:45 am] BILLING CODE 6450-01-P
    ENVIRONMENTAL PROTECTION AGENCY [Docket ID No. EPA-HQ-ORD-2009-0229; FRL-9951-62-ORD] Public Comment Draft for the Integrated Risk Information System (IRIS) Assessment of Ethyl Tertiary Butyl Ether (ETBE) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of public comment period.

    SUMMARY:

    The Environmental Protection Agency (EPA) is announcing a 60-day public comment period for the draft IRIS Toxicological Review of ETBE. The draft document was prepared by the National Center for Environmental Assessment (NCEA) within EPA's Office of Research and Development (ORD).

    As outlined in the May 21, 2009, IRIS process under step 4, EPA is releasing this draft IRIS assessment for public comment and discussion at the October 26, 2016, IRIS Public Science Meeting. This draft assessment is not final, as described in EPA's information quality guidelines, and it does not represent, and should not be construed to represent Agency policy or views. EPA will consider all public comments submitted in response to this notice when revising this document.

    DATES:

    The 60-day public comment period begins September 1, 2016, and ends October 31, 2016. Comments must be received on or before October 31, 2016.

    ADDRESSES:

    The draft IRIS Toxicological Review of ETBE will be available via the internet on EPA's IRIS Web page under Recent Additions at http://www.epa.gov/iris/iris-recent-additions or the public docket at http://www.regulations.gov, Docket ID: EPA-HQ-ORD-2009-0229.

    FOR FURTHER INFORMATION CONTACT:

    For information on the public comment period, contact the ORD Docket at the EPA Headquarters Docket Center; telephone: 202-566-1752; facsimile: 202-566-9744; or email: [email protected]

    For technical information on the draft IRIS assessment ETBE, contact Dr. Keith Salazar, NCEA; telephone: 703-347-0278; or email: [email protected]

    SUPPLEMENTARY INFORMATION: I. Information About IRIS

    EPA's IRIS Program is a human health assessment program that evaluates quantitative and qualitative risk information on effects that may result from exposure to chemicals found in the environment. Through the IRIS Program, EPA provides the highest quality science-based human health assessments to support the Agency's regulatory activities and decisions to protect public health. The IRIS database contains information on chemicals that can be used to support the first two steps (hazard identification and dose-response evaluation) of the human health risk assessment process. When supported by available data, IRIS provides health effects information and toxicity values for health effects (including cancer and effects other than cancer). Government and others combine IRIS toxicity values with exposure information to characterize public health risks of chemicals; this information is then used to support risk management decisions designed to protect public health.

    II. How To Submit Technical Comments to the Docket at www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2009-0229, by one of the following methods:

    www.regulations.gov: Follow the online instructions for submitting comments.

    Email: [email protected]

    Fax: 202-566-9744.

    Mail: U.S. Environmental Protection Agency, EPA Docket Center (ORD Docket), Mail Code: 28221T, 1200 Pennsylvania Avenue NW., Washington, DC 20460. The phone number is 202-566-1752.

    Hand Delivery: The ORD Docket is located in the EPA Headquarters Docket Center, EPA West Building, Room 3334, 1301 Constitution Avenue NW., Washington, DC.

    The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is 202-566-1744. Deliveries are only accepted during the docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. If you provide comments by mail or hand delivery, please submit three copies of the comments. For attachments, provide an index, number pages consecutively with the comments, and submit an unbound original and three copies.

    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-2009-0229. Please ensure that your comments are submitted within the specified comment period. Comments received after the closing date will be marked “late,” and may only be considered if time permits. It is EPA's policy to include all comments it receives in the public docket without change and to make the comments available online at www.regulations.gov, including any personal information provided, unless a comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information through www.regulations.gov or email that you consider to be CBI or otherwise protected. The www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at www.epa.gov/epahome/dockets.htm.

    Docket: Documents in the docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other materials, such as copyrighted material, are publicly available only in hard copy. Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy at the ORD Docket in the EPA Headquarters Docket Center.

    Dated: August 19, 2016. Chris Saint, Acting Deputy Director, National Center for Environmental Assessment.
    [FR Doc. 2016-21005 Filed 8-31-16; 8:45 am] BILLING CODE 6560-50-P
    FARM CREDIT ADMINISTRATION Farm Credit Administration Board; Sunshine Act; Regular Meeting AGENCY:

    Farm Credit Administration.

    SUMMARY:

    Notice is hereby given, pursuant to the Government in the Sunshine Act, of the regular meeting of the Farm Credit Administration Board (Board).

    DATES:

    Date and Time: The regular meeting of the Board will be held at the offices of the Farm Credit Administration in McLean, Virginia, on September 8, 2016, from 9:00 a.m. until such time as the Board concludes its business.

    FOR FURTHER INFORMATION CONTACT:

    Dale L. Aultman, Secretary to the Farm Credit Administration Board, (703) 883-4009, TTY (703) 883-4056.

    ADDRESSES:

    Farm Credit Administration, 1501 Farm Credit Drive, McLean, Virginia 22102-5090. Submit attendance requests via email to [email protected] See SUPPLEMENTARY INFORMATION for further information about attendance requests.

    SUPPLEMENTARY INFORMATION:

    Parts of this meeting of the Board will be open to the public (limited space available), and parts will be closed to the public. Please send an email to [email protected] at least 24 hours before the meeting. In your email include: Name, postal address, entity you are representing (if applicable), and telephone number. You will receive an email confirmation from us. Please be prepared to show a photo identification when you arrive. If you need assistance for accessibility reasons, or if you have any questions, contact Dale L. Aultman, Secretary to the Farm Credit Administration Board, at (703) 883-4009. The matters to be considered at the meeting are:

    OPEN SESSION A. Approval of Minutes • August 11, 2016 B. New Business • Final Rule: Amendment of Freedom of Information Act (FOIA) Regulations Required by the FOIA Improvement Act of 2016 • Quarterly Report on Economic Conditions and FCS Conditions CLOSED SESSION * • Office of Examination Quarterly Report

    * Session Closed-Exempt pursuant to 5 U.S.C. Section 552b(c)(8) and (9).

    Dated: August 30, 2016. Dale L. Aultman, Secretary, Farm Credit Administration Board.
    [FR Doc. 2016-21197 Filed 8-30-16; 4:15 pm] BILLING CODE 6705-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Agency Information Collection Activities: Submission for OMB Review; Comment Request (3064-0026) AGENCY:

    Federal Deposit Insurance Corporation (FDIC).

    ACTION:

    Notice and request for comment.

    SUMMARY:

    The FDIC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on the renewal of an existing information collection, as required by the Paperwork Reduction Act of 1995. On June 10, 2016, (81 FR 37665), the Office of the Comptroller of the Currency (OCC), the Board of Governors of the Federal Reserve System (the Board) and the FDIC requested comment for 60 days on a proposal to renew the information collection described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of this collection, and again invites comment on this renewal.

    DATES:

    Comments must be submitted on or before October 3, 2016.

    ADDRESSES:

    Interested parties are invited to submit written comments to the FDIC by any of the following methods:

    http://www.FDIC.gov/regulations/laws/federal/

    Email: [email protected] Include the name of the collection in the subject line of the message.

    Mail: Manny Cabeza, (202.898.3767), Counsel, Room MB-3105, Federal Deposit Insurance Corporation, 550 17th Street NW., Washington, DC 20429.

    Hand Delivery: Comments may be hand-delivered to the guard station at the rear of the 17th Street Building (located on F Street), on business days between 7:00 a.m. and 5:00 p.m.

    All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.

    FOR FURTHER INFORMATION CONTACT:

    Manny Cabeza, at the FDIC address above.

    SUPPLEMENTARY INFORMATION:

    Proposal to renew the following currently-approved collection of information:

    Title: Uniform Interagency Transfer Agent Registration and Amendment Form.

    OMB Number: 3064-0026.

    Form Number: Form TA-1.

    Affected Public: Private sector, insured state nonmember banks and state savings associations.

    Frequency of Response: On occasion.

    Estimated Number of Respondents: Registration—2; amendments—10.

    Estimated Average Time per Response: Registrations—1.25 hours; amendments—10 minutes.

    Estimated Total Annual Burden: 4.667 hours.

    General Description: Section 17A(c) of the Security Exchange Act of 1934 (the Act) requires all transfer agents for securities registered under section 12 of the Act or, if the security would be required to be registered except for the exemption from registration provided by Section 12(g)(2)(B) or Section 12(g)(2)(G), to “fil[e] with the appropriate regulatory agency . . . an application for registration in such form and containing such information and documents . . . as such appropriate regulatory agency may prescribe as necessary or appropriate in furtherance of the purposes of this section.” 1 In general, an entity performing transfer agent functions for a security is required to register with its appropriate regulatory agency (“ARA”) if the security is registered on a national securities exchange or if the issuer of the security has total assets exceeding $10 million and a class of equity security held of record by 2,000 persons or, for an issuer that is not a bank, BHC, or SLHC, by 500 persons who are not accredited investors.2 The Board's Regulation H (12 CFR 208.31(a)) and Regulation Y (12 CFR 225.4(d)), the OCC's 12 CFR 9.20, and the FDIC's 12 CFR part 341 implement these provisions of the Act.

    1 15 U.S.C. 78q-1.

    2 15 U.S.C. 78l(g)(1).

    To accomplish the registration of transfer agents, Form TA-1 was developed in 1975 as an interagency effort by the Securities and Exchange Commission (SEC) and the agencies. The agencies primarily use the data collected on Form TA-1 to determine whether an application for registration should be approved, denied, accelerated or postponed, and they use the data in connection with their supervisory responsibilities.

    Request for Comment

    Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

    Dated at Washington, DC, this 29th day of August, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-21054 Filed 8-31-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of the Termination of the Receivership of 10500—Slavie Federal Savings Bank Bel Air, Maryland

    Notice is hereby given that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for Slavie Federal Savings Bank, Bel Air, Maryland (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of Slavie Federal Savings Bank on May 30, 2014. The liquidation of the receivership assets has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

    Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.

    No comments concerning the termination of this receivership will be considered which are not sent within this time frame.

    Dated: August 29, 2016. Robert E. Feldman, Executive Secretary, Federal Deposit Insurance Corporation.
    [FR Doc. 2016-21053 Filed 8-31-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL MARITIME COMMISSION Notice of Agreements Filed

    The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the Federal Register. Copies of the agreements are available through the Commission's Web site (www.fmc.gov) or by contacting the Office of Agreements at (202)-523-5793 or [email protected]

    Agreement No.: 011730-006.

    Title: GWF/Dole Space Charter and Sailing Agreement.

    Parties: Dole Ocean Cargo Express, Inc. and Great White Fleet Liner Services Ltd.

    Filing Party: Wade S. Hooker, Esq., 211 Central Park West, New York, NY 10024.

    Synopsis: The amendment updates the address of one of the parties, Great White Fleet Liner Services Ltd.

    Agreement No.: 012178-002.

    Title: GWF/Crowley Space Charter Agreement.

    Parties: Great White Fleet Liner Services Ltd. and Crowley Latin American Services, LLC.

    Filing Party: Wade S. Hooker, Esquire, 211 Central Park W., New York, N.Y. 10024.

    Synopsis: The amendment changes the address of Great White Fleet Liner Services.

    Agreement No.: 012435.

    Title: CMA CGM/HLAG U.S.-West Med Slot Sale Arrangement.

    Parties: Hapag-Lloyd AG and CMA CGM S.A.

    Filing Party: Wayne Rohde, Esq., Cozen O'Connor, 1200 Nineteenth Street NW., Washington, DC 20036.

    Synopsis: The Agreement authorizes CMA CGM to sell space to Hapag Lloyd in the trade from Italy and Spain to ports in Mexico, Jamaica and on the U.S. Gulf Coast.

    By Order of the Federal Maritime Commission.

    Dated: August 26, 2016. Karen V. Gregory, Secretary.
    [FR Doc. 2016-20999 Filed 8-31-16; 8:45 am] BILLING CODE 6731-AA-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 September 29, 2016.

    A. Federal Reserve Bank of St. Louis (David L. Hubbard, Senior Manager) P.O. Box 442, St. Louis, Missouri 63166-2034. Comments can also be sent electronically to [email protected]:

    1. Monticello Bankshares, Inc., Monticello, Kentucky; to merge with Banco Harlan, Inc., Harlan, Kentucky, and thereby indirectly acquire The Bank of Harlan, Harlan, Kentucky.

    Board of Governors of the Federal Reserve System, August 29, 2016. Michele Taylor Fennell, Assistant Secretary of the Board.
    [FR Doc. 2016-21081 Filed 8-31-16; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than September 16, 2016.

    A. Federal Reserve Bank of Atlanta (Chapelle Davis, Assistant Vice President) 1000 Peachtree Street NE., Atlanta, Georgia 30309. Comments can also be sent electronically to [email protected]:

    1. Larry Ernest Cheek, Carol T. Cheek, Dover and Cheek, Inc., and Judd Cheek, all Buford, Georgia, and Carmen Cheek, Gainesville, Georgia; to retain the outstanding shares of Peoples BankTrust, Inc., and thereby indirectly retain, Peoples Bank & Trust Company, both of Buford, Georgia.

    B. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:

    1. The Stephen L. LaFrance, Jr. GW Investments Trust, the Jason P. LaFrance GW Investments Trust, the Amy Beth LaFrance GW Investments Trust, all of Little Rock, Arkansas, Stephen L. LaFrance, Jr., Little Rock, Arkansas, as trustee of the Stephen L. LaFrance, Jr. GW Investments Trust and co-trustee of the Jason P. LaFrance GW Investments Trust, and Jason P. LaFrance, Little Rock, Arkansas, as co-trustee of the Jason P. LaFrance GW Investments Trust and as trustee of the Amy Beth LaFrance GW Investments Trust and the Amy LaFrance Bancroft GW Investments Revocable Trust, Little Rock, Arkansas; to acquire voting shares of Greenwoods Financial Group, Inc., Lake Mills, Wisconsin, and thereby join the existing LaFrance Family Control Group that was approved to acquire 10 percent or more of the outstanding shares of Greenwoods Financial Group, Inc. Greenwoods Financial Group, Inc. controls The Greenwood's State Bank, Lake Mills, Wisconsin.

    Board of Governors of the Federal Reserve System, August 26, 2016. Michele Taylor Fennell, Assistant Secretary of the Board.
    [FR Doc. 2016-21009 Filed 8-31-16; 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 September 26, 2016.

    A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:

    1. Canadian Imperial Bank of Commerce, Toronto, Canada and its wholly-owned subsidiary, CIBC Holdco Inc., New York, New York; to acquire PrivateBancorp, Inc. and thereby indirectly acquire The PrivateBank and Trust Company, both in Chicago, Illinois.

    Board of Governors of the Federal Reserve System, August 26, 2016. Michele Taylor Fennell, Assistant Secretary of the Board.
    [FR Doc. 2016-21010 Filed 8-31-16; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Request for Nominations of Candidates To Serve on the Advisory Committee to the Director, Centers for Disease Control and Prevention (ACD, CDC)—Health Disparities Subcommittee (HDS)

    The Centers for Disease Control and Prevention (CDC) is soliciting nominations for possible membership on the ACD, CDC-HDS. This subcommittee consists of up to 16 experts in fields related to health policy, public health, global health, preparedness, preventive medicine, the faith-based and community-based sector, and allied fields who are selected by the CDC. The HDS provides interdisciplinary perspectives and subject matter expertise to the goal of reducing health disparities which may include research, program and policy analyses, and other developmental activities for the ACD, CDC on CDC's efforts to address health disparities which is integral to achieving the agency's overarching health impact goals. Specifically, the HDS will submit work products to the ACD, CDC for deliberation, discussion, and decision.

    Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishment of the subcommittee's mission. Nominees will be selected by the Designated Federal Officer of the ACD, CDC. Members may be invited to serve for terms of up to three years.

    The U.S. Department of Health and Human Services policy stipulates that committee membership shall be balanced in terms of professional training and background, points of view represented, and the committee's function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Subcommittee members are Special Government Employees, requiring the filing of financial disclosure reports at the beginning and annually during their terms.

    Note that the need for different expertise varies from year to year and a candidate who is not selected in one year may be reconsidered in a subsequent year.

    Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Candidates should submit the following items:

    Current curriculum vitae, including complete contact information (telephone numbers, mailing address, email address).

    At least one letter of recommendation from person(s) not employed by the U.S. Department of Health and Human Services. (Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by an HHS agency (e.g., CDC, NIH, FDA, etc.).

    Nomination materials must be date stamped by midnight on September 30, 2016 and sent to: [email protected] or to Tracie Strength, Office of the Chief of Staff, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop D14, Atlanta, Georgia 30329. Please direct questions to Tracie Strength at (404)498-6482.

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention (CDC).
    [FR Doc. 2016-21039 Filed 8-31-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Tribal Consultation Meetings AGENCY:

    Office of Head Start (OHS), Administration for Children and Families, Department of Health and Human Services.

    ACTION:

    Notice of meeting.

    SUMMARY:

    Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of a 1-day Tribal Consultation Session to be held between the Department of Health and Human Services (HHS), Administration for Children and Families, OHS leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)].

    DATES:

    October 19, 2016, from 8:00 a.m. to 1:00 p.m.

    LOCATION:

    ThrivAlaska Head Start Center at 1949 Gilliam Way, Fairbanks, Alaska 99701.

    FOR FURTHER INFORMATION CONTACT:

    Angie Godfrey, Regional Program Manager, Region XI AI/AN, OHS, email [email protected], or phone (202) 205-5811. Additional information and online meeting registration is available at: http://eclkc.ohs.acf.hhs.gov/hslc/hs/calendar/tc2016.

    SUPPLEMENTARY INFORMATION:

    HHS announces OHS Tribal Consultations for leaders of Tribal Governments operating Head Start and Early Head Start programs. The agenda for the scheduled OHS Tribal Consultations in Fairbanks, Alaska, will be organized around the statutory purposes of Head Start Tribal Consultations related to meeting the needs of American Indian and Alaska Native children and families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in that geographic location. In addition, OHS will share actions taken and in progress to address the issues and concerns raised in the 2016 OHS Tribal Consultation.

    The Consultation Session will be conducted with elected or appointed leaders of Tribal Governments and their designated representatives [42 U.S.C. 9835, Section 640(l)(4)(A)]. Designees must have a letter from the Tribal Government authorizing them to represent the tribe. Tribal Governments must submit the designee letter at least 3 days in advance of the Consultation Session to Angie Godfrey at [email protected] Other representatives of tribal organizations and Native nonprofit organizations are welcome to attend as observers.

    A detailed report of the Consultation Session will be prepared and made available within 45 days of the Consultation Session to all Tribal Governments receiving funds for Head Start and Early Head Start programs. Tribes wishing to submit written testimony for the report should send testimony to Angie Godfrey at [email protected] either prior to the Consultation Session or within 30 days after the meeting. OHS will summarize oral testimony and comments from the Consultation Session in a report without attribution, along with topics of concern and recommendations.

    Dated: August 26, 2016. Blanca E. Enriquez, Director, Office of Head Start.
    [FR Doc. 2016-21047 Filed 8-31-16; 8:45 am] BILLING CODE 4184-40-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Announcement of the Award of Single-Source Grants Under the Wilson-Fish Alternative Program (W-F); Correction; CFDA Number: 93.583 AGENCY:

    Office of Refugee Resettlement, ACF, HHS.

    ACTION:

    Notice; correction.

    SUMMARY:

    The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), published a document in the Federal Register of August 22, 2016, concerning the announcement of the award of 13 single-source grants for a total of $35,513,938 under the W-F Alternative Program. The document contained an incorrect address and telephone number.

    FOR FURTHER INFORMATION CONTACT:

    Colleen Mahar-Piersma, Program Analyst, Office of Refugee Resettlement, Mary E. Switzer Building, 330 C Street SW., Washington, DC 20201. Telephone: 202-205-5266; Email: [email protected]

    Correction

    In the Federal Register of August 22, 2016, in FR Doc. 2016-19923, on page 56655, in the third column, correct the FOR FURTHER INFORMATION CONTACT caption to read: Colleen Mahar-Piersma, Program Analyst, Office of Refugee Resettlement, Mary E. Switzer Building, 330 C Street SW., Washington, DC 20201. Telephone: 202-205-5266; Email: [email protected]

    Mary M. Wayland, Senior Grants Policy Specialist, Division of Grants Policy, Office of Administration.
    [FR Doc. 2016-21038 Filed 8-31-16; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee, Renewal AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; renewal of advisory committee.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the renewal of the Cardiovascular and Renal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Cardiovascular and Renal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until August 27, 2018.

    DATES:

    Authority for the Cardiovascular and Renal Drugs Advisory Committee will expire on August 27, 2016, unless the Commissioner formally determines that renewal is in the public interest.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Cardiovascular and Renal Drugs Advisory Committee. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Cardiovascular and Renal Drugs Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility.

    The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cardiovascular and renal disorders and makes appropriate recommendations to the Commissioner of Food and Drugs.

    The Committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics. Members will be invited to serve for overlapping terms of up to four years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests.

    Further information regarding the most recent charter and other information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ucm094743.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

    This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: August 26, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-21041 Filed 8-31-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] The Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program; Public Workshop AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshop.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing a public workshop entitled “The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program.” The purpose of the workshop is to describe the Sentinel Initiative and PRISM program, illustrate how PRISM is used by FDA for regulatory responsibilities (including how it has been integrated into FDA's regulatory review process and case examples), and discuss the future direction of PRISM in terms of expansion and further integration into the regulatory review process.

    DATES:

    The public workshop will be held on December 7, 2016, from 8:30 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information.

    ADDRESSES:

    The public workshop will be held at the National Institutes of Health, 8600 Rockville Pike, Lister Hill Center Auditorium, Building 38A, Bethesda, MD 20894.

    FOR FURTHER INFORMATION CONTACT:

    Chris Nguyen, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 4124, Silver Spring, MD 20993-0002; or Cynthia Whitmarsh, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 4122, Silver Spring, MD 20993-0002: For questions, email: [email protected] (Subject Line: Sentinel PRISM Workshop).

    SUPPLEMENTARY INFORMATION:

    The Sentinel Initiative is FDA's national electronic surveillance system for the post-market safety monitoring of medical products. The Sentinel System was implemented as an Active Post-Market Risk Identification and Analysis program in response to section 905 of the Food and Drug Administration Amendments Act of 2007. PRISM was initiated in 2009 as one of several national vaccine safety surveillance systems deployed during the H1N1 influenza pandemic. PRISM was integrated into the FDA Sentinel Initiative in September 2010. PRISM has been used on multiple occasions to evaluate for vaccine-adverse events, such as the risk of intussusception following rotavirus vaccination, and the risk of febrile seizure among children receiving the trivalent inactivated influenza vaccine.

    The PRISM distributed database covers more than 171 million individuals in a number of data partner organizations. The database is enhanced by linkages to State-wide registries and birth registries. PRISM is being used to develop broad-based signal detection tools that can be used to further evaluate vaccine safety. There are currently several active vaccine protocol-based assessments underway. More information can be found at: http://www.mini-sentinel.org/assessments/medical_events/default.aspx.

    The workshop will bring together other government agencies, academia, industry, and other stakeholder participants involved in vaccine development and safety. The goal of the workshop is to present and discuss the current capabilities of PRISM. Topics include: (1) The available data infrastructure, (2) methods, and (3) tools. In addition, a few representative examples of PRISM studies will be presented to demonstrate the program's success in safety signal refinement and evaluation and informing the regulatory process. There will also be a discussion of possible future directions for PRISM.

    Registration: Please visit the following Web site to register for the workshop by November 23, 2016, midnight Eastern Standard Time: https://www.eventbrite.com/e/the-sentinel-post-licensure-rapid-immunization-safety-monitoring-prism-system-public-workshop-tickets-22494636062. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registrants will receive confirmation once they have been accepted. FDA may limit the number of participants from each organization based on space limitations. Registration on the day of the public meeting will be provided on a space available basis beginning at 8:30 a.m. Those who are unable to attend the meeting in person can register to view a live Web cast of the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the Web cast. FDA will post the agenda approximately 5 days before the workshop at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm490175.htm.

    If you need special accommodations because of disability, please contact Chris Nguyen (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting.

    Transcripts: Please be advised that as soon as possible after a transcript of the public workshop is available, it will be accessible at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm490175.htm.

    Dated: August 26, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-21046 Filed 8-31-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1660] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; establishment of a public docket; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

    DATES:

    The meeting will be held on October 5, 2016, from 8 a.m. to 6 p.m.

    ADDRESSES:

    Gaithersburg Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD 20879. The hotel's telephone number is 301-948-8900. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.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-1660 for “Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” 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:

    Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2648, Silver Spring, MD 20993, [email protected], 301-796-0400, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: On October 5, 2016, during session I, the topic to be addressed will be reclassification of quantitative Cytomegalovirus (CMV) viral load devices from class III (Premarket approval) to class II (510(k)). A nucleic acid-based in vitro diagnostic device for the quantitation of CMV viral load, within the context of transplant patient management, is a post-amendment device classified into class III under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)). To date, the following product code has been established for CMV viral load devices: PAB (Cytomegalovirus (CMV) DNA Quantitative Assay). During session II, the topics to be addressed include appropriate initial classification for qualitative or quantitative viral load devices for Epstein-Barr virus (EBV), BK virus (BK), JC virus (JCV), Human Herpesvirus 6 (HHV6), and Adenovirus infections. FDA is seeking expert recommendations to assess the potential risks and benefits of these devices when used in patients following solid-organ or stem cell transplantation.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 29, 2016. Oral presentations from the public will be scheduled on October 5, 2016, between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 21, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 22, 2016.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA is establishing a docket for public comment on this document. The docket number is FDA-2016-N-1660. The docket will close on November 9, 2016. Comments received on or before September 21, 2016, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency.

    For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Artair Mallett at [email protected] or 301-796-9638, at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: August 26, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-21045 Filed 8-31-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee, Renewal AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; renewal of advisory committee.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Endocrinologic and Metabolic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until August 27, 2018.

    DATES:

    Authority for the Endocrinologic and Metabolic Drugs Advisory Committee will expire on August 27, 2016, unless the Commissioner formally determines that renewal is in the public interest.

    FOR FURTHER INFORMATION CONTACT:

    LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, [email protected]

    SUPPLEMENTARY INFORMATION:

    Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Endocrinologic and Metabolic Drugs Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility.

    The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders, and makes appropriate recommendations to the Commissioner of Food and Drugs.

    The Committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of endocrinology, metabolism, epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests.

    Further information regarding the most recent charter and other information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm100261.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

    This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: August 26, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-21040 Filed 8-31-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Office of Public Health Support; Division of Planning, Evaluation & Research; National Native Health Research Training Initiative

    Announcement Type: New.

    Funding Announcement Number: HHS-2017-IHS-DPER-001.

    Catalog of Federal Domestic Assistance Number: 93.933.

    Key Dates:

    Application Deadline Date: October 30, 2016.

    Approximate Review Date: November 2-4, 2016.

    Earliest Anticipated Start Date: November 15, 2016.

    Proof of Non-Profit Status Due Date: October 30, 2016.

    I. Funding Opportunity Description Statutory Authority

    The Indian Health Service (IHS) Office of Public Health Support (OPHS), Division of Planning, Evaluation and Research (DPER), is accepting applications for one new cooperative agreement for the National Native Health Research Training Initiative. This initiative will help build capacity and disseminate new and best practices for American Indian and Alaska Native (AI/AN) health research and promote Tribally-driven research activity through a variety of educational and training opportunities. Focus will be on the promotion of health research and related opportunities for AI/AN students, highlighting promising practices and practice-based approaches to improving the health of AI/AN people, and culture-based approaches to reducing health disparities between AI/AN people and the U.S. population. Other areas will focus on resilience and protective factors and their role in AI/AN health outcomes, innovative and culturally-based approaches to improving the health of AI/AN youth, and dissemination of study findings in AI/AN health science research to investigators and providers working in or with Tribal communities as well as Tribal leaders and health officials. Activities will include the planning, coordination, and hosting of research meetings and conferences, webinars, hosting of a Web site/Web page for dissemination of AI/AN health science research information, and other activities to be determined. This IHS activity is authorized under the Snyder Act, codified at 25 U.S.C. 13; the Transfer Act, codified at 42 U.S.C. 2001; the Consolidated Appropriations Act, 2012, Public Law 112-74 and the Continuing Appropriations Resolution, 2013, Public Law 112-175. This program is described in the Catalog of Federal Domestic Assistance under 93.933.

    Background

    The AI/AN populations have long experienced poorer health status compared to other Americans. Although major gains in reducing health disparities were made during the last half of the twentieth century, most gains stopped by the mid-1980s (Trends in Indian Health 1998-99) and a few diseases, e.g., diabetes, worsened. “All Indian” rates contain marked variation among the “IHS Areas” or regions (Regional Differences in Indian Health 2002-2003); variation by Tribe exists within Areas as well. The Trends and Regional Differences reference can be found on the IHS Web site at http://www.ihs.gov/dps/publications/. The daunting task confronting Tribes, research scientists, and health programs is to reduce the disparities among and within areas and Tribes. Factors known to contribute to health status and disparities are complex, and include underlying biology, physiology, and epigenetics, as well as ethnicity, culture, socioeconomic status, gender/sex, age, geographical access to care, and levels of insurance.

    Additional factors known to contribute to health status and disparities include:

    1. Family, home, and work environments;

    2. general or culturally specific health practices;

    3. social support systems;

    4. lack of access to culturally-appropriate health care; and

    5. attitudes and beliefs about health.

    Health disparities of AI/ANs may also reflect a lack of in depth research relevant to improving their health status. Many AI/ANs also distrust research for historical reasons. One approach that combats this distrust is to ensure that Tribes are managing partners in training and research that involves them, as for example in community-based participatory research (CBPR) (i.e., a collaborative research process between researchers and community representatives). This approach is especially helpful to design both training relevant to researchers from Tribal communities and research relevant to health needs of the communities. Another approach is increasing the number of AI/AN scientists and growing the intellectual community of researchers working with AIAN health research issues.

    DPER has the responsibility of promoting health research to help improve the health status of AI/ANs. The development of AI/AN scientists and scientist-practitioners and enhancing the ability of Tribes to participate in and initiate their own research projects is a key part of improving quality and delivery of health services. Scientific meetings, conferences, and other training opportunities will support AI/AN faculty and student development and promote participatory collaboration between Tribes and the academic community. Such meetings and other educational approaches will provide opportunities for Tribes and the academic community to learn about resilience and protective factors and their role in AI/AN health outcomes, culture-based prevention, intervention, and treatment modalities, and other research that may help improve health outcomes.

    Objectives

    A. To increase opportunities for AI/AN scientists and health professionals—Offering development and training opportunities to AI/AN scientists, students, and health professionals and to provide a means for the dissemination of biomedical, clinical, behavioral and health science research that is responsive to the needs of the AI/AN community and the goals of this initiative. The grantee will develop regular (at least annual) conference training and practice sharing opportunities for scientists, students, and health professionals to learn and share findings from scientifically meritorious research projects as well as exploration of methods for further study and evaluation of practice-based projects. The grantee will also support health science education and professional development projects designed to introduce and further develop research skills of AI/AN students, faculty, health professionals, and community members.

    B. To enhance Tribal-academic collaborations and improve the ability of Tribes to utilize research findings—Recent CBPR projects suggests that AI/AN communities can work collaboratively with health researchers to further the research needs of AI/ANs. Fully utilizing all cultural and scientific knowledge, strengths, and competencies, such partnerships can lead to better understanding of the biological, genetic, behavioral, psychological, cultural, social, and economic factors affecting health status of AI/ANs and support the development and evaluation of interventions to improve their health status. The grantee will develop training opportunities to inform and educate Tribal leaders and health personnel about health research methods, findings, and best practices in partnering with academic investigators in pursuit of research projects designed to meet the needs and advance the health care of AI/AN communities.

    C. To reduce health disparities—Research suggests that enhancing protective factors can be as effective as reducing risk factors in improving health outcomes, particularly among AI/ANs. A better understanding of protective factors among AI/ANs could be helpful in reducing health disparities. Anecdotal evidence suggests that AI/AN ceremonial and other cultural practices may help to ameliorate major harms and disruptions over the centuries. The grantee will promote health research methods designed to better understand the protective effects of Traditional Indian Medicine, Indigenous Knowledge, Traditional Ecological Knowledge, et al., on AI/AN health. The grantee will also identify and disseminate examples of successful co-delivery of Traditional cultural practices with western biomedical services.

    The annual conference will provide critical exposure to health research opportunities for both students and researchers. The applicant must provide opportunities for potential and new AI/AN students to learn the fundamentals of health research, provide exposure to cutting-edge research, and interaction with established AI/AN scientists to explore mentorship and funding opportunities. Mentorship is vital to success in the research field, especially for AIAN students, and mentorship is often not available at the geographic location where the student is enrolled. Therefore it is paramount that this opportunity occurs at least annually. New scientific research funding opportunities that become available will be explored and wide dissemination of this information will be given to Tribes, Tribal organizations, and Tribal-academic partnerships so they will have the opportunity to apply for this kind of funding.

    Purpose

    The purpose of this cooperative agreement is to fund a national membership organization of AI/AN scientists and/or researchers and students to further the IHS research program objectives with expanded outreach and education efforts for AI/AN students, faculty, and health professionals. This announcement requests applications to propose activities including, but not limited to, an annual national training opportunity in health research methods and findings of importance to AI/AN people and communities. Other activities may also be considered in coordination with the main annual event. This is an important annual event that will bring together health researchers and key stakeholders to share recent research findings, learn new research methodologies and best practices in service delivery, and learn about human research protections and opportunities for research funding. The annual research training event will be the primary event for AI/AN researchers and students to present their findings and obtain feedback from other researchers as well as Tribal health professionals. Students also have the opportunity to select and begin working with new mentors. This event will be held by a national membership organization of AI/AN scientists and/or researchers in collaboration with IHS in facilitating a forum designed to improve the health research capacity of AI/AN Tribes and researchers. The organization and continuity of annual national training events is vital to the morale of the health research and larger health professional field working for the benefit of the Tribes and other (including urban) AI/AN people.

    Pre-Conference Grant Requirements

    The awardee is required to comply with the “HHS Policy on Promoting Efficient Spending: Use of Appropriated Funds for Conferences and Meeting Space, Food, Promotional Items, and Printing and Publications,” dated December 16, 2013 (“Policy”), as applicable to conferences funded by grants and cooperative agreements. The Policy is available at http://www.hhs.gov/grants/contracts/contract-policies-regulations/conference-spending/.

    The awardee is required to:

    Provide a separate detailed budget justification and narrative for each conference anticipated. The cost categories to be addressed are as follows: (1) Contract/Planner, (2) Meeting Space/Venue, (3) Registration Web site, (4) Audio Visual, (5) Speakers Fees, (6) Non-Federal Attendee Travel, (7) Registration Fees, (8) Other (explain in detail and cost breakdown). For additional questions please contact Mose Herne on (301) 443-1549 or email him at [email protected]

    II. Award Information Type of Award

    Cooperative Agreement.

    Estimated Funds Available

    The total amount of funding identified for the current fiscal year (FY) 2017 is approximately $225,000. The award amount is anticipated to be between $100,000 and $225,000. The amount of funding available for competing and continuation awards issued under this announcement are subject to the availability of appropriations and budgetary priorities of the Agency. The IHS is under no obligation to make awards that are selected for funding under this announcement.

    Anticipated Number of Awards

    One award will be issued under this program announcement.

    Period of Performance

    The project period is for five years and will run consecutively from November 15, 2016 to November 14, 2021.

    Cooperative Agreement

    Cooperative agreements awarded by the HHS are administered under the same policies as a grant. However, the funding agency (IHS) is required to have substantial programmatic involvement in the project during the entire award segment. Below is a detailed description of the level of involvement required for both IHS and the grantee. IHS will be responsible for activities listed under section A and the grantee will be responsible for activities listed under section B as stated:

    Substantial Involvement Description for Cooperative Agreement A. IHS Programmatic Involvement

    The IHS assigned program official will monitor the overall progress of the awardee's execution of the requirements of the award as well as their adherence to the terms and conditions of the cooperative agreements. This includes providing guidance for required reports, development of agendas, tools and other products, and technical assistance with evaluation and overcoming any performance issues encountered. The IHS assigned program official must approve all presentations, electronic content, and other materials, including mass emails, developed by awardee pursuant to these awards and any supplemental awards prior to the presentation or dissemination of such materials to any party.

    IHS staff will provide support for the award as follows:

    i. The IHS assigned program official will work in partnership with the awardee in all decisions involving strategy, hiring of grantee personnel, deployment of resources, release of public information materials, quality assurance, coordination of activities, any training, reports, budget, and evaluation. Collaboration includes agenda setting, analysis, and reporting.

    ii. The IHS assigned program official will work closely with all participating IHS health services/programs, as appropriate, to coordinate award activities.

    iii. The IHS assigned program official will coordinate the following:

    • Discussion and release of any and all special grant conditions upon fulfillment.

    • Monthly scheduled conference calls.

    • Appropriate dissemination of required reports to each participating program.

    iv. The IHS will, jointly with the awardee, plan and set an agenda for each of the conference(s) mentioned in this announcement that:

    • Shares the training and/or accomplishments.

    • Fosters collaboration amongst the participating program offices, agencies, and/or departments.

    • Increases visibility for the partnership between the awardee and the IHS.

    v. IHS will provide guidance in addressing deliverables and requirements.

    vi. IHS will provide guidance in preparing articles for publication and/or presentations of program successes, lessons learned, and new findings.

    vii. IHS will communicate via monthly conference calls, individual or collective site visits, and meetings.

    viii. IHS will provide technical assistance to the entity as requested.

    ix. IHS staff may, at the request of the entity's board, participate on committees and may recommend topics for discussion.

    B. Grantee Cooperative Agreement Award Activities

    The awardee is responsible for the following:

    i. To succinctly and independently address the requirements for the award.

    ii. To facilitate a forum or forums at which concerns can be heard that are representative of Tribal governments in the area of health research.

    iii. To establish relationships with other national Indian organizations, with professional groups, and with Federal, State, and local entities and universities or medical centers supportive of AI/AN health research programs.

    iv. To improve and expand access for AI/AN Tribal governments to health research programs within HHS.

    v. To disseminate timely health research information to Tribal governments, AI/AN health boards, other national Indian organizations, professional groups, Federal, State, and local entities.

    vi. To reach out to and educate academic and research institutions, and Federal, state and local agencies on the needs and procedures for the conduct of health research in Indian Country, and to promote the academic recognition of the rights of Tribal governments to control their own research and to own their research data.

    vii. To establish an appropriate standard of practice for health research concerning AI/AN that addresses the relationship between academic freedom, government procedures, and Tribal rights.

    viii. Attendance at regularly scheduled meetings between awardee and the IHS assigned program official, evidenced by meeting minutes which highlight the awardee's specific involvement and participation.

    ix. The annual national research conference and other training activities as proposed by the grantee and approved by the program official.

    x. Copies of all promotional and educational materials provided to Tribal programs and other projects (electronic form and one hard copy).

    xi. Copies of all promotional materials provided to media and other outlets (electronic form and one hard copy).

    xii. Copies of all articles published (electronic form and one hard copy).

    xiii. Evidence of posting of conference and training-related information on organizational Web site(s).

    xiv. Workshops

    • The awardee may provide teleconference and/or webinar workshops on health research, subject to approval from the IHS assigned program official.

    • The awardee shall conduct workshops and/or presentations including, but not limited to, challenges, potential solutions, and successes in the form of promising practices of health research at one national conference (venue and content of presentations to be agreed upon by the awardee and the IHS assigned program official).

    III. Eligibility Information 1. Eligibility

    To be eligible for this “New Competition” under this announcement, an applicant must:

    • Be 501(c)(3) non-profit entities that are national membership organizations of AI/AN health researchers or scientists.

    Organizations claiming non-profit status must submit a copy of the 501(c)(3) Certificate with your application submission by the Application Deadline Date listed under Key Dates on page one of this announcement.

    • Demonstrate organizational expertise and successful experience in:

    ○ Conducting previous national research or scientific conferences.

    ○ Promoting and supporting AI/AN health research and science education and training.

    ○ Providing evidence of at least five years of successful experience providing health research and science education and outreach on a national scale.

    Note:

    Please refer to Section IV.2 (Application and Submission Information/Subsection 2, Content and Form of Application Submission) for additional proof of applicant status documents required such as Tribal resolutions, proof of non-profit status, etc.

    2. Cost Sharing or Matching

    The IHS does not require matching funds or cost sharing for grants or cooperative agreements.

    3. Other Requirements

    If application budgets exceed the highest dollar amount outlined under the “Estimated Funds Available” section within this funding announcement, the application will be considered ineligible and will not be reviewed for further consideration. If deemed ineligible, IHS will not return the application. The applicant will be notified by email by the Division of Grants Management (DGM) of this decision.

    Proof of Non-Profit Status

    Organizations claiming non-profit status must submit proof. A copy of the 501(c)(3) Certificate must be received with the application submission by the Application Deadline Date listed under the Key Dates section on page one of this announcement.

    An applicant submitting any of the above additional documentation after the initial application submission due date is required to ensure the information was received by the IHS by obtaining documentation confirming delivery (i.e. FedEx tracking, postal return receipt, etc.).

    IV. Application and Submission Information 1. Obtaining Application Materials

    The application package and detailed instructions for this announcement can be found at http://www.Grants.gov or http://www.ihs.gov/dgm/funding/.

    Questions regarding the electronic application process may be directed to Mr. Paul Gettys at (301) 443-2114.

    2. Content and Form Application Submission

    The applicant must include the project narrative as an attachment to the application package. Mandatory documents for all applicants include:

    • Table of contents.

    • Abstract (one page) summarizing the project.

    • Application forms:

    ○ SF-424, Application for Federal Assistance.

    ○ SF-424A, Budget Information—Non-Construction Programs.

    ○ SF-424B, Assurances—Non-Construction Programs.

    • Budget Justification and Narrative (must be single spaced and not exceed five pages).

    • Project Narrative (must not exceed 20 pages).

    ○ Background information on the organization.

    ○ Proposed scope of work, objectives, and activities that provide a description of what will be accomplished, including a one-page Timeframe Chart.

    • Letter of Support from organization's Board of Directors.

    • 501(c)(3) Certificate.

    • Biographical sketches for all Key Personnel.

    • Contractor/Consultant resumes or qualifications and scope of work.

    • Disclosure of Lobbying Activities (SF-LLL).

    • Certification Regarding Lobbying (GG-Lobbying Form).

    • Copy of current Negotiated Indirect Cost rate (IDC) agreement (required in order to receive IDC).

    • Organizational Chart (optional).

    • Documentation of current Office of Management and Budget (OMB) Financial Audit (if applicable).

    Acceptable forms of documentation include:

    ○ Email confirmation from Federal Audit Clearinghouse (FAC) that audits were submitted; or

    ○ Face sheets from audit reports. These can be found on the FAC Web site: http://harvester.census.gov/sac/dissem/accessoptions.html?submit=Go+To+Database.

    Public Policy Requirements

    All Federal-wide public policies apply to IHS grants and cooperative agreements with exception of the discrimination policy.

    Requirements for Project and Budget Narratives A. Project Narrative

    This narrative should be a separate Word document that is no longer than 20 pages and must: be single-spaced, type written, have consecutively numbered pages, use black type not smaller than 12 characters per one inch, and printed on one side only of standard size 81/2″ × 11″ paper.

    Be sure to succinctly answer all questions listed under the evaluation criteria (refer to Section V.1, Evaluation criteria in this announcement), and place all responses and required information in the correct section (noted below), or they will not be considered or scored. These narratives will assist the Objective Review Committee (ORC) in becoming more familiar with the grantee's activities and accomplishments prior to this possible cooperative agreement award. If the narrative exceeds the page limit, only the first 20 pages will be reviewed. The 20-page limit for the narrative does not include the work plan, standard forms, Tribal resolutions, table of contents, budget, budget justifications, narratives, and/or other appendix items.

    There are three parts to the narrative: Part A—Program Information; Part B—Program Planning and Evaluation; and Part C—Program Report. See below for additional details about what must be included in the narrative. The page limitations below are for each narrative and budget submitted.

    Part A: Program Information (3 Page Limitation) Section 1: Needs

    Describe your organization's understanding of the needs of this cooperative agreement and how your organization has the experience to provide outreach and education efforts regarding the pertinent changes and updates in health research.

    Part B: Program Planning and Evaluation (12 Page Limitation) Section 1: Program Plans

    Describe fully and clearly how the national AI/AN membership organization plans to address the requirements and tasks.

    Section 2: Program Evaluation

    Describe fully and clearly how your planned outreach and education efforts will impact changes in knowledge and awareness in Tribal health professionals and among AI/AN health researchers and health research students. Describe how your organization will measure/monitor/track these impacts; include existing or planned new data sources.

    Part C: Program Report (5 Page Limitation)

    Section 1: Identify and describe your organization's significant program activities and achievements over the past five years associated with the goals of this agreement, including improved delivery of quality health research education and the growth of the national community of AI/AN health researchers. Provide a comparison of the actual accomplishments to the goals established for the project period or, if applicable, provide justification for the lack of progress.

    B. Budget Narrative (5 Page Limitation)

    This narrative must include a line item budget with a narrative justification for all expenditures identifying reasonable allowable, allocable costs necessary to accomplish the goals and objectives as outlined in the project narrative. Budget should match the scope of work described in the project narrative.

    3. Submission Dates and Times

    Applications must be submitted electronically through Grants.gov by 11:59pm, Eastern Daylight Time (EDT) on the Application Deadline Date listed in the Key Dates section on page one of this announcement. Any application received after the application deadline will not be accepted for processing, nor will it be given further consideration for funding. Grants.gov will notify the applicant via email if the application is rejected.

    If technical challenges arise and assistance is required with the electronic application process, contact Grants.gov Customer Support via email to [email protected] or at (800) 518-4726. Customer Support is available to address questions 24 hours a day, 7 days a week (except on Federal holidays). If problems persist, contact Mr. Gettys, ([email protected]) DGM Grant Systems Coordinator, by telephone at (301) 443-2114 or (301) 443-5204. Please be sure to contact Mr. Gettys at least ten days prior to the application deadline. Please do not contact the DGM until you have received a Grants.gov tracking number. In the event you are not able to obtain a tracking number, call the DGM as soon as possible.

    4. Intergovernmental Review

    Executive Order 12372 requiring intergovernmental review is not applicable to this program.

    5. Funding Restrictions

    • Pre-award costs are not allowable.

    • The available funds are inclusive of direct and appropriate indirect costs.

    • Only one grant/cooperative agreement will be awarded.

    • IHS will not acknowledge receipt of applications.

    6. Electronic Submission Requirements

    All applications must be submitted electronically. Please use the http://www.Grants.gov Web site to submit an application electronically and select the “Find Grant Opportunities” link on the homepage. Download a copy of the application package, complete it offline, and then upload and submit the completed application via the http://www.Grants.gov Web site. Electronic copies of the application may not be submitted as attachments to email messages addressed to IHS employees or offices.

    If the applicant needs to submit a paper application instead of submitting electronically through Grants.gov, a waiver must be requested. A written waiver request must be sent to [email protected] with a copy to [email protected] The waiver must (1) be documented in writing (emails are acceptable), before submitting a paper application, and (2) include clear justification for the need to deviate from the required electronic grants submission process.

    Once the waiver request has been approved, the applicant will receive a confirmation of approval email containing submission instructions and the mailing address to submit the application. A copy of the written approval must be submitted along with the hardcopy of the application that is mailed to DGM. Paper applications that are submitted without a copy of the signed waiver from the Senior Policy Analyst of the DGM will not be reviewed or considered for funding. The applicant will be notified via email of this decision by the Grants Management Officer of the DGM. Paper applications must be received by the DGM no later than 5:00 p.m., EDT, on the Application Deadline Date listed in the Key Dates section on page one of this announcement. Late applications will not be accepted for processing or considered for funding. Applicants that do not adhere to the timelines for System for Award Management (SAM) and/or http://www.Grants.gov registration or that fail to request timely assistance with technical issues will not be considered for a waiver to submit a paper application.

    Please be aware of the following:

    • Please search for the application package in http://www.Grants.gov by entering the CFDA number or the Funding Opportunity Number. Both numbers are located in the header of this announcement.

    • If you experience technical challenges while submitting your application electronically, please contact Grants.gov Support directly at: [email protected] or (800) 518-4726. Customer Support is available to address questions 24 hours a day, 7 days a week (except on Federal holidays).

    • Upon contacting Grants.gov, obtain a tracking number as proof of contact. The tracking number is helpful if there are technical issues that cannot be resolved and a waiver from the agency must be obtained.

    • Applicants are strongly encouraged not to wait until the deadline date to begin the application process through Grants.gov as the registration process for SAM and Grants.gov could take up to fifteen working days.

    • Please use the optional attachment feature in Grants.gov to attach additional documentation that may be requested by the DGM.

    • All applicants must comply with any page limitation requirements described in this funding announcement.

    • After electronically submitting the application, the applicant will receive an automatic acknowledgment from Grants.gov that contains a Grants.gov tracking number. The DGM will download the application from Grants.gov and provide necessary copies to the appropriate agency officials. Neither the DGM nor OPHS will notify applicants that the application has been received.

    • Email applications will not be accepted under this announcement.

    Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS)

    All IHS applicants and grantee organizations are required to obtain a DUNS number and maintain an active registration in the SAM database. The DUNS number is a unique 9-digit identification number provided by D&B which uniquely identifies your entity. The DUNS number is site specific; therefore, each distinct performance site may be assigned a DUNS number. Obtaining a DUNS number is easy, and there is no charge. To obtain a DUNS number, you may access it through http://fedgov.dnb.com/webform, or to expedite the process, call (866) 705-5711.

    All HHS recipients are required by the Federal Funding Accountability and Transparency Act of 2006, as amended (“Transparency Act”), to report information on sub-awards. Accordingly, all IHS grantees must notify potential first-tier sub-recipients that no entity may receive a first-tier sub-award unless the entity has provided its DUNS number to the prime grantee organization. This requirement ensures the use of a universal identifier to enhance the quality of information available to the public pursuant to the Transparency Act.

    System for Award Management (SAM)

    Organizations that were not registered with Central Contractor Registration and have not registered with SAM will need to obtain a DUNS number first and then access the SAM online registration through the SAM home page at https://www.sam.gov (U.S. organizations will also need to provide an Employer Identification Number from the Internal Revenue Service that may take an additional 2-5 weeks to become active). Completing and submitting the registration takes approximately one hour to complete and your SAM registration will take 3-5 business days to process. Registration with the SAM is free of charge. Applicants may register online at https://www.sam.gov.

    Additional information on implementing the Transparency Act, including the specific requirements for DUNS and SAM, can be found on the IHS Grants Management, Grants Policy Web site: http://www.ihs.gov/dgm/policytopics/

    V. Application Review Information

    The instructions for preparing the application narrative also constitute the evaluation criteria for reviewing and scoring the application. Weights assigned to each section are noted in parentheses. The 20 page narrative should include only the first year of activities; information for multi-year projects should be included as an appendix. See “Multi-year Project Requirements” at the end of this section for more information. The narrative section should be written in a manner that is clear to outside reviewers unfamiliar with prior related activities of the applicant. It should be well organized, succinct, and contain all information necessary for reviewers to understand the project fully. Points will be assigned to each evaluation criteria adding up to a total of 100 points. A minimum score of 70 points is required for funding. Points are assigned as follows:

    1. Criteria A. Introduction and Need for Assistance (15 Points)

    (1) Describe your organization's understanding of the needs of this cooperative agreement.

    (2) Describe the organization's current operations as related to the spectrum of health research needs and dissemination of health research information and support to Tribes, AI/AN communities, and Tribal colleges and universities among others. Include information regarding technologies currently used (i.e., hardware, software, services, Web sites, etc.), and identify the source(s) of technical support for those technologies (i.e., in-house staff, contractors, vendors, etc.). Include information regarding how long the applicant has been operating and its length of association/partnerships with Area health boards or other organizations, etc. [historical collaboration].

    (3) Describe the organization's current technical assistance ability. Include what programs and services are currently provided, programs and services projected to be provided, and describe any memorandums of agreement with other national Indian organizations.

    (4) Describe the population to be served by the proposed project. Are they hard to reach? Are there barriers? Identify all previous IHS funds received, dates of funding and summaries of the projects' accomplishments. State how previous funds facilitated education, training and technical assistance nationwide for AI/ANs.

    (5) Describe collaborative and supportive efforts with Tribal Epidemiology Centers, NARCH grantees, university centers of AI/AN health research.

    (6) Explain the need/reason for your proposed projects by identifying specific gaps or weaknesses in health research training or infrastructure that will be addressed by the proposed projects. Describe the effect of the proposed project on current programs (i.e., Federally-funded, State funded, etc.)

    B. Project Objective(s), Work Plan and Approach (40 Points)

    (1) Identify the proposed project objective(s) for the project, as applicable, addressing the following:

    • Measurable and (if applicable) quantifiable.

    • results oriented.

    • time-limited.

    Example: Issue save the date notices, calls for papers, conference publicity, and registration information. Goals must be clear and concise.

    (2) Address the extent to which the proposed projects will provide, improve, or expand health research that address the need(s) of the target population. Submit a work plan in the Appendix that:

    • Provides the action steps on a timeline for accomplishing each of the projects' proposed objective(s).

    • Identifies who will perform the action steps.

    • Identifies who will supervise the action steps taken.

    • Identifies what tangible products will be produced during and at the end of the proposed project objective(s).

    • Identifies who will accept and/or approve work products during the duration of the proposed projects and at the end of the proposed projects.

    • Identifies any training that will take place during the proposed projects and who will be attending the training.

    • Identifies evaluation activities proposed in the work plans.

    (3) If consultants or contractors will be used during the proposed project, please include the following information in their scope of work (or note if consultants/contractors will not be used):

    • Educational requirements.

    • Desired qualifications and work experience.

    • Expected work products to be delivered on a timeline.

    If a potential consultant/contractor has already been identified, please include a resume in the Appendix.

    C. Program Evaluation (20 Points)

    Each proposed objective requires an evaluation component to assess its progress and ensure its completion. Also, include the evaluation activities in the work plan.

    Describe the proposed plan to evaluate both outcomes and process. Outcome evaluation relates to the results identified in the objectives, and process evaluation relates to the work plan and activities of the project.

    (1) For outcome evaluation, describe:

    • The criteria for determining success of each objective.

    • The data to be collected which will determine whether the objective was met.

    • Data collection intervals and frequency.

    • Who will collect the data and their qualifications.

    • How the data will be analyzed.

    • How results of evaluation will be used.

    (2) For process evaluation, describe:

    • How the projects will be monitored and assessed for potential problems and needs for quality improvements.

    • Who will be responsible for monitoring and managing project improvements based on results of ongoing process improvements and their qualifications.

    • How ongoing monitoring will be used to improve the project's performance.

    • Products that might be developed and how they might lend themselves to replication by others.

    • How the organization will document what is learned throughout the projects' grant periods.

    (3) Describe any evaluation efforts planned after the grant period has ended.

    (4) Describe the ultimate benefit to the AI/AN population served by the applicant organization that will be derived from these projects.

    D. Organizational Capabilities, Key Personnel and Qualifications (15 Points)

    This section outlines the broader capacity of the organization to complete the project outlined in the work plan. It includes the identification of personnel responsible for completing tasks and the chain of responsibility for successful completion of the projects outlined in the work plans.

    (1) Describe the organizational structure of the applicant.

    (2) Describe the ability of the organization to manage the proposed project. Include information regarding similarly sized projects in scope and financial assistance, as well as other conferences and projects successfully completed.

    (3) Describe equipment (i.e., fax machine, phone, computer, etc.) and facility space (i.e., office space) that will be available for use during the proposed projects. Include information about any equipment not currently available and will be purchased through the cooperative agreement.

    (4) List key personnel who will work on the projects. Include title used in the work plans. In the Appendix, include position descriptions and resumes for all key personnel. Position descriptions should clearly describe each position and duties, indicating desired qualifications and experience requirements related to the proposed project. Resumes must indicate that the proposed staff member is qualified to carry out the proposed project activities. If a position is to be filled, indicate that information on the proposed position description.

    (5) If personnel are to be only partially funded by this cooperative agreement, indicate the percentage of time to be allocated to this project and identify the resources used to fund the remainder of the individual's salary.

    E. Categorical Budget and Budget Justification (10 Points)

    This section should provide a clear estimate of the program costs and justification of expenses for the entire period of the cooperative agreement. The budget and budget justification should be consistent with the tasks identified in the work plans.

    (1) Provide a categorical budget for the 12-month budget period requested by the project.

    (2) If IDC are claimed, indicate and apply the current negotiated rate to the budget. Include a copy of the rate agreement in the Appendix. See Section VI. Award Administration Information, 3. Indirect Costs.

    (3) Provide a narrative justification explaining why each line item is necessary/relevant to the proposed project. Include sufficient costs and other details to facilitate the determination of cost (i.e., equipment specifications, etc.).

    Multi-Year Project Requirements

    Projects requiring second, third, fourth, and/or fifth year must include a brief project narrative and budget (one additional page per year) addressing the developmental plans for each additional year of the project.

    Additional Documents Can Be Uploaded as Appendix Items in Grants.gov

    • Work plan, logic model and/or time line for proposed objectives.

    • Position descriptions for key staff.

    • Resumes of key staff that reflect current duties.

    • Consultant or contractor proposed scope of work and letter of commitment (if applicable).

    • Current Indirect Cost Agreement.

    • Organizational chart(s) highlighting proposed project staff and their supervisors as well as other key contacts within the organization and key community contacts.

    • Additional documents to support narrative (i.e., data tables, key news articles, etc.).

    2. Review and Selection

    Each application will be prescreened by the DGM staff for eligibility and completeness as outlined in the funding announcement. Applications that meet the eligibility criteria shall be reviewed for merit by the ORC based on evaluation criteria in this funding announcement. The ORC could be composed of both Tribal and Federal reviewers appointed by the IHS program to review and make recommendations on these applications. The technical review process ensures selection of quality projects in a national competition for limited funding. Incomplete applications and applications that are non-responsive to the eligibility criteria will not be referred to the ORC. The applicant will be notified via email of this decision by the Grants Management Officer of the DGM. Applicants will be notified by DGM, via email, to outline minor missing components (i.e., budget narratives, audit documentation, key contact form) needed for an otherwise complete application. All missing documents must be sent to DGM on or before the due date listed in the email of notification of missing documents required.

    To obtain a minimum score for funding by the ORC, applicants must address all program requirements and provide all required documentation.

    VI. Award Administration Information 1. Award Notices

    The Notice of Award (NoA) is a legally binding document signed by the Grants Management Officer and serves as the official notification of the grant award. The NoA will be initiated by the DGM in our grant system, GrantSolutions (https://www.grantsolutions.gov). Each entity that is approved for funding under this announcement will need to request or have a user account in GrantSolutions in order to retrieve their NoA. The NoA is the authorizing document for which funds are dispersed to the approved entities and reflects the amount of Federal funds awarded, the purpose of the grant, the terms and conditions of the award, the effective date of the award, and the budget/project period.

    Disapproved Applicants

    Applicants who received a score less than the recommended funding level for approval (80 points) and were deemed to be disapproved by the ORC, will receive an Executive Summary Statement from the IHS program office within 30 days of the conclusion of the ORC outlining the weaknesses and strengths of their application submitted. The summary statement will be sent to the Authorized Organizational Representative that is identified on the face page (SF-424) of the application. The IHS program office will also provide additional contact information as needed to address questions and concerns as well as provide technical assistance if desired.

    Approved but Unfunded Applicants

    Approved but unfunded applicants that met the minimum scoring range and were deemed by the ORC to be “Approved”, but were not funded due to lack of funding, will have their applications held by DGM for a period of one year. If additional funding becomes available during the course of FY 2016 the approved but unfunded application may be re-considered by the awarding program office for possible funding. The applicant will also receive an Executive Summary Statement from the IHS program office within 30 days of the conclusion of the ORC.

    Note:

    Any correspondence other than the official NoA signed by an IHS Grants Management Official announcing to the Project Director that an award has been made to their organization is not an authorization to implement their program on behalf of IHS.

    2. Administrative Requirements

    Cooperative agreements are administered in accordance with the following regulations and policies:

    A. The criteria as outlined in this program announcement.

    B. Administrative Regulations for Grants:

    • Uniform Administrative Requirements for HHS Awards, located at 45 CFR Part 75.

    C. Grants Policy:

    • HHS Grants Policy Statement, Revised 01/07.

    D. Cost Principles:

    • Uniform Administrative Requirements for HHS Awards, “Cost Principles,” located at 45 CFR part 75, subpart E.

    E. Audit Requirements:

    • Uniform Administrative Requirements for HHS Awards, “Audit Requirements,” located at 45 CFR part 75, subpart F.

    3. Indirect Costs

    This section applies to all grant recipients that request reimbursement of indirect costs (IDC) in their grant application. In accordance with HHS Grants Policy Statement, Part II-27, IHS requires applicants to obtain a current IDC rate agreement prior to award. The rate agreement must be prepared in accordance with the applicable cost principles and guidance as provided by the cognizant agency or office. A current rate covers the applicable grant activities under the current award's budget period. If the current rate is not on file with the DGM at the time of award, the IDC portion of the budget will be restricted. The restrictions remain in place until the current rate is provided to the DGM.

    Generally, IDC rates for IHS grantees are negotiated with the Division of Cost Allocation (DCA) https://rates.psc.gov/ and the Department of Interior (Interior Business Center) http://www.doi.gov/ibc/services/Indirect_Cost_Services/index.cfm. For questions regarding the indirect cost policy, please call the Grants Management Specialist listed under “Agency Contacts” or the main DGM office at (301) 443-5204.

    4. Reporting Requirements

    The grantee must submit required reports consistent with the applicable deadlines. Failure to submit required reports within the time allowed may result in suspension or termination of an active grant, withholding of additional awards for the project, or other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in one or both of the following: (1) The imposition of special award provisions; and (2) the non-funding or non-award of other eligible projects or activities. This requirement applies whether the delinquency is attributable to the failure of the grantee organization or the individual responsible for preparation of the reports. Per DGM policy, all reports are required to be submitted electronically by attaching them as a “Grants Note” in the GrantSolutions. Personnel responsible for submitting reports will be required to obtain a login and password for GrantSolutions. Please see the Agency Contacts list in section VII for the systems contact information.

    The reporting requirements for this program are noted below.

    A. Progress Reports

    Program progress reports are required semiannually, within 30 days after the budget period ends. These reports must include a brief comparison of actual accomplishments to the goals established for the period, or, if applicable, provide sound justification for the lack of progress, and other pertinent information as required. A final report must be submitted within 90 days of expiration of the budget period/period of performance.

    B. Financial Reports

    Federal Financial Report FFR (SF-425), Cash Transaction Reports are due 30 days after the close of every calendar quarter to the Division of Payment Management, HHS at: http://www.dpm.psc.gov. It is recommended that the applicant also send a copy of the FFR (SF-425) report to the Grants Management Specialist. Failure to submit timely reports may cause a disruption in timely payments to the organization.

    Grantees are responsible and accountable for accurate information being reported on all required reports: The Progress Reports and Federal Financial Report.

    C. Post Conference Grant Reporting

    The following requirements were enacted in Section 3003 of the Consolidated Continuing Appropriations Act, 2013, and Section 119 of the Continuing Appropriations Act, 2014; Office of Management and Budget Memorandum M-12-12: All HHS/IHS awards containing grants funds allocated for conferences will be required to complete a mandatory post award report for all conferences. Specifically: The total amount of funds provided in this award/cooperative agreement that were spent for “Conference X”, must be reported in final detailed actual costs within 15 days of the completion of the conference. Cost categories to address should be: (1) Contract/Planner, (2) Meeting Space/Venue, (3) Registration Web site, (4) Audio Visual, (5) Speakers Fees, (6) Non-Federal Attendee Travel, (7) Registration Fees, (8) Other.

    D. Federal Sub-Award Reporting System (FSRS)

    This award may be subject to the Transparency Act sub-award and executive compensation reporting requirements of 2 CFR part 170.

    The Transparency Act requires the OMB to establish a single searchable database, accessible to the public, with information on financial assistance awards made by Federal agencies. The Transparency Act also includes a requirement for recipients of Federal grants to report information about first-tier sub-awards and executive compensation under Federal assistance awards.

    IHS has implemented a Term of Award into all IHS Standard Terms and Conditions, NoAs and funding announcements regarding the FSRS reporting requirement. This IHS Term of Award is applicable to all IHS grant and cooperative agreements issued on or after October 1, 2010, with a $25,000 sub-award obligation dollar threshold met for any specific reporting period. Additionally, all new (discretionary) IHS awards (where the project period is made up of more than one budget period) and where: (1) The project period start date was October 1, 2010 or after and (2) the primary awardee will have a $25,000 sub-award obligation dollar threshold during any specific reporting period will be required to address the FSRS reporting.

    For the full IHS award term implementing this requirement and additional award applicability information, visit the DGM Grants Policy Web site at: http://www.ihs.gov/dgm/policytopics/.

    E. Compliance With Executive Order 13166 Implementation of Services Accessibility Provisions for All Grant Application Packages and Funding Opportunity Announcements

    Recipients of Federal financial assistance (FFA) from HHS must administer their programs in compliance with Federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under Federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    Applicants will be required to sign the HHS-690 Assurance of Compliance form located at http://www.hhs.gov/sites/default/files/forms/hhs-690.pdf and send the original form to: U.S. Department of Health and Human Services, Office of Civil Rights, 200 Independence Ave. SW., Washington, DC 20201.

    F. Federal Awardee Performance and Integrity Information System (FAPIIS)

    The IHS is required to review and consider any information about the applicant that is in the Federal Awardee Performance and Integrity Information System (FAPIIS) before making any award in excess of the simplified acquisition threshold (currently $150,000) over the period of performance. An applicant may review and comment on any information about itself that a Federal awarding agency previously entered. IHS will consider any comments by the applicant, in addition to other information in FAPIIS in making a judgment about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR 75.205.

    As required by 45 CFR part 75 Appendix XII of the Uniform Guidance, non-federal entities (NFEs) are required to disclose in FAPIIS any information about criminal, civil, and administrative proceedings, and/or affirm that there is no new information to provide. This applies to NFEs that receive Federal awards (currently active grants, cooperative agreements, and procurement contracts) greater than $10,000,000 for any period of time during the period of performance of an award/project.

    Mandatory Disclosure Requirements

    As required by 2 CFR part 200 of the Uniform Guidance, and the HHS implementing regulations at 45 CFR part 75, effective January 1, 2016, the IHS must require a non-federal entity or an applicant for a Federal award to disclose, in a timely manner, in writing to the IHS or pass-through entity all violations of Federal criminal law involving fraud, bribery,or gratutity violations potentially affecting the Federal award.

    Submission is required for all applicants and recipients, in writing, to the IHS and to the HHS Office of Inspector General all information related to violations of Federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. 45 CFR 75.113.

    Disclosures must be sent in writing to:

    U.S. Department of Health and Human Services, Indian Health Service, Division of Grants Management, ATTN: Mr. Robert Tarwater, Director, 5600 Fishers Lane, Mailstop 09E70, Rockville, Maryland 20857, (Include “Mandatory Grant Disclosures” in subject line), Ofc: (301) 443-5204, Fax: (301) 594-0899, Email: [email protected]

    AND

    U.S. Department of Health and Human Services, Office of Inspector General, ATTN: Mandatory Grant Disclosures, Intake Coordinator, 330 Independence Avenue SW., Cohen Building, Room 5527, Washington, DC 20201, URL: http://oig.hhs.gov/fraud/reportfraud/index.asp, (Include “Mandatory Grant Disclosures” in subject line), Fax: (202) 205-0604 (Include “Mandatory Grant Disclosures” in subject line) or Email: [email protected]

    Failure to make required disclosures can result in any of the remedies described in 45 CFR 75.371. Remedies for noncompliance, including suspension or debarment (See 2 CFR parts 180 & 376 and 31 U.S.C. 3321).

    VII. Agency Contacts

    1. Questions on the programmatic issues may be directed to: Mr. Mose Herne, MPH, MS, IHS Research Director, 5600 Fishers Lane, Mailstop 09E10D, Rockville, Maryland 20857, Telephone: (301) 443-1549, Fax: (301) 443-0114, Email: [email protected]

    2. Questions on grants management and fiscal matters may be directed to: Ms. Patience Musikikongo, DGM, Grants Management Specialist, 5600 Fishers Lane, Mailstop 09E70, Rockville, Maryland 20857, Telephone: (301) 443-2059, Fax: (301) 443-9602, Email: [email protected]

    3. Questions on systems matters may be directed to: Mr. Paul Gettys, Grant Systems Coordinator, 5600 Fishers Lane, Mail Stop 09E70, Rockville, MD 20857, Phone: (301) 443-2114; or the DGM main line (301) 443-5204, Fax: (301) 443-9602, Email: [email protected]

    VIII. Other Information

    The Public Health Service strongly encourages all cooperative agreement and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of the facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the HHS mission to protect and advance the physical and mental health of the American people.

    Elizabeth A. Fowler, Deputy Director for Management Operations, Indian Health Service.
    [FR Doc. 2016-21049 Filed 8-31-16; 8:45 am] BILLING CODE 4165-16-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service [OMB Control Number 0917-0006] Request for Public Comment: 30-Day Proposed Information Collection: Application for Participation in the IHS Scholarship Program AGENCY:

    Indian Health Service, HHS.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for an extension for this collection, titled, “Application for Participation in the IHS Scholarship Program (OMB Control Number 0917-0006),” with an expiration date of September 30, 2016. This proposed information collection project was previously published in the Federal Register (81 FR 44030) on July 6, 2016, and allowed 60 days for public comment, as required by 3506(c)(2)(A). The IHS received no comments regarding this collection. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB.

    Proposed Collection: Title: “Application for Participation in the IHS Scholarship Program,” OMB Control No. 0917-0006. Type of Information Collection Request: Extension of the currently approved information collection “Application for Participation in the IHS Scholarship Program,” OMB Control No. 0917-0006. Form Number(s): IHS-856-3, IHS-856-5 through 856-19, IHS-856-21 through 856-24, IHS-817, and IHS-818 are retained for use by the IHS Scholarship Program (IHSSP) as part of this current information collection request. Reporting forms are found on the IHS Web site at www.ihs.gov/scholarship. Need and Use of Information Collection: The IHS Scholarship Branch needs this information for program administration and uses the information to: solicit, process, and award IHS Pre-graduate, Preparatory, and/or Health Professions Scholarship recipients; monitor the academic performance of recipients; and to place recipients at payback sites. The IHSSP application is electronically available on the internet at the IHS Web site at: https://www.ihs.gov/scholarship/applynow/. Affected Public: Individuals, not-for-profit institutions and State, local or Tribal Governments. Type of Respondents: Students pursuing health care professions.

    The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hours.

    Data collection instrument(s) Number
  • of
  • respondents
  • Responses
  • per
  • respondent
  • Total
  • annual
  • response
  • Burden
  • hour per
  • response *
  • Annual
  • burden
  • hours
  • Faculty/Employer Evaluation (IHS-856-3) 1,500 2 3,000 0.42 (25 min) 1250 Delinquent Federal Debt (IHS-856-5) 1,500 1 1,500 0.13 (8 min) 200 Course Curriculum Verification (IHS-856-6) 1,500 1 1,500 0.70 (42 min) 1,050 Verification of Acceptance or Decline of Award (IHS-856-7) 500 1 500 0.13 (8 min) 67 Recipient's Initial Program Progress Report (IHS-856-8) 1,200 1 1,200 0.13 (8 min) 160 Notification of Academic Problem (IHS-856-9) 50 1 50 0.13 (8 min) 7 Change of Status (IHS-856-10) 50 1 50 .045 (25 min) 21 Request for Approval of Deferment (IHS-856-11) 20 1 20 0.13 (8 min) 3 Preferred Placement (IHS-856-12) 150 1 150 0.50 (30 min) 75 Notice of Impending Graduation (IHS-856-13) 170 1 170 0.17 (10 min) 28 Notification of Deferment Program (IHS-856-14) 20 1 20 0.13 (8 min) 3 Placement Update (IHS-856-15) 170 1 170 0.18 (11 min) 31 Annual Status Report (IHS-856-16) 200 1 200 0.25 (15 min) 50 Extern Site Preference Request (IHS-856-17) 300 1 300 0.13 (8 min) 40 Request for Extern Travel Reimbursement (IHS-856-18) 150 1 150 0.10 (6 min) 15 Lost Stipend Payment (IHS-856-19) 50 1 50 0.13 (8 min) 7 Summer School Request (IHS-856-21) 100 1 100 0.10 (6 min) 10 Change of Name or Address (IHS-856-22) 20 1 20 0.13 (8 min) 3 Request for Credit Validation (IHS-856-23) 30 1 30 0.10 (6 min) 3 Faculty/Advisor Evaluation (IHS-856-24) 1,500 2 3,000 0.42 (25 min) 1,250 Scholarship Program Agreement (IHS-817) 175 1 175 0.16 (10 min) 29 Health Professions Contract (IHS-818) 225 1 225 0.16 (10 min) 38 Total 12,580 4,340 * For ease of understanding, burden hours are also provided in actual minutes.

    There are no direct costs to respondents other than their time to voluntarily complete the forms and submit them for consideration. The estimated cost in time to respondents, as a group, is $46,386 [4,303 burden hours × $10.78 per hour (2016 GS-3 hourly base pay rate)]. This total dollar amount is based upon the number of burden hours per data collection instrument, rounded to the nearest dollar.

    Request for Comments: Your written comments and/or suggestions are invited on one or more of the following points: (a) Whether the information collection activity is necessary to carry out an agency function; (b) whether the agency processes the information collected in a useful and timely fashion; (c) the accuracy of public burden estimate (the estimated amount of time needed for individual respondents to provide the requested information); (d) whether the methodology and assumptions used to determine the estimate are logical; (e) ways to enhance the quality, utility, and clarity of the information being collected; and (f) ways to minimize the public burden through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Send Requests for Further Information: For the proposed collection, or requests to obtain a copy of the data collection instrument(s) and instructions, send to: Robert E. Pittman, BPharm, MPH, Acting Chief, Scholarship Branch Director, Division of Health Professions Support, Indian Health Service, 5600 Fishers Lane, Mail Stop: OHR 11E53A, Rockville, MD 20857. Rockville, MD 20852, Call non-toll free (301) 443-6622, send via facsimile to (301) 443-6622, send via facsimile to (301) 443-6048, or send your email requests, and return address to: [email protected]

    Direct Your Comments to OMB: Send your comments and suggestions regarding the proposed information collection contained in this notice, especially regarding the estimated public burden and associated response time to: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for IHS.

    Comment Due Date: Comments regarding this information collection are best assured of having full effect if received within 30 days of the date of this publication.

    Dated: August 24, 2016. Elizabeth A. Fowler, Deputy Director for Management Operations, Indian Health Service.
    [FR Doc. 2016-21048 Filed 8-31-16; 8:45 am] BILLING CODE 4165-16-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders Draft 2017-2021 Strategic Plan AGENCY:

    National Institutes of Health.

    ACTION:

    Request for comment.

    SUMMARY:

    The National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH) is requesting public comment on the draft 2017-2021 NIDCD Strategic Plan. The Strategic Plan serves as a guide to the NIDCD in prioritizing its research investment, illustrates the current state-of-the-science, and highlights recent advances in the communication sciences. The draft Plan presents a series of goals and objectives that represent the most promising research needs within the NIDCD's mission areas.

    DATES:

    Comments will be accepted through September 30, 2016.

    ADDRESSES:

    The draft Plan is available for download at: https://www.nidcd.nih.gov/about/strategic-plan/2017-2021/public-comment. Comments must be submitted electronically via the web-based form at: https://www.nidcd.nih.gov/about/strategic-plan/2017-2021/public-comment. The web-based form accepts text but cannot accept attachments. You will receive an electronic confirmation acknowledging receipt of your response, but will not receive individualized feedback from NIDCD on any comments.

    FOR FURTHER INFORMATION CONTACT:

    Specific questions regarding the NIDCD draft Strategic Plan should be directed to: [email protected]

    SUPPLEMENTARY INFORMATION:

    The NIDCD mission is to conduct and support biomedical research, behavioral research, and research training in the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language. The institute also conducts and supports research and research training related to disease prevention and health promotion; addresses special biomedical and behavioral problems associated with people who have communication impairments or disorders; and supports efforts to create devices that substitute for lost and impaired sensory and communication function. To accomplish these goals, the NIDCD manages a broad portfolio of both basic and clinical research. The portfolio is organized into three program areas: Hearing and balance; taste and smell; and voice, speech, and language. The three program areas seek to answer fundamental scientific questions about normal function and disorders and to identify patient-oriented scientific discoveries for preventing, screening, diagnosing, and treating disorders of human communication.

    The draft 2017-2021 NIDCD Strategic Plan has been developed over the past 12 months by NIDCD staff in consultation with scientific experts and the National Deafness and Other Communication Disorders Advisory Council. (Details of the development process are included in Appendix B of the draft Plan.) The goals listed in the draft Plan are an assessment of research areas that present the greatest scientific opportunities and public health needs over the next five years for the three program areas: Hearing and balance; taste and smell; and voice, speech and language.

    The NIDCD has identified four Priority Areas that have the potential to increase our understanding of the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language and to further our knowledge in human communication sciences. They are:

    Priority Area 1Understanding Normal Function: Deepen our understanding of the mechanisms underlying normal function of the systems of human communication. By defining what is normal in both animal models and humans, we can better understand mechanisms of disease.

    Priority Area 2Understanding Diseases and Disorders: Increase our knowledge of the mechanisms of diseases, disorders, and dysfunctions that impair human communication and health. Understanding mechanisms that underlie diseases and disorders is an important step in developing better prevention and treatment strategies.

    Priority Area 3Improving Diagnosis, Treatment, and Prevention: Develop, test, and improve diagnosis, treatment, and prevention of diseases, disorders, and dysfunctions of human communication and health. Diagnosis considers normal function and provides targets for prevention and treatment. Improvements in prevention and treatment lead to better outcomes with fewer side effects.

    Priority Area 4Improving Outcomes for Human Communication: Accelerate the translation of research discoveries into practice; increase access to health care; and enhance the delivery, quality, and effectiveness of care to improve personal and public health. Scientifically-validated prevention and treatment models will lead to better personal and public health only if they are translated effectively into routine practice.

    The goals presented in the Plan are a guide for:

    Scientists: To better understand the directions that NIDCD research may take in the future;

    The NIDCD: To assist in developing funding opportunity announcements and to identify projects for high program priority nomination; and

    The Public: To understand the state of communication sciences and to discover the scientific breakthroughs that are possible with sustained investments in biomedical research.

    Responses to this request for comments are voluntary. Any personal identifiers (e.g., names, addresses, email addresses, etc.) will be removed when responses are compiled. Only the de-identified comments will be made publicly available. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

    This request for comment is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, or the NIH. The NIH does not intend to award a grant or contract to pay for the preparation of any information submitted or for the NIH's use of such information. No basis for claims against the NIH shall arise as a result of a response to this request for information or the NIH's use of such information as part of the NIDCD Strategic Plan.

    The NIDCD anticipates that the finalized plan will be published on the NIDCD Web site in January 2017.

    Dated: August 24, 2016. James F. Battey, Jr., Director, NIDCD, National Institutes of Health.
    [FR Doc. 2016-20905 Filed 8-31-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [Docket No. DHS-2016-0063] Privacy Act of 1974; Department of Homeland Security/U.S. Customs and Border Protection (DHS/CBP)-022 Electronic Visa Update System (EVUS) System of Records AGENCY:

    Privacy Office, Department of Homeland Security.

    ACTION:

    Notice of Privacy Act System of Records.

    SUMMARY:

    In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to establish a new DHS system of records titled, “Department of Homeland Security/U.S. Customs and Border Protection—DHS/CBP-022 Electronic Visa Update System (EVUS) System of Records.” At the same time, in accordance with 5 U.S.C. 552(j) and (k), DHS proposes to claim certain exemptions for this system. At the same time, in accordance with Privacy Act of 1974, DHS proposes to claim certain exemptions for this system. This system of records will allow the Department of Homeland Security (DHS)/U.S. Customs and Border Protection (CBP) to collect and maintain records on nonimmigrant aliens who hold a passport that was issued by an identified country approved for inclusion in the EVUS program and have been issued a U.S. nonimmigrant visa of a designated category seeking to travel to the United States. The system of records will also cover records of other persons, including U.S. citizens and lawful permanent residents, whose name is provided to DHS as part of a nonimmigrant alien's EVUS enrollment. Requiring aliens holding passports of identified countries containing U.S. nonimmigrant visas of a designated category with multiple year validity will allow DHS/CBP to collect updated information. The system is used to ensure a visa holder's information remains current. The information is also used to separately determine whether any admissibility issues may need to be addressed outside the EVUS enrollment process by vetting the information against selected security and law enforcement databases at DHS, including the use of CBP's TECS (not an acronym) (DHS/CBP-011 U.S. Customs and Border Protection TECS, December 19, 2008, 73 FR 77778) and the Automated Targeting System (ATS) (DHS/CBP-006 Automated Targeting System, May 22, 2012, 77 FR 30297). In addition, ATS retains a copy of EVUS enrollment data to identify EVUS enrollees who may pose a security risk to the United States. The ATS maintains copies of key elements of certain databases in order to minimize the impact of processing searches on the operational systems and to act as a backup for certain operational systems. DHS may also vet EVUS enrollment information against security and law enforcement databases at other Federal agencies to enhance DHS's ability to determine whether the enrollee poses a security risk to the United States or, although addressed through a separate process, is admissible to the United States. The results of this vetting may inform DHS's assessment of whether the enrollee's travel poses a law enforcement or security risk and whether the proposed travel should be permitted.

    This newly established system will be included in the Department of Homeland Security's inventory of record systems.

    DATES:

    This system will be effective October 3, 2016. Comments must be received on or before October 3, 2016.

    ADDRESSES:

    You may submit comments, identified by docket number DHS-2016-0063 by one of the following methods:

    Federal e-Rulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Fax: 202-343-4010.

    Mail: Jonathan R. Cantor, Acting Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528-0655.

    INSTRUCTIONS:

    All submissions received must include the agency name and docket number for this rulemaking. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided.

    DOCKET:

    For access to the docket to read background documents or comments received, please visit http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    For general questions, please contact: Debra L. Danisek, (202) 344-1610, Acting CBP Privacy Officer, Privacy and Diversity Office, 1300 Pennsylvania Ave. NW., Washington, DC 20229. For privacy questions, please contact: Jonathan R. Cantor, (202) 343-1717, Acting Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, DHS/CBP proposes to establish a new DHS/CBP system of records titled, “DHS/CBP-022 Electronic Visa Update System (EVUS) System of Records.”

    DHS has developed a fully automated electronic system that enables DHS to collect biographic and other information from certain nonimmigrant aliens on a periodic basis as determined by the Secretary. Specifically, EVUS enables DHS to obtain information from individuals who hold U.S. nonimmigrant visas of a designated category in a passport issued by an identified country. By requiring nonimmigrant aliens who hold a passport issued by an identified country containing a U.S. nonimmigrant visa of a designated category to enroll in EVUS, CBP will be able to collect periodic updates of biographical and other information over the length of the visa period that would otherwise not be obtained, which may assist in identifying persons who may pose a risk to the United States.

    The Electronic Visa Update System is a web-based system developed to collect updated information from visa holders subject to the EVUS program. The EVUS does not change the process for obtaining a visa. However, after issuance of a visa, nonimmigrant aliens subject to the EVUS requirements would need to successfully enroll in EVUS online every two years to ensure their visa remains valid for travel to the United States. The online enrollment will be designed as a user-friendly interface that would allow other persons to assist the traveler in completing the enrollment. Enrollees are able to submit and update biographic information and answer eligibility questions using the EVUS Web site. Successful EVUS enrollment is required for nonimmigrant aliens who hold a passport issued by an identified country containing a U.S. nonimmigrant visa of a designated category. In most cases, the enrollee will obtain an immediate response indicating whether the enrollment is successful. The Electronic Visa Update System enrollment and status must be verified by a carrier prior to the traveler boarding an air or sea carrier. Notifications are sent between DHS/CBP and carriers when the following events occur:

    • A traveler books travel • The Airline/Carrier sends Advance Passenger Information to DHS • The Airline/Carrier receives one of the following responses: ○ EVUS on file—OK to board carrier ○ No EVUS on file—Check for other valid travel documents ○ EVUS enrollment unsuccessful—Do not allow to travel ○ System Issues—Please resend

    Among other functions, CBP vets the EVUS enrollment information against selected security and law enforcement databases, including the use of TECS and the Automated Targeting System (ATS). The ATS will retain a copy of EVUS enrollment data to identify EVUS enrollees who may pose a security risk to the United States. ATS will maintain copies of key elements of certain databases to minimize the impact of processing searches on operational systems and to act as a backup for certain operational systems. DHS may also vet EVUS enrollment information against security and law enforcement databases at other federal agencies to enhance DHS's ability to determine whether the enrollee poses a security risk to the United States. The results of this vetting may support DHS's initial assessment of whether the enrollee's travel poses a law enforcement or security risk and whether there may be issues which may require separate consideration. The individual must attempt enrollment and receive a notification of compliance prior to boarding a carrier destined to the United States. Furthermore, the EVUS system will continuously query/vet enrollment information against law enforcement databases. EVUS status can change at any time.

    The data elements on the EVUS enrollment questionnaire will make the screening of travelers more robust. The required data elements strengthen security in the EVUS enrollment process by enhancing the capability to identify individuals who may pose a threat to the United States or otherwise be found inadmissible at the time that they apply for entry at a U.S. port of entry. Enrollment in EVUS will not guarantee admission into the United States. CBP will continue to employ standard entry procedures to determine admissibility at U.S. ports of entry.

    When a person submits an EVUS enrollment, CBP examines the enrollment questionnaire by screening the enrollee's data through ATS and TECS. The initial and updated biographic information obtained by EVUS is important to identify any concerns regarding future admissibility. Failure to successfully enroll in EVUS when required as described above will result in the automatic provisional revocation of the alien's visa, and the alien will not be authorized to travel to the United States unless or until the alien enrolls in EVUS and obtains a notification of compliance. If a visa is provisionally revoked on the basis of failing to provide or update information to EVUS, the person can attempt EVUS enrollment again, and if successful the provisional revocation of his/her visa would be reversed. In addition, non-compliance with EVUS would be a basis for commercial carriers to deny boarding to an individual seeking to travel to the United States. Because non-compliance with EVUS results in automatic provisional revocation of the individual's visa, the individual would not have valid travel documents upon attempting to board.

    DHS/CBP has authority to operate this system under sec. 402(4) of the Homeland Security Act of 2002, 6 U.S.C. 201, et seq., and sec. 103 (8 U.S.C. 1103), 214 (8 U.S.C. 1184), 215 (8 U.S.C. 1185), and 221 (8 U.S.C. 1201) of the Immigration and Nationality Act (INA), and 8 CFR part 2.

    Consistent with DHS's information sharing mission, information stored in EVUS may be shared with other DHS components that have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions. Information stored in EVUS may also be shared with other federal security and counterterrorism agencies, as well as on a case-by-case basis to appropriate State, local, tribal, territorial, foreign, or international government agencies. This external sharing takes place after DHS determines that it is compatible with the routine uses set forth in this system of records notice.

    Additionally, for ongoing, systematic sharing, DHS completes an information sharing and access agreement with federal partners to establish the terms and conditions of the sharing, including: documenting the need to know, identifying authorized users and uses, protecting the privacy of the data, and ensuring the confidentiality of visa records, as applicable. This updated system will be included in DHS's inventory of systems of records, located on the DHS Web site at http://www.dhs.gov/system-records-notices-sorns.

    II. Privacy Act

    The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which Federal Government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals when systems of records maintain information on U.S. citizens, lawful permanent residents, and visitors.

    Given the importance of providing privacy protections to international travelers, even prior to the collection of the data elements in EVUS that may include information about U.S. persons, DHS always administratively applies the privacy protections and safeguards of the Privacy Act to all international travelers subject to EVUS. The Electronic Visa Update System falls squarely within the mixed system policy and DHS will continue to extend the administrative protections of the Privacy Act to information about travelers and non-travelers whose information is provided to DHS as part of the EVUS enrollment.

    Below is the description of the DHS/CBP-022 Electronic Visa Update System (EVUS) System of Records.

    In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.

    System of Records

    Department of Homeland Security (DHS)/U.S. Customs and Border Protection (CBP)-022.

    System name:

    DHS/CBP-022 Electronic Visa Update System (EVUS)

    Security classification:

    Unclassified. The data may be retained on classified networks but this does not change the nature and character of the data until it is combined with classified information.

    System location:

    Records are maintained at DHS/CBP Headquarters in Washington, DC, and in field offices. Records are replicated from the operational system and maintained on the DHS unclassified and classified networks.

    Categories of individuals covered by the system:

    Categories of individuals covered by this system include:

    1. Nonimmigrant aliens who hold a passport issued by an identified country containing a U.S. nonimmigrant visa of a designated category; and

    2. Persons, including U.S. Citizens and lawful permanent residents, whose information is provided in response to EVUS enrollment questions.

    Categories of records in the system:

    Nonimmigrant aliens who hold a passport issued by an identified country containing a U.S. nonimmigrant visa of a designated category to obtain the required travel authorization by electronically submitting an enrollment consisting of biographic and other data elements via the EVUS Web site. The categories of records in EVUS include:

    • Full name (first, middle, and last);

    • Other names or aliases, if available;

    • Date of birth;

    • City and country of birth;

    • Gender;

    • Email address;

    • Telephone number (home, mobile, work, other);

    • Home address (address, apartment number, city, state/region);

    • Internet protocol (IP) address;

    • EVUS enrollment number;

    • Global Entry Program Number;

    • Country of residence;

    • Passport number;

    • Passport issuing country;

    • Passport issuance date;

    • Passport expiration date;

    • Department of Treasury Pay.gov payment tracking number (i.e., confirmation of payment; absence of payment confirmation will result in a “not cleared” determination);

    • Country of citizenship;

    • Other citizenship (country, passport number);

    • National identification number, if available;

    • Address while visiting the United States (number, street, city, state);

    • Emergency point of contact information (name, telephone number, email address);

    • U.S. Point of Contact (name, address, telephone number);

    • Parents' names;

    • Current job title;

    • Current or previous employer name;

    • Current or previous employer street address; and

    • Current or previous employer telephone number.

    The categories of records in EVUS also include responses to the following questions:

    • Do you have a physical or mental disorder, or are you a drug abuser or addict,[1] or do you currently have any of the following diseases (communicable diseases are specified pursuant to sec. 361(b) of the Public Health Service Act):

    [1] Immigration and Nationality Act 212(a)(1)(A). Pursuant to 8 U.S.C. 1182(a), aliens may be inadmissible to the United States if they have a physical or mental disorder and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others, or (ii) to have had a physical or mental disorder and a history of behavior associated with the disorder, which behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or to lead to other harmful behavior, or are determined (in accordance with regulations prescribed by the Secretary of Health and Human Services) to be a drug abuser or addict.

    ○ Cholera

    ○ Diphtheria

    ○ Tuberculosis, infection

    ○ Plague

    ○ Smallpox

    ○ Yellow Fever

    ○ Viral Hemorrhagic Fevers, including Ebola, Lassa, Marburg, Crimean-Congo

    ○ Severe acute respiratory illnesses capable of transmission to other persons and likely to cause mortality.

    • Have you ever been arrested or convicted for a crime that resulted in serious damage to property, or serious harm to another person or government authority?

    • Have you ever violated any law related to possessing, using, or distributing illegal drugs?

    • Do you seek to engage in or have you ever engaged in terrorist activities, espionage, sabotage, or genocide?

    • Have you ever committed fraud or misrepresented yourself or others to obtain, or assist others to obtain, a visa or entry into the United States?

    • Are you currently seeking employment in the United States or were you previously employed in the United States without prior permission from the U.S. government?

    • Have you ever been denied a U.S. visa you applied for with your current or previous passport, or have you ever been refused admission to the United States or withdrawn your application for admission at a U.S. port of entry? If yes, when and where?

    • Have you ever stayed in the United States longer than the admission period granted to you by the U.S. government?

    • Have you ever been a citizen or national of any other country? If yes, other countries of previous citizenship or nationality?

    Authority for maintenance of the system:

    Title IV of the Homeland Security Act of 2002, 6.U.S.C. 201 et seq., the Immigration and Naturalization Act, as amended, including sec.s 103 (8 U.S.C. 1103), 214 (8 U.S.C. 1184), 215 (8 U.S.C. 1185), and 221 (8 U.S.C. 1201) of the Immigration and Nationality Act (INA), and 8 CFR part 2; and the Travel Promotion Act of 2009, Public Law 111-145, 22 U.S.C. 2131.

    Purpose(s):

    The purpose of this system is to collect and maintain a record of nonimmigrant aliens holding a passport issued by an identified country containing a U.S. nonimmigrant visa of a designated category, and to determine whether there is information that requires separate, additional action.

    The Department of Treasury Pay.gov tracking number (associated with the payment information provided to Pay.gov and stored in the Credit/Debit Card Data System, DHS/CBP-003 Credit/Debit Card Data System (CDCDS), 76 FR. 67755 (November 2, 2011)) will be used to process EVUS and third-party administrator fees and to reconcile issues regarding payment between EVUS, CDCDS, and Pay.gov. Payment information will not be used for vetting purposes and is stored in a separate system (CDCDS) from the EVUS enrollment data.

    DHS maintains a replica of some or all of the data in EVUS on the unclassified and classified DHS networks to allow for analysis and vetting consistent with the above stated uses, purposes, and this published notice.

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

    In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside DHS as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

    A. To the Department of Justice (DOJ), including Offices of the United States Attorneys, or other Federal agency conducting litigation or in proceedings before any court, adjudicative, or administrative body, when it is relevant or necessary to the litigation and one of the following is a party to the litigation or has an interest in such litigation:

    1. DHS or any Component thereof;

    2. Any employee or former employee of DHS in his/her official capacity;

    3. Any employee or former employee of DHS in his/her individual capacity when DOJ or DHS has agreed to represent the employee; or

    4. The United States or any agency thereof.

    B. To a congressional office from the record of an individual in response to an inquiry from that congressional office made at the request of the individual to whom the record pertains.

    C. To the National Archives and Records Administration (NARA) or General Services Administration pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.

    D. To an agency or organization for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function.

    E. To appropriate agencies, entities, and persons when:

    1. DHS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised;

    2. DHS has determined that as a result of the suspected or confirmed compromise, there is a risk of identity theft or fraud, harm to economic or property interests, harm to an individual, or harm to the security or integrity of this system or other systems or programs (whether maintained by DHS or another agency or entity) that rely upon the compromised information; and

    3. The disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with DHS's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.

    F. To contractors and their agents, grantees, experts, consultants, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for DHS, when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to DHS officers and employees.

    G. To appropriate Federal, State, local, international, tribal, or foreign governmental agencies or multilateral governmental organizations responsible for investigating or prosecuting the violations of, or for enforcing or implementing, a statute, rule, regulation, order, license, or treaty when DHS determines that the information would assist in the enforcement of civil or criminal laws;

    H. To appropriate Federal, State, local, tribal, or foreign governmental agencies or multilateral governmental organizations for the purpose of protecting the vital health interests of a data subject or other persons (e.g., to assist such agencies or organizations in preventing exposure to or transmission of a communicable or quarantinable disease or to combat other significant public health threats; appropriate notice will be provided of any identified health threat or risk).

    I. To third parties during the course of a law enforcement investigation to the extent necessary to obtain information pertinent to the investigation, provided disclosure is appropriate in the proper performance of the official duties of the officer making the disclosure.

    J. To a Federal, State, tribal, local, international, or foreign government agency or entity for the purpose of consulting with that agency or entity: (1) To assist in making a determination regarding redress for an individual in connection to a program; (2) for the purpose of verifying the identity of an individual seeking redress in connection with the operations of a DHS Component or program; or (3) for the purpose of verifying the accuracy of information submitted by an individual who has requested such redress on behalf of another individual.

    K. To Federal and foreign government intelligence or counterterrorism agencies or components thereof when DHS becomes aware of an indication of a threat or potential threat to national or international security to assist in countering such threat, or to assist in anti-terrorism efforts.

    L. To the Department of State in the processing of petitions or applications for benefits under the Immigration and Nationality Act, and all other immigration and nationality laws including treaties and reciprocal agreements.

    M. To an organization or individual in either the public or private sector, either foreign or domestic, when there is a reason to believe that the recipient is or could become the target of a particular terrorist activity or conspiracy, to the extent the information is relevant to the protection of life or property.

    N. To the carrier transporting an individual to the United States, prior to travel, in response to a request from the carrier, to verify an individual's travel authorization status.

    O. To the Department of Treasury's Pay.gov, for payment processing and payment reconciliation purposes.

    P. To a court, magistrate, or administrative tribunal in the course of presenting evidence, including disclosures to opposing counsel or witnesses in the course of civil discovery, litigation, or settlement negotiations, in response to a subpoena, or in connection with criminal law proceedings.

    Q. To appropriate Federal, State, local, international, tribal, or foreign governmental agencies or multilateral governmental organizations responsible for investigating or prosecuting the violations of, or for enforcing or implementing, a statute, rule, regulation, order, license, or treaty when DHS determines that the information would assist in the enforcement of civil or criminal laws.

    R. To the news media and the public, with the approval of the Chief Privacy Officer in consultation with counsel, when there exists a legitimate public interest in the disclosure of the information, when disclosure is necessary to preserve confidence in the integrity of DHS, or when disclosure is necessary to demonstrate the accountability of DHS's officers, employees, or individuals covered by the system, except to the extent the Chief Privacy Officer determines that release of the specific information in the context of a particular case would constitute an unwarranted invasion of personal privacy;

    Disclosure to consumer reporting agencies:

    None.

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

    DHS/CBP stores records in this system electronically or on paper in secure facilities in a locked drawer behind a locked door. The records are safeguarded with passwords and encryption and may be stored on magnetic disc, tape, and digital media.

    Retrievability:

    DHS/CBP may retrieve records by any of the data elements supplied by the enrollee.

    Safeguards:

    DHS/CBP safeguards records in this system according to applicable rules and policies, including all applicable DHS automated systems security and access policies. CBP has imposed strict controls to minimize the risk of compromising the information that is being stored. Access to the computer system containing the records in this system is limited to those individuals who have a need to know the information for the performance of their official duties and who have appropriate clearances or permissions.

    Retention and disposal:

    Enrollment information submitted to EVUS generally expires and is deemed “inactive” two years after the initial submission of information by the enrollee. In the event that a traveler's passport remains valid for less than two years from the date of the EVUS notification of compliance, the EVUS enrollment will expire concurrently with the passport. Information in EVUS will be retained for one year after the EVUS travel enrollment expires. After this period, the inactive account information will be purged from online access and archived for 12 years. At any time during the 15-year retention period (generally 3 years active, 12 years archived) CBP will match data linked to active law enforcement lookout records to enforcement activities, and/or investigations or cases, including EVUS enrollment attempts that are unsuccessful, which will remain accessible for the life of the law enforcement activities to which they may become related. NARA guidelines for retention and archiving of data will apply to EVUS and CBP continues to negotiate with NARA for approval of the EVUS data retention and archiving plan. Records replicated on the unclassified and classified networks will follow the same retention schedule.

    Payment information is not stored in EVUS, but is forwarded to Pay.gov and stored in CBP's financial processing system, CDCDS, pursuant to the DHS/CBP-018, CDCDS system of records notice.

    When a traveler's EVUS data is used for purposes of processing his or her application for admission to the United States, the EVUS data will be used to create a corresponding admission record in the DHS/CBP-016 Non-Immigrant Information System (NIIS) (March 13, 2015, 80 FR 13398). This corresponding admission record will be retained in accordance with the NIIS retention schedule, which is 75 years.

    System Manager and address:

    Director, Office of Automated Systems, U.S. Customs and Border Protection Headquarters, 1300 Pennsylvania Avenue NW., Washington, DC 20229.

    Notification procedure:

    Enrollees may access their EVUS information to view and amend their enrollment by providing their EVUS number, birth date, and passport number through the EVUS Web site. Once they have provided their EVUS number, birth date, and passport number, enrollees may view their EVUS status (successful enrollment, unsuccessful enrollment, pending) and submit limited updates to their travel itinerary information. If an enrollee does not know his or her enrollment number, he or she can provide his or her name, passport number, date of birth, passport issuing country, and visa number to retrieve his or her enrollment number.

    In addition, EVUS enrollees and other individuals whose information is included on EVUS enrollment may submit requests and receive information maintained in this system as it relates to data submitted by or on behalf of a person who travels to the United States and crosses the border, as well as, for EVUS enrollees, the resulting determination (successful enrollment, pending, unsuccessful enrollment). However, the Secretary of Homeland Security has exempted portions of this system from certain provisions of the Privacy Act related to providing the accounting of disclosures to individuals because it is a law enforcement system. CBP will, however, consider individual requests to determine whether or not information may be released. In processing requests for access to information in this system, CBP will review not only the records in the operational system but also the records that were replicated on the unclassified and classified networks, and based on this notice provide appropriate access to the information.

    Individuals seeking notification of, and access to, any record contained in this system of records, or seeking to contest its content, may submit a request in writing to the Chief Privacy Officer and Headquarters Freedom of Information Act (FOIA) Officer, whose contact information can be found at http://www.dhs.gov/foia under “FOIA Contact Information.” If an individual believes more than one component maintains Privacy Act records concerning him or her, the individual may submit the request to the Chief Privacy Officer and Chief Freedom of Information Act Officer, Department of Homeland Security, 245 Murray Drive SW., Building 410, STOP-0655, Washington, DC 20528.

    When seeking records about yourself from this system of records or any other Departmental system of records, your request must conform with the Privacy Act regulations set forth in 6 CFR part 5. You must first verify your identity, meaning that you must provide your full name, current address, and date and place of birth. You must sign your request, and your signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty of perjury as a substitute for notarization. While no specific form is required, you may obtain forms for this purpose from the Chief Privacy Officer and Chief Freedom of Information Act Officer, http://www.dhs.gov/foia or 1-866-431-0486. In addition, you should:

    • Explain why you believe the Department would have information on you;

    • Identify which component(s) of the Department you believe may have the information about you;

    • Specify when you believe the records would have been created; and

    • Provide any other information that will help the FOIA staff determine which DHS component agency may have responsive records.

    If your request is seeking records pertaining to another living individual, you must include a statement from that individual certifying his or her agreement for you to access his or her records.

    Without the above information, the component(s) may not be able to conduct an effective search, and your request may be denied due to lack of specificity or lack of compliance with applicable regulations.

    Record access procedures:

    See “Notification procedure” above.

    Contesting record procedures:

    See “Notification procedure” above.

    Record source categories:

    Records are obtained from the online EVUS enrollment at https://www.cbp.gov/EVUS. Some record information is derived from visa records of the U.S. Department of State.

    Exemptions claimed for the system:

    No exemption shall be asserted with respect to information maintained in the system as it relates to data submitted by or on behalf of a person who travels to visit the United States and crosses the border, nor shall an exemption be asserted with respect to the resulting determination (authorized to travel, pending, or not authorized to travel). Information in the system may be shared with law enforcement and/or intelligence agencies pursuant to the above routine uses. The Privacy Act requires DHS to maintain an accounting of the disclosures made pursuant to all routines uses. Disclosing the fact that a law enforcement or intelligence agency has sought and been provided particular records may affect ongoing law enforcement activities. As such, pursuant to 5 U.S.C. 552a(j)(2), DHS will claim exemption from secs (c)(3), (e)(8), and (g) of the Privacy Act of 1974, as amended, as is necessary and appropriate to protect this information. Further, DHS will claim exemption from sec. (c)(3) of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(k)(2) as is necessary and appropriate to protect this information.

    Dated: August 29, 2016. Jonathan R. Cantor, Acting Chief Privacy Officer, Department of Homeland Security.
    [FR Doc. 2016-21100 Filed 8-31-16; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [16X L1109AF LLUT980300 L13100000.XZ0000 24-1A] Second Call for Nominations for the Utah Resource Advisory Council, State Agency Category AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The purpose of this notice is to request a second call for nominations for one open position on the Bureau of Land Management (BLM) Utah Resource Advisory Council (RAC) because we did not receive a sufficient number of applications from the first call for nominations. The vacant position is in category three, employees of a State agency responsible for the management of natural resources. The RAC provides advice and recommendations to the BLM on land use planning and management of the National System of Public Lands within their geographic areas. The BLM will accept public nominations for 30 days after the publication of this notice.

    DATES:

    All nominations must be received no later than October 3, 2016.

    ADDRESSES:

    All nominations must be sent to Lola Bird, Public Affairs Specialist, Bureau of Land Management, Utah State Office, 440 West 200 South, Suite 500, Salt Lake City, Utah 84101.

    FOR FURTHER INFORMATION CONTACT:

    Lola Bird, Public Affairs Specialist, Bureau of Land Management Utah State Office, 440 West 200 South, Suite 500, Salt Lake City, Utah 84101; by telephone (801) 539-4033 or by 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 leave a message or question for the above individual. The FIRS is available 24 hours a day, seven days a week. Replies are provided during normal business hours.

    SUPPLEMENTARY INFORMATION:

    The Federal Land Policy and Management Act (FLPMA) directs the Secretary of the Interior to involve the public in planning and issues related to management of public lands administered by the BLM. Section 309 of FLPMA (43 U.S.C. 1739) directs the Secretary to establish 10- to 15-member citizen-based advisory councils that are consistent with the Federal Advisory Committee Act (FACA). As required by FACA, RAC membership must be balanced and representative of the various interests concerned with the management of the public lands.

    The BLM-Utah RAC is hosting a call for nominations for a vacant position in category three (description addressed in the SUMMARY above). Upon appointment, the individual selected will fill the position until the term's ending date of June 22, 2018. Nominees must be residents of Utah. The BLM will evaluate nominees based on their training, education, experience, and knowledge of the council's geographical area. Nominees should also demonstrate a commitment to consensus building and collaborative resource decision-making. Individuals who are Federally registered lobbyists are ineligible to serve on all FACA and non-FACA boards, committees, or councils in an individual capacity. The term “individual capacity” refers to individuals who are appointed to exercise their own individual best judgment on behalf of the government, such as when they are designated Special Government Employees, rather than being appointed to represent a particular interest. All nominations must be accompanied by letters of reference from any represented interests or organizations, a completed RAC application, and any other information that speaks to the nominee's qualifications.

    The BLM-Utah will consult with the governor's office before forwarding its recommendations to the Secretary of the Interior for a final decision. Simultaneous with this notice, BLM-Utah will issue a press release providing additional information for submitting nominations.

    Authority:

    43 CFR 1784.4-1.

    Jenna Whitlock, Acting State Director.
    [FR Doc. 2016-21102 Filed 8-31-16; 8:45 am] BILLING CODE 4310-DQ-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-CONC-20859; PPWOBSADC0, PPMVSCS1Y.Y00000] Notice of Extension of Concession Contract AGENCY:

    National Park Service, Interior.

    ACTION:

    Public notice.

    SUMMARY:

    The National Park Service hereby gives public notice that it proposes to extend the following expiring concession contract until December 31, 2017, or until the effective date of a new contract, whichever occurs sooner:

    CONCID Concessioner Park unit GLCA001-06 Colorado River Discovery, LLC Glen Canyon National Recreation Area. DATES:

    Effective November 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Brian Borda, Chief, Commercial Services Program, National Park Service, 1201 Eye Street NW., 5th Floor, Washington, DC 20005, Telephone: 202-513-7156.

    SUPPLEMENTARY INFORMATION:

    The listed concession contract will expire by its terms on October 31, 2016. The National Park Service has determined the proposed short-term extension necessary to avoid interruption of visitor services and has taken all reasonable and appropriate steps to consider alternatives to avoid such interruption. The National Park Service considered issuing a temporary concession contract, but deemed that alternative impractical given the time constraints and likelihood it would not increase competition. Under the provisions of the current concession contract and pending the completion of the public solicitation of a prospectus for a new concession contract, the National Park Service authorizes the extension of visitor services under the terms and conditions of the current contract as amended. The extension of operations does not affect any rights with respect to selection for award of a new concession contract. The publication of this notice merely reflects the intent of the National Park Service but does not bind the National Park Service to extend the contract identified above.

    Dated: August 11, 2016. Lena McDowall, Chief Financial Officer.
    [FR Doc. 2016-21101 Filed 8-31-16; 8:45 am] BILLING CODE 4312-53-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-21656; PX.XVPAD0522.0.1] Change of Jurisdiction—National Park Service Units Within the Commonwealth of Kentucky AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice of change in jurisdiction.

    SUMMARY:

    On behalf of the United States, the National Park Service accepted exclusive jurisdiction from the Commonwealth of Kentucky over certain lands and waters administered by the National Park Service within Mammoth Cave National Park. The National Park Service also accepted concurrent jurisdiction between the United States and the Commonwealth of Kentucky on certain lands and waters administered by the National Park Service within Abraham Lincoln National Historic Site, Cumberland Gap National Historical Park, and Fort Donelson National Battlefield.

    DATES:

    Effective Date: Exclusive jurisdiction on certain lands and waters within Mammoth Cave National Park became effective on December 7, 2015. Concurrent jurisdiction on certain lands and waters of Abraham Lincoln National Historic Site, Cumberland Gap National Historical Park, and Fort Donelson National Battlefield became effective on July 28, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Jonathan Pierce, National Park Service, Southeast Region, 100 Alabama Street SW., 1924 Building, Atlanta, GA 30303. Phone: 404-507-5726.

    SUPPLEMENTARY INFORMATION: Exclusive Jurisdiction

    Mammoth Cave National Park (MACA) was created by Congress in 1926. In 1930, the Commonwealth of Kentucky ceded to the United States exclusive jurisdiction over all lands and waters acquired by the United States for MACA, effective when the United States accepted such jurisdiction by statute on June 5, 1942. By Kentucky law, the cession and acceptance was limited to lands owned by the United States. On July 2, 1986, the Director of the National Park Service (NPS) notified the Governor of Kentucky that he was accepting exclusive jurisdiction over lands and waters acquired by the United States within MACA between 1942 and 1986.

    Since July 2, 1986, the United States has acquired additional lands for MACA. Accordingly, in a letter dated May 21, 2014, the Director of the NPS notified the Governor of the Commonwealth of Kentucky that he formally accepted on behalf of NPS exclusive jurisdiction over lands and waters within the legislated boundaries of MACA, that were acquired by the U.S. Government after July 2, 1986. Exclusive jurisdiction over these lands was established by the Governor's acknowledgement of receipt of the letter on December 7, 2015.

    For the lands within MACA whereby exclusive jurisdiction had been accepted in 1942 and 1986, that acceptance remains in effect.

    Concurrent Jurisdiction

    On April 19, 1994, upon application by the NPS, the Governor of the Commonwealth of Kentucky signed Executive Order 94-355 (E.O.), ceding legislative jurisdiction on lands owned by the United States within Abraham Lincoln Birthplace National Historic Site (ABLI), Big South Fork National River and Recreation Area (BISO), and Cumberland Gap National Historical Park (CUGA). The Director of the NPS accepted the cession as required by Federal law. Part IV of the E.O. provided that, in the event of an alteration of the descriptions of the lands, the NPS would transmit new descriptions to be annexed to the E.O.

    Since April 19, 1994, the United States has acquired additional lands in Kentucky within the legislated boundaries of ABLI and CUGA. Further, an additional unit of the National Park System, Fort Donelson National Battlefield (FODO; Fort Heiman Unit), has been established in the Commonwealth of Kentucky. To bring these NPS administered lands under concurrent legislative jurisdiction, it was necessary to update the E.O. of April 19, 1994.

    Therefore, the Commonwealth of Kentucky through signature on a cession instrument by the Governor ceded to the United States such measure of jurisdiction as necessary to effectuate a status of concurrent legislative jurisdiction for purposes of criminal law enforcement on these acquired lands within ABLI, CUGA, and FODO.

    This cession is limited to lands within each of the above-listed units which were acquired since April 19, 1994. The NPS, acting through the Director, formally accepted the described cession of concurrent jurisdiction, through his signature on the cession instrument. Concurrent legislative jurisdiction became effective with entry of the cession instrument upon the Executive Journal for the Commonwealth of Kentucky on July 28, 2016.

    For all other NPS administered lands within these units whereby concurrent legislative jurisdiction had been ceded in 1994, that cession remains in effect.

    Dated: August 23, 2016. Michael T. Reynolds, Acting Director, National Park Service.
    [FR Doc. 2016-21098 Filed 8-31-16; 8:45 am] BILLING CODE 4312-EJ-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-21728; PPWOCRADN0-PCU00RP14.R50000] Notice of Inventory Completion: Tennessee Valley Authority, Knoxville, TN AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The Tennessee Valley Authority (TVA) has completed an inventory of human remains and associated funerary objects in consultation with the appropriate federally recognized Indian tribes, and has determined that a cultural affiliation between the human remains and associated funerary objects and any present-day federally recognized Indian tribes cannot be reasonably traced. Representatives of any federally recognized Indian tribe not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to TVA. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the federally recognized Indian tribe stated in this notice may proceed.

    DATES:

    Representatives of any federally recognized Indian tribe not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to TVA at the address in this notice by October 3, 2016.

    ADDRESSES:

    Dr. Thomas O. Maher, TVA, 400 West Summit Hill Drive, WT11D, Knoxville, TN 37902-1401, telephone (865) 632-7458, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of TVA. The human remains and associated funerary objects were removed from sites in Lauderdale County, AL.

    This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3) and 43 CFR 10.11(d). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.

    Consultation

    A detailed assessment of the human remains and associated funerary objects was made by TVA professional staff in consultation with the University of Alabama and representatives of the Alabama-Coushatta Tribe of Texas (previously listed as the Alabama-Coushatta Tribes of Texas); Alabama-Quassarte Tribal Town; Cherokee Nation; Coushatta Tribe of Louisiana; Eastern Band of Cherokee Indians; Eastern Shawnee Tribe of Oklahoma; Poarch Band of Creeks (previously listed as the Poarch Band of Creek Indians of Alabama); The Chickasaw Nation; The Choctaw Nation of Oklahoma; The Muscogee (Creek) Nation; Thlopthlocco Tribal Town; and the United Keetoowah Band of Cherokee Indians in Oklahoma.

    History and Description of the Remains

    The sites listed in this notice were excavated as part of TVA's Pickwick Reservoir project by the Alabama Museum of Natural History (AMNH) at the University of Alabama, using labor and funds provided by the Works Progress Administration. Details regarding these excavations and sites may be found in a report, An Archaeological Survey of Pickwick Basin in the Adjacent Portions of the States of Alabama, Mississippi, and Tennessee, by William S. Webb and David L. DeJarnette. The human remains and associated funerary objects listed in this notice have been in the physical custody of the AMNH at the University of Alabama since excavation but are under the control of TVA.

    In February 1937, human remains representing, at minimum, 24 individuals were removed from the Smithsonia Landing site, 1LU5, in Lauderdale County, AL. Excavation commenced after TVA acquired the land encompassing site 1LU5 on May 4, 1936. This shell midden site had been disturbed by a historic riverboat landing and associated buildings. This disturbance and rising reservoir water levels led to limited excavations revealing a Late Archaic (4000-1000 B.C.) occupation. The human remains include adults, juveniles, and infants of both sexes. No known individuals were identified. There are 19 associated funerary objects including 2 stone adzes, 1 chert biface, 2 bone awls, 2 Little Bear Creek projectile points, 3 fresh water pearl beads, and 9 shell beads.

    From August 1937 to April 1938, human remains representing, at minimum, 8 individuals were removed from 1LU21, in Lauderdale County, AL. Excavation commenced after TVA acquired the land encompassing this site on February 19, 1937. Excavations focused on the earthen mound, constructed in four stages and supported at least four superimposed structures and two peripheral single post structures. The primary occupation of this mound was during the Kogers Island phase (A.D. 1200-1500) of the Mississippian period. The human remains represent infants, adolescents, and adults. No known individuals were identified. The 179 associated funerary objects include 1 Bell Plain bottle; 1 Bell Plain double jar; 1 celt; 1 copper gorget fragment; 9 copper ear spool fragments; 2 copper covered wood bead fragments; 1 hooded owl effigy bottle; 1 Mississippi Plain bowl; 14 Mississippi Plain double jar fragments; 1 Mississippi Plain jar; 42 Mississippi Plain jar fragments; 27 Mississippi Plain sherds; 1 Mississippi Plain red-filmed rim; 1 Moundville Engraved bottle; 2 shell gorget fragments; 73 shell beads; and 1 shell-tempered incised and noded composite jar/bowl.

    From October 1937 to December 1938, human remains representing, at minimum, 159 individuals were removed from site 1LU92 in Lauderdale County, AL. Excavation commenced after TVA purchased this land on November 27, 1935. Site 1LU92 was composed of both a village and a cemetery and excavations focused on the cemetery. There was no clear stratigraphy at the site. The excavators believed the village midden was created by an earlier occupation than the cemetery. The cemetery occupation is attributed to the Kogers Island phase (A.D. 1200-1500) of the Mississippian period. The human remains include adults, juveniles, children, and infants of both sexes. No known individuals were identified. The 3,654 associated funerary objects include 39 antler tip projectile points; 1 antler tool; 1 Barton Incised, var. unspecified jar; 4 Baytown Plain sherds; 20 bear tooth beads; 1 beaver incisor; 119 Bell Plain sherds; 4 Bell Plain bottles; 3 Bell Plain bowl sherds; 2 Bell Plain bowls; 2 Bell plain Effigy bowls; 2 Bell Plain jars; 1 Bell Plain lobate bottle; 4 chert bifaces ; 1 bird bone; 109 bird sternum fragments; 28 bone awls; 6 bone awl fragments; 2 bone fragments; 2 bone needles; 12 bone pins; 4 bone tool fragments; 9 repousse copper cutouts; 7 copper ear bob fragments; 15 copper ear plug fragments; 1 copper stained bone needle; 1 cortical chert flake; 1 Crow Creek Noded jar; 4 Duck River sword projectile points/knives; 1 effigy pipe; 2 Elk River projectile points/knives; 1 Flint River projectile point/knife; 1 ground galena nodule; 4 greenstone celts; 2 Guntersville projectile points/knives; 1 hammerstone/abrader; 2 Ledbetter projectile points/knives; 1 Little Bear Creek projectile point/knife; 2 Madison projectile points/knives; 2 mammal tooth beads; 2 McIntire projectile points/knives; 1 McKee Island Brushed jar; 6 McKee Island Brushed sherds; 176 Mississippi Plain sherds; 1 Mississippi Plain bottle; 1 Mississippi Plain bowl; 14 Mississippi Plain jars; 1 modified fish jaw; 2 modified shells; 2 Moundville Engraved, var. Hemphill bottles; 21 Moundville Engraved, var. Tuscaloosa bottle sherds; 1 Moundville Incised, var. Carrolton jar; 1 Moundville Incised, var. unspecified jar; 18 Moundville Incised, var. unspecified sherds; 2 mussel shells; 3 stone palettes; 20 projectile points/knives; 1 rodent mandible; 2,335 shell beads; 3 shell cups; 3 shell ear plugs; 1 Cox style shell gorget; 1 spade/spatulate celt; 1 Stanfield projectile point/knife; 551 turtle shell fragments; 2 unmodified fish jaw; 1 unmodified limestone; 1 unmodified shell; and 58 unmodified stones.

    From February to May 1937, and from February to March 1938, human remains representing, at minimum, 13 individuals were removed from site 1LU64, 23 miles downstream from Florence on the Tennessee River in Lauderdale County, AL. TVA purchased the land encompassing site 1LU64 on October 28, 1936. Site 1LU64 was a Copena phase (A.D. 100-500) burial mound that was damaged by trenching in 1917. The human remains are fragmented and represent adults and children of indeterminate sex. No known individuals were identified. The 10 associated funerary objects include 2 copper beads, 6 galena nodules, 1 piece of galena ground into a discoidal, and 1 piece of red ochre.

    In February 1937, human remains representing, at minimum, one individual were removed from site 1LU65, adjacent to 1LU64 in Lauderdale County, AL. TVA purchased the land encompassing site 1LU65 on October 28, 1936. A small portion of this village was excavated before inundation of the Pickwick reservoir. The human remains represent one adult of unknown sex. No known individuals were identified. No associated funerary objects are present.

    From June to September 1936, human remains representing, at minimum, 109 individuals were removed from the Long Branch site, 1LU67 in Lauderdale County, AL. Excavation commenced after TVA purchased three parcels of land encompassing this site on January 11, 1935, September 16, 1935, and February 8, 1936. Site 1LU67 was located immediately adjacent to the Tennessee River. Although described as a mound, this site appears to have been created from the accumulation of discarded shell, village midden, and alluvial soils rather than an intentionally constructed earthwork. This shell midden extended to a depth of 11 feet below surface. The Long Branch site had multiple occupation including the Middle Archaic (6000-4000 B.C.), Late Archaic (4000-1000 B.C.), early Woodland (500-100 B.C.), Middle Woodland (100 B.C. to A.D. 500), Late Woodland (A.D. 500-1000), and Mississippian (A.D. 900-1500) periods. It is not possible to determine from which level of occupation the human remains originated. The human remains include adults, juveniles, children, and infants of both sexes. No known individuals were identified. The 2,330 associated funerary objects include 2 Alexander incised sherds; 1 Alexander Punctated var. Tibbee sherd; 1 antler handle; 2 antler shaft wrenches; 2 antler atlatl hook fragments; 2 Baldwin Plain sherds; 3 Bell Plain bowl rim sherds; 21 Bell Plain sherd; 2 Benton projectile points/knives; 4 chert bifaces; 1 Bluff Creek Simple Stamped sherd; 16 bone awls; 1 bone fragment; 11 bone pendants; 1 decorated bone pin; 14 chert beads; 1 Copena projectile points/knives; 9 fabric fragments; 139 Gastropod shell beads; 2 ground conch shell fragments; 1 hammerstone; 1 Jasper bead, ground; 15 Long Branch Fabric Marked sherds; 7 Mississippi Plain jar sherds; 1 Mulberry Creek Cord Marked sherd; 2 Mulberry Creek Plain sherds; 1,912 shell beads; 44 shell gorgets/pendants; 12 shell pendant fragments; 3 shell pins; 93 terrapin shell fragments; 3 unidentified bone fragments; and 1 Wright Creek Check Stamped sherd.

    From January to February 1938, human remains representing, at minimum, 31 individuals were removed from the Union Hollow site, 1LU72, Lauderdale County, AL. Excavation commenced after TVA purchased the land encompassing this site on October 5, 1936. Site 1LU72 was located immediately adjacent to the Tennessee River. This shell “mound” was created from the accumulation of discarded shell, village midden, and alluvial soils rather than intentionally constructed earthworks. This shell midden extended to a depth of 10 feet below surface. Early flooding of the Pickwick reservoir abbreviated excavations at this site. The Union Hollow site had multiple occupation including the Late Archaic (4000-1000 B.C.), Early Woodland (500-100 B.C.) and Mississippian (A.D. 1200-1500) periods. The human remains include infants, children, and adults of both sexes. No known individuals were identified. The 116 associated funerary objects include 2 antler drifts/tools; 1 Baytown Plain sherd; 14 Bell Plain jar sherds; 2 bone fish hooks; 23 bone pendants; 1 Flint Creek projectile point/knife; 1 ground stone abrader; 3 ground stone celts; 1 hammerstone; 2 Long Branch Cord Marked sherds; 1 Mississippi Plain jar; 8 Mississippi Plain sherds; 10 Mississippi Plain noded rim sherds; 3 Mulberry Creek Cord Marked sherds; 2 shell ear plugs; 2 shell cup/spoon fragments; 39 turtle carapace fragments; and 1 Wheeler Check Stamped sherd.

    TVA has determined that cultural affiliation between the human remains and associated funerary objects excavated from sites 1LU5, 1LU21, 1LU92, 1LU64, 1LU65, 1LU67, and 1LU72, and any present-day federally recognized tribes cannot be reasonably traced. Accordingly, these items are culturally unidentifiable, and TVA intends to transfer control of these items pursuant to 43 CFR 10.11(c).

    At the time of the excavation and removal of these human remains and associated funerary objects, the land from which the human remains and associated funerary objects were removed was not