Federal Register Vol. 83, No.160,

Federal Register Volume 83, Issue 160 (August 17, 2018)

Page Range40931-42015
FR Document

83_FR_160
Current View
Page and SubjectPDF
83 FR 41073 - Sunshine Act MeetingsPDF
83 FR 41113 - Sunshine Act MeetingsPDF
83 FR 41139 - E.O. 13224 Designation of Qassim Abdullah Ali Ahmed, aka Qassim al-Muamen, aka Qassim Al Muamen, aka Qassim Abdullah Ali, aka Qassim Abdullah as a Specially Designated Global TerroristPDF
83 FR 41140 - Review of the Designation as a Foreign Terrorist Organization of Boko Haram (and Other Aliases)PDF
83 FR 41140 - Review of the Designation as a Foreign Terrorist Organization of Abu Sayyaf Group (and Other Aliases)PDF
83 FR 41073 - Medicare and Medicaid Program; Application From DNV GL-Healthcare (DNV GL) for Continued Approval of Its Hospital Accreditation ProgramPDF
83 FR 41096 - Technical Mapping Advisory CouncilPDF
83 FR 41068 - Proposed Collection; Comment RequestPDF
83 FR 41065 - Procurement List; DeletionsPDF
83 FR 41064 - Procurement List; Proposed Addition and DeletionsPDF
83 FR 41035 - Approval and Promulgation of Air Quality Implementation Plans; State of Colorado; Motor Vehicle Inspection and Maintenance Program and Associated RevisionsPDF
83 FR 41069 - Proposed Collection; Comment RequestPDF
83 FR 41069 - Submission for OMB Review; Comment RequestPDF
83 FR 40985 - Drawbridge Operation Regulation; Columbia River, Portland, OR and Vancouver, WAPDF
83 FR 40986 - Drawbridge Operation Regulation; Willamette River at Portland, ORPDF
83 FR 41095 - Lifejacket Approval HarmonizationPDF
83 FR 41019 - Fisheries of the Exclusive Economic Zone Off Alaska; Sablefish in the West Yakutat District of the Gulf of AlaskaPDF
83 FR 41020 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Ocean Perch in the West Yakutat District of the Gulf of AlaskaPDF
83 FR 41078 - Process To Request a Review of Food and Drug Administration's Decision Not To Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
83 FR 41059 - Notice of Public Meeting of the Idaho Advisory CommitteePDF
83 FR 41026 - Proposed Removal of Temporary Regulations on a Partner's Share of a Partnership Liability for Disguised Sale Purposes; Hearing CancellationPDF
83 FR 41114 - New Postal ProductsPDF
83 FR 41097 - 60-Day Notice of Proposed Information Collection: Home Equity Conversion Mortgage (HECM) Counseling Standardization and RosterPDF
83 FR 41099 - 30-Day Notice of Proposed Information Collection: Single Family Mortgage Insurance on Hawaiian HomelandsPDF
83 FR 41098 - 30-Day Notice of Proposed Information Collection: Indian Community Development Block GrantPDF
83 FR 41077 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Controlled Correspondence Related to Generic Drug DevelopmentPDF
83 FR 41093 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 41080 - Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff; Information Available to Industry; Extension of the Proposal PeriodPDF
83 FR 41093 - Draft Report on Carcinogens Monograph on Night Shift Work and Light at Night; Availability of Document; Request for Comments; Notice of Peer-Review MeetingPDF
83 FR 41059 - Carbazole Violet Pigment 23 From India: Rescission of Countervailing Duty Administrative Review; 2016PDF
83 FR 41081 - National Institute of Neurological Disorders and Stroke; Notice of Closed MeetingsPDF
83 FR 41140 - Notice of National Grain Car Council MeetingPDF
83 FR 41067 - Submission for OMB Review; Comment RequestPDF
83 FR 41076 - Proposed Information Collection Activity; Comment RequestPDF
83 FR 41060 - Mid-Atlantic Fishery Management Council (MAFMC); Public HearingsPDF
83 FR 41061 - Pacific Fishery Management Council; Public MeetingsPDF
83 FR 41063 - North Pacific Fishery Management Council; Public MeetingPDF
83 FR 41063 - Fisheries of the Gulf of Mexico; Southeast Data, Assessment, and Review (SEDAR); Public MeetingPDF
83 FR 41062 - Marine Mammals; File No. 22222PDF
83 FR 41068 - Submission for OMB Review; Comment RequestPDF
83 FR 40973 - Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting Program for ManufacturersPDF
83 FR 41141 - Petition for Exemption; Summary of Petition Received; Headquarters Air Force Junior Reserve Officer Training CorpsPDF
83 FR 41075 - Proposed Information Collection Activity; Comment RequestPDF
83 FR 41021 - Proposed Amendment of VOR Federal Airways V-18, V-102, and V-278 in the Vicinity of Guthrie, TXPDF
83 FR 40967 - Amendment of Multiple Restricted Area Boundary Descriptions; FloridaPDF
83 FR 41046 - Rural Development Cooperative Agreement ProgramPDF
83 FR 41056 - Establishment of Maximum Interest RatePDF
83 FR 41032 - Special Local Regulation; Breton Bay, Leonardtown, MDPDF
83 FR 41029 - Special Local Regulation; Choptank River, Talbot and Dorchester Counties, MDPDF
83 FR 41072 - North Carolina Electric Membership Corporation v. Duke Energy Progress, LLC; Notice of ComplaintPDF
83 FR 41082 - National Institutes of Health (NIH) Office of Science Policy (OSP) Recombinant or Synthetic Nucleic Acid Research: Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)PDF
83 FR 41081 - Request for Information To Solicit Feedback on the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) InitiativePDF
83 FR 41071 - Agency Information Collection Activities; Comment Request; Federal Family Educational Loan Program-Servicemembers Civil Relief Act (SCRA)PDF
83 FR 41141 - Rescission of Notice of Intent (NOI) To Prepare an Environmental Impact Statement (EIS)PDF
83 FR 41140 - Meeting of the Regional Energy Resource CouncilPDF
83 FR 41100 - Endangered and Threatened Wildlife and Plants; Draft Recovery Plan for Neosho MucketPDF
83 FR 41108 - Notice of Availability of the Grand Staircase-Escalante National Monument-Grand Staircase, Kaiparowits, and Escalante Canyon Units and Federal Lands Previously Included in the Monument That Are Excluded From the Boundaries Draft Resource Management Plans and Associated Environmental Impact StatementPDF
83 FR 41111 - Notice of Availability of the Draft Bears Ears National Monument Indian Creek and Shash Jáa Units Monument Management Plans and Associated Environmental Impact Statement, UtahPDF
83 FR 41113 - Proposed Submission of Information Collection for OMB Review; Comment Request; Partitions of Eligible Multiemployer PlansPDF
83 FR 41080 - Agency Information Collection Activities; Proposed Collection; Public Comment RequestPDF
83 FR 41072 - Environmental Impact Statements; Notice of AvailabilityPDF
83 FR 41070 - Proposed Collection; Comment RequestPDF
83 FR 41138 - Presidential Declaration Amendment of a Major Disaster for the State of HawaiiPDF
83 FR 41071 - Agency Information Collection Activities; Comment Request; Servicemembers Civil Relief Act (SCRA): Interest Rate Limitation RequestPDF
83 FR 41117 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule Change, as Modified by Amendment No. 1, To Require Certain Member Organizations To Participate in Scheduled Market-Wide Circuit Breaker TestingPDF
83 FR 41121 - Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Section 7018(a) of the Exchange's RulesPDF
83 FR 41118 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change Relating To Amending the ICC Clearing Rules Regarding Mark-to-Market MarginPDF
83 FR 41126 - Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to the Exchange Rule 514 Priority on the ExchangePDF
83 FR 41058 - Notice of Public Meeting of the West Virginia Advisory CommitteePDF
83 FR 41124 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Exchange's Schedule of Fees Relating to Crossing Orders and Responses to Crossing Orders in Index Options on the Nasdaq 100 Reduced Value IndexPDF
83 FR 41115 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Delete and Replace the Current Rules on ArbitrationPDF
83 FR 41128 - Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of Filing of a Proposed Rule Change To Make Permanent Rule 11.24, Which Sets Forth the Exchange's Pilot Retail Price Improvement ProgramPDF
83 FR 41057 - Notice of Public Meeting of the Virginia Advisory CommitteePDF
83 FR 41057 - Agenda and Notice of Public Meeting of the Delaware Advisory CommitteePDF
83 FR 41058 - Agenda and Notice of Public Meeting of the District of Columbia Advisory CommitteePDF
83 FR 41076 - Science and Regulation of Live Microbiome-Based Products Used To Prevent, Treat, or Cure Diseases in Humans; Public WorkshopPDF
83 FR 41023 - Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for CommentsPDF
83 FR 41045 - Humboldt-Toiyabe National Forest; Clark Counties, Nevada; Lee Canyon Notice of AvailabilityPDF
83 FR 41101 - Indian Gaming; Approval of Tribal-State Class III Gaming Compact Amendments in the State of OklahomaPDF
83 FR 41102 - Indian Gaming; Approval of Tribal-State Class III Gaming Compact Amendments in the State of OklahomaPDF
83 FR 41139 - Changes to SBA Secondary Market ProgramPDF
83 FR 41042 - United States Standards for Grades of Pork CarcassesPDF
83 FR 41102 - Rate Adjustments for Indian Irrigation ProjectsPDF
83 FR 40931 - Cotton Board Rules and Regulations: Adjusting Supplemental Assessment on Imports (2018 Amendments)PDF
83 FR 41043 - Agency Information Collection Activities: Proposed Collection; Comment Request-Supplemental Nutrition Assistance Program (SNAP), Store Applications, Forms FNS-252, FNS-252-E, FNS-252-FE, FNS-252-R, FNS-252-2 and FNS-252-CPDF
83 FR 41066 - Proposed Extension of Approval of Information Collection; Comment Request; Notification Requirements for Coal and Wood Burning AppliancesPDF
83 FR 41066 - Proposed Extension of Approval of Information Collection; Comment Request-Testing and Recordkeeping Requirements for Carpets and RugsPDF
83 FR 41018 - Snapper-Grouper Fishery of the South Atlantic; 2018 Commercial Accountability Measure and Closure for the Other Jacks ComplexPDF
83 FR 41112 - Proposed Collection, Comment RequestPDF
83 FR 41006 - Air Plan Approval; California; San Joaquin Valley Unified Air Pollution Control District; Reasonably Available Control Technology DemonstrationPDF
83 FR 41039 - World Trade Center Health Program; Petition 019-Irritable Bowel Syndrome; Finding of Insufficient EvidencePDF
83 FR 40961 - Airworthiness Directives; Rolls-Royce Corporation EnginesPDF
83 FR 40963 - Airworthiness Directives; ATR-GIE Avions de Transport Régional AirplanesPDF
83 FR 40959 - Airworthiness Directives; Fokker Services B.V. AirplanesPDF
83 FR 40971 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous AmendmentsPDF
83 FR 40968 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous AmendmentsPDF
83 FR 41954 - Centralized Partnership Audit RegimePDF
83 FR 40945 - Amendment to the Annual Privacy Notice Requirement Under the Gramm-Leach-Bliley Act (Regulation P)PDF
83 FR 41026 - TRICARE; Extended Care Health Option (ECHO) Respite CarePDF
83 FR 41039 - Significant New Use Rules on Certain Chemical SubstancesPDF
83 FR 40986 - Significant New Use Rules on Certain Chemical SubstancesPDF
83 FR 41009 - Civilian Board of Contract Appeals; Rules of Procedure for Contract Disputes Act CasesPDF
83 FR 41786 - Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Pathways to SuccessPDF
83 FR 41144 - Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of ClaimsPDF

Issue

83 160 Friday, August 17, 2018 Contents Agricultural Marketing Agricultural Marketing Service RULES Cotton Board Rules and Regulations: Adjusting Supplemental Assessment on Imports (2018 Amendments), 40931-40945 2018-17723 NOTICES Standards for Grades of Pork Carcasses, 41042-41043 2018-17725 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Food and Nutrition Service

See

Forest Service

See

Rural Business-Cooperative Service

See

Rural Housing Service

See

Rural Utilities Service

AIRFORCE Air Force Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41067-41068 2018-17778 Consumer Financial Protection Bureau of Consumer Financial Protection RULES Annual Privacy Notice Requirement Under the Gramm-Leach-Bliley Act (Regulation P), 40945-40959 2018-17572 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims, 41144-41784 2018-16766 PROPOSED RULES Medicare Program: Medicare Shared Savings Program; Accountable Care Organizations Pathways to Success, 41786-41951 2018-17101 NOTICES Medicare and Medicaid Program: Application from DNV G--Healthcare for Continued Approval of its Hospital Accreditation Program, 41073-41075 2018-17815 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41075-41076 2018-17768 2018-17777 Civil Rights Civil Rights Commission NOTICES Meetings: Delaware Advisory Committee, 41057 2018-17734 District of Columbia Advisory Committee, 41058 2018-17733 Idaho Advisory Committee, 41059 2018-17795 Virginia Advisory Committee, 41057-41058 2018-17735 West Virginia Advisory Committee, 41058-41059 2018-17739 Coast Guard Coast Guard RULES Drawbridge Operations: Columbia River, Portland, OR and Vancouver, WA, 40985-40986 2018-17801 Willamette River at Portland, OR, 40986 2018-17800 PROPOSED RULES Special Local Regulations: Breton Bay, Leonardtown, MD, 41032-41035 2018-17763 Choptank River, Talbot and Dorchester Counties, MD, 41029-41032 2018-17762 NOTICES Lifejacket Approval Harmonization, 41095-41096 2018-17799 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 41064-41065 2018-17806 2018-17807 Consumer Product Consumer Product Safety Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Notification Requirements for Coal and Wood Burning Appliances, 41066-41067 2018-17721 Testing and Recordkeeping Requirements for Carpets and Rugs, 41066 2018-17720 Defense Department Defense Department See

Air Force Department

PROPOSED RULES TRICARE: Extended Care Health Option (ECHO) Respite Care, 41026-41029 2018-17463 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41068-41071 2018-17746 2018-17771 2018-17802 2018-17804 2018-17808
Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Family Educational Loan Program—Servicemembers Civil Relief Act, 41071 2018-17758 Servicemembers Civil Relief Act Interest Rate Limitation Request, 41071-41072 2018-17744 Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; San Joaquin Valley Unified Air Pollution Control District; Reasonably Available Control Technology Demonstration, 41006-41009 2018-17714 Significant New Use Rules on Certain Chemical Substances, 40986-41006 2018-17348 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Colorado; Motor Vehicle Inspection and Maintenance Program and Associated Revisions, 41035-41039 2018-17805 Significant New Use Rules on Certain Chemical Substances, 41039 2018-17349 NOTICES Environmental Impact Statements; Availability, etc.: Weekly Receipts, 41072-41073 2018-17747 Equal Equal Employment Opportunity Commission NOTICES Meetings; Sunshine Act, 41073 2018-17922 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: ATR-GIE Avions de Transport Regional Airplanes, 40963-40966 2018-17661 Fokker Services B.V. Airplanes, 40959-40961 2018-17624 Rolls-Royce Corporation Engines, 40961-40963 2018-17704 Amendment of Multiple Restricted Area Boundary Descriptions; Florida, 40967-40968 2018-17766 Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures, 40968-40973 2018-17616 2018-17619 PROPOSED RULES Amendment of VOR Federal Airways: V-18, V-102, and V-278 in the Vicinity of Guthrie, TX, 41021-41022 2018-17767 NOTICES Exemption Petitions; Summaries: Headquarters Air Force Junior Reserve Officer Training Corps, 41141 2018-17769 Federal Energy Federal Energy Regulatory Commission NOTICES Complaints: North Carolina Electric Membership Corp. v. Duke Energy Progress, LLC, 41072 2018-17761 Federal Highway Federal Highway Administration NOTICES Environmental Impact Statements; Availability, etc.; Rescission, 41141-41142 2018-17757 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Wildlife and Plants: Draft Recovery Plan for Neosho Mucket, 41100-41101 2018-17753 Food and Drug Food and Drug Administration RULES Medical Devices and Device-Led Combination Products: Voluntary Malfunction Summary Reporting Program for Manufacturers, 40973-40985 2018-17770 PROPOSED RULES Medical Devices: Classification of Accessories Distinct from Other Devices; Proposed List of Accessories Suitable for Class I, 41023-41026 2018-17731 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry: Controlled Correspondence Related to Generic Drug Development, 41077-41078 2018-17787 Guidance: Process to Request a Review of Food and Drug Administration's Decision Not to Issue Certain Export Certificates for Devices, 41078-41079 2018-17796 Information Available to Industry: Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff, 41080 2018-17783 Meetings: Science and Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans; Public Workshop, 41076-41077 2018-17732 Food and Nutrition Food and Nutrition Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Supplemental Nutrition Assistance Program, Store Applications, 41043-41045 2018-17722 Forest Forest Service NOTICES Environmental Impact Statements; Availability, etc.: Humboldt-Toiyabe National Forest, Clark Counties, Nevada, Lee Canyon, 41045-41046 2018-17730 General Services General Services Administration RULES Civilian Board of Contract Appeals: Rules of Procedure for Contract Disputes Act Cases, 41009-41018 2018-17213 Health and Human Health and Human Services Department See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

National Institutes of Health

PROPOSED RULES World Trade Center Health Program: Petition 019—Irritable Bowel Syndrome; Finding of Insufficient Evidence, 41039-41041 2018-17711 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41080-41081 2018-17748
Homeland Homeland Security Department See

Coast Guard

NOTICES Meetings: Technical Mapping Advisory Council, 41096-41097 2018-17813
Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Home Equity Conversion Mortgage Counseling Standardization and Roster, 41097-41098 2018-17790 Indian Community Development Block Grant, 41098-41099 2018-17788 Single Family Mortgage Insurance on Hawaiian Homelands, 41099-41100 2018-17789 Indian Affairs Indian Affairs Bureau NOTICES Indian Gaming: Approval of Tribal-State Class III Gaming Compact Amendments in the State of Oklahoma, 41101-41102 2018-17728 2018-17729 Rate Adjustments for Indian Irrigation Projects, 41102-41108 2018-17724 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

Land Management Bureau

Internal Revenue Internal Revenue Service PROPOSED RULES Centralized Partnership Audit Regime, 41954-42015 2018-17614 Removal of Temporary Regulations on a Partner's Share of a Partnership Liability for Disguised Sale Purposes; Hearing Cancellation, 41026 2018-17792 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Carbazole Violet Pigment 23 from India, 41059-41060 2018-17781 Labor Department Labor Department See

Labor Statistics Bureau

Labor Statistics Labor Statistics Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41112-41113 2018-17718 Land Land Management Bureau NOTICES Environmental Impact Statements; Availability, etc.: Draft Bears Ears National Monument Indian Creek and Shash Jaa Units Monument Management Plans, Utah, 41111-41112 2018-17750 Grand Staircase-Escalante National Monument-Grand Staircase, Kaiparowits, and Escalante Canyon Units and Federal Lands Previously Included in the Monument that are excluded from the Boundaries Draft Resource Management Plans, 41108-41111 2018-17751 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 41093 2018-17785 Draft Report on Carcinogens Monograph on Night Shift Work and Light at Night, 41093-41095 2018-17782 National Institute of Neurological Disorders and Stroke, 41081 2018-17780 Office of Science Policy Recombinant or Synthetic Nucleic Acid Research: Proposed Changes to the Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, 41082-41093 2018-17760 Requests for Information: Feedback on the Brain Research through Advancing Innovative Neurotechnologies Initiative, 41081-41082 2018-17759 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone off Alaska: Pacific Ocean Perch in the West Yakutat District of the Gulf of Alaska, 41020 2018-17797 Sablefish in the West Yakutat District of the Gulf of Alaska, 41019-41020 2018-17798 Snapper-Grouper Fishery of the South Atlantic: 2018 Commercial Accountability Measure and Closure for the Other Jacks Complex, 41018-41019 2018-17719 NOTICES Meetings: Fisheries of the Gulf of Mexico; Southeast Data, Assessment, and Review, 41063-41064 2018-17773 Mid-Atlantic Fishery Management Council, 41060-41061 2018-17776 North Pacific Fishery Management Council, 41063 2018-17774 Pacific Fishery Management Council, 41061-41062 2018-17775 Permit Applications: Marine Mammals; File No. 22222, 41062-41063 2018-17772 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Meetings; Sunshine Act, 41113 2018-17879 Pension Benefit Pension Benefit Guaranty Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Partitions of Eligible Multiemployer Plans, 41113-41114 2018-17749 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 41114-41115 2018-17791 Rural Business Rural Business-Cooperative Service NOTICES Rural Development Cooperative Agreement Program, 41046-41056 2018-17765 Rural Housing Service Rural Housing Service NOTICES Establishment of Maximum Interest Rate, 41056-41057 2018-17764 Rural Development Cooperative Agreement Program, 41046-41056 2018-17765 Rural Utilities Rural Utilities Service NOTICES Rural Development Cooperative Agreement Program, 41046-41056 2018-17765 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Cboe BYX Exchange, Inc., 41128-41138 2018-17736 ICE Clear Credit LLC, 41118-41121 2018-17741 MIAX PEARL, LLC, 41126-41128 2018-17740 Nasdaq BX, Inc., 41121-41124 2018-17742 Nasdaq ISE, LLC, 41124-41126 2018-17738 New York Stock Exchange LLC, 41117-41118 2018-17743 The Nasdaq Stock Market LLC, 41115-41116 2018-17737 Small Business Small Business Administration NOTICES Changes to SBA Secondary Market Program, 41139 2018-17726 Major Disaster Declarations: Hawaii, 41138-41139 2018-17745 State Department State Department NOTICES Designation as a Foreign Terrorist Organization: Abu Sayyaf Group (and Other Aliases), 41140 2018-17816 Boko Haram (and Other Aliases), 41140 2018-17817 Designation as a Specially Designated Global Terrorist: Qassim Abdullah Ali Ahmed, aka Qassim al-Muamen, aka Qassim Al Muamen, aka Qassim Abdullah Ali, aka Qassim Abdullah, 41139-41140 2018-17818 Surface Transportation Surface Transportation Board NOTICES Meetings: National Grain Car Council, 41140 2018-17779 Tennessee Tennessee Valley Authority NOTICES Meetings: Regional Energy Resource Council, 41140-41141 2018-17756 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

Treasury Treasury Department See

Internal Revenue Service

Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 41144-41784 2018-16766 Part III Health and Human Services Department, Centers for Medicare & Medicaid Services, 41786-41951 2018-17101 Part IV Treasury Department, Internal Revenue Service, 41954-42015 2018-17614 Reader Aids

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83 160 Friday, August 17, 2018 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 1205 [Doc. #AMS-CN-18-0013] Cotton Board Rules and Regulations: Adjusting Supplemental Assessment on Imports (2018 Amendments) AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Direct final rule.

SUMMARY:

The Agricultural Marketing Service (AMS) is amending the Cotton Board Rules and Regulations, increasing the value assigned to imported cotton for the purposes of calculating supplemental assessments collected for use by the Cotton Research and Promotion Program. This amendment is required each year to ensure that assessments collected on imported cotton and the cotton content of imported products will be the same as those paid on domestically produced cotton. In addition, AMS is updating the Harmonized Tariff Schedule (HTS) statistical reporting numbers that were amended since the last assessment adjustment in 2017.

DATES:

This direct rule is effective October 16, 2018, without further action or notice, unless significant adverse comment is received by September 17, 2018. If significant adverse comment is received, AMS will publish a timely withdrawal of the amendment in the Federal Register.

ADDRESSES:

Written comments may be submitted to the addresses specified below. All comments will be made available to the public. Please do not include personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publically disclosed. All comments may be posted on the internet and can be retrieved by most internet search engines. Comments may be submitted anonymously.

Comments, identified by AMS-CN-18-0013, may be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov. Please follow the instructions for submitting comments. In addition, comments may be submitted by mail or hand delivery to Cotton Research and Promotion, Cotton and Tobacco Program, AMS, USDA, 100 Riverside Parkway, Suite 101, Fredericksburg, Virginia, 22406. Comments should be submitted in triplicate. All comments received will be made available for public inspection at Cotton and Tobacco Program, AMS, USDA, 100 Riverside Parkway, Suite 101, Fredericksburg, Virginia 22406. A copy of this document may be found at: www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Shethir M. Riva, Director, Research and Promotion, Cotton and Tobacco Program, AMS, USDA, 100 Riverside Parkway, Suite 101, Fredericksburg, Virginia, 22406, telephone (540) 361-2726, facsimile (540) 361-1199, or email at [email protected]

SUPPLEMENTARY INFORMATION:

A. Background

Amendments to the Cotton Research and Promotion Act (7 U.S.C. 2101-2118) (Act) were enacted by Congress under Subtitle G of Title XIX of the Food, Agriculture, Conservation, and Trade Act of 1990 (Pub. L. 101-624, 104 Stat. 3909, November 28, 1990). These amendments contained two provisions that authorize changes in the funding procedures for the Cotton Research and Promotion Program. These provisions provide for: (1) The assessment of imported cotton and cotton products; and (2) termination of refunds to cotton producers. (Prior to the 1990 amendments to the Act, producers could request assessment refunds.)

As amended, the Cotton Research and Promotion Order (7 CFR part 1205) (Order) was approved by producers and importers voting in a referendum held July 17-26, 1991, and the amended Order was published in the Federal Register on December 10, 1991, (56 FR 64470). A proposed rule implementing the amended Order was published in the Federal Register on December 17, 1991, (56 FR 65450). Implementing rules were published on July 1 and 2, 1992, (57 FR 29181) and (57 FR 29431), respectively.

This direct final rule would amend the value assigned to imported cotton in the Cotton Board Rules and Regulations (7 CFR 1205.510(b)(2)) that is used to determine the Cotton Research and Promotion assessment on imported cotton and cotton products. The total value of assessment levied on cotton imports is the sum of two parts. The first part of the assessment is based on the weight of cotton imported—levied at a rate of $1 per bale of cotton, which is equivalent to 500 pounds, or $1 per 226.8 kilograms of cotton. The second part of the import assessment (referred to as the supplemental assessment) is based on the value of imported cotton lint or the cotton contained in imported cotton products—levied at a rate of five-tenths of one percent of the value of domestically produced cotton.

Section 1205.510(b)(2) of the Cotton Research and Promotion Rules and Regulations provides for assigning the calendar year weighted average price received by U.S. farmers for Upland cotton to represent the value of imported cotton. This is so that the assessment on domestically produced cotton and the assessment on imported cotton and the cotton content of imported products is the same. The source for the average price statistic is Agricultural Prices, a publication of the National Agricultural Statistics Service (NASS) of the Department of Agriculture. Use of the weighted average price figure in the calculation of supplemental assessments on imported cotton and the cotton content of imported products will yield an assessment that is the same as assessments paid on domestically produced cotton.

The current value of imported cotton as published in 2017 in the Federal Register (82 FR 41829) for the purpose of calculating assessments on imported cotton is $0.011510 per kilogram. Using the average weighted price received by U.S. farmers for Upland cotton for the calendar year 2017, this direct final rule would amend the new value of imported cotton to $0.011905 per kilogram to reflect the price paid by U.S. farmers for Upland cotton during 2017.

An example of the complete assessment formula and how the figures are obtained is as follows:

One bale is equal to 500 pounds. One kilogram equals 2.2046 pounds. One pound equals 0.453597 kilograms. One Dollar per Bale Assessment Converted to Kilograms A 500-pound bale equals 226.8 kg. (500 × 0.453597). $1 per bale assessment equals $0.002000 per pound or $0.2000 cents per pound (1/500) or $0.004409 per kg or $0.4409 cents per kg. (1/226.8). Supplemental Assessment of 5/10 of One Percent of the Value of the Cotton Converted to Kilograms The 2017 calendar year weighted average price received by producers for Upland cotton is $0.68 per pound or $1.499128 per kg. (0.68 × 2.2046). Five tenths of one percent of the average price equals $0.007496 per kg. (1.499128 × 0.005). Total Assessment

The total assessment per kilogram of raw cotton is obtained by adding the $1 per bale equivalent assessment of $0.004409 per kg. and the supplemental assessment $0.007496 per kg., which equals $0.011905 per kg.

The current assessment on imported cotton is $0.011510 per kilogram of imported cotton. The revised assessment in this direct final rule is $0.011905, an increase of $0.000395 per kilogram. This increase reflects the increase in the average weighted price of Upland cotton received by U.S. farmers during the period January through December 2017.

Import Assessment Table in section 1205.510(b)(3) indicates the total assessment rate ($ per kilogram) due for each Harmonized Tariff Schedule (HTS) number that is subject to assessment. This table must be revised each year to reflect changes in supplemental assessment rates and any changes to the HTS numbers. In this direct final rule, AMS is amending the Import Assessment Table.

AMS believes that these amendments are necessary to ensure that assessments collected on imported cotton and the cotton content of imported products are the same as those paid on domestically produced cotton. Accordingly, changes reflected in this rule should be adopted and implemented as soon as possible since it is required by regulation.

As described in this Federal Register document, the amendment to the value used to determine the Cotton Research and Promotion Program importer assessment will be updated to reflect the assessment already paid by U.S. farmers. For the reasons mentioned above, AMS finds that publishing a proposed rule and seeking public comment is unnecessary because the change is required annually by regulation in 7 CFR 1205.510.

Also, this direct-final rulemaking furthers the objectives of Executive Order 13563, which requires that the regulatory process “promote predictability and reduce uncertainty” and “identify and use the best, most innovative, and least burdensome tools for achieving regulatory ends.”

AMS has used the direct rule rulemaking process since 2013 and has not received any adverse comments; however, if AMS does receives significant adverse comment during the comment period, it will publish, in a timely manner, a document in the Federal Register withdrawing this direct final rule. AMS will then address public comments in a subsequent proposed rule and final rule based on the proposed rule.

B. Regulatory Impact Analysis Executive Order 13175

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

Executive Orders 12866 and 13563

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

Executive Order 12988

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 12 of the Act, any person subject to an order may file with the Secretary of Agriculture (Secretary) a petition stating that the order, any provision of the plan, or any obligation imposed in connection with the order is not in accordance with law and requesting a modification of the order or to be exempted therefrom. Such person is afforded the opportunity for a hearing on the petition. After the hearing, the Secretary would rule on the petition. The Act provides that the District Court of the United States in any district in which the person is an inhabitant, or has his principal place of business, has jurisdiction to review the Secretary's ruling, provided a complaint is filed within 20 days from the date of the entry of the Secretary's ruling.

Regulatory Flexibility Act and Paperwork Reduction Act

In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has examined the economic impact of this rule on small entities. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such action so that small businesses will not be unduly or disproportionately burdened. The Small Business Administration defines, in 13 CFR part 121, small agricultural producers as those having annual receipts of no more than $750,000 and small agricultural service firms (importers) as having receipts of no more than $7,500,000. In 2017, an estimated 20,000 importers are subject to the rules and regulations issued pursuant to the Cotton Research and Promotion Order. Most are considered small entities as defined by the Small Business Administration.

This rule would only affect importers of cotton and cotton-containing products and would increase the assessments paid by the importers under the Cotton Research and Promotion Order. The current assessment on imported cotton is $0.011510 per kilogram of imported cotton. The amended assessment would be $0.011905, which was calculated based on the 12-month weighted average of price received by U.S. cotton farmers. Section 1205.510, “Levy of assessments”, provides “The rate of the supplemental assessment on imported cotton will be the same as that levied on cotton produced within the United States.” In addition, section 1205.510 provides that the 12-month weighted average of prices received by U.S. farmers will be used as the value of imported cotton for the purpose of levying the supplemental assessment on imported cotton.

Under the Cotton Research and Promotion Program, assessments are used by the Cotton Board to finance research and promotion programs designed to increase consumer demand for Upland cotton in the United States and international markets. In 2016 (the last audited year), producer assessments totaled $36.5 million and importer assessments totaled $36.51 million. According to the Cotton Board, should the volume of cotton products imported into the U.S. remain at the same level in 2018, one could expect an increase of assessments by approximately $1,278,951.

Imported organic cotton and products may be exempt from assessment if eligible under section 1205.519 of the Order.

There are no Federal rules that duplicate, overlap, or conflict with this rule.

In compliance with Office of Management and Budget (OMB) regulations (5 CFR part 1320) which implement the Paperwork Reduction Act (PRA) (44 U.S.C. Chapter 35) the information collection requirements contained in the regulation to be amended have been previously approved by OMB and were assigned control number 0581-0093, National Research, Promotion, and Consumer Information Programs. This rule does not result in a change to the information collection and recordkeeping requirements previously approved.

A 30-day comment period is provided to comment on the changes to the Cotton Board Rules and Regulations proposed herein. This period is deemed appropriate because an amendment is required to adjust the assessments collected on imported cotton and the cotton content of imported products to be the same as those paid on domestically produced cotton. Accordingly, the change in this rule, if adopted, should be implemented as soon as possible.

List of Subjects in 7 CFR Part 1205

Advertising, Agricultural research, Cotton, Marketing agreements, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, AMS amends 7 CFR part 1205 as follows:

PART 1205—COTTON RESEARCH AND PROMOTION 1. The authority citation for part 1205 continues to read as follows: Authority:

7 U.S.C. 2101-2118; 7 U.S.C 7401.

2. In § 1205.510, paragraph (b)(2) and the table in paragraph (b)(3) are revised to read as follows:
§ 1205.510 Levy of assessments.

(b) * * *

(2) The 12-month average of monthly weighted average prices received by U.S. farmers will be calculated annually. Such weighted average will be used as the value of imported cotton for the purpose of levying the supplemental assessment on imported cotton and will be expressed in kilograms. The value of imported cotton for the purpose of levying this supplemental assessment is $1.1905 cents per kilogram.

(3) * * *

Import Assessment Table [Raw cotton fiber] HTS No. Conv.
  • factor
  • Cents/kg.
    5007106010 0.2713 0.3229827 5007106020 0.2713 0.3229827 5007906010 0.2713 0.3229827 5007906020 0.2713 0.3229827 5112904000 0.1085 0.1291693 5112905000 0.1085 0.1291693 5112909010 0.1085 0.1291693 5112909090 0.1085 0.1291693 5201000500 1 1.1905000 5201001200 1 1.1905000 5201001400 1 1.1905000 5201001800 1 1.1905000 5201002200 1 1.1905000 5201002400 1 1.1905000 5201002800 1 1.1905000 5201003400 1 1.1905000 5201003800 1 1.1905000 5204110000 1.0526 1.2531203 5204190000 0.6316 0.7519198 5204200000 1.0526 1.2531203 5205111000 1 1.1905000 5205112000 1 1.1905000 5205121000 1 1.1905000 5205122000 1 1.1905000 5205131000 1 1.1905000 5205132000 1 1.1905000 5205141000 1 1.1905000 5205142000 1 1.1905000 5205151000 1 1.1905000 5205152000 1 1.1905000 5205210020 1.044 1.2428820 5205210090 1.044 1.2428820 5205220020 1.044 1.2428820 5205220090 1.044 1.2428820 5205230020 1.044 1.2428820 5205230090 1.044 1.2428820 5205240020 1.044 1.2428820 5205240090 1.044 1.2428820 5205260020 1.044 1.2428820 5205260090 1.044 1.2428820 5205270020 1.044 1.2428820 5205270090 1.044 1.2428820 5205280020 1.044 1.2428820 5205280090 1.044 1.2428820 5205310000 1 1.1905000 5205320000 1 1.1905000 5205330000 1 1.1905000 5205340000 1 1.1905000 5205350000 1 1.1905000 5205410020 1.044 1.2428820 5205410090 1.044 1.2428820 5205420021 1.044 1.2428820 5205420029 1.044 1.2428820 5205420090 1.044 1.2428820 5205430021 1.044 1.2428820 5205430029 1.044 1.2428820 5205430090 1.044 1.2428820 5205440021 1.044 1.2428820 5205440029 1.044 1.2428820 5205440090 1.044 1.2428820 5205460021 1.044 1.2428820 5205460029 1.044 1.2428820 5205460090 1.044 1.2428820 5205470021 1.044 1.2428820 5205470029 1.044 1.2428820 5205470090 1.044 1.2428820 5205480020 1.044 1.2428820 5205480090 1.044 1.2428820 5206110000 0.7368 0.8771604 5206120000 0.7368 0.8771604 5206130000 0.7368 0.8771604 5206140000 0.7368 0.8771604 5206150000 0.7368 0.8771604 5206210000 0.7692 0.9157326 5206220000 0.7692 0.9157326 5206230000 0.7692 0.9157326 5206240000 0.7692 0.9157326 5206250000 0.7692 0.9157326 5206310000 0.7368 0.8771604 5206320000 0.7368 0.8771604 5206330000 0.7368 0.8771604 5206340000 0.7368 0.8771604 5206350000 0.7368 0.8771604 5206410000 0.7692 0.9157326 5206420000 0.7692 0.9157326 5206430000 0.7692 0.9157326 5206440000 0.7692 0.9157326 5206450000 0.7692 0.9157326 5207100000 0.9474 1.1278797 5207900000 0.6316 0.7519198 5208112020 1.0852 1.2919306 5208112040 1.0852 1.2919306 5208112090 1.0852 1.2919306 5208114020 1.0852 1.2919306 5208114040 1.0852 1.2919306 5208114060 1.0852 1.2919306 5208114090 1.0852 1.2919306 5208116000 1.0852 1.2919306 5208118020 1.0852 1.2919306 5208118090 1.0852 1.2919306 5208124020 1.0852 1.2919306 5208124040 1.0852 1.2919306 5208124090 1.0852 1.2919306 5208126020 1.0852 1.2919306 5208126040 1.0852 1.2919306 5208126060 1.0852 1.2919306 5208126090 1.0852 1.2919306 5208128020 1.0852 1.2919306 5208128090 1.0852 1.2919306 5208130000 1.0852 1.2919306 5208192020 1.0852 1.2919306 5208192090 1.0852 1.2919306 5208194020 1.0852 1.2919306 5208194090 1.0852 1.2919306 5208196020 1.0852 1.2919306 5208196090 1.0852 1.2919306 5208198020 1.0852 1.2919306 5208198090 1.0852 1.2919306 5208212020 1.0852 1.2919306 5208212040 1.0852 1.2919306 5208212090 1.0852 1.2919306 5208214020 1.0852 1.2919306 5208214040 1.0852 1.2919306 5208214060 1.0852 1.2919306 5208214090 1.0852 1.2919306 5208216020 1.0852 1.2919306 5208216090 1.0852 1.2919306 5208224020 1.0852 1.2919306 5208224040 1.0852 1.2919306 5208224090 1.0852 1.2919306 5208226020 1.0852 1.2919306 5208226040 1.0852 1.2919306 5208226060 1.0852 1.2919306 5208226090 1.0852 1.2919306 5208228020 1.0852 1.2919306 5208228090 1.0852 1.2919306 5208230000 1.0852 1.2919306 5208292020 1.0852 1.2919306 5208292090 1.0852 1.2919306 5208294020 1.0852 1.2919306 5208294090 1.0852 1.2919306 5208296020 1.0852 1.2919306 5208296090 1.0852 1.2919306 5208298020 1.0852 1.2919306 5208298090 1.0852 1.2919306 5208312000 1.0852 1.2919306 5208314020 1.0852 1.2919306 5208314040 1.0852 1.2919306 5208314090 1.0852 1.2919306 5208316020 1.0852 1.2919306 5208316040 1.0852 1.2919306 5208316060 1.0852 1.2919306 5208316090 1.0852 1.2919306 5208318020 1.0852 1.2919306 5208318090 1.0852 1.2919306 5208321000 1.0852 1.2919306 5208323020 1.0852 1.2919306 5208323040 1.0852 1.2919306 5208323090 1.0852 1.2919306 5208324020 1.0852 1.2919306 5208324040 1.0852 1.2919306 5208324060 1.0852 1.2919306 5208324090 1.0852 1.2919306 5208325020 1.0852 1.2919306 5208325090 1.0852 1.2919306 5208330000 1.0852 1.2919306 5208392020 1.0852 1.2919306 5208392090 1.0852 1.2919306 5208394020 1.0852 1.2919306 5208394090 1.0852 1.2919306 5208396020 1.0852 1.2919306 5208396090 1.0852 1.2919306 5208398020 1.0852 1.2919306 5208398090 1.0852 1.2919306 5208412000 1.0852 1.2919306 5208414000 1.0852 1.2919306 5208416000 1.0852 1.2919306 5208418000 1.0852 1.2919306 5208421000 1.0852 1.2919306 5208423000 1.0852 1.2919306 5208424000 1.0852 1.2919306 5208425000 1.0852 1.2919306 5208430000 1.0852 1.2919306 5208492000 1.0852 1.2919306 5208494010 1.0852 1.2919306 5208494020 1.0852 1.2919306 5208494090 1.0852 1.2919306 5208496010 1.0852 1.2919306 5208496020 1.0852 1.2919306 5208496030 1.0852 1.2919306 5208496090 1.0852 1.2919306 5208498020 1.0852 1.2919306 5208498090 1.0852 1.2919306 5208512000 1.0852 1.2919306 5208514020 1.0852 1.2919306 5208514040 1.0852 1.2919306 5208514090 1.0852 1.2919306 5208516020 1.0852 1.2919306 5208516040 1.0852 1.2919306 5208516060 1.0852 1.2919306 5208516090 1.0852 1.2919306 5208518020 1.0852 1.2919306 5208518090 1.0852 1.2919306 5208521000 1.0852 1.2919306 5208523020 1.0852 1.2919306 5208523035 1.0852 1.2919306 5208523045 1.0852 1.2919306 5208523090 1.0852 1.2919306 5208524020 1.0852 1.2919306 5208524035 1.0852 1.2919306 5208524045 1.0852 1.2919306 5208524055 1.0852 1.2919306 5208524065 1.0852 1.2919306 5208524090 1.0852 1.2919306 5208525020 1.0852 1.2919306 5208525090 1.0852 1.2919306 5208591000 1.0852 1.2919306 5208592015 1.0852 1.2919306 5208592025 1.0852 1.2919306 5208592085 1.0852 1.2919306 5208592095 1.0852 1.2919306 5208594020 1.0852 1.2919306 5208594090 1.0852 1.2919306 5208596020 1.0852 1.2919306 5208596090 1.0852 1.2919306 5208598020 1.0852 1.2919306 5208598090 1.0852 1.2919306 5209110020 1.0309 1.2272865 5209110025 1.0309 1.2272865 5209110035 1.0309 1.2272865 5209110050 1.0309 1.2272865 5209110090 1.0309 1.2272865 5209120020 1.0309 1.2272865 5209120040 1.0309 1.2272865 5209190020 1.0309 1.2272865 5209190040 1.0309 1.2272865 5209190060 1.0309 1.2272865 5209190090 1.0309 1.2272865 5209210020 1.0309 1.2272865 5209210025 1.0309 1.2272865 5209210035 1.0309 1.2272865 5209210050 1.0309 1.2272865 5209210090 1.0309 1.2272865 5209220020 1.0309 1.2272865 5209220040 1.0309 1.2272865 5209290020 1.0309 1.2272865 5209290040 1.0309 1.2272865 5209290060 1.0309 1.2272865 5209290090 1.0309 1.2272865 5209313000 1.0309 1.2272865 5209316020 1.0309 1.2272865 5209316025 1.0309 1.2272865 5209316035 1.0309 1.2272865 5209316050 1.0309 1.2272865 5209316090 1.0309 1.2272865 5209320020 1.0309 1.2272865 5209320040 1.0309 1.2272865 5209390020 1.0309 1.2272865 5209390040 1.0309 1.2272865 5209390060 1.0309 1.2272865 5209390080 1.0309 1.2272865 5209390090 1.0309 1.2272865 5209413000 1.0309 1.2272865 5209416020 1.0309 1.2272865 5209416040 1.0309 1.2272865 5209420020 0.9767 1.1627614 5209420040 0.9767 1.1627614 5209420060 0.9767 1.1627614 5209420080 0.9767 1.1627614 5209430030 1.0309 1.2272865 5209430050 1.0309 1.2272865 5209490020 1.0309 1.2272865 5209490040 1.0309 1.2272865 5209490090 1.0309 1.2272865 5209513000 1.0309 1.2272865 5209516015 1.0852 1.2919306 5209516025 1.0852 1.2919306 5209516032 1.0852 1.2919306 5209516035 1.0852 1.2919306 5209516050 1.0852 1.2919306 5209516090 1.0852 1.2919306 5209520020 1.0852 1.2919306 5209520040 1.0852 1.2919306 5209590015 1.0852 1.2919306 5209590025 1.0852 1.2919306 5209590040 1.0852 1.2919306 5209590060 1.0852 1.2919306 5209590090 1.0852 1.2919306 5210114020 0.6511 0.7751346 5210114040 0.6511 0.7751346 5210114090 0.6511 0.7751346 5210116020 0.6511 0.7751346 5210116040 0.6511 0.7751346 5210116060 0.6511 0.7751346 5210116090 0.6511 0.7751346 5210118020 0.6511 0.7751346 5210118090 0.6511 0.7751346 5210191000 0.6511 0.7751346 5210192020 0.6511 0.7751346 5210192090 0.6511 0.7751346 5210194020 0.6511 0.7751346 5210194090 0.6511 0.7751346 5210196020 0.6511 0.7751346 5210196090 0.6511 0.7751346 5210198020 0.6511 0.7751346 5210198090 0.6511 0.7751346 5210214020 0.6511 0.7751346 5210214040 0.6511 0.7751346 5210214090 0.6511 0.7751346 5210216020 0.6511 0.7751346 5210216040 0.6511 0.7751346 5210216060 0.6511 0.7751346 5210216090 0.6511 0.7751346 5210218020 0.6511 0.7751346 5210218090 0.6511 0.7751346 5210291000 0.6511 0.7751346 5210292020 0.6511 0.7751346 5210292090 0.6511 0.7751346 5210294020 0.6511 0.7751346 5210294090 0.6511 0.7751346 5210296020 0.6511 0.7751346 5210296090 0.6511 0.7751346 5210298020 0.6511 0.7751346 5210298090 0.6511 0.7751346 5210314020 0.6511 0.7751346 5210314040 0.6511 0.7751346 5210314090 0.6511 0.7751346 5210316020 0.6511 0.7751346 5210316040 0.6511 0.7751346 5210316060 0.6511 0.7751346 5210316090 0.6511 0.7751346 5210318020 0.6511 0.7751346 5210318090 0.6511 0.7751346 5210320000 0.6511 0.7751346 5210392020 0.6511 0.7751346 5210392090 0.6511 0.7751346 5210394020 0.6511 0.7751346 5210394090 0.6511 0.7751346 5210396020 0.6511 0.7751346 5210396090 0.6511 0.7751346 5210398020 0.6511 0.7751346 5210398090 0.6511 0.7751346 5210414000 0.6511 0.7751346 5210416000 0.6511 0.7751346 5210418000 0.6511 0.7751346 5210491000 0.6511 0.7751346 5210492000 0.6511 0.7751346 5210494010 0.6511 0.7751346 5210494020 0.6511 0.7751346 5210494090 0.6511 0.7751346 5210496010 0.6511 0.7751346 5210496020 0.6511 0.7751346 5210496090 0.6511 0.7751346 5210498020 0.6511 0.7751346 5210498090 0.6511 0.7751346 5210514020 0.6511 0.7751346 5210514040 0.6511 0.7751346 5210514090 0.6511 0.7751346 5210516020 0.6511 0.7751346 5210516040 0.6511 0.7751346 5210516060 0.6511 0.7751346 5210516090 0.6511 0.7751346 5210518020 0.6511 0.7751346 5210518090 0.6511 0.7751346 5210591000 0.6511 0.7751346 5210592020 0.6511 0.7751346 5210592090 0.6511 0.7751346 5210594020 0.6511 0.7751346 5210594090 0.6511 0.7751346 5210596020 0.6511 0.7751346 5210596090 0.6511 0.7751346 5210598020 0.6511 0.7751346 5210598090 0.6511 0.7751346 5211110020 0.6511 0.7751346 5211110025 0.6511 0.7751346 5211110035 0.6511 0.7751346 5211110050 0.6511 0.7751346 5211110090 0.6511 0.7751346 5211120020 0.6511 0.7751346 5211120040 0.6511 0.7751346 5211190020 0.6511 0.7751346 5211190040 0.6511 0.7751346 5211190060 0.6511 0.7751346 5211190090 0.6511 0.7751346 5211202120 0.6511 0.7751346 5211202125 0.6511 0.7751346 5211202135 0.6511 0.7751346 5211202150 0.6511 0.7751346 5211202190 0.6511 0.7751346 5211202220 0.6511 0.7751346 5211202240 0.6511 0.7751346 5211202920 0.6511 0.7751346 5211202940 0.6511 0.7751346 5211202960 0.6511 0.7751346 5211202990 0.6511 0.7751346 5211310020 0.6511 0.7751346 5211310025 0.6511 0.7751346 5211310035 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0.2935773
    (Authority: 7 U.S.C. 2101-2118)
    Dated: August 13, 2018 Bruce Summers, Administrator.
    [FR Doc. 2018-17723 Filed 8-16-18; 8:45 am] BILLING CODE 3410-02-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION 12 CFR Part 1016 [Docket No. CFPB-2016-0032] RIN 3170-AA60 Amendment to the Annual Privacy Notice Requirement Under the Gramm-Leach-Bliley Act (Regulation P) AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Final rule.

    SUMMARY:

    The Bureau of Consumer Financial Protection (Bureau) is amending Regulation P, which requires, among other things, that financial institutions provide an annual notice describing their privacy policies and practices to their customers. The amendment implements a December 2015 statutory amendment to the Gramm-Leach-Bliley Act providing an exception to this annual notice requirement for financial institutions that meet certain conditions.

    DATES:

    The amendments to Regulation P in this final rule will become effective on September 17, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Monique Chenault, Paralegal Specialist; Joseph Devlin, Senior Counsel; Office of Regulations, at (202) 435-7700.

    SUPPLEMENTARY INFORMATION: I. Summary of the Final Rule

    Title V, Subtitle A of the Gramm-Leach-Bliley Act (GLBA) 1 and Regulation P, which implements the GLBA, mandate that financial institutions provide their customers with annual notices regarding those institutions' privacy policies. If financial institutions share certain consumer information with particular types of third parties, the annual notices must also provide customers with an opportunity to opt out of the sharing. Regulation P sets forth requirements for how financial institutions must deliver these annual privacy notices. In certain circumstances, Regulation P permits financial institutions to use an alternative delivery method to provide annual notices. This method requires, among other things, that the annual notice be posted on a financial institution's website.

    1 15 U.S.C. 6801 through 6809.

    On December 4, 2015, Congress amended the GLBA as part of the Fixing America's Surface Transportation Act (FAST Act). This amendment, titled Eliminate Privacy Notice Confusion,2 added new GLBA section 503(f). This subsection provides an exception under which financial institutions that meet certain conditions are not required to provide annual privacy notices to customers. Section 503(f)(1) requires that to qualify for this exception, a financial institution must not share nonpublic personal information about customers except as described in certain statutory exceptions. (Sharing as described in these specified statutory exceptions does not trigger the customer's statutory right to opt out of the financial institution's sharing.) In addition, section 503(f)(2) requires that the financial institution must not have changed its policies and practices with regard to disclosing nonpublic personal information from those that the institution disclosed in the most recent privacy notice it sent.

    2 FAST Act, Public Law 114-94, section 75001.

    Section 503(f) took effect upon enactment in December 2015. In July 2016 the Bureau proposed to update Regulation P to reflect the change in the underlying law. As part of its implementation, the Bureau is also amending Regulation P to provide timing requirements for delivery of annual privacy notices in the event that a financial institution that qualified for this annual notice exception later changes its policies or practices in such a way that it no longer qualifies for the exception. The Bureau is further removing the Regulation P provision that allows for use of the alternative delivery method for annual privacy notices because the Bureau believes the alternative delivery method will no longer be used in light of the annual notice exception. Finally, the Bureau is amending Regulation P to make a technical correction to one of its definitions.

    II. Background A. The Statute and Regulation

    The GLBA was enacted into law in 1999 and governs the privacy practices of a broad range of financial institutions.3 Rulemaking authority to implement the GLBA privacy provisions was initially spread among many agencies. The Federal Reserve Board (Board), the Office of Comptroller of the Currency (OCC), the Federal Deposit Insurance Corporation (FDIC), and the Office of Thrift Supervision (OTS) jointly adopted final rules in 2000 to implement the notice requirements of the GLBA.4 The National Credit Union Administration (NCUA), Federal Trade Commission (FTC), Securities and Exchange Commission (SEC), and Commodity Futures Trading Commission (CFTC) were part of the same interagency process, but each of these agencies issued separate rules.5 In 2009, all of the agencies with the authority to issue rules to implement the GLBA privacy notice provisions issued a joint final rule with a model form that financial institutions could use, at their option, to provide required initial and annual disclosures.6

    3 Public Law 106-102, 113 Stat. 1338 (1999).

    4 65 FR 35162 (June 1, 2000).

    5 65 FR 31722 (May 18, 2000) (NCUA final rule); 65 FR 33646 (May 24, 2000) (FTC final rule); 65 FR 40334 (June 29, 2000) (SEC final rule); 66 FR 21236 (Apr. 27, 2001) (CFTC final rule).

    6 74 FR 62890 (Dec. 1, 2009).

    In 2011, the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) 7 transferred GLBA privacy notice rulemaking authority from the Board, NCUA, OCC, OTS, the FDIC, and the FTC (in part) to the Bureau.8 The Bureau then restated the implementing regulations in Regulation P, 12 CFR part 1016, in late 2011 through an interim final rule.9 In April 2016, the Bureau finalized that interim final rule as amended by 79 FR 64057 (Oct. 28, 2014).10

    7 Public Law 111-203, 124 Stat. 1376 (2010).

    8 Public Law 111-203, section 1093. The FTC retained rulewriting authority over any financial institution that is a person described in 12 U.S.C. 5519 (i.e., motor vehicle dealers predominantly engaged in the sale and servicing of motor vehicles, the leasing and servicing of motor vehicles, or both).

    9 76 FR 79025 (Dec. 21, 2011).

    10 81 FR 25323 (Apr. 28, 2016).

    The Bureau has the authority to promulgate GLBA privacy rules for depository institutions and many non-depository institutions. However, rulewriting authority with regard to securities and futures-related companies is vested in the SEC and CFTC, respectively, and rulewriting authority with respect to certain motor vehicle dealers is vested in the FTC.11 The four agencies are required to consult with each other and with representatives of State insurance authorities to assure, to the extent possible, consistency and comparability among implementing rules.12 Toward that end, the Bureau has consulted and coordinated with these agencies and with the National Association of Insurance Commissioners (NAIC) concerning this final rule and the proposal that preceded it. The Bureau has also consulted with prudential regulators and other appropriate Federal agencies, as required under Section 1022 of the Dodd-Frank Act as part of its general rulewriting process.13

    11 15 U.S.C. 6804; 12 CFR 1016.1(b).

    12 15 U.S.C. 6804(a)(2).

    13 12 U.S.C. 5512(b)(2)(B).

    The GLBA and Regulation P require that financial institutions provide consumers with certain notices describing their privacy policies.14 Financial institutions are generally required to provide an initial notice of these policies when a customer relationship is established and to provide an annual notice to customers every year that the customer relationship continues.15 Except as otherwise authorized in the regulation, if a financial institution chooses to disclose nonpublic personal information about a consumer to a nonaffiliated third party other than as described in its initial notice, the institution is also required to deliver a revised privacy notice.16 The types of information required to be included in the initial, annual, and revised notices are identical. Each notice must describe whether and how the financial institution shares consumers' nonpublic personal information with other entities.17 The notices must also briefly describe how financial institutions protect the nonpublic personal information they collect and maintain.18

    14 When a financial institution has a continuing relationship with the consumer, an annual privacy notice is required and the consumer is then referred to as a “customer.” 12 CFR 1016.3(i), 1016.3(j)(1).

    15 12 CFR 1016.4(a)(1), 1016.5(a)(1). Financial institutions are also required to provide initial notices to consumers before disclosing any nonpublic personal information to a nonaffiliated third party outside of certain exceptions. 12 CFR 1016.4(a)(2).

    16 12 CFR 1016.8.

    17 12 CFR 1016.6(a)(1)-(5), (9).

    18 12 CFR 1016.6(a)(8).

    GLBA Section 502 and Regulation P also require that initial, annual, and revised notices provide information about the right to opt out of certain financial institution sharing of nonpublic personal information with some types of nonaffiliated third parties. For example, a mortgage customer has the right to opt out of a financial institution disclosing his or her name and address to an unaffiliated home insurance company. On the other hand, a financial institution is not required to allow a consumer to opt out of the institution's disclosure of his or her nonpublic personal information to third party service providers and pursuant to joint marketing arrangements subject to certain requirements; disclosures relating to maintaining and servicing accounts, securitization, law enforcement and compliance, and consumer reporting; and certain other disclosures described in the GLBA and Regulation P as exceptions to the opt-out requirement.19

    19 15 U.S.C. 6802(b)(2), (e); 12 CFR 1016.13, 1016.14, 1016.15.

    In addition to opt-out rights under the GLBA, annual privacy notices also may include information about certain consumer opt-out rights under the Fair Credit Reporting Act (FCRA). The privacy notices under the GLBA/Regulation P and affiliate disclosures under the FCRA/Regulation V interact in two ways. First, section 603(d)(2)(A)(iii) of the FCRA excludes from that statute's definition of a consumer report 20 the sharing of certain information about a consumer with the institution's affiliates if the consumer is notified of such sharing and is given an opportunity to opt out.21 Section 503(c)(4) of the GLBA and Regulation P require financial institutions to incorporate into any required Regulation P notices the notification and opt-out disclosures provided pursuant to section 603(d)(2)(A)(iii) of the FCRA, if the institution provides such disclosures.22

    20 15 U.S.C. 1681a(d).

    21 15 U.S.C. 1681a(d)(2)(A)(iii).

    22 15 U.S.C. 6803(c)(4); 12 CFR 1016.6(a)(7).

    Second, section 624 of the FCRA and Regulation V's Affiliate Marketing Rule provide that an affiliate of a financial institution that receives certain information (e.g., transaction history)  23 from the institution about a consumer may not use the information to make solicitations for marketing purposes unless the consumer is notified of such use and provided with an opportunity to opt out of that use.24 Section 624 of the FCRA and Regulation V also permit (but do not require) financial institutions to incorporate any opt-out disclosures provided under section 624 of the FCRA and subpart C of Regulation V into privacy notices provided pursuant to the GLBA and Regulation P.25

    23 The type of information to which section 624 applies is information that would be a consumer report, but for the exclusions provided by section 603(d)(2)(A)(i), (ii), or (iii) of the FCRA.

    24 15 U.S.C. 1681s-3 and 12 CFR pt. 1022, subpart C.

    25 15 U.S.C. 1681s-3(b); 12 CFR 1022.23(b).

    B. The Alternative Delivery Method for Annual Privacy Notices

    In pursuit of the Bureau's goal of reducing unnecessary or unduly burdensome regulations, the Bureau in December 2011 issued a Request for Information (RFI) seeking specific suggestions from the public for streamlining regulations the Bureau had inherited from other Federal agencies. In that RFI, the Bureau specifically identified the annual privacy notice as a potential opportunity for streamlining and solicited comment on possible alternatives to delivering the annual privacy notice.26 Numerous industry commenters responded to the RFI by advocating for the elimination or limitation of the annual notice requirement.

    26 76 FR 75825, 75828 (Dec. 5, 2011).

    Financial institutions historically have provided annual notices generally by U.S. postal mail.27 In 2014, the Bureau adopted a rule to allow financial institutions to use an alternative delivery method to provide annual privacy notices through posting the notices on their websites if they meet certain conditions.28 Specifically, financial institutions were allowed to use the alternative delivery method for annual notices if: (1) No opt-out rights were triggered by the financial institution's information sharing practices under the GLBA; (2) no FCRA section 603 opt-out notices were required to appear on the annual notice and any opt-outs required by FCRA section 624 had previously been provided, if applicable, or the annual notice was not the only notice provided to satisfy those requirements; (3) the information included in the annual notice had not changed since the customer received the previous notice; and (4) the financial institution used the model form provided in Regulation P for its annual notice.

    27 Regulation P, however, does allow financial institutions to provide notices electronically (e.g., by email) with consent. 12 CFR 1016.9(a) (stating that a financial institution may deliver the notice electronically if the consumer agrees). The Bureau believes that most consumers do not receive privacy notices electronically.

    28 79 FR 64057 (revising 12 CFR 1016.9(c)). The Bureau's alternative delivery method became effective on October 28, 2014. Id.

    In addition, to assist customers with limited or no access to the internet, an institution using the alternative delivery method was required to mail annual notices to customers who requested them by telephone. To make customers aware that its annual privacy notice was available through the website or by phone, the institution was required to include a clear and conspicuous statement of availability at least once per year on an account statement, coupon book, or a notice or disclosure the institution issued under any provision of law.

    C. Statutory Amendment and Proposed Rule

    On December 4, 2015, Congress amended the GLBA as part of the FAST Act. This amendment, titled Eliminate Privacy Notice Confusion,29 added new GLBA section 503(f), which provides an exception under which financial institutions that meet two conditions are not required to provide annual notices to customers.30 New GLBA section 503(f)(1) states the first condition for the annual notice exception: That a financial institution must provide nonpublic personal information only in accordance with certain exceptions in the GLBA; providing nonpublic personal information under these exceptions does not trigger consumer opt-out rights.31 New GLBA section 503(f)(2) states the second condition for the annual notice exception: That a financial institution must not have changed its policies and practices with regard to disclosing nonpublic personal information from the policies and practices that were disclosed in the most recent disclosure sent to consumers in accordance with GLBA section 503. The statutory amendment became effective upon enactment in December 2015.

    29 FAST Act, Public Law 114-94, section 75001.

    30 In order to avoid confusion and facilitate responsiveness to consumer requests, the Bureau notes that a financial institution that qualifies for the annual notice exception could provide a privacy notice to a customer without jeopardizing the availability of the exception, such as in response to a customer specifically requesting a copy of the notice.

    31 These provisions are in GLBA section 502(b)(2) or (e) and are incorporated into existing Regulation P at § 1016.13, § 1016.14, and § 1016.15. They provide exceptions from the requirement that a financial institution provide notice and an opportunity to opt out of sharing nonpublic personal information with a nonaffiliated third party.

    On July 15, 2016, the Bureau published a proposed rule to implement the FAST Act statutory amendment to the GLBA. The Bureau has considered the comments received on that proposed rule, and now issues this final rule based on it.

    D. Effective Date

    As discussed above, the statutory exception to the annual notice requirement is already effective. The amendments to Regulation P in this final rule will be effective 30 days from the date of publication in the Federal Register.

    E. Privacy Considerations

    In developing this final rule, the Bureau considered its potential impact on consumer privacy. The rule will not affect the collection or use of consumers' nonpublic personal information by financial institutions. The rule implements a new statutory exception to limit the circumstances under which financial institutions subject to Regulation P will be required to deliver annual privacy notices to their customers. Delivery of annual privacy notices is required under the rule if financial institutions make certain types of changes to their privacy policies or if the statute and Regulation P afford customers the right to opt out of financial institutions' sharing of customers' nonpublic personal information with nonaffiliated third parties. The statutory exception and this final rule do not affect the requirement to deliver an initial privacy notice, and all consumers will continue to receive such notices describing the privacy policies of any financial institutions with which they do business to the extent currently required.

    III. Legal Authority

    The Bureau is issuing this final rule pursuant to its authority under section 504 of the GLBA, as amended by section 1093 of the Dodd-Frank Act.32 The Bureau is also issuing this rule pursuant to its authority under sections 1022 and 1061 of the Dodd-Frank Act.33

    32 15 U.S.C. 6804.

    33 12 U.S.C. 5512, 5581.

    IV. Section-by-Section Analysis Section 1016.3 Definitions 3(s)(1)

    Regulation P's substantive requirements, including the requirement to deliver privacy notices, are generally imposed upon entities that meet the definition of “You” in § 1016.3(s)(1). That provision defines “You” as a “financial institution or other person for which the Bureau has rulemaking authority under section 504(a)(1)(A) of the GLBA.” In order to coordinate this definition more correctly with the term's usage in the regulation, the Bureau proposed to limit “You” to financial institutions.

    The Bureau received no comments on this technical amendment, and adopts it now as proposed.

    As explained above, Regulation P's substantive requirements, including the requirement to deliver privacy notices, are generally imposed upon entities that meet the definition of “You” in § 1016.3(s)(1). The Bureau has rulemaking authority over entities other than financial institutions pursuant to GLBA section 504(a)(1)(A).34 The statute's privacy notice requirements, however, specifically apply only to financial institutions.35 The Bureau therefore believes that it is appropriate to limit the definition of “You” in § 1016.3(s)(1) to financial institutions. For this reason, the Bureau is amending § 1016.3(s)(1) to remove the phrase “or other persons.” The Bureau does not believe this technical amendment to § 1016.3(s)(1) will change the settled understanding of the scope of Regulation P's privacy notice requirements. Instead, the Bureau believes it will clarify that the scope of Regulation P's privacy notice requirements is consistent with the understanding of stakeholders.

    34 Such rulemaking authority has been exercised with respect to nonaffiliated third parties to which a financial institution discloses nonpublic personal information and that third party's affiliates for purposes of GLBA section 502(c)'s limits on reuse of information. See 12 CFR 1016.11(c)-(d).

    35See GLBA sections 502(a)-(b) and 503(a).

    Section 1016.5 Annual Privacy Notice to Customers Required 5(a) General Rule

    The Bureau proposed to amend the general requirement in § 1016.5(a)(1) that financial institutions provide annual notices, to clarify that the Bureau has added an exception to this requirement in § 1016.5(e) to incorporate the amendment to GLBA section 503.

    No commenters specifically discussed the conforming change to the general rule in § 1016.5(a). One commenter suggested that the Bureau remove any GLBA privacy notice requirement and instead require financial institutions to post their privacy notices online, allow all consumers to choose whether to receive any privacy notices, make electronic notices the default for any consumers who opt to receive any privacy notices, and allow financial institutions to charge fees for any paper privacy notices they provide.

    The Bureau now adopts the conforming amendment to the general requirement in § 1016.5(a)(1) that financial institutions provide annual notices, to clarify that the Bureau has added an exception to this requirement in § 1016.5(e) to incorporate the amendment to GLBA section 503. The Bureau does not believe that the comment is relevant to the proposal and it does not provide a basis to change the approach proposed by the Bureau. Congress did not include revisions along the lines the commenter suggested in the statutory provision that the Bureau is implementing in this rulemaking.

    5(e) Exception to Annual Notice Requirement

    New GLBA § 503(f) provides that a financial institution is excepted from providing an annual notice if it meets the two conditions described below. The Bureau proposed to add new § 1016.5(e) to incorporate into Regulation P the exception created by new § 503(f). Under proposed § 1016.5(e), as in section 503(f), a financial institution would be excepted from providing an annual notice if it meets the two conditions discussed below.

    The commenters overwhelmingly supported proposed § 1016.5(e). Although some commenters asked that the exception be broadened, no commenters who discussed the proposed exception objected to it. The commenters stated that the exception would reduce burden and would not harm consumers, and was less complicated and burdensome than the previous alternative delivery method. Some suggested that the provision would benefit consumers. The comments that specifically discussed either of the two requirements for the exception, in § 1016.5(e)(1)(i) and (ii), are discussed below in relation to those provisions.

    A trade association representing credit unions requested that to eliminate confusion and protect institutions from citations, the rule should be effective retroactive to December 4, 2015, the date the statutory GLBA amendments took effect. In addition, an attorney suggested that the Bureau preempt State privacy statutes that might require institutions to continue providing annual privacy notices in spite of the Federal exception. The attorney recommended the Bureau modify § 1016.17 to expressly preempt contrary State law, and instead require that an institution make its privacy notice continually available online.

    After considering the comments and for the reasons discussed below, the Bureau now adopts the exception to the annual notice requirement largely as proposed, with certain changes to the timing provisions in § 1016.5(e)(2), as discussed below.

    In regard to the comment recommending that § 1016.17 be modified, § 1016.17 implements GLBA § 507,36 which provides specific standards regarding preemption of State law. The Bureau does not believe that the comment is relevant to the proposal and it does not provide a basis to change the approach proposed by the Bureau. Congress did not include revisions along the lines the commenter suggested in the statute that the Bureau is implementing in this rulemaking.

    36 15 U.S.C. 6807.

    In regard to the comment on retroactivity, the Bureau has made clear in the proposed rule and this final rule that new GLBA § 503(f) became effective upon enactment in December 2015.37 As the central elements of this rule are already in effect, the Bureau believes that there is no need to make this rule retroactive. To the extent that this rule changes applicable law, the Bureau notes that retroactive rulemaking is disfavored by the courts, and the commenter has not established why it would be appropriate here. This rule takes effect 30 days after its publication in the Federal Register.

    37 See above, Part II.C.

    5(e)(1) When Exception Available 5(e)(1)(i)

    New GLBA section 503(f)(1) states the first condition for the annual privacy notice exception: that a financial institution provide nonpublic personal information only in accordance with the provisions of subsection (b)(2) or (e) of section 502 of the GLBA. The Bureau proposed § 1016.5(e)(1)(i) to incorporate this condition by requiring that to qualify for the annual notice exception, any nonpublic personal information that financial institutions provide to nonaffiliated third parties must be provided only in accordance with § 1016.13, § 1016.14 or § 1016.15 of Regulation P.

    Almost no commenters specifically discussed the first of the two requirements of the new statutory exception. One credit union explained that it does not share nonpublic personal information beyond the exceptions provided in § 1016.13, § 1016.14 or § 1016.15 of Regulation P, and that it believes the § 1016.5(e)(1)(i) requirement will work well. Another commenter discussed voluntary opt-outs that a financial institution may offer, asking whether the inclusion on the privacy notice of opt-outs that allow consumers to opt out of sharing that is described in § 1016.13, § 1016.14 or § 1016.15 of Regulation P would interfere with meeting the requirement in § 1016.5(e)(1)(i).

    The Bureau now adopts § 1016.5(e)(1)(i) as proposed. Section 1016.5(e)(1)(i) will incorporate the first requirement of GLBA § 503(f) by requiring that to qualify for the annual notice exception, any nonpublic personal information that financial institutions provide to nonaffiliated third parties must be provided only in accordance with § 1016.13, § 1016.14 or § 1016.15 of Regulation P; these regulatory sections implement subsections (b)(2) and (e) of section 502.38 A financial institution sharing information only pursuant to these exceptions is not required to provide customers with a right to opt out of that sharing. In addition, because they would only involve information sharing within the exceptions of § 1016.13, § 1016.14 or § 1016.15, voluntary opt-outs included on privacy notices would not affect compliance with the § 1016.5(e)(1)(i) requirement or the annual notice exception.

    38 The sharing described in these provisions includes, among other things, sharing involving third party service providers, joint marketing arrangements, maintaining and servicing accounts, securitization, law enforcement and compliance, and reporting to consumer reporting agencies.

    The Bureau notes that § 1016.6(a)(7) requires that annual privacy notices incorporate any disclosures made under FCRA section 603(d)(2)(A)(iii) regarding the consumer's ability to opt out of sharing of information among affiliates. Further, the notices may incorporate any opt-out disclosures provided under FCRA section 624.39 GLBA section 503(f)(1) does not mention information sharing that would trigger an opt-out notice under FCRA sections 603(d)(2)(A)(iii) or 624.

    39 15 U.S.C. 1681s-3(b); 12 CFR 1022.23(b).

    Given the structure of the statute, the Bureau does not interpret GLBA section 503(f)(1) to preclude financial institutions that provide nonpublic personal information in accordance with FCRA sections 603(d)(2)(A)(iii) or 624 from qualifying for the exception. Thus, as the Bureau stated in its proposal, the presence or absence of these FCRA disclosures on a financial institution's privacy notice will not affect whether the institution satisfies GLBA section 503(f)(1) and § 1016.5(e)(1)(i). As the Bureau noted, however, financial institutions that choose to take advantage of the annual notice exception must still provide any opt-out disclosures required under FCRA sections 603(d)(2)(A)(iii) and 624, if applicable. Under the FCRA, neither of these opt-outs is required to be provided annually.40 Accordingly, institutions can provide these disclosures through other methods, for example, through their initial privacy notices in most circumstances.

    40See 15 U.S.C. 1681a(d)(2)(A)(iii); 12 CFR 1022.21, 1022.27; 72 FR 62910, 62930 (Nov. 7, 2007).

    5(e)(1)(ii)

    New GLBA section 503(f)(2) states the second condition for the annual notice exception: that a financial institution not have changed its “policies and practices with regard to disclosing nonpublic personal information” from the policies and practices that were disclosed in the most recent notice sent to consumers in accordance with GLBA section 503. Because the Bureau determined that the statutory language was ambiguous as to the exact types of sharing intended, the Bureau proposed § 1016.5(e)(1)(ii) to resolve this ambiguity by requiring that, to qualify for the annual notice exception, a financial institution must not have changed its policies and practices with regard to disclosing nonpublic personal information from the policies and practices that were disclosed to the customer under § 1016.6(a)(2) through (5) and (9) in the most recent privacy notice the financial institution provided.

    As with the first requirement for the annual notice exception at § 1016.5(e)(1)(i), few commenters specifically discussed the second requirement at § 1016.5(e)(1)(ii). However, the commenters overwhelmingly signaled their support for these provisions by supporting the Bureau's implementation of the statutory exception. Two trade associations representing credit unions did specifically express support for the proposed interpretation of the statutory language as referring only to a change to a disclosure under § 1016.6(a)(2) through (5) and (9).

    The Bureau now adopts § 1016.5(e)(1)(ii) as proposed, providing that, to qualify for the annual notice exception, a financial institution must not have changed its policies and practices with regard to disclosing nonpublic personal information from the policies and practices that were disclosed to the customer under § 1016.6(a)(2) through (5) and (9) in the most recent privacy notice the financial institution provided.

    Paragraphs (1) through (9) of § 1016.6(a) list the specific information that must be included in privacy notices. Section 1016.6(a)(2) through (5) and (9) require a financial institution to include information related to its policies and practices with regard to disclosing nonpublic personal information, but § 1016.6(a)(1) (information collection) and § 1016.6(a)(8) (confidentiality and security) do not.41 Accordingly, the Bureau believes that only changes to an institution's policies and practices that would require changes to any of the disclosures required by § 1016.6(a)(2) through (5) and (9) would cause a financial institution to be unable to use the exception in § 1016.5(e)(1)(ii).42

    41 The information specified in § 1016.6(a)(6) describes the consumer's right pursuant to Regulation P to opt out of an institution's disclosure of information and would be inapplicable where a financial institution qualifies for the annual notice exception.

    42 To have used the Bureau's former alternative delivery method, the information a financial institution was required to convey on its annual privacy notice pursuant to § 1016.6(a)(1) through (5), (8), and (9) was required not to have changed from the information disclosed in the most recent privacy notice provided to the consumer. See removed 12 CFR 1016.9(c)(2)(D). Thus, changes to the information a financial institution was required to convey pursuant to § 1016.6(a)(1) and (8) would have prevented a financial institution from using the alternative delivery method but such changes will not prevent a financial institution from satisfying § 1016.5(e)(1)(ii) for the annual notice exception. Because institutions that include information on their privacy notice pursuant to § 1016.6(a)(7) (which relates to opt-out notices provided pursuant to the FCRA) were not permitted to use the alternative delivery method in any case, § 1016.6(a)(7) was not listed as a type of information that if changed would have prevented a financial institution from using the alternative delivery method.

    Section 1016.6(a)(7) requires that any disclosure an institution makes under FCRA section 603(d)(2)(A)(iii), which describes a consumer's ability to opt out of disclosures of information among affiliates, be included on the privacy notice. The Bureau believes that the statute is ambiguous as to whether a financial institution that changes the disclosure required under § 1016.6(a)(7) from the most recent notice sent to consumers would satisfy GLBA section 503(f)(2). In the proposed rule, the Bureau sought comment on whether proposed § 1016.5(e)(1)(ii) should include changes to disclosures required by § 1016.6(a)(7) and on how frequently institutions change that disclosure. The Bureau further sought comment on whether institutions would prefer to inform customers of these changes through sending an annual privacy notice or through sending a disclosure describing only the FCRA section 603(d)(2)(A)(iii) opt-outs, if applicable, and also sought comment on the impact on consumers of these two methods.

    All the commenters who addressed these issues stated that changes to the disclosures required by FCRA section 603(d)(2)(A)(iii) should not affect the availability of the annual notice exception. A State-wide trade association representing credit unions indicated that the presence or absence of FCRA disclosures on a credit union's privacy notice, and subsequent changes to those FCRA sharing practices, should not impact whether an institution qualifies for the annual notice exception. This trade association stated, without providing data, that it believed that changes by credit unions in its State to FCRA section 603(d)(2)(A)(iii) information disclosures are infrequent, and that few such credit unions share data in a way that trigger a FCRA opt-out in the first place. Other commenters who discussed the 603(d)(2)(A)(iii) information disclosures stated that allowing changes to disqualify financial institutions from the annual notice exception would interfere with the burden reduction intended, and that FCRA has its own disclosure requirements.

    Given the structure of the statute, the Bureau does not interpret GLBA section 503(f)(2) to preclude financial institutions that make changes to disclosures required by § 1016.6(a)(7) from qualifying for the exception. The Bureau also notes that a change in the 603(d)(2)(A)(iii) information disclosures only requires a one-time notice and opt out. The Bureau does not believe that consumers would be materially benefited by requiring this one-time notice to be included in a privacy notice under Regulation P, especially where it is required in a separate notice required by the FCRA.

    In addition to the discussion of 603(d)(2)(A)(iii) information disclosures, the Bureau noted in the proposed rule that a financial institution would satisfy § 1016.5(e)(1)(ii) if it changes its disclosures describing policies and practices with regard to disclosing nonpublic personal information that are included in the institution's privacy notice without being required by the GLBA or § 1016.6 (e.g., disclosures describing sharing with affiliates under FCRA section 624 or voluntary disclosures and opt-outs). The Bureau sought comment on whether changes to disclosures that are not required to be included in privacy notices by the GLBA or § 1016.6 should cause an institution not to satisfy § 1016.5(e)(1)(ii).

    The Bureau received few comments on this issue. A trade association representing credit unions stated that later changes to initial voluntary disclosures should not trigger the need to send annual privacy notices. The commenter suggested that imposing such a requirement would dissuade institutions from making voluntary disclosures. A banking and insurance trade association stated that affiliate marketing policy changes should not impact the availability of the exception. A trade association representing banks stated that changes to disclosures that are not required to be included in privacy notices should not trigger non-compliance. The trade association believed it would be costly and burdensome to add additional disclosures.

    As indicated in the preamble to the proposed rule, the Bureau has determined that disclosures describing sharing with affiliates under FCRA section 624 or voluntary disclosures and opt-outs will not affect a financial institution's eligibility for the annual privacy notice exception under GLBA § 503(f). The Bureau believes that the alternative interpretation could discourage the use of voluntary disclosures while adding unnecessary burden.

    5(e)(2) Delivery of Annual Privacy Notice After Financial Institution No Longer Meets Requirements for Exception

    New GLBA section 503(f) states that a financial institution that meets the requirements for the annual notice exception will not be required to provide annual notices “until such time” as the financial institution fails to comply with the criteria described in section 503(f)(1) and 503(f)(2), which are now implemented in § 1016.5(e)(1)(i) and (ii). A financial institution will no longer meet the requirements for the exception either by beginning to share nonpublic personal information in ways that trigger rights to opt-out notices under the GLBA and Regulation P, or by otherwise changing its policies and practices with regard to disclosing nonpublic personal information from the policies and practices that were disclosed to the customer under § 1016.6(a)(2) through (5) and (9) in the most recent privacy notice the financial institution provided.

    Financial institutions that no longer meet the conditions for the exception must provide customers with annual privacy notices. However, the GLBA, including new GLBA section 503(f), does not clearly specify when institutions must provide these notices. Thus, the statute is ambiguous on the point. It could be read to require the financial institution to provide an annual privacy notice by the time it changes its policies or practices in such a way that it no longer qualifies for the exception. Alternatively, it could be read to subject the financial institution, at the time it changes its policies or practices in such a way that it no longer qualifies for the exception, to the requirement to provide an annual privacy notice while being silent as to the timing for providing that notice.

    Pursuant to its authority in GLBA section 504 to issue rules to implement the GLBA, the Bureau proposed to resolve this ambiguity by adopting this second reading and issuing standards for when institutions must provide these notices. Specifically, in proposed § 1016.5(e)(2)(i) and (ii), the Bureau proposed to use its rulemaking authority under GLBA section 504(a) to establish timing requirements for providing an annual notice in these circumstances. The Bureau proposed to establish these requirements to ensure that delivery of the annual privacy notice in these circumstances is consistent with the existing timing requirements for privacy notices in the regulation, where applicable, and to provide clarity to financial institutions regarding these requirements.

    In developing the proposed framework, the Bureau looked to existing requirements under the statute and regulation because they already address circumstances in which a financial institution might change its policies and procedures in a way that affects the content of the notices. Specifically, § 1016.8 requires that the financial institution provide a revised notice to consumers before implementing certain types of changes; in other cases, the statute and regulation currently contemplate that a change in policy and procedure that affects the content of the notices would simply be reflected on the next regular annual notice provided to the customer. The Bureau is therefore proposing different timing requirements for the resumption of the annual notice requirement depending on whether the change at issue would trigger the requirement for a revised notice under § 1016.8 prior to the change taking effect.

    Accordingly, the timing requirements in proposed § 1016.5(e)(2)(i) and (ii) would differ depending on whether the change that causes the financial institution to no longer satisfy the conditions for the annual notice exception also triggers a requirement under existing Regulation P to deliver a revised notice. Section 1016.8 currently requires that financial institutions provide revised notices to consumers before the institutions share nonpublic personal information with a nonaffiliated third party if their sharing would be different from what the institution described in the initial notice it delivered. After delivering the revised notice, the financial institution must also give the consumer a reasonable opportunity to opt out of any new information sharing beyond the Regulation P exceptions before the new sharing occurs.

    Three-fifths of all industry commenters on the proposed rule specifically addressed the proposed timing requirements. The comments on the timing requirements viewed the requirement in § 1016.5(e)(2)(i) and that in § 1016.5(e)(2)(ii) very differently, as will be discussed below in regard to those sections. In regard to the overall timing requirements, one trade association representing credit unions expressed appreciation for the Bureau's proposal, stating that such clarification will eliminate confusion surrounding delivery requirements after a financial institution no longer meets the requirements for the exception. A trade association representing banks supported the proposed timing requirements, asserting that institutions will not find it difficult to comply with the suggested conditions. This commenter also requested clarification that once notices are sent and there are no further privacy changes, an institution will be able to again qualify for the exception, thus excepting them from having to send further annual notices.

    The Bureau is adopting the timing provisions largely as proposed, with a change to the duration of the timing requirement in § 1016.5(e)(2)(ii), as discussed below. The Bureau is also adding another example to § 1016.5(e)(2)(iii) to clarify whether a financial institution again qualifies for the annual notice exception after delivering an annual notice under § 1016.5(e)(2).

    5(e)(2)(i) Changes Preceded by a Revised Privacy Notice

    For changes to a financial institution's policies or practices that cause it to no longer satisfy the conditions for the exception and also trigger an obligation to send a revised notice prior to the change, the Bureau proposed in § 1016.5(e)(2)(i) that financial institutions would be required to resume delivery of their subsequent regular annual notices pursuant to the existing timing requirements that govern delivery of annual notices generally. Because the revised notice would inform the customer of the institution's changed policies and practices before any new sharing occurs, the Bureau believed that there is no clear urgency regarding delivery of the first annual notice subsequent to implementation of the new policies and procedures.

    Specifically, § 1016.4(a)(1) generally requires a financial institution to provide an initial notice to an individual who becomes the institution's customer no later than when it establishes a customer relationship. Section 1016.5(a) requires a financial institution to provide a privacy notice to its customers “not less than annually” during the continuation of any customer relationship. Section 1016.5(a)(1) defines annually to mean “at least once in any period of 12 consecutive months.” It further provides that a financial institution “may define the 12-consecutive-month period, but [] must apply it to the customer on a consistent basis.” Section 1016.5(a)(2) provides an example of the meaning of “annually” in relation to the delivery of the first annual notice after the initial notice:

    You provide a notice annually if you define the 12-consecutive-month period as a calendar year and provide the annual notice to the customer once in each calendar year following the calendar year in which you provided the initial notice. For example, if a customer opens an account on any day of year 1, you must provide an annual notice to that customer by December 31 of year 2.

    The example in § 1016.5(a)(2) provides financial institutions with the flexibility to select a specific date during the year to provide annual notices to all customers, regardless of when a particular customer relationship began. This flexibility avoids burdening institutions with either having to provide annual notices on the anniversary of initial notices, or alternatively providing two notices in the first year of the customer relationship to get all accounts originated in a given calendar year on the same cycle for delivering subsequent annual notices.

    The Bureau proposed that the approach to timing of the annual notice in § 1016.5(a)(2) be applied if a financial institution makes a change that causes it to lose the exception and triggers the requirement to deliver a revised notice prior to the change. Under the proposed approach, if a financial institution provides a revised notice on any day of year 1 in advance of changing its policies or practices such that it loses the exception, that revised notice would be treated as analogous to an initial notice in § 1016.5(a)(2). Assuming that the financial institution defines the 12-month period as the calendar year, the financial institution would have to provide the first annual notice after losing the exception by December 31 of year 2.

    The Bureau invited comment on the timing conditions proposed in § 1016.5(e)(2)(i). Few commenters separately discussed § 1016.5(e)(2)(i). All commenters who explicitly addressed the proposed timing requirements under § 1016.5(e)(2)(i) agreed with the Bureau's proposed approach. No industry commenters suggested alternative timing conditions. One credit union asserted that the proposed timing condition would incentivize credit unions to plan and notify their members in advance of making changes to privacy policies. Two trade associations representing banks and credit unions supported the timing requirement because it would prevent institutions from having to send out multiple notices within the same year. The trade association representing credit unions asserted that redundant notices provide no benefit to consumers and pose a burden and expense on credit unions.

    The Bureau now adopts § 1016.5(e)(2)(i) as proposed. The Bureau believes that using the same approach in § 1016.5(e)(2)(i) as in existing § 1016.5(a)(2) is appropriate for two reasons. First, customers will receive a revised notice informing them of the change in the financial institution's policies or practices before the change occurs, and thus customers will not be harmed by the financial institution taking a longer period of time in which to deliver the first annual notice after the annual notice exception has been lost. Second, this approach will preserve flexibility for financial institutions and avoid requiring them to deliver a revised notice and an annual notice in the same year, and allowing them to use a convenient delivery date for annual notices for all customers. The Bureau believes this flexibility is justified because a financial institution that is required to deliver a revised privacy notice pursuant to § 1016.8 may have continuing annual notice obligations after the exception is lost. Such an institution could be sharing other than as described in the Regulation P exceptions and thus fail to satisfy § 1016.5(e)(1)(i), making the annual notice exception unavailable in future years.

    5(e)(2)(ii) Changes Not Preceded by a Revised Privacy Notice

    For financial institutions that change their policies and practices in such a way as to lose the § 503(f) exception, but do not share information in a way that triggers the requirement under § 1016.8 to deliver a revised notice prior to the change, the Bureau proposed that a financial institution must deliver the annual notice within 60 days after the change that caused the institution to lose the exception. The Bureau proposed this 60-day period for providing the annual notice in this situation because customers would not receive a revised notice from the financial institution prior to the institution's change in policies or practices.

    The Bureau requested comment on whether 60 days is an appropriate period for delivering annual notices in these circumstances or if another period would be more appropriate. Approximately half of all commenters specifically addressed the timing conditions proposed under § 1016.5(e)(2)(ii). These commenters generally opposed the 60-day requirement, advocating instead for an increased amount of time for institutions to deliver the revised notice. The majority of these commenters requested at least 90 days to deliver the notice.

    Trade associations representing credit unions cited cost concerns with the 60-day requirement, asserting that because they send quarterly statements to many consumers, the timing requirement would require institutions to send out an additional notice. Some of these commenters suggested that 90 days was a more appropriate timeframe, as it would allow institutions to minimize costs by sending the revised notice with the next quarterly statement. One of these trade associations representing credit unions also asserted that 60 days was too brief, particularly for small credit unions addressing inadvertent changes. This commenter suggested 90 to 120 days to allow credit unions the opportunity to include the notice with the quarterly periodic statement, and noted that while all members may not receive monthly statements, most receive account statements quarterly.

    Other industry commenters suggested 120 days as an appropriate time to deliver the annual notice. A few of these commenters cited the same above-mentioned cost concerns that are associated with separate mailers. These commenters asserted that 120 days would allow the notice to be included with regularly scheduled member statements, therefore eliminating the need for an additional mailer. One industry commenter representing credit unions noted that a separate mailer would be especially costly for smaller credit unions with fewer resources.

    Industry commenters who suggested 120 days also stated, without specific explanation, that the proposed 60-day requirement did not provide institutions enough time to perform. A few of these industry commenters asserted that smaller credit unions, particularly those with fewer resources, would find the 60-day time frame too short. Some of those same commenters thought that larger credit unions with numerous departments working to consolidate information would also struggle to meet the 60-day requirement. Several trade associations representing credit unions stated that a longer time frame would allow credit unions time to organize logistics, educate staff, and command the resources necessary to draft and send the required notice. One industry commenter stated that an extension would not negatively impact consumers because prior notice is still required when changes allow sharing with third parties of non-public personal information and the option to opt out in advance.

    One trade association commenter representing credit unions suggested at least 180 days, citing the fact that § 1016.8 does not require a revised privacy notice under the circumstances described in § 1016.5(e)(2)(ii). This commenter also suggested that to combat costs, financial institutions should have the option to include a message on periodic statements or mailers that there has been a change to the privacy notice, and direct the recipient to the financial institution's website to view and download an electronic copy of the revised notice.

    The Bureau now adopts the timing provision in § 1016.5(e)(2)(ii) with a 100 calendar day period during which the financial institution must provide the annual privacy notice. The unanimous industry objection to the 60-day period suggests that the proposal likely would have imposed costs that the Bureau had not anticipated. The 100-day period will accommodate the inclusion of the notice with quarterly statements. The Bureau believes that providing 10 days in addition to the 90 days many commenters requested is appropriate because most calendar quarters are slightly longer than 90 days, and a short additional period should be allowed for administrative activities and to provide flexibility if the end date falls on a weekend or holiday. The Bureau does not believe that consumers will be harmed by this extension of the time period from the proposal.

    However, the Bureau notes that the commenters requesting 120 or 180 days provided no specific reason why allowing such additional time would contribute to cost savings beyond allowing the notice to be included in quarterly statements. The Bureau is not aware of any other reason, and therefore declines to adopt a longer period.

    The Bureau believes that the 100-day deadline will not impose undue or unreasonable costs on financial institutions, particularly since the delivery requirement is effectively a one-time burden absent additional changes to a financial institution's policies and practices. Specifically, after providing the one annual notice, the financial institution will likely once again meet both of the conditions for the exception—it will not be sharing nonpublic personal information with nonaffiliates other than as described in a Regulation P exception to the opt-out requirements and its policies and practices will not have changed since it provided the annual notice. Because the financial institution likely will once again meet the conditions for the exception, it likely will not be required to provide future annual notices. In other words, these financial institutions will likely lose the exception for only a single year. The Bureau is including an additional example in § 1016.5(e)(2)(iii)(B) for clarity. Given that financial institutions delivering notices pursuant to § 1016.5(e)(2)(ii) will likely have no continuing obligation to send annual notices, they likely will not need flexibility in choosing a convenient delivery date for future annual notices, beyond the 100 days of flexibility being provided for a single privacy notice.43

    43 If the financial institution were to make changes in the future to its practices and policies, these changes could trigger a new obligation to provide annual privacy notices.

    In regard to the comment that the regulation should allow financial institutions to include a message on periodic statements or mailers directing customers to an electronic copy of the annual notice, the Bureau believes that any reduction in costs would be minimal because the financial institution is likely not required to provide more than one notice. In addition, the Bureau did not propose or request comment on such an option.

    The Bureau also notes that financial institutions have substantial flexibility in managing the burden involved in sending the one annual notice because institutions can generally choose when they change their policies or practices. Accordingly, an institution can choose when to make the change triggering the commencement of the 100-day period for delivery of the annual notice, so that the date of delivery can be as convenient and low-cost as possible.

    5(e)(2)(iii) Examples

    In order to facilitate compliance with proposed § 1016.5(e)(2), the Bureau proposed § 1016.5(e)(2)(iii) to provide an example for when an institution must provide an annual notice after changing its policies or practices such that it no longer meets the requirements for the annual notice exception set forth in proposed § 1016.5(e)(1).

    The Bureau did not receive any comments specifically discussing the example provided in § 1016.5(e)(2)(iii). Because the Bureau believes that the example will provide clarity and facilitate compliance, it is now being made final in § 1016.5(e)(2)(iii)(A), with a minor change due to the alteration of the time frame in § 1016.5(e)(2)(ii). In addition, the Bureau is providing a second example, in § 1016.5(e)(2)(iii)(B), to facilitate compliance when a financial institution must only provide one annual notice before it again qualifies for the § 1016.5(e)(1) exception.

    Section 1016.5(e)(2)(iii)(A) provides an example for when an institution must provide an annual notice after changing its policies or practices such that it no longer meets the requirements for the annual notice exception in § 1016.5(e)(1). The Bureau believes this example will facilitate compliance with § 1016.5(e)(2). The example assumes that an institution changes its policies or practices effective April 1 of year 1 and defines the 12-consecutive-month period pursuant to § 1016.5(a)(1) as a calendar year. Section 1016.5(e)(2)(iii)(A) states that the institution must provide an annual notice by December 31 of year 2 if the institution was required to provide a revised notice prior to the change and provided that revised notice on March 1 of year 1 in advance of the change. Section 1016.5(e)(2)(iii)(A) further states that the institution must provide an annual notice by July 9 of year 1 if the institution was not required to provide a revised notice prior to the change.

    The Bureau is also providing a second example, in § 1016.5(e)(2)(iii)(B), to facilitate compliance when a financial institution must provide only one annual notice before it again qualifies for the § 1016.5(e)(1) exception, as discussed above in relation to § 1016.5(e)(2)(ii). The example assumes that a financial institution changes its policies and practices in such a way that it no longer meets the requirements of § 1016.5(e)(1), and so provides an annual notice to its customers. The example further assumes that after providing the annual notice to its customers, the financial institution once again meets the requirements of § 1016.5(e)(1) for an exception to the annual notice requirement. The example explains that the financial institution does not need to provide additional annual notices to its customers until such time as it no longer meets the requirements of § 1016.5(e)(1).

    Section 1016.9 Delivering Privacy and Opt Out Notices 9(c)(2) Alternative Delivery Method for Providing Certain Annual Notices

    As discussed in Part II, the Bureau amended Regulation P in October 2014 to allow financial institutions that met certain criteria to deliver annual notices pursuant to the “alternative delivery method.” Because financial institutions that met the conditions in Regulation P to use the alternative delivery method will also meet the conditions for the statutory exception in section 503(f), the Bureau proposed to remove the alternative delivery method from Regulation P by removing § 1016.9(c)(2) and renumbering existing § 1016.9(c)(1) as § 1016.9(c).

    Commenters generally expressed support for the proposed removal of the alternative delivery method. Ten commenters addressed the issue, with eight supporting the proposal and two opposing it.

    Some commenters welcomed elimination of the alternative delivery method, asserting that the conditions associated with the 2014 provision deterred institutions from taking advantage of the intended relief. A debt collector organization stated that the alternative delivery method did not provide a solution for many debt collectors and consumers. This commenter asserted that the alternative delivery required model form created a significant risk of class action litigation because of claims that the language conflicts with the Fair Debt Collection Practices Act's prohibitions on third-party disclosure. A commenter representing several trade associations stated that the alternative delivery method requirement to post the notice online eliminated any benefits from the 2014 rule.

    Two trade associations agreed that the alternative delivery method would no longer be useful in light of the statutory exception to the annual notice requirement, and one of these trade associations stated that it was unlikely that financial institutions would continue to use a complex means of compliance when a simpler one was available.

    Several commenters discussed benefits associated with eliminating the alternative delivery method. One trade association stated that removing the alternative delivery method would eliminate confusion between the rule and the statute. Another trade association representing banks expressed appreciation of the elimination of the alternative delivery method, arguing that it would remove the confusion of having both an exception from the annual privacy notice and an alternative to the delivery requirement. One trade association stated that consumers will benefit from the elimination of the method, as they will experience decreasing information overload.

    One trade association representing banks requested clarification that institutions that qualify for the exception but still keep a copy of the privacy policy on their websites will not be criticized or penalized.

    Two trade association commenters representing the consumer credit industry and credit unions did not support removal of the alternative delivery method. These commenters stated that their customers or members prefer to receive communications electronically. Both commenters cited cost burdens associated with mailing privacy notices.

    The trade association representing the consumer credit industry stated that several of their member financial institutions, particularly those that provide indirect auto loans, do not qualify for the statutory exception to the annual notice requirement because the institutions share consumer information with nonaffiliated third parties other than as described in §§ 1016.13, 14 and 15. These institutions are required under § 1016.10 of Regulation P to inform consumers through the institution's annual privacy notice that the consumer has a right to opt out of that information sharing. The trade association representing the consumer credit industry encouraged expansion of the alternative delivery method, highlighting the cost effectiveness of electronic delivery and stating that many institutions upgraded systems to implement the alternative delivery method under the 2014 rule. This commenter also urged the Bureau to consider allowing institutions that share with nonaffiliated third parties to deliver their privacy notices electronically, such as via website posting, similar to the method permitted by the alternative delivery method.

    After considering the comments, the Bureau now adopts the proposed change, removing the alternative delivery method from Regulation P by removing § 1016.9(c)(2) and renumbering former § 1016.9(c)(1) as § 1016.9(c).

    Any financial institution that met the conditions to use the alternative delivery method will also meet the conditions to be excepted from delivering an annual privacy notice pursuant to new GLBA section 503(f). First, new GLBA section 503(f)(1) is substantively identical to the first requirement for using the alternative delivery method: 44 That the financial institution share nonpublic personal information about customers with nonaffiliated third parties only in ways that do not give rise to the customer's right to opt out of that sharing.45 Second, new GLBA section 503(f)(2) is similar to the fourth requirement for using the alternative delivery method: that the institution must not have changed its policies and practices with regard to disclosing nonpublic personal information from those that were disclosed to the customer in the most recent privacy notice.46 Accordingly, any financial institution that would have met the requirements in former § 1016.9(c)(2) will also meet the requirements of section 503(f).

    44 See removed 12 CFR 1016.9(c)(2)(i)(A).

    45 This sharing is pursuant to GLBA section 503(b)(2) and (e), which correspond to Regulation P §§ 1016.13, 1016.14, and 1016.15.

    46 See removed 12 CFR 1016.9(c)(2)(i)(D). The requirement in former § 1016.9(c)(2)(i)(D) was somewhat more restrictive because it required a financial institution not to have changed its practices with respect to disclosing nonpublic personal information and protecting the confidentiality and security of nonpublic personal information whereas section 503(f)(2) requires that the institution not have changed its policies only with respect to disclosing nonpublic personal information. See the section-by-section analysis of § 1016.5(e)(1)(ii) for further discussion.

    The Bureau believes that a financial institution that has both options available to it would choose not to send the annual privacy notice at all, rather than to deliver it pursuant to the alternative delivery method, so that it can eliminate rather than merely reduce the cost of providing annual notices. Given that any financial institution that qualifies to use the alternative delivery method for its annual notices also meets the qualifications for the new annual notice exception, the Bureau believes that including the alternative delivery method in Regulation P is no longer useful.

    The Bureau notes that financial institutions that delivered annual notices using the alternative delivery method while it was in effect delivered those notices using a method that was in compliance with Regulation P, notwithstanding that the alternative delivery method provision is now being removed from the regulation. The Bureau further notes that financial institutions that qualify for the new annual notice exception may still choose to post privacy notices on their websites, deliver privacy notices to consumers who request them, and notify consumers of the notices' availability. Such activities will not affect a financial institution's eligibility for the new 503(f) exception.

    The Bureau has considered the comments suggesting that it retain and expand the alternative delivery method for providing annual privacy notices. In this rulemaking, the Bureau is implementing the FAST Act amendments to the GLBA, which eliminate the requirement that financial institutions provide an annual privacy notice if certain conditions are met. In making these amendments to the GLBA, Congress did not address the delivery method financial institutions must or may use if they continue to be required to provide an annual privacy notice, including where financial institutions have not changed their privacy policies since their last privacy notice and they share information with nonaffiliated third parties other than as described in §§ 1016.13, .14, and .15. Because Congress did not address these issues in the FAST Act amendments to the GLBA, the Bureau declines to address them in this rulemaking to implement those amendments.

    V. Dodd-Frank Act Section 1022(b)(2) Analysis A. Overview

    In developing the final rule, the Bureau has considered the potential benefits, costs, and impacts as required by section 1022(b)(2) of the Dodd-Frank Act.47 The Bureau requested comment on the preliminary analysis as well as the submission of additional data that could inform the Bureau's analysis of the benefits, costs, and impacts of the rule. The Bureau received one comment on the preliminary analysis, which it has considered in developing this final analysis. In addition, the Bureau has consulted and coordinated with the SEC, CFTC, FTC, and NAIC, and consulted with or offered to consult with the OCC, Federal Reserve Board, FDIC, NCUA, and HUD, including regarding consistency with any prudential, market, or systemic objectives administered by such agencies.

    47 Specifically, section 1022(b)(2)(A) of the Dodd-Frank Act calls for the Bureau to consider the potential benefits and costs of a regulation to consumers and covered persons, including the potential reduction of access by consumers to consumer financial products or services; the impact on depository institutions and credit unions with $10 billion or less in total assets as described in section 1026 of the Dodd-Frank Act; and the impact on consumers in rural areas.

    This final rule implements the December 2015 amendment to the GLBA by amending § 1016.5 of Regulation P to provide that a financial institution is not required to deliver an annual privacy notice if it:

    (1) Provides nonpublic personal information to nonaffiliated third parties only in accordance with the provisions of § 1016.13, § 1016.14, or § 1016.15; and

    (2) Has not changed its policies and practices with regard to disclosing nonpublic personal information from the policies and practices that were disclosed to the customer under § 1016.6(a)(2) through (5) and (9) in the most recent privacy notice provided.

    In considering the potential benefits, costs, and impacts of the rule, the Bureau takes as the baseline for the analysis the legal regime that existed prior to the FAST Act's amendment of the GLBA.48 This regime includes the current provisions of Regulation P. The Bureau assumes that all financial institutions that can use the alternative delivery method provided in § 1016.9(c)(2) are doing so.

    48 The proposal referred to this as the “regulatory regime that currently exists.” 81 FR at 44808. However, the baseline the Bureau is using did not and does not reflect that the FAST Act has taken effect. The Bureau has discretion in each rulemaking to choose the relevant provisions to discuss and to choose the most appropriate baseline for that particular rulemaking.

    B. Potential Benefits and Costs to Consumers and Covered Persons

    The impact on consumers of § 1016.5(e) depends on whether the particular consumer prefers or would otherwise benefit from receiving an annual privacy notice that does not offer the consumer an opt-out under the GLBA and is largely unchanged49 from previous notices. Under § 1016.5(e), financial institutions that meet the requirements for the annual notice exception would not be required to provide consumers with annual privacy notices, and the Bureau anticipates that most institutions would decide not to provide notices in these circumstances. While there is no data available on the number of consumers who are indifferent to (or dislike) receiving unchanged privacy notices every year, the limited use of opt-outs and anecdotal evidence suggest that there are such consumers.50 For this group of consumers, § 1016.5(e) might provide a benefit because it would be available to some institutions that cannot use the alternative delivery method, so that more consumers would stop receiving mailed annual privacy notices.

    49 As discussed in part IV in the section-by-section analysis of § 1016.5(e)(1)(ii), certain changes to an institution's policies or practices would not cause the institution to lose the annual notice exception.

    50 One early analysis of the use of the opt-outs reported at most 5% of consumers make use of them in any year, and likely fewer. See Jeffrey M. Lacker, The Economics of Financial Privacy: To Opt Out or Opt In?, 88/3 Fed. Res. Bank Rich. Econ. Q., at 11 (Summer 2002), available at https://www.richmondfed.org/-/media/richmondfedorg/publications/research/economic_quarterly/2002/summer/pdf/lacker.pdf. One commenter on the proposed rule also estimated that 5% of consumers use opt-outs. AFSA Comment letter, August 10, 2016.

    For other consumers who would prefer or otherwise benefit from receiving the annual notices, there will be some cost because many institutions that previously delivered notices—whether through the standard delivery methods or through the alternative delivery method that includes posting on the institution's website—will no longer deliver annual notices. Consumers may be less informed about opportunities to limit a financial institution's information sharing practices if the financial institution meets the requirements for the annual notice exception and chooses not to provide annual notices. For example, some consumers will receive fewer notices in which a financial institution offers voluntary opt-outs, i.e., opt-outs that the financial institution is not required by Regulation P to offer (because, for example, the type of sharing the financial institution does is covered by an exception) but that the institution decides to provide anyway via the annual privacy notice. Voluntary opt-outs do not appear to be common, however.51 Further, institutions may continue to offer voluntary opt-outs and may offer them through other mechanisms even if they do not provide annual privacy notices.

    51See Lorrie Faith Cranor et al., Are They Actually Any Different? Comparing Thousands of Financial Institutions' Privacy Practices, available at http://www.econinfosec.org/archive/weis2013/papers/CranorWEIS2013.pdf (submitted as part of The Twelfth Workshop on the Economics of Information Security (WEIS 2013), June 11-12, 2013, Georgetown University, Washington, DC). Their findings (Table 2) imply that at most 15% of the 3,422 FDIC insured depositories that post the model privacy form on their websites offer at least one voluntary opt-out. Data from a much larger group of financial institutions analyzed by Cranor et al. (undated) imply (Table 2) that at most 27% of the 6,191 financial institutions that post the model privacy form on their websites offer at least one voluntary opt-out.

    If financial institutions choose not to provide notices pursuant to the annual notice exception, consumers may also be less informed of their opt-out rights under the FCRA. Section 503(c)(4) of the GLBA and Regulation P require financial institutions providing initial and annual privacy notices to incorporate into them any notification and opt-out disclosures provided pursuant to section 603(d)(2)(A)(iii) of the FCRA.52 Section 624 of the FCRA and Regulation V also permit (but do not require) financial institutions providing initial and annual privacy notices under Regulation P to incorporate any opt-out disclosures provided under section 624 of the FCRA and subpart C of Regulation V into those notices.53 Because financial institutions will likely decide not to provide annual notices pursuant to the exception in proposed § 1016.5(e), consumers may be less informed of their opt-out rights pursuant to these sections of the FCRA to the extent that institutions use less effective methods to convey information about these rights to consumers.54 Consumers also may be less informed about a financial institution's data collection practices and its policies and practices with respect to protecting the confidentiality and security of nonpublic personal information.

    52 15 U.S.C. 6803(c)(4); 12 CFR 1016.6(a)(7).

    53 15 U.S.C. 1681s-3(b); 12 CFR 1022.23(b).

    54 As explained in the section-by-section analysis of § 1016.5(e)(1)(i) in part IV, the annual notice exception in § 1016.5(e) does not relieve financial institutions of the obligation to provide consumers with the information that is required under FCRA sections 603(d)(2)(A)(iii) or 624.

    Regarding benefits and costs to covered persons, the primary effect of the rule will be burden reduction achieved by lowering the costs to industry of providing annual privacy notices. Section 1016.5(e) imposes no new compliance requirements on any financial institution. Any institution that could use the alternative delivery method will meet the requirements for the annual notice exception pursuant to § 1016.5(e).55 A financial institution that is in compliance with current law will not be required to take any different or additional action unless it chooses to take advantage of the annual notice exception and thus will be required to separately meet its opt-out obligations, if any, pursuant to the FCRA.56 This analysis assumes that no financial institution will do so unless the net result of the choice is burden reducing.

    55 Any financial institution that meets the conditions to use the alternative delivery method will also meet the conditions to be excepted from delivering an annual privacy notice pursuant to new GLBA section 503(f) because the two conditions for section 503(f) are closely related to conditions for using the alternative delivery method. See the section-by-section analysis of § 1016.9(c) for further explanation.

    56 See the section-by-section analysis to § 1016.5(e)(1)(i) in part IV for an explanation of the interaction between the annual notice exception and the opt-outs provided under FCRA sections 603(d)(2)(A)(iii) and 624.

    The expected cost savings to financial institutions from the revisions to § 1016.5(e) depend on whether the financial institution uses the alternative delivery method under the baseline. Financial institutions that currently use the alternative delivery method will likely cease complying with the requirements in current § 1016.9(c)(2) since they necessarily meet the requirements of the exception to the annual notice requirement and thus will no longer be required to deliver an annual notice.57 However, the Bureau expects that financial institutions that change from using the alternative delivery method to provide annual notices to not providing these notices at all will achieve little cost savings.58 Financial institutions that currently do not use the alternative delivery method are expected to use the proposed annual notice exception if the expected costs of any changes required to use the exception and the costs of any consequences of not providing the annual disclosure will be lower than the costs of complying with current Regulation P. The Bureau believes that few such financial institutions will find it in their interests to change their information sharing practices in order to use the annual notice exception. Thus, the Bureau takes the information sharing practices of financial institutions as given and considers how many financial institutions that do not currently meet the requirements to use the alternative delivery method can use the annual notice exception.59 As a practical matter, the Bureau identifies these institutions solely by their information sharing practices: That is to say, the Bureau identifies the financial institutions whose current information sharing practices do not meet the standards in § 1016.9(c)(2) but will meet the standards in § 1016.5(e). The Bureau then estimates the ongoing savings in costs to these financial institutions from no longer sending the annual privacy notice.60

    57See supra note 52.

    58 The Bureau believes that the alternative delivery method imposes little ongoing cost to financial institutions that have adopted it. These costs derive from the additional text on an account statement, coupon book, notice or disclosure the institution already provides; maintaining a web-page dedicated to the annual privacy notice; responding to telephone calls from a very small number of consumers requesting that the model form be mailed; and mailing the forms prompted by these calls.

    59 Because the Bureau takes institutions' sharing practices as given and because the cost savings estimate is based on a single year, the expected cost savings for institutions does not account for a reduction or increase in aggregate cost savings that may occur if any institutions change their sharing practices in the future such that they no longer meet the requirements for the annual notice exception or they begin to meet those requirements.

    60 The Bureau assumes that a financial institution used the alternative delivery method whenever the Bureau can obtain the annual privacy notice from the website of the financial institution and the Bureau concludes from the information on the privacy notice that the information sharing practices of the financial institution comply with removed § 1016.9(c)(2). If a financial institution did not use the model form, the Bureau assumes that the financial institution would have adopted the model form if the information sharing practices complied with § 1016.9(c)(2). This methodology overstates the number of these financial institutions that could have used the alternative delivery method, because some of these financial institutions might not have met all of the requirements of § 1016.9(c)(2), and therefore understates the benefits of the annual notice exception to these financial institutions. On the other hand, if a financial institution does not have a website, the Bureau cannot (as a practical matter) obtain and evaluate its information sharing practices. In this case, the Bureau assumes that the financial institution cannot use either the alternative delivery method or the annual notice exception. This also tends to understate the benefits of the annual notice exception to these financial institutions, since none of them could have used the alternative delivery method but some might be able to use the annual notice exception.

    For the 2014 Annual Privacy Notice Rule, the Bureau collected a sample of privacy policies from banks and credit unions and estimated both the number of financial institutions that would adopt the alternative delivery method and the aggregate cost savings that would result.61 Specifically, the Bureau examined the privacy policies of 19 banks with assets over $100 billion as well as the privacy policies of 106 additional banks selected through random sampling. The Bureau previously concluded that 80% of banks could use the alternative delivery method that was set forth in § 1016.9(c)(2). For the current rulemaking, the Bureau re-analyzed this sample to identify banks with information sharing practices that do not meet the standard in § 1016.9(c)(2) but will meet the standard in § 1016.5(e). In the re-analysis, the Bureau finds that 48% of banks that could not use the alternative delivery method can use the proposed exception to the annual notice requirement. Most of these banks were not able to use the alternative delivery method because they offered opt-outs to consumers pursuant to FCRA section 603(d)(2)(A)(iii); a financial institution can meet the requirements for the annual notice exception in § 1016.5(e) even if it offers such opt-outs. Specifically, the Bureau previously estimated that approximately 1,350 banks could not use the alternative delivery method and our re-analysis shows that 650 of these banks (48%) will be able to use the annual notice exception.62 For banks with assets over $10 billion, 70% of those that could not use the alternative delivery method can use the annual notice exception. For banks with assets of $10 billion or less and banks with assets of $500 million or less, the respective figures are 47% and 40%.

    61See 79 FR 64057, 64076-64077 (Oct. 28, 2014). Note that the term “banks” as used throughout this rule includes savings associations.

    62 While these 650 banks are just 9.5% of all banks, this percentage does not take into account the fact that the majority of banks could not potentially benefit from the exception to the annual privacy notice requirement since (by our previous analysis) they already use the alternative delivery method.

    The Bureau also previously examined the privacy policies of the four credit unions with assets over $10 billion as well as the privacy policies of 50 additional credit unions selected through random sampling. The Bureau previously concluded that 46% of credit unions could use the alternative delivery method. The information evaluated in the re-analysis shows that none of the credit unions that could not use the alternative delivery method will be able to use the exception to the annual notice requirement. Credit unions that clearly could not use the alternative delivery method generally shared information with nonaffiliated third parties other than as specified in the exceptions in §§ 1016.13, 1016.14, and 1016.15. However, there are a number of cases in which the Bureau could not readily evaluate the information sharing practices of the sampled credit union because it did not have a website, did not post the privacy notice on its website, or did not use the model form.63 In the proposal, the Bureau requested data and other factual information on the use of the alternative delivery method by credit unions and the likely use of the proposed annual notice exception by credit unions that cannot use the alternative delivery method. No comments provided data in response to this request.64

    63 One or more of these conditions held for a number of credit unions with assets of $500 million or less. As explained above, if a financial institution did not have a website or did not post the privacy notice on their website, the Bureau made the conservative assumption that it did not benefit from the alternative delivery method and will not benefit from the new annual notice exception. See also 79 FR 64057, 64076 (Oct. 28, 2014).

    64 Although no credit unions or credit union advocates commented or provided data, one State trade association representing banks stated that many financial institutions will appreciate and take advantage of the exception, but it will not create additional costs or harm to consumers. That commenter did not provide data.

    Regarding the number of non-depository financial institutions that will benefit from the exception to the annual notice requirement, the Bureau uses the same basic methodology as in its prior analysis. Specifically, the Bureau assumes that the fraction of non-depository financial institutions that cannot use the alternative delivery method but can use the new annual notice exception is the same for non-depository institutions as for banks (9.5%).65

    65 For further discussion, see id. at 64077.

    Having identified the financial institutions that will benefit from the exception to the annual notice requirement, the Bureau estimates the benefit using the same basic methodology as in its prior analysis.66 For banks, the Bureau allocated the total burden of providing the annual privacy notices to asset-size groups in proportion to the share of assets in the group. The Bureau then estimated an amount of burden reduction specific to each asset-size group using the results from the privacy notice analysis described above. The total burden reduction is then the sum of the burden reductions in each asset-size group. The estimated reduction in burden for banks using this methodology is approximately $3.158 million annually. The estimated reduction in burden for non-depository financial institutions is an additional $231,000 annually.67 Thus, the Bureau believes that the total reduction in burden is approximately $3.389 million dollars annually.68 This represents about 28% of the total $12.162 million annual cost of providing the annual privacy notice under Regulation P.

    66See id. at 64076-64077.

    67 Note that this figure excludes auto dealers. Auto dealers are regulated by the FTC and will not be directly impacted by this amendment to Regulation P.

    68 Some of these banks and non-depository financial institutions that currently include on their annual privacy notice the opt-out notices pursuant to FCRA section 603(d)(2)(A)(iii) or FCRA section 624 and the Affiliate Marketing Rule may now be required to deliver these notices separately. The Bureau does not have the data necessary to estimate the frequency with which these opt-out notices will be delivered separately or to subtract the cost of delivering them separately from the savings from no longer providing the annual privacy notice.

    The Bureau requested comment on the preliminary presentation of this analysis as well as the submission of additional data that could inform the Bureau's consideration of the cost savings to financial institutions. No comments addressed this request.

    The Regulation P exception to the annual notice requirement implements a December 2015 statutory amendment to the GLBA. The Bureau considered alternatives to the timeline for delivery of annual notices when a financial institution that qualified for the annual exception changes its policies or practices such that it no longer qualifies. Because the estimates of costs and benefits to consumers and covered persons take institutions' sharing policies and practices as given, the alternatives with respect to the timeline for delivery of annual notices do not impact those estimates. Further, even if the estimates allowed for changes in sharing policies and practices that can cause institutions to meet or fail to meet the requirements for the annual notice exception, the aggregate annual benefits and costs of delivery will not likely be significantly impacted by the timeline for delivery of annual notices. The Bureau does note, however, that changing from 60 to 100 days for delivery of the annual privacy notice under § 1016.5(e)(2)(ii) should result in a small burden reduction from the proposal, as financial institutions will be able to send the notice with quarterly statements as they requested.

    C. Impact on Depository Institutions With No More Than $10 Billion in Assets

    The Bureau currently estimates that approximately 600 banks with $10 billion or less in assets cannot use the alternative delivery method but can use the annual notice exception. This constitutes 47% of banks with $10 billion or less in assets that do not use the alternative delivery method and 8.8% of all banks with $10 billion or less in assets. As reported above, 70% of banks with more than $10 billion in assets that do not use the alternative delivery method can use the proposed exception to the annual notice requirement. This is 55% of all banks with more than $10 billion in assets. Thus, the rule may have different impacts on federally insured depository institutions with $10 billion or less in assets as described in section 1026 of the Dodd-Frank Act. The Bureau currently believes that no credit unions of any size that could not use the alternative delivery method will be able to use the exception to the annual notice requirement.

    D. Impact on Access to Credit and on Consumers in Rural Areas

    The Bureau does not believe that the rule will reduce consumers' access to consumer financial products or services or have a unique impact on rural consumers.

    VI. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, requires each agency to consider the potential impact of its regulations on small entities, including small businesses, small governmental units, and small not-for-profit organizations. The RFA defines a “small business” as a business that meets the size standard developed by the Small Business Administration pursuant to the Small Business Act. The RFA generally requires an agency to conduct an initial regulatory flexibility analysis (IRFA) and a final regulatory flexibility analysis (FRFA) of any rule subject to notice-and-comment rulemaking requirements, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities.69 The Bureau also is subject to certain additional procedures under the RFA involving the convening of a panel to consult with small business representatives prior to proposing a rule for which an IRFA is required.70

    69 5 U.S.C. 603 through 605.

    70 5 U.S.C. 609.

    At the proposed rule stage, the Bureau determined that an IRFA was not required because the proposal, if adopted, would not have a significant economic impact on a substantial number of small entities. For this final rule, the Bureau continues to believe that that determination is accurate. The Bureau does not expect the rule to impose costs on small entities. All methods of compliance under current law will remain available to small entities when this rule is adopted. Thus, a small entity that is in compliance with current law need not take any different or additional action under the new rule. In addition, based on the data analysis described previously, the Bureau believes that the annual notice exception will allow some small institutions to stop sending the annual notice and to thereby reduce costs.

    Accordingly, the undersigned certifies that this rule will not have a significant economic impact on a substantial number of small entities.

    VII. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (PRA),71 Federal agencies are generally required to seek Office of Management and Budget (OMB) approval for information collection requirements prior to implementation. This proposal would amend Regulation P, 12 CFR part 1016. The collections of information related to Regulation P have been previously reviewed and approved by OMB in accordance with the PRA and assigned OMB Control Number 3170-0010. Under the PRA, the Bureau may not conduct or sponsor, and, notwithstanding any other provision of law, a person is not required to respond to an information collection, unless the information collection displays a valid control number assigned by OMB.

    71 44 U.S.C. 3501 through 3558.

    As explained below, the Bureau has determined that this rule does not contain any new or substantively revised information collection requirements other than those previously approved by OMB. The rule will implement the December 2015 amendment to the GLBA and amend § 1016.5 of Regulation P to provide that a financial institution is not required to deliver an annual privacy notice if it:

    (1) Provides nonpublic personal information to nonaffiliated third parties only in accordance with the provisions of § 1016.13, § 1016.14, or § 1016.15 and;

    (2) Has not changed its policies and practices with regard to disclosing nonpublic personal information from the policies and practices that were disclosed to the customer under § 1016.6(a)(2) through (5) and (9) in the most recent privacy notice provided.

    Under Regulation P, the Bureau generally accounts for the paperwork burden for the following respondents pursuant to its enforcement/supervisory authority: Federally insured depository institutions with more than $10 billion in total assets, their depository institution affiliates, and certain non-depository institutions. The Bureau and the FTC generally both have enforcement authority over non-depository institutions subject to Regulation P. Accordingly, the Bureau has allocated to itself half of the final rule's estimated reduction in burden on non-depository financial institutions subject to Regulation P. Other Federal agencies, including the FTC, are responsible for estimating and reporting to OMB the paperwork burden for the institutions for which they have enforcement and/or supervision authority. They may use the Bureau's burden estimation methodology, but need not do so.

    The Bureau does not believe that this final rule will impose any new or substantively revised collections of information as defined by the PRA, and instead believes that it will have the overall effect of reducing the previously approved estimated burden on industry for the information collections associated with the Regulation P annual privacy notice. Using the Bureau's burden estimation methodology, the reduction in the estimated ongoing burden will be approximately 62,197 hours annually for the roughly 13,500 banks and credit unions subject to the rule, including Bureau respondents, and the roughly 29,400 entities regulated by the FTC also subject to the rule (i.e., entities over which the FTC has Regulation P administrative enforcement authority). The reduction in estimated ongoing costs from the reduction in ongoing burden will be approximately $3.389 million annually.72

    72 The total hours and costs consist of: (a) 51,230 hours at banks and credit unions evaluated at $61.65/hour; and (b) 10,967 hours at entities regulated by the FTC also subject to the rule, evaluated at $21.07/hour.

    The Bureau believes that the one-time cost of adopting the annual notice exception for financial institutions that adopt it will be de minimis. The Bureau's methodology for estimating the reduction in ongoing burden was discussed above. The method is similar to that described in the PRA analysis in the 2014 Annual Privacy Notice Rule. The only difference is that instead of estimating the fraction of institutions that will be able to use the alternative delivery method, the Bureau estimates the fraction of institutions that will be able to use the annual notice exception and are not already using the alternative delivery method, to compute the reduction in burden relative to the baseline.73

    73See 79 FR 64057, 64080 (Oct. 28, 2014).

    The Bureau takes all of the reduction in ongoing burden from banks and credit unions with assets $10 billion and above and half the reduction in ongoing burden from the non-depository institutions subject to the FTC enforcement authority that are subject to the Bureau's Regulation P. The total reduction in ongoing burden taken by the Bureau is 53,216 hours or $3.058 million annually.74

    74 The total hours and costs consist of: (a) 47,733 hours at banks and credit unions evaluated at $61.65/hour; and (b) 5,484 hours at entities regulated by the FTC also subject to the rule, evaluated at $21.07/hour.

    The Bureau has determined that the final rule does not contain any new or substantively revised information collection requirements as defined by the PRA and that the burden estimate for the previously approved information collections should be revised as explained above. The Bureau requested comments on these determinations or any other aspect of the proposal for purposes of the PRA, but received none.

    Summary of Burden Changes Information collections Previously
  • approved total
  • burden hours
  • Net
  • change in
  • burden
  • hours
  • New total
  • burden
  • hours
  • Notices and disclosures 366,134 −53,216 312,917
    VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Bureau will submit a report containing this rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to the rule taking effect. The Office of Information and Regulatory Affairs (OIRA) has designated this rule as not a “major rule” as defined by 5 U.S.C. 804(2).

    List of Subjects in 12 CFR Part 1016

    Banks, Banking, Consumer protection, Credit, Credit unions, Foreign banking, Holding companies, National banks, Privacy, Reporting and recordkeeping requirements, Savings associations, Trade practices.

    Authority and Issuance

    For the reasons set forth in the preamble, the Bureau amends Regulation P, 12 CFR part 1016, as set forth below:

    PART 1016—PRIVACY OF CONSUMER FINANCIAL INFORMATION (REGULATION P) 1. The authority citation for part 1016 continues to read as follows: Authority:

    12 U.S.C. 5512, 5581; 15 U.S.C. 6804.

    2. Section 1016.3 is amended by revising paragraph (s)(1) to read as follows:
    § 1016.3 Definitions.

    (s)(1) You means a financial institution for which the Bureau has rulemaking authority under section 504(a)(1)(A) of the GLB Act (15 U.S.C. 6804(a)(1)(A)).

    Subpart A—Privacy and Opt Out Notices 3. Section 1016.5 is amended by revising the first sentence of paragraph (a)(1) and adding paragraph (e) to read as follows:
    § 1016.5 Annual privacy notice to customers required.

    (a)(1) * * * Except as provided by paragraph (e) of this section, you must provide a clear and conspicuous notice to customers that accurately reflects your privacy policies and practices not less than annually during the continuation of the customer relationship. * * *

    (e) Exception to annual privacy notice requirement. (1) When exception available. You are not required to deliver an annual privacy notice if you:

    (i) Provide nonpublic personal information to nonaffiliated third parties only in accordance with the provisions of § 1016.13, § 1016.14, or § 1016.15; and

    (ii) Have not changed your policies and practices with regard to disclosing nonpublic personal information from the policies and practices that were disclosed to the customer under § 1016.6(a)(2) through (5) and (9) in the most recent privacy notice provided pursuant to this part.

    (2) Delivery of annual privacy notice after financial institution no longer meets requirements for exception. If you have been excepted from delivering an annual privacy notice pursuant to paragraph (e)(1) of this section and change your policies or practices in such a way that you no longer meet the requirements for that exception, you must comply with paragraph (e)(2)(i) or (e)(2)(ii) of this section, as applicable.

    (i) Changes preceded by a revised privacy notice. If you no longer meet the requirements of paragraph (e)(1) of this section because you change your policies or practices in such a way that § 1016.8 requires you to provide a revised privacy notice, you must provide an annual privacy notice in accordance with the timing requirements in paragraph (a) of this section, treating the revised privacy notice as an initial privacy notice.

    (ii) Changes not preceded by a revised privacy notice. If you no longer meet the requirements of paragraph (e)(1) of this section because you change your policies or practices in such a way that § 1016.8 does not require you to provide a revised privacy notice, you must provide an annual privacy notice within 100 days of the change in your policies or practices that causes you to no longer meet the requirements of paragraph (e)(1) of this section.

    (iii) Examples. (A) You change your policies and practices in such a way that you no longer meet the requirements of paragraph (e)(1) of this section effective April 1 of year 1. Assuming you define the 12-consecutive-month period pursuant to paragraph (a) of this section as a calendar year, if you were required to provide a revised privacy notice under § 1016.8 and you provided that notice on March 1 of year 1, you must provide an annual privacy notice by December 31 of year 2. If you were not required to provide a revised privacy notice under § 1016.8, you must provide an annual privacy notice by July 9 of year 1.

    (B) You change your policies and practices in such a way that you no longer meet the requirements of paragraph (e)(1) of this section, and so provide an annual notice to your customers. After providing the annual notice to your customers, you once again meet the requirements of paragraph (e)(1) of this section for an exception to the annual notice requirement. You do not need to provide additional annual notices to your customers until such time as you no longer meet the requirements of paragraph (e)(1) of this section.

    4. Section 1016.9 is amended by revising paragraph (c) to read as follows:
    § 1016.9 Delivering privacy and opt out notices.

    (c) Annual notices only. You may reasonably expect that a customer will receive actual notice of your annual privacy notice if:

    (1) The customer uses your website to access financial products and services electronically and agrees to receive notices at the website, and you post your current privacy notice continuously in a clear and conspicuous manner on the website; or

    (2) The customer has requested that you refrain from sending any information regarding the customer relationship, and your current privacy notice remains available to the customer upon request.

    Dated: August 9, 2018. Mick Mulvaney, Acting Director, Bureau of Consumer Financial Protection.
    [FR Doc. 2018-17572 Filed 8-16-18; 8:45 am] BILLING CODE 4810-AM-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0303; Product Identifier 2018-NM-006-AD; Amendment 39-19360; AD 2018-17-06] RIN 2120-AA64 Airworthiness Directives; Fokker Services B.V. Airplanes AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. This AD was prompted by a report that the retraction actuator eye-end of a Goodrich main landing gear (MLG) failed. This AD requires a one-time general visual inspection of the left-hand (LH) and right-hand (RH) MLG retraction actuators and replacement if necessary. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective September 21, 2018.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of September 21, 2018.

    ADDRESSES:

    For service information identified in this final rule, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email [email protected]; internet http://www.myfokkerfleet.com. You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0303.

    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-2018-0303; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the regulatory evaluation, any comments received, and other information. The address for Docket Operations (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.

    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 Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. The NPRM published in the Federal Register on April 27, 2018 (83 FR 18488). The NPRM was prompted by a report that the retraction actuator eye-end of a Goodrich MLG failed. The NPRM proposed to require a one-time general visual inspection of the LH and RH MLG retraction actuators and replacement if necessary.

    We are issuing this AD to address failure of the retraction actuator eye-end of a Goodrich MLG, which could prevent retraction of the MLG and/or its complete extension, possibly resulting in damage to the airplane during landing, and consequent injury to occupants.

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0001, dated January 4, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. The MCAI states:

    An occurrence was reported where, following take-off after gear up selection, the retraction actuator eye-end (P/N [part number] 41518-3) of a Goodrich MLG failed. After the LG UNSAFE indication, the flight crew successfully selected gear down and locked by applying the alternate extension procedure, and an uneventful landing was made. Investigation results showed that the final overload fracture of the eye-end was preceded by fatigue cracks, believed to have been caused by interference between the MLG retraction actuator eye-end and the actuator bracket. It was also highlighted that the affected eye-end had been installed incorrectly, i.e. with the grease nipple located on the lower side, thus causing damage to the eye-end due to interference with the bracket. Further investigations revealed other occurrences of interference between retraction actuator eye-end and bracket with resulting damage.

    This condition, if not detected and corrected, could prevent retraction of the MLG and/or its complete extension, possibly resulting in damage to the aeroplane during landing, and consequent injury to occupants.

    To address this potential unsafe condition, Fokker Services published SBF100-32-168 to provide inspection and replacement instructions.

    For the reasons described above, this AD requires a one-time [general visual] inspection [for deficiencies] (check the eye-end for presence of interference/damage and for orientation of the greasing nipple) of the MLG retraction actuators, left-hand (LH) and right-hand (RH) sides, and, depending on findings, replacement.

    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-2018-0303.

    Comments

    We gave the public the opportunity to participate in developing this final rule. We received no comments on the NPRM 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 this final rule 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 addressing 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

    Fokker Services B.V. has issued Fokker Service Bulletin SBF100-32-168, dated May 22, 2017. This service information describes procedures for a one-time general visual inspection for deficiencies of the Goodrich MLG retraction actuators and replacement of the actuator if necessary (e.g., if the retraction actuator greasing nipple is not located on the upper side MLG retraction actuator eye-end or if interference damage or evidence of removed damage is present on the eye-end of the MLG retraction actuator). 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 5 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 Inspection 1 work-hour × $85 per hour = $85 per inspection cycle $0 $85 per inspection cycle $425 per inspection cycle.

    We estimate the following costs to do any necessary replacements 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 replacements:

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Replacement 1 work-hour × $85 per hour = $85 $0 $85
    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.

    This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.

    Regulatory Findings

    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): 2018-17-06 Fokker Services B.V.: Amendment 39-19360; Docket No. FAA-2018-0303; Product Identifier 2018-NM-006-AD. (a) Effective Date

    This AD is effective September 21, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes, certificated in any category, all serial numbers, if equipped with Goodrich main landing gear (MLG), part number (P/N) 41050-x (all dashes) or P/N 41060-x (all dashes).

    (d) Subject

    Air Transport Association (ATA) of America Code 32, Landing gear.

    (e) Reason

    This AD was prompted by a report that the retraction actuator eye-end of a Goodrich MLG failed. We are issuing this AD to address failure of the retraction actuator eye-end of a Goodrich MLG, which could prevent retraction of the MLG and/or its complete extension, possibly resulting in damage to the airplane during landing, and consequent injury to occupants.

    (f) Compliance

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

    (g) Definition

    For the purposes of this AD, a “serviceable part” is a serviceable retraction actuator with an eye-end that does not have any indication of interference or damage, as specified in the Accomplishment Instructions of Fokker Service Bulletin SBF100-32-168, dated May 22, 2017.

    (h) Inspection and Corrective Action

    Within 12 months after the effective date of this AD, perform a general visual inspection of the left-hand (LH) and right-hand (RH) MLG retraction actuators for deficiencies (i.e., check for the presence of interference damage, including evidence of removed damage, and for the orientation of the greasing nipple), in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100-32-168, dated May 22, 2017. If any deficiency is found, before further flight, replace the affected MLG retraction actuator with a serviceable part, in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100-32-168, dated May 22, 2017.

    (i) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Section, Transport Standards Branch, 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 Section, send it to the attention of the person identified in paragraph (j)(2) of this AD. 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.

    (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 Section, Transport Standards Branch, FAA; or the European Aviation Safety Agency (EASA); or Fokker Services B.V.'s EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

    (j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2018-0001, dated January 4, 2018, 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-2018-0303.

    (2) For more information about this AD, contact Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.

    (k) 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) Fokker Service Bulletin SBF100-32-168, dated May 22, 2017.

    (ii) Reserved.

    (3) For service information identified in this AD, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email [email protected]; internet http://www.myfokkerfleet.com.

    (4) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    (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 Des Moines, Washington, on August 7, 2018. Michael Kaszycki, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-17624 Filed 8-16-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0259; Product Identifier 2018-NE-09-AD; Amendment 39-19358; AD 2018-17-04] RIN 2120-AA64 Airworthiness Directives; Rolls-Royce Corporation Engines AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain Rolls-Royce Corporation (RRC) AE 2100D2A and AE 2100D3 model turboprop engines and AE 3007A2 model turbofan engines. This AD was prompted by the possibility of a low-cycle fatigue failure on certain turbine wheels. This AD requires removing the affected turbine wheels at the next engine shop visit or before reaching the new reduced life limit, whichever occurs first, and replacing them with parts eligible for installation. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective September 21, 2018.

    The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of September 21, 2018.

    ADDRESSES:

    For service information identified in this final rule, contact Rolls-Royce Corporation, 450 South Meridian Street, Indianapolis, IN 46225; phone: 317-230-3774. You may view this service information at the FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call 781-238-7759. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0259.

    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-2018-0259; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the regulatory evaluation, any comments received, and other information. The address for Docket Operations (phone: 800-647-5527) is Docket Operations, 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:

    Kyri Zaroyiannis, Aerospace Engineer, Chicago ACO Branch, FAA, 2300 E. Devon Ave., Des Plaines, IL 60018; phone: 847-294-7836; fax: 847-294-7834; 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 certain RRC AE 2100D2A and AE 2100D3 model turboprop engines and AE 3007A2 model turbofan engines. The NPRM published in the Federal Register on April 30, 2018 (83 FR 18751). The NPRM was prompted by the possibility of a low-cycle fatigue failure on certain turbine wheels. The affected turbine wheels include 1st-stage gas generator turbine wheels, installed on AE 2100D2A and AE 2100D3 model turboprop engines, and 1st-stage high-pressure turbine (HPT) wheels, installed on AE 3007A2 turbofan engines. The NPRM proposed to require removing the affected turbine wheels at the next engine shop visit or before reaching the new reduced life limit, whichever occurs first, and replacing them with parts eligible for installation. We are issuing this AD to address the unsafe condition on these products.

    Comments

    We gave the public the opportunity to participate in developing this final rule. We have considered the comment received. RRC supported the NPRM.

    Conclusion

    We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule as proposed.

    Related Service Information Under 1 CFR Part 51

    We reviewed RRC Alert Service Bulletin (ASB) AE 2100D2-A-72-090, Revision 1, dated July 11, 2014, and RRC ASB AE 2100D3-A-72-286, Revision 1, dated July 11, 2014 (one document, referred to herein as “RRC ASB AE 2100D2-A-72-090/AE 2100D3-A-72-286”), and RRC ASB AE 3007A-A-72-419, Revision 2, dated December 4, 2017. RRC ASB AE 2100D2-A-72-090/AE 2100D3-A-72-286 provides removal and replacement instructions and a new life limit for the affected 1st-stage gas generator turbine wheels installed on RRC AE 2100D2A and AE 2100D3 model turboprop engines. ASB AE 3007A-A-72-419 provides removal and replacement instructions and a new life limit for 1st-stage HPT wheels installed on RRC AE 3007A2 model turbofan engines. 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 nine engines installed on 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
    Replace turbine wheels 0 work-hours × $85 per hour = $0 $160,829 $160,829 $1,447,461
    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.

    This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.

    Regulatory Findings

    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 adding the following new airworthiness directive (AD): 2018-17-04 Roll-Royce Corporation (Type Certificate previously held by Allison Engine Company): Amendment 39-19358; Docket No. FAA-2018-0259; Product Identifier 2018-NE-09-AD. (a) Effective Date

    This AD is effective September 21, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to:

    (1) Rolls-Royce Corporation (RRC) AE 2100D2A turboprop engines with 1st-stage gas generator turbine wheels, part number (P/N) 23089692, with serial numbers (S/Ns) MW65898 or MW68310, installed.

    (2) RRC AE 2100D3 turboprop engines with 1st-stage gas generator turbine wheels, P/N 23088906, with S/Ns MW65895, MW65896, MW65900, MW65901, MW65903, MW68305, MW68306, MW68307, MW68312, MW68314, MW68316, MW68318, or MW68319, installed.

    (3) RRC AE 3007A2 turbofan engines with 1st-stage high-pressure turbine (HPT) wheels, P/N 23088906, with S/Ns MW65894, MW68303, or MW68315, installed.

    (d) Subject

    Joint Aircraft System Component (JASC) Code 7250, Turbine section.

    (e) Unsafe Condition

    This AD was prompted by the possibility of steel inclusions in the turbine wheel forging. We are proposing this AD to prevent a low-cycle fatigue failure of a 1st-stage gas generator turbine wheel or 1st-stage HPT wheel. The unsafe condition, if not addressed, could result in uncontained turbine wheel release, damage to the engine, and damage to the airplane.

    (f) Compliance

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

    (g) Required Actions

    (1) Remove the affected 1st-stage gas generator turbine wheel and replace with a part eligible for installation at the next engine shop visit or before exceeding the life limit of 4,800 engine cycles, whichever occurs first, in accordance with the Accomplishment Instructions, Paragraph 2, of RRC Alert Service Bulletin (ASB) AE 2100D2-A-72-090, Revision 1, dated July 11, 2014, and RRC ASB AE 2100D3-A-72-286, Revision 1, dated July 11, 2014 (co-published as one document).

    (2) Remove the affected 1st-stage HPT wheel and replace with a part eligible for installation at the next engine shop visit or before exceeding the life limit of 5,600 engine cycles, whichever occurs first, in accordance with the Accomplishment Instructions, Paragraph 2, of RRC ASB AE 3007A-A-72-419, Revision 2, dated December 4, 2017.

    (h) Definition

    For the purpose of this AD, an “engine shop visit” is the induction of an engine into the shop for maintenance involving the separation of pairs of major mating engine flanges, except that the separation of engine flanges solely for the purposes of transportation without subsequent engine maintenance is not an engine shop visit.

    (i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Chicago ACO Branch, 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 certification office, send it to the attention of the person identified in paragraph (j) of this AD.

    (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.

    (j) Related Information

    For more information about this AD, contact Kyri Zaroyiannis, Aerospace Engineer, Chicago ACO Branch, FAA, 2300 E. Devon Ave., Des Plaines, IL, 60018; phone: 847-294-7836; fax: 847-294-7834; email: [email protected]

    (k) 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) Rolls-Royce Corporation (RRC) Alert Service Bulletin (ASB) AE 2100D2-A-72-090, Revision 1, dated July 11, 2014, and RRC ASB AE 2100D3-A-72-286, Revision 1, dated July 11, 2014 (co-published as one document).

    (ii) RRC ASB AE 3007A-A-72-419, Revision 2, dated December 4, 2017.

    (3) For RRC service information identified in this AD, contact Rolls-Royce Corporation, 450 South Meridian Street, Indianapolis, IN, 46225; phone: 317-230-3774.

    (4) You may view this service information at FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA, 01803. For information on the availability of this material at the FAA, call 781-238-7759.

    (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 Burlington, Massachusetts, on August 13, 2018. Karen M. Grant, Acting Manager, Engine and Propeller Standards Branch, Aircraft Certification Service.
    [FR Doc. 2018-17704 Filed 8-16-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0712; Product Identifier 2018-NM-089-AD; Amendment 39-19361; AD 2018-17-07] RIN 2120-AA64 Airworthiness Directives; ATR—GIE Avions de Transport Régional Airplanes AGENCY:

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

    ACTION:

    Final rule; request for comments.

    SUMMARY:

    We are superseding Airworthiness Directive (AD) 2017-24-01, which applied to certain ATR—GIE Avions de Transport Régional Model ATR42-500 airplanes and Model ATR72-212A airplanes. AD 2017-24-01 required an inspection for routing attachments of electrical harness bundles and for wire damage, and corrective actions if necessary. This new AD adds additional airplanes to the applicability. This AD was prompted by a determination that additional airplanes are affected by the unsafe condition. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective September 4, 2018.

    The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of September 4, 2018 .

    We must receive comments on this AD by October 1, 2018.

    ADDRESSES:

    You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

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

    Fax: 202-493-2251.

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

    Hand Delivery: U.S. Department of Transportation, Docket Operations,M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    For service information identified in this final rule, contact ATR—GIE Avions de Transport Régional, 1 Allée Pierre Nadot, 31712 Blagnac Cedex, France; telephone +33 (0) 5 62 21 62 21; fax +33 (0) 5 62 21 67 18; email [email protected]; http://www.atr-aircraft.com. You may view this referenced service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0712.

    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-2018-0712; 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 listed above. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Shahram Daneshmandi, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-321-3220.

    SUPPLEMENTARY INFORMATION:

    Discussion

    We issued AD 2017-24-01, Amendment 39-19105 (82 FR 55755, November 24, 2017) (“AD 2017-24-01”), which applied to certain Model ATR42-500 airplanes and Model ATR72-212A airplanes. AD 2017-24-01 was prompted by reports of electrical harness bundle chafing with a window blinding panel in the fuselage due to missing routing attachments. AD 2017-24-01 required an inspection for routing attachments (i.e., brackets) of electrical harness bundles and for wire damage, and corrective actions if necessary. We issued AD 2017-24-01 to detect and correct missing routing attachments of fuselage electrical harness bundles, which could result in wire failure (cut or shorted) and, in case of several failures in combination, the loss of systems, possibly resulting in reduced control of the airplane.

    Since we issued AD 2017-24-01, we have determined that additional airplanes are affected by the unsafe condition.

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2018-0105, dated May 08, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Model ATR42-500 airplanes and Model ATR72-212A airplanes. The MCAI states:

    An event was reported of several spurious alarms on a recently delivered ATR 72 aeroplane. During subsequent trouble-shooting, damage was found on the electrical harness wire bundle (Route 1M), due to chafing with a window blinding panel located on the left-hand (LH) side of the fuselage, zone 231. A bracket, necessary to maintain the harness wire bundle close to the structure of the fuselage and avoid chafing, was missing. The same bracket was also found missing on the right-hand (RH) side of the fuselage, zone 232, Route 2M, although without damage on the harness wire bundle. A quality investigation revealed another aeroplane on the production line where same brackets were not installed.

    This condition, if not detected and corrected, may lead to wire failure (cut or shorted) and, in case of several failures in combination, to loss of systems, possibly resulting in reduced control of the aeroplane.

    To address this potential unsafe condition, ATR published the applicable SB [service bulletin] to provide inspection instructions. Consequently, EASA issued AD 2017-0118 [which corresponds to FAA AD 2017-24-01] to require verification of the installation of the brackets, a one-time inspection of the wire bundles, and depending on findings, accomplishment of applicable corrective action(s).

    Since that [EASA] AD was issued, an occurrence was reported of engine intermittent auto-feather, caused by damage on the electrical harness bundle Route 1M. The affected aeroplane MSN [manufacturer serial number] was not identified in the Applicability of EASA AD 2017-0118.

    For the reason described above, this [EASA] AD retains the requirements of EASA AD 2017-0118, which is superseded, and expands the Applicability to include additional aeroplanes, identified by MSN in Group 2 as specified in section `Definitions' of this [EASA] AD.

    The MCAI includes MSNs 1071, 1141, 1341, 1367, and 1377 in its applicability, but those MSNs are not identified in the definitions for the affected groups. Those MSNs are not affected by the identified unsafe condition. Therefore, we have not included those MSNs in our applicability. You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0712.

    Related Service Information Under 1 CFR Part 51

    ATR has issued Service Bulletin ATR42-92-0033, Revision 02, dated April 12, 2018; and Service Bulletin ATR72-92-1044, Revision 02, dated April 12, 2018. This service information describes procedures for an inspection of routing attachments (i.e., brackets) of electrical harness bundles and for wire damage, and corrective actions if necessary. These documents are distinct since they apply to different airplane models. 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.

    FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

    FAA's Justification and Determination of the Effective Date

    There are currently no domestic operators of this product. Therefore, we good cause find that notice and opportunity for prior public comment are unnecessary and that, for the same reason, good cause exists for making this amendment effective in less than 30 days.

    Comments Invited

    This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0712; Product Identifier 2018-NM-089-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

    Costs of Compliance

    Currently, there are no affected U.S.-registered airplanes. If an affected airplane is imported and placed on the U.S. Register in the future, we provide the following cost estimates to comply with this AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Inspection 3 work-hours × $85 per hour = $255 $0 $255

    We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.

    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.

    This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

    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 removing airworthiness directive (AD) 2017-24-01, Amendment 39-19105 (82 FR 55755, November 24, 2017), and adding the following new AD: 2018-17-07 ATR—GIE Avions de Transport Régional: Amendment 39-19361; Docket No. FAA-2018-0712; Product Identifier 2018-NM-089-AD. (a) Effective Date

    This AD is effective September 4, 2018.

    (b) Affected ADs

    This AD replaces AD 2017-24-01, Amendment 39-19105 (82 FR 55755, November 24, 2017) (“AD 2017-24-01”).

    (c) Applicability

    This AD applies to the ATR—GIE Avions de Transport Régional airplanes identified in paragraphs (c)(1) and (c)(2) of this AD, certificated in any category.

    (1) Model ATR42-500 airplanes, manufacturer serial numbers (MSNs) 1001 through 1014 inclusive, 1016 through 1019 inclusive, and 1201 through 1212 inclusive.

    (2) Model ATR72-212A airplanes, MSNs 1048 through 1070 inclusive, 1072 through 1140 inclusive, 1142 through 1200 inclusive, 1220 through 1340 inclusive, 1342 through 1353 inclusive, 1355 through 1366 inclusive, 1368 through 1376 inclusive, 1378 through 1380 inclusive, 1382, 1385, and 1388.

    (d) Subject

    Air Transport Association (ATA) of America Code 92, Electric.

    (e) Reason

    This AD was prompted by reports of electrical harness bundle chafing with a window blinding panel in the fuselage due to missing routing attachments and by a determination that additional airplanes that were not identified in AD 2017-24-01 are affected by the unsafe condition. We are issuing this AD to detect and correct missing routing attachments of fuselage electrical harness bundles, which could result in wire failure (cut or shorted), and, in case of several failures in combination, the loss of systems, possibly resulting in reduced control of the airplane.

    (f) Compliance

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

    (g) Definitions

    (1) For the purposes of this AD, Group 1 airplanes are identified as the following: MSNs 1014, 1016 through 1019 inclusive, 1165 through 1212 inclusive, 1220 through 1340 inclusive, 1342 through 1353 inclusive, 1355 through 1366 inclusive, 1368 through 1376 inclusive, 1378 through 1380 inclusive, 1382, 1385 and 1388.

    (2) For the purposes of this AD, Group 2 airplanes are identified as the following: MSNs 1001 through 1013 inclusive, 1048 through 1070 inclusive, 1072 to 1140 inclusive 1142 through 1164 inclusive.

    (h) Retained Inspection With New Service Information and Revised Compliance Language

    This paragraph restates the requirements of paragraph (g) of AD 2017-24-01, with new service information and revised compliance language. For Group 1 airplanes: Within 6 months or 500 flight hours after December 11, 2017 (the effective date of AD 2017-24-01), whichever occurs first, do a detailed inspection for missing brackets and damage (including but not limited to chafing and electrical shorting) to wire bundles of the Route 1M and Route 2M electrical harness, in accordance with the flowchart in paragraph 1.C., “Description,” and the Accomplishment Instructions of ATR Service Bulletin ATR42-92-0033, Revision 02, dated April 12, 2018 (for Model ATR42-500 airplanes); or ATR Service Bulletin ATR72-92-1044, Revision 02, dated April 12, 2018 (for Model ATR72-212A airplanes); as applicable. Although ATR Service Bulletin ATR42-92-0033, Revision 02, dated April 12, 2018; and ATR Service Bulletin ATR72-92-1044, Revision 02, dated April 12, 2018; specify reporting, this AD does not include that requirement.

    (i) New Requirement of This AD: Inspection

    For Group 2 airplanes: Within 6 months or 500 flight hours after the effective date of this AD, whichever occurs first, do a detailed inspection for missing brackets and damage (including but not limited to chafing and electrical shorting) to wire bundles of the Route 1M and Route 2M electrical harness, in accordance with the flowchart in paragraph 1.C., “Description,” and the Accomplishment Instructions of ATR Service Bulletin ATR42-92-0033, Revision 02, dated April 12, 2018 (for Model ATR42-500 airplanes); or ATR Service Bulletin ATR72-92-1044, Revision 02, dated April 12, 2018 (for Model ATR72-212A airplanes); as applicable. Although ATR Service Bulletin ATR42-92-0033, Revision 02, dated April 12, 2018; and ATR Service Bulletin ATR72-92-1044, Revision 02, dated April 12, 2018; specify reporting, this AD does not include that requirement.

    (j) New Requirements of This AD: Corrective Action

    If the inspection required by paragraph (h) or (i) of this AD reveals that any bracket is missing or any wire is damaged, before further flight, do applicable corrective actions, in accordance with the flowchart in paragraph 1.C., “Description,” and the Accomplishment Instructions of ATR Service Bulletin ATR42-92-0033, Revision 02, dated April 12, 2018 (for Model ATR42-500 airplanes); or ATR Service Bulletin ATR72-92-1044, Revision 02, dated April 12, 2018 (for Model ATR72-212A airplanes); as applicable. Where ATR Service Bulletin ATR42-92-0033, Revision 02, dated April 12, 2018; and ATR Service Bulletin ATR72-92-1044, Revision 02, dated April 12, 2018; specify to contact ATR-GIE Avions de Transport Régional for appropriate action, before further flight, accomplish corrective actions in accordance with the procedures specified in paragraph (l)(2) of this AD.

    (k) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraphs (h), (i), and (j) of this AD, if those actions were performed before the effective date of this AD using ATR Service Bulletin ATR42-92-0033, dated May 3, 2017, or Revision 01, dated July 20, 2017; or ATR Service Bulletin ATR72-92-1044, dated May 3, 2017, or Revision 01, dated July 20, 2017, as applicable. ATR Service Bulletin ATR42-92-0033, dated May 3, 2017; and ATR72-92-1044, dated May 3, 2017, were previously incorporated by reference in AD 2017-24-01. ATR Service Bulletin ATR42-92-0033 Revision 01, dated July 20, 2017; and ATR72-92-1044, Revision 01, dated July 20, 2017, were not previously incorporated by reference.

    (l) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Section, Transport Standards Branch, 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 Section, send it to the attention of the person identified in paragraph (m)(2) of this AD. 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.

    (2) Contacting the Manufacturer: As of the effective date of this AD, 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 Section, Transport Standards Branch, FAA; or, the European Aviation Safety Agency (EASA); or, ATR—GIE Avions de Transport Régional's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

    (m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2018-0105, dated May 08, 2018, 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-2018-0712.

    (2) For more information about this AD, contact Shahram Daneshmandi, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-321-3220.

    (3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (n)(3) and (n)(4) of this AD.

    (n) 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) ATR Service Bulletin ATR42- 92-0033, Revision 02, dated April 12, 2018.

    (ii) ATR Service Bulletin ATR72-92-1044, Revision 02, dated April 12, 2018.

    (3) For service information identified in this AD, contact ATR—GIE Avions de Transport Régional, 1 Allée Pierre Nadot, 31712 Blagnac Cedex, France; telephone +33 (0) 5 62 21 62 21; fax +33 (0) 5 62 21 67 18; email [email protected]; internet http://www.atr-aircraft.com.

    (4) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    (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 Des Moines, Washington, on August 8, 2018. Michael Kaszycki, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-17661 Filed 8-16-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 73 [Docket No. FAA-2018-0728; Airspace Docket No. 18-ASO-2] RIN 2120-AA66 Amendment of Multiple Restricted Area Boundary Descriptions; Florida AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule; technical amendment.

    SUMMARY:

    This action makes minor adjustments to the boundary descriptions of restricted areas R-2905A and R-2905B, Tyndall AFB, FL; R-2914B, and R-2919B, Valparaiso, FL; R-2915A and R-2915C, Eglin AFB, FL. The changes are needed because the FAA has adopted updated digital data that more precisely define maritime limits and other geophysical features used in the boundary descriptions. This requires minor changes to certain latitude/longitude points in the boundary descriptions of the above restricted areas in order to match the updated data and ensure accurate boundary depiction on aeronautical charts.

    DATES:

    Effective date: 0901 UTC, November 8, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Paul Gallant, Airspace Policy Group, AJV-11, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.

    This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it supports updating certain boundary coordinates for restricted areas Tyndall AFB, FL, Valparaiso, FL, and, Eglin AFB, FL.

    Background

    Some restricted area boundary descriptions use maritime limits, such as references to the shoreline of the U.S., to identify the shape of the area (e.g., “3 nautical miles from and parallel to the shoreline”). These boundary descriptions contain latitude/longitude coordinates that were intended to intersect a line running 3 NM from, and parallel to, the shoreline. In other cases, boundaries are defined with reference to geophysical features such as a railroad track or highway.

    For a variety of reasons, maritime limits change over time. The FAA has received updated digital data for maritime limits from the National Oceanic and Atmospheric Administration (NOAA). Digital data are more precise than measurements used in the past. The FAA, through the implementation of its data-driven charting process, was able to utilize this new data to accurately update the U.S. maritime limit boundaries used for aeronautical charting. Prior to the update, the maritime limit boundary data used for charting were over 25 years old. In applying the updated data, FAA found that some restricted area boundary descriptions that were based on the maritime limits, did not correspond to the updated shoreline data. Consequently, there are minor mismatches between some restricted area latitude/longitude coordinates and the actual shoreline position. Similarly, more accurate digital data is available for railroads and highways and the FAA is applying that information as well.

    This rulemaking action updates the affected boundary coordinates of restricted areas R-2905A, R-2905B, R-2914B, R-2915C, and R-2919B, in Florida to ensure that the published boundaries match the actual relation to the U.S. shoreline, and maintain aeronautical chart accuracy. R-2915A is amended to reflect digital positional data for the L and N Railroad and the Navarre-Milton Highway, which form part of that restricted area's boundary.

    The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR) part 73 by making minor updates to certain latitude/longitude coordinates in the descriptions of restricted areas R-2905A, R-2905B, R-2914B, R-2915A, R-2915C, and R-2919B, in Florida. The changes are needed because the FAA has adopted the use of digital data for aeronautical charting. This more precise digital plotting of points revealed minor mismatches between some current restricted area boundary coordinates and the updated digital data for those points. The specific restricted area boundary updates are shown below:

    R-2905A: The point “lat. 29°56′01″ N, long. 85°33′00″ W” is amended to “lat. 29°56′06″ N, long. 85°32′57″ W.” The point “lat. 29°59′01″ N, long. 85°36′30″ W” is amended to “lat. 29°59′05″ N, long. 85°36′24″ W.” These changes reflect updated digital shoreline data.

    R-2905B: The point “lat. 29°54′01″ N, long. 85°27′00″ W” is amended to “lat. 29°54′09″ N, long. 85°27′00″ W.” The point “lat. 29°56′01″ N, long. 85°33′00″ W” is amended to “lat. 29°56′06″ N, long. 85°32′57″ W.” These changes reflect updated digital shoreline data.

    R-2914B: The point “lat. 30°11′01″ N, long. 85°56′00″ W” is amended to “lat. 30°11′08″ N, long. 85°56′00″W.” The point “lat. 30°15′01″ N, long. 86°06′15″ W” is amended to “lat. 30°15′18″ N, long. 86°06′19″ W.” These changes reflect updated digital shoreline data.

    R-2915A: The point “lat. 30°33′41″ N, long. 86°55′00″ W” is amended to “lat. 30°33′30″ N, long. 86°55′00″ W.” The point “lat. 30°38′46″ N, long. 86°55′00″ W” is amended to “lat. 30°38′52″ N, long. 86°55′00″ W.” The point “lat. 32°42′46″ N, long. 86°45′45″ W” is amended to “lat. 30°42′46″ N, long. 86°45′23″ W.” The point “lat. 30°26′31″ N, long. 86°52′20″ W” is amended to “lat. 30°26′31″ N, long. 86°52′00″ W.” These amended points are based on digital data for the L and N Railroad and the Navarre-Milton Highway.

    R-2915C: The point “lat. 30°20′51″ N, long. 86°38′50″ W” is amended to “lat. 30°20′47″ N, long. 86°38′51″ W.” The point “lat. 30°19′31″ N, long. 86°51′30″ W” is amended to “lat. 30°19′45″ N, long. 86°51′30″ W.” These changes reflect updated digital shoreline data.

    R-2919B: The point “lat. 30°15′01″ N, long. 86°06′15″ W” is amended to “lat. 30°15′18″ N, long. 86°06′19″ W.” The point “lat. 30°19′46″ N, long. 86°23′45″ W” is amended to “lat. 30°19′41″ N, long. 86°23′46″ W.” These changes reflect updated digital shoreline data.

    These minor editorial changes update existing restricted area boundaries with more precise digital information. It does not affect the location, designated altitudes, or activities conducted within the restricted areas; therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.

    Regulatory Notices and Analyses

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

    Environmental Review

    The FAA has determined that this action of making minor adjustments to the boundary descriptions of restricted areas R-2905A and R-2905B, Tyndall AFB, FL; R-2914B, Valparaiso, FL; R-2915A and R-2915C, Eglin AFB, FL; and R-2919B, Valparaiso, FL qualifies for categorical exclusion under the National Environmental Policy Act and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5.d, Modification of the technical description of special use airspace (SUA) that does not alter the dimension, altitudes, or times of designation of the airspace. This airspace action makes minor updates to certain boundary coordinates of restricted areas R-2905A and R-2905B, Tyndall AFB, FL; R-2914B, Valparaiso, FL; R-2915C, Eglin AFB, FL; and R-2919B, Valparaiso, FL, to match the more precise digital shoreline data received from the National Oceanic and Atmospheric Administration (NOAA). This ensures that the affected boundaries continue to match the NOAA-defined position of the U.S. shoreline, and more accurate digital data for geophysical references. It does not alter the location, altitudes, or activities conducted within the airspace; therefore, it is not expected to cause any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. The FAA has determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact study.

    List of Subjects in 14 CFR Part 73

    Airspace, Prohibited areas, Restricted areas.

    Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 73, as follows:

    PART 73—SPECIAL USE AIRSPACE 1. The authority citation for part 73 continues to read as follows: Authority:

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

    § 73.29 [Amended]
    2. Section 73.29 is amended as follows: R-2905A Tyndall AFB, FL [Amended]

    By removing the current boundaries and adding in its place the following:

    Boundaries. Beginning at lat. 30°01′31″ N, long. 85°32′30″ W; to lat. 30°01′16″ N, long. 85°30′00″ W; to lat. 29°56′06″ N, long. 85°32′57″ W; thence 3 nautical miles from and parallel to the shoreline to lat. 29°59′05″ N, long. 85°36′24″ W; to the point of beginning.

    R-2905B Tyndall AFB, FL [Amended]

    By removing the current boundaries and adding in its place the following:

    Boundaries. Beginning at lat. 30°01′16″ N, long. 85°30′00″ W; to lat. 30°01′01″ N, long. 85°27′00″ W; to lat. 29°54′09″ N, long. 85°27′00″ W; thence 3 nautical miles from and parallel to the shoreline to lat. 29°56′06″ N, long. 85°32′57″ W; to the point of beginning.

    R-2914B Valparaiso, FL [Amended]

    By removing the current boundaries and adding in its place the following:

    Boundaries. Beginning at lat. 30°22′01″ N, long. 86°08′00″ W; to lat. 30°19′16″ N, long. 85°56′00″ W; to lat. 30°11′08″ N, long. 85°56′00″ W; thence 3 nautical miles from and parallel to the shoreline to lat. 30°15′18″ N, long. 86°06′19″ W; to the point of beginning.

    R-2915A Eglin AFB, FL [Amended]

    By removing the current boundaries and adding in its place the following:

    Boundaries. Beginning at lat. 30°33′30″ N, long. 86°55′00″ W; to lat. 30°38′52″ N, long. 86°55′00″ W; thence along the L and N Railroad to lat. 30°42′46″ N, long. 86°45′23″ W; to lat. 30°42′51″ N, long. 86°38′02″ W; to lat. 30°29′02″ N, long. 86°38′02″ W; to lat. 30°26′31″ N, long. 86°51′30″ W; to lat. 30°26′31″ N, long. 86°52′00″ W; thence along the Navarre-Milton Highway to the point of beginning.

    R-2915C Eglin AFB, FL [Amended]

    By removing the current boundaries and adding in its place the following:

    Boundaries. Beginning at lat. 30°22′47″ N, long. 86°51′30″ W; thence along the shoreline to lat. 30°23′46″ N, long. 86°38′15″ W; to lat. 30°20′47″ N, long. 86°38′51″ W; thence 3 nautical miles from and parallel to the shoreline to lat. 30°19′45″ N, long. 86°51′30″ W; to the point of beginning.

    R-2919B Valparaiso, FL [Amended]

    By removing the current boundaries and adding in its place the following:

    Boundaries. Beginning at lat. 30°25′01″ N, long. 86°22′26″ W; to lat. 30°22′01″ N, long. 86°08′00″ W; to lat. 30°15′18″ N, long. 86°06′19″ W; thence 3 NM from and parallel to the shoreline to lat. 30°19′41″ N, long. 86°23′46″ W; to the point of beginning.

    Issued in Washington, DC, on August 13, 2018. Rodger A. Dean, Jr., Manager, Airspace Policy Group.
    [FR Doc. 2018-17766 Filed 8-16-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 31207; Amdt. No. 3812] Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

    DATES:

    This rule is effective August 17, 2018. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.

    The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of August 17, 2018.

    ADDRESSES:

    Availability of matter incorporated by reference in the amendment is as follows:

    For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;

    2. The FAA Air Traffic Organization Service Area in which the affected airport is located;

    3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,

    4. The National Archives and Records Administration (NARA).

    For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center online at nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff Minimums and ODP copies may be obtained from the FAA Air Traffic Organization Service Area in which the affected airport is located.

    FOR FURTHER INFORMATION CONTACT:

    Thomas J. Nichols, Flight Procedure Standards Branch (AFS-420) Flight Technologies and Procedures Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK. 73125) telephone: (405) 954-4164.

    SUPPLEMENTARY INFORMATION:

    This rule amends Title 14, Code of Federal Regulations, part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary.

    This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

    Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as listed in the ADDRESSES section.

    The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

    The Rule

    This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

    The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

    Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference, Navigation (air).

    Issued in Washington, DC, on July 27, 2018. Rick Domingo, Executive Director, Flight Standards Service. Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

    PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority:

    49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

    2. Part 97 is amended to read as follows:

    By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:

    * * * Effective Upon Publication AIRAC date State City Airport FDC No. FDC date Subject 13-Sep-18 ID Coeur D'Alene Coeur D'Alene—Pappy Boyington Field 8/0531 7/23/18 ILS OR LOC/DME RWY 6, Amdt 5D. 13-Sep-18 AK Homer Homer 8/1026 7/23/18 LOC RWY 4, Amdt 11A. 13-Sep-18 CA Palm Springs Bermuda Dunes 8/1171 7/10/18 RNAV (GPS) RWY 28, Orig. 13-Sep-18 CA Palm Springs Bermuda Dunes 8/1175 7/10/18 VOR-C, Orig-A. 13-Sep-18 MO Salem Salem Memorial 8/1892 7/25/18 RNAV (GPS) RWY 17, Orig. 13-Sep-18 MO Salem Salem Memorial 8/1893 7/25/18 RNAV (GPS) RWY 35, Orig. 13-Sep-18 TX Graham Graham Muni 8/1894 7/25/18 RNAV (GPS) RWY 3, Orig. 13-Sep-18 TX Graham Graham Muni 8/1899 7/25/18 RNAV (GPS) RWY 21, Orig. 13-Sep-18 NC Elizabethtown Curtis L Brown Jr Field 8/1954 7/10/18 RNAV (GPS) RWY 33, Orig. 13-Sep-18 MD Churchville Harford County 8/2250 7/23/18 RNAV (GPS)-B, Orig. 13-Sep-18 MO St Louis Creve Coeur 8/2299 7/23/18 RNAV (GPS) RWY 34, Amdt 1. 13-Sep-18 MO St Louis Creve Coeur 8/2302 7/23/18 VOR-A, Amdt 5. 13-Sep-18 MO St Louis Creve Coeur 8/2309 7/23/18 RNAV (GPS) RWY 16, Amdt 1A. 13-Sep-18 AL Troy Troy Muni At N Kenneth Campbell Field 8/2470 7/23/18 RNAV (GPS) RWY 25, Amdt 3. 13-Sep-18 MD Ocean City Ocean City Muni 8/2476 7/25/18 VOR-A, Amdt 3A. 13-Sep-18 MD Ocean City Ocean City Muni 8/2477 7/25/18 RNAV (GPS) RWY 2, Orig-B. 13-Sep-18 MD Ocean City Ocean City Muni 8/2478 7/25/18 RNAV (GPS) RWY 32, Orig-B. 13-Sep-18 MD Ocean City Ocean City Muni 8/2479 7/25/18 RNAV (GPS) RWY 14, Orig-F. 13-Sep-18 MD Ocean City Ocean City Muni 8/2480 7/25/18 LOC RWY 14, Amdt 2A. 13-Sep-18 IN Indianapolis Indy South Greenwood 8/2629 7/25/18 RNAV (GPS) RWY 19, Amdt 1B. 13-Sep-18 WI Neillsville Neillsville Muni 8/2675 7/25/18 RNAV (GPS) RWY 28, Orig. 13-Sep-18 WI Rhinelander Rhinelander—Oneida County 8/3121 7/25/18 Takeoff Minimums and Obstacle DP, Amdt 4. 13-Sep-18 GA Griffin Griffin—Spalding County 8/3323 7/23/18 RNAV (GPS) RWY 14, Orig-D. 13-Sep-18 AL Birmingham Birmingham—Shuttlesworth Intl 8/3333 7/23/18 RNAV (GPS) Y RWY 6, Amdt 1B. 13-Sep-18 TX Austin Austin—Bergstrom Intl 8/3410 7/25/18 ILS OR LOC RWY 35L, Amdt 6. 13-Sep-18 TX Crosbyton Crosbyton Muni 8/3666 7/23/18 RNAV (GPS) RWY 35, Orig-A. 13-Sep-18 CA Napa Napa County 8/3668 7/23/18 ILS OR LOC RWY 36L, Orig-B. 13-Sep-18 CA Napa Napa County 8/3669 7/23/18 RNAV (GPS) Y RWY 36L, Amdt 2B. 13-Sep-18 NE Fairbury Fairbury Muni 8/3783 7/23/18 NDB-A, Amdt 3B. 13-Sep-18 NE Fairbury Fairbury Muni 8/3785 7/23/18 RNAV (GPS) RWY 35, Orig-A. 13-Sep-18 MD Annapolis Lee 8/3830 7/23/18 RNAV (GPS)-A, Orig. 13-Sep-18 WI Medford Taylor County 8/4100 7/23/18 RNAV (GPS) RWY 9, Orig-A. 13-Sep-18 WI Medford Taylor County 8/4102 7/23/18 RNAV (GPS) RWY 16, Orig-A. 13-Sep-18 WI Medford Taylor County 8/4103 7/23/18 RNAV (GPS) RWY 34, Orig-A. 13-Sep-18 AK Kenai Kenai Muni 8/4752 7/10/18 RNAV (GPS) RWY 2L, Amdt 3. 13-Sep-18 AK Kenai Kenai Muni 8/4753 7/10/18 RNAV (GPS) RWY 20R, Amdt 4. 13-Sep-18 AK Kenai Kenai Muni 8/4754 7/10/18 VOR RWY 2L, Amdt 10. 13-Sep-18 AK Kenai Kenai Muni 8/4755 7/10/18 VOR RWY 20R, Amdt 21. 13-Sep-18 AK Kenai Kenai Muni 8/4756 7/10/18 Takeoff Minimums and Obstacle DP, Amdt 2. 13-Sep-18 ND Harvey Harvey Muni 8/4762 7/10/18 RNAV (GPS) RWY 11, Orig. 13-Sep-18 ND Harvey Harvey Muni 8/4763 7/10/18 RNAV (GPS) RWY 29, Orig-B. 13-Sep-18 TX Angleton/Lake Jackson Texas Gulf Coast Rgnl 8/5556 7/23/18 RNAV (GPS) RWY 35, Amdt 2. 13-Sep-18 TX Angleton/Lake Jackson Texas Gulf Coast Rgnl 8/5557 7/23/18 RNAV (GPS) RWY 17, Amdt 2. 13-Sep-18 NY Le Roy Le Roy 8/5610 7/25/18 VOR-A, Amdt 1B. 13-Sep-18 NY Le Roy Le Roy 8/5616 7/25/18 RNAV (GPS) RWY 28, Orig-C. 13-Sep-18 NY Le Roy Le Roy 8/5617 7/25/18 RNAV (GPS) RWY 10, Orig-B. 13-Sep-18 MA Worcester Worcester Rgnl 8/5622 7/25/18 RNAV (GPS) RWY 33, Orig-A. 13-Sep-18 IL Mount Sterling Mount Sterling Muni 8/5665 7/23/18 RNAV (GPS) RWY 36, Orig. 13-Sep-18 IL Mount Sterling Mount Sterling Muni 8/5667 7/23/18 RNAV (GPS) RWY 18, Orig. 13-Sep-18 IA Mapleton James G Whiting Memorial Field 8/5671 7/23/18 RNAV (GPS) RWY 2, Orig. 13-Sep-18 IA Mapleton James G Whiting Memorial Field 8/5673 7/23/18 RNAV (GPS) RWY 20, Orig. 13-Sep-18 WV Summersville Summersville 8/6177 7/25/18 Takeoff Minimums and Obstacle DP, Amdt 3A. 13-Sep-18 PA Grove City Grove City 8/6588 7/23/18 RNAV (GPS) RWY 28, Amdt 1A. 13-Sep-18 PA Grove City Grove City 8/6590 7/23/18 RNAV (GPS) RWY 10, Amdt 1A. 13-Sep-18 KS Topeka Topeka Rgnl 8/6797 7/23/18 RNAV (GPS) RWY 13, Orig-B. 13-Sep-18 IL Litchfield Litchfield Muni 8/6815 7/23/18 RNAV (GPS) RWY 9, Orig. 13-Sep-18 AR Magnolia Ralph C Weiser Field 8/6897 7/23/18 RNAV (GPS) RWY 36, Amdt 1A. 13-Sep-18 TX Houston George Bush Intercontinental/Houston 8/7516 7/23/18 RNAV (RNP) Y RWY 27, Amdt 2. 13-Sep-18 TX Houston George Bush Intercontinental/Houston 8/7530 7/23/18 RNAV (RNP) Y RWY 8L, Orig-A. 13-Sep-18 TX Houston George Bush Intercontinental/Houston 8/7531 7/23/18 RNAV (RNP) Y RWY 9, Orig-A. 13-Sep-18 OH Shelby Shelby Community 8/7532 7/23/18 VOR-A, Amdt 5. 13-Sep-18 TX Houston George Bush Intercontinental/Houston 8/7533 7/23/18 RNAV (RNP) Y RWY 26R, Orig-C. 13-Sep-18 CA Van Nuys Van Nuys 8/7957 7/10/18 LDA-C, Amdt 3. 13-Sep-18 FL Fort Lauderdale Fort Lauderdale/Hollywood Intl 8/8174 7/10/18 ILS OR LOC RWY 10L, Amdt 24. 13-Sep-18 FL Fort Lauderdale Fort Lauderdale/Hollywood Intl 8/8183 7/10/18 ILS OR LOC RWY 10R, Amdt 1. 13-Sep-18 FL Fort Lauderdale Fort Lauderdale/Hollywood Intl 8/8189 7/10/18 ILS OR LOC RWY 28R, Amdt 11. 13-Sep-18 FL Fort Lauderdale Fort Lauderdale/Hollywood Intl 8/8201 7/10/18 RNAV (GPS) RWY 10R, Amdt 1. 13-Sep-18 FL Fort Lauderdale Fort Lauderdale/Hollywood Intl 8/8211 7/10/18 RNAV (GPS) RWY 28L, Amdt 1. 13-Sep-18 FL Fort Lauderdale Fort Lauderdale/Hollywood Intl 8/8232 7/10/18 RNAV (RNP) Y RWY 10L, Amdt 1A. 13-Sep-18 FL Fort Lauderdale Fort Lauderdale/Hollywood Intl 8/8240 7/10/18 RNAV (GPS) Y RWY 28R, Amdt 4. 13-Sep-18 FL Fort Lauderdale Fort Lauderdale/Hollywood Intl 8/8244 7/10/18 RNAV (GPS) Z RWY 10L, Amdt 4. 13-Sep-18 GA Calhoun Tom B David Fld 8/8262 7/23/18 RNAV (GPS) RWY 35, Amdt 1B. 13-Sep-18 GA Calhoun Tom B David Fld 8/8265 7/23/18 RNAV (GPS) RWY 17, Amdt 1A. 13-Sep-18 AL Mobile Mobile Downtown 8/8670 7/10/18 RNAV (GPS) RWY 14, Amdt 2. 13-Sep-18 NJ Ocean City Ocean City Muni 8/8675 7/10/18 GPS RWY 6, Orig-B. 13-Sep-18 NJ Ocean City Ocean City Muni 8/8676 7/10/18 VOR-A, Orig-B. 13-Sep-18 TX Houston David Wayne Hooks Memorial 8/8861 7/25/18 RNAV (GPS) RWY 35L, Amdt 1C. 13-Sep-18 TX Houston David Wayne Hooks Memorial 8/8862 7/25/18 RNAV (GPS) RWY 17R, Amdt 1D. 13-Sep-18 TX Houston David Wayne Hooks Memorial 8/8863 7/25/18 LOC RWY 17R, Amdt 3D. 13-Sep-18 OK Oklahoma City Will Rogers World 8/9620 7/23/18 VOR RWY 17L, Amdt 2. 13-Sep-18 KS Independence Independence Muni 8/9691 7/23/18 RNAV (GPS) RWY 17, Amdt 2. 13-Sep-18 MN Moose Lake Moose Lake Carlton County 8/9703 7/25/18 NDB RWY 4, Amdt 1.
    [FR Doc. 2018-17616 Filed 8-16-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 31206; Amdt. No. 3811] Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

    DATES:

    This rule is effective August 17, 2018. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.

    The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of August 17, 2018.

    ADDRESSES:

    Availability of matters incorporated by reference in the amendment is as follows:

    For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001.

    2. The FAA Air Traffic Organization Service Area in which the affected airport is located;

    3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,

    4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff Minimums and ODP copies may be obtained from the FAA Air Traffic Organization Service Area in which the affected airport is located.

    FOR FURTHER INFORMATION CONTACT:

    Thomas J. Nichols, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Divisions, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) Telephone: (405) 954-4164.

    SUPPLEMENTARY INFORMATION:

    This rule amends Title 14 of the Code of Federal Regulations, part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

    The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

    Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as listed in the ADDRESSES section.

    The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.

    The Rule

    This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.

    The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

    Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference, Navigation (air).

    Issued in Washington, DC, on July 27, 2018. Rick Domingo, Executive Director, Flight Standards Service. Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

    PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority:

    49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

    2. Part 97 is amended to read as follows: Effective 13 September 2018 Ketchikan, AK, Ketchikan Intl, RNAV (GPS) RWY 29, Orig Ketchikan, AK, Ketchikan Intl, RNAV (GPS)-B, Amdt 1 Geneva, AL, Geneva Muni, Takeoff Minimums and Obstacle DP, Amdt 1 Fayetteville, AR, Drake Field, LDA RWY 34, Amdt 5 Fayetteville, AR, Drake Field, VOR/DME-B, Orig-B, CANCELED Oakland, CA, Metropolitan Oakland Intl, RNAV (RNP) Z RWY 12, Amdt 2 San Francisco, CA, San Francisco Intl, ILS OR LOC RWY 19L, Amdt 22 San Francisco, CA, San Francisco Intl, RNAV (GPS) RWY 19R, Amdt 3 Watsonville, CA, Watsonville Muni, Takeoff Minimums and Obstacle DP, Amdt 5A Watsonville, CA, Watsonville Muni, WATSONVILLE FOUR, Graphic DP Augusta, GA, Daniel Field, RNAV (GPS) RWY 5, Orig Cedartown, GA, Polk County Airport—Cornelius Moore Field, RNAV (GPS) RWY 10, Orig-B Cedartown, GA, Polk County Airport—Cornelius Moore Field, RNAV (GPS) RWY 28, Orig-B Paris, ID, Bear Lake County, RNAV (GPS) RWY 10, Orig Paris, ID, Bear Lake County, RNAV (GPS) RWY 28, Orig Paris, ID, Bear Lake County, Takeoff Minimums and Obstacle DP, Orig Bolingbrook, IL, Bolingbrook's Clow Intl, RNAV (GPS)-B, Amdt 1A Bolingbrook, IL, Bolingbrook's Clow Intl, VOR-A, Amdt 1A Springfield, IL, Abraham Lincoln Capital, ILS OR LOC RWY 22, Amdt 9C French Lick, IN, French Lick Muni, RNAV (GPS) RWY 8, Amdt 1C French Lick, IN, French Lick Muni, RNAV (GPS) RWY 26, Orig-C Indianapolis, IN, Indianapolis Rgnl, RNAV (GPS) RWY 34, Amdt 1B Topeka, KS, Topeka Rgnl, TACAN RWY 13, Amdt 4B New Roads, LA, False River Rgnl, LOC RWY 36, Amdt 2 New Roads, LA, False River Rgnl, NDB RWY 36, Amdt 2A, CANCELED New Roads, LA, False River Rgnl, RNAV (GPS) RWY 18, Amdt 1 New Roads, LA, False River Rgnl, RNAV (GPS) RWY 36, Amdt 1 Boston, MA, General Edward Lawrence Logan Intl, RNAV (GPS) RWY 4R, Amdt 2B Detroit, MI, Detroit Metropolitan Wayne County, ILS OR LOC RWY 4R, ILS RWY 4R SA CAT I, ILS RWY 4R CAT II, ILS RWY 4R CAT III, Amdt 19A Detroit, MI, Detroit Metropolitan Wayne County, ILS PRM RWY 4R (CLOSE PARALLEL), ILS PRM RWY 4R (CLOSE PARALLEL) SA CAT I, ILS PRM RWY 4R (CLOSE PARALLEL) CAT II, ILS PRM RWY 4R (CLOSE PARALLEL) CAT III, Amdt 3A Greenville, MI, Greenville Muni, Takeoff Minimums and Obstacle DP, Amdt 2B Marquette, MI, Sawyer Intl, ILS OR LOC RWY 1, Amdt 1 Marquette, MI, Sawyer Intl, RNAV (GPS) RWY 1, Amdt 1 Marquette, MI, Sawyer Intl, RNAV (GPS) RWY 19, Amdt 2 Marquette, MI, Sawyer Intl, VOR RWY 19, Amdt 1 Hinckley, MN, Field of Dreams, RNAV (GPS) RWY 24, Orig-A, CANCELED Red Wing, MN, Red Wing Rgnl, Takeoff Minimums and Obstacle DP, Amdt 2A Bismarck, ND, Bismarck Muni, ILS OR LOC RWY 31, Amdt 34A Garrison, ND, Garrison Muni, RNAV (GPS) RWY 13, Amdt 2 Garrison, ND, Garrison Muni, RNAV (GPS) RWY 31, Amdt 2 Manchester, NH, Manchester, Takeoff Minimums and Obstacle DP, Amdt 10B Mesquite, NV, Mesquite, RNAV (GPS) Y RWY 2, Orig Mesquite, NV, Mesquite, RNAV (GPS) Z RWY 2, Orig Mesquite, NV, Mesquite, Takeoff Minimums and Obstacle DP, Orig Minden, NV, Minden-Tahoe, RNAV (GPS)-A, Amdt 1 Minden, NV, Minden-Tahoe, RNAV (GPS)-B, Amdt 1 Columbus, OH, Bolton Field, ILS OR LOC RWY 4, Amdt 5A Columbus, OH, Bolton Field, NDB RWY 4, Amdt 7A Columbus, OH, Bolton Field, RNAV (GPS) RWY 4, Orig-B Lebanon, OH, Warren County/John Lane Field, NDB-A, Amdt 6 Idabel, OK, Mc Curtain County Rgnl, RNAV (GPS) RWY 2, Amdt 1 Idabel, OK, Mc Curtain County Rgnl, RNAV (GPS) RWY 20, Amdt 1 Corvallis, OR, Corvallis Muni, ILS OR LOC RWY 17, Amdt 5 Corvallis, OR, Corvallis Muni, RNAV (GPS) RWY 35, Amdt 3 Corvallis, OR, Corvallis Muni, VOR RWY 17, Amdt 8 Corvallis, OR, Corvallis Muni, VOR RWY 35, Amdt 12 Corvallis, OR, Corvallis Muni, VOR-A, Amdt 11 Borger, TX, Hutchinson County, RNAV (GPS) RWY 17, Amdt 1 Borger, TX, Hutchinson County, RNAV (GPS) RWY 35, Amdt 1 Dallas, TX, Dallas Love Field, ILS OR LOC RWY 31L, Amdt 22A Dallas, TX, Dallas Love Field, ILS OR LOC RWY 31R, ILS RWY 31R SA CAT I, ILS RWY 31R SA CAT II, Amdt 7 Dallas, TX, Dallas Love Field, ILS Y OR LOC Y RWY 13L, Amdt 33A Dallas, TX, Dallas Love Field, ILS Y OR LOC Y RWY 13R, Amdt 6A Dallas, TX, Dallas Love Field, RNAV (GPS) Y RWY 13L, Amdt 1C Dallas, TX, Dallas Love Field, RNAV (GPS) Y RWY 13R, Orig-B Dallas, TX, Dallas Love Field, RNAV (GPS) Y RWY 31L, Amdt 1E Dallas, TX, Dallas Love Field, RNAV (GPS) Y RWY 31R, Amdt 3 Dallas, TX, Dallas Love Field, RNAV (GPS) Z RWY 13L, Amdt 3B Dallas, TX, Dallas Love Field, RNAV (GPS) Z RWY 13R, Amdt 2A Dallas, TX, Dallas Love Field, RNAV (RNP) W RWY 13L, Orig-C Dallas, TX, Dallas Love Field, RNAV (RNP) X RWY 13L, Orig-C Houston, TX, West Houston, RNAV (GPS) RWY 15, Amdt 1C Houston, TX, West Houston, RNAV (GPS) RWY 33, Amdt 1B Houston, TX, West Houston, VOR-D, Amdt 1, CANCELED La Grange, TX, Fayette Rgnl Air Center, Takeoff Minimums and Obstacle DP, Amdt 1 Port Lavaca, TX, Calhoun County, Takeoff Minimums and Obstacle DP, Orig-A

    RESCINDED: On July 16, 2018 (83 FR 32766), the FAA published an Amendment in Docket No. 31202, Amdt No. 3807, to Part 97 of the Federal Aviation Regulations under section 97.25, 97.29, 97.33, and 97.37. The following entries for Asheville, NC, and Cleveland, TN, effective September 13, 2018, are hereby rescinded in their entirety:

    Asheville, NC, Asheville Rgnl, ILS OR LOC RWY 35, Orig Asheville, NC, Asheville Rgnl, ILS OR LOC RWY 35, Orig, CANCELED Asheville, NC, Asheville Rgnl, LOC RWY 17, Orig Asheville, NC, Asheville Rgnl, RNAV (GPS) RWY 17, Orig Asheville, NC, Asheville Rgnl, RNAV (GPS) RWY 17, Orig, CANCELED Asheville, NC, Asheville Rgnl, RNAV (GPS) RWY 35, Orig Asheville, NC, Asheville Rgnl, RNAV (GPS) RWY 35, Orig, CANCELED Asheville, NC, Asheville Rgnl, Takeoff Minimums and Obstacle DP, Amdt 1 Cleveland, TN, Cleveland Rgnl Jetport, RNAV (GPS) RWY 3, Amdt 2 Cleveland, TN, Cleveland Rgnl Jetport, RNAV (GPS) RWY 21, Amdt 2 Cleveland, TN, Cleveland Rgnl Jetport, Takeoff Minimums and Obstacle DP, Amdt 2
    [FR Doc. 2018-17619 Filed 8-16-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 803 [Docket No. FDA-2017-N-6730] Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification; order granting alternative.

    SUMMARY:

    The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research are announcing that the Agency is granting an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. We refer to this alternative as the “Voluntary Malfunction Summary Reporting Program.” This voluntary program reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV Commitment Letter).

    DATES:

    This voluntary program applies only to reportable malfunction events that manufacturers become aware of on or after August 17, 2018. See further discussion in section IV.F. “Submission Schedule and Logistics.”

    FOR FURTHER INFORMATION CONTACT:

    Michelle Rios, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3222, Silver Spring, MD 20993, 301-796-6107, [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911; or CBER, Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or by calling 1-800-835-4709 or 240-402-8010; or email: [email protected].

    SUPPLEMENTARY INFORMATION:

    I. Background

    Every year, FDA receives hundreds of thousands of MDRs of suspected device-associated deaths, serious injuries, and malfunctions. The Agency's MDR program is one of the postmarket surveillance tools FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments. Malfunction reports represent a substantial fraction of the MDRs FDA receives on an annual basis.

    Medical device reporting requirements for manufacturers are set forth in section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360i) and the regulations contained in part 803 (21 CFR part 803). Among other things, part 803 requires the submission of an individual MDR when a manufacturer becomes aware of information, from any source, which reasonably suggests that one of its marketed devices malfunctioned and the malfunction of the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur (§§ 803.10(c)(1) and 803.50(a)(2). Throughout this document, we refer to such malfunctions as “reportable malfunctions” or “reportable malfunction events.”

    The Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85) amended section 519(a) of the FD&C Act related to the reporting of device malfunctions. FDAAA did not alter the malfunction reporting requirements for class III devices and those class II devices that are permanently implantable, life supporting, or life sustaining. Under section 519(a)(1)(B)(i) of the FD&C Act, as amended by FDAAA, manufacturers of those devices must continue to submit malfunction reports in accordance with part 803 (or successor regulations), unless FDA grants an exemption or variance from, or an alternative to, a requirement under such regulations under §  803.19. However, FDAAA amended the FD&C Act to require that malfunction MDRs for class I and those class II devices that are not permanently implantable, life supporting, or life sustaining—other than any type of class I or II device that FDA has, by notice, published in the Federal Register or by letter to the person who is the manufacturer or importer of the device, indicated should be subject to part 803 in order to protect the public health—be submitted in accordance with the criteria established by FDA. The criteria require the malfunction reports to be in summary form and made on a quarterly basis (section 519(a)(1)(B)(ii) of the FD&C Act). In the Federal Register of March 8, 2011 (76 FR 12743), FDA explained that, pending further notice from the Agency, all class I devices and those class II devices that are not permanently implantable, life supporting, or life sustaining would remain subject to individual reporting requirements under part 803 to protect the public health, pursuant to section 519(a)(1)(B)(i)(III) of the FD&C Act. Consequently, unless granted an exemption, variance, or alternative, manufacturers of those devices have continued to be required to submit individual malfunction reports under part 803. Under § 803.19, FDA may grant exemptions or variances from, or alternatives to, any or all of the reporting requirements in part 803, and may change the frequency of reporting to quarterly, semiannually, annually, or other appropriate time period. FDA may grant such modifications upon request or at its discretion, and when granting such modifications, FDA may impose other reporting requirements to ensure the protection of the public health. (See § 803.19(c))

    In the Federal Register of December 26, 2017 (82 FR 60922), FDA issued a notification outlining FDA's proposal to grant an alternative under § 803.19 to permit manufacturer reporting of certain device malfunctions in summary form on a quarterly basis, subject to certain conditions, and requested comments (2017 Proposal). As explained in the 2017 Proposal, the Voluntary Malfunction Summary Reporting Program is intended to reflect goals for streamlining malfunction reporting that FDA and industry agreed to in the MDUFA IV Commitment Letter (Ref. 1). The 2017 Proposal also summarized FDA's previous experience with summary reporting programs, key findings from an FDA pilot program for the submission of MDRs in summary format on a quarterly basis (see 80 FR 50010, August 18, 2015), additional background regarding the development of the proposal, and the anticipated benefits of summary reporting under the proposal. Interested persons were given the opportunity to submit comments by February 26, 2018.

    II. Comments on the Proposed Alternative and FDA's Response

    In response to the 2017 Proposal, FDA received 24 comments from industry, professional societies, trade organizations, and individual consumers by the close of the comment period, each containing one or more comments on one or more issues. A summary of the comments to the docket and our responses follow. To make it easier to identify comments and our responses, the word “Comment” appears in parentheses before the comment's description, and the word “Response” in parentheses precedes the response. The comments are grouped based on common themes and numbered sequentially.

    A. General Comments

    (Comment 1) Three comments suggested that the proposal was inconsistent with amendments made by section 227 of FDAAA to section 519(a) of the FD&C Act regarding malfunction reporting requirements. Two of these comments specifically recommended that FDA immediately implement summary, quarterly malfunction reporting under section 519(a)(1)(B)(ii) of the FD&C Act for all class I devices and those class II devices that are not permanently implantable, life supporting, or life sustaining.

    (Response 1) FDA disagrees with these comments. As discussed in the 2017 Proposal, currently, there are still reportable malfunctions for which submission of individual malfunction reports on a prompter basis than quarterly is necessary to protect the public health—for example, when remedial action is needed to prevent an unreasonable risk of substantial harm to the public health. Those situations may involve class I devices and class II devices that are not permanently implantable, life supporting, or life sustaining, and it is not feasible for FDA to provide notice in the Federal Register or by letter to individual manufacturers, pursuant to section 519(a)(1)(B)(i)(III) of the FD&C Act, each time one of these situations arises. For example, FDA may not become aware of the situation until it receives an MDR from a manufacturer. Therefore, in accordance with section 519(a)(1)(B)(i)(III) of the FD&C Act, manufacturers of class I devices and those class II devices that are not permanently implantable, life supporting, or life sustaining remain subject to individual reporting requirements in part 803, unless granted an exemption, variance, or alternative, to protect the public health. However, FDA does believe that malfunction summary reporting on a quarterly basis, in accordance with the conditions described in section IV, will reduce burden on FDA and manufacturers and allow FDA to effectively monitor many devices. Accordingly, the Agency is granting an alternative under section 519(a)(1)(B)(i) of the FD&C Act and § 803.19 to permit manufacturers of those devices to submit summary, quarterly malfunction reports, with certain conditions.

    (Comment 2) Several comments raised concerns that the proposed program would be unable to provide FDA with critical information on adverse event reporting. Many of the comments from individual consumers also raised concerns that the proposed program would limit transparency of malfunction event data that is publicly available to patients and physicians, including transparency regarding the number of reported malfunctions. However, another comment indicated that the proposed program would minimize burden while maintaining patient safety. That same comment further indicated that the proposed malfunction summary reporting format would enhance public visibility into the events and associated investigation compared to a format previously used for the Alternative Summary Reporting (ASR) program.

    (Response 2) FDA disagrees with the comments suggesting that the Voluntary Malfunction Summary Reporting Program will negatively affect patient safety and the transparency of malfunction reports. Summary, quarterly reporting in accordance with this program will result in some malfunction reports being submitted to FDA and added to the publicly available Manufacturer and User Facility Device Experience (MAUDE) database later than this occurs under FDA's current individual reporting requirements. However, as explained in our 2017 Proposal, we believe this reporting format and schedule will also yield benefits for FDA and the public, such as helping FDA process malfunction reports more efficiently and helping both FDA and the public more readily identify malfunction trends.

    While summary malfunction reports submitted under this program will change the format in which information is presented to FDA, we do not believe there will be an adverse impact on the content of information provided to FDA. The format for summary reporting described in section IV.D includes a narrative section for describing malfunctions, similar to the narrative section required for individual reporting. In addition, each narrative section is required to include a sentence specifying the number of malfunction events summarized in the report, providing transparency for the public regarding the number of events that a summary report available in MAUDE represents. Therefore, we agree with the comment that the summary reporting format will improve transparency for the public when compared to some past summary reports submitted to FDA, such as reports submitted under the ASR program (Ref. 2).

    (Comment 3) One comment requested clarification as to whether a manufacturer would need to apply or obtain permission to participate in the program and asked FDA to clarify how the proposed program would work with other alternative summary reporting situations. Another comment asked FDA to clarify whether manufacturers can still apply for an exemption or variance to be granted under § 803.19 for their devices that do not fall under an eligible product code.

    (Response 3) FDA is clarifying in the description of the alternative that manufacturers do not need to submit a request or application to FDA before participating in the Voluntary Malfunction Summary Reporting Program. For devices that fall within eligible product codes, the alternative that FDA is granting under § 803.19 provides that manufacturers may choose or “self-elect” to participate, subject to the program conditions identified in section IV. If a manufacturer wishes to request a different exemption, variance, or alternative under § 803.19 (including for devices in product codes that are eligible for the Voluntary Malfunction Summary Reporting Program) the manufacturer may submit a request to FDA. For more information regarding the recommended content of such requests, see section 2.27 of the Agency's guidance entitled “Medical Device Reporting for Manufacturers: Guidance for Industry and Food and Drug Administration Staff” (MDR Guidance) (Ref. 3).

    Whether participation in the Voluntary Malfunction Summary Reporting Program will have an impact on a manufacturer being granted a different exemption, variance, or alternative under § 803.19 will depend on the scope of the other exemption, variance, or alternative. FDA will make a case-by-case determination on requests for an exemption, variance, or alternative submitted under § 803.19(b).

    B. Scope of Program

    (Comment 4) Several comments also discussed the scope of product codes that should be eligible for the proposed program. One comment expressed concern about including class III devices and class II devices that are permanently implantable, life-supporting, or life-sustaining in the program and urged FDA to issue another Federal Register notice with the list of eligible product codes for these categories of devices for public comment before allowing summary, quarterly malfunction reporting for those devices. In contrast, another comment asserted that all devices should be eligible for malfunction summary reporting, unless there is an express determination, subject to public input, that permitting summary reporting for a device would present public health concerns. Other comments recommended that all device product codes should be eligible for summary, quarterly malfunction reporting, with the exception of product codes for class III devices and class II devices that are permanently implantable, life supporting, or life sustaining when those product codes have been in existence for less than 2 years.

    (Response 4) FDA disagrees that it should publish another Federal Register notice for public comment listing product codes that would be eligible or ineligible for the program. Among other reasons, the Agency expressly requested comment on the product codes that should be eligible for the proposed program, and many commenters submitted proposed lists of eligible product codes or identified specific devices about which they had concerns. FDA has considered these comments and has also conducted an extensive review of all product codes, regardless of device class, to determine whether each product code would be eligible. In addition, consistent with its 2017 Proposal, product codes that have been in existence for less than 2 years are not included in the list of eligible product codes, unless the new product code was created solely for administrative reasons. In FDA's experience, this 2-year period is an important period for having more timely, detailed information to monitor malfunction events. That 2-year timeframe for new product codes is also consistent with the MDUFA IV Commitment Letter (Ref. 1).

    (Comment 5) Three comments recommended that importers be included within the scope of the proposed program and indicated that FDA should provide a rationale for not including them. One of those comments suggested that without more information, it appeared arbitrary that FDA did not include importers and user facilities in the summary reporting program.

    (Response 5) FDA disagrees with these comments. Unlike manufacturers, device user facilities are not required to submit malfunction reports under part 803. User facilities, such as hospitals or nursing homes, are required to submit MDRs to FDA and/or the manufacturer only for reportable death or serious injury events. (See section 519(b) of the FD&C Act; § 803.30(a)).

    Importers are also subject to different requirements for reporting device malfunctions than those for manufacturers under part 803. Under § 803.40, importers are required to submit a report to the device manufacturer, not to FDA, within 30 days after becoming aware of a reportable malfunction event. Manufacturers then determine the reportability of the information received from the importer and accordingly submit those reports to FDA. This program specifically addresses malfunction summary reporting to FDA. In addition, we believe it is important for importers to continue to submit individual malfunction MDRs to device manufacturers in accordance with § 803.40 so that manufacturers receive detailed information necessary to conduct adequate investigations and follow up related to malfunction events.

    C. Individual Reporting Conditions

    (Comment 6) One comment suggested that when requesting that a manufacturer submit a 5-day report, FDA should have an objective and documented basis for making such a request, as well as an opportunity for manufacturers to appeal. Other comments asked FDA to define the term “substantially similar” as used in describing the program condition regarding 5-day reports and to clarify what constitutes an “imminent hazard” and whether this is analogous to reportable malfunctions requiring a 5-day report.

    (Response 6) The circumstances in which a 5-day report is required are defined under § 803.53, and those circumstances remain unchanged for manufacturers participating in the Voluntary Malfunction Summary Reporting Program. As stated in the 2017 Proposal, the reporting requirements at § 803.53 will continue to apply to manufacturers of devices in eligible product codes who participate in this program. We have added a separate heading to the description of the alternative to clarify this point further. For more information regarding the handling of a 5-day report, please see section 2.20 of the Agency's MDR Guidance (Ref. 3).

    The first individual reporting condition requires that if a manufacturer submits a 5-day report for an event or events that require remedial action to prevent an unreasonable risk of substantial harm to public health, all subsequent reportable malfunctions of the same nature that involve substantially similar devices must be submitted as individual MDRs in accordance with §§ 803.50 and 803.52 until the date that the remedial action has been resolved to FDA's satisfaction. For purposes of this individual reporting condition, a “substantially similar” device could be, for example, a device that is the same except for certain performance characteristics or a device that is the same except for certain cosmetic differences in color or shape.

    Regarding the term “imminent hazard,” FDA notes that the term is used to describe one of the general overarching principles for summary reporting, but is not included in the descriptions of any of the individual reporting conditions. For purposes of these overarching principles, we intend “imminent hazard” to capture situations in which a device poses a significant risk to health and creates a public health situation that should be addressed immediately to prevent injury. Use of that term in one of the overarching principles was not intended to indicate any change in the standard for a 5-day report under § 803.53.

    (Comment 7) One comment indicated that there should be objective and documented criteria for when FDA would provide written notice that manufacturers must submit an individual, 30-day malfunction report in accordance with the proposed program conditions, along with an opportunity for appeal. The comment further asserted that due process considerations need to be made regarding these reporting requirements, including notice, a written justification for the request, and a process to appeal.

    (Response 7) FDA disagrees that there should be fixed criteria for notifying a manufacturer that it must submit an individual, 30-day malfunction report in accordance with the program conditions. Manufacturers who are notified to submit individual reports in accordance with the individual reporting conditions will need to comply with MDR requirements to which they would otherwise be subject if not granted this alternative under § 803.19. FDA has provided examples of when it would make these notifications, but public health issues that require submission of individual MDRs to monitor device safety are not uniform and may arise in various ways.

    FDA will provide written notice to manufacturers when they need to submit individual MDRs pursuant to individual reporting conditions 3 and 4, as described in section IV.B. In addition, the Agency already has a process in place for stakeholders to request review of decisions made by CDRH employees. For more information, refer to the FDA Guidance entitled “Center for Devices and Radiological Health Appeals Processes” (Ref. 4).

    (Comment 8) Some comments disagreed with the proposed program condition that would have required manufacturers to submit individual, 30-day MDRs for reportable malfunction events that are the subject of any ongoing device recall and suggested that the condition be modified or removed. The comments cited several different reasons for objecting to this condition, including that the condition is not mentioned in the MDUFA IV Commitment Letter, that the condition may discourage manufacturers from conducting voluntary or class III recalls, that the condition is duplicative of information that FDA receives during a recall, and that it may be difficult for manufacturers to manage the requirements (e.g., new events may be uncovered during a product investigation leading to confusion and multiple reports for the same incident). Suggestions from the commenters regarding this individual reporting condition included the following: (a) The condition should only apply to mandatory or FDA-initiated recalls, and summary reporting should be permitted for voluntary or low-risk class III recalls and for incidents related to remedial action after the first (parent) MDR is submitted, unless a death or serious injury is associated; (b) FDA should clarify how to handle malfunction events that were not submitted as individual MDRs, but subsequently, prior to the next summary reporting date, are identified to be the result of an issue addressed by a recall; (c) the timeframe for submitting individual MDRs should be changed from 90 days past the date of the termination of the recall to 90 days past the date of the recall; and (d) FDA should clarify what it means by “malfunction events of the same nature.”

    (Response 8) FDA disagrees with the comments recommending removal of this individual reporting condition. Recall classification takes into account both the severity of harm and the likelihood of occurrence, and it is important for FDA to have access to more timely information on malfunctions related to certain recalls to ensure that the recall has been appropriately classified and that the recall strategy is effective.

    FDA also provides the following responses to the additional specific issues raised in the comments: (a) For the reasons discussed above, FDA continues to believe that it is important for malfunctions related to certain recalls to be reported as individual MDRs. However, after considering the comments, FDA has determined that this individual reporting condition should only apply to reportable malfunctions that are the subject of a recall involving a correction or removal that must be reported to FDA under part 806 (21 CFR part 806). Under part 806, manufacturers and importers are required to make a written report to FDA of any correction or removal of a device if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act caused by the device that may present a risk to health, unless the information has already been submitted to FDA in accordance with other reporting requirements. (See § 806.10(a) and (f).) Because the definition of “risk to health” under part 806 tracks the definitions of class I and class II recalls in § 7.3(m) (21 CFR 7.3(m)), reports of corrections and removals are required for actions that meet the definition of class I and class II recalls. However, under part 806, manufacturers and importers need not report events that are categorized as class III recalls under § 7.3(m) (see 62 FR 27183, May 19, 1997). Therefore, an action that meets the definition of a class III recall would not, on its own, trigger the requirement to submit individual reports under the Voluntary Malfunction Summary Reporting Program.

    (b) FDA agrees that it is important to provide clarity regarding when the requirement to submit individual MDRs is triggered under this individual reporting condition and the events to which that requirement applies. Therefore, FDA is revising the alternative to clarify that, as of the date a manufacturer submits a required report of a correction or removal under part 806 (or the date that the manufacturer submits a report of the correction or removal under 21 CFR part 803 or part 1004 instead, as permitted under § 806.10(f)), the manufacturer must submit reportable malfunction events related to that correction or removal as individual MDRs in accordance with §§ 803.50 and 803.52. We believe these revisions will help provide manufacturers with a clear date on which this individual reporting obligation is triggered.

    With respect to malfunction events that were identified for inclusion in a summary report but are subsequently identified as the subject of a reportable correction or removal prior to the end of the relevant summary reporting period, FDA is revising the alternative to state that a summary MDR must be submitted for those reportable malfunctions within 30 calendar days of when the manufacturer submits the required report of correction or removal. In the summary report, the manufacturer must include a check on the box for “Recall” in SECTION H.7 of the electronic Form FDA 3500A. We have similarly revised the description of individual reporting conditions 3 and 4 to clarify the requirements for handling malfunction events identified for inclusion in a summary report (but not yet submitted) prior to the date that individual reporting is triggered.

    (c) As part of its recall termination process, FDA considers MDR information, including reported malfunctions to help evaluate the effectiveness of the recall. Therefore, FDA disagrees with the suggestion to limit the duration of individual reporting under this condition to 90 days past the date of a recall. However, after considering the comments, we do not believe it is necessary to receive individual MDRs for reportable malfunction events that are the subject of a recall after FDA has terminated the recall. We have revised the alternative accordingly (see Section IV.B.2.). For similar reasons, we have revised the first individual reporting condition to state that individual MDRs associated with a 5-day report are only required until the remedial action at issue is resolved to FDA's satisfaction.

    (d) By “malfunction events of the same nature,” FDA means additional reportable malfunction events involving the same malfunction that prompted the recall.

    (Comment 9) One comment, regarding proposed individual reporting condition 3, suggested that FDA provide information on the timing for when the Agency will provide written notice to a manufacturer that the manufacturer can resume participation in the Voluntary Malfunction Summary Reporting Program.

    (Response 9) FDA cannot provide a uniform timeframe for when the Agency would notify manufacturers submitting individual reports due to an identified public health issue that they can resume submission of summary, quarterly malfunction reports for those devices because the timing and resolution of public health issues is specific to each situation.

    (Comment 10) Three comments recommended that FDA clarify what constitutes a “new type of reportable malfunction” that is exempt from summary reporting. One of these comments indicated that FDA should provide additional information regarding when a manufacturer can begin submitting summary reports for these new types of device malfunctions.

    (Response 10) FDA disagrees that the meaning of the phrase “new type of reportable malfunction” was unclear in the proposal. Manufacturers are required under § 820.198 (21 CFR 820.198) to evaluate complaints to determine if they represent events that must be reported to FDA under part 803 or if an investigation is required. Through this process, if a manufacturer identifies a new type of reportable malfunction that has not previously been reported to FDA over the life of that device, this information must be submitted to FDA as an individual MDR in accordance with §§ 803.50 and 803.52 and may not be reported to FDA in a summary malfunction report. This will allow FDA and manufacturers to better understand and address emergent issues with medical devices. We have revised this individual reporting condition to clarify that after manufacturers submit an individual MDR for the initial occurrence of a previously unreported type of reportable malfunction for a device, subsequent reports for that same type of malfunction for that device may be in summary form, unless they are subject to individual reporting for another reason.

    D. Reporting Format

    (Comment 11) Some comments suggested that FDA allow manufacturers to “bundle together” reportable malfunction events in a summary report by product code or product family and allow the use of International Medical Device Regulators Forum's (IMDRF) Level 1,2 codes to bundle like events in a summary report.

    (Response 11) FDA disagrees with the suggestion that manufacturers be permitted to bundle reportable malfunction events by product code or product family for purposes of submitting a summary report. Each unique combination of device brand name (corresponding to SECTION D1 of the Form FDA 3500A), device model, and device problem code(s) (corresponding to SECTION F10/H6 of the Form FDA 3500A) can be summarized together in reports submitted under this program. (Comments regarding the number of brand names that should be included in each summary report are further addressed in the response to Comment 16 below, and we have made corrections to the summary reporting instructions for SECTION D.4 to be clear that each summary malfunction report should summarize events for a single device model.) Bundling together malfunction reports by product codes or device families would make summarizing and interpreting the information in a summary report difficult for manufacturers, FDA, and the public because a product code or product family could contain several devices with different functions, components, and modes of operation that are important for purposes of understanding malfunction events and the causes of those events. The intent of the Voluntary Malfunction Summary Reporting Program is to streamline reporting of events that are the same or similar, yet not to over bundle reports such that important details regarding device performance are obscured.

    The IMDRF (Ref. 5) is working towards harmonization of all medical device coding, including device problem codes. To harmonize medical device coding globally, device problem codes have been organized in a hierarchical arrangement, such that higher level codes (e.g., electrical issue) describe more general device problems, while lower level codes (e.g., insulation issue) provide more granularity into the type of device problem described. For purposes of grouping device issues for reports submitted under this Voluntary Malfunction Summary Reporting Program, we recommend that all coding be grouped at the lowest level of coding available, when IMDRF codes are available. Based on our experience, FDA does not believe grouping by the lowest level of coding will eliminate the efficiency benefits of summary reporting. FDA does not specify a specific level of coding, but expects the most specific appropriate code to be used.

    (Comment 12) One comment noted that it was unclear whether a summary malfunction report will be available in MAUDE or another database. Another comment recommended that FDA allow Excel spreadsheets with malfunction report data to be uploaded to MAUDE.

    (Response 12) FDA plans to make summary reports submitted under the Voluntary Malfunction Summary Reporting Program publicly available in MAUDE. However, FDA will not upload Excel spreadsheets to MAUDE because they are incompatible with the MAUDE interface.

    (Comment 13) One comment indicated that FDA should consider amending the requirement that an individual process the complaints twice—once for reporting assessment and then quarterly.

    (Response 13) FDA disagrees with this comment. FDA is granting an alternative to the individual reporting requirements under part 803 for certain reportable malfunction events. The Quality System (QS) regulation requires manufacturers to evaluate all complaints to determine if they represent events that must be reported to FDA under part 803 (§ 820.198(a)). If a complaint represents an MDR reportable event, then the manufacturer must, among other things, investigate it and submit an MDR to FDA. (See §§ 803.10(c), 803.50, and 820.198(d)) The difference for manufacturers that have been granted the alternative described in this document is that they could choose to report certain malfunction events to FDA as a summary report instead of as an individual report.

    (Comment 14) One comment requested that FDA provide more detail concerning the terms “similar device” and “similar complaint,” as used in the discussion of the rationale for the proposed summary reporting format.

    (Response 14) The term “similar device” is used in FDA's MDR regulations to describe malfunction events for which manufacturers must submit a report to FDA. (see e.g., § 803.50(a)(2)) As used in this alternative, the term “similar device” is intended to have the same meaning as it does for purposes of part 803. FDA's MDR Guidance (Ref. 3), provides more information regarding the factors that FDA and manufacturers may consider in determining if a device is “similar” to another device.

    FDA does not believe it is necessary to provide a formal definition of the term “similar complaint” for purposes of this alternative because that term is not used in describing any of the conditions of the Voluntary Malfunction Summary Reporting Program, including the required reporting format. Whether a complaint constitutes a “similar complaint” for purposes of conducting an investigation under FDA's QS regulation is outside the scope of this alternative.

    (Comment 15) One comment asked FDA to provide further information on how a manufacturer is to provide supplemental information, including whether FDA expects such information to be shared with the Agency. Some comments also noted that FDA should explain how a previously submitted summary malfunction report should be updated with new information, including how to handle new information regarding a previously reported event that would change the categorization of the event (e.g., if the manufacturer subsequently became aware that a serious injury was associated with a previously reported malfunction event).

    (Response 15) FDA understands the need for clarification of how to handle additional information and supplemental reporting under this program and has revised the alternative to address this issue. A manufacturer participating in the Voluntary Malfunction Summary Reporting Program must submit an initial summary report within the Summary Malfunction Reporting Schedule timeframe described in table 1. Supplemental reports to a summary malfunction report must also be submitted within that timeframe. For example, if a manufacturer submits a summary report for certain malfunction events of which it became aware in January to March and in May of that same year becomes aware of additional information that would have been required in the initial summary report if it had been known to the manufacturer, then the manufacturer must submit a supplemental report with that additional information by July 31. Manufacturers do not need to submit a supplemental report for new information if they would not have been required to report that information had it been known or available at the time of filing the initial summary malfunction report.

    However, this timing for supplemental reports would not apply when additional information is learned about an event or events included in a previously submitted summary report that triggers individual reporting requirements. For example, if the manufacturer becomes aware of additional information reasonably suggesting that a previously reported malfunction meets the criteria for a reportable serious injury or death event, then the manufacturer must submit an initial, individual MDR for the identified serious injury or death within 30 calendar days of becoming aware of the additional information. The manufacturer must simultaneously submit a supplement to the initial MDR summary report reducing the number of events summarized by 1, so that the total number of events remains the same. The alternative has been revised to reflect that these are requirements for participating in the Voluntary Malfunction Summary Reporting Program.

    (Comment 16) One comment stated that Form FDA 3500A is not an optimal format because it is only used for single event reporting. Other comments made specific recommendations and/or raised issues regarding the proposed summary reporting format using Form FDA 3500A, including the following: (a) In Form FDA 3500A, SECTIONS B.5 and H.10, FDA should request that information be entered in a summary, high-level form, rather than requiring detailed descriptions or itemized investigation findings; (b) clarify the most “up to date” information that is expected to be received in the report; (c) clarify that only one brand name per product code should be entered in the field with additional brand names being provided in a separate attachment (SECTION D.1); (d) inclusion of patient age, weight, and breakdown of gender and race is inappropriate for summary malfunction reporting, and it is not clear if such information is required in a summary malfunction report; (e) clarify that manufacturers can submit summary malfunction reports for devices manufactured at multiple manufacturing sites (SECTION D.3); (f) the summary format should permit a serial number to be used instead of a lot number to identify the devices that are the subject of a summary report (SECTION D.4); and (g) address how a manufacturer should link a device problem code with a method code, result code, and evaluation conclusion code (if different) for a single summary report that includes more than one device problem.

    (Response 16) FDA does not believe the summary reporting format should be changed to use a new form. The Voluntary Malfunction Summary Reporting Program aims to, among other things, consolidate reporting of same or similar events into a single summary report to reduce the overall volume of reports, while still providing critical content to FDA. While the Form FDA 3500A was developed for individual MDRs, manufacturers successfully used the Form FDA 3500A to submit summary malfunction reports in FDA's pilot program. In addition, as explained in our 2017 Proposal, for purposes of streamlining changes that FDA and manufacturers must make to process or submit summary reports under the Voluntary Malfunction Summary Reporting Program, we believe that using the Form FDA 3500A is the most efficient approach. We provide the following responses to the specific recommendations/issues raised regarding the summary reporting format: (a) FDA continues to believe that it is important for summary malfunction reports submitted under this program to provide a similar level of detail in text narratives as is available in an individual report to allow for sufficient understanding of the malfunction, any circumstances that led to the malfunction, and any follow-up steps the manufacturer has taken to investigate, correct, and prevent the malfunction from happening again. These narrative text fields are key to helping ensure that summary reporting under this program streamlines malfunction reporting without reducing the reporting of important details regarding device performance and transparency to the public. (b) Each summary report must be “up to date,” meaning that it must include all required information available, as of the close of the quarterly time period listed in the Summary Malfunction Reporting Schedule (see table 1). FDA has clarified this in section IV.F. (c) FDA disagrees that separate attachments with additional brand names should be permitted to accompany a summary malfunction report. Each summary malfunction report may only summarize malfunction events for a single brand name. We further clarified this in the instructions for the summary reporting format at section IV.D. Including multiple brand names in an attachment to a single summary report would, among other things, result in FDA having difficulty identifying the specific malfunction event to the exact device brand. (d) FDA agrees that information summarizing patient age, weight, gender, race, and ethnicity may not be relevant for many summary malfunction reports. FDA is revising the description of the summary reporting format to clarify that inclusion of this information in Section B.5 is not a required entry for the form. However, FDA recommends including descriptors such as patient weight or race in a text narrative for a malfunction summary report if the information is available and indicates that a malfunction is more likely to affect a specific group of patients. (e) FDA is revising the description of the summary reporting format to clarify that multiple manufacturing sites could be entered in SECTION G.1 if the device is manufactured at multiple sites. We note that depending on their roles, each manufacturing site may be responsible for submitting MDRs. (See e.g., section 2.17 of FDA's MDR Guidance (Ref. 3), which provides additional information regarding reporting obligations for contract manufacturers.) (f) FDA agrees that a serial number may be included in SECTION D.4 and has added “serial number” to the reporting format instructions for that section. (g) The summary reporting format requires firms to identify the method, result, and conclusion codes in Block H6 of the Form FDA 3500A, including as many codes as are necessary to describe the event problem and evaluation for the reportable malfunction events that are being summarized. If the report summarizes reportable events that involved more than one type of device problem (see e.g., Case Scenario #2, Report #3 in Appendix A (Ref. 6)), differences in the conclusion code according to the different device problems can be explained in SECTION H.10.

    E. Consideration of Combination Products

    (Comment 17) Some comments raised issues regarding the application of the malfunction summary reporting for combination products that contain a device constituent part but that are marketed under drug or biological product marketing authorization pathways (referred to in this document as drug and biologic-led combination products), as opposed to those under device marketing authorization pathways (device-led combination products). Issues raised in these comments include: Concerns about a device product code-based eligibility approach for drug and biologic-led combination products because such products may not have a device product code; the quarterly schedule proposed because it would create redundancies for drug and biologic-led combination products, which are subject to periodic reporting; the format proposed because it might not be compatible with the reporting systems for drugs or biological products that are utilized for drug and biologic-led combination products; and development of a single report that includes malfunction summary reporting and satisfies other combination product reporting requirements.

    (Response 17) Among other things, the final rule on postmarketing safety reporting (PMSR) for combination products (81 FR 92603, December 20, 2016), codified in part 4, subpart B (21 CFR part 4, subpart B), clarified that all combination product applicants must comply with malfunction reporting requirements as described in part 803 if their combination product contains a device constituent part. Accordingly, in the 2017 Proposal, FDA requested comment on how the Voluntary Malfunction Summary Reporting Program might be implemented for combination products, including drug and biologic-led combination products. Shortly after the issuance of the proposal for this program, FDA also published a draft guidance entitled, “Postmarketing Safety Reporting for Combination Products; Guidance for Industry and FDA Staff” (PMSR draft guidance) (Ref. 7) regarding compliance with the final rule on PMSR for combination products, and an Immediately in Effect guidance announcing FDA's compliance policy for that rule (Ref. 8). The PMSR draft guidance noted that the Agency was proposing the Voluntary Malfunction Summary Reporting Program and stated that the Agency intends to update the PMSR draft guidance if combination products are included in the program. The compliance policy guidance announced the Agency's intent to delay enforcement of certain provisions of the rule, including malfunction reporting requirements for drug and biologic-led combination products, to provide applicants with additional time to consider Agency recommendations and technical specifications as they update their systems and procedures to comply with those provisions.

    Applicants of device-led combination products must submit MDRs in accordance with part 803 (see § 4.104 (21 CFR 4.104)), and therefore, they report malfunctions using the same system as device manufacturers. Thus, FDA believes the eMDR data system and instructions support use of the Voluntary Malfunction Summary Reporting Program for such products. Accordingly, we are including device-led combination products in the Voluntary Malfunction Summary Reporting Program. However, combination product applicants for drug and biologic-led combination products with a device constituent part must submit malfunction reports under a different system. Under § 4.104(b), malfunction reports must be submitted in accordance with 21 CFR 314.80(g) or 600.80(h)) for these combination products. Additional considerations, including the issues raised in comments as discussed above, need to be addressed before drug and biologic-led combination products could be included in the Voluntary Malfunction Summary Reporting Program. As noted above, the Agency intends to delay enforcement of the malfunction reporting requirements for drug and biologic-led combination products under the PMSR final rule. FDA will consider all relevant comments submitted on the 2017 Proposal as well as those submitted on the PMSR draft guidance in developing an approach for voluntary malfunction summary reporting for such combination products.

    F. Submission Schedule and Logistics

    (Comment 18) One comment recommended that FDA permit manufacturers to submit individual reports for each adverse event within 90 calendar days from the date they become aware of the reportable event, while using the summary format. The comment also suggested that FDA provide an additional 30 days for the submission of summary reports because the manufacturer may need more than a month between the end of the reporting period and the due date to aggregate reports.

    (Response 18) FDA disagrees with this comment. Permitting manufacturers to submit individual reports using the summary format within 90 calendar days would delay the submission of malfunction information to FDA without providing the anticipated benefits of summary reporting that FDA identified in the 2017 Proposal, such as increased efficiency in processing malfunction reports and more readily apparent malfunction trends. While we recognize that a manufacturer may become aware of some reportable malfunction events toward the end of a quarter, manufacturers will have at least 30 days from that time to prepare and submit summary malfunction reports. FDA does not believe that manufacturers will need an additional 30 days beyond the reporting schedule outlined in the 2017 Proposal to aggregate malfunction reports into a summary report. Therefore, we have retained the Summary Malfunction Reporting Schedule that was included in the 2017 Proposal (see table 1).

    (Comment 19) One comment suggested that FDA use a more generic reporting number format or a completely different reporting number format.

    (Response 19) FDA disagrees with this comment. The required reporting number format for this program uses the existing common format that manufacturers must use to submit individual reports through their electronic reporting systems under part 803. Therefore, we believe there is no need for a separate MDR reporting number format to identify summary reports.

    (Comment 20) One comment suggested that FDA clarify what the manufacturer should do if an investigation is not completed within the reported timeframe.

    (Response 20) As discussed in response to Comment 15, FDA has revised the alternative to include instructions regarding supplemental reporting for summary reports submitted under this voluntary program. In situations where a manufacturer is not able to complete its investigation regarding a reportable malfunction by the deadline for submitting a summary report, the manufacturer is still required to report the event within the timeframes specified in the Summary Malfunction Reporting Schedule (see table 1). If additional information becomes known or available to the manufacturer after submission of a summary report, including additional information that becomes known through an investigation, the manufacturer is required to submit supplemental reports amending its initial submission as needed.

    G. Addition of Product Codes to the Program

    (Comment 21) Some comments suggested that FDA should explain more clearly how industry would make a request under § 803.19(b) and provide a mechanism for industry to request an exemption, when appropriate, for product codes that may be newly assigned within the first 2 years.

    (Response 21) FDA is not making any changes to the alternative in response to this comment. As discussed in section VI, FDA intends to periodically assess the eligibility of product codes after they have been in existence for 2 years and will update the FDA's Product Classification database accordingly. Manufacturers can also send a request for a product code to be added to the list of eligible product codes and for manufacturers of devices within that product code to be granted the same alternative for malfunction events associated with those devices. Information about where to send such requests is provided in section VI.

    H. Other Comments

    (Comment 22) One comment stated that the average Paperwork Reduction Act (PRA) burden on manufacturers of 6 minutes per response appears to be a very low estimate.

    (Response 22) FDA disagrees with this comment. The estimation of time is the amount of time needed to submit a summary malfunction report. It is essentially the same amount of time needed to submit an individual report because the event narrative should be similar, with the exception of one additional line that is entered that indicates the number of adverse events represented by the report. It does not include the time needed to evaluate and investigate complaints that may represent reportable malfunction events.

    (Comment 23) Two comments suggested that FDA should provide clarity on how the program will apply with national competent authorities via the National Competent Authority Report (NCAR) exchange program.

    (Response 23) FDA disagrees with this comment. The NCAR exchange program is separate from FDA's MDR reporting requirements. Malfunction summary reporting under this program does not change the information shared through the NCAR exchange program, and the NCAR program is currently outside the scope of the Voluntary Malfunction Summary Reporting Program.

    (Comment 24) One comment suggests that FDA should use IBM's Watson Platform for Health GxP (Watson) to conduct an analysis to identify the product codes that represent the largest opportunity described in the business case for patients, industry, and FDA instead of other database systems.

    (Response 24) FDA disagrees with this comment. Among other reasons, the IBM Watson Platform is not an FDA-owned resource; therefore, it is not logistically feasible for FDA to use this platform to identify product codes eligible for the Voluntary Malfunction Summary Reporting Program at this time.

    III. Principles for Malfunction Summary Reporting

    Informed by the findings from the Pilot Program for Medical Device Reporting on Malfunctions, FDA identified the following overarching principles for summary reporting of malfunctions:

    • The collection of information in summary format should allow FDA to collect sufficient detail to understand reportable malfunction events.

    • To increase efficiency, summary malfunction reporting should occur in a common format for the electronic reporting system used.

    • Information about reportable malfunctions should be transparent to FDA and to the public, regardless of whether the information is reported as an individual MDR or a summary report. Information contained in a summary malfunction report that is protected from public disclosure under applicable disclosure laws would be redacted prior to release of the report.

    • Manufacturers should communicate information regarding an imminent hazard at the earliest time possible.

    • Summary reporting is meant to streamline the process of reporting malfunctions. It does not change regulatory requirements for MDR-related investigations or recordkeeping by manufacturers. (For example, manufacturers participating in the Voluntary Malfunction Summary Reporting Program remain subject to requirements for establishing and maintaining MDR event files under § 803.18. In addition, under the QS regulation, manufacturers must evaluate, review, and investigate any complaint that represents an MDR reportable event (see § 820.198).

    • Summary reporting information should not be duplicative of information received through other MDR reporting processes.

    IV. Voluntary Malfunction Summary Reporting Program

    For the reasons discussed in the 2017 Proposal and in section II, the Agency has determined that, at this time, pursuant to section 519(a)(1)(B)(i)(III) of the FD&C Act, all devices should remain subject to the reporting requirements of part 803, to protect the public health. However, based on the findings from the 2015 Pilot Program, the Agency's experience with summary reporting programs, its experience with MDR reporting generally, and the comments received on 2017 Proposal, FDA has determined that for many devices, it is appropriate to permit manufacturers to submit malfunction summary reports on a quarterly basis, for certain malfunctions, instead of individual, 30-day malfunction reports.

    Therefore, under § 803.19, FDA is granting the manufacturers of devices within eligible product codes, as identified in FDA's Product Classification Database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm) on August 17, 2018, an alternative to the reporting requirements at §§ 803.10(c)(1), 803.20(b)(3)(ii), 803.50(a)(2), 803.52, and 803.56 with respect to reportable malfunction events associated with those devices. The list reflects FDA's consideration of a list proposed by industry representatives, consistent with the MDUFA IV Commitment Letter, as well as the comments received on the 2017 Proposal regarding eligible product codes. To assist manufacturers and the public in identifying which product codes are eligible for participation in this voluntary program, FDA's searchable Product Classification Database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm) has been updated to reflect such eligibility. As discussed in section II, FDA is also making some changes to the conditions of the alternative after considering the comments received on the 2017 Proposal.

    The alternative permits manufacturers of devices within eligible product codes to submit malfunction reports in summary format on a quarterly basis for those devices, subject to the conditions of the alternative described in the remainder of this section. Such manufacturers “self-elect” to participate by submitting summary malfunction reports in accordance with the conditions of the alternative. They do not need to submit a separate application to FDA to participate.1

    1 We note that the Voluntary Malfunction Summary Reporting Program does not apply to importers or device user facilities. Therefore, requirements under part 803 for importers and device user facilities are unaffected by this alternative. For example, importers will continue to submit individual MDRs to the manufacturer under § 803.40.

    The remainder of this section describes the following conditions that manufacturers must follow if they choose to submit summary malfunction reports for devices within eligible product codes under the alternative: (1) The conditions under which individual malfunction reports are required; (2) submission of supplemental reports; (3) the format for summary malfunction reports; (4) considerations for combination products; and (5) the schedule and other logistics for submission of summary reports. Because this is an alternative, if a manufacturer does not submit summary reports for reportable malfunction events in accordance with the conditions described in this section, including the reporting schedule and format, then the manufacturer must submit individual malfunction reports in compliance with all requirements under part 803 (unless the manufacturer has been granted a different exemption, variance, or alternative that applies).

    A. Events Outside the Scope of This Alternative

    The Voluntary Malfunction Summary Reporting Program does not apply to reportable death or serious injury events, which are still required to be reported to FDA within the mandatory 30-calendar-day timeframe, under §§  803.50 and 803.52, or within the 5-work day timeframe under §  803.53. Thus, if a manufacturer participating in the program becomes aware of information reasonably suggesting that a device that it markets may have caused or contributed to a death or serious injury, then the manufacturer must submit an individual MDR for that event because it involves a reportable death or serious injury.

    The reporting requirements at § 803.53 also continue to apply to manufacturers participating in the program. Under § 803.53(a), a 5-day report must be filed if a manufacturer becomes aware of an MDR reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. Further, under § 803.53(b), if FDA has made a written request for the submission of a 5-day report, the manufacturer must submit, without further requests, a 5-day report for all subsequent reportable malfunctions of the same nature that involve substantially similar devices for the time period specified in the written request. FDA may extend the time period stated in the original written request if the Agency determines it is in the interest of the public health (see § 803.53(b)).

    B. Individual Reporting Conditions

    Manufacturers of devices in eligible product codes may continue submitting individual, 30-day malfunction reports in compliance with §§ 803.50 and 803.52 if they choose to do so. However, those manufacturers may submit all reportable malfunction events for devices in eligible product codes in the summary format and according to the schedule described below in section IV.D and F, unless one of the following individual reporting conditions applies:

    1. A Reportable Malfunction Is Associated With a 5-Day Report

    After submitting a 5-day report required under § 803.53(a), all subsequent reportable malfunctions of the same nature that involve substantially similar devices must be submitted as individual MDRs in compliance with §§ 803.50 and 803.52 until the date that the remedial action has been terminated to FDA's satisfaction. Summary reporting of malfunctions may then resume on the regularly scheduled summary reporting cycle. Submission of reportable malfunctions associated with 5-day reports in this manner will assist FDA in monitoring the time course and resolution of the issue presenting an unreasonable risk of substantial harm to the public health.

    2. A Reportable Malfunction Is the Subject of Certain Device Recalls

    When a device is the subject of a recall involving the correction or removal of the device to address a malfunction and that correction or removal is required to be reported to FDA under part 806,2 all reportable malfunction events of the same nature that involve the same device or a similar device marketed by the manufacturer must be submitted as individual MDRs in accordance with §§ 803.50 and 803.52 until the date that the recall is terminated. After the recall is terminated, summary reporting may resume on the regularly scheduled summary reporting cycle. The requirement to submit individual reports under this condition is triggered on the date that the manufacturer submits a report of a correction or removal required under part 806 (or the date that the manufacturer submits a report of the correction or removal under part 803 or part 1004 instead, as permitted under § 806.10(f)). This will allow FDA to monitor the frequency of reportable malfunctions associated with the recall and effectiveness of the recall strategy.

    2 FDA regulations provide that “[e]ach device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated: (1) To reduce a risk to health posed by the device or (2) to remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as set forth in paragraph (f) of this section or the corrective or removal action is exempt from the reporting requirements under § 806.1(b).” We note that under part 806, manufacturers and importers are not required to report a correction or removal that meets the definition of a class III recall under 21 CFR part 7. (See 21 CFR 7.3(g) and (m), 806.2(d) and (j) through (k), and 806.10; see also 62 FR 27183 at 27184.)

    If a manufacturer becomes aware of reportable malfunction events before the date that the requirement to submit individual reports is triggered and a summary report for those events has not yet been submitted to FDA, then the manufacturer must submit any of those malfunction events related to the recall in a summary MDR format within 30 calendar days of submitting the required report of correction or removal. In the summary MDR, the manufacturer must include a check box of recall in section H.7 of the electronic Form FDA 3500A.

    3. FDA Has Determined That Individual MDR Reporting Is Necessary To Address a Public Health Issue

    If FDA has determined that individual malfunction reports are necessary to provide additional information and more rapid reporting for an identified public health issue involving certain devices, manufacturers must submit reportable malfunction events for those devices as individual MDRs in compliance with §§ 803.50 and 803.52. Under these circumstances, FDA will provide written notification to manufacturers of relevant devices that individual MDR submissions are necessary. FDA will provide further written notice when manufacturers of those devices may resume participation in summary malfunction reporting.

    The requirement to submit individual reports under this condition is triggered on the date the manufacturer receives the written notification from FDA. If a manufacturer became aware of reportable malfunction events before the date that the requirement to submit individual reports is triggered and a summary report for those events has not yet been submitted to FDA, then the manufacturer must submit any of those malfunction events for the identified devices to FDA within 30 calendar days of receiving notification from FDA.

    4. FDA Has Determined That a Device Manufacturer May Not Report in Summary Reporting Format

    FDA may determine that a specific manufacturer is no longer allowed to participate in the Voluntary Malfunction Summary Reporting Program for reasons including, but not limited to, failure to comply with applicable MDR requirements under part 803, failure to follow the conditions of the program, or the need to monitor a public health issue. In that case, FDA will provide written notification to the device manufacturer to submit individual malfunction reports in compliance with §§ 803.50 and 803.52. The requirement to submit individual reports under this condition is triggered on the date the manufacturer receives the written notification from FDA. If a manufacturer became aware of reportable malfunction events before the date that the requirement to submit individual reports is triggered under this condition and a summary report for those events has not yet been submitted to FDA, then the manufacturer must submit those malfunction events within 30 calendar days of receiving notification from FDA.

    5. A New Type of Reportable Malfunction Occurs for a Device

    If a manufacturer becomes aware of information reasonably suggesting a reportable malfunction event has occurred for a device that the manufacturer markets and the reportable malfunction is a new type of malfunction that the manufacturer has not previously reported to FDA for that device, then the manufacturer must submit an individual report for that reportable malfunction in compliance with §§ 803.50 and 803.52. After the manufacturer submits this initial individual report, subsequent malfunctions of this type may be submitted in summary form according to the reporting schedule in table 1, unless another individual reporting condition applies.

    C. Supplemental Reports

    In general, if a manufacturer obtains information required in a malfunction summary report (see section IV.D. describing the required content of a summary report), that the manufacturer did not provide because it was not known or was not available when the manufacturer submitted the initial summary malfunction report, the manufacturer must submit the supplemental information to FDA in an electronic format in accordance with § 803.12(a). The supplemental information must be submitted to FDA by the submission deadline described in the Summary Malfunction Reporting Schedule (table 1), according to the date on which the manufacturer becomes aware of the supplemental information. Manufacturers must continue to follow the requirements for the content of supplemental reports set forth at § 803.56(a) thorough (c), meaning that on a supplemental or follow up report, the manufacturer must: (a) Indicate that the report being submitted is a supplemental or follow up report; (b) submit the appropriate identification numbers of the report that you are updating with the supplemental information (e.g., your original manufacturer report number and the user facility or importer report number of any report on which your report was based), if applicable; and (c) include only the new, changed, or corrected information.

    However, if a manufacturer submits a summary malfunction report and subsequently becomes aware of information reasonably suggesting that an event (or events) summarized therein represents a reportable serious injury or death event, or a new type of reportable malfunction, then the manufacturer must submit reports as follows: The manufacturer must submit an initial, individual MDR for the identified serious injury, death, or new type of reportable malfunction event within 30 calendar days of becoming aware of the additional information. The manufacturer must simultaneously submit a supplement to the initial malfunction summary report reducing the number of events summarized accordingly, so that the total number of events remains the same.

    D. Malfunction Reporting Summary Format

    Manufacturers of devices in eligible product codes who elect to participate in the Voluntary Malfunction Summary Reporting Program must submit summary malfunction reports in the format described below. As detailed in the 2017 Proposal and Appendix, the format largely adopts the format that was tested in FDA's Pilot Program for Medical Device Reporting on Malfunctions and is compatible with the Form FDA 3500A (Ref. 9), which allows manufacturers to submit MDRs using the same electronic submission form that they use to submit individual MDRs, in accordance with the eMDR Final Rule (79 FR 8832, February 14, 2014). Because summary malfunction reports represent a grouping of malfunction events for a specific model of a device, the summary reporting format would require an additional element in the summary text narrative to identify the number of reportable malfunctions that each report represents. As described below, the XML tags “<NOE>” and “<NOE/>” are placed on both sides of the number of events (NOE) to make the number extractable from the report. FDA believes that submission of summary reports in the format described below will provide the most compact and efficient reporting mechanism for streamlining malfunction reporting that still provides sufficient detail for FDA to monitor devices effectively.

    Format Instructions: Separate summary malfunction reports must be submitted for each unique combination of brand name, device model, and problem code(s). (See Appendix A for case examples of how to report (Ref. 6).) Each summary malfunction report must include at least the following information collected on Form FDA 3500A and must be submitted in an electronic format:

    • SECTION B.5: Describe Event or Problem—To distinguish this report as a summary malfunction report, the first sentence of the device event narrative must read: “This report summarizes <NOE> XXX </NOE> malfunction events,” where XXX is replaced by the number of malfunction events being summarized.

    The device event narrative must then include a detailed description of the nature of the events and, if relevant and available, we recommend including a range of patient age and weight and a breakdown of patient gender, race, and ethnicity.

    • SECTION D.1: Brand Name.

    • SECTION D.2 and D.2.b: Common Device Name and Product Code. Include the common name of the device and Product Classification Code (Procode).

    • SECTION D.3: Manufacturer Name, City, and State.

    • SECTION D.4: Device Identification—Enter the model and/or catalog number and lot number(s) and/or serial number(s) for the devices that are the subject of the MDR. Include any device identifier (DI) portion of the unique device identifier (UDI) for the device version or model that is the subject of the MDR.

    • SECTION G.1: Contact Office (and Manufacturing Site(s) for Devices)—Enter the name, address, and email of the manufacturer reporting site (contact office), including the contact name for the summary report being submitted. Enter the name and address of the manufacturing site(s) for the device, if different from the contact office.

    • SECTION G.2: Phone Number of Contact Office.

    • SECTION G.5: Combination Products—If applicable, indicate that the report involves a combination product (see section IV.E.).

    • SECTION H.1: Type of Reportable Event—Check “Malfunction” in this box.

    • SECTION H.6: Event Problem and Evaluation Codes—

    ○ Enter the device problem code(s). (See Appendix A for case examples of how to report (Ref. 6).)

    ○ Enter the evaluation code(s) for the following categories: Method, Results, Conclusion.

    ○ Enter a Conclusion Code, even if the device was not evaluated.

    • SECTION H.10: Additional Manufacturer Narrative—Provide a summary of the results of the investigation for the reported malfunctions, including any follow up actions taken, and any additional information that would be helpful in understanding how the manufacturer addressed the malfunction events summarized in the report. Enter a breakdown of the malfunction events summarized in the report, including the number of devices that were returned, the number of devices that were labeled “for single use” (if any), and the number of devices that were reprocessed and reused (if any).

    E. Combination Product Considerations

    As noted in the response to comment 17 above, device-led combination products are included in this alternative that we are granting under § 803.19 to permit voluntary malfunction summary reporting. The eMDR data system and instructions support use of the Voluntary Malfunction Summary Reporting Program for device-led combination products. However, as discussed in response to comment 17 above, additional considerations need to be addressed before drug and biologic-led combination products could be included in the Voluntary Malfunction Summary Reporting Program. As noted in Response 17, the Agency intends to delay enforcement of the malfunction reporting requirements for drug and biologic-led combination products under the PMSR final rule. FDA will consider the relevant comments received on the 2017 Proposal, as well as any additional, relevant comments relating to malfunction reporting for drug and biologic-led combination products submitted in relation to the PMSR draft guidance in developing an approach for voluntary malfunction summary reporting for such combination products.

    F. Submission Schedule and Logistics

    Manufacturers submitting malfunction summary reports or supplemental reports to a malfunction summary report must use electronic reporting (Ref. 10) to submit those reports on a quarterly basis according to the schedule in table 1. The summary malfunction report must include the MDR Number, which consists of the registration number of the manufacturer, the year in which the event is being reported, and a 5-digit sequence number. Information included in a malfunction summary report must be current as of the last date of the quarterly timeframe identified in the first column of table 1.

    Table 1—Summary Malfunction Reporting Schedule Reportable malfunctions or supplemental information that you become aware of during these timeframes: Must be submitted to FDA by: January 1-March 31 April 30. April 1-June 30 July 31. July 1-September 30 October 31. October 1-December 31 January 31.

    The Voluntary Malfunction Summary Reporting Program applies only to reportable malfunction events that manufacturers become aware of on or after August 17, 2018. The deadline for FDA accepting the first round of quarterly reports for this program is October 31, 2018.

    Under §§ 803.17 and 803.18, manufacturers are required to develop, maintain, and implement written MDR procedures and establish and maintain MDR event files, and those requirements remain applicable for manufacturers that elect to participate in this program. Among other things, a manufacturer must develop, maintain, and implement MDR procedures that provide for timely transmission of complete MDRs to FDA. (See § 803.17(a)(3)). Manufacturers participating in the Voluntary Malfunction Summary Reporting Program will need to update their internal MDR processes and procedures to provide for submitting summary malfunction reports within the Summary Malfunction Reporting Schedule.

    V. Implementation Strategy

    The goal of the Voluntary Malfunction Summary Reporting Program is to permit manufacturers of devices under certain product codes to report malfunctions on a quarterly basis and in a summary format, as outlined in the MDUFA IV Commitment Letter (Ref. 1), in a manner that provides for effective monitoring of devices and is beneficial for FDA, industry, and the public. An important part of this voluntary program is providing clarification to manufacturers regarding the product codes eligible for the program.

    Consistent with the MDUFA IV Commitment Letter (Ref. 1), FDA has identified eligible product codes for the Voluntary Malfunction Summary Reporting Program in FDA's Product Classification Database, available on FDA's website, as part of granting the alternative (see https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm). Manufacturers that choose to participate in quarterly, summary reporting through this program will remain responsible for complying with applicable MDR requirements under part 803 (e.g., requirements to establish and maintain MDR event files under § 803.18) and QS requirements under part 820 (21 CFR part 820) (e.g., the requirement to evaluate, review, and investigate any complaint that represents an MDR reportable event under § 820.198).

    If FDA determines that individual malfunction reports are necessary from a specific manufacturer or for specific devices, FDA will notify relevant manufacturers that they must submit individual reports and provide an explanation for that decision and, as appropriate, the steps necessary to return to summary, quarterly reporting. The Agency also notes that, under § 803.19(d), it may revoke or modify in writing an exemption, variance, or alternative reporting requirement if it determines that revocation or modification is necessary to protect the public health.

    VI. Updating Product Codes for Inclusion Into the Program

    FDA recognizes that new product codes will be created after the date of granting the Voluntary Malfunction Summary Reporting Program alternative under § 803.19. In general, FDA does not intend to consider devices under product codes in existence for less than 2 years to be eligible for the program, unless the new product code was issued solely for administrative reasons. Any product code in existence after the publication date will be initially ineligible to participate in the program. However, FDA will periodically evaluate new product codes after they have been in existence for 2 years to determine whether they should be added to the list of product codes eligible for the Voluntary Malfunction Summary Reporting Program. If FDA determines that a new product code should be added, then it will grant manufacturers of devices within that product code the same alternative under § 803.19 for malfunction events associated with those devices and update FDA's Product Classification database accordingly to reflect the changes.

    Manufacturers can send a request for a product code to be added to the list of eligible product codes and for manufacturers of devices within that product code to be granted the same alternative for malfunction events associated with those devices to the [email protected] mailbox. You may also mail your written request to MDR Policy Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3217, Silver Spring, MD 20993-0002.

    VII. Conclusion

    In accordance with section 519(a)(1)(B)(i) of the FD&C Act and § 803.19, FDA is granting the alternative described in section IV to manufacturers of devices in eligible product codes, as identified in the FDA Product Classification Database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm) on August 17, 2018. FDA believes that for the devices in eligible product codes, quarterly, summary reporting in accordance with the conditions of the alternative will be as effective as the current MDR regulatory requirements for purposes of identifying and monitoring potential device safety concerns and device malfunctions. The Voluntary Malfunction Summary Reporting Program will allow manufacturers to submit summary reports with event narratives that will help FDA more efficiently process malfunction reports and identify malfunction trends. In addition, FDA's determination of product code eligibility and the conditions of participation in the program will require submission of individual 30-day or 5-day malfunction reports in circumstances where such reports are necessary to protect public health.

    VIII. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    IX. Paperwork Reduction Act of 1995

    The Voluntary Malfunction Summary Reporting Program described in this Notice contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). These provisions have been approved under OMB control number 0910-0437.

    This document also refers to previously approved collections of information. These collections of information are subject to review by the OMB under the PRA (44 U.S.C. 3501-3520). The collections of information in part 4, subpart B, regarding postmarketing safety reporting for combination products have been approved under OMB control number 0910-0834; the collections of information in part 803, regarding medical device reporting, have been approved under OMB control number 0910-0437; the collections of information in 806, regarding corrections and removals, have been approved under OMB control number 0910-0359; the collections of information in 21 CFR part 807, subpart E, regarding premarket notification, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 810, regarding medical device recall authority, have been approved under OMB control number 0910-0432; the collections of information in part 820, regarding quality system regulations, have been approved under OMB control number 0910-0073; the collections of information in 21 CFR parts 1002 through 1050, regarding radiological health, have been approved under OMB control number 0910-0025; the collections of information regarding the MedWatch: The Food and Drug Administration Medical Products Reporting Program have been approved under OMB control number 0910-0291; and the collections of information regarding the Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)) have been approved under OMB control number 0910-0471.

    X. References

    The following references are on display in the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

    1. Medical Device User Fee Agreement IV Commitment Letter, available at https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM535548.pdf. 2. Food and Drug Administration, “Medical Device Reporting—Alternative Summary Reporting (ASR) Program; Guidance for Industry,” (October 19, 2000); available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072102.pdf. 3. Food and Drug Administration, “Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff,” (November 8, 2016); available at https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm359566.pdf. 4. Food and Drug Administration, “Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and Food and Drug Administration Staff,” (May 17, 2013); available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284670.pdf. 5. Food and Drug Administration, “International Medical Device Regulators Forum,” available at https://www.fda.gov/MedicalDevices/InternationalPrograms/IMDRF/default.htm. 6. Appendix A, “Case Examples of Summary Malfunction Reporting,” available in Docket No. FDA-2017-N-6730. 7. Food and Drug Administration, “Postmarketing Safety Reporting for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff,” (March 2018); available at https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM601454.pdf. 8. Food and Drug Administration, “Compliance Policy for Combination Product Postmarketing Safety Reporting, Immediately in Effect Guidance for Industry and Food and Drug Administration Staff,” available at https://www.fda.gov/RegulatoryInformation/Guidances/ucm601456.htm. 9. Food and Drug Administration, Form FDA 3500A, available at https://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm048334.pdf. 5. 10. Electronic Medical Device Reporting (eMDR) (manufacturers may obtain information on how to prepare and submit reports in an electronic format that FDA can process, review, and archive), available at: https://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm. Dated: August 13, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-17770 Filed 8-16-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2018-0775] Drawbridge Operation Regulation; Columbia River, Portland, OR and Vancouver, WA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Interstate 5 (I-5) Bridges across the Columbia River, mile 106.5, between Portland, Oregon, and Vancouver, Washington. The deviation is necessary to facilitate the presence of participants in the Hands Across the Bridge Project. This deviation allows the bridges to remain in the closed-to-navigation position during the event.

    DATES:

    This deviation is effective from 11 a.m. to 2 p.m. on September 3, 2018.

    ADDRESSES:

    The docket for this deviation, USCG-2018-0775 is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Oregon Department of Transportation (bridge owner) requested a temporary deviation from the operating schedule for the I-5 Bridges, mile 106.5, across the Columbia River between Vancouver, WA, and Portland, OR, to facilitate safe passage of participants in the Hands Across the Bridge Project. The I-5 Bridges provides three designated navigation channels with vertical clearances ranging from 39 to 72 feet above Columbia River Datum 0.0 while the lift spans are in the closed-to-navigation position. The normal operating schedule for the I-5 Bridges is 33 CFR 117.869. The subject bridges need not open to marine vessels during the deviation period from 11 a.m. to 2 p.m. on September 3, 2018. The bridge shall operate in accordance with 33 CFR 117.869 at all other times. Waterway usage on this part of the Columbia River includes vessels ranging from large commercial ships, tug and tow vessels to recreational pleasure craft.

    Vessels able to pass under the bridges in the closed-to-navigation positions may do so at any time. Both bridges will be able to open for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

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

    Dated: August 9, 2018. Steven M. Fischer, Bridge Administrator, Thirteenth Coast Guard District.
    [FR Doc. 2018-17801 Filed 8-16-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2018-0676] Drawbridge Operation Regulation; Willamette River at Portland, OR AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation; modification.

    SUMMARY:

    The Coast Guard has modified a temporary deviation from the operating schedule that governs the Hawthorne Bridge crosses the Willamette River, mile 13.1, at Portland, OR. The deviation is necessary to accommodate a filming event for a movie. This modified deviation changes the period the bridge is authorized to remain in the closed-to-navigation position.

    DATES:

    This modified deviation is effective from 6 p.m. on September 8, 2018, to 12:01 a.m. on September 9, 2018.

    ADDRESSES:

    The docket for this deviation, USCG-2018-0676 is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this modification, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email [email protected]

    SUPPLEMENTARY INFORMATION:

    On July 19, 2018, we published a temporary deviation entitled “Drawbridge Operation Regulation; Willamette River at Portland, OR” in the Federal Register (83 FR 34041). That temporary deviation allowed the subject bridge to not open to marine vessels from 6 p.m. on September 1, 2018 to 12:01 a.m. on September 2, 2018. Multnomah County, the bridge owner, requested a modification of the current published deviation to the following times: 6 p.m. on September 8, 2018, to 12:01 a.m. on September 9, 2018. This change is due to scheduling issues with the filming crew for a movie.

    The Hawthorne Bridge provides a vertical clearance of 49 feet in the closed-to-navigation position referenced to the vertical clearance above Columbia River Datum 0.0. The subject bridge operates per 33 CFR 117.897(c)(3)(v). Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. The Coast Guard requested objections to this modification from local mariners via email. No objections were submitted to us. Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft.

    Vessels able to pass through the bridge in the closed-to-navigation position may do so at any time. The bridge will be able to open for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard will inform the users of the waterway, through our Local and Broadcast Notices to Mariners, of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

    Dated: August 9, 2018. Steven M. Fischer, Bridge Administrator, Thirteenth Coast Guard District.
    [FR Doc. 2018-17800 Filed 8-16-18; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA-HQ-OPPT-2017-0414; FRL-9971-37] RIN 2070-AB27 Significant New Use Rules on Certain Chemical Substances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Direct final rule.

    SUMMARY:

    EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 27 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to Orders issued by EPA pursuant to section 5(e) of TSCA. This action requires persons who intend to manufacture (defined by statute to include import) or process any of these 27 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.

    DATES:

    This rule is effective on October 16, 2018. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on August 31, 2018.

    Written adverse comments on one or more of these SNURs must be received on or before September 17, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments on one or more of these SNURs before September 17, 2018, EPA will withdraw the relevant sections of this direct final rule before its effective date.

    For additional information on related reporting requirement dates, see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2017-0414, by one of the following methods:

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

    Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

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

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: [email protected]

    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]

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

    You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

    This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after September 17, 2018 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

    B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

    II. Background A. What action is the Agency taking?

    1. Direct Final Rule. EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices obligates EPA to assess risks that may be associated with the significant new uses under the conditions of use and, if appropriate, to regulate the proposed uses before they occur.

    2. Proposed Rule. In addition to this Direct Final Rule, elsewhere in this issue of the Federal Register, EPA is issuing a Notice of Proposed Rulemaking for this rule. If EPA receives no adverse comment, the Agency will not take further action on the proposed rule and the direct final rule will become effective as provided in this action. If EPA receives adverse comment on one or more of SNURs in this action by September 17, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION), the Agency will publish in the Federal Register a timely withdrawal of the specific SNURs that the adverse comments pertain to, informing the public that the actions will not take effect. EPA would then address all adverse public comments in a response to comments document in a subsequent final rule, based on the proposed rule.

    B. What is the Agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A.

    C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register, a statement of EPA's findings.

    III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

    • The projected volume of manufacturing and processing of a chemical substance.

    • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

    • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

    • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

    In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.

    To determine what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.

    IV. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping requirements for 27 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

    • PMN number.

    • Chemical name (generic name, if the specific name is claimed as CBI).

    • Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).

    • Basis for the TSCA section 5(e) Order.

    • Information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.

    This information may include testing required in a TSCA section 5(e) Order to be conducted by the PMN submitter, as well as testing not required to be conducted but which would also help characterize the potential health and/or environmental effects of the PMN substance. Any recommendation for information identified by EPA was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the chemical substance. Further, any such testing identified by EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models. EPA also recognizes that whether testing/further information is needed will depend on the specific exposure and use scenario in the SNUN. EPA encourages all SNUN submitters to contact EPA to discuss any potential future testing. See Unit VIII. for more information.

    • CFR citation assigned in the regulatory text section of this rule.

    The regulatory text section of each rule specifies the activities designated as significant new uses. Certain new uses, including exceedance of production volume limits (i.e., limits on manufacture volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.

    These rules include 27 PMN substances that are subject to Orders issued under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that it has insufficient information to conduct a reasoned evaluation and the activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).

    Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) Order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) Orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. EPA expects that persons whose § 721.30 requests to use the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) Order for the same chemical substance.

    PMN Numbers: P-12-277, P-12-278, P-12-280, P-12-281, P-12-282, P-12-283, and P-12-284

    Chemical names: Alkanes, C20-28, chloro (P-12-277), Slack waxes (petroleum), chloro (P-12-278), Hexacosane, chloro derivs. and octacosane, chloro derivs. (P-12-280), Alkanes, C20-24, chloro (P-12-281), Alkanes, C14-16, chloro (P-12-282), Tetradecane, chloro derivs. (P-12-283), and Octadecane, chloro derivs. (P-12-284).

    CAS numbers: 2097144-43-7 (P-12-277), 2097144-44-8 (P-12-278), 2097144-46-0 and 2097144-47-1 (P-12-280), 2097144-45-9 (P-12-281), 1372804-76-6 (P-12-282), 198840-65-2 (P-12-283), 2097144-48-2 (P-12-284).

    Effective date of TSCA section 5(e) Order: June 5, 2017.

    Basis for TSCA section 5(e) Order: The PMNs state that the PMN substances will be used as flame retardants and plasticizers in polyvinyl chloride (PVC), polymers, and rubber; flame retardants, plasticizers, and lubricants in adhesives, caulk, sealants, and coatings; additives in lubricants including metalworking fluids; and flame retardants and waterproofers in textiles. Based on the physical/chemical properties of the PMN substances (as described in the New Chemical Program's PBT category at 64 FR 60194; November 4, 1999; FRL-6097-7) and test data on structurally similar medium-chain chlorinated paraffins (MCCP), the PMN substances are a potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN substances will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on data on MCCP, EPA has identified concerns for systemic toxicity as well as aquatic and terrestrial toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substances may present an unreasonable risk of injury to health or the environment. To protect against these risks, the Order requires:

    1. Submission of certain toxicity testing on the representative congener groups prior to exceeding a certain time period specified in the Order.

    2. Use of the PMN substances only for the uses specified in the Order: Flame retardants and plasticizers in PVC, polymers, and rubber; flame retardants, plasticizers, and lubricants in adhesives, caulk, sealants, and coatings; additives in lubricants including metalworking fluids; and flame retardants and waterproofers in textiles.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the fate, and terrestrial and aquatic toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed a certain time limit without performing chronic aquatic and terrestrial toxicity and biodegradation testing.

    CFR citations: 40 CFR 721.11068 (P-12-277), 40 CFR 721.11069 (P-12-278), 40 CFR 721.11070 (P-12-280), 40 CFR 721.11071 (P-12-281), 40 CFR 721.11072 (P-12-282 and P-14-684), 40 CFR 721.11073 (P-12-283 and P-14-683), and 40 CFR 721.11074 (P-12-284).

    PMN Numbers: P-12-433, P-12-453, and P-12-505

    Chemical names: Alkanes, C18-20, chloro (P-12-433), Alkanes, C14-17, chloro (P-12-453) and Alkanes, C22-30, chloro (P-12-505).

    CAS numbers: 106262-85-3 (P-12-433), 85535-85-9 (P-12-453) and 288260-42-4 (P-12-505).

    Effective date of TSCA section 5(e) Order: June 5, 2017.

    Basis for TSCA section 5(e) Order: The PMN states that the PMN substances will be used as flame retardants and plasticizers in PVC, polymers, and rubber; flame retardants, plasticizers, and lubricants in adhesives, caulk, sealants, and coatings; additives in lubricants including metalworking fluids; and flame retardants and waterproofers in textiles. Based on the physical/chemical properties of the PMN substances (as described in the New Chemical Program's PBT category at 64 FR 60194; November 4, 1999; FRL-6097-7) and test data on structurally similar medium-chain chlorinated paraffins (MCCP), the PMN substances are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN substances will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on test data on MCCP EPA has identified concerns for systemic toxicity as well as aquatic and terrestrial toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substances may present an unreasonable risk of injury to health or the environment. To protect against these risks, the Order requires:

    1. Submission of certain toxicity testing on the representative congener groups prior to exceeding a certain time period specified in the Order.

    2. Use of the PMN substances only for the uses specified in the Order: Flame retardants and plasticizers in PVC, polymers, and rubber; flame retardants, plasticizers, and lubricants in adhesives, caulk, sealants, and coatings; additives in lubricants including metalworking fluids; and flame retardants and waterproofers in textiles.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the fate, and terrestrial and aquatic toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed a certain time limit without performing chronic aquatic and terrestrial toxicity and biodegradation testing.

    CFR citations: 40 CFR 721.11075 (P-12-433), 40 CFR 721.11076 (P-12-453), 40 CFR 721.11077 (P-12-505).

    PMN Numbers: P-14-683 and P-14-684

    Chemical names: Tetradecane, chloro derivs. (P-14-683) and Alkanes, C14-16, chloro (P-14-684).

    CAS numbers: 198840-65-2 (P-14-683) and 1372804-76-6 (P-14-684).

    Effective date of TSCA section 5(e) Order: May 17, 2017.

    Basis for TSCA section 5(e) Order: The PMNs state that the substances will be used as flame retardants and plasticizers in PVC, polymers, and rubber; flame retardants, plasticizers, and lubricants in adhesives, caulk, sealants, and coatings; additives in lubricants including metalworking fluids; and flame retardants and waterproofers in textiles. Based on the physical/chemical properties of the PMN substances (as described in the New Chemical Program's PBT category at 64 FR 60194; November 4, 1999; FRL-6097-7) and test data on structurally similar medium-chain chlorinated paraffins (MCCP), the PMN substances are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN substances will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Further, EPA has identified concerns for systemic toxicity, as well as aquatic and terrestrial toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substances may present an unreasonable risk of injury to health or the environment. To protect against these risks, the Order requires:

    1. Submission of certain toxicity testing on the representative congener groups prior to exceeding a certain time period specified in the Order.

    2. Use of the PMN substances only for the uses specified in the Order: Flame retardants and plasticizers in PVC, polymers, and rubber; flame retardants, plasticizers, and lubricants in adhesives, caulk, sealants, and coatings; additives in lubricants including metalworking fluids; and flame retardants and waterproofers in textiles.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the fate, and terrestrial and aquatic toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed a certain time limit without performing chronic aquatic and terrestrial toxicity and biodegradation testing.

    CFR citations: 40 CFR 721.11072 (P-12-282 and P-14-684), 40 CFR 721.11073 (P-12-283 and P-14-683).

    PMN Number: P-16-150

    Chemical name: Chloroflurocarbon (generic).

    CAS number: Not available.

    Effective date of TSCA section 5(e) Order: May 31, 2017.

    Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as an intermediate. Based on test data on the PMN substance, EPA identified concerns for acute human toxicity. Based on analogue data EPA identified concerns for toxicity to aquatic and terrestrial organisms. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I), 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to health and the environment and that the substance will be produced in substantial quantities and may be reasonably anticipated to enter the environment in substantial quantities. To protect against these risks, the Order requires:

    1. Submission of certain toxicity testing on the substance prior to exceeding the production limits specified in the Order.

    2. Use of personal protective equipment to prevent dermal exposure (where there is a potential for dermal exposure).

    3. Use of a National Institute of Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 1000 (where there is a potential for inhalation exposure) in conjunction with a minimum set of engineering controls described in the PMN, or compliance with a new chemical exposure limit (NCEL) of 170 parts per billion (ppb) as an 8-hour time-weighted average to prevent inhalation exposure.

    4. Use of engineering controls to limit worker exposure and air release of the PMN substance to the environment.

    5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the Safety Data Sheet (SDS).

    6. Manufacture, processing, and use in an enclosed process.

    7. Use only as a chemical intermediate.

    8. No release of the substance resulting in surface water concentrations that exceed 240 ppb.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the human health and aquatic toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the confidential production limit without performing specific target organ toxicity testing, reproductive and developmental toxicity testing, and acute and chronic aquatic toxicity testing.

    CFR citation: 40 CFR 721.11078.

    PMN Number: P-16-379

    Chemical name: Silane, 1,1′-(1,2-ethanediyl)bis[1,1-dichloro-1-methyl]-, hydrolysis products with chloroethenyldimethylsilane.

    CAS number: 1485477-78-8.

    Effective date of TSCA section 5(e) Order: June 8, 2017.

    Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance is as a chemical intermediate for polymer synthesis. Based on SAR analysis of test data on analogous substances, EPA has identified concerns for liver toxicity and mutagenicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substances may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:

    1. Submission of certain toxicity testing on the substance prior to exceeding the confidential production volume limit specified in the Order.

    2. Use of personal protective equipment including impervious gloves and clothing which covers any other exposed areas of the arms, legs and torso (where there is a potential for dermal exposure).

    3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

    4. No domestic manufacture of the substance.

    5. Use of the substance only for the confidential uses specified in the Order.

    6. No use involving application methods that generate a dust, mist, vapor, or aerosol.

    7. Disposal of the substance only by water or landfill.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the confidential production limit without performing specific target organ toxicity and mutagenicity testing. In addition, EPA has determined that the results of other specific target organ toxicity testing of the PMN substance may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request.

    CFR citation: 40 CFR 721.11079.

    PMN Number: P-16-410

    Chemical name: Silicophosphonate—sodium silicate (generic).

    CAS number: Not available.

    Effective date of TSCA section 5(e) Order: May 4, 2017.

    Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as an automotive engine fluid additive. Based on test data on the PMN substance, EPA has identified concerns for skin and eye irritation, corrosion, and systemic toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

    1. No domestic manufacture of the substance.

    2. Use of the substance in formulations containing no greater than 0.2% of the chemical substance and for the confidential uses specified in the Order.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the effects of the substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of irritation testing may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request.

    CFR citation: 40 CFR 721.11080.

    PMN Number: P-16-438

    Chemical name: 3-Butenenitrile, 2-(acetyloxy)-.

    CAS number: 15667-63-7.

    Effective date of TSCA section 5(e) Order: June 23, 2017.

    Basis for TSCA section 5(e) Order: The PMN states the substance will be used as a chemical intermediate for a pesticide inert. Based on test data on the PMN substance, EPA identified concerns for acute toxicity, irritation to all tissues, developmental toxicity, and neurotoxicity. EPA identified concerns for aquatic organism toxicity based on submitted data. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to health and the environment. Further, based on SAR analysis of test data on analogous vinyl/allyl esters vinyl/allyl esters nitriles and test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 8 ppb in surface waters. To protect against these risks, the Order requires:

    1. Submission of monitoring data on the substance.

    2. Use of personal protective equipment including impervious gloves and protective clothing (where there is a potential for dermal exposures) and a NIOSH-certified powered air purifying particulate respirator with an Assigned Protection Factor (APF) of at least 1000 (where there is a potential for inhalation exposures).

    3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

    4. Manufacture, process, and use of the substance in a closed system as specified in the PMN.

    5. Use of the substance only as a chemical intermediate.

    6. No release of the substance into the surface waters of the United States.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the aquatic toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of chronic aquatic toxicity testing of the PMN substance may be potentially useful in characterizing the environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and use will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request.

    CFR citation: 40 CFR 721.11081.

    PMN Number: P-16-543

    Chemical name: Halogenophosphoric acid metal salt (generic).

    CAS number: Not available.

    Effective date of TSCA section 5(e) Order: May 24, 2017.

    Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use will be as a battery ingredient. Based on test data on the PMN substance and an analogue, EPA has identified concerns for irritation, corrosion, acute toxicity, immunotoxicity, developmental toxicity, neurotoxicity, and cancer. Further, based on test data on the PMN substance, EPA identified concerns for aquatic organism toxicity at surface water concentrations that exceed 3 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:

    1. Submission of monitoring data as specified in the Order.

    2. Use of personal protective equipment as specified in the Order (where there is a potential for dermal exposure).

    3. Use of a NIOSH-certified respirator with an APF of at least 1000 (where there is a potential for inhalation exposure).

    4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

    5. No domestic manufacture of the substance.

    6. Use of the substance only in an enclosed process.

    7. Use of the substance only for the confidential uses specified in the Order.

    8. Manufacture, process, or use of the substance without the engineering controls required by the Order to control dermal and inhalation exposure.

    9. Disposal of the substance by hazardous waste incineration except when in wastewater.

    10. No release of the substance resulting in surface water concentrations that exceed 3 ppb.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the human health toxicity, human exposure, aquatic toxicity, and fate of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed to conduct an exposure monitoring program for employees who are reasonably likely to be exposed to the PMN substance and a hydrolysis product of the PMN substance. In addition, EPA has determined that the results of specific target organ toxicity, acute aquatic toxicity, and biodegradation testing of the PMN substance may be potentially useful in characterizing the health and environmental effects of the PMN substance. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request.

    CFR citation: 40 CFR 721.11082.

    PMN Number: P-16-596

    Chemical names: Alkenoic acid, reaction products with polyethylene glycol ether with hydroxyalkyl substituted alkane (generic).

    CAS numbers: Not available.

    Effective date of TSCA section 5(e) Order: June 5, 2017.

    Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as a site-limited intermediate used for production of ultraviolet (UV) curable coating resin. Based on SAR analysis on structurally similar substances, EPA has identified concerns for irritation, sensitization, developmental toxicity, liver and kidney effects, and oncogenicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substances may present an unreasonable risk of injury to health and the environment. EPA's estimates indicate that variations of the parameters (including batch size, number of processing sites, days per year of operation) of the uses identified below would not result in inhalation exposure. To protect against these risks, the Order requires:

    1. Submission of test data on the substance prior to exceeding the confidential production volume limit specified in the Order.

    2. Use of personal protective equipment including impervious gloves (where there is a potential for dermal exposure).

    3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

    4. No domestic manufacture of the substance.

    5. Use of the substance only as a site-limited intermediate for the production of UV curable coating resin.

    6. No release of the substance to surface waters of the United States.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of a reproductive/developmental toxicity testing may be potentially useful in characterizing the health effects of the PMN substance. The submitter has agreed not to manufacture beyond a certain production volume limit without performing reproductive/developmental toxicity testing.

    CFR citation: 40 CFR 721.11083.

    PMN Number: P-17-10

    Chemical name: Alkyl substituted alkenoic acid, alkyl ester, polymer with alkyl substituted alkenoate and alkenoic acid, hydroxy substituted[(oxoalkyl)oxy]alkyl ester, reaction products with alkanoic acid, dipentaerythritil and isocyanate substituted carbomonocycle, compds. with alkylamine (generic).

    CAS number: Not available.

    Effective date of TSCA section 5(e) Order: June 31, 2017.

    Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as a UV curable coating resin. Based on test data on structurally similar substances, EPA has identified concerns for irritation, sensitization, developmental effects, internal organ effects (liver and kidney), and cancer. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:

    1. Use of personal protective equipment including impervious gloves to prevent dermal exposure (where there is a potential for dermal exposure).

    2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

    3. No domestic manufacture of the substance.

    4. No manufacture, process, or use of the substance that results in generation of a vapor, mist, or aerosol.

    5. No manufacture of the substance where there is more than 0.1% residual isocyanate by weight.

    6. Use of the substance only as a UV curable coating resin.

    7. Only import the substance in totes.

    8. Manufacture of the substance to have an average molecular weight of greater than 2,000 daltons.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of reproductive/developmental toxicity testing may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and use will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request.

    CFR citation: 40 CFR 721.11084.

    PMN Number: P-17-15

    Chemical name: Heteromonocycle ester with alkanediol (generic).

    CAS numbers: Not available.

    Effective date of TSCA section 5(e) Order: June 13, 2017.

    Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the PMN substance is a precursor for a photochromatic substance. Based on SAR analysis of test data on analogous esters, EPA has identified concerns for irritation to skin, eye, and mucous membrane, and systemic toxicity. Further, based on SAR analysis of test data on analogous nonionic esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 ppb of the PMN substance in surface waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substances may present an unreasonable risk of injury to health and the environment. EPA's estimates indicate that variations of the parameters (including batch size, number of processing sites, days per year of operation of the uses identified below) would not result in inhalation exposure. To protect against these risks, the Order requires:

    1. Submission of certain toxicity testing on the substance prior to exceeding the confidential production volume limit specified in the Order.

    2. Use of personal protective equipment including impervious gloves to prevent dermal exposure (where there is a potential for dermal exposure).

    3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

    4. No domestic manufacture of the substance.

    5. No use of the substance other than other than for the confidential uses identified in the Order.

    6. No release of the substance resulting in surface water concentrations that exceed 3 ppb.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the human health and aquatic toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the confidential production limit without performing reproductive/developmental toxicity and acute aquatic toxicity testing.

    CFR citation: 40 CFR 721.11085.

    PMN Number: P-17-29

    Chemical name: Substituted carbomonocycle, polymer with (aminoalkyl)-alkanediamine, (haloalkyl)oxirane, dialkyl-alkanediamine and alkyl-alkanamine, reaction products with dialkanolamine and [[(alkyl)oxy]alkyl]oxirane (generic).

    CAS number: Not available.

    Effective date of TSCA section 5(e) Order: May 10, 2017.

    Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance is an intermediate prepolymer. Based on the physical/chemical properties of the substance and SAR analysis of test data on analogous aliphatic amines, EPA has identified concerns for irritation, lung effects, and aquatic toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:

    1. Submission of certain toxicity testing on the substance prior to exceeding the confidential production volume limit specified in the Order.

    2. Use of personal protective equipment including impervious gloves to prevent dermal exposure (where there is a potential for dermal exposure).

    3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

    4. No use other than for the confidential uses identified in the Order.

    5. No use involving an application method that generates a vapor, mist, or aerosol.

    6. No domestic manufacture of the substance.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the human health and aquatic toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the confidential production limit without performing irritation and acute aquatic toxicity testing. In addition, EPA has determined that the results of a pulmonary effects testing of the PMN substance may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request.

    CFR citation: 40 CFR 721.11086.

    PMN Numbers: P-17-154, P-17-155, and P-17-156

    Chemical names: Carboxylic acid amine (1:1) (generic) (P-17-154), Mix fatty acids compd. with amine (1:1) (generic) (P-17-155), and Mix fatty acids compd. with amine (1:1) (generic) (P-17-156).

    CAS number: Not available.

    Effective date of TSCA section 5(e) Order: June 15, 2017.

    Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substances is as a coating. Based on physical/chemical properties of the substances and SAR analysis of test data on amines, EPA identified concerns for irritation, corrosion, developmental toxicity, reproductive toxicity, neurotoxicity, and thyroid toxicity. Further, based on test data on analogous anionic surfactants and aliphatic amines, EPA identified concern for toxicity to aquatic organisms at surface water concentrations that exceed 240 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substances may present an unreasonable risk of injury to health and the environment. EPA's estimates indicate that variations of the parameters (including batch size, number of processing sites, days per year of operation) of the uses for the chemical substance would not result in increased inhalation exposure. To protect against these risks, the Order requires:

    1. Submission of certain toxicity testing on the substances prior to exceeding the confidential production volume limit specified in the Order.

    2. Use of personal protective equipment to prevent dermal exposure (where there is a potential for dermal exposure).

    3. Establishment and use of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed to not exceed a confidential production volume without performing reproductive/developmental toxicity testing.

    CFR citation: 40 CFR 721.11087 (P-17-154), 40 CFR 721.11088 (P-17-155), 40 CFR 721.11089 (P-17-156).

    PMN Number: P-17-218

    Chemical name: Bicyclo[2.2.1]heptane-1-methanesulfonic acid, 7,7-dimethyl-2-oxo-, compd. with N,N-diethylethanamine (1:1).

    CAS number: 67019-84-5.

    Effective date of TSCA section 5(e) Order: May 19, 2017.

    Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance is a processing aid for membrane production. Based on SAR analysis of test data on structurally similar respirable particles, EPA identified concerns for corrosivity, irritation, sensitization, developmental toxicity, specific target organ toxicity, and neurotoxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:

    1. Submission of certain toxicity testing on the substance prior to exceeding the confidential production volume limit specified in the Order.

    2. Use of personal protective equipment including impervious gloves to prevent dermal exposure (where there is a potential for dermal exposure).

    3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

    4. No manufacture, processing, or use involving an application method that generates a vapor, mist, aerosol, or dust.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the confidential production limit without performing a skin sensitization study. In addition, EPA has determined that the results of reproductive/developmental toxicity testing of the PMN substance may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, and use will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request.

    CFR citation: 40 CFR 721.11090.

    PMN Number: P-17-226

    Chemical name: Manganese(2+), bisoctahydro-1,4,7-trimethyl-1H-1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7)tri-.mu.-oxidi-, hexafluorophosphate(1-) (1:2).

    CAS number: 116633-52-4.

    Effective date of TSCA section 5(e) Order: June 15, 2017.

    Basis for TSCA section 5(e) Order: The PMN states the generic (non-confidential) use of the substance will be as a detergent additive. Based on test data on the substance and analogue test data, EPA has identified concerns for eye irritation, thyroid, blood, and liver toxicity, male reproductive toxicity, neurotoxicity, immunosuppression, respiratory sensitization, and mutagenicity. Based on test data on the substance and test data on analogous neutral organics, EPA identified concern for toxicity to aquatic organisms at surface water concentrations that exceed 240 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:

    1. Use of personal protective equipment to prevent dermal exposure (where there is a potential for dermal exposure).

    2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

    3. No use other than the confidential use allowed in the Order.

    4. No domestic manufacture of the substance.

    5. No processing without appropriate engineering controls to prevent inhalation exposure, including dust removal with 99.9% efficiency when loading or unloading the substance in powder form.

    6. No release of the substance resulting in surface water concentrations that exceed 240 ppb.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity testing of the PMN substance may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, and use will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request.

    CFR citation: 40 CFR 721.11091.

    PMN Numbers: P-17-228 and P-17-229

    Chemical names: 2′-Fluoro-4″-alkyl-4-propyl-1,1′:4′1″-terphenyl (generic) (P-17-228) and 4-ethyl-2′-fluoro-4″-alkyl-1,1′:4′1″-terphenyl (generic) (P-17-229).

    CAS numbers: Not available.

    Effective date of TSCA section 5(e) Order: May 18, 2017.

    Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substances is a coating for displays. Based on the physical/chemical properties of the substances (as described in the New Chemical Program's PBT category at 64 FR 60194; November 4, 1999; FRL-6097-7) and test data on structurally similar substances, the substances are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the substances will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Further, based on test data on structurally similar chemicals, EPA has identified concerns for reproductive effects, adrenal and liver toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substances may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:

    1. Use of personal protective equipment including impervious gloves to prevent dermal exposure (where there is a potential for dermal exposure).

    2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

    3. No manufacture beyond the confidential annual production volume limit specified in the Order.

    4. No processing or use of the substances in an application method that generates a dust, mist, or aerosol.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the fate and human health toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of biodegradation and reproductive/developmental toxicity testing of the PMN substances may be potentially useful in characterizing the health effects of the PMN substances. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request.

    CFR citations: 40 CFR 721.11092 (P-17-228) and 40 CFR 721.11093 (P-17-229).

    PMN Number: P-17-261

    Chemical name: Poly(oxy-1,2-ethanediyl),-.alpha.-(2-benzoylbenzoyl)-.omega.-[(2-benzoylbenzoyl)oxy]-.

    CAS number: Not available.

    Effective date of TSCA section 5(e) Order: June 19, 2017.

    Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as a difunctional type II photoinitiator for use in inks and coatings. Based on physical/chemical properties, SAR analysis and test data on analogous esters with branched polyols, EPA has identified concerns for corrosion of the skin, eyes, and mucous membranes, developmental toxicity, systemic toxicity, and blood effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to health and the environment. EPA's estimates indicate that variations of the parameters (including batch size, number of processing sites, days per year of operation) of the uses identified for the chemical substance would not result in increased inhalation exposure. To protect against these risks, the Order requires:

    1. Submission of certain toxicity testing on the substance prior to exceeding the confidential production volume limit specified in the Order.

    2. Use of personal protective equipment including impervious gloves (where there is a potential for dermal exposure).

    3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

    4. No domestic manufacture of the substance.

    The SNUR would designate as a “significant new use” the absence of these protective measures.

    Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the confidential production limit in the Order without performing irritation testing.

    CFR citation: 40 CFR 721.11094.

    V. Rationale and Objectives of the Rule A. Rationale

    During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for all 27 chemical substances regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters.

    The SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).

    B. Objectives

    EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:

    • EPA will receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.

    • EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.

    • EPA will be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.

    • EPA will identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).

    Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

    VI. Direct Final Procedures

    EPA is issuing these SNURs as direct final rules. The effective date of these rules is September 17, 2018 without further notice, unless EPA receives written adverse comments before September 17, 2018.

    If EPA receives written adverse comments on one or more of these SNURs before September 17, 2018, EPA will withdraw the relevant sections of this direct final rule before its effective date.

    This rule establishes SNURs for a number of chemical substances. Any person who submits adverse comments must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment.

    VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.

    When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) Orders have been issued for all of the chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which will be designated as significant new uses. The identities of 13 of the 27 chemical substances subject to this rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per §§ 720.25 and 721.11) for a chemical substance covered by this action. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

    Therefore, EPA designates August 17, 2018 as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the direct final rule.

    Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons will have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.

    VIII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: Development of test data is required where the chemical substance subject to the SNUR is also subject to a rule, order or consent agreement under TSCA section 4 (see TSCA section 5(b)(1)).

    In the absence of a TSCA section 4 test rule covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists potentially useful information for all of the listed SNURs. Descriptions of this information are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.

    In certain of the TSCA section 5(e) Orders for the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of specified tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) Orders, each PMN submitter is required to submit each study at least 14 weeks (earlier TSCA section 5(e) Orders required submissions at least 12 weeks) before reaching the specified production limit. The SNURs contain the same production volume limits as the TSCA section 5(e) Orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing.

    Any request by EPA for the triggered and pended testing described in the Orders was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models.

    Potentially useful information identified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data or other information may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to generate useful information.

    SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

    • Human exposure and environmental release that may result from the significant new use of the chemical substances.

    • Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

    IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at § 721.1725(b)(1).

    Under these procedures a manufacturer or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in § 721.1725(b)(1) with that under § 721.11 into a single step.

    If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

    X. SNUN Submissions

    According to § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

    XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2017-0414.

    XII. Statutory and Executive Order Reviews A. Executive Order 12866

    This action establishes SNURs for several new chemical substances that were the subject of PMNs and TSCA section 5(e) Orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993).

    B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.

    The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

    Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

    C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true:

    1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

    2. The SNUR submitted by any small entity would not cost significantly more than $8,300.

    A copy of that certification is available in the docket for this action.

    This action is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit XI. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:

    • A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

    • Submission of the SNUN would not cost any small entity significantly more than $8,300.

    Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities.

    D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

    E. Executive Order 13132

    This action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).

    F. Executive Order 13175

    This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action.

    G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

    H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

    I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.

    J. Executive Order 12898

    This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    XIII. Congressional Review Act

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

    List of Subjects 40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

    40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.

    Dated: August 3, 2018. Mark A. Hartman, Acting Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

    PART 9—[AMENDED] 1. The authority citation for part 9 continues to read as follows: Authority:

    7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.

    2. In § 9.1, add the following sections in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:
    § 9.1 OMB approvals under the Paperwork Reduction Act. 40 CFR citation OMB
  • control No.
  • *    *    *    *    * Significant New Uses of Chemical Substances *    *    *    *    * 721.11068 2070-0012 721.11069 2070-0012 721.11070 2070-0012 721.11071 2070-0012 721.11072 2070-0012 721.11073 2070-0012 721.11074 2070-0012 721.11075 2070-0012 721.11076 2070-0012 721.11077 2070-0012 721.11078 2070-0012 721.11079 2070-0012 721.11080 2070-0012 721.11081 2070-0012 721.11082 2070-0012 721.11083 2070-0012 721.11084 2070-0012 721.11085 2070-0012 721.11086 2070-0012 721.11087 2070-0012 721.11088 2070-0012 721.11089 2070-0012 721.11090 2070-0012 721.11091 2070-0012 721.11092 2070-0012 721.11093 2070-0012 721.11094 2070-0012 *    *    *    *    *
    PART 721—[AMENDED] 3. The authority citation for part 721 continues to read as follows: Authority:

    15 U.S.C. 2604, 2607, and 2625(c).

    4. Add § 721.11068 to subpart E to read as follows:
    § 721.11068 Alkanes, C20-28, chloro.

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alkanes, C20-28, chloro (PMN P-12-277, CAS No. 2097144-43-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (flame retardants and plasticizers in polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, and lubricant in adhesives, caulk, sealants, and coatings; additive in lubricants including metalworking fluids; and flame retardant and waterproofer in textiles). It is a significant new use to manufacture the chemical substance more than 5 years.

    (ii) [Reserved]

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    5. Add § 721.11069 to subpart E to read as follows:
    § 721.11069 Slack waxes (petroleum), chloro.

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as slack waxes (petroleum), chloro (PMN P-12-278, CAS No. 2097144-44-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (flame retardants and plasticizers in polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, and lubricant in adhesives, caulk, sealants, and coatings; additive in lubricants including metalworking fluids; and flame retardant and waterproofer in textiles). It is a significant new use to manufacture the chemical substance more than 5 years.

    (ii) [Reserved]

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    6. Add § 721.11070 to subpart E to read as follows:
    § 721.11070 Hexacosane, chloro derivs. and octacosane, chloro derivs.

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as hexacosane, chloro derivs. and octacosane, chloro derivs. (PMN P-12-280, CAS Nos. 2097144-46-0 and 2097144-47-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (flame retardants and plasticizers in polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, and lubricant in adhesives, caulk, sealants, and coatings; additive in lubricants including metalworking fluids; and flame retardant and waterproofer in textiles). It is a significant new use to manufacture the chemical substance more than 5 years.

    (ii) [Reserved]

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    7. Add § 721.11071 to subpart E to read as follows:
    § 721.11071 Alkanes, C20-24, chloro.

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alkanes, C20-24, chloro (PMN P-12-281, CAS No. 2097144-45-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (flame retardants and plasticizers in polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, and lubricant in adhesives, caulk, sealants, and coatings; additive in lubricants including metalworking fluids; and flame retardant and waterproofer in textiles). It is a significant new use to manufacture the chemical substance more than 5 years.

    (ii) [Reserved]

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    8. Add § 721.11072 to subpart E to read as follows:
    § 721.11072 Alkanes, C14-16, chloro.

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alkanes, C14-16, chloro (PMNs P-12-282 and P-14-684, CAS No. 1372804-76-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (flame retardants and plasticizers in polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, and lubricant in adhesives, caulk, sealants, and coatings; additive in lubricants including metalworking fluids; and flame retardant and waterproofer in textiles). It is a significant new use to manufacture the chemical substance more than 5 years.

    (ii) [Reserved]

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    9. Add § 721.11073 to subpart E to read as follows:
    § 721.11073 Tetradecane, chloro derivs.

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as tetradecane, chloro derivs. (PMNs P-12-283 and P-14-683, CAS No. 198840-65-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (flame retardants and plasticizers in polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, and lubricant in adhesives, caulk, sealants, and coatings; additive in lubricants including metalworking fluids; and flame retardant and waterproofer in textiles). It is a significant new use to manufacture the chemical substance more than 5 years.

    (ii) [Reserved]

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    10. Add § 721.11074 to subpart E to read as follows:
    § 721.11074 Octadecane, chloro derivs.

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as octadecane, chloro derivs. (PMN P-12-284, CAS No. 2097144-48-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (flame retardants and plasticizers in polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, and lubricant in adhesives, caulk, sealants, and coatings; additive in lubricants including metalworking fluids; and flame retardant and waterproofer in textiles). It is a significant new use to manufacture the chemical substance more than 5 years.

    (ii) [Reserved]

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    11. Add § 721.11075 to subpart E to read as follows:
    § 721.11075 Alkanes, C18-20, chloro.

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alkanes, C18-20, chloro (PMN P-12-433, CAS No. 106262-85-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (flame retardants and plasticizers in polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, and lubricant in adhesives, caulk, sealants, and coatings; additive in lubricants including metalworking fluids; and flame retardant and waterproofer in textiles). It is a significant new use to manufacture the chemical substance more than 5 years.

    (ii) [Reserved]

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    12. Add § 721.11076 to subpart E to read as follows:
    § 721.11076 Alkanes, C14-17, chloro.

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alkanes, C14-17, chloro (PMN P-12-453, CAS No. 85535-85-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (flame retardants and plasticizers in polyvinyl chloride polymers, and rubber; flame retardant, plasticizer, and lubricant in adhesives, caulk, sealants, and coatings; additive in lubricants including metalworking fluids; and flame retardant and waterproofer in textiles). It is a significant new use to manufacture the chemical substance more than 5 years.

    (ii) [Reserved]

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    13. Add § 721.11077 to subpart E to read as follows:
    § 721.11077 Alkanes, C22-30, chloro.

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alkanes, C22-30, chloro (PMN P-12-505, CAS No. 288260-42-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (flame retardants and plasticizers in polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, and lubricant in adhesives, caulk, sealants, and coatings; additive in lubricants including metalworking fluids; and flame retardant and waterproofer in textiles). It is a significant new use to manufacture the chemical substance more than 5 years.

    (ii) [Reserved]

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    14. Add § 721.11078 to subpart E to read as follows:
    § 721.11078 Chloroflurocarbon (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as chloroflurocarbon (PMN P-16-150) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3), and (4), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000), (a)(6) (liquid), and (c).

    (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) Order for this substance. The NCEL is 170 ppb as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) Order.

    (B) [Reserved]

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1) (fatal if inhaled), (g)(2)(ii), (iv), (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 170 ppb), (g)(2)(v), (g)(3)(i), (ii), (g)(4) (release to water restrictions apply), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(a) through (c), (g), and (q). It is a significant new use to manufacture, process, or use the PMN substance without the engineering controls described in the corresponding TSCA section 5(e) Order to prevent worker and environmental exposures. It is a significant new use to manufacture the chemical substance more than one year.

    (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 240.

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

    15. Add § 721.11079 to subpart E to read as follows:
    § 721.11079 Silane, 1,1′-(1,2-ethanediyl)bis[1,1-dichloro-1-methyl]-, hydrolysis products with chloroethenyldimethylsilane.

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as Silane, 1,1′-(1,2-ethanediyl)bis[1,1-dichloro-1-methyl]-, hydrolysis products with chloroethenyldimethylsilane (PMN P-16-379, CAS No. 1485477-78-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iv), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(6)(particulate), (a)(6)(v), (vi), (b) (concentration set at 1.0%), and (c).

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1) (liver toxicity), (mutagenicity), (g)(2)(i), (ii), (iii), (v), (g)(4)(i), (do not incinerate), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), (q), (y)(1) and (2).

    (iv) Disposal. Requirements as specified in § 721.85(a) (water), (a)(2), (b) (water), (b)(2), (c) (water), and (c)(2).

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (j) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

    16. Add § 721.11080 to subpart E to read as follows:
    § 721.11080 Silicophosphonate—sodium silicate (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as silicophosphonate—sodium silicate (PMN P-16-410) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (k). A significant new use is any use in formulations containing greater than 0.2% of the chemical substance.

    (ii) [Reserved]

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.

    17. Add § 721.11081 to subpart E to read as follows:
    § 721.11081 3-Butenenitrile, 2-(acetyloxy).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 3-butenenitrile, 2-(acetyloxy) (PMN P-16-438, CAS No. 15667-63-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), (a)(4), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1000), (a)(6)(particulate), (a)(6)(v), (vi), (b)(concentration set at 1.0%), and (c). It is a significant new use to manufacture, process or use the substance without following the monitoring procedure as specified in the worker protection section of the corresponding TSCA section 5(e) Order.

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1) (fatal if swallowed), (fatal if in contact with skin), (toxic if inhaled), (g)(2)(i), (ii), (iii), (iv), (v), (g)(3)(i), (ii), (g)(4)(i), (ii), (iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g). It is a significant new use to manufacture or use the substance other than in an enclosed system as described in the PMN.

    (iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

    18. Add § 721.11082 to subpart E to read as follows:
    § 721.11082 Halogenophosphoric acid metal salt (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as halogenophosphoric acid metal salt (PMN P-16-543) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(the confidential dermal protection described in the corresponding TSCA section 5(e) Order “the Order”), (a)(2)(ii), (iii), (iv), (a)(3), (a)(4), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 1,000), (a)(6) (particulate), (a)(6)(v), (vi), (b)(concentration set at 0.1%), and (c). It is a significant new use to manufacture, process or use the substance without following the monitoring procedure as specified in the worker protection section of the Order.

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i), (ii), (iii), (iv), (v), (vii), (viii), (ix), (g)(2)(i), (ii), (iii), (use protective engineering controls or equipment for dermal and inhalation protection, (g)(3)(i), (ii), (g)(4)(i), (ii), (water release restrictions apply), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(c), (f), and (k). It is a significant new use to vary or alter, the manufacturing, processing, and use, distribution/transportation, treatment and disposal processes, process equipment, engineering controls, and handling practices (including worker activities and cleaning procedures) described in the PMN in such a way as to increase the magnitude of inhalation exposure.

    (iv) Disposal. Requirements as specified in § 721.85. It is a significant new use to dispose of the substance other than by hazardous waste incineration according to 40 CFR parts 260 through 299 unless the substance is in waste water. When the substance is in wastewater it may be disposed of as required in paragraph (a)(2)(v) of this section.

    (v) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=3.

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (k) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraphs (a)(2)(i) and (iii) of this section.

    19. Add § 721.11083 to subpart E to read as follows:
    § 721.11083 Alkenoic acid, reaction products with polyethylene glycol ether with hydroxyalkyl substituted alkane (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkenoic acid, reaction products with polyethylene glycol ether with hydroxyalkyl substituted alkane (PMN P-16-596) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (b) (concentration set at 0.1%), and (c).

    (ii) Hazard communication. Requirements as specified in § 721.72 (a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), (dermal sensitization), (g)(1)(iv), (cancer, if inhaled), (g)(1)(ix), (g)(2)(i), (ii), (iii), (v), (g)(4)(iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (q).

    (iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

    20. Add § 721.11084 to subpart E to read as follows:
    § 721.11084 Alkyl substituted alkenoic acid, alkyl ester, polymer with alkyl substituted alkenoate and alkenoic acid, hydroxy substituted[(oxoalkyl)oxy]alkyl ester, reaction products with alkanoic acid, dipentaerythritil and isocyanate substituted carbomonocycle, compds. with alkylamine (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl substituted alkenoic acid, alkyl ester, polymer with alkyl substituted alkenoate and alkenoic acid, hydroxy substituted[(oxoalkyl)oxy]alkyl ester, reaction products with alkanoic acid, dipentaerythritil and isocyanate substituted carbomonocycle, compds. with alkylamine (PMN P-17-10) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(6)(particulate), (a)(6)(v), (vi), (b) (concentration set at 0.1%), and (c).

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i), (sensitization), (g)(1)(vii), (systemic effects), (g)(1)(ix), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k) (ultraviolet curable coating resin), and (y)(1). It is a significant new use to manufacture the chemical substance with an average molecular weight below 2,000 daltons or containing greater than 0.1% residual isocyanate. It is a significant new use to import the substance other than in totes.

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    21. Add § 721.11085 to subpart E to read as follows:
    § 721.11085 Heteromonocycle ester with alkanediol (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as heteromonocycle ester with alkanediol (PMN P-17-15) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (b) (concentration set at 1.0%), and (c).

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (g)(4) (release to water restrictions apply), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (q).

    (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=3.

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

    22. Add § 721.11086 to subpart E to read as follows:
    § 721.11086 Substituted carbomonocycle, polymer with (aminoalkyl)-alkanediamine, (haloalkyl)oxirane, dialkyl-alkanediamine and alkyl-alkanamine, reaction products with dialkanolamine and [[(alkyl)oxy]alkyl]oxirane (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted carbomonocycle, polymer with (aminoalkyl)-alkanediamine, (haloalkyl)oxirane, dialkyl-alkanediamine and alkyl-alkanamine, reaction products with dialkanolamine and [[(alkyl)oxy]alkyl]oxirane (PMN P-17-29) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (b) (concentration set at 1.0%), and (c).

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (eye irritation), (g)(1)(ii), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (g)(4)(iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), (q), and (y)(1).

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

    23. Add § 721.11087 to subpart E to read as follows:
    § 721.11087 Carboxylic acid amine (1:1) (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carboxylic acid amine (1:1) (PMN P-17-154) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (ii), (iv), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(6) (particulate), (a)(6)(v), (vi), (b) (concentration set at 1.0%), and (c).

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii), (iii), (thyroid effects), (g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(q).

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

    24. Add § 721.11088 to subpart E to read as follows:
    § 721.11088 Mix fatty acids compd with amine (1:1) (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mix fatty acids compd with amine (1:1) (PMN P-17-155) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been reacted (cured).

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (ii), (iv), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(6) (particulate), (a)(6)(v), (vi), (b) (concentration set at 1.0%), and (c).

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii), (iii), (thyroid effects), (g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(q).

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

    25. Add § 721.11089 to subpart E to read as follows:
    § 721.11089 Mix fatty acids compd with amine (1:1) (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mix fatty acids compd with amine (1:1) (PMN P-17-156) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(6) (particulate), (a)(6)(v), (vi), (b) (concentration set a 1.0%), and (c).

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii), (iii), (thyroid effects), (g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(q).

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

    26. Add § 721.11090 to subpart E to read as follows:
    § 721.11090 Bicyclo[2.2.1]heptane-1-methanesulfonic acid, 7,7-dimethyl-2-oxo-, compd. with N,N-diethylethanamine (1:1).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as bicyclo[2.2.1]heptane-1-methanesulfonic acid, 7,7-dimethyl-2-oxo-, compd. with N,N-diethylethanamine (1:1) (PMN P-17-218. CAS No. 67019-84-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(6) (particulate), (a)(6)(v), (vi), (b) (concentration set 1.0%), and (c).

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (corrosivity), (sensitization), (g)(1)(iii), (iv), (ix), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(q), (y)(1) and (2).

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

    27. Add § 721.11091 to subpart E to read as follows:
    § 721.11091 Manganese (2+), bisoctahydro-1,4,7-trimethyl-1H-1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7) tri-.mu.-oxidi-, hexafluorophosphate(1-) (1:2).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as manganese (2+), bisoctahydro-1,4,7-trimethyl-1H-1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7) tri-.mu.-oxidi-, hexafluorophosphate(1-) (1:2) (1:1) (PMN P-17-226, CAS No. 116633-52-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(6) (particulate), (b) (concentration set at 0.1%), and (c).

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1) (eye irritation), (respiratory sensitization), (g)(1)(iii), (iv), (vi), (vii), (viii), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (g)(4) (release to water provisions apply), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (k). It is a significant new use to process or use the substance without engineering controls to prevent exposure, including dust removal with 99.9% efficiency when loading or unloading the substance in powder form.

    (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=240.

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

    28. Add § 721.11092 subpart E to read as follows:
    § 721.11092 2′-Fluoro-4″-alkyl-4-propyl-1,1′:4′1″-terphenyl (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2′-fluoro-4″-alkyl-4-propyl-1,1′:4′1″-terphenyl (PMN P-17-228) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (b) (concentration set at 1.0%), and (c).

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(vi), (adrenal effects), (liver effects), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(t) and (y)(1).

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

    29. Add § 721.11093 to subpart E to read as follows:
    § 721.11093 4-ethyl-2′-fluoro-4″-alkyl-1,1′:4′,1″-terphenyl (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 4-ethyl-2′-fluoro-4″-alkyl-1,1′:4′,1″-terphenyl (PMN P-17-229) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (b) (concentration set 1.0%), and (c).

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set 1.0%), (f), (g)(1)(vi), (adrenal effects), (liver effects), (g)(2)(i), (ii), (iii), (v), and (g)(5).

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(t) and (y)(1).

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

    30. Add § 721.11094 to subpart E to read as follows:
    § 721.11094 Poly(oxy-1,2-ethanediyl),alpha-(2-benzoyl)-omega-[(2-benzoylbenzoyl)oxy]-.

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly(oxy-1,2-ethanediyl),alpha-(2-benzoyl)-omega-[(2-benzoylbenzoyl)oxy]- (PMN P-17-261) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (b) (concentration set at 1.0%), and (c).

    (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1) (irritation), (photosensitization), (g)(2)(i), (ii), (iii), (v), and (g)(5).

    (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (q).

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

    [FR Doc. 2018-17348 Filed 8-16-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2018-0272; FRL-9981-09-Region 9] Air Plan Approval; California; San Joaquin Valley Unified Air Pollution Control District; Reasonably Available Control Technology Demonstration AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking final action to approve revisions to the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD or “District”) portion of the California State Implementation Plan (SIP). These revisions concern the District's 2014 demonstration regarding Reasonably Available Control Technology (RACT) requirements for the 2008 8-hour ozone National Ambient Air Quality Standard (NAAQS). We are also taking final action to approve into the California SIP the following documents that help support the District's RACT demonstration: SJVUAPCD's supplement to its 2014 RACT SIP demonstration, which contains SJVUAPCD's negative declarations where the District concludes it has no sources subject to certain Control Techniques Guidelines (CTG) documents and relevant permit conditions to implement RACT level requirements for J.R. Simplot's Nitric Acid plant in Helm, California (CA); and SJVUAPCD's 2016 Ozone Plan for the 2008 8-Hour Ozone Standard—Chapter 3.4 and Appendix C only. We are approving local SIP revisions to demonstrate that RACT is implemented as required under the Clean Air Act (CAA or the “the Act”).

    DATES:

    This rule will be effective on September 17, 2018.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2018-0272. All documents in the docket are listed on the https://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information 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 through https://www.regulations.gov, or please contact the person identified in the FOR FURTHER INFORMATION CONTACT section for additional availability information.

    FOR FURTHER INFORMATION CONTACT:

    Stanley Tong, EPA Region IX, (415) 947-4122, [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document, “we,” “us” and “our” refer to the EPA.

    Table of Contents I. Proposed Action II. Public Comments and EPA Responses III. EPA Action IV. Incorporation by Reference V. Statutory and Executive Order Reviews I. Proposed Action

    On May 17, 2018 (83 FR 22908), the EPA proposed to approve SJVUACPD's “2014 Reasonably Available Control Technology (RACT) Demonstration for the 8-Hour Ozone State Implementation Plan (SIP)” (2014 RACT SIP), submitted to the EPA by the California Air Resources Board (CARB) on July 18, 2014,1 for approval as a revision to the California SIP.

    1 The SJVUAPCD adopted its 2014 RACT SIP on June 19, 2014.

    In addition to the 2014 RACT SIP, our May 17, 2018 proposed rule was also based on our evaluation of the public draft version of SJVUAPCD's “Supplement to the 2014 Reasonably Available Control Technology (RACT) State Implementation Plan (SIP) for the 2008 8-hour Ozone Standard” (Supplement to the 2014 RACT SIP) that was transmitted by CARB on May 4, 2018, along with a request for parallel processing.2 The District's Supplement to the 2014 RACT SIP contained relevant RACT permit conditions in a permit to operate for J.R. Simplot's Nitric Acid plant in Helm, CA, and negative declarations where the District concluded it had no sources subject to the following CTG source categories: Surface coating of insulation of magnetic wire; manufacture of synthesized pharmaceutical products; manufacture of pneumatic rubber tires; leaks from synthetic organic chemical polymer and resin manufacturing equipment; volatile organic compound (VOC) emissions from manufacture of high-density polyethylene, polypropylene and polyester resins; VOC emissions from air oxidation processes in synthetic organic chemical manufacturing industry (SOCMI); VOC emissions from reactor processes and distillation operations in SOCMI; and surface coating operations at shipbuilding and ship repair facilities.3 We indicated that we would not take final action on the Supplement to the 2014 RACT SIP until CARB submitted the final adopted version to the EPA as a SIP revision. On June 21, 2018, the SJVUAPCD held a public hearing and adopted the Supplement to the 2014 RACT SIP. 4 On June 29, 2018, CARB submitted the Supplement to the 2014 RACT SIP to the EPA for approval as a revision to the California SIP.5 The final adopted version of the Supplement to the 2014 RACT SIP includes non-substantive changes from the public draft version that was the basis for our May 17, 2018 proposed rule. These changes include streamlining J.R. Simplot's introductory section listing the plant's major equipment to just state “Nitric Acid Plant”; restoring a permit condition that EPA Reference Method 7 will be used to determine compliance with oxides of nitrogen (NOX) limits; and removing reference citations to a local rule and federal regulations that were inadvertently left in the permit. The NOX emission limits remain unchanged from the version of the permit included in our May 17, 2018 proposed rule. In addition, when comparing the public draft version included in our May 17, 2018 proposed rule and the final version adopted by the District on June 21, 2018, we noted minor editorial changes in the text preceding the list of negative declarations. The primary substance of the District's negative declarations, that is, recertification of three prior negative declarations, and the adoption of five new negative declarations, remain unchanged. We therefore consider these editorial changes to also be non-substantive. On July 11, 2018, we found the Supplement to the 2014 RACT SIP, including the relevant operating permit conditions to implement NOX RACT for J.R. Simplot's Nitric Acid Plant in Helm, CA, and several negative declarations, met the completeness criteria in 40 CFR part 51, appendix V.

    2 CARB's May 4, 2018 transmittal letter contained a public draft version of the Supplement to the 2014 RACT SIP along with a request that the EPA provide parallel processing of the documents concurrently with the state's public process. See footnote 1 in our May 17, 2018 proposed rule.

    3See Supplement to the 2014 RACT SIP, Appendix B.

    4 On June 21, 2018, the SJVUAPCD Governing Board adopted “Revision to the State Implementation Plan (SIP) to Address Federal Clean Air Act Requirements for Reasonably Available Control Technology (RACT)”. Appendix A: “J.R. Simplot Permit Conditions” and Appendix B: “Negative Declarations”, as contained in the adopted document, are substantially similar to the versions contained in the District's parallel processing request which the EPA proposed to approve on May 17, 2018. We will reference the District's June 21, 2018 adopted document as “Supplement to the 2014 RACT SIP” to maintain consistency with how this action was referenced in our May 17, 2018 proposed rulemaking.

    5 As explained in our May 17, 2018 proposed rulemaking, the EPA is following its regulatory procedures for parallel processing. See 40 CFR part 51, appendix V. These procedures allow the EPA to approve a state's submittal, following parallel state and federal comment periods, provided the final provision adopted at the state level has no significant changes from the proposal.

    We are also approving portions of SJVUAPCD's “2016 Ozone Plan for the 2008 8-Hour Ozone Standard” (2016 Ozone Plan), which help to supplement the District's 2014 RACT SIP. The plan was adopted by the District on June 16, 2016, and submitted by CARB to the EPA on August 24, 2016, as a revision to the California SIP. Specifically, as discussed in our May 17, 2018 proposed rule, Chapter 3.4 of the 2016 Ozone Plan states that “the District updated the RACT evaluation and included VOC sources in the evaluation in Appendix C.” Appendix C of the 2016 Ozone Plan, which is titled, “Stationary and Area Source Control Strategy Evaluations,” includes evaluations of individual rules for RACT. We are only approving Chapter 3.4 and Appendix C of the 2016 Ozone Plan in order to demonstrate VOC RACT for all applicable sources for the 2008 NAAQS.

    As discussed in our proposed rule, the District's 2014 RACT SIP contains its analysis of NOX RACT for the 2008 NAAQS. For more background information and a more extensive discussion of the 2014 RACT SIP, the Supplement to the 2014 RACT SIP, Chapter 3.4 and Appendix C of the 2016 Ozone Plan, and our evaluation of them for compliance with CAA RACT requirements, please see our proposed rule and related technical support document.

    II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period. During this period, we received one anonymous comment that was outside the scope of this rulemaking. The comment was not germane to our evaluation of the submitted SJVUAPCD documents to demonstrate that the District's stationary sources are subject to RACT requirements.

    III. EPA Action

    No comments were submitted that change our assessment of the submitted documents as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving the following documents into the California SIP: SJVUAPCD's 2014 RACT SIP; the Supplement to the 2014 RACT SIP including relevant permit conditions for J.R. Simplot's Nitric Acid Plant in Helm, CA and negative declarations for the CTG source categories: Surface coating of insulation of magnetic wire; manufacture of synthesized pharmaceutical products; manufacture of pneumatic rubber tires; leaks from synthetic organic chemical polymer and resin manufacturing equipment; VOC emissions from manufacture of high-density polyethylene, polypropylene and polyester resins; VOC emissions from air oxidation processes in SOCMI; VOC emissions from reactor processes and distillation operations in SOCMI; and surface coating operations at shipbuilding and ship repair facilities; and the 2016 Ozone Plan—only Chapter 3.4 and Appendix C.

    IV. 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 certain permit conditions for the J.R. Simplot Nitric Acid Plan in Helm, CA and described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

    V. 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, the 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);

    • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

    • 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 the 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 the 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. The 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 16, 2018. 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. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: July 12, 2018. Michael Stoker, Regional Administrator, Region IX.

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

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

    42 U.S.C. 7401 et seq.

    Subpart F—California 2. Section 52.220 is amended by adding paragraphs (c)(449)(ii)(D), (c)(496)(ii)(B), and (c)(507) to read as follows:
    § 52.220 Identification of plan—in part.

    (c) * * *

    (449) * * *

    (ii) * * *

    (D) San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD).

    (1) SJVUAPCD “2014 Reasonably Available Control Technology (RACT) Demonstration for the 8-Hour Ozone State Implementation Plan (SIP),” dated June 19, 2014, as adopted by the SJVUAPCD on June 19, 2014.

    (496) * * *

    (ii) * * *

    (B) San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD).

    (1) SJVUAPCD “2016 Ozone Plan for 2008 8-Hour Ozone Standard,” dated June 16, 2016, Chapter 3.4 and Appendix C only, as adopted by the SJVUAPCD on June 16, 2016.

    (507) New regulations for the following APCD were submitted on June 29, 2018 by the Governor's designee.

    (i) Incorporation by reference. (A) San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD).

    (1) Permit #C-705-3-19, J.R. Simplot Company, Nitric Acid Plant, Helm, CA, adopted by the SJVUAPCD, Resolution No.18-06-14, June 21, 2018.

    (ii) Additional materials. (A) San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD).

    (1) SJVUAPCD “Appendix B Negative Declarations For Proposed Revision to the State Implementation Plan (SIP) to Address Federal Clean Air Act Requirements for Reasonably Available Control Technology (RACT) June 21, 2018,” containing negative declarations, as adopted by the SJVUAPCD on June 21, 2018.

    3. Section 52.222 is amended by adding paragraph (a)(8)(iii) to read as follows:
    § 52.222 Negative declarations.

    (a) * * *

    (8) * * *

    (iii) The following negative declarations for the 2008 NAAQS were adopted by the San Joaquin Valley Unified Air Pollution Control District on June 21, 2018, and submitted to the EPA on June 29, 2018.

    Negative Declarations for the 2008 Ozone NAAQS CTG document No. Title EPA-450/2-77-033 Control of Volatile Organic Emissions from Existing Stationary Sources—Volume IV: Surface Coating of Insulation of Magnet Wire. EPA-450/2-78-029 Control of Volatile Organic Emissions from Manufacture of Synthesized Pharmaceutical Products. EPA-450/2-78-030 Control of Volatile Organic Emissions from Manufacture of Pneumatic Rubber Tires. EPA-450/3-83-006 Control of Volatile Organic Compound Leaks from Synthetic Organic Chemical Polymer and Resin Manufacturing Equipment. EPA-450/3-83-008 Control of Volatile Organic Compound Emissions from Manufacture of High-Density Polyethylene, Polypropylene, and Polystyrene Resins. EPA-450/3-84-015 Control of Volatile Organic Compound Emissions from Air Oxidation Processes in Synthetic Organic Chemical Manufacturing Industry. EPA-450/4-91-031 Control of Volatile Organic Compound Emissions from Reactor Processes and Distillation Operations in Synthetic Organic Chemical Manufacturing Industry. EPA-453/R-94-032 Alternative Control Technology Document—Surface Coating Operations at Shipbuilding and Ship Repair Facilities 61 FR 44050 8/27/96 Control Techniques Guidelines for Shipbuilding and Ship Repair Operations (Surface Coating).
    [FR Doc. 2018-17714 Filed 8-16-18; 8:45 am] BILLING CODE 6560-50-P
    GENERAL SERVICES ADMINISTRATION 48 CFR Parts 6101 and 6102 [CBCA Case 2018-61-1; Docket No. 2018-0006; Sequence No. 1] RIN 3090-AK02 Civilian Board of Contract Appeals; Rules of Procedure for Contract Disputes Act Cases AGENCY:

    Civilian Board of Contract Appeals; General Services Administration (GSA).

    ACTION:

    Final rule.

    SUMMARY:

    The Civilian Board of Contract Appeals (Board) amends its rules of procedure for cases arising under the Contract Disputes Act, and for disputes between insurance companies and the Department of Agriculture's Risk Management Agency in which decisions of the Federal Crop Insurance Corporation are brought before the Board under the Federal Crop Insurance Act. The Board's current rules were issued in 2008 and were last amended in 2011. After considering the one responsive comment received, the Board now promulgates its final rules of procedure.

    DATES:

    September 17, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Mr. J. Gregory Parks, Chief Counsel, Civilian Board of Contract Appeals, 1800 M Street NW, Suite 600, Washington, DC 20036; at 202-606-8787; or email at [email protected], for clarification of content. For information pertaining to the status or publication schedules, contact the Regulatory Secretariat at 202-501-4755. Please cite BCA Case 2018-61-1.

    SUPPLEMENTARY INFORMATION: A. Background

    The Board was established within GSA by section 847 of the National Defense Authorization Act for Fiscal Year 2006, Public Law 109-163. Board members are administrative judges appointed by the Administrator of General Services under 41 U.S.C. 7105(b)(2). Among its other functions, the Board hears and decides contract disputes between Government contractors and most civilian Executive agencies under the Contract Disputes Act, 41 U.S.C. 7101-7109, and its implementing regulations, and disputes pursuant to the Federal Crop Insurance Act, 7 U.S.C. 1501 et seq., between insurance companies and the Department of Agriculture's Risk Management Agency (RMA) involving actions of the Federal Crop Insurance Corporation (FCIC).

    The Board's rules of procedure for Contract Disputes Act cases and Federal Crop Insurance Act cases were adopted in May 2008 (73 FR 26947) and were last amended in August 2011 (76 FR 50926). The Board published in the Federal Register at 83 FR 13211, March 28, 2018, proposed, amended rules of procedure along with a notice inviting comments on those rules. This notice announced the intention to promulgate final rules, following the Board's review and consideration of all comments.

    The period for comments closed on May 29, 2018. The Board has considered all comments received, revising the proposed rules, in part, as explained in part B below, and now promulgates its final rules of procedure. These rules simplify and modernize access to the Board by establishing a preference for electronic filing, increase conformity between the Board's rules and the Federal Rules of Civil Procedure, streamline the wording of the Board's rules, and clarify current rules and practices. In addition, the time for filing is amended from 4:30 p.m. to midnight Eastern Time, and the stated monetary limitations for electing the accelerated and small claims procedures are deleted and replaced with references to the requirements stated in the Contract Disputes Act.

    B. Comments and Changes

    The Board received comments from two commenters. Commenters included one attorney from a Federal agency and one anonymous source. Comments from the anonymous source concerned matters wholly unrelated to the proposed rule, and the concerns noted by the attorney were already addressed in the proposed rule. The Board carefully considered the comments but has not revised its proposed rule based on issues the commenters raised. The final rule incorporates minor, non-substantive corrections to the proposed rule. The corrections are addressed below.

    Part 6101

    Sections 6101.1, 6101.3, 6101.4, 6101.12, and 6101.23 are amended to correct spelling, grammatical, or spacing errors; include a cross-reference; and clarify a phrase.

    C. Regulatory Flexibility Act

    GSA certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 602 et seq., and the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, because the final rule does not impose any additional costs on small or large businesses.

    D. Paperwork Reduction Act

    The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., does not apply because this final rule does not impose any information collection requirements that require the approval of the Office of Management and Budget.

    E. Congressional Review Act

    The final rule is exempt from Congressional review under Public Law 104-121 because it relates solely to agency organization, procedure, and practice and does not substantially affect the rights or obligations of non-agency parties.

    F. Executive Orders 12866 and 13563

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993, or E.O. 13563, Improving Regulation and Regulatory Review, dated January 18, 2011. This final rule is not a major rule under 5 U.S.C. 804.

    G. Executive Order 13771

    This final rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.

    List of Subjects in 48 CFR Parts 6101 and 6102

    Administrative practice and procedure; Government procurement; Agriculture.

    Dated: August 6, 2018. Jeri Kaylene Somers, Chair, Civilian Board of Contract Appeals, General Services Administration.

    Therefore, GSA revises 48 CFR parts 6101 and 6102 to read as follows:

    PART 6101—RULES OF PROCEDURE OF THE CIVILIAN BOARD OF CONTRACT APPEALS Sec. 6101.1 General information; definitions [Rule 1]. 6101.2 Filing appeals, petitions, and applications; consolidation [Rule 2]. 6101.3 Computing and extending time [Rule 3]. 6101.4 Appeal file [Rule 4]. 6101.5 Appearing; notice of appearance [Rule 5]. 6101.6 Pleadings; amending pleadings [Rule 6]. 6101.7 Service of documents [Rule 7]. 6101.8 Motions [Rule 8]. 6101.9 Record; content and access [Rule 9]. 6101.10 Admissibility of evidence [Rule 10]. 6101.11 Conferences [Rule 11]. 6101.12 Stays and dismissals [Rule 12]. 6101.13 Discovery generally [Rule 13]. 6101.14 Interrogatories; requests for production; requests for admission [Rule 14]. 6101.15 Depositions [Rule 15]. 6101.16 Subpoenas [Rule 16]. 6101.17 Exhibits [Rule 17]. 6101.18 Election of hearing or record submission [Rule 18]. 6101.19 Record submission without a hearing [Rule 19]. 6101.20 Scheduling hearings [Rule 20]. 6101.21 Hearing procedures [Rule 21]. 6101.22 Transcripts [Rule 22]. 6101.23 Briefs [Rule 23]. 6101.24 Closing the record [Rule 24]. 6101.25 Decisions and settlements [Rule 25]. 6101.26 Reconsideration [Rule 26]. 6101.27 Relief from decision or order [Rule 27]. 6101.28 Full Board consideration [Rule 28]. 6101.29 Clerical mistakes; harmless error [Rule 29]. 6101.30 Award of fees and other expenses [Rule 30]. 6101.31 Payment of award [Rule 31]. 6101.32 Appeal from Board decision [Rule 32]. 6101.33 Remand from appellate Court [Rule 33]. 6101.34 Ex parte communications [Rule 34]. 6101.35 Standards of conduct; sanctions [Rule 35]. 6101.36 Board seal [Rule 36]. 6101.37-6101.50 [Reserved]. 6101.51 Alternative procedures [Rule 51]. 6101.52 Small claims procedure [Rule 52]. 6101.53 Accelerated procedure [Rule 53]. 6101.54 Alternative dispute resolution [Rule 54]. Authority:

    41 U.S.C. 7101-7109.

    6101.1 General information; definitions [Rule 1].

    (a) Scope. The rules of this chapter govern cases filed with the Board on or after September 17, 2018, and all further proceedings in cases then pending, unless the Board decides that using the rules in this part in a case pending on their effective date would be inequitable or infeasible. The Board may alter these procedures on its own initiative or on request of a party to promote the just, informal, expeditious, and inexpensive resolution of a case.

    (b) Definitions.

    Appeal; appellant. “Appeal” means a contract dispute filed with the Board under the Contract Disputes Act (CDA), 41 U.S.C. 7101-7109, or under a disputes clause in a non-CDA contract that allows for Board review. An “appellant” is the contractor filing an appeal.

    Appeal file. “Appeal file” means the submissions to the Board under Rule 4 (48 CFR 6101.4).

    Application; applicant. “Application” means a submission to the Board under Rule 30 (48 CFR 6101.30) of a request for an award of fees and other expenses under the Equal Access to Justice Act (EAJA), 5 U.S.C. 504, or another provision authorizing such an award. An “applicant” is a party filing an application.

    Attorney. “Attorney” means a person licensed to practice law in a State, commonwealth, or territory of the United States or in the District of Columbia.

    Board judge; judge. “Board judge” or “judge” means a member of the Board.

    Business days and hours. The Board's business days are days other than Saturdays, Sundays, Federal holidays, days on which the Board is required to close before 4:30 p.m., or days on which the Board does not open for any reason, such as inclement weather. The Board's business hours are 8 a.m. to 4:30 p.m. Eastern Time.

    Case. “Case” means an appeal, petition, or application.

    Clerk of the Board. The “Clerk” of the Board receives filings, dockets cases, and prepares official correspondence for the Board.

    Efile; efiling. The Clerk accepts electronic filings (“efilings”), meaning documents submitted through the Board's email system (“efiled”). Parties may efile documents by sending an email (usually with attachments) to [email protected], except for documents that are classified or submitted in camera or under protective order (Rule 9). Efiling occurs upon receipt by the Board's email server, except that attachments must be in .pdf format and 18 megabytes (MB) or smaller or they will be rejected.

    Electronically stored information. “Electronically stored information” means information created, manipulated, communicated, stored, and best used in digital form with computer hardware and software.

    Equal Access to Justice Act (EAJA), 5 U.S.C. 504. This statute governs applications for awards of fees and other expenses in certain cases.

    Facsimile (fax) transmissions. The Board sends and accepts facsimile transmissions. A document is filed by fax at the time the Board receives all of it. The Board does not automatically extend filing deadlines if its fax machine is busy or otherwise unavailable.

    Filing. A notice of appeal or application is filed upon the earlier of its receipt by the Clerk or, if mailed through the United States Postal Service (USPS), the date it is mailed to the Board. A USPS postmark is prima facie evidence of a mailing date. Any other document is filed upon receipt by the Clerk.

    Party. “Party” means an appellant, applicant, petitioner, or respondent.

    Petition; petitioner. “Petition” means a request that the Board direct a contracting officer to issue a written decision on a claim. A “petitioner” is a party submitting a petition.

    Receipt. The Board deems a party's “receipt” of a document to occur upon the earlier of the emailing of the document to the party's email address of record (without notice of delivery failure) or the party's possession of a document sent by other means.

    Respondent. A “respondent” is the government agency whose decision, action, or inaction is the subject of an appeal, petition, or application.

    (c) Construction. The Board construes this part to promote the just, informal, expeditious, and inexpensive resolution of every case. The Board may apply principles of the Federal Rules of Civil Procedure (28 U.S.C. App.) to resolve issues not covered by this part.

    (d) Panels. The Board assigns each case to a panel of three judges, one of whom presides. The presiding judge sets the case schedule, oversees discovery, and conducts conferences, hearings, and other proceedings. The presiding judge may without participation by other panel members decide any appeal under the small claims procedure of Rule 52, any nondispositive motion, or any petition, and may dismiss a case as permitted by Rule 12(c) (48 CFR 6101.12(c)). The Board decides all other matters by majority vote of a panel unless the full Board decides a matter under Rule 28 (48 CFR 6101.28). Only panel and full Board decisions are precedential.

    (e) Location and addresses. The Board is physically located at 1800 M Street NW, 6th Floor, Washington, DC 20036. The mailing address is 1800 F Street NW, Washington, DC 20405. The Clerk's telephone number is (202) 606-8800. The Clerk's fax number is (202) 606-0019. The Clerk's email address for efiling is [email protected] The Board's website is http://www.cbca.gov.

    (f) Clerk's office hours. The Clerk's office is open to the public and for physical deliveries during business hours (Rule 1(b) (48 CFR 6101.1(b)). Efilings received after midnight are considered filed the next business day. The Clerk's office is closed when the Board's physical address is closed for any reason, including any closure of the Federal Government in the Washington, DC, metropolitan area.

    6101.2 Filing appeals, petitions, and applications; consolidation [Rule 2].

    (a) Filing an appeal. A notice of appeal shall be in writing; signed by the appellant, the appellant's attorney, or an authorized representative (see Rule 5 (48 CFR 6101.5)); and filed with the Board, with a copy to the contracting officer who received or issued the claim, or the successor contracting officer. A notice of appeal should include:

    (1) The name, telephone number, and mailing and email addresses of the appellant and/or its attorney or authorized representative;

    (2) The contract number;

    (3) The name of the contracting officer who received or issued the claim, with that person's telephone number, mailing address, and email address;

    (4) A copy of the claim with any certification; and

    (5) A copy of the contracting officer's decision on the claim or a statement that the appeal is from a failure to issue a decision (“a deemed denial”).

    (b) Filing a petition. A petition shall be in writing; signed by the petitioner, the petitioner's attorney, or an authorized representative (see Rule 5 (48 CFR 6101.5)); and filed with the Board, with a copy to the contracting officer who received the claim, or the successor contracting officer. A petition shall ask the Board to order the contracting officer to issue a decision and should include:

    (1) The name, telephone number, and mailing and email addresses of the petitioner and/or its attorney or authorized representative;

    (2) The contract number;

    (3) The name of the contracting officer who received the claim, with that person's telephone number, mailing address, and email address; and

    (4) A copy of the claim with any certification.

    (c) Filing an EAJA application. See Rule 30 (48 CFR 6101.30).

    (d) Time limits. (1) Under the CDA, a notice of appeal must be filed within 90 calendar days after the date of receipt of a contracting officer's decision on a claim.

    (2) Alternatively, under the CDA, a contractor may appeal when a contracting officer has not issued a decision on a claim within the time allowed by the CDA or the time set by a tribunal acting on a petition.

    (3) Under the CDA, a petition may be filed in the period between—

    (i) Receipt of notice from a contracting officer, within 60 days after the submission of a claim, that the contracting officer intends to issue a decision on the claim more than 60 days after its submission, and

    (ii) The due date stated by the contracting officer.

    (4) Under EAJA, an application must be filed within 30 days after the date that the decision in the underlying appeal becomes no longer subject to appeal.

    (e) Notice of docketing. Upon receipt of a notice of appeal, a petition, or an application, the Clerk issues a written notice of docketing to all parties.

    (f) Consolidation. The Board may consolidate cases wholly or in part if they involve common questions of law or fact.

    6101.3 Computing and extending time [Rule 3].

    (a) Computing time. Consistent with Rule 6 of the Federal Rules of Civil Procedure: In computing any time period, omit the day of the event from which the period begins to run. Omit nonbusiness days only if the period is less than 11 days; otherwise include them. A period ends on a business day. If a computed period would otherwise end on a nonbusiness day, it ends on the next business day.

    (b) Extensions. Parties should act sooner than required whenever practicable. However, the Board extends time when appropriate. A motion for an extension shall be in writing and shall state the other party's position on the motion or describe the movant's effort to learn the other party's position. The Board cannot extend statutory deadlines.

    6101.4 Appeal file [Rule 4].

    (a) Filing. Within 30 days after receiving the Board's docketing notice, the respondent shall file and serve all documents relevant to the appeal, including:

    (1) The contracting officer's decision on the claim;

    (2) The contract, including all pertinent specifications, amendments, plans, drawings, and incorporated proposals or parts thereof;

    (3) All correspondence between the parties relevant to the appeal;

    (4) The claim with any certification;

    (5) Relevant affidavits, witness statements, or transcripts of testimony taken before the appeal;

    (6) All documents relied on by the contracting officer to decide the claim; and

    (7) Relevant internal memoranda, reports, and notes.

    (b) Organization of electronic appeal file. (1) Unless otherwise ordered, parties shall file the appeal file and supplements thereto in an electronic storage medium (e.g., hard disk or solid state drive, compact disc (CD), or digital versatile disc (DVD)), labeled with the docket number, case name, and range of exhibit numbers.

    (2) A party may efile an appeal file or a supplement thereto by permission of the Board.

    (3) Appeal file exhibits shall be in .pdf format or will be rejected. The appeal file index and each exhibit shall be separate documents, without embedded documents.

    (4) Appeal file exhibits shall be complete, legible, arranged in chronological order, numbered, and indexed. Parties shall avoid filing duplicative exhibits and shall number exhibits continuously and consecutively from one filing to the next, so that a complete appeal file consists of one set of consecutively numbered exhibits.

    (5) Parties shall number the pages of each exhibit consecutively, unless an exhibit is already paginated in another logical manner.

    (6) The appeal file index shall describe each exhibit by date and content.

    (7) Parties may file documents in camera only by permission of the Board.

    (c) Organization of paper appeal file. (1) Appeal files and supplements thereto may be filed on paper only by permission of the Board.

    (2) Appeal file exhibits shall be complete, legible, arranged in chronological order, tabbed, and indexed. Parties shall avoid filing duplicative exhibits and shall number exhibits continuously and consecutively from one filing to the next, so a complete appeal file consists of one set of consecutively tabbed exhibits.

    (3) Parties shall number the pages of each paper exhibit consecutively, unless an exhibit is already paginated in another logical manner.

    (4) Parties shall file exhibits in 3-ring binders with spines no wider than 3 inches, labeled on the cover and spine with the name of the appeal, CBCA number, and tab numbers in each binder. Include in each binder the index of the entire filing.

    (5) The appeal file index shall describe each exhibit by date and content.

    (6) Parties shall separately file and index documents submitted in camera or under a protective order. However, documents may be submitted in camera only by permission of the Board.

    (d) Supplements. Within 30 days after the respondent files the appeal file, the appellant may file non-duplicative documents relevant to the claim, organized as instructed in Rule 4(b) or (c) (paragraph (b) or (c) of this section), starting with the next available exhibit number.

    (e) Classified or protected material. Neither classified nor protected material may be efiled.

    (f) Submission by order. The Board may order a party to supplement the appeal file, including by filing an exhibit in another format.

    (g) Status of exhibits. The Board considers appeal file exhibits part of the record for decision under Rule 9(a) unless a party objects to an exhibit within the time set by the Board and the Board sustains the objection.

    (h) Other procedures. The Board may postpone or waive the filing of an appeal file.

    6101.5 Appearing; notice of appearance [Rule 5].

    (a) Appearing before the Board—(1) Appellant; petitioner; applicant. An appellant, petitioner, or applicant may appear before the Board through an attorney. An individual appellant, petitioner, or applicant may appear for himself or herself. A corporation, trust, or association may appear by one of its officers. A limited liability corporation, partnership, or joint venture may appear by one of its members. Each individual appearing on behalf of an appellant, petitioner, or applicant must have legal authority to appear.

    (2) Respondent. A respondent may appear before the Board through an attorney or, if allowed by the agency, by the contracting officer or the contracting officer's authorized representative.

    (3) Others. The Board may permit a special or limited appearance of or for a nonparty, such as an amicus curiae.

    (b) Notice of appearance. The Board deems the person who signed a notice of appeal, petition, or application to have appeared for the appellant, petitioner, or applicant. The Board deems the head of the respondent's litigation office to have appeared for the respondent unless otherwise notified. Other participating attorneys shall file notices of appearance including all of the information required by the sample notice of appearance posted on the Board's website. Attorneys representing parties before the Board shall list their bar numbers or other identifying data for each State bar to which they are admitted.

    (c) Withdrawal of appearance. Anyone who has filed a notice of appearance and wishes to withdraw from a case must file a motion identifying by name, telephone number, mailing address, and email address the person who will assume responsibility for representing the party in question. The motion must state grounds for withdrawal, unless the motion represents that the party in question will meet the existing case schedule.

    6101.6 Pleadings; amending pleadings [Rule 6].

    (a) Complaint. Within 30 days after receiving the notice of docketing, the appellant shall file a complaint stating in simple, concise, and direct terms the factual basis for each claim and the amount in controversy. Alternatively, the appellant or the Board may designate as a complaint the notice of appeal, a claim submission, or any other document containing the information required in a complaint. The Board may in its discretion order a respondent asserting a claim to file a complaint.

    (b) Answer. Within 30 days after receiving the complaint or a designation of a complaint, the respondent (or the appellant, if so ordered) shall file an answer stating in simple, concise, and direct terms its responses to the allegations of the complaint and any affirmative defenses it chooses to assert.

    (c) Amendments. A party may amend a pleading once, before a responsive pleading is filed, with permission of the other party. Amending a pleading restarts the time to respond, if any. The Board may allow a party to amend a pleading in other circumstances.

    (d) Motion in lieu of answer. The Board may allow a party to file a dispositive motion or to move for a more definite statement in lieu of filing an answer.

    6101.7 Service of documents [Rule 7].

    A party filing any document not submitted in camera (see Rule 9(c)(2) (48 CFR 6101.9(c)(2)) shall send a copy to the other party by a method at least as fast as the filing method. The filing party shall indicate the method and address of service, otherwise the Board may consider a document not served and not properly filed.

    6101.8 Motions [Rule 8].

    (a) Generally. A party may make a motion for a Board action orally on the record in the presence of the other party or in a written filing. A written motion shall be a document titled as a motion and shall state the relief sought and the legal basis (see Rule 23(b) (48 CFR 6101.23(b)). Except for joint or dispositive motions, all motions shall represent that the movant tried to resolve the motion with the other party before filing. The Board may hold oral argument on a motion.

    (b) Jurisdictional motions. A party challenging the Board's jurisdiction should file such a motion promptly.

    (c) Procedural motions. A party may move for an extension of time (Rule 3(b) (48 CFR 6101.3(b)). The Board may in its discretion consider motions on other procedural matters. A procedural motion shall state the other party's position on the motion or describe the movant's effort to learn the other party's position.

    (d) Discovery motions. See Rule 13(e) (48 CFR 6101.13(e)).

    (e) Motions to dismiss for failure to state a claim. A party may move to dismiss all or part of a claim for failure to state grounds on which the Board could grant relief. In deciding such motions, the Board looks to Rule 12(b)(6) of the Federal Rules of Civil Procedure for guidance.

    (f) Summary judgment motions. A party may move for summary judgment on all or part of a claim or defense if the party believes in good faith it is entitled to judgment as a matter of law based on undisputed material facts. In deciding motions for summary judgment, the Board looks to Rule 56 of the Federal Rules of Civil Procedure for guidance.

    (1) Statement of undisputed material facts. The movant shall file with its summary judgment motion a separate document titled, “Statement of Undisputed Material Facts.” This document shall set forth facts supporting the motion in separate, numbered paragraphs, citing appeal file exhibits, admissions in pleadings, and/or evidence filed with the motion.

    (2) Statement of genuine issues. The opposing party shall file with its opposition a separate document titled, “Statement of Genuine Issues.” This document shall respond to specific paragraphs of the movant's Statement of Undisputed Material Facts by identifying material facts in genuine dispute, citing appeal file exhibits, admissions in pleadings, and/or evidence filed with the opposition.

    (g) Briefing. A party may file a brief in opposition to a motion under Rule 26, Rule 27, Rule 28, or Rule 29 (48 CFR 6101.26, 6101.27, 6101.28, or 6101.29) only by permission of the Board. Unless otherwise ordered, a brief in opposition to any other nonprocedural motion is due 30 days after receipt of the motion, and a movant's reply brief is due 15 days after receipt of an opposition brief. A nonmovant may file a surreply only by permission of the Board. Unless otherwise ordered, a brief in opposition to a procedural motion is due 5 days after receipt of the motion, and there shall be no reply.

    (h) Effect of pending motion. Unless otherwise stated in this part, the filing of a motion does not affect a party's obligations under the Board's rules or orders.

    6101.9 Record; content and access[Rule 9].

    (a) Record for decision. The record on which the Board will decide a case includes the following:

    (1) Evidence. Evidence in a case includes:

    (i) Rule 4 (48 CFR 6101.4) appeal file exhibits other than those to which an objection is sustained;

    (ii) Other documents or parts thereof admitted as evidence;

    (iii) Tangible things admitted as evidence;

    (iv) Transcripts or recordings of testimony before the Board; and

    (v) Factual stipulations and factual admissions.

    (2) Other material. The Board may also rely on to decide a case:

    (i) The notice of appeal, petition, or application;

    (ii) The complaint, answer, and amendments thereto;

    (iii) Motions and briefs on motions;

    (iv) Other briefs;

    (v) Demonstrative hearing exhibits; and

    (vi) Anything else the Board may expressly admit or take notice of.

    (b) Other contents of case file. The Board's administrative record may be broader than the record for decision. Material in the Board's case file that is not listed in Rule 9(a) (48 CFR 6101.9(a)) is part of the administrative record but is not part of the record for decision.

    (c) Enlarging or reopening the record. The Board may enlarge or reopen the record for decision on terms fair to the parties.

    (d) Protected and in camera submissions. The Board may limit access to specified material in a record for decision.

    (1) Protective orders. The Board may limit access to specified material in a record for decision if the Board finds good cause to treat the material as privileged, confidential, or otherwise sensitive.

    (2) In camera submissions. The Board may allow a party to submit a document solely for the Board's review in camera if:

    (i) The party submits the document to explain a discovery dispute;

    (ii) The Board denies a motion for protective order, and the movant asks that the record include a document that the party would have used in the case with a protective order, for possible later review of the Board's denial; or

    (iii) Good cause exists to find that in camera review may limit or prevent needless harm to a party, witness, or other person.

    (3) Status in record. A document submitted and accepted under a protective order or in camera is part of the record for decision. If the Board's decision is judicially reviewed, the Board will endeavor to preserve the protected or in camera nature of the document to the extent consistent with judicial review.

    (e) Review and copying. The Clerk makes records for decision, except evidence submitted under a protective order or in camera, available for review on reasonable notice during business hours, and provides copies of such available documents for a reasonable fee. The Clerk will not relinquish possession of material in the Board's files.

    6101.10 Admissibility of evidence[Rule 10].

    The Board may in its discretion receive any evidence to which no party objects. In ruling on evidentiary objections, the Board is guided but not bound by the Federal Rules of Evidence, except that the Board generally admits hearsay unless the Board finds it unreliable.

    6101.11 Conferences [Rule 11].

    The Board may order a conference of the parties for any purpose. Conferences are usually telephonic and are rarely recorded or transcribed. No one may record a conference by any means without Board approval. If the Board issues a memorandum or order memorializing a conference, a party has 5 days from receipt of the memorandum or order to object in writing to the memorialization.

    6101.12 Stays and dismissals [Rule 12].

    (a) Stays. The Board may stay a case for a specific duration, or until a specific event, for good cause.

    (b) Dismissals—(1) Generally. The Board may dismiss a case or part of a case either on motion of a party or after permitting a response to an order to show cause. Dismissal is with prejudice unless a Board order or other applicable law provides otherwise.

    (2) Voluntary dismissal. Subject to Rule 12(b)(3) (paragraph (b)(3) of this section), the Board will dismiss all or part of a case on the terms requested if the appellant, petitioner, or applicant moves for dismissal with prejudice or moves jointly with the respondent for dismissal with or without prejudice.

    (3) For lack of jurisdiction. If the Board finds that it lacks jurisdiction to decide all or part of a case, the Board will dismiss the case or the part of the case, regardless of the parties' positions on jurisdiction or dismissal.

    (4) For failure to prosecute. The Board may dismiss all or part of a case for failure to prosecute.

    (c) Dismissal orders and decisions. The presiding judge acting alone may stay a case or grant voluntary dismissal with or without prejudice. A panel or the full Board may dismiss a case on other grounds.

    (d) Admonition. Dismissal of a party's case without prejudice does not necessarily mean that the party may later refile the case at the Board or in another forum under the jurisdictional and procedural laws applicable to the case.

    6101.13 Discovery generally [Rule 13].

    (a) Methods. Parties may obtain discovery by depositions, interrogatories, requests for production, and requests for admission.

    (b) Scope. Unless otherwise ordered, the scope of discovery is the same as under Rule 26(b)(1) of the Federal Rules of Civil Procedure.

    (c) Limits. The Board may limit the frequency or extent of discovery for a reason stated in Rule 26(b)(2) of the Federal Rules of Civil Procedure.

    (d) Timing. The Board encourages parties to agree on a discovery plan that the Board may adopt in a scheduling order. The Board may modify an agreed discovery plan.

    (e) Disputes—(1) Objections. A party objecting to a written discovery request must make the objection in writing no later than the date that its response to the discovery request is due.

    (2) Duty to cooperate. Parties shall try in good faith to resolve objections to discovery requests without involving the Board. The Board may impose an appropriate sanction under Rule 35 (48 CFR 6101.35) on a party that does not meet its discovery obligations.

    (3) Motions to compel. A party may move to compel a response or a supplemental response to a discovery request. The movant shall attach to its motion a copy of each discovery request and response at issue, and shall represent in the motion that the movant complied with Rule 13(e)(2) (paragraph (e)(2) of this section).

    (f) Subpoenas. A party may request a subpoena under Rule 16 (48 CFR 6101.16).

    6101.14 Interrogatories; requests for production; requests for admission[Rule 14].

    (a) Generally. Interrogatories, requests for production, requests for admission, and responses thereto shall be in writing and served on the other party.

    (b) Interrogatories. Interrogatories shall be answered or objected to separately in writing, under signed oath, within 30 days of service. A party may answer an interrogatory by specifying records from which the answer may be derived or ascertained when that response would be allowed under Rule 33(d) of the Federal Rules of Civil Procedure.

    (c) Requests for production. Responses and objections to requests for production, inspection, and/or copying of documents, electronically stored information, or tangible things are due within 30 days of service of the requests and shall state when and how the responding party will make responsive material available.

    (d) Requests for admission—(1) Content. A party may serve requests for admission that would be proper under Rule 36(a)(1) of the Federal Rules of Civil Procedure.

    (2) Responses and failure to respond. Responses and objections shall comply with Rule 36(a)(4) and (5) of the Federal Rules of Civil Procedure. If the served party does not respond within 30 days of service of a request, the Board may on motion deem a matter admitted and conclusively established solely for the pending case.

    (3) Relief from admission. The Board may allow a party to withdraw or amend an admission for good cause.

    (e) Altering time to respond. The parties may agree to alter deadlines to respond to discovery requests. The Board may alter the deadlines to meet the needs of a case.

    (f) Supplementing and correcting responses. A party must supplement or correct a response to a discovery request if and when this action would be required by Rule 26(e)(1) of the Federal Rules of Civil Procedure.

    6101.15 Depositions [Rule 15].

    (a) Generally. Unless otherwise ordered, parties may take depositions after service of the answer. If the parties agree in writing on the deponent, time, place, recording method, and maximum duration of a deposition, no formal deposition notice is needed. The Board may order a deposition on motion under Rule 8 (48 CFR 6101.8) or by subpoena under Rule 16 (48 CFR 6101.16).

    (b) Use. Parties may use deposition testimony in a case to the extent that would be permitted by Rule 32(a) of the Federal Rules of Civil Procedure.

    (c) To perpetuate testimony. If the Board has decided a case, and either the time to appeal has not expired or an appeal has been taken, the Board may for good cause grant leave to take a deposition as if the case were still before the Board in order to preserve testimony for possible further proceedings before the Board.

    6101.16 Subpoenas [Rule 16].

    (a) Expectation of cooperation in lieu of subpoena. Subpoenas should rarely be necessary, as the Board expects parties to respond cooperatively to discovery requests and to try in good faith to secure the cooperation of third parties who have or may have evidence responsive to discovery requests.

    (b) Generally. The Board may issue a subpoena for a purpose for which a United States district court may issue a subpoena under Rule 45(a)(1) of the Federal Rules of Civil Procedure. Parties and the Board shall take all reasonable steps to avoid imposing undue burden on a person subject to a subpoena.

    (c) How requested; form. A party may ask the Board to issue a subpoena by motion under Rule 8 (48 CFR 6101.8), substantially before the proposed compliance date. The movant shall attach to its motion a completed subpoena form for signing by a Board judge, and shall explain in the motion why the proposed subpoena scope is reasonable and how the evidence sought is relevant to the case.

    (d) Production cost. The Board's policy is to require a requesting party to advance a subpoenaed person the reasonable cost of producing subpoenaed material.

    (e) Service. The requesting party shall serve a subpoena and provide proof of service as would be required by Rule 45(b) of the Federal Rules of Civil Procedure.

    (f) Motion to quash or modify. On or before the date specified for compliance, a subpoenaed person may file a motion to quash or modify the subpoena for a reason stated in Rule 45(d)(3) of the Federal Rules of Civil Procedure. The Board may rule on the motion any time after the party that served the subpoena receives the motion.

    (g) Enforcement. As necessary, the Board may ask the Attorney General of the United States to petition a United States district court to enforce a Board subpoena.

    (h) Letter rogatory in lieu of subpoena. If a person to be subpoenaed resides in a foreign country, the Board may facilitate the issuance of a letter rogatory to the person by the United States Department of State under 28 U.S.C. 1781-1784.

    6101.17 Exhibits [Rule 17].

    (a) Marking exhibits. Unless otherwise ordered, parties shall, to the fullest extent practicable, submit exhibits for inclusion in the appeal file before a hearing starts under Rule 20 (48 CFR 6101.20) or before the first brief is filed when a case is submitted on the written record under Rule 19 (48 CFR 6101.19). Parties shall mark any exhibits offered in evidence thereafter as sequential additions to the appeal file. Such exhibits shall become part of the appeal file if admitted as evidence.

    (b) Copies. The Board expects all document exhibits to be true, complete, and legible copies rather than originals. The Board may order a party to substitute a better copy or to make an original document available for inspection.

    (c) Withdrawal. The Board may allow a party to withdraw an exhibit from the appeal file and the record for decision on terms fair to the other party.

    (d) Disposition. Unless the Board advises the parties of another deadline, the Board may discard physical (non-electronic) exhibits in its possession 90 days after the time to appeal the Board's decision in the case expires.

    6101.18 Election of hearing or record submission [Rule 18].

    (a) Generally. The Board will hold a hearing in a case if the Board must find facts and either party elects a hearing. A party may elect to submit its case for decision on the written record under Rule 19 (48 CFR 6101.19). The presiding judge will set the deadline for an election under this rule.

    (b) Hybrid election. A party may elect to submit its case on the written record under Rule 19 (48 CFR 6101.19) and also elect to appear at a hearing, solely to cross-examine the other party's witnesses and to object to evidence offered at the hearing.

    6101.19 Record submission without a hearing [Rule 19].

    (a) Generally. If a party elects to submit its case on the record without a hearing, the Board will set a schedule for the parties to complete the evidentiary record and file briefs.

    (b) Evidence and objections. When a party elects submission on the record without a hearing, that party may submit material for inclusion in the record no later than the date the party files its initial brief. Unless otherwise ordered, the other party may object to the admission of such material as evidence within 5 days after receiving the submission. If one party elects a hearing and the other party elects record submission (or makes a hybrid election under Rule 18(b) (48 CFR 6101.18(b)), the evidentiary record shall close at the end of the hearing. The Board may rule on objections either before or in its decision.

    (c) Briefs and argument. The Board may receive briefs and/or oral argument on a record submission. If one party elects a hearing and the other party elects record submission, the first brief of the party submitting its case on the record shall be due no later than the start of the hearing.

    6101.20 Scheduling hearings [Rule 20].

    (a) Generally. The Board will set the time, place, duration, and subject matter of a hearing in a written order after consulting with the parties.

    (b) Subject matter. The Board may schedule for hearing all or some of the claims or issues in a case, or all or some of the claims, issues, or questions of fact or law common to more than one case.

    (c) Unexcused absence. If a party fails without good excuse to appear at a hearing of which it received notice under this rule, the Board will deem that party to have elected to submit its case on the record under Rule 19.

    6101.21 Hearing procedures [Rule 21].

    (a) Generally. The Board generally holds hearings in public hearing rooms. Except as necessary under a protective order or in camera procedures, hearings are open to the public. The Board entrusts the conduct of hearings to the discretion of the presiding judge.

    (b) Witnesses, evidence, other exhibits. A party that intends to offer testimony, other evidence, or other material for the record at a hearing shall arrange for the witness, evidence, or other material to be present in the hearing room. The Board may in its discretion allow testimony by telephone or video.

    (c) Exclusion of witnesses. The Board may exclude witnesses from a hearing, other than one designated representative for each party or a person authorized by statute to be present, so that witnesses are not influenced by the testimony of other witnesses.

    (d) Sworn testimony. Hearing witnesses shall testify under oath or affirmation. If a person called as a witness refuses to so swear or affirm, the Board may receive the person's testimony under penalty of making a materially false statement in a Federal proceeding under 18 U.S.C. 1001. Alternatively, the Board may disallow the testimony and may draw inferences from the person's refusal to swear or affirm.

    6101.22 Transcripts [Rule 22].

    The Board arranges transcription of hearings, other than hearings under the small claims procedure of Rule 52 (48 CFR 6101.52). The Board may, but generally does not, arrange transcription of conferences or other proceedings. No one may record or transcribe a Board proceeding without the Board's permission. The Board may order or acknowledge corrections to an official transcript. Each party is responsible for obtaining its own copy of a transcript.

    6101.23 Briefs [Rule 23].

    (a) Generally. The Board may order or invite briefs on any issue in a case at any time. Briefs shall be formatted for 8.5 by 11-inch paper, double spaced, with body and footnote text no smaller than 13 point.

    (b) Prehearing, post-hearing, and other briefs. Prehearing and post-hearing briefs, briefs filed under Rule 19, and briefs on non-procedural motions shall cite record evidence for factual statements and legal authority for legal arguments.

    6101.24 Closing the record [Rule 24].

    (a) Closing the evidentiary record. Unless otherwise ordered, the evidence as defined in Rule 9(a)(1) (48 CFR 6101.9(a)(1)) is closed at the end of a hearing under Rule 20 or at the start of merits briefing when a case is submitted on the record under Rule 19 (48 CFR 6101.19).

    (b) Closing the record for decision. Unless otherwise ordered, the record for decision as defined in Rule 9(a) (48 CFR 6101.9(a)) is closed when the Board receives the final scheduled brief on the matters to be decided.

    6101.25 Decisions and settlements[Rule 25].

    (a) Decisions. The Board issues decisions in writing, except as allowed by Rule 52 (48 CFR 6101.52). The Board will send a copy of a decision to each party, requesting confirmation of receipt (see Rule 1 (48 CFR 6101.1)), and will post the decision on its website. If a decision reserves any part of a case for later proceedings, it is conclusive as to the matters it resolves, except as provided in Rules 26 and 28 (48 CFR 6101.26 and 6101.28).

    (b) Settlements. Parties may settle a case by stipulating to an award. The Board may issue a decision making the stipulated award if:

    (1) The Board is satisfied that it has jurisdiction; and

    (2) The stipulation states that no party will seek reconsideration of, seek relief from, or appeal the Board's decision.

    6101.26 Reconsideration [Rule 26].

    (a) Grounds. The Board may on motion reconsider a decision or order for a reason recognized in Rule 59 of the Federal Rules of Civil Procedure. Arguments and evidence previously presented are not grounds for reconsideration.

    (b) Time limit for motion. A party may move for reconsideration of a decision or order on an appeal or petition within 30 days after that party receives the decision or order. A party may move for reconsideration of a decision or order on an application within 7 days after receiving the decision or order. The Board does not extend these time limits.

    (c) Effect of motion. A pending reconsideration motion does not affect any obligation to comply with a decision or order.

    6101.27 Relief from decision or order [Rule 27].

    (a) Grounds. The Board may grant relief, for a reason recognized in Rule 60 of the Federal Rules of Civil Procedure, from a decision or order that, alone or in conjunction with prior decisions or orders, resolves all of an appeal, petition, or application.

    (b) Time limit for motion. A party may move for relief under this rule within 120 days after that party receives the decision or order at issue.

    (c) Effect of motion. A pending motion for relief under this rule does not affect any obligation to comply with a decision or order.

    6101.28 Full Board consideration[Rule 28].

    (a) By motion. The full Board may consider a decision or order when necessary to maintain uniformity of Board decisions or if the matter is exceptionally important. Motions for full Board consideration are disfavored and are decided by a majority of the Board. A party may move for full Board consideration within 10 days after that party receives the decision or order at issue. An order granting full Board consideration will include concurring or dissenting opinions, if any.

    (b) By Board initiative. A majority of the Board may initiate full Board consideration of any matter in a case, up to 10 days after a judge or panel issues a decision or order on that matter. The full Board will inform the parties by order of the matter or matters to be considered. The order will include concurring or dissenting opinions, if any.

    (c) Full Board decision. The full Board decides matters by majority vote. A full Board decision will include concurring or dissenting opinions, if any.

    (d) Effect of motion. A pending motion for full Board consideration does not affect any obligation to comply with a decision or order.

    6101.29 Clerical mistakes; harmless error [Rule 29].

    (a) Clerical mistakes. The Board may correct clerical mistakes while a case is pending, or within 60 days thereafter if a decision has not been appealed. If a Board decision is appealed, the Board may correct clerical mistakes only by leave of the appellate Court.

    (b) Harmless error. The Board disregards errors that do not affect a substantive right of a party. No error in a ruling, order, or decision of the Board will be grounds for a new hearing or for vacating, reconsidering, modifying, or otherwise disturbing a decision or order unless refusing to correct the error will prejudice a party or work a substantial injustice.

    6101.30 Award of fees and other expenses [Rule 30].

    (a) Application for fees and other expenses. A party in an appeal may apply for an award of fees and other expenses as permitted under EAJA or any other provision that may entitle the party to such an award.

    (b) Time for filing. A party may file an application for fees and other expenses only after the time to seek appellate review of a Board decision has expired. A party may file an application within 30 calendar days after that date.

    (c) Application requirements. An application for fees and other expenses shall:

    (1) Specify the applicant, appeal, and amount sought;

    (2) Explain why the applicant is legally eligible for an award;

    (3) Provide a schedule of fees and expenses with supporting documentation;

    (4) Be signed by the applicant or a person appearing for the applicant, with a declaration under penalty of perjury that the information in the application is correct;

    (5) Provide evidence of the applicant's small business status or net worth; and

    (6) Justify any request for attorney fees exceeding the statutory rate.

    (d) Proceedings. (1) Within 30 days after receiving an application, the respondent may file an answer with any objections to the award requested, supported by facts and legal analysis.

    (2) The Board may order further proceedings if necessary for a full and fair resolution of issues arising from an application.

    (e) Decision. The Board will issue a written decision on an application.

    6101.31 Payment of award [Rule 31].

    When permitted by law, Board awards under contracts may be paid from the permanent indefinite judgment fund under 31 U.S.C. 1304 and 31 CFR part 256. An EAJA award is paid from funds of the respondent.

    6101.32 Appeal from Board decision[Rule 32].

    (a) Notice. A party filing a notice of appeal with the United States Court of Appeals for the Federal Circuit (or with a district court in an admiralty case) shall provide a copy of the notice to the Board.

    (b) Record on review. The record on appellate review is the record for decision under Rule 9(a) (48 CFR 6101.9(a)) and any other material in a case file that the appellate Court may require.

    (c) Certified list. The Clerk will provide the clerk of the appellate Court a certified list as required by the Court's rules.

    (d) Inspection or copying of record. The Clerk will make a record on appeal available for inspection and copying in accordance with the rules of the appellate Court.

    6101.33 Remand from appellate Court [Rule 33].

    If a Court remands a case to the Board for further proceedings, each party shall, within 30 days of receipt of the appellate mandate, recommend procedures to comply with the remand order. The Board will then issue an order on further proceedings.

    6101.34 Ex parte communications[Rule 34].

    No member of the Board or of the Board's staff will communicate with a party about any material issue in a case outside of the presence of the other party, and no one shall attempt such communications on behalf of a party. This rule does not bar such communications about the Board's administrative functions or procedures.

    6101.35 Standards of conduct; sanctions [Rule 35].

    (a) Standards of conduct. All parties and their representatives, attorneys, and any expert or consultant retained by them or their attorneys shall obey directions and orders of the Board and adhere to standards of conduct applicable to such parties and persons. Standards applying to an attorney include the rules of professional conduct and ethics of the jurisdictions in which the attorney is licensed to practice, to the extent that those rules are relevant to conduct affecting the integrity of the Board, its process, or its proceedings.

    (b) Sanctions. If a party or its representative, attorney, expert, or consultant fails to comply with any direction or order of the Board (including an order to provide or permit discovery) or engages in misconduct affecting the Board, its process, or its proceedings, the Board may make such orders as are just, including the imposition of appropriate sanctions. Sanctions may include, but are not limited to:

    (1) Taking the facts pertaining to the matter in dispute to be established for the purpose of the case in accordance with the contention of the party who is not at fault;

    (2) Forbidding the challenge of the accuracy of any evidence;

    (3) Refusing to allow the party to support or oppose designated claims or defenses;

    (4) Prohibiting the party from introducing into evidence designated claims or defenses;

    (5) Striking pleadings or parts thereof, or staying further proceedings until the order is obeyed;

    (6) Dismissing the case or any part thereof;

    (7) Enforcing the protective order and disciplining individuals subject to such order for violation thereof, including disqualifying a party's representative, attorney, expert, or consultant from further participation in the case;

    (8) Drawing evidentiary inferences adverse to the party; or

    (9) Imposing such other sanctions as the Board deems appropriate.

    (c) Denial of access to protected material. The Board may in its discretion deny access to protected material to any person found to have previously violated a protective order, regardless of who issued the order.

    (d) Disciplinary proceedings—(1) Sanctions. The Board may discipline individual party representatives, attorneys, experts, or consultants for violating any Board order, direction, or standard of conduct if the violation seriously affects the integrity of the Board, its process, or its proceedings. Sanctions may be public or private, and may include admonishment, reprimand, disqualification from a particular matter, referral to an appropriate licensing authority, or other action that circumstances may warrant.

    (2) Suspension. The Board may suspend an individual from appearing before the Board as a party representative, attorney, expert, or consultant, if, after affording such individual notice and opportunity to be heard, a majority of the members of the full Board determine such a sanction is warranted.

    6101.36 Board seal [Rule 36].

    The seal of the Board is a circular logo with “Civilian Board of Contract Appeals” on the outer margin. The seal is a means of authenticating records, notices, orders, dismissals, opinions, subpoenas, and certificates issued by the Board.

    6101.37-6101.50 [Reserved]
    6101.51 Alternative procedures [Rule 51].

    An appellant in an eligible case may elect the small claims procedure under Rule 52 (48 CFR 6101.52) or the accelerated procedure under Rule 53 (48 CFR 6101.53). Parties may jointly elect alternative dispute resolution under Rule 54 (48 CFR 6101.54).

    6101.52 Small claims procedure [Rule 52].

    (a) Election. The small claims procedure is available solely at an appellant's election and is limited to appeals in which there is a monetary amount in dispute and the requirements for expedited disposition set forth in the Contract Disputes Act, 41 U.S.C. 7106(b), are met. An appellant may elect the small claims procedure up to 30 days after receiving the respondent's answer.

    (b) Procedure. The respondent may object to an election, on the grounds that Rule 52(a) (paragraph (a) of this section) is not satisfied, within 10 days after receiving the election. If the small claims procedure is used, the Board will set a schedule for timely resolution of the appeal. The schedule may restrict or eliminate pleadings, discovery, and other prehearing activities.

    (c) Decision. The presiding judge may issue a decision in summary form. A decision is final and conclusive, shall not be set aside except for fraud, and is not precedential. If possible, the Board will resolve the appeal within 120 days after the appellant elects the small claims procedure. The Board may extend the appeal schedule if an appellant does not adhere to the established schedule.

    6101.53 Accelerated procedure [Rule 53].

    (a) Election. The accelerated procedure is available solely at an appellant's election and is limited to appeals in which there is a monetary amount in dispute and the requirements for accelerated disposition set forth in the Contract Disputes Act, 41 U.S.C. 7106(a), are met. The appellant may elect the accelerated procedure up to 30 days after receiving the respondent's answer.

    (b) Procedure. The respondent may object to an election, on the grounds that Rule 53(a) (paragraph (a) of this section) is not satisfied, within 10 days after receiving the election. If the accelerated procedure is used, the Board will set a schedule for timely resolution of the appeal. The schedule may restrict or eliminate pleadings, discovery, and other prehearing activities.

    (c) Decision. The presiding judge may issue a decision with the concurrence of at least one panel member. If the presiding judge and a panel member disagree, the panel will decide the appeal. If possible, the Board will resolve the appeal within 180 days after the appellant elects the accelerated procedure. The Board may extend the appeal schedule if an appellant does not adhere to the established schedule.

    6101.54 Alternative dispute resolution [Rule 54].

    (a) Availability. The CDA requires boards of contract appeals to provide to the fullest extent practicable informal, expeditious, and inexpensive resolution of disputes. Resolution of a dispute at the earliest stage feasible, by the fastest and least expensive method possible, benefits both parties. The Board provides alternative dispute resolution (ADR) services for pre-claim and pre-final decision matters, as well as appeals pending before the Board. The Board may also conduct ADR proceedings for any Federal agency. The use of ADR proceedings does not toll any statutory time limits.

    (b) Procedures for requesting ADR. Parties may jointly ask the Board Chair to appoint a judge as an ADR Neutral. The parties may request a particular judge or judges, to include the presiding judge. To facilitate full, frank, and open participation, a Neutral will not discuss the substance of the case or the parties' conduct in ADR with other Board personnel, and a Neutral who participates in a nonbinding ADR procedure that does not resolve the dispute is recused from further participation in the matter unless the parties agree otherwise in writing and the Board concurs.

    (c) Confidentiality. Written material prepared for use in ADR, oral presentations made in ADR, and all discussions between the parties and the Neutral are confidential, subject to 5 U.S.C. 574, and, unless otherwise specifically agreed by the parties, inadmissible as evidence in any Board proceeding, although evidence otherwise admissible before the Board is not rendered inadmissible merely because of its use in ADR.

    (d) ADR agreement. Parties shall agree in writing to an ADR method and the procedures and requirements for implementing it. The ADR agreement shall provide that the parties and counsel will not subpoena the Neutral in any legal action or administrative proceeding of any kind to provide documents or testimony relating to the ADR.

    (e) Types of ADR. Parties and the Board may agree on any type of binding or nonbinding ADR suited to a dispute.

    PART 6102—CROP INSURANCE CASES Sec. 6102.201 Scope of rules [Rule 201]. 6102.202 Rules for crop insurance cases [Rule 202]. Authority:

    7 U.S.C. 1501 et seq.; 41 U.S.C. 438(c)(2).

    6102.201 Scope of rules [Rule 201].

    These procedures govern the Board's resolution of disputes between insurance companies and the Department of Agriculture's Risk Management Agency (RMA) involving actions of the Federal Crop Insurance Corporation (FCIC). Prior to the creation of this Board, the Department of Agriculture Board of Contract Appeals resolved this variety of dispute pursuant to statute, 7 U.S.C. 1501 et seq. (the Federal Crop Insurance Act), and regulation, 7 CFR 24.4(b) and 400.169. The Board has this authority under an agreement with the Secretary of Agriculture, as permitted under section 42(c)(2) of the Office of Federal Procurement Policy Act, 41 U.S.C. 438(c)(2).

    6102.202 Rules for crop insurance cases [Rule 202].

    The rules of procedure for these cases are the same as the rules of procedure for Contract Disputes Act appeals, with these exceptions:

    (a) Rule 1(b)(48 CFR 6101.1(b)). (1) The term “appeal” means a dispute between an insurance company that is a party to a Standard Reinsurance Agreement (or other reinsurance agreement) and the RMA, and the term “appellant” means the insurance company filing an appeal.

    (2) A notice of appeal is filed upon its receipt by the Office of the Clerk of the Board, not when it is mailed.

    (3) The terms “petition” and “petitioner” do not apply to FCIC cases.

    (b) Rule 2 (48 CFR 6101.2). (1) Rule 2(a) (48 CFR 6101.2(a)) is replaced with the following for FCIC cases: A notice of appeal shall be in writing and shall be signed by the appellant or by the appellant's attorney or authorized representative. If the appeal is from a determination by the Deputy Administrator of Insurance Services regarding an action alleged not to be in accordance with the provisions of a Standard Reinsurance Agreement (or other reinsurance agreement), or if the appeal is from a determination by the Deputy Administrator of Compliance concerning a determination regarding a compliance matter, the notice of appeal should describe the determination in enough detail to enable the Board to differentiate that decision from any other; the appellant can satisfy this requirement by attaching to the notice of appeal a copy of the Deputy Administrator's determination. If an appeal is taken from the failure of the Deputy Administrator to make a timely determination, the notice of appeal should describe in detail the matter that the Deputy Administrator has failed to determine; the appellant can satisfy this requirement by attaching to the notice of appeal a copy of the written request for a determination it sent to the Deputy Administrator.

    (2) In Rule 2(a) (48 CFR 6101.2(a)), the references to “contracting officer” are references to “Deputy Administrator.”

    (3) Rule 2(b) (48 CFR 6101.2(b)) does not apply to FCIC cases.

    (4) In Rule 2(d)(1) (48 CFR 6101.2(d)(1)), an appeal from a determination of a Deputy Administrator shall be filed no later than 90 calendar days after the date the appellant receives that determination. The Board is authorized to resolve only those appeals that are timely filed.

    (5) In Rule 2(d)(2) (48 CFR 6101.2(d)(2)), an appeal may be filed with the Board if the Deputy Administrator fails or refuses to issue a determination within 90 days after the appellant submits a request for a determination.

    (c) Rule 4 (48 CFR 6101.4). (1) In Rule 4, the references to “contracting officer” are references to “Deputy Administrator.”

    (2) In Rule 4(a), paragraphs (1) through (7) (48 CFR 6101.4(a)(1) through (7)), describing materials included in the appeal file, are replaced by the following:

    (i) The determination of the Deputy Administrator that is the subject of the dispute;

    (ii) The reinsurance agreement (with amendments or modifications) at issue in the dispute;

    (iii) Pertinent correspondence between the parties that is relevant to the dispute, including prior administrative determinations and related submissions;

    (iv) Documents and other tangible materials on which the Deputy Administrator relied in making the underlying determination; and

    (v) Any additional material pertinent to the authority of the Board or the resolution of the dispute.

    (3) The following subsection is added to Rule 4 (48 CFR 6101.4): Media on which appeal file is to be submitted. All appeal file submissions, including the index, shall be submitted in two forms: Paper and in a text or .pdf format submitted on a compact disk. Each compact disk shall be labeled with the name and docket number of the case. The judge may delay the submission of the compact disk copy of the appeal file until the close of the evidentiary record.

    (d) Rule 5 (48 CFR 6101.5). In Rule 5(a)(2) (48 CFR 6101.5(a)(2)), the references to “contracting officer” are references to “Deputy Administrator.”

    (e) Rule 15 (48 CFR 6101.15). In Rule 15(c) (48 CFR 6101.15(c)), the final sentence does not apply to FCIC cases.

    (f) Rule 16 (48 CFR 6101.16). Rules 16 (b) through (h) (48 CFR 6101.16(b) through (h)) do not apply to FCIC cases. Instead, upon the written request of any party filed with the Office of the Clerk of the Board, or upon the initiative of a judge, a judge is authorized by delegation from the Secretary of Agriculture to request the appropriate United States Attorney to apply to the appropriate United States District Court for the issuance of subpoenas pursuant to 5 U.S.C. 304.

    (g) Rule 25 (48 CFR 6101.25). In Rule 25(a) (48 CFR 6101.25(a)), the phrase, “except as allowed by Rule 52,” does not apply to FCIC cases.

    (h) Rule 32 (48 CFR 6101.32). Rule 32 (a) through (c) (48 CFR 6101.32(a) through (c)) are replaced with the following for FCIC cases:

    (1) Finality of Board decision. A decision of the Board is a final administrative decision.

    (2) Appeal permitted. An appellant may file suit in the appropriate United States District Court to challenge the Board's decision. An appellant filing such a suit shall provide the Board with a copy of the complaint.

    (i) Rule 52 (48 CFR 6101.52). Rule 52 does not apply to FCIC cases.

    (j) Rule 53 (48 CFR 6101.52). Rule 53 does not apply to FCIC cases.

    [FR Doc. 2018-17213 Filed 8-16-18; 8:45 am] BILLING CODE 6820-AL-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 120815345-3525-02] RIN 0648-XG420 Snapper-Grouper Fishery of the South Atlantic; 2018 Commercial Accountability Measure and Closure for the Other Jacks 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 Jacks Complex commercial sector in the exclusive economic zone (EEZ) of the South Atlantic for the 2018 fishing year through this temporary rule. The Other Jacks Complex is composed of the lesser amberjack, almaco jack, and banded rudderfish. NMFS projects that commercial landings of the Other Jacks Complex will reach the combined commercial annual catch limit (ACL) by August 22, 2018. Therefore, NMFS closes the commercial sector for this complex in the South Atlantic EEZ, on August 22, 2018, and it will remain closed until the start of the next fishing year on January 1, 2019. This closure is necessary to protect the lesser amberjack, almaco jack, and banded rudderfish resources.

    DATES:

    This temporary rule is effective at 12:01 a.m., local time, on August 22, 2018, until 12:01 a.m., local time, on January 1, 2019.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    The snapper-grouper fishery of the South Atlantic includes lesser amberjack, almaco jack, and banded rudderfish, which combined are the Other Jacks Complex. The Other Jacks Complex 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 combined commercial ACL for the Other Jacks Complex is 189,422 lb (85,920 kg), round weight. Under 50 CFR 622.193(l)(1)(i), NMFS is required to close the commercial sector for the Other Jacks Complex when the commercial ACL has been reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined that the commercial sector for this complex is projected to reach its ACL by August 22, 2018. Therefore, this temporary rule implements an AM to close the commercial sector for the Other Jacks Complex in the South Atlantic, effective at 12:01 a.m., local time, on August 22, 2018.

    The operator of a vessel with a valid commercial permit for South Atlantic snapper-grouper having lesser amberjack, almaco jack, or banded rudderfish on board must have landed and bartered, traded, or sold such species prior to 12:01 a.m., local time, on August 22, 2018. During the commercial closure, the recreational bag limit specified in 50 CFR 622.187(b)(8) and the possession limits specified in 50 CFR 622.187(c) apply to all harvest or possession of lesser amberjack, almaco jack, or banded rudderfish in or from the South Atlantic EEZ, while the recreational sector is open. These recreational bag and possession limits apply in the South Atlantic on board a vessel for which a valid Federal commercial or charter vessel/headboat permit for South Atlantic snapper-grouper has been issued, regardless of whether such species were harvested in state or Federal waters. During the commercial closure, the sale or purchase of lesser amberjack, almaco jack, or banded rudderfish taken from the South Atlantic EEZ is prohibited.

    Classification

    The Regional Administrator for the NMFS Southeast Region has determined this temporary rule is necessary for the conservation and management of the fish in the Other Jacks Complex, a component of the South Atlantic snapper-grouper fishery, and is consistent with the Magnuson-Stevens Act and other applicable laws.

    This action is taken under 50 CFR 622.193(l)(1)(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 public comment.

    This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA) finds that the need to immediately implement this action to close the commercial sector for the Other Jacks 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 itself has 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 of the need to immediately implement this action to protect the species in the Other Jacks Complex, since the capacity of the fishing fleet allows for rapid harvest of the commercial ACL. Prior notice and opportunity for public comment would require time and would potentially result in a harvest well in excess of the established commercial 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 13, 2018. Margo B. Schulze-Haugen, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-17719 Filed 8-16-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 170816769-8162-02] RIN 0648-XG402 Fisheries of the Exclusive Economic Zone Off Alaska; Sablefish in the West Yakutat District of 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 retention of sablefish by vessels using trawl gear in the West Yakutat District of the Gulf of Alaska (GOA). This action is necessary because the 2018 total allowable catch of sablefish allocated to vessels using trawl gear in the West Yakutat District of the GOA will be reached.

    DATES:

    Effective 1200 hours, Alaska local time (A.l.t.), August 14, 2018, through 2400 hours, A.l.t., December 31, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Steve Whitney, 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 2018 total allowable catch (TAC) of sablefish allocated to vessels using trawl gear in the West Yakutat District of the GOA is 240 metric tons (mt) as established by the final 2018 and 2019 harvest specifications for groundfish of the GOA (83 FR 8768, March 1, 2018).

    In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2018 TAC of sablefish allocated to vessels using trawl gear in the West Yakutat District of the GOA will be reached. Therefore, NMFS is requiring that sablefish caught by vessels using trawl gear in the West Yakutat District of the GOA be treated as prohibited species in accordance with § 679.21(b).

    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 prohibiting the retention of sablefish by vessels using trawl gear in the West Yakutat District of 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 13, 2018.

    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 §§ 679.20 and 679.21 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: August 14, 2018. Margo B. Schulze-Haugen, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-17798 Filed 8-14-18; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 170816769-8162-02] RIN 0648-XG400 Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Ocean Perch in the West Yakutat District of 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 Pacific ocean perch in the West Yakutat District of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2018 total allowable catch of Pacific ocean perch in the West Yakutat District of the GOA.

    DATES:

    Effective 1200 hours, Alaska local time (A.l.t.), August 14, 2018, through 2400 hours, A.l.t., December 31, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Steve Whitney, 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 2018 total allowable catch (TAC) of Pacific ocean perch in the West Yakutat District of the GOA is 3,371 metric tons (mt) as established by the final 2018 and 2019 harvest specifications for groundfish of the GOA (83 FR 8768, March 1, 2018).

    In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2018 TAC of Pacific ocean perch in the West Yakutat District of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 3,271 mt, and is setting aside the remaining 100 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch in the West Yakutat District of the GOA. While this closure remains effective 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 directed fishing for Pacific ocean perch in the West Yakutat District of 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 13, 2018.

    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 § 679.20 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: August 14, 2018. Margo B. Schulze-Haugen, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-17797 Filed 8-14-18; 4:15 pm] BILLING CODE 3510-22-P
    83 160 Friday, August 17, 2018 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2018-0769; Airspace Docket No. 18-ASW-10] RIN 2120-AA66 Proposed Amendment of VOR Federal Airways V-18, V-102, and V-278 in the Vicinity of Guthrie, TX AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend VHF Omnidirectional Range (VOR) Federal airways V-18, V-102, and V-278 in the vicinity of Guthrie, TX. The modifications are necessary due to the planned decommissioning of the Guthrie, TX, VOR/Tactical Air Navigation (VORTAC) navigation aid (NAVAID), which provides navigation guidance for portions of the affected air traffic service (ATS) routes. The Guthrie VORTAC is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.

    DATES:

    Comments must be received on or before October 1, 2018.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2018-0769; Airspace Docket No. 18-ASW-10 at the beginning of your comments. You may also submit comments through the internet at http://www.regulations.gov.

    FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11B at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Colby Abbott, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.

    SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify the route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System.

    Comments Invited

    Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

    Communications should identify both docket numbers (FAA Docket No. FAA-2018-0769; Airspace Docket No. 18-ASW-10) and be submitted in triplicate to the Docket Management Facility (see ADDRESSES section for address and phone number). You may also submit comments through the internet at http://www.regulations.gov.

    Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2018-0769; Airspace Docket No. 18-ASW-10.” The postcard will be date/time stamped and returned to the commenter.

    All communications received on or before the specified comment closing date will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Operations Support Group, Central Service Center, Federal Aviation Administration, 10101 Hillwood Blvd., Fort Worth, TX 76177.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    Background

    The FAA is planning decommissioning activities for the Guthrie, TX, VORTAC in 2019 as one of the candidate VORs identified for discontinuance by the FAA's VOR MON program and listed in the final policy statement notice, “Provision of Navigation Services for the Next Generation Air Transportation System (NextGen) Transition to Performance-Based Navigation (PBN) (Plan for Establishing a VOR Minimum Operational Network),” published in the Federal Register of July 26, 2016 (81 FR 48694), Docket No. FAA-2011-1082. Although the VOR portion of the Guthrie, TX, VORTAC NAVAID is planned for decommissioning, the Distance Measuring Equipment (DME) portion is being retained. The ATS routes effected by the Guthrie VORTAC are VOR Federal airways V-18, V-102, and V-278.

    With the planned decommissioning of the Guthrie VORTAC, the remaining ground-based NAVAID coverage in the area is insufficient to enable the continuity of the affected airways. As such, proposed modifications to V-18, V-102, and V-278 would result in gaps in the route structures. To overcome the gaps, instrument flight rules (IFR) traffic could use adjacent VOR Federal airways V-14 and V-114 between the Lubbock, TX, VORTAC and Wichita Falls, TX, VORTAC; Federal airways V-14, V-114, and V-355 between the Lubbock, TX, VORTAC and Bowie, TX, VORTAC; or Federal airways V-62 and V-66 between the Lubbock, TX, VORTAC and Millsap, TX, VORTAC to circumnavigate the affected area. Additionally, IFR traffic could file point to point through the affected area using fixes that will remain in place, or receive air traffic control (ATC) radar vectors through the area. Visual flight rules pilots who elect to navigate via the airways through the affected area could also take advantage of the adjacent VOR Federal airways or ATC services listed previously.

    The Proposal

    The FAA is proposing an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 by modifying VOR Federal airways V-18, V-102, and V-278. The planned decommissioning of the Guthrie, TX, VORTAC has made these actions necessary. The proposed VOR Federal airway changes are outlined below.

    V-18: V-18 currently extends between the Guthrie, TX, VORTAC and the Charleston, SC, VORTAC. The FAA proposes to remove the airway segment between the Guthrie, TX, VORTAC and the Millsap, TX, VORTAC. The unaffected portions of the existing airway would remain as charted.

    V-102: V-102 currently extends between the Salt Flat, TX, VORTAC and the Wichita Falls, TX, VORTAC. The FAA proposes to remove the airway segment between the Lubbock, TX, VORTAC and the Wichita Falls, TX, VORTAC. The unaffected portions of the existing airway would remain as charted.

    V-278: V-278 currently extends between the Texico, NM, VORTAC and the Vulcan, AL, VORTAC. The FAA proposes to remove the airway segment between the Plainview, TX, VOR/DME and the Bowie, TX, VORTAC. The unaffected portions of the existing airway would remain as charted.

    VOR Federal airways are published in paragraph 6010(a) of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airways listed in this document would be subsequently published in the Order.

    Regulatory Notices and Analyses

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

    Environmental Review

    This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017 and effective September 15, 2017, is amended as follows: Paragraph 6010(a) Domestic VOR Federal Airways. V-18 [Amended]

    From Millsap, TX; Glen Rose, TX; Cedar Creek, TX; Quitman, TX; Belcher, LA; Monroe, LA; Magnolia, MS; Meridian, MS; Crimson, AL; Vulcan, AL; Talladega, AL; Atlanta, GA; Colliers, SC; to Charleston, SC.

    V-102 [Amended]

    From Salt Flat, TX; Carlsbad, NM; Hobbs, NM; to Lubbock, TX.

    V-278 [Amended]

    From Texico, NM; to Plainview, TX. From Bowie, TX; Bonham, TX; Paris, TX; Texarkana, AR; Monticello, AR; Greenville, MS; Sidon, MS; Bigbee, MS; to Vulcan, AL.

    Issued in Washington, DC, on August 13, 2018. Rodger A. Dean Jr., Manager, Airspace Policy Group.
    [FR Doc. 2018-17767 Filed 8-16-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 876, 878, and 886 [Docket No. FDA-2018-N-3066] Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification; request for comments.

    SUMMARY:

    As required by the FDA Reauthorization Act of 2017 (FDARA), the Food and Drug Administration (FDA or Agency) has identified a list of accessories for which the Agency believes general controls alone are sufficient to provide reasonable assurance of safety and effectiveness, so the accessories could be in class I. FDA is publishing this document proposing to classify these accessories into class I and distinct from other devices, as well as seek public comment in accordance with procedures established by FDARA. This document does not represent FDA's final determination with respect to the proposed accessories listed in this document.

    DATES:

    Submit either electronic or written comments on the document by October 16, 2018.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 16, 2018 The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 16, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-2018-N-3066 for “Medical Devices; Classification of Accessories Distinct from Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Ian Ostermiller, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5454, Silver Spring, MD 20993-0002, 301-796-5678.

    SUPPLEMENTARY INFORMATION: I. Background

    On August 18, 2017, FDARA was signed into law (Pub. L. 115-52). Section 707 of FDARA amended section 513(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and, among other amendments, created a process for FDA to propose a list of accessories suitable for distinct classification into class I (see section 513(f)(6)(D)(i) of the FD&C Act (21 U.S.C. 360c(f)(6)(D)(i))). Section 707 of FDARA mandated that FDA make the first such proposal within a year of enactment of FDARA, and FDA is publishing this document in accordance with this statutory mandate.

    Section 201(h) of the FD&C Act defines “device” to include, among other articles, an “accessory” (see 21 U.S.C. 321(h)). As such, all articles that meet the definition of “device”, including accessories, are regulated under the FD&C Act. Based on sections 201(h) and 513(f)(6) of the FD&C Act, we have described our current thinking on which devices we would generally consider to be accessories in the guidance document, “Medical Device Accessories—Describing Accessories and Classification Pathways,” available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429672 (“Accessories Guidance”). That guidance defines an accessory as a “finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices.”

    Section 513 of the FD&C Act defines three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval). Some accessories may be granted marketing authorization as part of a submission for another device with which they are intended to be used and in class II or III that, if considered distinctly from another device (such as the parent device), may be suitable for classification into class I if general controls alone are sufficient to provide a reasonable assurance of safety and effectiveness of the accessory.

    Section 513(h)(1) defines general controls as the controls authorized by or under sections 501, 502, 510, 516, 518, 519, and 520 of the FD&C Act. These controls include, but are not limited to, provisions related to adulteration and misbranding, registration and listing, records and reports on devices, and good manufacturing practices. The regulations for good manufacturing practices are under 21 CFR part 820, the Quality System regulation. Subject to the exceptions identified in § 820.30(a)(2) (21 CFR 820.30(a)(2)) for specific devices and those automated with computer software, design controls under § 820.30 do not generally apply to a class I device.

    This document represents FDA's compliance with FDARA's requirement to identify the first list of accessories suitable for distinct classification into class I. As required by FDARA, we are providing you with the opportunity to provide comment. Once the comment period ends, we will consider the comments and publish in the Federal Register a final action classifying such suitable accessories into class I.

    II. Factors for Consideration

    The classification of each accessory will be based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used (see section 513(f)(6)(A) of the FD&C Act).

    In general, we considered an accessory to be eligible for classification into class I distinct from another device if the accessory: (1) Is not for use in supporting or sustaining human life, or of substantial importance in preventing impairment to human health; (2) does not represent a potential unreasonable risk of illness or injury; and (3) general controls alone would be sufficient to provide a reasonable assurance of safety and effectiveness of the accessory.

    Note that by regulation, design controls apply to class I devices only if the devices are automated with computer software or are listed under § 820.30(a)(2)(ii). Thus, if an accessory is not automated with computer software but would require design controls to provide reasonable assurance of safety and effectiveness, we did not consider it eligible for classification through the final action based on this document.

    You may wish to propose additional accessories as suitable for distinct classification into class I using the factors described above where the accessories are otherwise eligible for classification under section 513(f)(6)(D)(i) of the FD&C Act. Should you wish to propose additional accessories, your comment should briefly explain why you think general controls alone will provide reasonable assurance of safety and effectiveness. Conversely, should you disagree with any of the proposed accessories for class I, your comments should briefly explain why additional regulatory controls, such as premarket review through a 510(k) submission or premarket approval (PMA), are necessary to provide reasonable assurance of safety and effectiveness.

    III. Policy Clarification for Classification of Certain Accessories Used in Orthopedic Surgery

    Certain manual orthopedic instruments that are for use with other devices in orthopedic surgery meet FDA's definition of an accessory described in the Accessories Guidance. Accordingly, we are clarifying our intended regulatory approach for certain accessories used in orthopedic surgery to distinguish which accessories may be candidates for classification per section 513(f)(6)(D)(i) of the FD&C Act.

    Instruments for use in orthopedic surgery vary widely from general manual surgical instruments used to manipulate tissue to more complex accessories specifically designed for use with a parent device/system. Orthopedic manual surgical instruments are classified in § 888.4540 (21 CFR 888.4540), and many “general use” instruments fall within this classification. This regulation pertains to “nonpowered hand-held device[s] intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.” These devices are class I, subject to general controls, and exempt from premarket notification procedures, subject to the limitations of exemptions in 21 CFR 888.9. This classification was based upon recommendations provided to FDA by the Orthopedic Device Classification Panel (the Panel) in October 1977 regarding classification of medical devices in commercial distribution before May 28, 1976. The Panel identified the following risks to health for this device type: “Tissue damage and adverse tissue reaction: Inadequate mechanical properties, such as lack of material strength of the device, may result in device fracture and possible tissue damage and, if fragments of the fractured device remain in the tissue, an adverse tissue reaction may result” (47 FR 29052).

    FDA agreed that class I was appropriate because general controls alone were sufficient to mitigate the risk of tissue damage and adverse tissue reaction associated with inadequate mechanical properties and provide a reasonable assurance of the safety and effectiveness of these devices. Over time, manufacturers have developed and sought to market orthopedic instrumentation with designs unique to a device system, and these types of instruments may present new or different risks compared to inadequate mechanical properties. For example, certain device-specific instruments are accessories and require precise technical specifications or design characteristics to function as intended to support, supplement or augment the parent device, and if not designed appropriately, could cause implant malpositioning or migration. Accordingly, FDA considers design controls (see § 820.30) to be an important element in the regulation of device-specific accessories, among other regulatory controls, to ensure appropriate compatibility between the accessory and the parent device. In contrast, class I orthopedic manual surgical instruments do not require such controls.

    Instruments that are “device-specific,” or designed for use with a specific parent device/system and thus are accessories, have historically been reviewed in the same premarket submission as the parent device. In an effort to ensure a common understanding as to which orthopedic accessories fall under the existing class I regulation (§ 888.4540), and which devices do not and, therefore, may be candidates for classification under section 513(f)(6)(D)(i) of the FD&C Act, we propose the following definition: A device-specific orthopedic instrument is considered to be an accessory designed specifically for appropriate implantation or placement of the parent device, based upon unique dimensions, geometry, and/or deployment. In these cases, design specifications are critical to the proper use of the accessory in supporting, supplementing, and/or augmenting the performance of the parent device and/or a specific system. This excludes general use orthopedic instruments that are provided as a part of a system.

    It is often necessary for orthopedic instruments to be described in a premarket submission (e.g., 510(k), PMA) to evaluate that the parent device functions as intended. Such orthopedic instruments may be appropriately classified in an existing class I regulation (§ 888.4540) if they do not meet the definition of a device-specific orthopedic accessory above and their risk profile and necessary regulatory controls are commensurate with that of orthopedic manual surgical instruments. If they do meet the definition of a device-specific orthopedic accessory above, then such orthopedic accessories may still be eligible for classification under section 513(f)(6)(D)(ii) of the FD&C Act.

    We welcome comments to help identify accessories in other product areas where the classification of the accessory relative to the parent device may be unclear and would benefit from this type of policy clarification.

    IV. Proposed List of Accessories That May Be Suitable for Distinct Classification Into Class I

    We are proposing the following accessories, which have been granted marketing authorization as part of a premarket submission (i.e., 510(k), De Novo classification request, or PMA) for another device with which they are intended to be used, as suitable for distinct classification into class I (see Table 1). When we publish the final list of accessories based on this list and the factors in section II, we will consider those accessories classified into class I, distinct from other devices, through such action.

    We would place each of these accessories in 21 CFR part 876, 878, or 886, as appropriate. Each of these accessories would be class I, exempt from the premarket notification procedures in 21 CFR part 807, subject to the applicable limitations of exemption (i.e., 21 CFR 876.9, 878.9, or 886.9). We intend to make conforming changes to existing classification regulations as appropriate.

    Table 1—Proposed Accessories for Classification Into Class I and Distinct From Other Devices Current status of accessory Current classification regulation
  • (21 CFR)
  • Device type
  • (existing product code)
  • Proposed device type identification
    876.1075 Gastroenterology-urology accessories to a biopsy instrument (FCG) Accessories used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas. 876.3350 and 876.3630 Penile implant surgical accessories (JCW and FHW) Manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, temporary tubing plug, and hemostat shod tubing. 876.4620 Ureteral stent accessories (FAD) Accessories that aid in the insertion of the ureteral stent that is placed into the ureter to provide ureteral rigidity and allow the passage of urine. This generic type of device includes the stent positioner, wire guide, and pigtail straightener. 876.5010 Biliary stent, drain, and dilator accessories (FGE) Manual devices that aid in the introduction and connection of biliary stents, drains, or dilators. This generic type of device includes the guiding catheter, pushing catheter, pigtail straightener, flap protector, nasal transfer tube, and drainage connecting tube. 876.5090 Suprapubic catheter accessories (KOB) Manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath. 876.5280 Implanted mechanical/hydraulic urinary continence device surgical accessories (EZY) Manual devices designed to be used for surgical procedures associated with the implantation of an implanted mechanical/hydraulic urinary continence device. This generic type of device includes the measurement tool or tape, connector assembly tool, temporary tubing plug, incision closing tool, tubing passer, and hemostat shod tubing. 878.5070 Air-handling apparatus accessory (FYD) Supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room. This device provides an interface between the components of the device or can be used to switch electrical power. This generic type of device includes fittings, adapters, couplers, remote switches, and footswitches. No corresponding CFR Section Corneal inlay inserter handle (LQE) Hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.
    V. Paperwork Reduction Act of 1995

    This document refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the following table:

    21 CFR part; guidance; or FDA form Topic OMB control No. 807, subpart E Premarket notification 0910-0120 814, subparts A through E Premarket approval 0910-0231 “De Novo Classification Process (Evaluation of Automatic Class III Designation)” De Novo classification process 0910-0844 800, 801, and 809 Medical Device Labeling Regulations 0910-0485 820 Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation 0910-0073 “Medical Device Accessories—Describing Accessories and Classification Pathways for New Accessory Types” Medical Device Accessories 0910-0823 Dated: August 13, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-17731 Filed 8-16-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-131186-17] RIN 1545-BO05 Proposed Removal of Temporary Regulations on a Partner's Share of a Partnership Liability for Disguised Sale Purposes; Hearing Cancellation AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Cancellation of notice of public hearing on proposed rulemaking.

    SUMMARY:

    This document cancels a public hearing on proposed regulations concerning how partnership liabilities are allocated for disguised sale purposes.

    DATES:

    The public hearing, originally scheduled for August 21, 2018 at 10:00 a.m. is cancelled.

    FOR FURTHER INFORMATION CONTACT:

    Regina Johnson of the Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration) at (202) 317-6901 (not a toll-free number).

    SUPPLEMENTARY INFORMATION:

    A notice of proposed rulemaking and notice of public hearing that appeared in the Federal Register on Tuesday, June 19, 2018 (83 FR 28397) announced that a public hearing was scheduled for August 21, 2018 at 10:00 a.m. in the IRS Auditorium, Internal Revenue Service Building, 1111 Constitution Avenue NW, Washington, DC. The subject of the public hearing is under section 707 of the Internal Revenue Code.

    The public comment period for these regulations expired on July 19, 2018. The notice of proposed rulemaking and notice of hearing instructed those interested in testifying at the public hearing to submit a request to speak and an outline of the topics to be discussed. The outline of topics to be discussed was due by August 3, 2018. As of August 3, 2018, no one has requested to speak. Therefore, the public hearing scheduled for August 21, 2018 at 10:00 a.m. is cancelled.

    Martin V. Franks, Branch Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration).
    [FR Doc. 2018-17792 Filed 8-16-18; 8:45 am] BILLING CODE 4830-01-P
    DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 199 [Docket ID DOD-2016-HA-0112] RIN 0720-AB69 TRICARE; Extended Care Health Option (ECHO) Respite Care AGENCY:

    Office of the Secretary, Department of Defense (DoD).

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule requests public comment on a proposed revision to the TRICARE Extended Care Health Option (ECHO) respite care benefit. Under the current program, TRICARE beneficiaries enrolled in ECHO are eligible for 16 hours of respite care per month in any month during which the beneficiary receives another ECHO authorized benefit (other than the EHHC benefit). This proposed rule seeks to eliminate the concurrent ECHO benefit requirement and allow beneficiaries enrolled in ECHO to receive a maximum of 16 hours of respite care per month, regardless of whether another ECHO benefit is received in the same month.

    DATES:

    Written comments received at the address indicated below by October 16, 2018 will be accepted.

    ADDRESSES:

    You may submit comments, identified by docket number or Regulatory Information Number (RIN) and title, by either 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 and docket number or RIN for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Trish Reilly, Defense Health Agency, TRICARE Clinical Policy Division, telephone (619) 236-5332.

    SUPPLEMENTARY INFORMATION:

    I. Executive Summary A. Purpose of the Proposed Rule

    This proposed rule seeks to amend the TRICARE ECHO program regulation to expand beneficiary access to ECHO respite care services. This proposed rule, if implemented, would eliminate the concurrent ECHO benefit requirement and allow beneficiaries enrolled in ECHO to receive a maximum of 16 hours of respite care per month, regardless of whether another ECHO benefit is received in the same month.

    This regulation is proposed under the authority of 5 U.S.C. 301 which allows the Secretary of Defense to prescribe regulations for the government of DoD and 10 U.S.C. 1079(d) and (e), which directs the Secretary of Defense to establish a program to provide extended benefits for eligible active duty dependents, which may include the provision of comprehensive health care services, including case management services, to assist in the reduction of the disabling effects of a qualifying condition of an eligible dependent. The Department is authorized to provide “respite care for the primary caregiver of the eligible dependent” as one of the specifically enumerated extended benefits under the ECHO program pursuant to 10 U.S.C. 1079(e)(6). The ECHO program has been implemented through regulation at 32 CFR 199.5.

    B. Summary of the Major Provisions of the Proposed Rule

    Per 32 CFR 199.5(c)(7), ECHO beneficiaries are eligible for a maximum of 16 hours of respite care per month in any month during which the beneficiary otherwise receives an ECHO benefit(s). This requirement for a concurrent ECHO benefit was originally implemented to ensure optimal medical management of the beneficiary's ECHO-qualifying condition. TRICARE proposes to eliminate the requirement for a beneficiary to receive a concurrent ECHO benefit in order to qualify for respite care. This change will expand access to respite care services (as recommended by the Military Compensation and Retirement Modernization Commission (MCRMC)), allowing families to access those hours without receiving another ECHO benefit during the same month the respite care is received.

    C. Expected Costs

    The proposed rule is estimated to cost the Department of Defense $5.7 million annually (based on FY17 data). If the proposed rule is implemented, it is anticipated that 2,924 ECHO beneficiaries will participate in the respite care program at an average cost of $1,937 per beneficiary (this number does not include homebound beneficiaries who receive respite care under the ECHO Home Health Care (EHHC) program). These beneficiaries are already in ECHO and, therefore, have completed all registration requirements. This expansion of the benefit requires nothing additional from the beneficiaries and will not result in an increased burden to the public. Currently, beneficiaries may not access ECHO respite care services if they are not utilizing another ECHO benefit during the same month, and this rulemaking action will eliminate this barrier to care.

    II. Discussion of the Proposed Rule A. Background

    Military families face unique challenges in caring for family members with special medical or educational needs that are complicated by frequent moves and repeated deployments. Support for these families involves a multi-faceted system coordinated across numerous functional areas within the Department of Defense and Military Services to include: The Military Health System (MHS); military personnel support services; housing programs; dependents' education programs; child and youth services; morale, welfare, and recreation activities; and community support activities, among others.

    The Exceptional Family Member Program (EFMP) is designed to identify active duty military family members with special medical and/or educational needs to ensure coordination of care and continuity of benefits throughout the military assignment and relocation process. EFMP provides additional support to these active duty military families to alleviate some of the challenges associated with frequent family relocations and deployments of their sponsoring service member as required by military duties. EFMP family support services have traditionally included respite care provided by certified day care providers in order to provide temporary relief to military family members who are responsible for the regular care of dependent family members with special needs. The Office of the Under Secretary of Defense for Personnel and Readiness published a proposed rule entitled “Exceptional Family Member Program (EFMP)” in the Federal Register (80 FR 76881-76889) on December 11, 2015, that provides additional details. The Assistant Secretary of Defense for Health Affairs is tasked with advising on the availability of specialized medical services to families with special needs in the Military Health System and ensuring there is a medical case management program to support eligible beneficiaries' medical needs.

    Active Duty families enrolled in EFMP may be eligible, based on qualifying conditions, for TRICARE Extended Health Care Option (ECHO) expanded benefits. ECHO is a supplemental program to the TRICARE Basic Program that provides eligible Active Duty Family Members extended benefits to include comprehensive health care services (including services necessary to maintain, or minimize or prevent deterioration of function of the patient) and case management services with respect to the qualifying condition which include serious physical disabilities and extraordinary physical or psychological conditions as defined in 32 CFR 199.2. The purpose of ECHO is to provide an additional financial resource for an integrated set of services and supplies designed to assist in the reduction of the disabling effects of the beneficiary's qualifying condition. The ECHO program provides coverage for medical, habilitative, and rehabilitative services and supplies not covered under the TRICARE Basic Program; durable medical equipment, including adaptation and maintenance; assistive technologies devices and training to use the devices; comprehensive home health care services (e.g., ventilator support, medication administration); and other services to support eligible family members.

    The final rule implementing the ECHO Program (which was previously called the Program for Persons with Disabilities (PFPWD) from 1997-2004, and before that the Program for the Handicapped (PFTH) from origination in 1966-1997), amended the TRICARE regulations governing the PFPWD and was published in the Federal Register (69 FR 44947) on July 28, 2004.

    ECHO-registered beneficiaries who are not receiving ECHO Home Health Care (EHHC) services currently are eligible to receive a maximum of 16 hours of respite care in any calendar month in which they also receive any other ECHO authorized benefit other than the EHHC benefit. Respite care consists of providing skilled and non-skilled health care services for the covered beneficiary such that in the absence of the primary caregiver, management of the beneficiary's ECHO qualifying condition and safety are provided. In order to assure the quality of care for beneficiaries enrolled in ECHO, all ECHO respite care services must be provided by Medicare or Medicaid certified Home Health Agencies (HHAs) who have in effect at the time of services a valid agreement to participate in the TRICARE program. The ECHO respite care program (which provides health care services by a home health agency) should not be considered a substitute for EFMP respite care (which provides day care services by a certified day care provider), because not all EFMP family members qualify for ECHO or require specific health care services in the absence of the primary caregiver. The goal is to ensure that these families have access to the appropriate services to meet their specific needs while still ensuring fiscally prudent expenditures of appropriated funds.

    In addition to EFMP respite care and ECHO respite care, there is a third type of respite care, EHHC respite care. The EHHC benefit provides coverage of home health care services and respite care services for ECHO eligible beneficiaries who require more than intermittent or part-time home health services covered under the TRICARE Basic Program. This would include ventilator-dependent beneficiaries and others with extraordinary physical conditions. EHHC beneficiaries whose plan of care includes frequent interventions by the primary caregiver(s) (e.g., frequent suctioning, tube feeding, medication administration etc.) are eligible for respite services under EHHC in lieu of the ECHO general respite benefit. EHHC respite care may include a maximum of 8 hours per day, 5 days per week, by a TRICARE-authorized home health agency. The Department is not proposing any changes to the robust EHHC respite care benefit as part of this proposed rule, but includes a description of the program in order to clarify the full spectrum of respite care programs available to active duty military families with special needs.

    B. Proposed Change to the ECHO Respite Care Benefit

    The Department of Defense remains committed to supporting Service members and their family members with special needs. Together, the Office of Community Support for Military Families with Special Needs, the Services, and the MHS, are working to enhance and improve support for these families, including everything from complex medical management to non-clinical case management and family support services. The Department is also committed to eliminating unnecessary requirements that act as barriers to care. Consistent with these principles, the Department is proposing this specific amendment to the existing regulations governing the ECHO program.

    The requirement to receive a concurrent ECHO benefit in order to be entitled to ECHO respite care was originally imposed as a medical management tool. We now conclude that this specific requirement is no longer necessary and may serve as an inappropriate barrier to receipt of respite services for some families. Even in those months where no other ECHO services are provided (where all needed care may already be covered under the Basic Program or under demonstration authority), there may still be some health care services rendered to the beneficiary enrolled in ECHO by the primary caregiver for which respite care provided by a home health agency is warranted.

    We note that the January 2015 Report of the MCRMC cited a need to improve support for military members with special needs dependents and made a number of recommendations. We have already implemented or are taking steps to implement several of their specific recommendations, including the recommendation to allow families to access ECHO respite care without receiving another ECHO benefit during the same month that respite care is received which is proposed in this rule. The Department is still studying some of the other recommendations that were made in order to identify and implement, as appropriate, ECHO enhancements that will be of greatest benefit to our beneficiaries. Finally, we believe some of the recommendations fall outside the purview of the ECHO program specifically, and the Military Health System in general, and are more appropriately directed to the Office of Community Support for Military Families with Special Needs, including the provision of respite care that does not involve health care services (i.e., EFMP respite).

    We propose that elimination of the requirement for a simultaneous ECHO benefit will provide maximum flexibility to families without sacrificing the goal of ensuring the safe and effective management of the beneficiary's ECHO qualifying condition. First, we note that TRICARE beneficiaries with complex medical needs may receive case management services including medical management, disease management and chronic care coordination, under the TRICARE Basic Program, regardless of whether the beneficiary is an ECHO eligible beneficiary. As the TRICARE program has evolved over time, continuing to require an ECHO eligible beneficiary to receive a concurrent ECHO benefit as a medical management tool is no longer necessary. Based on our current program structure, beneficiaries should already be receiving medical management services and the receipt of any ECHO benefit, including ECHO respite care, provides an additional opportunity to ensure the safe and effective management of the beneficiary's qualifying condition. Furthermore, in accordance with 32 CFR 199.5(h)(3), all ECHO benefits, including ECHO respite care, require authorization prior to receipt of such benefits. Paragraph (i) discusses required documentation as a prerequisite to authorizing ECHO benefits. As a practical matter, the home health agency providing the respite services must document the health care services needed by the ECHO beneficiary in the absence of the family caregiver and the schedule for the services during the provision of respite care in order to ensure an appropriately trained provider is sent and the beneficiary's needs are met. If this regulatory change is enacted, after public comment, additional details regarding required documentation to be provided to the Managed Care Support Contractor and home health agency for authorization of ECHO respite services will be published in the TRICARE Policy Manual available at http://manuals.tricare.osd.mil. We believe that this approach will provide greater flexibility and eliminate unnecessary barriers for families to access to ECHO respite care services while still ensuring the safe and effective medical management of the beneficiary's medical condition(s).

    III. Regulatory Procedures Executive Order 12866, “Regulatory Planning and Review” and Executive Order 13563, “Improving Regulation and Regulatory Review”

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. A regulatory impact analysis must be prepared for major rules with economically significant effects ($100 million or more in any one year). This rulemaking is neither “economically significant” as measured by the $100 million threshold, nor is it otherwise significant.

    Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs”

    This proposed rule is not expected to be an E.O. 13771 regulatory action because it is not significant under E.O. 12866.

    Congressional Review Act, 5 U.S.C. 804(2)

    Under the Congressional Review Act, a major rule may not take effect until at least 60 days after submission to Congress of a report regarding the rule. A major rule is one that would have an annual effect on the economy of $100 million or more or have certain other impacts. This proposed rule is not a major rule under the Congressional Review Act.

    Public Law 96-354, “Regulatory Flexibility Act” (RFA), (Title 5, U.S.C., Sec. 601)

    The Regulatory Flexibility Act requires that each Federal agency analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. This proposed rule is not an economically significant regulatory action, and it will not have a significant impact on a substantial number of small entities. Therefore, this rule is not subject to the requirements of the RFA.

    Public Law 104-4, Sec. 202, “Unfunded Mandates Reform Act”

    Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any one year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $140 million. This final rule will not mandate any requirements for state, local, or tribal governments or the private sector.

    Public Law 96-511, “Paperwork Reduction Act” (Title 44, U.S.C., Chapter 35)

    This rule will not impose significant additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 3502-3511). Existing information collection requirements of the TRICARE and Medicare programs will be utilized. TRICARE ECHO respite care providers will be coding and filing claims in the same manner as they currently are with TRICARE.

    Executive Order 13132, “Federalism”

    This rule has been examined for its impact under E.O. 13132, and it does not contain policies that have federalism implications that would have substantial direct effects on the States, on the relationship between the national Government and the States, or on the distribution of powers and responsibilities among the various levels of Government. Therefore, consultation with State and local officials is not required.

    List of Subjects in 32 CFR Part 199

    Claims, Dental health, Health care, Health insurance, Individuals with disabilities, Military personnel.

    Accordingly, 32 CFR part 199 is proposed to be amended as follows:

    PART 199—CIVILIAN HEALTH AND MEDICAL PROGRAM OF THE UNIFORMED SERVICES (CHAMPUS) 1. The authority citation for part 199 continues to read as follows: Authority:

    5 U.S.C. 301; 10 U.S.C. chapter 55.

    2. Revise § 199.5(c)(7) introductory text to read as follows:
    § 199.5 TRICARE Extended Care Health Option (ECHO).

    (c) * * *

    (7) Respite care. TRICARE beneficiaries enrolled in ECHO are eligible for a maximum of 16 hours of respite care per month. Respite care in defined is § 199.2. Respite care services will be provided by a TRICARE-authorized home health agency and will be designed to provide health care services for the covered beneficiary, and not baby-sitting or child-care services for other members of the family. The benefit will not be cumulative, that is, any respite hours not used in one month will not be carried over or banked for use on another occasion.

    Dated: August 9, 2018. Shelly E. Finke, Alternate OSD Federal Register, Liaison Officer, Department of Defense.
    [FR Doc. 2018-17463 Filed 8-16-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2018-0577] RIN 1625-AA08 Special Local Regulation; Choptank River, Talbot and Dorchester Counties, MD AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to establish special local regulations for certain navigable waters of the Choptank River. This action is necessary to provide for the safety of life on these waters near Oxford, MD, from October 7, 2018, through October 15, 2018, during a sailboat regatta. This proposed rule would prohibit persons and vessels from being in the regulated area unless authorized by the Captain of the Port Maryland-National Capital Region or the Coast Guard Patrol Commander. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before September 17, 2018.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2018-0577 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this proposed rulemaking, call or email Mr. Ronald Houck, U.S. Coast Guard Sector Maryland-National Capital Region; telephone 410-576-2674, email [email protected]

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking PATCOM Patrol Commander § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

    On February 13, 2018, the Tred Avon Yacht Club of Oxford, MD, notified the Coast Guard through submission of a marine event application that it is planning to conduct a sailboat regatta from October 5, 2018, through October 15, 2018, the 2018 Star World Championship. Race activities on navigable waters are planned each afternoon of the regatta beginning on October 7th. The regatta consists of approximately 100 2-person, 23-foot long International Star Class sailboats. These vessels will operate along a designated and marked 2.5 nautical mile long course. The course is located on the Choptank River, in Talbot and Dorchester Counties, near Oxford, MD. Hazards from the sailboat regatta include participants operating within and adjacent to a designated navigation channel and interfering with vessels intending to operate within that channel, as well as injury to persons and damage to property that involve vessel mishaps during sailboat regattas conducted on navigable waters. The Captain of the Port Maryland-National Capital Region (COTP) has determined that potential hazards associated with the sailboat regatta would be a safety concern for anyone intending to operate in or near the race area.

    The purpose of this rulemaking is to protect event participants, spectators, and transiting vessels on waters in and near the race area before, during, and after the scheduled event. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1233, which authorizes the Coast Guard to establish special local regulations to promote the safety of life on navigable waters during regattas or marine parades.

    III. Discussion of Proposed Rule

    The COTP Maryland-National Capital Region is proposing to establish special local regulations that would be enforced from 11:30 a.m. until 5:30 p.m., each day, from October 7, 2018, through October 15, 2018. The proposed regulated area is rectangular in shape, measuring approximately six nautical miles in length by four nautical miles in width. The area would cover all navigable waters of the Choptank River, within an area bounded by the following coordinates: commencing at latitude 38°41′39.02″ N, longitude 076°11′19.18″ W, thence south to latitude 38°37′28.68″ N, longitude 076°11′19.18″ W, thence west to latitude 38°37′28.68″ N, longitude 076°18′18.35″ W, thence north to latitude 38°41′39027″ N, longitude 076°18′18.35″ W, thence east to point of origin, located near Oxford, MD.

    This proposed rule provides additional information about an area within the regulated area, the “Race Area”, and its definition.

    The proposed duration of the special local regulations and size of the regulated area are intended to ensure the safety of life on these navigable waters before, during, and after races, scheduled from noon until 5 p.m. on October 7, 8, 9, 10, 11, 12, 13, 14, and 15, 2018. The COTP and PATCOM would have authority to forbid and control the movement of vessels and persons, including event participants, in the regulated area. When hailed or signaled by an official patrol, a vessel or person in the regulated area would be required to immediately comply with directions given by the COTP or PATCOM. If a person or vessel fails to follow such directions, the Coast Guard may expel them from the area, issue them a citation for failure to comply, or both.

    Except for 2018 Star World Championship participants, a vessel or person would be required to get permission from the COTP or PATCOM before entering the regulated area. Vessel operators can request permission to enter and transit through the regulated area by contacting the PATCOM on VHF-FM channel 16. Vessel traffic would be able to safely transit the regulated area once the PATCOM deems it safe to do so. A person or vessel not registered with the event sponsor as a participant or assigned as official patrols would be considered a spectator. Official Patrols are any vessel assigned or approved by the Commander, Coast Guard Sector Maryland-National Capital Region with a commissioned, warrant, or petty officer on board and displaying a Coast Guard ensign.

    If permission is granted permission by the COTP or PATCOM, a person or vessel would be allowed to enter the regulated area or pass directly through the regulated area as instructed. Vessels would be required to operate at a safe speed that minimizes wake while within the regulated area. Official patrol vessels will direct spectator vessels while within the regulated area. Vessels would be prohibited from loitering within the navigable channel.

    The regulatory text we are proposing appears at the end of this document.

    IV. Regulatory Analyses

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

    A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

    This regulatory action determination is based on the size, duration and location of the regulated area. Vessel traffic would be able to safely transit around this regulated area, which would impact a small designated area of the Choptank River for 54 hours. The Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the status of the regulated area. Moreover, the rule would allow vessels to seek permission to enter the regulated area, and vessel traffic would be able to safely transit the regulated area once the PATCOM deems it safe to do so.

    B. Impact on Small Entities

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

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this proposed rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves implementation of regulations within 33 CFR part 100 applicable to organized marine events on the navigable waters of the United States. The temporary regulated area that would be enforced daily during a nine-day period during the sailboat regatta.. Normally such actions are categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Memorandum For Record for Categorically Excluded Actions supporting this determination is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

    G. Protest Activities

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

    V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

    We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

    We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit http://www.regulations.gov/privacyNotice.

    Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

    List of Subjects in 33 CFR Part 100

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

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

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

    33 U.S.C. 1233; 33 CFR 1.05-1.

    2. Add § 100.501T05-0577 to read as follows:
    § 100.501T05-0577 Special Local Regulation; Choptank River, Talbot and Dorchester Counties, MD.

    (a) Definitions. As used in this section:

    Captain of the Port (COTP) Maryland-National Capital Region means the Commander, U.S. Coast Guard Sector Maryland-National Capital Region or any Coast Guard commissioned, warrant or petty officer who has been authorized by the COTP to act on the COTP's behalf.

    Coast Guard Patrol Commander (PATCOM) means a commissioned, warrant, or petty officer of the U.S. Coast Guard who has been designated by the Commander, Coast Guard Sector Maryland-National Capital Region.

    Official Patrol means a vessel assigned or approved by the Commander, Coast Guard Sector Maryland-National Capital Region with a commissioned, warrant, or petty officer on board and displaying a Coast Guard ensign.

    Participant means a person or vessel registered with the event sponsor as participating in the 2018 Star World Championship regatta or otherwise designated by the regatta's sponsor as having a function tied to the event.

    Spectator means a person or vessel not registered with the event sponsor as a participant or assigned as an official patrol.

    (b) Locations. All coordinates reference Datum NAD 1983.

    (1) Regulated area. All navigable waters of the Choptank River, bounded by a line connecting the following coordinates: Commencing at latitude 38°41′39.02″ N, longitude 076°11′19.18″ W, thence south to latitude 38°37′28.68″ N, longitude 076°11′19.18″ W, thence west to latitude 38°37′28.68″ N, longitude 076°18′18.35″ W, thence north to latitude 38°41′39027″ N, longitude 076°18′18.35″ W, thence east to point of origin, located near Oxford, MD. The following location is within the regulated area:

    (2) Race Area. The race area is a circle in shape with its center located at position latitude 38°39′48.00″ N, longitude 076°15′03.42″ W. The area is bounded by a line measuring approximately 2.5 nautical miles in diameter.

    (c) Special local regulations: (1) The COTP Maryland-National Capital Region or PATCOM may forbid and control the movement of all vessels and persons, including event participants, in the regulated area. When hailed or signaled by an official patrol, a vessel or person in the regulated area must immediately comply with the directions given by the patrol. Failure to do so may result in the Coast Guard expelling the person or vessel from the area, issuing a citation for failure to comply, or both. The COTP Maryland-National Capital Region or PATCOM may terminate the event, or a participant's operations at any time the COTP Maryland-National Capital Region or PATCOM believes it necessary to do so for the protection of life or property.

    (2) Except for participants and vessels already at berth, a person or vessel within the regulated area at the start of enforcement of this section must immediately depart the regulated area.

    (3) A spectator must contact the PATCOM to request permission to either enter or pass through the regulated area. The PATCOM, and official patrol vessels enforcing this regulated area, can be contacted on marine band radio VHF-FM channel 16 (156.8 MHz) and channel 22A (157.1 MHz). If permission is granted, the spectator may enter the regulated area or pass directly through the regulated area as instructed by PATCOM. A vessel within the regulated area must operate at a safe speed that minimizes wake. A spectator vessel must not loiter within the navigable channel while within the regulated area.

    (4) Only participant vessels and official patrol vessels are allowed to enter the race area.

    (5) A person or vessel that desires to transit, moor, or anchor within the regulated area must first obtain authorization from the COTP Maryland-National Capital Region or PATCOM. A person or vessel seeking such permission can contact the PATCOM on Marine Band Radio, VHF-FM channel 16 (156.8 MHz).

    (6) The Coast Guard will publish a notice in the Fifth Coast Guard District Local Notice to Mariners and issue a marine information broadcast on VHF-FM marine band radio announcing specific event date and times.

    (d) Enforcement periods. This section will be enforced during each of the following times:

    (1) From 11:30 a.m. until 5:30 p.m. on October 7, 2018.

    (2) From 11:30 a.m. until 5:30 p.m. on October 8, 2018.

    (3) From 11:30 a.m. until 5:30 p.m. on October 9, 2018.

    (4) From 11:30 a.m. until 5:30 p.m. on October 10, 2018.

    (5) From 11:30 a.m. until 5:30 p.m. on October 11, 2018.

    (6) From 11:30 a.m. until 5:30 p.m. on October 12, 2018.

    (7) From 11:30 a.m. until 5:30 p.m. on October 13, 2018.

    (8) From 11:30 a.m. until 5:30 p.m. on October 14, 2018.

    (9) From 11:30 a.m. until 5:30 p.m. on October 15, 2018.

    Dated: August 13, 2018. Joseph B. Loring, Captain, U.S. Coast Guard, Captain of the Port Maryland-National Capital Region.
    [FR Doc. 2018-17762 Filed 8-16-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2018-0225] RIN 1625-AA08 Special Local Regulation; Breton Bay, Leonardtown, MD AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to establish special local regulations for certain waters of the Breton Bay. This action is necessary to provide for the safety of life on these navigable waters of Breton Bay, at Leonardtown, MD, on October 6, 2018 and October 7, 2018. This proposed rulemaking would prohibit persons and vessels from being in the regulated area unless authorized by the Captain of the Port Maryland-National Capital Region or a designated representative. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before September 17, 2018.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2018-0225 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this proposed rulemaking, call or email MST2 Dane Grulkey, U.S. Coast Guard Sector Maryland-National Capital Region; telephone 410-576-2570, email [email protected]

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking Pub. L. Public Law § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

    On January 22, 2018, the Southern Maryland Boat Club notified the Coast Guard that they will be conducting their fall regatta from 8 a.m. to 5 p.m. on October 6, 2018, and October 7, 2018. The regatta consists of approximately 40 boats, participating in an exhibition of vintage outboard racing V-hull boats; the regatta is not a competition but rather a demonstration of the vintage race craft. Hazards from the regatta include vessels reaching speeds of 90 mph and include risks of injury or death resulting from near or actual contact among participant vessels and spectator vessels or waterway users if normal vessel traffic were to interfere with the event. The COTP Maryland-National Capital Region has determined that potential hazards associated with the regatta would be a safety concern for anyone intending to operate within specified waters.

    The purpose of this rulemaking is to protect marine event participants, spectators and transiting vessels on specified waters of Breton Bay before, during, and after the scheduled event. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1233, which authorize the Coast Guard to establish and define special local regulations.

    III. Discussion of Proposed Rule

    The COTP Maryland-National Capital Region proposes to establish special local regulations to be enforced from 7:30 a.m. to 5:30 p.m. on October 6, 2018, and from 7:30 a.m. to 5:30 p.m. on October 7, 2018. The regulated area would include all navigable waters within Breton Bay, from shoreline to shoreline, within an area bound by a line drawn along latitude 38°16′43″ N; and bounded to the west by a line drawn along longitude 76°38′29.5″ W, located at Leonardtown, MD. This rule provides additional information about designated areas within the regulated area, including “Race Area”, “Buffer Zone” and “Spectator Area(s).” The duration of the regulated area is intended to ensure the safety of event participants and vessels within the specified navigable waters before, during, and after the regatta, scheduled to occur between 8 a.m. to 5 p.m. each day of the event. Except for participants, no vessel or person would be permitted to enter the regulated area without obtaining permission from the COTP Maryland-National Capital Region or the Coast Guard Patrol Commander.

    IV. Regulatory Analyses

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

    A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

    This regulatory action determination is based on the size and duration of the regulated area, which would impact a small designated area of Breton Bay during October 6-7, 2018, for a total of 18 hours. The Coast Guard would issue a Broadcast Notice to Mariners via marine band radio VHF-FM channel 16 about the status of the regulated area. Moreover, the rule would allow vessel operators to request permission to enter the regulated area for the purpose of safely transiting the regulated area if deemed safe to do so by the Coast Guard Patrol Commander.

    B. Impact on Small Entities

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

    While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section IV-A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this proposed rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves the creation of a special local regulation to be enforced a total of 18 hours over two days. This category of marine event water activities includes but is not limited to sail boat regattas, boat parades, power boat racing, swimming events, crew racing, canoe and sail board racing. Normally such actions are categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Memorandum For Record for Categorically Excluded Actions is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

    G. Protest Activities

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

    V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

    We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

    We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit http://www.regulations.gov/privacyNotice.

    Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

    List of Subjects in 33 CFR Part 100

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

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

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

    33 U.S.C. 1233.

    2. Add § 100.501T05-0225 to read as follows:
    § 100.501T05-0225 Special Local Regulation; Breton Bay, Leonardtown, MD.

    (a) Definitions. (1) Captain of the Port Maryland-National Capital Region means the Commander, U.S. Coast Guard Sector Maryland-National Capital Region or a Coast Guard commissioned, warrant or petty officer who has been authorized by the Captain of the Port to act on his behalf.

    (2) Coast Guard Patrol Commander means a commissioned, warrant, or petty officer of the U.S. Coast Guard who has been designated by the Commander, Coast Guard Sector Maryland-National Capital Region.

    (3) Official Patrol means any vessel assigned or approved by Commander, Coast Guard Sector Maryland-National Capital Region with a commissioned, warrant, or petty officer on board and displaying a Coast Guard ensign.

    (4) Spectator means any person or vessel not registered with the event sponsor as a participant or an official patrol vessel.

    (5) Participant means any person or vessel participating in the Southern Maryland Boat Club Fall Regatta event under the auspices of the Marine Event Permit issued to the event sponsor and approved by Commander, Coast Guard Sector Maryland-National Capital Region.

    (b) Regulated area. All coordinates reference Datum NAD 1983.

    (1) Coordinates: The following location is a regulated area: All navigable waters within Breton Bay, MD, immediately adjacent to Leonardtown, MD shoreline, from shoreline to shoreline, within an area bounded to the east by a line drawn along latitude 38°16′43″ N and bounded to the west by a line drawn along longitude 076°38′29.5″ W, located at Leonardtown, MD.

    (2) Race area: Located within the waters of Breton Bay, MD in an area bound by a line commencing at position latitude 38°17′07.2″ N, longitude 076°38′17.3″ W, thence southeast to latitude 38°16′55.3″ N, longitude 076°37′48″ W, thence southwest to latitude 38°16′50.1″ N, longitude 076°37′51.3″ W, thence northwest to latitude 38°17′01.9″ N, longitude 076°38′21″ W, thence northeast to point of origin.

    (3) Buffer zone: Located within the waters of Breton Bay, MD. The area surrounds the entire race area described in the preceding paragraph of this section. This area is rectangular in shape and provides a buffer of approximately 125 yards around the perimeter of the race area. The area is bounded by a line commencing at position latitude 38°17′12″ N, longitude 076°38′19.6″ W; thence southeast to latitude 38°16′57″ N, longitude 076°37′40.5″ W; thence southwest to latitude 38°16′44.8″ N, longitude 076°37′48.2″ W; thence northwest to latitude 38°17′00.2″ N, longitude 076°38′27.8″ W; thence northeast to point of origin.

    (4) Spectator areas: (i) Spectator area A. The area is bounded by a line commencing at position latitude 38°16′52.1″ N, longitude 076°38′14.2″ W; thence northeast to latitude 38°16′54″ N, longitude 076°38′12.5″ W; thence southeast to latitude 38°16′48.6″ N, longitude 076°37′59.3″ W; thence south to latitude 38°16′47.4″ N, longitude 076°37′59.3″ W; thence northwest along the shoreline to point of origin.

    (ii) Spectator area B. The area is bounded by a line commencing at position latitude 38°16′59.1″ N, longitude 076°37′45.6″ W; thence southeast to latitude 38°16′57.1″ N, longitude 076°37′40.2″ W; thence southwest to latitude 38°16′54.3″ N, longitude 076°37′41.9″ W; thence southeast to latitude 38°16′51.8″ N, longitude 076°37′36.4″ W; thence northeast to latitude 38°16′55.2″ N, longitude 076°37′34.2″ W; thence northwest to latitude 38°16′59.2″ N, longitude 076°37′37.2″ W; thence west to latitude 38°17′01.7″ N, longitude 076°37′43.7″ W; thence south to point of origin.

    (iii) Spectator area C. The area is bounded by a line commencing at position latitude 38°16′47.2″ N, longitude 076°37′54.8″ W; thence south to latitude 38°16′43.3″ N, longitude 076°37′55.2″ W; thence east to latitude 38°16′43.2″ N, longitude 076°37′47.8″ W; thence north to latitude 38°16′44.7″ N, longitude 076°37′48.5″ W; thence northwest to point of origin.

    (c) Special local regulations: (1) The Captain of the Port Maryland-National Capital Region or the Coast Guard Patrol Commander may forbid and control the movement of all vessels and persons, including event participants, in the regulated area. When hailed or signaled by an official patrol, a vessel or person in the regulated area shall immediately comply with the directions given. Failure to do so may result in expulsion from the area, citation for failure to comply, or both.

    (2) The operator of any vessel in the regulated area shall:

    (i) Stop the vessel immediately when directed to do so by any Official Patrol and then proceed only as directed.

    (ii) All persons and vessels shall comply with the instructions of the Official Patrol.

    (iii) When authorized to transit the regulated area, all vessels shall proceed at the minimum speed necessary to maintain a safe course that minimizes wake near the race course.

    (3) The Coast Guard Patrol Commander may terminate the event, or the operation of any participant, at any time it is deemed necessary for the protection of life or property.

    (4) The Race Area is an area described by a line bounded by coordinates provided in latitude and longitude that outlines the boundary of a Race Area within the regulated area defined in paragraph (b)(2) of this section. The actual placement of the race course will be determined by the marine event sponsor but must be located within the designated boundaries of the Race Area. Only participants and official patrol vessels are allowed to enter the Race Area.

    (5) The Buffer Zone is an area that surrounds the perimeter of the Race Area within the regulated area defined in paragraph (b)(3) of this section. The purpose of a Buffer Zone is to minimize potential collision conflicts with participants and spectators or nearby transiting vessels. This area provides separation between the Race Area and Spectator Area or other vessels that are operating in the vicinity of the regulated area defined in paragraph (b)(1) of this section. Only participants and official patrol vessels are allowed to enter the Buffer Zone.

    (6) The Spectator Area is an area described by a line bounded by coordinates provided in latitude and longitude that outlines the boundary of a spectator area within the regulated area defined in paragraph (b)(4) of this section. Spectators are only allowed inside the regulated area if they remain within the Spectator Area. All spectator vessels shall be anchored or operate at a no-wake speed while transiting within the Spectator Area. Spectators may contact the Coast Guard Patrol Commander to request permission to either enter the Spectator Area or pass through the regulated area. If permission is granted, spectators must enter the Spectator Area or pass directly through the regulated area as instructed at safe speed and without loitering.

    (7) The Coast Guard Patrol Commander and official patrol vessels enforcing this regulated area can be contacted on marine band radio VHF-FM channel 16 (156.8 MHz) and channel 22A (157.1 MHz). Persons and vessels desiring to transit, moor, or anchor within the regulated area must obtain authorization from Captain of the Port Maryland-National Capital Region or Coast Guard Patrol Commander. The Captain of the Port Maryland-National Capital Region can be contacted at telephone number 410-576-2693 or on Marine Band Radio, VHF-FM channel 16 (156.8 MHz). The Coast Guard Patrol Commander can be contacted on Marine Band Radio, VHF-FM channel 16 (156.8 MHz).

    (8) The Coast Guard will publish a notice in the Fifth Coast Guard District Local Notice to Mariners and issue a marine information broadcast on VHF-FM marine band radio.

    (d) Enforcement periods. This section will be enforced from 7:30 a.m. to 5:30 p.m. on October 6, 2018 and from 7:30 a.m. to 5:30 p.m. on October 7, 2018.

    Dated: August 13, 2018. Joseph B. Loring, Captain, U.S. Coast Guard, Captain of the Port Maryland-National Capital Region.
    [FR Doc. 2018-17763 Filed 8-16-18; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R08-0AR-2018-0530; FRL-9982-03—Region 8] Approval and Promulgation of Air Quality Implementation Plans; State of Colorado; Motor Vehicle Inspection and Maintenance Program and Associated Revisions AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing approval of two State Implementation Plan (SIP) revisions submitted by the State of Colorado. The revisions involve amendments to Colorado's Regulation Number 11, “Motor Vehicle Emissions Inspection Program.” The revisions enhance the use of Regulation Number 11's Clean Screen Program, allow self-inspecting vehicle fleets to use the On-Board Diagnostics (OBD) testing procedure, provide corrections to the Low Emitter Index (LEI) component of the Clean Screen Program, clarify existing provisions, correct administrative errors, delete obsolete language, establish inspection procedures for when emission control equipment tampering is detected, and make several other minor associated revisions. These actions are being taken under section 110 of the Clean Air Act (CAA).

    DATES:

    Written comments must be received on or before September 17, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R08-OAR-2018-0530, to the Federal Rulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from www.regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    Docket: All 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 material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy at the Air Program, Environmental Protection Agency (EPA), Region 8, 1595 Wynkoop Street, Denver, Colorado 80202-1129. The EPA requests that if at all possible, you contact the individual listed in the FOR FURTHER INFORMATION CONTACT section to view the hard copy of the docket. You may view the hard copy of the docket Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Tim Russ, Air Program, EPA, Region 8, Mail-code 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6479, or [email protected]

    SUPPLEMENTARY INFORMATION:

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

    I. Background

    Colorado's Regulation Number 11 (hereafter “Reg. No. 11”) addresses the implementation of the State's motor vehicle inspection and maintenance (I/M) program. The I/M program consists of an “enhanced” component that utilizes a dynamometer-based EPA IM240 1 test for 1982 and newer light-duty gasoline vehicles and a two-speed idle test (TSI) 2 for 1981 and older light-duty gasoline vehicles. To improve motorist convenience and reduce program implementation costs, the State also administers a remote sensing-based “Clean Screen” component of the I/M program. Remote sensing is a method for measuring vehicle emissions, while simultaneously photographing the license plate, when a vehicle passes through infrared or ultraviolet beams of light. Owners of vehicles meeting the Clean Screen criteria are notified by the County Clerk that their vehicles have passed the motor vehicle inspection process and are exempt from their next regularly scheduled IM240 test.

    1 See 40 CFR part 51, subpart S for a complete description of EPA's IM240 test. The IM240 test is essentially an enhanced motor vehicle emissions test to measure mass tailpipe emissions while the vehicle follows a computer generated driving cycle trace for 240 seconds and while the vehicle is on a dynamometer.

    2 See 40 CFR part 51, subpart S for a complete description of EPA's two-speed idle test. The two-speed idle test essentially measures the mass tailpipe emissions of a stationary vehicle; one reading is at a normal idle of approximately 700 to 800 engine revolutions per minute (RPM) and one reading at 2,500 RPM.

    The Clean Screen program component of Colorado's Reg. No. 11 was originally approved, for implementation in the Metro-Denver area, with the Denver carbon monoxide redesignation to attainment and maintenance plan (see: 66 FR 64751, December 14, 2001). The Clean Screen criteria that was approved in 2001 by the EPA required two valid passing remote sensing readings on different days or from different sensors, that met the applicable emissions reading requirements in Part F of Reg. No. 11, within a 12-month period to clean-screen a vehicle (see 66 FR 44097, August 22, 2001).

    Colorado revised Reg. No. 11 to expand the definition and requirements for a “clean-screened vehicle” to also include vehicles identified as low emitting vehicles in the state-determined LEI which have one passing remote sensing reading prior to the vehicle's registration renewal date. As part of the LEI process, the Colorado Department of Public Health and Environment, Air Pollution Control Division (APCD) develops an LEI on or before July 1 of each year. The LEI is based on a tabulation of the previous calendar year's IM240 inspection program results for specific make, model, and model year vehicles that passed IM240 vehicle inspections the previous year at a minimum rate of 98%.

    Beginning in January 2015, Colorado also began implementing an OBD test for certain model year vehicles. An OBD I/M test essentially means the electronic retrieval, by connecting an OBD test analyzer to the computer port data link in the vehicle, of information from a vehicle's computer system. The electronic information retrieved includes stored readiness status, diagnostic trouble codes (DTC), malfunction indicator light (MIL) illumination and other data. If emission related DTCs are present or the MIL is commanded on, that would indicate an emissions related malfunction.3

    3 The EPA required that OBD II testing requirements be in place by January 1, 2002 (66 FR 18156; April 5, 2001). All 1996 and newer model year light duty gasoline and alternate fuel passenger cars and trucks are required to have OBD II systems. OBD-II is an improvement over OBD-I in both capability and standardization. The OBD-II standard specifies the type of diagnostic connector and its pinout, the electrical protocols available, and the messaging format. The OBD-II standard provides a list of standardized DTCs. OBD-II standardization was prompted to simplify diagnosis of increasingly complicated emissions equipment.

    In addition, Colorado also extended the Reg. No. 11 exemption from I/M testing for new vehicles from 4 years to 7 years. This revision was based on Colorado's gathering of emissions testing information over a period of several years, which demonstrated that historically new and newer vehicles typically did not fail the IM240 or OBD emissions test within the first seven years of the vehicle's life.

    II. What action is the Agency taking?

    As explained below, the EPA is proposing to approve various revisions to Colorado's Reg. No. 11 that the State submitted to the EPA on February 20, 2015, and on May 14, 2018. Most of the revisions involve minor updates to several sections of Reg. No. 11 and the deletion of obsolete language. More specifically, the substantive SIP revisions involve:

    a. Addition of a definition of “Tampering” to Part A.II.

    b. Revisions to Part B.IV.B to require span gases to be labelled in accordance with Attachment VI of Appendix A.

    c. Revisions to Part A.II.16 and Part C.XII. (A.3 and C.2) to increase clean screening efficiency by removing the requirement that two qualifying clean screen observations must be made on different days or at different locations.

    d. Revisions to Part C.II.B.4 to remove incomplete and obsolescent qualifying criteria for certain vehicles that are unable to be tested on the IM240 chassis dynamometer.

    e. Revisions to Part C.II.C to allow self-inspecting gasoline vehicle fleets to utilize the more effective and more convenient OBD II testing procedure on all 1996 model year and newer vehicles.

    f. Revisions to Part C.II.C.3 regarding acceptable readiness criteria for OBD sensors and monitors.

    g. Revisions to Part C.II.C.9 and C.10 regarding I/M240 tests and tampering associated with OBD tests.

    h. Revisions to Part C.VIII and IX to clarify and modernize provisions for issuance of emissions repair, diagnostic and economic hardship waivers.

    i. Revisions to Part D.I.B. 5, 6, and 7 to remove obsolete language regarding dwell meters, timing lights, and idle adjustment.

    j. Revisions to Part F.VI.B, the roadside remote sensing clean screen LEI, to allow for greater utilization of this component of the I/M program.

    k. Revisions to Part F.VII with regard to OBD testing criteria.

    l. Revisions to Appendix A, Attachment IV, Section 2.2, and the deletion of Appendix B in its entirety such as to remove obsolete specifications and procedures for vehicle inspection analyzer calibration gasses.

    m. Corrections of typographical, grammatical, and formatting errors throughout Reg. No. 11.

    We note that the specific basis for our proposed action and our analyses and findings are discussed in this proposed rulemaking. Technical information that we relied upon in this proposal is contained in the docket, available at http://www.regulations.gov, Docket No. EPA-R08-OAR-2018-0530.

    III. What was the State's process?

    Section 110(a)(2) of the CAA requires that a state provide reasonable notice and public hearing before adopting a SIP revision and submitting it to us.

    The State's February 20, 2015 SIP Submittal

    On October 16, 2014, the Colorado Air Quality Control Commission (AQCC) conducted a public hearing to consider the adoption of revisions and additions to the Colorado SIP. The revisions affecting the SIP involved the Reg. No. 11 revisions noted above and as discussed below in section IV. There were no public comments. After conducting a public hearing, the AQCC adopted the proposed revisions to Reg. No 11 on October 16, 2014. The SIP revisions became State effective on November 30, 2014.

    We evaluated the State's February 20, 2015 SIP submittal for Reg. No. 11 and determined that the State met the requirements for reasonable notice and public hearing under section 110(a)(2) of the CAA. By operation of law under section 110(k)(1)(B) of the CAA, the State's February 20, 2015 submittal was deemed complete on August 20, 2015.

    The State's May 14, 2018 SIP Submittal

    On May 17, 2017, the AQCC conducted a public hearing to consider the adoption of revisions and additions to the Colorado SIP. The revisions affecting the SIP involved the Reg. No. 11 revisions noted above and as discussed below in section V. There were no public comments. After conducting a public hearing, the AQCC adopted the proposed revisions to Reg. No. 11 on May 17, 2017. The SIP revisions became State effective on September 30, 2017.

    We evaluated the State's May 14, 2018 SIP submittal for Reg. No. 11 and determined that the State met the requirements for reasonable notice and public hearing under section 110(a)(2) of the CAA. In addition, our evaluation of the SIP revisions submittal also concluded that it met the minimum “completeness” criteria found in 40 CFR part 51, Appendix V.

    IV. EPA's Evaluation of the State's 2015 Revisions to Part A, Part B, Part C, Part F, Appendix A and Appendix B

    The sections of Reg. No. 11 that were revised with the State's February 20, 2015 submittal were as follows:

    1. Part A, section II: Add a new definition number 50, “Tampering.” Renumber definitions number 51 and higher. The new definition is consistent with the prohibitions in CAA section 203(a)(3)(A).

    2. Part B, section IV: Modify section IV.B to require span gases to be labelled in accordance with Attachment VI of Appendix A and to require span and calibration gas suppliers to be approved by the Colorado Automobile Inspection and Readjustment (AIR) Program Standards Lab.

    3. Part C, section II: Modify section II.B.4 to replace specific criteria for eligibility for an alternative test to the IM240 test with an eligibility list that is maintained in the Colorado APCD Emission Technical Center Procedures Manual.

    4. Part C, section II: Modify section II.C to indicate that effective July 1, 2015, 1996 and newer light duty vehicles that are owned by a fleet that operates a Fleet Inspection Station shall administer an OBD test as specified in 40 CFR 85.2222.

    5. Part C, section VIII: Modify sections VIII.B.1 to require, as part of eligibility for an emissions test waiver, there are no visible smoke emissions from the vehicle's exhaust, there has been no tampering, and VIII.B.3 (renumbered to VIII.B.2) to clarify requirements for expenditures needed to qualify for an emissions test waiver. Remove prior sections VIII.B.2, VIII.B.4, and VIII.B.5. We note that section VIII.B.2 involved certain aspects of the basic I/M program that are obsolete and sections VIII.B.4 and VIII.B.5 contained emissions reduction and operating parameter requirements that are not required under 40 CFR 51.360 for waivers.

    6. Part C, section VIII: Modify section VIII.C to require a vehicle to be evaluated via an IM240 test if the OBD MIL remains illuminated even after the maximum expenditure for repairs has been met.

    7. Part C, section VIII: Modify section VIII.D.1 to add failure for an OBD test.

    8. Part C, section VIII: Modify section VIII.F to remove unnecessary language regarding the generation of an emissions sticker and removal of the prior emissions sticker by an emissions inspector.

    9. Part C, section IX: Remove this section in its entirety to delete obsolete language regarding engine and emissions equipment adjustment procedures. These procedures are no longer performed by inspectors; instead, if a vehicle does not pass the owner must have the necessary repairs done before the vehicle is retested.

    10. Part C, section X: Modify section X.A and X.B to include provisions for emissions related repairs that are necessary to extinguish the OBD MIL light.

    11. Part C, section X: Modify section X.C to state the specific requirements to meet the emissions maximum expenditure for repairs cost limit, with respect to an OBD test, in order for a vehicle to be eligible to apply for a waiver.

    12. Part F, section VI: The State modified section VI.B.3 to remove a 98% passing criteria for Clean Screen vehicles and instead indicate the passing criteria would be based on sound scientific evidence. The EPA is not acting on this revision in the State's February 20, 2015 SIP submittal, as it has been superseded by the 2018 revisions.

    13. Part F, section VI: The State added section VI.B.4 to include that the State would establish the low emitting vehicle index, without review by the EPA or the public, and would retain the low emitting vehicle index in the State's Emission Technical Center Procedures Manual. The EPA is not acting on this revision in the State's February 20, 2015 SIP submittal, as it has been superseded by the May 14, 2018 submitted revisions.

    14. Appendix A, Technical Specifications: Modify section 2.11 to remove a reference to gas blender specifications in the obsolete Appendix B and change to indicate as approved by the Colorado APCD.

    15. Appendix A, Technical Specifications, Attachment IV: Modify section IV.2.2 to indicate that the Colorado97 procedure shall use two tri-blend span gas blends that meet the California BAR97 span gas low (blend 31) and high (blend 34) specifications.

    16. Appendix A, Technical Specifications, Attachment IV: Modify section IV.2.3 to indicate that audit gases shall meet the California BAR97 audit gas specification.

    17. Appendix A, Technical Specifications, Attachment VI: Modify section VI to revise the label figure to indicate that it represents the Colorado-approved calibration span gas.

    18. Appendix B, Standards and Specifications for Calibration/Span Gas Suppliers: Appendix B was removed by the State in its entirety as it contained obsolete specifications and procedures for inspection analyzer calibration gases.

    V. EPA's Evaluation of the State's 2018 Revisions to Part C, Part D, Part F and Appendix A

    The sections of Reg. No. 11 that were revised with the State's May 14, 2018 submittal were as follows:

    1. Part C, section II: Modify section II.C.3.a to replace the existing monitor readiness evaluation with a monitor readiness evaluation that ensures that the oxygen sensor and/or heated oxygen sensor monitor(s) shall be ready if supported, the catalyst monitor shall be ready if supported, 2001 and newer vehicles shall only be allowed to have one supported monitor in a not ready status, and 2000 and older vehicles shall only be allowed to have two supported monitors in a not ready status. In addition, if the above criteria are not met and the vehicle's MIL light is commanded off, then the vehicle will be required to be evaluated via an IM240 test.

    2. Part C, section II: Modify section II.C.9 to indicate that for the 5 percent vehicles that are selected at random from the OBD test for a subsequent IM240 test, the IM240 test shall be the pass/fail determination for these vehicles.

    3. Part C, section II: New section II.C.10 that states if the vehicle's OBD responds that the catalyst readiness monitor is not supported and that all readiness monitors are supported, or if any other OBD tampering indicators are present, then the OBD test will be failed.

    4. Part D, section I: Modify sections I.B to remove sections I.B.5, I.B.6 and I.B.7 to delete obsolete terms and renumber the remaining sections in I.B.

    5. Part D, section I: Modify renumbered section I.B.10 to indicate that renumbered sections I.B.5 and I.B.6 are not required for licensing as an inspection-only station or inspection-only facility.

    6. Part D, section I: Remove prior numbered section I.B.15 as it contains obsolete language.

    7. Part F, section VI: Modify section VI.B.1 to remove the restricting term “IM240” which then allows all types of test results to be evaluated.

    8. Part F, section VI: Modify section VI.B.2 to remove the unnecessary term “exhaust.”

    9. Part F, section VI: Modify section VI.B.3 to remove the minimum 98% passing rate criteria for the LEI and instead require that the passing rate criteria ensures equivalent air quality benefits as a second remote sensing test.

    10. Part F, section VI: Modify section VI.B.4 to remove prior language and to add that the passing rate criteria for the LEI, as established by the APCD, will be maintained and contained in the APCD's Emissions Technical Center Procedures Manual, and will be submitted to the EPA on or before July 1 of each year.

    11. Part F, section VII: Modify section VII to remove the obsolete sections VII.E and VII.F.

    12. Appendix A, Technical Specifications, Attachment V: Modify Attachment V “Specifications for Colorado On-Board Diagnostic (OBD) Stand-Alone Analyzer” to remove the obsolete language regarding readiness criteria for a vehicle's oxygen sensor, catalyst sensor and the allowable number of not-ready sensors for 2001 and newer vehicles and 2000 and older vehicles. The revised language now contains overall requirements for OBD readiness such that if the readiness evaluation indicates that a vehicle has more than one unset (not ready) readiness monitor, and the MIL is commanded off, then the inspection is automatically aborted with the reason printed out on the Vehicle Inspection Report.

    VI. Conclusion

    Our review of the State's Reg. No. 11 revisions, as presented above in sections IV and V, involved numerous revisions to Reg. No. 11 Parts A, B, C, D, F, Appendix A, the deletion of Appendix B, and overall formatting, correction of typographic errors and other non-substantive changes. Based on our review and evaluation discussed above, we propose that the Reg. No. 11 SIP revisions, submitted by the State in letters dated February 20, 2015, and May 14, 2018, sufficiently address applicable provisions in 40 CFR part 51, subpart S, 40 CFR part 85, subpart W, and that our approval is warranted.

    VII. Consideration of Section 110(1) of the Clean Air Act

    Section 110(1) of the CAA states that a SIP revision cannot be approved if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress towards attainment of a National Ambient Air Quality Standard or any other applicable requirement of the CAA. In view of the evaluations presented in sections IV and V above, the EPA proposes that the revisions to Colorado's Reg. No. 11 that are contained in the State's SIP submittals dated February 20, 2015, and May 14, 2018 will not interfere with attainment, reasonable further progress, or any other applicable requirement of the CAA.

    VIII. Proposed Action

    The EPA is proposing approval of the February 20, 2015, submitted SIP revisions to Colorado's Regulation Number 11, Part A, Part B, Part C, Part F, Appendix A and the deletion of Appendix B. The EPA notes that revisions to Part F, sections VI.B.3 and VI.B.4 were also provided with the State's February 20, 2015 submittal. The EPA is not proposing action on these sections of Part F for the reasons noted above in section IV of this action.

    In addition, the EPA is proposing approval of the May 14, 2018, submitted SIP revisions to Regulation Number 11, Part C, Part D, Part F and Appendix A.

    IX. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the amendments described in sections IV and V, above. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 8 Office (please contact the person identified in the For Further Information Contact section of this preamble for more information).

    X. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve 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);

    • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

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

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

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

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

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

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

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

    • Does not provide the 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 the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed 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).

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: August 13, 2018. Douglas Benevento, Regional Administrator, EPA Region 8.
    [FR Doc. 2018-17805 Filed 8-16-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [EPA-HQ-OPPT-2017-0414; FRL-9981-82] RIN 2070-AB27 Significant New Use Rules on Certain Chemical Substances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 27 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to Orders issued by EPA pursuant to section 5(e) of TSCA. This action would require persons who intend to manufacture (defined by statute to include import) or process any of these 27 chemical substances for an activity that is designated as a significant new use by these rules to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notification, and has taken such actions as are required with that determination. In addition to this notice of proposed rulemaking, EPA is issuing the action as a direct final rule elsewhere in this issue of the Federal Register.

    DATES:

    Comments must be received on or before September 17, 2018.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2017-0414, by one of the following methods:

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

    Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

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

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: [email protected]

    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    In addition to this Notice of Proposed Rulemaking, EPA is issuing the action as a direct final rule elsewhere in this issue of the Federal Register. For further information about the proposed significant new use rules, please see the information provided in the direct final action, with the same title, that is located in the “Rules and Regulations” section of this issue of the Federal Register.

    List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.

    Dated: August 3, 2018. Mark A. Hartman, Acting Director, Office of Pollution Prevention and Toxics.
    [FR Doc. 2018-17349 Filed 8-16-18; 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 019—Irritable Bowel Syndrome; Finding of Insufficient Evidence AGENCY:

    Centers for Disease Control and Prevention, HHS.

    ACTION:

    Denial of petition for addition of a health condition.

    SUMMARY:

    On May 17, 2018, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 019) to add irritable bowel syndrome (IBS) to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add IBS to the List. The Administrator also 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 August 17, 2018.

    ADDRESSES:

    Visit the WTC Health Program website at https://www.cdc.gov/wtc/received.html to review Petition 019.

    FOR FURTHER INFORMATION CONTACT:

    Rachel Weiss, Program Analyst, 1090 Tusculum Avenue, MS: C-48, 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. Procedures for Evaluating a Petition C. Petition 019 D. Review of Scientific and Medical Information and Administrator Determination E. Administrator's Final Decision on Whether To Propose the Addition of IBS to the List F. Approval To Submit Document to the Office of the Federal Register 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 (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 James Zadroga 9/11 Health and Compensation Act of 2010 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 document mean the Director of the National Institute for Occupational Safety and Health (NIOSH) or his 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 88.15. Within 90 days after receipt of a valid 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) of the PHS Act and § 88.16(a)(2) of the Program regulations: (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.

    B. Procedures for Evaluating a Petition

    In addition to the regulatory provisions, the WTC Health Program has developed policies to guide the review of submissions and petitions,2 as well as the analysis of evidence supporting the potential addition of a non-cancer health condition to the List.3

    2See WTC Health Program [2014], 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.

    3See WTC Health Program [2017], Policy and Procedures for Adding Non-Cancer Conditions to the List of WTC-Related Health Conditions, February 14, 2017, https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_14_February_2017.pdf.

    A valid petition must include sufficient medical basis for the association between the September 11, 2001, terrorist attacks and the health condition to be added; in accordance with WTC Health Program policy, 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 may demonstrate the required medical basis.4 Studies linking 9/11 agents to the petitioned health condition may also provide sufficient medical basis for a valid petition.

    4See supra note 2.

    After the Program has determined that a petition is valid, the Administrator must direct the Program to conduct 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 health condition to the List.5 The literature review includes a search for peer-reviewed, published, epidemiologic studies (including direct observational studies in the case of health conditions such as injuries) about the health condition among 9/11-exposed populations. The Program evaluates the scientific quality of each peer-reviewed, published, epidemiologic study of the health condition identified in the literature search; the Program then compiles the scientific results of each study to assess whether a causal relationship between 9/11 exposures and the health condition is supported, and evaluates whether the results of the studies are representative of the 9/11-exposed population of responders and survivors. A health condition may be added to the List if peer-reviewed, published, epidemiologic studies provide support that the health condition is substantially likely 6 to be causally associated with 9/11 exposures. If the evaluation of evidence provided in peer-reviewed, published, epidemiologic studies of the health condition in 9/11 populations demonstrates a high, but not substantial, likelihood of a causal association between the 9/11 exposures and the health condition, then the Administrator may consider additional highly relevant scientific evidence regarding exposures to 9/11 agents 7 from sources using non-9/11-exposed populations. If that additional assessment establishes that the health condition is substantially likely to be causally associated with 9/11 exposures among 9/11-exposed populations, the health condition may be added to the List.

    5See supra note 3.

    6 The “substantially likely” standard is met when the scientific evidence, taken as a whole, demonstrates a strong relationship between the 9/11 exposures and the health condition.

    7 9/11 agents are chemical, physical, biological, or other hazards reported in a published, peer-reviewed exposure assessment study of responders, recovery workers, or survivors who were present in the New York City disaster area, or at the Pentagon site, or the Shanksville, Pennsylvania site, as those locations are defined in 42 CFR 88.1, as well as those hazards not identified in a published, peer-reviewed exposure assessment study, but which are reasonably assumed to have been present at any of the three sites.

    C. Petition 019

    On May 17, 2018, the Administrator received a petition (Petition 019) from a WTC survivor who was caught in the dust cloud near Ground Zero, requesting the addition of “irritable bowel syndrome (IBS)” to the List.8 The petition included one scientific article, by Marynowski et al. [2015],9 reviewing the findings of peer-reviewed, published epidemiologic studies concerning the association of IBS with environmental pollution (including particulate matter, a 9/11 agent). Although the Marynowski article on its own did not provide a sufficient medical basis for the submission to be considered a valid petition, the article referenced a peer-reviewed, published study by Kaplan et al. [2012] 10 regarding IBS symptoms in non-9/11-exposed populations. Kaplan et al. conducted an epidemiologic study to evaluate the association between daily concentrations of air pollutants, including particulate matter, with emergency department visits for non-specific abdominal pain, a symptom necessary for a diagnosis of IBS. The inclusion of a reference to this study provides sufficient medical basis for the submission to be considered a valid petition.

    8See Petition 019, WTC Health Program: Petitions Received, http://www.cdc.gov/wtc/received.html.

    9 Marynowski M, Likońska A, Zatorski H, Fichna J [2015], Role of Environmental Pollution in Irritable Bowel Syndrome, World J Gastroentero 21(40):11371-11378.

    10 Kaplan GG, Szyszkowicz M, Fichna J, Rowe BH, Porada E, Vincent R, Madsen K, Ghosh S, Storr M [2012], Non-Specific Abdominal Pain and Air Pollution: A Novel Association, PLOS ONE 7(10).

    D. Review of Scientific and Medical Information and Administrator Determination

    In response to Petition 019, and pursuant to the Program policy on the addition of non-cancer health conditions to the List,11 the Program conducted a review of the scientific literature on IBS.12 The Program was unable to identify any references to the petitioned health condition, IBS, in 9/11-exposed populations for further scientific evaluation based on the literature search. Since Kaplan et al. [2012] is not an epidemiologic study of IBS in 9/11-exposed populations, it does not meet the threshold for evaluation established in Program policy; therefore, the article was not further reviewed.

    11Supra note 3.

    12 Databases searched include: CINAHL, Embase, NIOSHTIC-2, ProQuest Health & Safety, PsycINFO, PubMed, Scopus, and Toxicology Abstracts/TOXLINE.

    E. Administrator's Final Decision on Whether To Propose the Addition of IBS to the List

    The Administrator has determined that insufficient evidence is available to take further action at this time, including proposing the addition of IBS to the List (pursuant to PHS Act, sec. 3312(a)(6)(B)(ii) and 42 CFR 88.16(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 88.16(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 88.16(a)(2)(i)) is unwarranted.

    For the reasons discussed above, the Petition 019 request to add IBS to the List of WTC-Related Health Conditions is denied.

    F. Approval To Submit Document to the Office of the Federal Register

    The Secretary, HHS, or his 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. Robert Redfield M.D., Director, CDC, and Administrator, ATSDR, approved this document for publication on August 10, 2018.

    Dated: August 10, 2018. Frank J. Hearl, Chief of Staff, National Institute for Occupational Safety and Health, Delegated the duties of the 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. 2018-17711 Filed 8-16-18; 8:45 am] BILLING CODE 4163-18-P
    83 160 Friday, August 17, 2018 Notices DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Docket No. AMS-LPS-17-0046] United States Standards for Grades of Pork Carcasses AGENCY:

    Agricultural Marketing Service, USDA.

    ACTION:

    Notice.

    SUMMARY:

    This Notice informs the public that the U.S. Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) will not proceed with revisions to the United States Standards for Grades of Pork Carcasses (pork standards) at this time.

    DATES:

    August 17, 2018.

    ADDRESSES:

    USDA, AMS, Livestock and Poultry Program (LP), Quality Assessment Division (QAD); 1400 Independence Ave. SW; Room 3932-S, STOP 0258; Washington, DC 20250-0258.

    FOR FURTHER INFORMATION CONTACT:

    David Bowden, Chief, Standardization Branch; USDA, AMS, LP, QAD; 1400 Independence Avenue SW; Room 3932-S, STOP 0258; Washington, DC 20250-0258; phone (202) 690-3148; or via email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Official USDA grade standards and associated voluntary, fee-for-service grading programs are authorized under the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621 et seq.) (the Act). Specifically, section 203(c) of the Act directs and authorizes the Secretary of Agriculture “to develop and improve standards of quality, condition, quantity, grade, and packaging and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices” (7 U.S.C. 1622(c)). AMS is committed to carrying out this authority in a manner that facilitates the marketing of agricultural products. Accordingly, the primary purpose of USDA grade standards is to divide the population of a commodity into uniform groups (of similar quality, yield, value, etc.) to facilitate marketing. Currently, AMS maintains standards for a wide variety of commodities and in many cases, applies those standards to commodities on a fee-for-service basis.

    AMS recognizes that the pork standards must be relevant to be of value to stakeholders and, therefore, recommendations for changes in the standards may be initiated by AMS or by interested parties at any time to achieve that goal. AMS originally posted this Notice seeking comment on the revised pork standards on October 23, 2017, with a closing date of December 22, 2017. Subsequently, AMS reopened the Notice for an additional 60-day comment period, ending March 19, 2018.

    Comments

    In all, 47 comments were received: There were 19 comments in favor of updating the pork standards, while 24 were opposed; 2 only requested extending the comment period; and 2 commenters did not clearly state a position. Responses received were representative of the pork industry and stakeholders, with the most comments coming from pork industry associations, packers, and producers.

    The 19 commenters in support of revised pork standards said that changes were needed in the pork industry to revitalize domestic consumer demand and that the updated standards may be helpful in addressing the decline in purchases of fresh pork products, citing data that the average American consumer buys fresh pork only seven times a year. Some commenters expressed that a revised standard could lead to a USDA fee-for-service grading program, which would enhance uniformity of pork quality and build consumer confidence in pork purchasing decisions. Commenters also said that the revisions were scientifically sound and applicable to pork quality attributes that are consumer-recognized and tied to an improved eating experience. While some recognized the challenge of implementing the proposed standards revisions via a grading program in the modern processing environment, they expressed support for a standardized, objective carcass grading system focused more on quality than percent lean.

    Most of the 24 comments against the proposed revisions were similar in nature and asserted the new grades would not add value for pork producers. Some commenters noted that the pork industry and individual companies have worked for many years to improve product quality attributes and promote their efforts through product branding and “niche” marketing, and the revised pork standards would endanger these efforts. Further, some commenters noted that proposed nomenclature of Prime, Choice, and Select, if implemented for pork, could result in devaluation of the established beef grading system. Pork packers and processors expressed concern that implementation of the revised pork standards would be impractical, in part because the technology available to accurately assess quality factors for pork is not yet effective while maintaining today's processing line speeds. Commenters opposed to the revisions also expressed concern that implementation at this time would cause disruption to existing producer-packer relationships and established logistics. Others were concerned that application of the standard specifically to the loin primal without positive correlation with the remaining carcass parts would be misleading, and that any premium generated by applying the standards would not offset the cost of implementing a USDA fee-for-service grading program in the plant.

    A few commenters provided responses that were both for and against the revisions, outlining opportunities and challenges similar to those discussed above. All comments are available at the following website: https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentDueDate&po=0&dct=PS&D=AMS-LPS-17-0046.

    Based on the responses received from the Notices, AMS will not pursue any revisions to the pork standards at this time. AMS stands ready to assist agricultural industries in establishing voluntary standards and grading programs for commodities for which it has authority to do so; the pork industry retains this option should the need arise.

    Dated: August 13, 2018. Bruce Summers, Administrator, Agricultural Marketing Service.
    [FR Doc. 2018-17725 Filed 8-16-18; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF AGRICULTURE Food and Nutrition Service Agency Information Collection Activities: Proposed Collection; Comment Request—Supplemental Nutrition Assistance Program (SNAP), Store Applications, Forms FNS-252, FNS-252-E, FNS-252-FE, FNS-252-R, FNS-252-2 and FNS-252-C AGENCY:

    Food and Nutrition Service (FNS), USDA.

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on the proposed collection. This is a revision of a currently approved collection in the Supplemental Nutrition Assistance Program and concerns Retail Store Applications (Forms FNS-252; FNS-252-E; FNS-252-FE; FNS-252-R; FNS-252-2; and FNS-252-C).

    DATES:

    Written comments must be received on or before October 16, 2018.

    ADDRESSES:

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, 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 collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical or other technological collection techniques or other forms of information technology.

    Comments may be sent to: Nicole Budzius, Chief, Retailer Administration Branch, Supplemental Nutrition Assistance Program, Retailer Policy and Management Division, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Room 422, Alexandria, VA 22302. Comments may be faxed to the attention of Ms. Budzius at (703) 305-1863 or via email to: [email protected] Comments will also be accepted through the Federal eRulemaking Portal. Go to http://www.regulations.gov, and follow the online instructions for submitting comments electronically. All written comments will be open for public inspection at the FNS office located at 3101 Park Center Drive, Room 422, Alexandria, Virginia 22302, during regular business hours (8:30 a.m. to 5 p.m. Monday through Friday).

    All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of this information collection should be directed to Nicole Budzius at [email protected]

    SUPPLEMENTARY INFORMATION:

    Title: Supplemental Nutrition Assistance Program (SNAP)—Store Applications.

    Form Number: FNS-252; 252-E; 252-FE; 252-R; 252-2; and 252-C.

    OMB Number: 0584-0008.

    Expiration Date: January 31, 2021.

    Type of Request: Revision of a currently approved collection of information.

    Abstract: Section 9(a) of the Food and Nutrition Act of 2008, as amended, (the Act) (7 U.S.C. 2011 et seq.) requires that FNS determine the eligibility of retail food stores and certain food service organizations to accept SNAP benefits and to monitor them for compliance and continued eligibility and to ensure Program integrity.

    FNS is also responsible for requiring updates to application information and reviewing retail food store applications at least once every five years to ensure that each firm is under the same ownership and continues to meet eligibility requirements. The Act specifies that only those applicants whose participation will “effectuate the purposes of the program” should be authorized.

    There are six forms associated with this approved Office of Management and Budget (OMB) information collection number 0584-0008—the Supplemental Nutrition Assistance Program Application for Stores, Forms FNS-252 (English and Spanish) and FNS-252-E (paper and online version respectively); Farmer's Market Application, Form FNS-252-FE; Meal Service Application, Form FNS-252-2; Reauthorization Application, Form FNS-252-R; and the Corporation Supplemental Application, Form FNS-252-C used for individual (chain) stores under a corporation. For new authorizations, the majority of applicants use form FNS-252 or FNS-252-E (paper or online, respectively). FNS is responsible for reviewing retail food store applications at least once every five years to ensure that each firm is under the same ownership and continues to meet eligibility guidelines. In order to accomplish this regulatory requirement, form FNS-252-R is used for reauthorization. In addition to these forms, during authorization or reauthorization, FNS may conduct an on-site store visit of the firm. The store visit of the firm helps FNS confirm that the information provided on the application is correct. An FNS representative or store visit contractor obtains permission to fill in the store visit checklist, photograph the store and asks the store owner or manager about the continued ownership of the store.

    Applicants using form FNS-252-E or FNS-252-FE must also first self-register for a Level 1 access account through the USDA eAuthentication system in order to start an online application. USDA eAuthentication facilitates the electronic authentication of an individual.

    The Agricultural Act of 2014 (2014 Farm Bill) amended the Food and Nutrition Act of 2008 (the Act) and the Supplemental Nutrition Assistance Program (SNAP) revised all retailer application forms (paper and electronic) in January, 2018, as a result of regulatory changes required by the Act and amended by the 2014 Farm Bill. Such changes to the Act amended the definition of “retail food store” to clarify when a retailer is a restaurant rather than a retail food store. Among the changes made to the SNAP retailer application form(s), the Food and Nutrition Service (FNS) added a new question, Question 18, concerning restaurant licensing, and revised Question 22, regarding total retail sales on Form FNS-252. Currently, respondents select a Yes or No response if they have or are applying for a restaurant license for their store in Question 18. Question 22 currently asks retailers to enter their total retail sales by category in dollars for a one year period. Sales categories include gasoline, lottery, tobacco, alcohol, other nonfood, and hot foods, cold prepared foods, accessory foods, and staple foods. Due to concern with the manner in which FNS is currently asking for retailer sales data, FNS is updating the retailer application question regarding sales. FNS is also removing the question concerning restaurant licensing and the requirement for businesses located in community property states to provide spousal information for each owner. Question 22 will revert back to asking for percentages for each category as opposed to exact dollar amounts. FNS will also change from asking for individual sales amounts for each non-food category to asking for the percentage of total sales in gasoline and an aggregate percentage of all other total non-foods sold by the firm.

    FNS intends to (1) rename Question 3, “Doing Business As (if different from Store Name)” to “Legal Business Name (if different from Store Name)”, (2) update Question 14 to remove the sentence requiring spousal information for businesses located in community property states, and in the Business Title section remove the word “spouse” in questions 14a-14d, (3) delete Question 18 regarding restaurant licensing, (4) revise Question 22 concerning total retail sales in the following manner: (a) Respondents will provide a response for either estimated or actual sales for a one year period. If actual sales are provided, the respondent will indicate the applicable tax year for this information. FNS also added back in the option to provide estimated retail sales per day, week, month, or year for total retail sales in Question 22b, and (b) provide a percentage of total retail sales for each category of product sold: Staple foods; accessory foods; hot foods, cold foods prepared on site; gasoline, and other non-food items, (5) add a new sentence to the Certification and Signature Statement to more clearly outline the risk for owners that are disqualified or fined for violation of Program rules; and (6) where appropriate, re-number the questions and update assistance material such as the General and Specific Instructions sections and on-line help screens. With the exception of the question identified in 4(b) above, no new questions or data information is being asked.

    A draft of the proposed revision to Question 22 is provided in Attachment A. FNS also shared a draft of the proposed changes with our stakeholders. The proposed revision incorporates the feedback FNS received with the exception of any changes that would render FNS unable to make an eligibility decision or complete retailer monitoring activities. FNS would like to take this opportunity to clarify that while cold foods prepared on-site, such as at an in-store deli or salad bar, are eligible for purchase with SNAP benefits, collection of the percentage sales information is