Federal Register Vol. 83, No.177,

Federal Register Volume 83, Issue 177 (September 12, 2018)

Page Range46067-46347
FR Document

83_FR_177
Current View
Page and SubjectPDF
83 FR 46103 - Addition of Certain Entities to the Entity List, Revision of Entries on the Entity List and Removal of Certain Entities From the Entity ListPDF
83 FR 46347 - Continuation of the Exercise of Certain Authorities Under the Trading With the Enemy ActPDF
83 FR 46345 - National Days of Prayer and Remembrance, 2018PDF
83 FR 46067 - Continuation of the National Emergency With Respect to Certain Terrorist AttacksPDF
83 FR 46193 - Sunshine Act Meetings; National Science BoardPDF
83 FR 46188 - Filing of Plats of Survey: AlaskaPDF
83 FR 46237 - Community Advantage Pilot ProgramPDF
83 FR 46117 - National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the Old Southington Landfill Superfund SitePDF
83 FR 46160 - Certain New Chemicals or Significant New Uses; Statements of Findings for April to July 2018PDF
83 FR 46115 - Metschnikowia Fructicola Strain NRRLY-27328; Exemption From the Requirement of a TolerancePDF
83 FR 46159 - Pesticide Product Registration; Receipt of Applications for New UsesPDF
83 FR 46251 - Pilot Program for Expedited Project DeliveryPDF
83 FR 46199 - Information Collection: NRC Form 7, Application for NRC Export/Import License, Amendment, Renewal or Consent Request(s)PDF
83 FR 46104 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human FoodPDF
83 FR 46148 - Energy Conservation Program: Decision and Order Granting a Waiver to ITW Food Equipment Group, LLC From the Department of Energy Commercial Refrigeration Equipment Test ProcedurePDF
83 FR 46141 - Reorganization and Expansion of Foreign-Trade Zone 135 Under Alternative Site Framework; Palm Beach, FloridaPDF
83 FR 46141 - Approval of Subzone Status; Driftwood LNG, LLC, Sulphur, LouisianaPDF
83 FR 46161 - Regular Meeting; Farm Credit System Insurance Corporation BoardPDF
83 FR 46196 - FirstEnergy Nuclear Operating Company (FENOC) and FirstEnergy Nuclear Generation, LLC, Beaver Valley Power Station, Units 1 and 2, Davis-Besse Nuclear Power Station, Unit No. 1, Perry Nuclear Power Plant, Unit No. 1PDF
83 FR 46258 - Annual Pay Ranges for Physicians, Dentists, and Podiatrists of the Veterans Health Administration (VHA)PDF
83 FR 46142 - Reorganization of Foreign-Trade Zone 105 Under Alternative Site Framework Providence, Rhode IslandPDF
83 FR 46121 - Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by IrradiationPDF
83 FR 46142 - Reorganization of Foreign-Trade Zone 179 Under Alternative Site Framework, Madawaska, MainePDF
83 FR 46142 - Reorganization of Foreign-Trade Zone 158 Under Alternative Site Framework; Vicksburg/Jackson, MississippiPDF
83 FR 46146 - Application To Amend Presidential Permit; Vermont Electric Power Company, Inc., as Agent for the Joint Owners in the Highgate Interconnection FacilitiesPDF
83 FR 46188 - Notice of Public Meetings for the Southeast Oregon Resource Advisory CouncilPDF
83 FR 46223 - Investment Company Act Release No. 33220; 812-14928 Broadstone Real Estate Access Fund and Broadstone Asset Management, LLCPDF
83 FR 46253 - Reports, Forms, and Recordkeeping RequirementsPDF
83 FR 46164 - Board Meeting; 77 K St. NE, Washington, DC; 10th Floor; September 17, 2018; 8:30 a.m.PDF
83 FR 46143 - Polyethylene Terephthalate Resin From Canada: Notice of Rescission of Antidumping Duty Administrative Review; 2017-2018PDF
83 FR 46147 - Biological and Environmental Research Advisory CommitteePDF
83 FR 46152 - Electricity Advisory CommitteePDF
83 FR 46147 - State Energy Advisory Board; TeleconferencePDF
83 FR 46136 - Notice of Request for Approval of New Information Collection for Almonds Grown in California (Marketing Order No. 981)PDF
83 FR 46163 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
83 FR 46069 - Cranberries Grown in States of Massachusetts, et al.; Establishment of 2018-19 Seasonal Volume RegulationPDF
83 FR 46195 - Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978PDF
83 FR 46192 - Notice of Antarctic Meteorite Collection, Documentation, and Curation Plan Received Under the Antarctic Conservation Act of 1978PDF
83 FR 46193 - Notice of Permit Modification Received Under the Antarctic Conservation Act of 1978PDF
83 FR 46118 - Fisheries of the Exclusive Economic Zone Off Alaska; Yellowfin Sole for Vessels Participating in the BSAI Trawl Limited Access Fishery in the Bering Sea and Aleutian Islands Management AreaPDF
83 FR 46137 - Submission for OMB Review; Comment RequestPDF
83 FR 46256 - Notice of OFAC Sanctions ActionsPDF
83 FR 46254 - Notice of OFAC Sanctions ActionsPDF
83 FR 46254 - Notice of OFAC Sanctions ActionPDF
83 FR 46170 - Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient; Public Workshop; Request for CommentsPDF
83 FR 46153 - Transcontinental Gas Pipe Line Company, LLC; Notice of Revised Schedule for Environmental Review of the Northeast Supply Enhancement ProjectPDF
83 FR 46154 - Midwest Energy Recycling, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing ApplicationsPDF
83 FR 46153 - Swan Lake North Hydro LLC; Notice of Anticipated Schedule of Final Order for Swan Lake North Pumped Storage Hydroelectric ProjectPDF
83 FR 46156 - Peterson Machinery Sales; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing ApplicationsPDF
83 FR 46173 - Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar ApplicantPDF
83 FR 46158 - Enel Green Power Hilltopper Wind, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
83 FR 46154 - City of Oakland, California v. Pacific Gas and Electric Company; Notice of ComplaintPDF
83 FR 46157 - Langdon Renewables, LLC, Rush Springs Energy Storage, LLC, Origis Energy, Palmer's Creek Wind Farm, LLC, Meadowlark Wind I LLC, Foard City Wind, LLC, Torrecillas Wind Energy, LLC, Holloman Lessee LLC, Solfuture Gestion, S.L.U., Glicinia Instalaciones Fotovoltaicas, S.L.U.; Notice of Effectiveness of Exempt Wholesale Generator and Foreign Utility Company StatusPDF
83 FR 46158 - KO Transmission Company; Notice of AmendmentPDF
83 FR 46155 - Texas Eastern Transmission, LP; Notice of Intent To Prepare an Environmental Assessment for the Proposed Line 1-N Abandonment Project and Request for Comments on Environmental IssuesPDF
83 FR 46157 - Combined Notice of Filings #1PDF
83 FR 46255 - Notice of OFAC Sanctions ActionPDF
83 FR 46192 - NASA Aerospace Safety Advisory Panel; MeetingPDF
83 FR 46190 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection: Mortality in Correctional Institutions (State Prisons)PDF
83 FR 46107 - New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants; Delegation of Authority to New MexicoPDF
83 FR 46199 - Disposition of Information Related to the Time Period That Safety-Related Structures, Systems, or Components Are InstalledPDF
83 FR 46164 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring CommitteesPDF
83 FR 46176 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 46178 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed MeetingsPDF
83 FR 46178 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed MeetingsPDF
83 FR 46177 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 46242 - Petition for Exemption; Summary of Petition Received; The Boeing CompanyPDF
83 FR 46189 - Strontium Chromate From Austria and France; Institution of Anti-Dumping Duty Investigations and Scheduling of Preliminary Phase InvestigationsPDF
83 FR 46145 - Consumer Advisory Board Subcommittee MeetingsPDF
83 FR 46143 - Credit Union Advisory Council MeetingPDF
83 FR 46144 - Community Bank Advisory Council MeetingPDF
83 FR 46255 - Notice of OFAC Sanctions ActionsPDF
83 FR 46137 - Announcement of Disaster Assistance Grant Application Deadlines and Funding LevelsPDF
83 FR 46179 - Wisconsin; Major Disaster and Related DeterminationsPDF
83 FR 46192 - Advisory Committee for Cyberinfrastructure; Notice of MeetingPDF
83 FR 46194 - Advisory Committee for Environmental Research and Education Notice of MeetingPDF
83 FR 46194 - Proposal Review Panel for Computing and Communication Foundations; Notice of MeetingPDF
83 FR 46179 - Hawaii; Amendment No. 1 to Notice of an Emergency DeclarationPDF
83 FR 46242 - Certification Pursuant to Sections 7045(a)(3)(A) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2018PDF
83 FR 46200 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing of Amendment No. 3 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 3, To List and Trade Shares of the Western Asset Total Return ETFPDF
83 FR 46230 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing of a Proposed Rule Change To Amend Rule 6.2, Interpretation and Policy .01 Concerning Strategy OrdersPDF
83 FR 46228 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Amendment No. 1 and Order Approving on an Accelerated Basis a Proposed Rule Change, as Modified by Amendment No. 1, Relating to the Continued Listing Criteria Applicable to the Shares of the iShares California AMT Free Muni Bond ETF and iShares New York AMT-Free Muni Bond ETFPDF
83 FR 46225 - PIMCO Flexible Credit Income Fund, et al.PDF
83 FR 46198 - Guidance About Administrative Licensing ProceduresPDF
83 FR 46098 - Special Conditions: The Boeing Company (Boeing), Model 787-8, 787-9, and 787-10 Series Airplanes; Dynamic Test Requirements for Single-Occupant, Oblique (Side-Facing) Seats With or Without Airbag Devices or 3-Point RestraintsPDF
83 FR 46101 - Special Conditions: The Boeing Company (Boeing), Model 777 Series Airplanes; Dynamic Test Requirements for Single Occupant Oblique Seats, With or Without Airbag Devices or 3-Point RestraintsPDF
83 FR 46241 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of NebraskaPDF
83 FR 46145 - Agency Information Collection Activities; Comment Request; Grantee Reporting Form-Rehabilitation Services Administration (RSA) Annual Payback ReportPDF
83 FR 46174 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco ProductsPDF
83 FR 46166 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting ProgramPDF
83 FR 46172 - Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsPDF
83 FR 46243 - Notice of Funding Opportunity for Positive Train Control Systems Grants Under the Consolidated Rail Infrastructure and Safety Improvements ProgramPDF
83 FR 46180 - Relief From HUD Requirements Available During Calendar Year (CY) 2018 to Public Housing Agencies To Assist With Recovery and Relief Efforts on Behalf of Families Affected by Presidentially-Declared Major DisastersPDF
83 FR 46119 - Pears Grown in Oregon and Washington; Decreased Assessment Rate for Processed PearsPDF
83 FR 46162 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated AuthorityPDF
83 FR 46163 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated AuthorityPDF
83 FR 46257 - Members of Senior Executive Service Performance Review BoardsPDF
83 FR 46126 - Hazardous Waste Management System; Proposed Exclusion for Identifying and Listing Hazardous WastePDF
83 FR 46075 - Disclosure of Records and InformationPDF
83 FR 46262 - National Emission Standards for Hazardous Air Pollutants: Surface Coating of Large Appliances; Printing, Coating, and Dyeing of Fabrics and Other Textiles; and Surface Coating of Metal Furniture Residual Risk and Technology ReviewsPDF

Issue

83 177 Wednesday, September 12, 2018 Contents Agricultural Marketing Agricultural Marketing Service RULES Cranberries Grown in States of Massachusetts, et al.: Establishment of 2018-19 Seasonal Volume Regulation, 46069-46075 2018-19825 PROPOSED RULES Pears Grown in Oregon and Washington: Decreased Assessment Rate for Processed Pears, 46119-46121 2018-19683 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Almonds Grown in California (Marketing Order No. 981), 46136-46137 2018-19827 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Rural Utilities Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46137 2018-19820
Consumer Financial Protection Bureau of Consumer Financial Protection RULES Disclosure of Records and Information, 46075-46098 2018-19384 NOTICES Meetings: Community Bank Advisory Council, 46144-46145 2018-19787 Consumer Advisory Board Subcommittee, 46145 2018-19789 Credit Union Advisory Council, 46143-46144 2018-19788 Commerce Commerce Department See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Grantee Reporting Form: Rehabilitation Services Administration Annual Payback Report, 46145-46146 2018-19745 Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Application to Amend Presidential Permit: Vermont Electric Power Co., Inc., 46146-46147 2018-19842 Energy Conservation Program: Decision and Order Granting Waiver to ITW Food Equipment Group, LLC from Department of Energy Commercial Refrigeration Equipment Test Procedure, 46148-46152 2018-19852 Meetings: Biological and Environmental Research Advisory Committee, 46147 2018-19830 Electricity Advisory Committee, 46152-46153 2018-19829 State Energy Advisory Board, 46147 2018-19828
Environmental Protection Environmental Protection Agency RULES National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of Old Southington Landfill Superfund Site, 46117-46118 2018-19874 New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants: Delegation of Authority to New Mexico, 46107-46115 2018-19801 Pesticide Tolerances; Exemptions: Metschnikowia fructicola strain NRRL Y-27328, 46115-46117 2018-19870 PROPOSED RULES Hazardous Waste Management System: Exclusion for Identifying and Listing Hazardous Waste, 46126-46135 2018-19595 National Emission Standards for Hazardous Air Pollutants: Surface Coating of Large Appliances; Printing, Coating, and Dyeing of Fabrics and Other Textiles; and Surface Coating of Metal Furniture Residual Risk and Technology Reviews, 46262-46341 2018-19018 NOTICES Certain New Chemicals or Significant New Uses; Statements of Findings, 46160-46161 2018-19873 Pesticide Product Registrations: Applications for New Uses, 46159-46160 2018-19869 Farm Credit System Insurance Farm Credit System Insurance Corporation NOTICES Meetings: Farm Credit System Insurance Corporation Board, 46161 2018-19849 Federal Aviation Federal Aviation Administration RULES Special Conditions: The Boeing Company (Boeing), Model 777 Series Airplanes; Dynamic Test Requirements for Single Occupant Oblique Seats, with or without Airbag Devices or 3-point Restraints, 46101-46103 2018-19752 The Boeing Company (Boeing), Model 787-8, 787-9, and 787-10 Series Airplanes; Dynamic Test Requirements for Single-Occupant, Oblique (side facing) Seats with or without Airbag Devices or 3-point Restraints, 46098-46101 2018-19753 NOTICES Petitions for Exemption; Summaries: Boeing Co., 46242-46243 2018-19792 Federal Emergency Federal Emergency Management Agency NOTICES Emergency Declarations: Hawaii; Amendment No. 1, 46179-46180 2018-19779 Major Disasters and Related Determinations: Wisconsin, 46179 2018-19783 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Midwest Energy Recycling, LLC, 46154-46155 2018-19814 Swan Lake North Hydro, LLC, 46153-46154 2018-19813 Applications; Amendments: KO Transmission Co., 46158-46159 2018-19807 Combined Filings, 46157-46158 2018-19805 Complaints: City of Oakland, CA v. Pacific Gas and Electric Co., 46154 2018-19809 Environmental Assessments; Availability, etc.: Texas Eastern Transmission, LP; Line 1-N Abandonment Project, 46155-46156 2018-19806 Transcontinental Gas Pipe Line Co., LLC, 46153 2018-19815 Exempt Wholesale Generator and Foreign Utility Company Status: Langdon Renewables, LLC, et al., 46157 2018-19808 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Enel Green Power Hilltopper Wind, LLC, 46158 2018-19810 Permit Applications: Peterson Machinery Sales, 46156-46157 2018-19812 Federal Railroad Federal Railroad Administration NOTICES Funding Opportunities: Positive Train Control Systems Grants under Consolidated Rail Infrastructure and Safety Improvements Program, 46243-46251 2018-19740 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Board Approval under Delegated Authority, 46162-46164 2018-19675 2018-19676 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 46163 2018-19826 Federal Retirement Federal Retirement Thrift Investment Board NOTICES Meetings: Federal Retirement Thrift Investment Board, 46164 2018-19833 Federal Transit Federal Transit Administration NOTICES Pilot Program for Expedited Project Delivery, 46251-46253 2018-19860 Food and Drug Food and Drug Administration RULES Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, 46104-46107 2018-19855 PROPOSED RULES Approved New Drug Application for Drugs Sterilized by Irradiation; Repeal, 46121-46126 2018-19845 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees, 46164-46166 2018-19799 Guidance on Meetings with Industry and Investigators on Research and Development of Tobacco Products, 46174-46176 2018-19743 MedWatch: The Food and Drug Administration Medical Products Reporting Program, 46166-46170 2018-19742 Meetings: Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient; Public Workshop, 46170-46172 2018-19816 Oncologic Drugs Advisory Committee, 46172-46173 2018-19741 Patent Infringement Complaints Filed Against Biosimilar Applicant, 46173-46174 2018-19811 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 46254-46256 2018-19785 2018-19804 2018-19818 Sanctions Actions, 46254, 46256-46257 2018-19817 2018-19819 Foreign Trade Foreign-Trade Zones Board NOTICES Reorganizations and Expansions under Alternative Site Frameworks: Foreign-Trade Zone 105, Providence, Rhode Island, 46142 2018-19846 Foreign-Trade Zone 135, Palm Beach, FL, 46141 2018-19851 Foreign-Trade Zone 158, Vicksburg/Jackson, MS, 46142 2018-19843 Foreign-Trade Zone 179, Madawaska, Maine, 46142-46143 2018-19844 Subzone Status; Approvals: Driftwood LNG, LLC, Sulphur, LA, 46141-46142 2018-19850 Health and Human Health and Human Services Department See

Food and Drug Administration

See

National Institutes of Health

Homeland Homeland Security Department See

Federal Emergency Management Agency

Housing Housing and Urban Development Department NOTICES Relief from Requirements Available During Calendar Year 2018 to Public Housing Agencies to Assist with Recovery and Relief Efforts on Behalf of Families Affected by Presidentially-declared Major Disasters, 46180-46188 2018-19708 Industry Industry and Security Bureau RULES Entity List; Additions, Revisions, Removals, 46103-46104 C2--2018--18766 Interior Interior Department See

Land Management Bureau

Internal Revenue Internal Revenue Service NOTICES Members of Senior Executive Service Performance Review Boards, 46257-46258 2018-19618 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Polyethylene Terephthalate Resin from Canada, 46143 2018-19831 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Strontium Chromate from Austria and France, 46189-46190 2018-19790 Justice Department Justice Department See

Justice Programs Office

Justice Programs Justice Programs Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Mortality in Correctional Institutions, 46190-46191 2018-19802 Land Land Management Bureau NOTICES Meetings: Southeast Oregon Resource Advisory Council, 46188 2018-19839 Plats of Surveys: Alaska; Filing, 46188-46189 2018-19890 NASA National Aeronautics and Space Administration NOTICES Meetings: Aerospace Safety Advisory Panel, 46192 2018-19803 National Highway National Highway Traffic Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46253-46254 2018-19836 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 46176-46178 2018-19793 2018-19796 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 46178 2018-19795 National Institute of Diabetes and Digestive and Kidney Diseases, 46178-46179 2018-19794 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Yellowfin Sole for Vessels Participating in BSAI Trawl Limited Access Fishery in Bering Sea and Aleutian Islands Management Area, 46118 2018-19821 National Science National Science Foundation NOTICES Antarctic Conservation Act Permits, 46193-46194 2018-19822 Antarctic Meteorite Collection, Documentation, and Curation Plan Received under Antarctic Conservation Act of 1978, 46192-46193 2018-19823 Meetings: Advisory Committee for Cyberinfrastructure, 46192 2018-19782 Advisory Committee for Environmental Research and Education, 46194 2018-19781 Proposal Review Panel for Computing and Communication Foundations, 46194-46195 2018-19780 Meetings; Sunshine Act, 46193 2018-19927 Permit Applications under Antarctic Conservation Act, 46195 2018-19824 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46199-46200 2018-19859 Disposition of Information Related to Time Period That Safety-Related Structures, Systems, or Components are Installed, 46199 2018-19800 Exemptions: FirstEnergy Nuclear Operating Co. and FirstEnergy Nuclear Generation, LLC, Beaver Valley Power Station, Units 1 and 2, Davis-Besse Nuclear Power Station, Unit No. 1, Perry Nuclear Power Plant, Unit No. 1, 46196-46198 2018-19848 Guidance: Administrative Licensing Procedures, 46198-46199 2018-19755 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: National Days of Prayer and Remembrance (Proc. 9781), 46343-46346 2018-20012 ADMINISTRATIVE ORDERS Terrorist Attacks; Continuation of National Emergency With Respect to Certain (Notice of September 10, 2018), 46067 2018-19945 Trading With the Enemy Act; Continuation of Certain Authorities (Presidential Determination No. 2018-11 of September 10, 2018), 46347 2018-20014 Rural Utilities Rural Utilities Service NOTICES Funding Availability: Disaster Assistance Grant Application Deadlines and Funding Levels, 46137-46141 2018-19784 Securities Securities and Exchange Commission NOTICES Applications: Broadstone Real Estate Access Fund and Broadstone Asset Management, LLC, 46223-46225 2018-19837 PIMCO Flexible Credit Income Fund, et al., 46225-46228 2018-19765 Self-Regulatory Organizations; Proposed Rule Changes: Cboe Exchange, Inc., 46230-46237 2018-19773 Nasdaq Stock Market, LLC, 46200-46222 2018-19774 NYSE Arca, Inc., 46228-46230 2018-19772 Small Business Small Business Administration NOTICES Community Advantage Pilot Program, 46237-46241 2018-19885 Major Disaster Declarations: Nebraska, 46241-46242 2018-19751 State Department State Department NOTICES Determinations under Department of State, Foreign Operations, and Related Programs Appropriations Act: El Salvador, 46242 2018-19776 Guatemala, 46242 2018-19777 Honduras, 46242 2018-19775 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Railroad Administration

See

Federal Transit Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department See

Foreign Assets Control Office

See

Internal Revenue Service

Veteran Affairs Veterans Affairs Department NOTICES Annual Pay Ranges for Physicians, Dentists, and Podiatrists of Veterans Health Administration, 46258-46259 2018-19847 Separate Parts In This Issue Part II Environmental Protection Agency, 46262-46341 2018-19018 Part III Presidential Documents, 46343-46347 2018-20012 2018-20014 Reader Aids

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

To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.

83 177 Wednesday, September 12, 2018 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 929 [Doc. No. AMS-SC-18-0012; SC18-929-2 FR] Cranberries Grown in States of Massachusetts, et al.; Establishment of 2018-19 Seasonal Volume Regulation AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Final rule.

SUMMARY:

This rule implements a recommendation to establish a grower allotment percentage for the 2018-19 crop year and allows for the diversion of processed products from that year under the marketing order for cranberries grown in the production area (Order). This action also specifies handlers subject to the regulation, revises the definition of outlets for excess fruit, revises dates by which certain actions are due, and establishes exemptions to the action.

DATES:

Effective October 12, 2018.

FOR FURTHER INFORMATION CONTACT:

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

Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected].

SUPPLEMENTARY INFORMATION:

This final rule, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This final rule is issued under Marketing Agreement and Order No. 929, as amended (7 CFR part 929), regulating the handling of cranberries grown in the States of Massachusetts, Rhode Island, Connecticut, New Jersey, Wisconsin, Michigan, Minnesota, Oregon, Washington, and Long Island in the State of New York. Part 929 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Cranberry Marketing Committee (Committee) locally administers the Order and is comprised of growers of cranberries operating within the production area, and a public member.

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

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Order provisions provide that the Committee may recommend and implement, subject to USDA approval, volume control regulation which would decrease the available supply of cranberries whenever the Secretary of Agriculture (Secretary) finds that “such regulation will tend to effectuate the declared policy of the Act.” Accordingly, this rule establishes a marketable quantity and grower allotment percentage for cranberries produced during the 2018-19 crop year, beginning September 1, 2018, and ending August 31, 2019.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This final rule establishes a marketable quantity and grower allotment percentage for the 2018-19 crop year. This rule is the result of the Committee's recommendations made during its August 4, and August 31, 2017, meetings, and a February 18, 2018, email vote. This rule establishes a marketable quantity of 7.275 million barrels and a grower allotment percentage of 75 percent. This action also allows handlers to process up to 50 percent of the excess cranberries they receive above their growers' allotment, provided they divert an equivalent amount of 2018-19 cranberry processed products. It also establishes an exemption for organically grown cranberries, specifies handlers subject to the regulation, revises the definition of outlets for excess fruit, and revises dates by which certain actions are due.

The Committee also recommended an exemption for organically grown cranberries, and an exemption of 2,500 barrels for each grower. After much consideration, USDA determined the recommended grower exemption of 2,500 barrels should be revised. Consequently, this final rule does not include the exemption of 2,500 barrels for each grower and instead exempts handlers that processed less than 125,000 barrels during the 2017-18 fiscal year, or handlers that did not have carryover inventory at the end of the 2017-18 fiscal year. Accordingly, growers delivering their fruit to exempt handlers are not subject to the allotment.

In addition, in a February 18, 2018, vote by email, the Committee voted unanimously to adjust reporting dates associated with the allotment regulation. These changes were previously discussed and supported by the Committee at a meeting on April 22, 2014, as part of the consideration of another volume regulation for which a rule was not issued.

The recommendations included in this rule will adjust supply to more closely meet market demand, improve grower and handler returns, and help reduce inventory.

Sections 929.49 and 929.52 provide, in part, authority to establish a marketable quantity and grower allotment percentage. Section 929.14 defines marketable quantity as the volume of cranberries needed to meet market demand and provide for an adequate carryover into the next season. The allotment percentage is derived by dividing the marketable quantity by the total of all growers' sales histories. Section 929.48 outlines procedures for computing a grower's sales history.

Section 929.49 also prescribes how the grower allotment percentage is calculated and distributed to growers and handlers. Each grower's allotment volume is calculated by multiplying the individual's sales history by the allotment percentage. A grower's allotment is the total volume a handler may purchase from, or handle on behalf of, that grower during a year of volume regulation. Cranberries received by a handler that exceed the sum of their growers' allotments can be used to fill unused allotment. Any remaining cranberries are defined as excess cranberries as defined in § 929.59, which also outlines the procedures and dates by which excess cranberries are to be diverted. Section 929.61 prescribes outlets for excess cranberries, which are further defined in § 929.104.

In addition, § 929.50 provides authority for the transfer of sales history and annual allotment. Section 929.51 requires the Committee to consider market conditions, including supply and demand, prior to recommending an allotment percentage, and that any recommendation be made by March 1. Section 929.58(a) provides the authority to exempt from any or all requirements the handling of cranberries in such minimum quantities as the Committee, with the approval of the Secretary, may prescribe. Section 929.58(b) provides, in part, the authority to exempt from any or all requirements the handling of cranberries of such forms or types, including organic cranberries, as the Committee, with the approval of the Secretary, may prescribe.

Domestic cranberry production has been increasing over the past few years, up from 8.0 million barrels in 2012 to 9.6 million barrels in 2016. During the last few years, demand has remained relatively flat, and has not kept pace with the increases in supply. This has led to increasing levels of inventories. Ending inventory levels increased from 5.8 million barrels in 2012 to 9.7 million barrels in 2016.

Demand for cranberries is inelastic, meaning changes in consumer price have a minimal effect on total sales. However, grower prices are very sensitive to changes in supply. Consequently, higher inventory levels place downward pressure on grower prices for cranberries and reduce grower returns. Data reviewed by the Committee indicates that the price per barrel received by some growers has fallen from $30 a barrel in 2011 to $10 a barrel in 2016. With the cost of production estimated at approximately $35 a barrel, for many growers returns have fallen below the cost of production.

The Committee met on August 4, 2017, and again on August 31, 2017, and discussed the estimated levels of supply and demand and how market conditions were impacting the industry. The Committee discussed the approximate levels of production for the 2017-18 season, forecasting production at approximately 9.1 million barrels. Carryover inventory was estimated at approximately 9.9 million barrels and foreign acquired cranberries were expected to provide an additional 2.1 million barrels, for a total available supply of approximately 21.1 million barrels for the year. After accounting for shrinkage, the Committee agreed on an adjusted supply of 20.4 million barrels for the 2017-18 crop year.

Using these numbers, with estimated sales of 9.5 million barrels for 2017-18, the Committee calculated a potential carryover for the 2018-19 season of 10.9 million barrels. This is an approximately one million barrel increase from the carryover inventory for the 2017-18 crop year. Based on these numbers, carryover inventory for the 2018-19 crop year would be approximately 115 percent of annual sales.

In discussing market conditions, the Committee recognized that sales have been relatively flat. The Committee also noted supply has been exceeding demand by about one million barrels a year. Using crop and sales estimates similar to 2017-18, and the estimated carryover from the 2017-18 season of 10.9 million barrels, the potential carryover supply at the end of the 2018-19 crop year could increase by another one million barrels to 11.9 million if no action is taken to regulate supply.

In reviewing these numbers, the Committee agreed the industry is faced with a large inventory that continues to build. To address the problems associated with oversupply and to try to stabilize grower returns, the Committee discussed the need to establish volume regulation. The Committee considered several options, including establishing free and restricted percentages under a handler withholding for the 2017-18 crop year, establishing a grower allotment for the 2018-19 season, or recommending both regulations.

Considering the levels of inventory and low grower returns, the Committee voted to recommend a handler withholding, setting the free and restricted percentages of 85 percent and 15 percent, respectively, for the 2017-18 season. AMS agreed with the Committee's analysis and recommendation and published the rule establishing these percentages in the Federal Register on April 4, 2018 (83 FR 14350). The Committee estimated that the 15 percent restriction would remove approximately one million barrels from inventory, helping to maintain inventories at current levels. While the Committee recognized a small restriction would not immediately balance supply with demand, even a small restriction would remove a portion of the volume from the market and help prevent an additional increase in inventory.

With the handler withholding removing an estimated one million barrels from the market, the industry would still have approximately 10 million barrels remaining in inventory. Given the static demand and anticipated market conditions for the 2018-19 fiscal year, the Committee also recommended establishing a grower allotment percentage for the 2018-19 fiscal year.

The Committee discussed various levels of restriction, being sensitive to the impact volume control could have on small growers and handlers. Some small handlers are able to sell all their production each year and do not maintain an inventory. Several Committee members stated a large restriction would place a hardship on these small handlers. However, the Committee also recognized that volume control measures could help increase grower returns by helping to align supply with demand.

In addition, establishing an allotment regulation can help growers reduce production costs. Growers could choose to take bogs out of production, or reduce inputs such as fertilizer and pesticides in order to reduce their production volume to match their allotment. These and other steps could help growers reduce their costs of production for the 2018-19 crop.

Based on the information available, the Committee recommended establishing a marketable quantity of 7.275 million barrels and an allotment percentage of 75 percent for the 2018-19 crop year. With volume regulation, returns are expected to be higher than without volume regulation. This increase is beneficial to all growers and handlers regardless of size, and enhances total revenues in comparison to no volume regulation. Establishing an allotment percentage allows the industry to help stabilize supplies. This rule could remove a potential 2 million barrels from supply, reduce industry inventory, and increase industry returns. This rule adds a new § 929.253 to establish the marketable quantity and grower allotment.

The Committee also recommended that handlers have the option to receive cranberries over their grower allotment and process up to 50 percent of the excess cranberries received rather than divert them in fresh form, as currently required. Handlers that do so need to divert an amount of 2018-19 cranberry processed products equivalent to the volume of excess cranberries processed.

The Committee made this recommendation recognizing that processing fresh fruit to produce one of its top-selling items, sweetened dried cranberries (SDC), results in juice concentrate as a by-product. A significant amount of current inventory is in the form of juice concentrate. By allowing handlers to process a portion of the excess cranberries they receive, more fresh cranberries are available to produce products requiring whole cranberries, such as SDC, and the diversion of concentrate will help prevent additional build-up of inventory. Handlers still have the option to divert fresh berries as excess supply.

To allow for the diversion of processed products, § 929.104(b), which currently prohibits the handling of excess fruit, is removed. To ensure the diversion of processed products in lieu of fresh cranberries is correctly accounted for, the final rule for volume regulation for the 2017-18 season (83 FR 14350) adds guidance under § 929.107 along with a conversion table. The table recognizes different conversion equivalencies of cranberries to processed product based on the volume of Brix concentrate.

Brix is the method for measuring the amount of sugar contained in the cranberry products, and the industry average for concentrate is 50 Brix. The Committee acknowledged that the Brix level can vary depending on the growing region and farming practices. The table helps ensure that the diversion of processed product in lieu of fresh berries is applied equitably among all handlers.

Using the conversion table, handlers can determine the amount of cranberry concentrate they need to divert, in lieu of fresh berries, to cover the fresh cranberry equivalent of any excess cranberries processed. Juice concentrate should comprise the vast majority of processed product used for diversion. Should requests be made to use other processed products for diversion, conversion rates for those products will be provided by the Committee based on information provided by the requesting handler.

For example, a grower with a sales history of 1,000 barrels will have an allotment of 750 barrels (1,000 × .75). If the grower delivered all 1,000 barrels to the handler, the handler will have 250 barrels of excess fruit. Under this final rule, the handler could divert 250 barrels of fresh fruit to approved outlets or divert half (125 barrels of fresh fruit) and process half, diverting a 125 barrel equivalent in 2018-19 processed product.

The Committee also recommended changes to date requirements currently specified in the Order. Section 929.59(b) currently states that “prior to January 1, or such other date as recommended by the committee and approved by the Secretary, handlers holding excess cranberries shall submit to the committee a written plan outlining procedures for the systematic disposal of such cranberries in the outlets prescribed in § 929.61.” The Committee agreed the date for submitting disposal plans should be extended in order to give handlers more time to consider how to divert their excess cranberries. Therefore, the Committee recommended changing the deadline prescribed in § 929.59(b) from January 1 to March 1 of the regulated season.

Section 929.59(c) states that “prior to March 1, or such other date as recommended by the committee and approved by the Secretary, all excess cranberries shall be disposed of pursuant to § 929.61.” Given the change in the due date for the diversion plans, the Committee agreed that this date should also be changed to provide handlers with enough time to comply with this requirement. Therefore, the Committee recommended changing the date by which diversion is to be completed from March 1 to August 31. AMS agrees with the Committee's analysis and recommendation and is issuing this rule to add a new § 929.159 to make these date changes.

Section 929.62(a) requires each grower to file a report with the Committee by January 15 of each year providing the following information: Total acreage harvested and whether owned or leased; total commercial cranberry sales in barrels from such acreage; the amount of acres either in production but not harvested, or taken out of production, and the reason(s) why; the amount of new or replanted acreage coming into production; the name of the handler(s) to whom commercial cranberry sales were made; and such other information as may be needed for implementation and operation of this section. Growers might not have all necessary information to complete the report by the current deadline. Therefore, the Committee recommended changing the grower reporting date from January 15 to March 1.

The Committee also recommended organically grown cranberries be exempt from this regulation as they serve a niche market and represent a very small portion of the total crop. All other cranberry production, including fresh cranberries, are subject to regulation under the grower allotment volume regulation.

To address the burden the volume regulation would have on small growers and handlers, the Committee also recommended providing an exemption of 2,500 barrels for all growers. Under the Committee's recommendation, the exemption would be applied following the calculation of a grower's allotment. However, after much consideration, USDA determined the exemption recommendation should be revised. Rather than provide an exemption of 2,500 barrels for each grower, this action exempts small handlers who processed less than 125,000 barrels from the allotment requirement. Further, handlers who did not have carryover inventory at the end of the 2017-18 fiscal year are also exempt from the allotment requirement. Accordingly, growers delivering their fruit to exempt handlers are not subject to the allotment.

These changes allow handlers who have matched their production with market demand to continue to serve their customer base and maintain their market share. Small growers also have the option of delivering their fruit to handlers who are not subject to the regulation. Handlers subject to the allotment percentage should be able to meet any market shortfalls by utilizing cranberries or cranberry products available in inventory. The provision allowing handlers to process a portion of their excess cranberries also helps provide some flexibility.

With this action, only those handlers carrying inventory are subject to meeting the allotment requirement. In reviewing the Committee's recommendation and other available industry information, USDA has determined that existing inventories in excess of 9 million barrels are putting the most downward pressure on returns to both growers and handlers. Consequently, this rule puts more focus on reducing the volume in inventory.

Section 929.125 provides authority for a grower to request a review by an appeals subcommittee if the grower is dissatisfied with his or her sales history calculation provided by the Committee. The grower must request the review within 30 days after receipt of the Committee's determination of sales history and must submit documentation showing why he or she believes the calculation is inaccurate. Within 15 days after notification of the appeals subcommittee's decision, if the grower is not satisfied with the decision, the grower may further appeal to the Secretary.

A grower may transfer all or part of their allotment to another grower, provided that the transferred allotment remains assigned to the same handler. Transfers of allotment between growers having different handlers may occur with the consent of both handlers. All such transfers have to be reported to the Committee. After all allotment transfers have occurred, any unused allotment would be transferred to the Committee. The Committee would then redistribute any unused allotment to handlers having excess cranberries in an amount proportionate to each handler's total allotment. These provisions help ensure that excess supply is utilized, to the extent possible, through unfilled allotment.

The Committee considered the estimated level of production and anticipated demand, and determined that without some action on the part of the Committee, inventory levels will continue to increase throughout the 2018-19 season. The Committee believes using the volume control authorities in the Order will help stabilize marketing conditions for cranberries by helping to adjust supply to meet market demand and improve grower returns.

Accordingly, this final rule establishes a grower allotment at 75 percent for the 2018-19 season. It also gives handlers the option to process up to 50 percent of the excess cranberries they receive above their growers' allotment, provided they divert an equivalent amount of 2018-19 cranberry processed products. This final rule also exempts organically grown cranberries, specifies handlers subject to the regulation, revises the definition of outlets for excess fruit, and revises dates by which certain actions are due.

Final Regulatory Flexibility Analysis

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

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

There are approximately 1,100 cranberry growers in the regulated area and approximately 65 cranberry handlers subject to regulation under the Order. Small agricultural growers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

According to industry and Committee data, the average grower price for cranberries during the 2016-17 season was $23.50 per barrel and total sales were approximately 9.5 million barrels. The value for cranberries that year totaled $223,250,000 ($23.50 per barrel multiplied by 9.5 million barrels). Taking the total value of production for cranberries and dividing it by the total number of cranberry growers provides an average return per grower of $202,955. Using the average price and utilization information, and assuming a normal distribution, the majority of cranberry growers receive less than $750,000 annually.

According to USDA's Market News report, the average free on board (f.o.b.) price for cranberries was approximately $30.00 per barrel. Multiplying the f.o.b. price by total utilization of 9.5 million barrels results in an estimated handler-level cranberry value of $285 million. Dividing this figure by the number of handlers (65) yields an estimated average annual handler receipt of $4.3 million, which is below the SBA threshold for small agricultural service firms. Therefore, the majority of growers and handlers of cranberries may be classified as small entities.

While cranberry production has continued to rise, demand has failed to keep pace, and inventories have been increasing. In an industry such as cranberries, product can be stored in inventory for long periods of time. Large inventories are costly to maintain, difficult to market, and have a price-depressing effect. When supply outpaces demand and results in high levels of inventories, grower and handler returns can be negatively impacted.

Demand for cranberries is inelastic, meaning changes in price have a minimal effect on total sales volume. However, grower prices are very sensitive to changes in supply. A grower allotment program results in a decrease in supply as handlers can only purchase a portion of a grower's production, which is based on the grower's past sales history. Even a small shift in supply can have a positive effect on grower prices. Therefore, using a grower allotment program to reduce supply should increase grower prices and revenues.

This final rule establishes a grower allotment of 75 percent for the 2018-19 crop year. It also allows handlers to process up to 50 percent of the excess cranberries they receive above their growers' allotment, provided they divert an equivalent amount of 2018-19 cranberry processed products. In addition, this rule exempts organically grown cranberries, specifies handlers subject to the regulation, revises the definition of outlets for excess fruit, and revises dates by which certain actions are due. These actions are designed to help stabilize marketing conditions, reduce burdensome inventories, and improve grower and handler returns. This rule revises §§ 929.104 and 929.105 and establishes new §§ 929.159 and 929.253. The authority for these actions is provided for in §§ 929.48, 929.49, 929.51, 929.52, 929.58, 929.59, 929.61, and 929.62. These changes are based on Committee recommendations from meetings on August 4 and August 31, 2017, and a February 18, 2018, email vote.

While these actions could result in some additional costs to the industry, the benefits are expected to outweigh them. The purpose of establishing an allotment percentage is to address oversupply conditions and to stabilize grower prices. The industry has a significant volume in inventory, and this has had a negative impact on grower and handler returns. Without volume control, inventories will likely continue to increase, further lowering returns.

Inventories have significantly increased since 2011. In 2011, existing inventories were around 4.6 million barrels. By the end of the 2016-17 season, inventories were approximately 9.9 million barrels, and by the end of the 2017-18 season, inventories are projected to be approximately 10.9 million barrels. Inventories as a percentage of total sales have also been increasing from approximately 50 percent in 2010 to approximately 103 percent in 2016, and could reach an anticipated 115 percent after the 2017-18 season. These inventories have had a depressing effect on grower prices, which for many growers have fallen below their cost of production.

Retail demand for cranberries is highly inelastic, which indicates changes in consumer prices do not result in significant changes in the quantity demanded. Consumer prices are also not significantly impacted by minor changes in cranberry supplies. Therefore, this action should have little or no effect on consumer prices and should not result in a reduction in retail sales. However, even a small shift in supply could increase grower and handler returns. The use of allotment percentages will likely have a positive impact on grower and handler returns for this crop year.

This rule will result in some fruit being taken off the market. However, a sufficient amount of fruit will still be available to supply all aspects of the market. In addition, allowing handlers the option to process up to 50 percent of the excess cranberries they receive above their growers' allotment, provided they divert an equivalent amount of 2018-19 cranberry processed products, provides handlers some additional flexibility and may help reduce inventories of juice concentrate, one of the largest segments of existing inventory.

There are also secondary outlets available for excess fruit, including foreign markets except Canada, charitable institutions, nonhuman food use, and research and development projects. While these alternatives may provide different levels of return than sales to primary markets, they play an important role for the industry. In addition, if demand is greater than anticipated, there are significant amounts of fruit in inventory that can be utilized to meet demand.

This action also exempts small handlers who processed less than 125,000 barrels in 2017-18 from the allotment percentage. Consequently, small handlers whose acquired volume is 125,000 barrels or less are exempt from the allotment volume restriction. This will reduce the burden the volume restriction has on small handlers and their growers.

In addition, handlers who did not have carryover inventory at the end of the 2017-18 fiscal year are also exempt from the allotment percentage. This allows handlers that have matched their production with market demand to continue to serve their customer base and maintain their market share. Handlers subject to the restriction should be able to meet any shortfalls by utilizing cranberries or cranberry products they have in inventory.

Further, making the recommendation to regulate the volume handled under a grower allotment program could result in some cost savings for growers depending upon what actions they may take to adjust supply.

As the allotment represents a percentage of the grower's sales history, the costs, when applicable, are proportionate and should not place an extra burden on small entities as compared to large entities. Likewise, growers and handlers, regardless of size, benefit from the stabilizing effects of this action.

One alternative considered by the Committee was not to impose a volume regulation during the 2018-19 crop year. However, Committee members believed that inventory levels were such that some form of volume control was necessary to help stabilize marketing conditions.

The Committee also considered other allotment percentage levels. However, some members were concerned that setting an allotment percentage that was too restrictive could negatively impact small growers. The Committee also considered not recommending a provision to allow a percentage of excess cranberries to be processed into cranberry products. The Committee determined that allowing handlers to process up to 50 percent of the excess cranberries they receive above their growers' allotment would provide additional volumes of fresh cranberries for processing and would provide handlers some flexibility while not adding additional juice concentrate to the existing inventory levels. Therefore, for the reasons mentioned above, these alternatives were rejected by the Committee.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189, Fruit Crops. No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.

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

As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.

AMS is committed to complying with the E-Government Act to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

In addition, the Committee's meetings were widely publicized throughout the cranberry industry and all interested persons were invited to attend the meetings and participate in Committee deliberations on all issues. Like all Committee meetings, the August 4, 2017 and August 31, 2017 meetings were public meetings and all entities, both large and small, were able to express views on these issues.

A proposed rule concerning this action was published in the Federal Register on April 27, 2018 (83 FR 18462). Copies of the proposed rule were sent via email to Committee members and cranberry handlers. Additionally, the rule was made available through the internet by USDA and the Office of the Federal Register. A 30-day comment period ending May 29, 2018, was provided to allow interested persons to respond to the proposal.

During the comment period, 24 comments were received in response to the proposal. Of the comments received, 12 were in support of the regulation, but also requested some changes to the proposal, 11 were opposed to the regulation, and 1 took no position.

Comments: In the comments that supported volume regulation, but with changes from what was included in the proposed rule, the 12 commenters stated the volume regulation was a way to reduce supply and benefit the industry. These 12 comments also specifically supported the handler's flexibility to divert excess fruit, stating it would help handlers maximize the value of the fruit.

The 12 comments also suggested handlers be allowed to divert 100 percent of their excess fruit in processed form, rather than the 50 percent allowed under the proposed rule. They stated that with a significant amount of the current inventory in the form of juice concentrate, this would help prevent additional build-up of inventory.

Response: While a significant portion of existing inventory is concentrate, not all handlers produce concentrate or concentrate as a byproduct of SDC production. Allowing the use of 50 percent of 2018-19 cranberry products to meet the excess fruit restriction recognizes the need to reduce cranberry concentrate inventory, while also addressing the overall oversupply facing the industry.

Comments: Eleven of these commenters also expressed that the exemption for small handlers does not help small growers. These commenters asked USDA to reconsider its decision to do away with the 2,500 barrel exemption for each grower as recommended by the Committee.

Response: In reviewing the Committee's recommendation and other available industry information, USDA has determined that existing inventories in excess of 9 million barrels are putting the most downward pressure on returns to both growers and handlers. Consequently, this rule puts more focus on reducing the volume in inventory, which should benefit both small growers and small handlers.

Rather than provide an exemption of 2,500 barrels for each grower, an action which would have exempted nearly 2.75 million barrels, this action exempts small handlers who processed less than 125,000 barrels during the 2017-18 fiscal year from the allotment requirement. Small handlers processing less than 125,000 barrels make up nearly 88 percent of all handlers, yet combined, account for less than 10 percent of the total volume of cranberries processed. Based on Committee data, these small handlers were holding little or no volume in inventory at the end of the 2016-17 season. USDA's revisions to the Committee's proposal therefore exempts these handlers from the allotment requirement. Although focused on handlers, this change is expected to have a positive impact on grower returns by reducing overall supply in the market. Additionally, small growers would have the option of delivering their fruit to handlers who are not subject to the regulation.

In addition, handlers who did not have carryover inventory at the end of the 2017-18 fiscal year are also exempt. USDA believes that this will allow handlers who have matched their production with market demand to continue to serve their customer base and maintain their market share. Only those handlers carrying inventory will be subject to meeting the allotment requirement.

Handlers subject to the allotment percentage should be able to meet any market shortfalls by utilizing cranberries or cranberry products available in inventory. The provision allowing handlers to process a portion of their excess cranberries also helps provide some flexibility.

Comment: Another comment stated they did not support using 2017 deliveries to determine the 2018 exemptions, and that the no carryover inventory exemption is flawed.

Response: Regarding using 2017-18 information to determine 2018-19 exemptions, this is a grower's production allotment volume regulation. As such, it is important for growers to have an idea of what their allotment will be for the upcoming season. Growers can then use that information to make determinations regarding their production. By using the information from 2017-18, USDA provided growers with exemptions they could use to determine whether their production would be subject to the allotment, or the potential opportunity to choose to deliver their production to an exempt handler.

Comments: Of the 11 comments in opposition of the proposed rule, five support the reinstatement of the 2,500 barrel exemption for each grower as discussed above. Four stated the proposed change would do little or nothing to accomplish USDA's stated goal of controlling the overage of cranberry concentrate.

Response: Concentrate represents a large portion of existing inventory. However, at the end of the 2016-17 fiscal year, of the estimated 9.7 million barrels in inventory, approximately 4.2 million barrels were frozen berries, while approximately 3.7 million barrels were concentrate. The rule provides for the diversion of processed product to meet 50 percent of the restriction as a way to reduce the inventory of concentrate. However, reducing overall supply, including whole fruit, is also important in addressing the current level of inventory.

Comments: Six comments stated that the proposed regulation would negatively impact independent growers and another stated that this would hurt small growers. Four commenters stated this regulation would adversely affect midsize handlers.

Response: While these actions could result in some additional costs to the industry, the allotment percentage established by this rule applies uniformly to all those regulated, regardless of size. A grower's allotment is the total volume a handler may purchase from, or handle on behalf of, that grower during a year of volume regulation. Each grower's allotment volume is calculated by multiplying the individual's sales history by the allotment percentage. As the allotment percentage is applied to each grower's sales history, the costs, when applicable, are proportionate and should not place an extra burden on small entities as compared to large entities.

Further, the benefits are expected to outweigh any additional costs and positively impact all growers and handlers, regardless of size. The industry has a significant volume in inventory, and this has had a negative impact on all grower and handler returns. If steps are not taken to reduce the level of inventory, these downward pressures will persist. The purpose of establishing the allotment percentage is to address the oversupply conditions which are negatively impacting industry returns. Generally, reducing supply levels results in prices increasing for growers and handlers. Therefore, lowering inventory levels is expected to result in positive returns for the entire industry.

Comments: Four comments stated the shortage in the 2017 crop makes the grower allotment unnecessary and harmful, and the rule will create an artificial spike in market price for finished goods. Another commenter questioned regulating cranberries when Canadian production is not subject to the allotment.

Response: In reviewing the Committee's recommendation and other available industry information, USDA has determined that existing inventory is putting the most downward pressure on returns to both growers and handlers. Even with the shortfall in the 2017 crop and the handler withhold established for the 2017-18 season, the industry will enter the 2018-19 season with inventory levels that will continue to negatively affect industry returns. In addition, existing inventory, combined with an additional 9 million barrels of anticipated 2017 domestic production, will provide a more than ample domestic supply to meet sales requirements. Consequently, this regulation should have little effect on consumer prices. Moreover, while the Order does not regulate the volume of imports, given the current levels of available domestic supply, this rule is not expected to lead to an increase in imported product.

Comment: One comment in opposition to the proposal stated it would be implemented too late, as growers have already made their production decisions. It further stated the rule should be implemented next season when they have more time to make economic decisions relating to their crop.

Response: Utilizing a production allotment allows growers to make adjustments to reduce their costs. Given the oversupply, it is important to take action on this issue. Further, growers have been aware of this recommendation for some time, and the proposed rule on this action published on April 27, 2018.

Comment: Another commenter stated the proposed regulation originated from the major cooperative.

Response: As stated above, the proposal for production allotment was discussed and ultimately recommended by the Committee for USDA's consideration at the August 4, 2017 and August 31, 2017 meetings. The Committee is comprised of growers of cranberries operating within the production area and a public member, and all meetings are open to industry and public participation.

Comment: The one comment taking a neutral position on the proposed action also indicated support for reestablishing the 2,500-barrel exemption for each grower, as recommended by the Committee, should USDA decide to go forward with the regulation.

Response: For the reasons given above, the 2,500-barrel exemption for growers will not be reestablished.

Comments: Additional comments were received that addressed issues outside the scope of the proposed rule.

For the reasons discussed above, no changes will be made to the rule as proposed, based on the comments received.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant matter presented, including the information and recommendation of the Committee and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

List of Subjects in 7 CFR Part 929

Cranberries, Marketing agreements, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, 7 CFR part 929 is amended as follows:

PART 929—CRANBERRIES GROWN IN STATES OF MASSACHUSETTS, RHODE ISLAND, CONNECTICUT, NEW JERSEY, WISCONSIN, MICHIGAN, MINNESOTA, OREGON, WASHINGTON, AND LONG ISLAND IN THE STATE OF NEW YORK 1. The authority citation for part 929 continues to read as follows: Authority:

7 U.S.C. 601-674.

Subpart B—Administrative Requirements 2. In § 929.104, revise paragraph (a) introductory text and remove and reserve paragraph (b).

The revision reads as follows:

§ 929.104 Outlets for excess cranberries.

(a) In accordance with § 929.61, excess cranberries may be diverted only to the following noncommercial or noncompetitive outlets:

3. In § 929.105, add paragraph (c) to read as follows:
§ 929.105 Reporting.

(c) Beginning with crop year 2018-19, the due date for the grower report required under § 929.62(a) is changed to March 1.

4. Add § 929.159 to read as follows:
§ 929.159 Excess cranberries.

(a) Beginning with crop year 2018-19, handlers holding excess cranberries shall submit to the Committee a written plan outlining procedures for the systematic disposal of such cranberries as specified in § 929.59(b) by March 1.

(b) Beginning with crop year 2018-19, all excess cranberries shall be diverted as specified in § 929.59(c) prior to August 31.

6. Add § 929.253 to read as follows:
§ 929.253 Marketable quantity and allotment percentage for the 2018-19 crop year.

(a) The marketable quantity for the 2018-19 crop year is set at 7.275 million barrels and the allotment percentage is designated at 75 percent.

(b) Organically grown fruit shall be exempt from the volume regulation requirements of this section. Small handlers who processed less than 125,000 barrels during the 2017-18 fiscal year are exempt from the volume regulation requirements of this section. Any handler who did not have carryover inventory at the end of the 2017-18 fiscal year is also exempt from the volume regulation requirements of this section.

(c) Handlers have the option to process up to 50 percent of the excess cranberries received over their growers' allotments into dehydrated cranberries or other processed products. Handlers utilizing this option shall divert an amount of 2018-19 processed products equivalent to the volume of excess cranberries processed as provided for in § 929.107. The remaining volume of excess cranberries must be diverted as whole fruit.

Dated: September 7, 2018. Bruce Summers, Administrator, Agricultural Marketing Service.
[FR Doc. 2018-19825 Filed 9-11-18; 8:45 am] BILLING CODE 3410-02-P
BUREAU OF CONSUMER FINANCIAL PROTECTION 12 CFR Part 1070 [Docket No. CFPB-2016-0039] RIN 3170-AA63 Disclosure of Records and Information AGENCY:

Bureau of Consumer Financial Protection.

ACTION:

Final rule.

SUMMARY:

This final rule amends the procedures used by the public to obtain information from the Bureau of Consumer Financial Protection (Bureau) under the Freedom of Information Act, the Privacy Act of 1974, and in legal proceedings.

DATES:

This final rule is effective October 12, 2018.

FOR FURTHER INFORMATION CONTACT:

David Snyder, Senior Counsel, Legal Division, at 202-435-7758. If you require this document in an alternative electronic format, please contact [email protected]

SUPPLEMENTARY INFORMATION: I. Background

The Bureau first published the procedures used by the public to obtain information from it under the Freedom of Information Act, the Privacy Act of 1974, and in legal proceedings in an interim final rule on July 28, 2011, 76 FR 45371 (Jul. 28, 2011). This was followed by a final rule on February 15, 2013, 78 FR 11483 (Feb. 15, 2013). Based on its experience over the last several years, the Bureau published a notice of proposed rulemaking on August 24, 2016, 81 FR 58310 (Aug. 24, 2016), that proposed to amend the rule to clarify, correct, and amend certain provisions of the rule, and it solicited comments on the proposal. The Bureau is issuing this final rule in response to the comments. The Bureau's August 24, 2016 notice of proposed rulemaking also proposed to amend the Bureau's rule regarding the confidential treatment of information obtained from persons in connection with the exercise of its authorities under Federal consumer financial law. This final rule only pertains to portions of the Bureau's proposal related to the Freedom of Information Act, the Privacy Act of 1974, and requests for Bureau information in legal proceedings.

II. Summary of the Final Rule

The final rule revises subparts A, B, C, and E of section 1070 of title 12 of the Code of Federal Regulations.

The revisions to subpart A address procedures related to the certification of authenticity of Bureau records and the service of summonses or complaints on the Bureau. Subpart A also contains definitions of terms used throughout the remainder of the part, and the final rule revises the definition of “Chief FOIA Officer.”

Subpart B implements the Freedom of Information Act, 5 U.S.C. 552 (the FOIA). The Bureau has revised this subpart to clarify its practices, provide additional flexibility for requesters, and reflect recent changes made to the FOIA by the FOIA Improvement Act of 2016 (Pub. L. 114-185). Additionally, these changes streamline the Bureau's process for assessing FOIA fees and notifying requesters of such fees. These changes will allow the Bureau to process FOIA requests more efficiently and provide records to requesters more quickly. The Bureau has made some minor revisions to its proposal in response to comments.

The final rule does not revise subpart D.

Subpart C (sometimes referred to as Touhy Regulations) sets forth procedures for requests for information from the Bureau in connection with legal proceedings between others, and describes the Bureau's procedures for considering such requests or demands for official information. The Bureau has made organizational and clarifying revisions to the provisions previously set forth in this subpart. The Bureau received no comments on this subpart and it finalizes the proposed subpart without modification.

Subpart E contains the Bureau's rule implementing the Privacy Act of 1974, 5 U.S.C. 552a. The Bureau has revised the subpart to clarify the Chief Privacy Officer's authority, to provide additional flexibility for requestors, and to make technical corrections. The Bureau received no comments on this subpart and it finalizes the proposed subpart without modification.

III. Overview of Comments Received

The Bureau received eight comment letters that pertained to its proposal regarding FOIA implementation. These included three comment letters from industry trade associations; and one comment letter each from an individual; an opposition research and communication organization; a financial institution; a consumer advocacy organization; and a Federal agency with responsibilities related to implementation of the FOIA. These comment letters largely proposed minor modifications to the proposed rule in order to clarify it and/or facilitate public access to information. The Bureau also received input from another Federal agency during the comment period. These suggestions primarily focused on procedural and technical changes to the proposed rule. The Bureau made some changes to the final rule based on this input.

The Bureau received no comment letters regarding its proposed revisions to subpart C or subpart E, regarding its Touhy Regulations and implementation of the Privacy Act of 1974, respectively.1

1 The Bureau received twenty-seven total comment letters in response to its notice of proposed rulemaking. The Bureau continues to consider the comments pertaining to its proposals related to the confidential treatment of Bureau information, and these comments are not addressed in this final rule.

IV. Legal Authority

The Bureau proposed the rule pursuant to its authority under (1) Title X of the Dodd-Frank Act, 12 U.S.C. 5481 et seq., including (a) Section 1022(b)(1), 12 U.S.C. 5512(b)(1); (b) Section 1022(c)(6)(A), 12 U.S.C. 5512(c)(6)(A); and (c) Section 1052(d), 12 U.S.C. 5562(d); (2) the Freedom of Information Act, 5 U.S.C. 552; (3) the Privacy Act of 1974, 5 U.S.C. 552a; (4) the Right to Financial Privacy Act, 12 U.S.C. 3401 et seq.; (5) the Trade Secrets Act, 18 U.S.C. 1905; (6) 18 U.S.C. 641; (7) the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., and (8) the Federal Records Act, 44 U.S.C. 3101. The Bureau received no comments on the applicability of these statutes, and it promulgates the final rule pursuant to these authorities.

V. Section-by-Section Analysis Part 1070—Disclosure of Records and Information Subpart A—General Provisions and Definitions Section 1070.2 General Definitions Section 1070.2(c) Chief FOIA Officer

The Bureau had proposed no change to the defined term, “Chief FOIA Officer.” However, a Federal agency noted that the Bureau's status quo definition permitted a broader delegation of the Chief FOIA Officer's authority than is permitted by the FOIA. The previous definition allowed the Chief Operating Officer to delegate the Chief FOIA Officer's authority to “any employee,” but the FOIA requires that the Chief FOIA Officer be at the assistant secretary level or above. The Bureau agrees that this provision allowed a broader delegation of authority than is permissible under the FOIA and has removed the phrase “or any CFPB employee to whom the Chief Operating Officer has delegated authority to act under this part” from the final rule. The Bureau believes that this provision, in conjunction with § 1070.2(d), provides the Bureau with the necessary flexibility to delegate some of the responsibilities of the Chief FOIA Officer to other CFPB employees without delegating more authority than is permissible under the FOIA.

Section 1070.3 Custodian of Records; Certification; Alternative Authority Section 1070.3(b) Certification of Record

Section 1070.3(b) authorizes the Bureau's Chief Operating Officer to certify the authenticity of any Bureau record or any copy of such record. The Bureau proposed revising the rule to clarify that the Chief Operating Officer can also certify the absence of a record. Such certification is contemplated in Rule 44 of the Federal Rules of Civil Procedure and Rule 902 of the Federal Rules of Evidence. See also Federal Rule of Evidence 803(10). The Bureau received no comments regarding this proposal, and it finalizes the proposal without modification.

Section 1070.5 Service of Summonses and Complaints

The Bureau proposed moving § 1070.31—which provides the process for serving the Bureau with summonses or complaints—to a new section in subpart A for clarity, in order to separate the rule governing service when the Bureau is a party from the remaining provisions in subpart C, which deal with requests for information for other proceedings. In addition, the Bureau proposed revising paragraph (d)'s requirement that documents be “stamped” “Service Accepted for Official Capacity Only” by replacing the word “stamped” with the word “marked.” This proposal was intended to clarify that the documents may be labeled using a variety of methods. The Bureau received no comments regarding these proposals, and it finalizes them without modification.

Subpart B—Freedom of Information Act

The Bureau received several general comments concerning its proposed changes to the regulations implementing the FOIA and the Bureau's FOIA process. Some commenters expressed support for the Bureau's proposed changes to the extent that they would expedite the FOIA process. Some of these commenters also raised concerns about the timeliness of the Bureau's FOIA process and its commitment to openness and transparency. The Bureau remains committed to open government and strives to be a leader by being transparent with respect to its own activities. In addition, the Bureau will continue to improve its FOIA process to ensure that all requests are responded to in a timely fashion.

The Bureau also made several technical and typographical revisions to the rule in response to comments, including updating cross-referenced provisions, ensuring consistent spelling of certain terms, and ensuring the consistent use of terminology throughout the rule.

Section 1070.11 Information Made Available; Discretionary Disclosures Section 1070.11(a) In General Section 1070.11(a)(2)

Section 1070.11(a)(2) identifies a category of information and records that the FOIA requires Federal agencies to make publicly available. The Bureau proposed to remove the phrase “and copying” and replace it with “in an electronic format.” The Bureau proposed similar revisions to § 1070.13. These changes are required by the FOIA Improvement Act of 2016. The Bureau received no comments on this proposal and it finalizes the proposal without modification.

Section 1070.11(b) Discretionary disclosures

Section 1070.11(b) says that, even if a FOIA exemption applies to requested information or records, the Bureau has discretion to disclose it to the extent that the disclosure is not otherwise precluded by law. The paragraph further notes that such disclosures are not precedential. The Bureau proposed no revisions to this paragraph. However, another Federal agency suggested that the phrase “but is merely an indication that, in the processing of the particular request, the CFPB finds no necessity for applying the exemption” is unnecessary. The phrase at issue is contained in the part of § 1070.11(b) noting that the Bureau's decision to discretionarily disclose a record in one case has no precedential value in the processing of another request. The Bureau agrees that this phrase is unnecessary and has removed it from the final rule.

Section 1070.13 & Public Inspection and Copying Section 1070.13(d) Redaction of Identifying Details

Section 1070.13 addresses the requirement that the Bureau make certain records available on its public website, and paragraph (d) addresses privacy-related redaction of those records. The Bureau proposed no revisions to this paragraph. However, one commenter noted that although § 1070.13(d) discusses redacting records in the Bureau's FOIA reading room for personal privacy, it does not mention any other FOIA exemptions. Although the commenter is correct that § 1070.13(d) does not mention any other FOIA exemptions, the Bureau does not believe any changes to this provision are warranted because § 1070.13(a) already informs requesters that documents published in the Bureau's FOIA reading room are “[s]ubject to the application of the FOIA exemptions and exclusions . . . .” The Bureau finalizes the provision in the final rule without modification.

Section 1070.14 Requests for CFPB Records Section 1070.14(b) Form of Request

Section 1070.14(b) specifies the form of FOIA requests, and it previously distinguished between requests made in writing and by electronic means. The Bureau proposed a technical change to this provision, to remove the phrase “or by electronic means” and add “as follows:” in its place. The Bureau also proposed changes to § 1070.14(b)(1) and (2) to clarify how requesters must submit FOIA requests to the Bureau. The Bureau proposed similar changes to the following sections: 1070.17(b)(1); 1070.21(c); and 1070.22(e)(1)(i). The Bureau received no comments on these proposals and it finalizes them without modification.

Section 1070.14(c) Content of Request

Section 1070.14(c) specifies the content of FOIA requests. Although the Bureau did not propose revisions to paragraphs (c)(1), (3), and (6), it received several suggestions from another Federal agency concerning these provisions. First, the agency suggested revising paragraph (c)(1) to say that a “FOIA request must describe the records that the requester seeks in sufficient detail.” The Bureau agrees and will make this edit as it is a core requirement of a perfected FOIA request.

The agency also suggested removing the phrase “[a]s a general rule” from the last sentence of paragraph (c)(1) because it is unnecessary. The Bureau agrees and has removed this text from the final rule.

Next, the agency suggested removing the part of paragraph (c)(3) that concerns requests to inspect records. The Bureau agrees that this provision is unnecessary and that, as a practical matter, requesters do not seek to inspect records prior to production. In response, the Bureau has removed the provision concerning the inspection of records and added a provision directing that the “request should state whether the requester wishes to receive the records in a specific format.”

Finally, the agency suggested changing paragraph (c)(6) to allow requesters to seek expedited processing at any time during the processing. The Bureau's rule previously required requesters to seek expedited processing with their initial requests. The agency noted that this provision could frustrate requesters by requiring them to withdraw and resubmit a request that includes a request for expedited processing. The Bureau agrees with the agency's suggestion, but has instead changed § 1070.17(b)(1) in the final rule to address this concern. As such, revision to § 1070.14(c)(6) is not necessary in response to this suggestion.

Section 1070.14(c)(4)

Section 1070.14(c)(4) provides that a FOIA requester should indicate in the request whether the requester is a commercial user, an educational institution, non-commercial scientific institution, representative of the news media or “other” requester, as those terms are defined in § 1070.22(b). The section also informs requesters that they may contact the Bureau's FOIA Public Liaison to seek assistance in determining the appropriate fee category. Previously, the provision only permitted the Bureau to use information provided to the FOIA Public Liaison by a requester for the purpose of determining the requester's fee category. The Bureau proposed to remove this limitation so that it could use this information for other purposes, such as aiding a requester in clarifying the scope of a request, assisting in identifying records sought by a requester, and helping to resolve disputes related to a request.

The Bureau received two comment letters regarding this provision. One commenter noted that the section included a fee category, “governmental entity,” which is not recognized under the FOIA and is not defined anywhere in the Bureau's regulations. The Bureau agrees and has removed this fee category from the final rule. Another commenter raised concerns about the removal of language limiting the purposes for which the FOIA Public Liaison could use information provided by a requester. The commenter suggested that the Bureau narrow its proposal to codify certain specified uses for which the FOIA Public Liaison could use the information. The Bureau declines to make this change. The purpose of this proposal was to provide the FOIA Public Liaison with additional flexibilities in using the information to assist requesters in the processing of their requests. The Bureau removed this provision with the goal of maximizing the FOIA Public Liaison's ability to assist requesters with the processing of their requests and it believes that placing restrictions on the FOIA Public Liaison will hamper those efforts. For the aforementioned reasons, the Bureau finalizes the proposal without modification.

Section 1070.14(c)(5)

Section 1070.14(c)(5) provides that if a requester seeks a waiver or reduction of fees associated with processing a request, then the request shall include a statement to that effect. The text previously included a statement that any request that does not seek a waiver or reduction of fees constitutes an agreement of the requester to pay all fees up to $25. The Bureau proposed to remove this language in light of other proposed fee-related revisions. Under the Bureau's proposed revisions to § 1070.22(d) and (f), FOIA requesters could still specify an upper limit on the fees that they are willing to pay to process a request and the Bureau would notify a requester of any potential fees beyond that limit before processing the request. The Bureau received no comments on this proposal and it finalizes the proposal without modification.

Section 1070.14(e) Requests by an Individual for CFPB Records Pertaining to That Individual

Section 1070.14(e) directs individuals who wish to inspect or obtain records pertaining to themselves to seek access to the records pursuant to the Bureau's regulations that implement the Privacy Act of 1974, in subpart E of the rule. The Bureau proposed no revisions to this provision. However, another Federal agency suggested that the Bureau directly reference its Privacy Act request identity verification procedures at § 1070.53(c) for first-party FOIA requests. It is the Bureau's practice to use the same identity verification procedures outlined in § 1070.53(c) for both Privacy Act requests and first-party FOIA requests, and such a change would codify the Bureau's current practice in its regulations. As such, the Bureau agrees with the commenter's suggestion and has made this change in the final rule.

Section 1070.14(g) Assistance From FOIA Public Liaison

Section 1070.14 instructs requesters on how to request records from the Bureau under the FOIA. The Bureau received a suggestion from another Federal agency suggesting that it make the FOIA Public Liaison available more broadly to assist requesters. The Bureau agrees with the commenter's suggestion and has added a new provision to its final rule, § 1070.14(g), which informs requesters that they can contact the FOIA Public Liaison to resolve any problems that arise during the processing of their requests. The Bureau believes that this change renders the reference to the FOIA Public Liaison in § 1070.14(c)(4) unnecessary and has removed it from the final rule.

Section 1070.15 Responsibility for Responding to Requests for CFPB Records

Section 1070.15 addresses, among other things, the process by which the Bureau consults with other agencies regarding FOIA requests and/or refers FOIA requests to other agencies. The Bureau did not propose any revisions to this provision. However, one commenter noted that the Bureau separately proposed a new definition of “agency” in § 1070.2(a) that included entities that are not subject to the FOIA. Were § 1070.15 to be read in conjunction with this proposed definition, the rule would seem to allow the Bureau to refer FOIA requests to agencies that are not subject to the FOIA. Because the Bureau is not finalizing the proposed definitions in § 1070.2 in this final rule, this comment is moot.

In addition, a Federal agency suggested that the Bureau update and clarify its process for referrals and consultations, and that the Bureau allow for an additional process whereby the Bureau would coordinate with another agency when referral and consultation are not appropriate. The Bureau agrees with this suggestion and has added language to the final rule concerning referrals, consultations, and coordination. The changes to the rule clarify when it is appropriate for the Bureau to refer a request to, consult, or coordinate with another agency when processing a FOIA request. It also clarifies how the Bureau will document referrals and notify requesters when the Bureau has decided to refer a request to another agency.

Section 1070.16 Timing of Responses to Requests for CFPB Records Section 1070.16(d) Unusual Circumstances

Section 1070.16(d) addresses circumstances where the Bureau requires an extension to respond to a FOIA request. The Bureau proposed no revisions to this provision. However, one commenter suggested that the Bureau add language to § 1070.16(d) stating that it will notify requesters of the availability of the services provided by the Bureau's FOIA Public Liaison and the National Archives and Records Administration (NARA), Office of Government Information Services (OGIS) when the Bureau requires an extension due to “unusual circumstances” under this provision. The Bureau agrees with this suggestion and has revised the final rule to incorporate this change.

In addition, a Federal agency suggested that the Bureau remove several of the references to FOIA appeals in this paragraph. Although “unusual circumstances” may apply to the processing of a FOIA appeal, the agency pointed out that in such circumstances the Bureau would not give the requester an opportunity to modify the scope of the appeal. The Bureau agrees with this suggestion and has implemented it in the final rule, as this part of the paragraph is intended to apply to requests, not FOIA appeals.

Section 1070.17 Requests for Expedited Processing Section 1070.17(b) Form and Content of a Request for Expedited Processing

Section 1070.17(b) instructs requesters on how to request expedited processing of a FOIA request. The Bureau proposed no revisions to this section. However, as explained above with respect to § 1070.14(c), in response to a suggestion from another Federal agency, the Bureau has revised § 1070.17(b)(1) of the final rule to state that requesters may request expedited processing at any time during the processing of their requests.

In addition, the Federal agency recommended that the Bureau revise § 1070.17(b)(2)(ii) to clarify what a requester must show to obtain expedited processing of the requested records. The Bureau agrees and has revised the rule accordingly. The FOIA provides for expedited processing of a request upon a showing of a “compelling need,” which includes a request by a “person primarily engaged in disseminating information” where there is an “urgency to inform the public concerning actual or alleged Federal Government activity.” 5 U.S.C. 552(a)(6)(E). The rule did not previously explain what requesters must show to demonstrate that they are persons “primarily engaged in disseminating information.” The revised rule clarifies that a requester who is not a full-time member of the media must establish that the requester is a person “whose primary professional activity or occupation is information dissemination.” The revised rule also informs requesters that the existence of numerous articles on a given subject can be helpful in establishing that there is an “urgency to inform” the public on the topic of the request.

Section 1070.17(c) Determinations of Requests for Expedited Processing

Section 1070.17(c) states that the Bureau will decide requests for expedited processing within ten calendar days of its receipt of the request, and that it will notify the requester of its decision in writing. The Bureau proposed no revisions to this section. However, one commenter suggested that the Bureau revise the provision to require the Bureau to process requests for expedited processing within five business days, and to require the Bureau to provide requested records within three business days of granting a request for expedited processing. The Bureau declines to adopt this recommendation. The current rule requires the Bureau to decide whether to grant a request for expedited processing in ten calendar days, which is what the FOIA requires. Additionally, the Bureau notes that, as reflected in its most recent Annual FOIA Report, the average amount of time it takes the Bureau to adjudicate a request for expedited processing is one day.

The Bureau also declines to commit itself to releasing requested records within three business days of granting a request for expedited processing. When the Bureau grants a request for expedited processing, it processes the request as quickly and efficiently as possible. As noted above, the Bureau, on average, adjudicates requests for expedited processing in one day. Processing a request within three days after expedited processing is granted will not be feasible in many cases, particularly in cases involving a large number of responsive records.

For the aforementioned reasons, the Bureau finalizes the provision without modification.

Section 1070.18 Responses to Requests for CFPB Records Section 1070.18(a) Acknowledgement of Requests

Section 1070.18(a) requires the Bureau to acknowledge its receipt of FOIA requests. The provision previously created this requirement only for perfected requests. A Federal agency recommended that the Bureau delete the word “perfected,” thus requiring the Bureau to also acknowledge and provide requesters with tracking numbers for requests that have not been perfected. The Bureau agrees with this recommendation. This is the Bureau's current practice, and it has revised the final rule to adopt this suggestion.

Section 1070.18(a)(4)

Section 1070.18(a)(4) specifies what fee-related information the Bureau will include in acknowledgement letters it sends to requesters. The Bureau proposed to make a technical change to this provision, removing the phrase “(of not less than $25)” to account for the proposed revisions to fee-related provisions in § 1070.22(d) and (f). The Bureau received no comments on this proposal and it finalizes the proposal without modification.

Section 1070.18(b) Initial Determination To Grant or Deny a Request Section 1070.18(b)(2)

Section 1070.18(b)(2) addresses the Bureau's response to a request that has been granted in full or in part. The Bureau proposed no revisions to this provision. However, a Federal agency recommended that the Bureau revise § 1070.18(b)(2) to notify requesters that they can seek assistance from the Bureau's FOIA Public Liaison when the Bureau grants a request in full or in part. The Bureau agrees with this recommendation and has revised the final rule to incorporate it.

Section 1070.18(b)(4)

Section 1070.18(b)(4) addresses the Bureau's response to a request that it determines should be denied in whole or in part. The Bureau proposed to add a new provision at § 1070.18(b)(4)(iv) requiring it to inform requesters of the right to seek dispute resolution services from the Bureau's FOIA Public Liaison or OGIS. The Bureau also proposed to renumber the existing provisions under § 1070.18(b)(4) to accommodate this change. The Bureau noted in its proposal that this change is required by the FOIA Improvement Act of 2016. The Bureau received no comments on this proposal and it finalizes the proposal without modification.

Section 1070.18(c) Resolution of Disputes

The Bureau proposed a new paragraph in § 1070.18 to inform requesters about the resources available to resolve any disputes that may arise during the request process. These resources are the Bureau's FOIA Public Liaison and mediation services provided by OGIS. One commenter suggested that the Bureau remove a provision in § 1070.18(c)(2) stating that the Bureau will not “defer to OGIS mediation decision in particular cases.” The commenter reasoned that this provision is not necessary because OGIS does not issue decisions. The Bureau agrees and it has revised the final rule to incorporate this recommendation.

Section 1070.18(d) Format of Records Disclosed

The Bureau proposed a new paragraph to inform requesters that they may request records in a particular format. Under this proposal, the Bureau would provide records in a requested format when the requested format can readily be reproduced from the original file. The Bureau received no comments on this proposal and it finalizes the proposal without modification.

Section 1070.20 Requests for Business Information Provided to the CFPB Section 1070.20(f) Opportunity To Object to Disclosure

Section 1070.20(f) provides a submitter of business information with ten business days to object to the Bureau's disclosure of the submitter's business information. The Bureau proposed to make two technical changes to this provision clarifying that the Bureau will delay any release of information to afford the submitter ten business days to object to the disclosure. The Bureau received one comment in support of this proposed change and it finalizes the proposal without modification.

Section 1070.21 Administrative Appeals Section 1070.21(b) Time Limits for Filing Administrative Appeals

Section 1070.21(b) provides the time limits for filing administrative appeals. The Bureau proposed to revise this provision to clarify that the time period for filing an appeal begins on the day after the date the initial determination is sent to the requester or the date of the letter transmitting the last records released, whichever is later. The Bureau also proposed to change the time limit for filing an administrative appeal from 45 days to 90 days. This change is required by the FOIA Improvement Act of 2016. The Bureau received no comments on these proposals and it finalizes them without modification.

Section 1070.21(d) Processing of Administrative Appeals

Section 1070.21(d) specifies how the Bureau will process administrative appeals. The Bureau proposed to remove the requirement that appeals be stamped with the date of their receipt by the FOIA Office. The FOIA Office does not stamp an appeal with the date the Bureau received it, but the date is recorded in the Bureau's system for tracking FOIA requests. This requirement is outmoded and the Bureau proposed to remove it to account for its current practice.

Section 1070.21(d) also previously provided that appeals would be processed in the order in which they are received. Since adopting this provision in 2011, the Bureau has found that it is not always practicable to complete action on appeals in the order in which they are received, and sometimes has chosen to act on a simple later-received appeal rather than delay action pending completion of a more complex earlier-received appeal. In order to better align the regulation with current practice, the Bureau proposed to delete the provision calling for first-in-first-out processing of appeals.

The Bureau received no comments on these proposals and it finalizes them without modification.

Section 1070.21(e) Determinations To Grant or Deny Administrative Appeals

Section 1070.21(e) authorizes the General Counsel to decide administrative appeals, and § 1070.21(e)(3) allows for remand of a FOIA determination as one option for the General Counsel's disposition of an appeal. The Bureau proposed to amend the first sentence of § 1070.21(e) to add a reference to remands so that all options for disposition of appeals are listed in that sentence. The Bureau received no comments on its proposed revision and it finalizes the revision without modification. In addition, one commenter recommended that the Bureau also include a provision in § 1070.21(e) committing the Bureau to work as an active partner during the OGIS dispute resolution process when the Bureau agrees to participate in the process concerning a particular request. The Bureau agrees with this recommendation and has revised the final rule to incorporate it.

Section 1070.22 Fees for Processing Requests for CFPB Records Section 1070.22(a) In General

Section 1070.22(a) directs the Bureau to determine whether and to what extent to charge a requester fees for processing a FOIA request. Among other things, the provision previously stated that the Bureau charges certain fees “unless circumstances exist . . . that render fees inapplicable or inadvisable or unless the requester has requested and the [Bureau] has granted a reduction in or waiver of fees. . . .” The Bureau proposed no revisions to this provision. However, a Federal agency recommended that the Bureau remove the phrase “or inadvisable” from § 1070.22(a) because it is not clear what the phrase means in this context. The Bureau agrees and has removed this phrase from the final rule.

Section 1070.22(b) Categories of Requesters

Section 1070.22(b) identifies appropriate fee categories for requesters. One commenter suggested that community-based organizations and non-profits “be added to the category that would obtain the lowest fees” or, alternatively, that the Bureau create a new fee category for such groups where they would pay the lowest processing fees. The Bureau declines to adopt this recommendation. The fee categories are defined by statute and the Office of Management and Budget's fee guidance, and the Bureau does not believe it would be appropriate for it to create a new fee category that was not contemplated by the FOIA. The Bureau also cannot commit to placing all non-profits and community based organizations in the lowest fee categories because not all such organizations will meet the requirements for placement in these fee categories. The Bureau believes that the current FOIA fee categories and the fee waiver provisions in the Bureau's rule are sufficient to address the concerns raised by the commenter.

Section 1070.22(b)(1)(i)

Section 1070.22(b)(1)(i) defines the “Commercial user” category of requester. The Bureau proposed to amend this provision to clarify that the Bureau's decision to place a requester in the commercial user category will be made on a case-by-case basis based on how the requester will use the information. The Bureau proposed this change to clarify how it will make decisions whether to place a requester in the commercial user category. The Bureau received no comments on this proposal and it finalizes the proposal without modification.

Section 1070.22(b)(1)(ii)

Section 1070.22(b)(1)(ii) defines the “Educational institution” category of requester. Several commenters suggested that the Bureau update the definition to more accurately reflect the text of the FOIA and recent case law expanding the scope of the term “educational institution” to include students at educational institutions who submit a FOIA request in furtherance of coursework or other school-sponsored activities. See Sack v. U.S. Dep't of Defense, 823 F.3d 687 (D.C. Cir. 2016). The Bureau agrees with the commenters and has so revised this provision in the final rule, including by adding three examples of requesters to clarify under which circumstances a requester would fall within the scope of this fee category. The Bureau has also made corresponding changes to § 1070.22(c)(2), removing information that is no longer necessary in light of the revisions to § 1070.22(b)(1)(ii).

Section 1070.22(b)(2)

Section 1070.22(b)(2) provides that the Bureau will notify a requester of its determination as to the proper fee category to apply to the requester. The provision previously provided that the Bureau make its determination based on a review of the requester's submission and the Bureau's own records. The Bureau proposed to delete this limitation to clarify that it may base its determination on other appropriate information, including phone conversations with the requester and publicly available information. The Bureau received no comments on this proposal and it finalizes the proposal without modification.

Section 1070.22(d) Other Circumstances When Fees Are Not Charged

Section 1070.22(d) provides certain circumstances where the Bureau may not charge a requester a fee for processing a FOIA request. The Bureau proposed to insert a new paragraph at § 1070.22(d)(2) and to renumber § 1070.22(d) to accommodate the new paragraph. The Bureau explained in its proposal that the new paragraph would provide that it will not charge a requester any fees when the fee, excluding duplication costs, is less than $250. The Bureau proposed this change as part of its larger goal of revising the process for how it assesses FOIA processing fees and how the Bureau notifies requesters of such fees. The Bureau explained that this new provision would streamline its process for assessing FOIA fees. This change would allow the Bureau to process FOIA requests more quickly and efficiently because the Bureau would no longer need to contact a FOIA requester concerning processing fees when the cost to process the request is less than $250. As such, this provision would provide information to these requesters more quickly and at a reduced cost to the requesters.

A Federal agency suggested that the Bureau should remove § 1070.22(d)(1) because it is no longer necessary given other revisions the Bureau has proposed to its FOIA regulations. The agency also recommended that the Bureau clarify § 1070.22(d)(2) because it is not clear from the proposed revisions whether duplication costs would be included in the proposed $250 threshold.

The Bureau intended its proposed $250 fee threshold to only apply to search and review costs, not duplication costs. Under its proposal, the Bureau would not charge any fees if the search and review fees were less than $250, but it did not intend for duplication costs to be subject to this threshold. The Bureau intended to subject duplication costs to § 1070.22(d)(1), which provides that the Bureau will not charge a requester any FOIA processing fee when the cost of collecting the fee is equal to or greater than the fee itself. The Bureau intended to make this distinction because most of its FOIA responses are transmitted to requesters electronically and result in no duplication costs. The Bureau did not intend to offer requesters up to $250 worth of duplication without charge when the Bureau can almost always provide records in an electronic format. The Bureau has made clarifying revisions to its rule to address the agency's comments.

Section 1070.22(d)(4)

Section 1070.22(d)(4) addresses miscellaneous circumstances where the Bureau may not assess fees. The Bureau proposed to revise this provision to prohibit it from charging search fees, or in certain cases duplication fees, when the Bureau has failed to comply with time limits under § 1070.16 or § 1070.21, unless (1) unusual circumstances apply to the processing of the request; (2) the Bureau has provided timely written notice of the unusual circumstances to the requester; (3) more than 5,000 pages are necessary to respond to the request; and (4) the Bureau has discussed with the requester (or made three good-faith attempts to do so) how the requester could effectively limit the scope of the request. These changes are required by the FOIA Improvement Act of 2016.

A Federal agency recommended that the Bureau revise § 1070.22(d)(4), reasoning that the proposal's exception to when the Bureau can charge FOIA processing fees when it does not meet FOIA timelines was technically broader than the FOIA's requirements. In addition, the Federal agency recommended revising the paragraph to account for a scenario where a court determines that exceptional circumstances apply to a request. The Federal agency also noted a technical error in a cross-reference in the paragraph. The Bureau had intended for proposed § 1070.22(d)(4) to be coextensive with the FOIA. In response to these suggestions, the Bureau has revised the provision to more closely align with the FOIA's requirements, and it has added a paragraph to address a potential court determination that exceptional circumstances apply. It has also fixed the identified cross-reference. The Bureau otherwise finalizes its proposal.

Section 1070.22(e) Waiver or Reduction of Fees Section 1070.22(e)(5)

Section 1070.22(e)(5) provides that the Bureau will decide whether to grant or deny a request to reduce or waive fees prior to processing the FOIA request and that the Bureau will notify the requester of such a determination in writing. The Bureau proposed to delete this requirement because it is unnecessary in light of other proposed fee-related revisions. The Bureau explained in its proposal that in many cases involving requests for fee waivers, the Bureau would be able to process the FOIA request without deciding the merits of the fee waiver request because the processing fees would be less than $250. It further reasoned that removing this requirement would allow the Bureau to process FOIA requests more efficiently and provide information to requesters more quickly. Under the Bureau's proposal, the Bureau would notify a requester when it had denied a fee waiver request and processing the request would incur fees. The Bureau received no comments on this proposal and it finalizes the proposal without modification.

Section 1070.22(e)(6)

Section 1070.22(e)(6) specifies what information the Bureau will include in the letter it sends notifying the requester that the Bureau has denied a request for a waiver or reduction of fees. The Bureau proposed to make a technical change to this provision, removing the phrase “(of not less than $25)” to account for other newly proposed fee-related provisions. The Bureau received no comments on this proposal and it finalizes the proposal without modification.

Section 1070.22(f) Advance Notice and Prepayment of Fees

Section 1070.22(f) describes the Bureau's process for notifying a requester of any processing fees associated with a FOIA request. The Bureau proposed several changes to this provision to clarify and streamline its process for assessing FOIA processing fees and for notifying requesters of such fees. First, the Bureau proposed to revise § 1070.22(f) to provide that the Bureau would notify a requester of the estimated fees to process a FOIA request when the estimated fees are $250 or more and the estimated fees exceed the limit set by the requester, the requester has not specified a limit, or the Bureau has denied a request for a reduction or waiver of fees. Next, the Bureau proposed to revise § 1070.22(f) to raise the fee threshold above which a requester must pre-pay estimated processing fees from $250 to $1000. The Bureau explained in its proposal that this change was necessary because of the Bureau's proposed change to § 1070.22(d): The Bureau proposed raising its previous pre-payment threshold of $250 because it would no longer charge fees for processing a request when the fees are $250 or less. The Bureau further explained that its proposed revisions to § 1070.22(f) would require a requester to agree to pay processing fees before the Bureau began processing the request. The Bureau said that such an agreement would provide sufficient assurance of payment for fees less than $1000, and that this change was in accordance with the Bureau's practice for requiring pre-payment of fees. Furthermore, the Bureau explained that this change would allow it to process FOIA requests more efficiently and provide records to requesters more quickly. The Bureau received no comments on these proposals and it finalizes them with only technical changes to the numbering of paragraphs in the section.

Section 1070.23 Authority and Responsibilities of the Chief FOIA Officer Section 1070.22(a) Chief FOIA Officer

Section 1070.22(a) discusses the role of the Bureau's Chief FOIA Officer. The Bureau proposed inserting two new paragraphs. The first concerns the Chief FOIA Officer's responsibility to offer training to Bureau staff regarding their responsibilities under the FOIA, and the second concerns the Chief FOIA Officer's role as the primary Bureau liaison with the OGIS and the Department of Justice's Office of Information Policy. The Bureau also proposed to renumber the provisions in this section to accommodate these changes. These changes are required by the FOIA Improvement Act of 2016. The Bureau received no comments on these proposals and it finalizes them without modification.

Subpart C—Disclosure of CFPB Information in Connection With Legal Proceedings

Subpart C addresses the disclosure of Bureau information in connection with legal proceedings. The Bureau proposed several technical corrections throughout the subpart. The Bureau received no comments regarding these technical corrections, and it finalizes them without modification.

Section 1070.30 Purpose and Scope; Definitions Section 1070.30(a)

Section 1070.30(a) defines the circumstances for which the procedures outlined in subpart C apply. The Bureau proposed to delete paragraph (a)(1) from this provision and to renumber the section accordingly. This was intended as a technical change to account for moving § 1070.31 to subpart A. The Bureau received no comments regarding this proposal, and it finalizes the proposal without modification.

Section 1070.30(e) Section 1070.30(e)(2)

Section 1070.30(e)(2) defines the term “legal proceeding” for subpart C. The Bureau proposed to add the phrase “their agents” to the last sentence of this provision to clarify that this definition applies to formal and informal requests made by both attorneys and their agents. The Bureau received no comments regarding this proposal, and it finalizes the proposal without modification.

Former § 1070.31 Service of Summonses and Complaints

Former § 1070.31 provided the process for serving the Bureau with summonses or complaints. As discussed above with respect to proposed § 1070.5, the Bureau proposed to delete § 1070.31 from subpart C and move it to a new § 1070.5 in subpart A. The Bureau also proposed to renumber sections and cross-references in subpart C to account for this change. The Bureau received no comments regarding these proposals, and it finalizes them without modification.

Proposed § 1070.31 Service of Subpoenas, Court Orders, and Other Demands for CFPB Information or Action

Proposed § 1070.31(d)

Proposed § 1070.31(d) (formerly § 1070.32(d)) provides that the Bureau is not authorized to accept on behalf of its employees any subpoenas, orders, or other demands or requests, which are not related to the employees' official duties. The previous text of the provision implied that it is the Bureau's practice to accept such demands or requests “upon the express, written authorization of the individual CFPB employee to whom such demand or request is directed.” The Bureau proposed to delete this part of the provision because it is not the general practice of the Bureau to accept service on behalf of individual employees. The Bureau further proposed deleting the paragraph's introductory caveat, “[e]xcept as otherwise provided in this subpart,” because the subpart does not otherwise provide for the Bureau to act as an agent for service for subpoenas, orders, or other demands or requests that do not relate to employees' official conduct. The Bureau received no comments regarding these proposals, and it finalizes them without modification.

Section 1070.33 Procedure When Testimony or Production of Documents is Sought; General Section 1070.33(b)

Section 1070.33(b) provides that the General Counsel may require a party seeking official information through testimony, Bureau records, or other material, to describe all reasonably foreseeable demands for such information. The Bureau proposed to make several technical changes to clarify this provision. The Bureau received no comments regarding these changes, and it finalizes the proposal without modification.

Subpart E—The Privacy Act Section 1070.51 Authority and Responsibilities of the Chief Privacy Officer

Section 1070.51 specifies the authority and responsibilities of the Bureau's Chief Privacy Officer. The Bureau proposed to add a new paragraph at § 1070.51(a) authorizing the Chief Privacy Officer to “[d]evelop, implement, and maintain an organization-wide privacy program” and to renumber the other paragraphs in § 1070.51 to reflect this change. This change is in accordance with National Institute of Standards and Technology (NIST) Special Publication 800-53 Revision 4, which provides that agencies should “[appoint] a Senior Agency Official for Privacy (SAOP)/Chief Privacy Officer (CPO) accountable for developing, implementing, and maintaining an organization-wide governance and privacy program to ensure compliance with all applicable laws and regulations regarding the collection, use, maintenance, sharing, and disposal of personally identifiable information (PII) by programs and information systems. . . .” The Bureau proposed this change to clarify the authority of its Chief Privacy Officer. The Bureau received no comments on this proposal, and it finalizes the proposal without modification.

Section 1070.53 Request for Access to Records Section 1070.53(a) Procedures for Making a Request for Access to Records

Section 1070.53(a) specifies the procedures for making Privacy Act requests for records. The previous text distinguished between requests made in writing and by electronic means. The Bureau proposed a technical change to this provision, to remove the phrase “or by electronic means” and add “as follows:” in its place. The Bureau also proposed changes to § 1070.53(a)(1) to clarify how requesters must submit Privacy Act requests to the Bureau. The Bureau proposed similar changes to §§ 1070.56(a) and 1070.58(b). The Bureau received no comments on this proposal and it finalizes the proposal without modification.

Section 1070.56 Request For Amendment of Records Section 1070.56(a) Procedures for Making Request Section 1070.56(a)(2)(i)

Section 1070.56(a)(2)(i) provides that an individual requesting an amendment of a record must identify the system of records containing the record. The Bureau proposed to revise this provision to allow an individual to provide a description of the record in sufficient detail to allow Bureau personnel to locate the system of records containing the record. This revision was intended to provide a requester with more flexibility in the event that the requester does not know the precise name of the applicable system of records. Furthermore, this proposal was consistent with § 1070.53(b)(2), which specifies requirements for requests for access to records. The Bureau received no comments on this proposal, and it finalizes the proposal without modification.

Section 1070.61 Training; Rules of Conduct; Penalties for Non-Compliance

Section 1070.61 addresses, among other things, the Bureau's obligations to conduct privacy-related training and establish rules of conduct related to privacy. The Bureau proposed to replace references to “employees of Government contractors” with the term “contract personnel” to avoid confusion with respect to § 1070.2(k) (proposed § 1070.2(l)), which defines the term “employee.” The Bureau received no comments on this proposal, and it finalizes the proposal without modification.

VI. Section 1022(b)(2)(A) of the Dodd-Frank Act

In developing this final rule, the Bureau has considered the potential benefits, costs, and impacts as required by section 1022(b)(2)(A) of the Dodd-Frank Act.2 This analysis describes these impacts solely for the Touhy procedures as the remaining provisions of this rule are not promulgated under federal consumer financial protection laws. The benefits and costs of those provisions are discussed above. The Bureau has consulted, or offered to consult with, the prudential regulators and the Federal Trade Commission, including consultation regarding consistency with any prudential, market, or systemic objectives administered by such agencies.

2 Section 1022(b)(2)(A) of the Dodd-Frank Act addresses the consideration of the potential benefits and costs of 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. Section 1022(b)(2)(B) directs the Bureau to consult, before and during the rulemaking, with appropriate prudential regulators or other Federal agencies, regarding consistency with objectives those agencies administer.

The Bureau has chosen to consider the benefits, costs, and impacts of the final rule as compared to the status quo, namely the Bureau's regulations as set forth by the Bureau on February 15, 2013, 78 FR 11483 (Feb. 15, 2013).3 The Bureau does not have data with which to quantify the benefits or costs of the final rule, nor were any data provided by commenters. As such, the discussion below considers the qualitative costs, benefits, and impacts that the Bureau anticipates from the rule. The Bureau also notes that the discussion below should be read in conjunction with the discussion of benefits and costs in the Section-by-Section discussion above.

3 The Bureau has discretion in any rulemaking to choose an appropriate scope of analysis with respect to potential benefits and costs and an appropriate baseline.

As relevant, the final rule revises subparts A and C of part 1070 of title 12 of the Code of Federal Regulations: The revisions to Subpart A offer clarifications of procedures related to the certification of authenticity of Bureau records and the service of summonses or complaints on the Bureau; the revisions to Subpart C include organizational and clarifying revisions to the provisions related to the Bureau's Touhy regulations.

As these revisions mainly include clarifications, corrections and technical changes, they will have limited impacts on consumers and covered persons.

The final rule will not have an appreciable impact on consumers' access to consumer financial products or services, as the scope of the final rule is limited to matters related to access to certain types of information, and does not relate to credit access.

The final rule will not have a unique impact on insured depository institutions or insured credit unions with $10 billion or less in assets as described in section 1026(a) of the Dodd-Frank Act as the rule does not distinguish information regarding such institutions or procedures applicable to such institutions.

The final rule will not have a unique impact on consumers in rural areas as the rule does not distinguish information regarding consumers in rural areas or procedures applicable to such consumers.

VII. Procedural Requirements

The Regulatory Flexibility Act, 5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (the RFA), 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, unless the head of the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The undersigned so certifies. The rule does not impose any obligations or standards of conduct for purposes of analysis under the RFA, and it therefore does not give rise to a regulatory compliance burden for small entities.

Finally, the Bureau has determined that this rule does not impose any new recordkeeping, reporting, or disclosure requirements on members of the public that would be collections of information requiring approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

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 U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to the rule's published effective date. The Office of Information and Regulatory Affairs 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 1070

Confidential business information, Consumer protection, Freedom of information, Privacy.

Authority and Issuance

For the reasons set forth in the preamble, the Bureau amends 12 CFR part 1070 to read as follows:

PART 1070—DISCLOSURE OF RECORDS AND INFORMATION 1. The authority citation is revised to read as follows: Authority:

12 U.S.C. 5481 et seq.; 5 U.S.C. 552; 5 U.S.C. 552a; 18 U.S.C. 1905; 18 U.S.C. 641; 44 U.S.C. ch. 31; 44 U.S.C. ch. 35; 12 U.S.C. 3401 et seq.

Subpart A—General Provisions and Definitions 2. Revise § 1070.1 to read as follows:
§ 1070.1 Authority, purpose, and scope.

(a) Authority. (1) This part is issued by the Bureau of Consumer Financial Protection, an independent Bureau within the Federal Reserve System, pursuant to the Consumer Financial Protection Act of 2010, 12 U.S.C. 5481 et seq.; the Freedom of Information Act, 5 U.S.C. 552; the Privacy Act of 1974, 5 U.S.C. 552a; the Federal Records Act, 44 U.S.C. 3101; the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.; the Right to Financial Privacy Act of 1978, 12 U.S.C. 3401; the Trade Secrets Act, 18 U.S.C. 1905; 18 U.S.C. 641; and any other applicable law that establishes a basis for the exercise of governmental authority by the CFPB.

(2) This part establishes mechanisms for carrying out the CFPB's statutory responsibilities under the statutes in paragraph (a)(1) of this section to the extent those responsibilities require the disclosure, production, or withholding of information. In this regard, the CFPB has determined that the CFPB, and its delegates, may disclose information of the CFPB, in accordance with the procedures set forth in this part, whenever it is necessary or appropriate to do so in the exercise of any of the CFPB's authority. The CFPB has determined that all such disclosures, made in accordance with the rules and procedures specified in this part, are authorized by law.

(b) Purpose and scope. This part contains the CFPB's rules relating to the disclosure of records and information generated by and obtained by the CFPB.

(1) Subpart A contains general provisions and definitions used in this part.

(2) Subpart B implements the Freedom of Information Act, 5 U.S.C. 552.

(3) Subpart C sets forth the procedures with respect to subpoenas, orders, or other requests for CFPB information in connection with legal proceedings.

(4) Subpart D provides for the protection of confidential information and procedures for sharing confidential information with supervised institutions, government Agencies, and others in certain circumstances.

(5) Subpart E implements the Privacy Act of 1974, 5 U.S.C. 552a.

3. Revise § 1070.2(c) to read as follows:
§ 1070.2 General definitions.

(c) Chief FOIA Officer means the Chief Operating Officer of the CFPB.

4. Revise §§ 1070.3 and 1070.4 to read as follows:
§ 1070.3 Custodian of records; certification; alternative authority.

(a) Custodian of records. The Chief Operating Officer is the official custodian of all records of the CFPB, including records that are in the possession or control of the CFPB or any CFPB employee.

(b) Certification of record. The Chief Operating Officer may certify the authenticity of any CFPB record or any copy of such record, or the absence thereof, for any purpose, and for or before any duly constituted Federal or State court, tribunal, or agency.

(c) Alternative authority. Any action or determination required or permitted to be done by the Chief Operating Officer may be done by any employee who has been duly designated for this purpose by the Chief Operating Officer.

§ 1070.4 Records of the CFPB not to be otherwise disclosed.

Except as provided by this part, employees or former employees of the CFPB, or others in possession of a record of the CFPB that the CFPB has not already made public, are prohibited from disclosing such records, without authorization, to any person who is not an employee of the CFPB.

5. Add § 1070.5 to read as follows:
§ 1070.5 Service of summonses and complaints.

(a) Only the General Counsel is authorized to receive and accept summonses or complaints sought to be served upon the CFPB or CFPB employees sued in their official capacity. Such documents should be served upon the General Counsel, Consumer Financial Protection Bureau, 1700 G Street NW, Washington, DC 20552. This authorization for receipt shall in no way affect the requirements of service elsewhere provided in applicable rules and regulations.

(b) If, notwithstanding paragraph (a) of this section, any summons or complaint described in that paragraph is delivered to an employee of the CFPB, the employee shall decline to accept the proffered service and may notify the person attempting to make service of the regulations set forth herein. If, notwithstanding this instruction, an employee accepts service of a document described in paragraph (a) of this section, the employee shall immediately notify and deliver a copy of the summons and complaint to the General Counsel.

(c) When a CFPB employee is sued in an individual capacity for an act or omission occurring in connection with duties performed on behalf of the CFPB (whether or not the officer or employee is also sued in an official capacity), the employee by law is to be served personally with process. See Fed. R. Civ. P. 4(i)(3). An employee sued in an individual capacity for an act or omission occurring in connection with duties performed on behalf of the CFPB shall immediately notify, and deliver a copy of the summons and complaint to, the General Counsel.

(d) The CFPB will only accept service of process for an employee sued in his or her official capacity. Documents for which the General Counsel accepts service in official capacity shall be marked “Service Accepted in Official Capacity Only.” Acceptance of service shall not constitute an admission or waiver with respect to jurisdiction, propriety of service, improper venue, or any other defense in law or equity available under applicable laws or rules.

6. Revise subparts B and C to read as follows: Subpart B—Freedom of Information Act Sec. 1070.10 General. 1070.11 Information made available; discretionary disclosures. 1070.12 Publication in the Federal Register. 1070.13 Public inspection in an electronic format. 1070.14 Requests for CFPB records. 1070.15 Responsibility for responding to requests for CFPB records. 1070.16 Timing of responses to requests for CFPB records. 1070.17 Requests for expedited processing. 1070.18 Responses to requests for CFPB records. 1070.19 Classified information. 1070.20 Requests for business information provided to the CFPB. 1070.21 Administrative appeals. 1070.22 Fees for processing requests for CFPB records. 1070.23 Authority and responsibilities of the Chief FOIA Officer. Subpart C—Disclosure of CFPB Information in Connection With Legal Proceedings Sec. 1070.30 Purpose and scope; definitions. 1070.31 Service of subpoenas, court orders, and other demands for CFPB information or action. 1070.32 Testimony and production of documents prohibited unless approved by the General Counsel. 1070.33 Procedure when testimony or production of documents is sought; general. 1070.34 Procedure when response to demand is required prior to receiving instructions. 1070.35 Procedure in the event of an adverse ruling. 1070.36 Considerations in determining whether the CFPB will comply with a demand or request. 1070.37 Prohibition on providing expert or opinion testimony. Subpart B—Freedom of Information Act
§ 1070.10 General.

This subpart contains the regulations of the CFPB implementing the Freedom of Information Act (the FOIA), 5 U.S.C. 552, as amended. These regulations set forth procedures for requesting access to records maintained by the CFPB. These regulations should be read together with the FOIA, the 1987 Office of Management and Budget Guidelines for FOIA Fees, the CFPB's Privacy Act regulations set forth in subpart E of this part, and the FOIA web page on the CFPB's website, http://www.consumerfinance.gov, which provide additional information about this topic.

§ 1070.11 Information made available; discretionary disclosures.

(a) In general. The FOIA provides for public access to information and records developed or maintained by Federal agencies. Generally, the FOIA divides agency information into three major categories and provides methods by which each category of information is to be made available to the public. The three major categories of information are as follows:

(1) Information required to be published in the Federal Register (see § 1070.12);

(2) Information required to be made available for public inspection in an electronic format or, in the alternative, to be published and offered for sale (see § 1070.13); and

(3) Information required to be made available to any member of the public upon specific request (see §§ 1070.14 through 1070.22).

(b) Discretionary disclosures. Even though a FOIA exemption may apply to the information or records requested, the CFPB may, if not precluded by law, elect under the circumstances not to apply the exemption. The fact that the exemption is not applied by the CFPB in response to a particular request shall have no precedential significance in processing other requests.

(c) Disclosures of records frequently requested. Subject to the application of the FOIA exemptions and exclusions (5 U.S.C. 552(b) and (c)), the CFPB shall make publicly available, as provided by § 1070.13, all records regardless of form or format, which have been released previously to any person under 5 U.S.C. 552(a)(3) and §§ 1070.14 through 1070.22, and which the CFPB determines have become or are likely to become the subject of subsequent requests for substantially the same records. When the CFPB receives three (3) or more requests for substantially the same records, then the CFPB shall also make the released records publicly available.

§ 1070.12 Publication in the Federal Register.

(a) Requirement. The CFPB shall separately state, publish and maintain current in the Federal Register for the guidance of the public the following information:

(1) Descriptions of its central and field organization and the established place at which, the persons from whom, and the methods whereby, the public may obtain information, make submissions or requests, or obtain decisions;

(2) Statements of the general course and method by which its functions are channeled and determined, including the nature and requirements of all formal and informal procedures available;

(3) Rules of procedure, descriptions of forms available or the places at which forms may be obtained, and instructions as to the scope and contents of all papers, reports, or examinations;

(4) Substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the CFPB; and

(5) Each amendment, revision, or repeal of matters referred to in paragraphs (a)(1) through (4) of this section.

(b) Exceptions. Publication of the information under paragraph (a) of this section shall be subject to the application of the FOIA exemptions and exclusions (5 U.S.C. 552(b) and (c)) and the limitations provided in 5 U.S.C. 552(a)(1).

§ 1070.13 Public inspection in an electronic format.

(a) In general. Subject to the application of the FOIA exemptions and exclusions (5 U.S.C. 552(b) and (c)), the CFPB shall, in conformance with 5 U.S.C. 552(a)(2), make available for public inspection in an electronic format, including by posting on the CFPB's website, http://www.consumerfinance.gov, or, in the alternative, promptly publish and offer for sale the following information:

(1) Final opinions, including concurring and dissenting opinions, and orders made in the adjudication of cases;

(2) Those statements of policy and interpretations which have been adopted by the CFPB but are not published in the Federal Register;

(3) Its administrative staff manuals and instructions to staff that affect a member of the public;

(4) Copies of all records made publicly available pursuant to § 1070.11; and

(5) A general index of the records referred to in paragraph (a)(4) of this section.

(b) Information made available online. For records required to be made available for public inspection in an electronic format pursuant to 5 U.S.C. 552(a)(2) (paragraphs (a)(1) through (4) of this section), as soon as practicable, the CFPB shall make such records available on its e-FOIA Library, located at http://www.consumerfinance.gov.

(c) Record availability at the on-site e-FOIA Library. Any member of the public may, upon request, access the CFPB's e-FOIA Library via a computer terminal at 1700 G Street NW, Washington, DC 20552. Such a request may be made by electronic means as set forth on the CFPB's website, http://www.consumerfinance.gov, or in writing, to the Chief FOIA Officer, Consumer Financial Protection Bureau, 1700 G Street NW, Washington, DC 20552. The request must indicate a preferred date and time for the requested access. The CFPB reserves the right to arrange a different date and time with the requester, if necessary.

(d) Redaction of identifying details. To prevent a clearly unwarranted invasion of personal privacy, the CFPB may redact identifying details contained in any matter described in paragraphs (a)(1) through (4) of this section before making such matters available for inspection or publication. The justification for the redaction shall be explained fully in writing, and the extent of such redaction shall be indicated on the portion of the record which is made available or published, unless including that indication would harm an interest protected by the exemption in 5 U.S.C. 552(b) under which the redaction is made. If technically feasible, the extent of the redaction shall be indicated at the place in the record where the redaction is made.

§ 1070.14 Requests for CFPB records.

(a) In general. Subject to the application of the FOIA exemptions and exclusions (5 U.S.C. 552(b) and (c)), the CFPB shall promptly make its records available to any person pursuant to a request that conforms to the rules and procedures of this section.

(b) Form of request. A request for records of the CFPB shall be made in writing as follows:

(1) If a request is submitted by mail or delivery service, it shall be addressed to the Chief FOIA Officer, Consumer Financial Protection Bureau, 1700 G Street NW, Washington, DC 20552. The request shall be labeled “Freedom of Information Act Request.”

(2) If a request is submitted by electronic means, it shall be submitted as set forth on the CFPB's website, http://www.consumerfinance.gov. The request shall be labeled “Freedom of Information Act Request.”

(c) Content of request. (1) In order to ensure the CFPB's ability to respond in a timely manner, a FOIA request must describe the records that the requester seeks in sufficient detail to enable CFPB personnel to locate them with a reasonable amount of effort. Whenever possible, the request should include specific information about each record sought, such as the date, title or name, author, recipient, and subject matter of the record. If known, the requester should include any file designations or descriptions for the records requested. The more specific the requester is about the records or type of records requested, the more likely the CFPB will be able to locate those records in response to the request;

(2) In order to ensure the CFPB's ability to communicate effectively with the requester, a request should include contact information for the requester, including the name of the requester and, to the extent available, a mailing address, telephone number, and email address at which the CFPB may contact the requester regarding the request;

(3) The request should state whether the requester wishes to receive the records in a specific format;

(4) A requester should indicate in the request whether the requester is a commercial user, an educational institution, non-commercial scientific institution, representative of the news media, or “other” requester, as those terms are defined in § 1070.22(b), and the basis for claiming that fee category;

(5) If a requester seeks a waiver or reduction of fees associated with processing a request, then the request shall include a statement to that effect as is required by § 1070.22(e); and

(6) If a requester seeks expedited processing of a request, then the request must include a statement to that effect as is required by § 1070.17.

(d) Perfected requests; effect of request deficiencies. For purposes of computing its deadline to respond to a request, the CFPB will deem itself to have received a request only if, and on the date that, it receives a request that contains substantially all of the information required by and that otherwise conforms with paragraphs (b) and (c) of this section. The CFPB need not accept a request, process a request, or be bound by any deadlines in this subpart for processing a request that fails to conform, in any material respect, to the requirements of paragraphs (b) and (c) of this section. If a request is deficient in any material respect, then the CFPB may return it to the requester and if it does so, it shall advise the requester in what respect the request is deficient, and what additional information is needed to respond to the request. The requester may then amend or resubmit the request. A determination by the CFPB that a request is deficient in any respect is not a denial of a request for records and such determinations are not subject to appeal. If a requester fails to respond to a CFPB notification that a request is deficient within thirty (30) days of the CFPB's notification, the CFPB will deem the request withdrawn.

(e) Requests by an individual for CFPB records pertaining to that individual. An individual who wishes to inspect or obtain copies of records of the Bureau that pertain to that individual shall provide identity verification in accordance with § 1070.53(c).

(f) Requests for CFPB records pertaining to another individual. Where a request for records pertains to a third party, a requester may receive greater access by submitting either a notarized authorization signed by that individual or a declaration by that individual made in compliance with the requirements set forth in 28 U.S.C. 1746 authorizing disclosure of the records to the requester, or submits proof that the individual is deceased (e.g., a copy of a death certificate or an obituary). The CFPB may require a requester to supply additional information if necessary in order to verify that a particular individual has consented to disclosure.

(g) Assistance from FOIA Public Liaison. Requesters may contact the CFPB's FOIA Public Liaison to seek assistance in determining the appropriate fee category, formatting of requests, or resolving any problems that arise prior to submitting a request or during the processing of a request. The FOIA Public Liaison can be contacted at the telephone number listed on the CFPB's website, http://www.consumerfinance.gov.

§ 1070.15 Responsibility for responding to requests for CFPB records.

(a) In general. In determining which records are responsive to a request, the CFPB ordinarily will include only records in its possession as of the date the CFPB begins its search for them. If any other date is used, the CFPB shall inform the requester of that date.

(b) Authority to grant or deny requests. The Chief FOIA Officer shall be authorized to grant or deny any request for a record of the CFPB.

(c) Consultations, referrals and coordination. When reviewing a record in response to a request, the CFPB will determine whether another agency is better able to determine whether the record is exempt from disclosure under the FOIA. As to any such record, the agency must proceed in one of the following ways:

(1) Referral. (i) When a requested record has been created by an agency other than the CFPB, the CFPB shall refer the record to that agency for a direct response to the requester.

(ii) Whenever the CFPB refers any part of the responsibility for responding to a request to another agency, it must document the referral, maintaining a copy of the record that it refers, and notify the requester of the referral, informing the requester of the name of the agency to which the record was referred, including that agency's FOIA contact information.

(2) Consultation. When a FOIA request is received for a record created by the CFPB that includes information originated by another agency, the CFPB shall consult the originating agency for review and recommendation on disclosure. The CFPB shall not release any such records without prior consultation with the originating agency.

(3) Coordination. The standard referral procedure is not appropriate where disclosure of the identity of the agency to which the referral would be made could harm an interest protected by an applicable exemption, such as the exemptions that protect personal privacy or national security interests. In such instances, in order to avoid harm to an interest protected by an applicable exemption, the agency that received the request should coordinate with the originating agency to seek its views on the disclosability of the record. The release determination for the record that is the subject of the coordination should then be conveyed to the requester by the agency that originally received the request.

§ 1070.16 Timing of responses to requests for CFPB records.

(a) In general. Except as set forth in paragraphs (b) through (d) of this section, and § 1070.17, the CFPB shall respond to requests according to their order of receipt.

(b) Multitrack processing. (1) The CFPB may establish separate tracks to process simple and complex requests. The CFPB may assign a request to the simple or complex track(s) based on the amount of work and/or time needed to process the request. The CFPB shall process requests in each track based on the date the request was perfected in accordance with § 1070.14(d).

(2) The CFPB may provide a requester in its complex track with an opportunity to limit the scope of the request to qualify for faster processing within the specified limits of the simple track(s).

(c) Time period for responding to requests for records. Ordinarily, the CFPB shall have twenty (20) business days from when a request is received by the CFPB to determine whether to grant or deny a request for records. The twenty (20) business day time period set forth in this paragraph (c) shall not be tolled by the CFPB except that the CFPB may:

(1) Make one reasonable demand to the requester for clarifying information about the request and toll the twenty (20) business day time period while it awaits the clarifying information; or

(2) Toll the twenty (20) business day time period while it awaits clarification from or addresses any dispute with the requester regarding the assessment of fees.

(d) Unusual circumstances. (1) Where the CFPB determines that due to unusual circumstances it cannot respond either to a request within the time period set forth in paragraph (c) of this section or to an appeal within the time period set forth in § 1070.21, the CFPB may extend the applicable time periods by informing the requester in writing of the unusual circumstances and of the date by which the CFPB expects to complete its processing of the request or appeal. Any extension or extensions of time with respect to a request or an appeal shall not cumulatively total more than ten (10) business days. However, if the CFPB determines that it needs additional time beyond a ten (10) business day extension to process a request, then the CFPB shall notify the requester, provide the requester with an opportunity to limit the scope of the request, arrange for an alternative time frame for processing the request, or modify the request, and notify the requester of the availability of services provided by its FOIA Public Liaison and the Office of Government Information Services (OGIS).

(2) As used in this paragraph (d), “unusual circumstances” means:

(i) The need to search for and collect the requested records from field facilities or other establishments that are separate from the office processing the request;

(ii) The need to search for, collect, and appropriately examine a voluminous amount of separate and distinct records which are demanded in a single request; or

(iii) The need for consultation, which shall be conducted with all practicable speed, with another agency having a substantial interest in the determination of the request, or among two or more CFPB offices having substantial subject matter interest therein.

§ 1070.17 Requests for expedited processing.

(a) In general. The CFPB shall process a request on an expedited basis whenever a requester demonstrates a compelling need for expedited processing in accordance with the requirements of this paragraph (a) or in other cases that the CFPB deems appropriate.

(b) Form and content of a request for expedited processing. A request for expedited processing shall be made as follows:

(1) A request for expedited processing shall be made in writing and submitted as part of a request for records in accordance with § 1070.14(b), or at any time during the processing of the request. When a request for records includes a request for expedited processing, the request shall be labeled “Expedited Processing Requested.”

(2) A request for expedited processing shall contain a statement that demonstrates a compelling need for the requester to obtain expedited processing of the requested records. A “compelling need” is defined as follows:

(i) Failure to obtain the requested records on an expedited basis could reasonably be expected to pose an imminent threat to the life or physical safety of an individual. The requester shall fully explain the circumstances warranting such an expected threat so that the CFPB may make a reasoned determination that a delay in obtaining the requested records could pose such a threat; or

(ii) With respect to a request made by a person primarily engaged in disseminating information, urgency to inform the public concerning actual or alleged Federal government activity. A requester who is not a full-time member of the news media must establish that the requester is a person whose primary professional activity or occupation is information dissemination, though it need not be the requester's sole occupation. Such a requester also must establish a particular urgency to inform the public about the government activity involved in the request—one that extends beyond the public's right to know about government activity generally. The existence of numerous articles published on a given subject can be helpful in establishing the requirement that there be an “urgency to inform” the public on the topic.

(3) The requester shall certify the written statement that purports to demonstrate a compelling need for expedited processing to be true and correct to the best of the requester's knowledge and belief. The certification must be in the form prescribed by 28 U.S.C. 1746: “I declare under penalty of perjury that the foregoing is true and correct to the best of my knowledge and belief. Executed on [date].” The requester shall mail or submit electronically a copy of such written certification to the Chief FOIA Officer as set forth in § 1070.14(b). The CFPB may waive this certification requirement in appropriate circumstances.

(c) Determinations of requests for expedited processing. Within ten (10) calendar days of its receipt of a request for expedited processing, the CFPB shall decide whether to grant it and shall notify the requester of the determination in writing.

(d) Effect of granting requests for expedited processing. If the CFPB grants a request for expedited processing, then the CFPB shall give the expedited request priority over non-expedited requests and shall process the expedited request as soon as practicable. The CFPB may assign expedited requests to their own simple and complex processing tracks based upon the amount of work and/or time needed to process them. Within each such track, an expedited request shall be processed in the order of its receipt.

(e) Appeals of denials of requests for expedited processing. If the CFPB denies a request for expedited processing, then the requester shall have the right to submit an appeal of the denial determination in accordance with § 1070.21. The CFPB shall communicate this appeal right as part of its written notification to the requester denying expedited processing. The requester shall label its appeal request “Appeal for Expedited Processing.” The CFPB shall act expeditiously upon an appeal of a denial of a request for expedited processing.

§ 1070.18 Responses to requests for CFPB records.

(a) Acknowledgements of requests. Upon receipt of a request, the CFPB will assign to the request a unique tracking number. The CFPB will send an acknowledgement letter to the requester by mail or email within ten (10) calendar days of receipt of the request. The acknowledgment letter will contain the following information:

(1) The applicable request tracking number;

(2) The date of receipt of the request, as determined in accordance with § 1070.14(d), as well as the date when the requester may expect a response;

(3) A brief statement identifying the subject matter of the request; and

(4) A confirmation, with respect to any fees that may apply to the request pursuant to § 1070.22, that the requester has sought a waiver or reduction in such fees, has agreed to pay any and all applicable fees, or has specified an upper limit that the requester is willing to pay in fees to process the request.

(b) Initial determination to grant or deny a request. (1) The officer designated in § 1070.15(b), or his or her delegate, shall make initial determinations either to grant or to deny in whole or in part requests for records.

(2) If the request is granted in full or in part, and if the requester requests a copy of the records requested, then a copy of the records shall be mailed or emailed to the requester in the requested format, to the extent the records are readily producible in the requested format. The CFPB shall also send the requester a statement of the applicable fees, either at the time of the determination or shortly thereafter, and inform the requester of the availability of its FOIA Public Liaison to offer assistance.

(3) In the case of a request for inspection, the requester shall be notified in writing of the determination, when and where the requested records may be inspected, and of the fees incurred in complying with the request. The CFPB shall then promptly make the records available for inspection at the time and place stated, in a manner that will not interfere with CFPB's operations and will not exclude other persons from making inspections. The requester shall not be permitted to remove the records from the room where inspection is made. If, after making inspection, the requester desires copies of all or a portion of the requested records, copies shall be furnished upon payment of the established fees prescribed by § 1070.22. Fees may be charged for search and review time as stated in § 1070.22.

(4) If it is determined that the request for records should be denied in whole or in part, the requester shall be notified by mail or by email. The letter of notification shall:

(i) State the exemptions relied upon in denying the request;

(ii) If technically feasible, indicate the amount of information deleted and the exemptions under which the deletion is made at the place in the record where such deletion is made (unless providing such indication would harm an interest protected by the exemption relied upon to deny such material);

(iii) Set forth the name and title or position of the responsible official;

(iv) Advise the requester of the right to seek dispute resolution services from the Bureau's FOIA Public Liaison or the Office of Governmental Information Services;

(v) Advise the requester of the right to administrative appeal in accordance with § 1070.21; and

(vi) Specify the official or office to which such appeal shall be submitted.

(5) If it is determined, after a reasonable search for records, that no responsive records have been found to exist, the requester shall be notified in writing or by email. The notification shall also advise the requester of the right to administratively appeal the CFPB's determination that no responsive records exist (i.e., to challenge the adequacy of the CFPB's search for responsive records) in accordance with § 1070.21. The response shall specify the official or office to which the appeal shall be submitted for review.

(c) Resolution of disputes. The CFPB is committed to efficiently resolving disputes during the request process. The following resources are available to requesters to resolve any disputes that may arise during the request process:

(1) FOIA Public Liaison. Any request related questions or concerns should be directed to the FOIA Public Liaison, who is responsible for reducing delays, increasing transparency and understanding of the status of requests, and assisting in the resolution of disputes.

(2) Dispute resolution. The National Archives and Records Administration (NARA), Office of Government Information Services (OGIS) offers non-compulsory, non-binding dispute resolution services to help resolve FOIA disputes. A requester may contact OGIS directly at Office of Government Information Services, National Archives and Records Administration, Room 2510, 8601 Adelphi Road, College Park, MD 20740-6001, Email: [email protected], Phone: (301) 837-1996, Fax: (301) 837-0348. This information is provided as a public service only. By providing this information, the CFPB does not commit to refer disputes to OGIS.

(d) Format of records disclosed. (1) The CFPB will provide records in the requested format if the records can readily be reproduced from the original file to that specific format.

(2) The CFPB may charge fees associated with converting records or files into the requested format in accordance with § 1070.22.

§ 1070.19 Classified information.

Whenever a request is made for a record containing information that another agency has classified, or which may be appropriate for classification by another agency under Executive Order 13526 or any other executive order concerning the classification of information, the CFPB shall refer the responsibility for responding to the request to the classifying or originating agency, as appropriate.

§ 1070.20 Requests for business information provided to the CFPB.

(a) In general. Business information provided to the CFPB by a business submitter shall not be disclosed pursuant to a FOIA request except in accordance with this section.

(b) Definitions. For purposes of this section:

(1) Business information means commercial or financial information obtained by the CFPB from a submitter that may be protected from disclosure under Exemption 4 of the FOIA, 5 U.S.C. 552(b)(4).

(2) Submitter means any person from whom the CFPB obtains business information, directly or indirectly. The term includes, without limitation, corporations, State, local, and tribal governments, and foreign governments.

(c) Designation of business information. A submitter of business information will use good-faith efforts to designate, by appropriate markings, either at the time of submission or at a reasonable time thereafter, any portions of its submission that it considers to be protected from disclosure under Exemption 4 of the FOIA. These designations will expire ten (10) years after the date of the submission unless the submitter requests otherwise and provides justification for, a longer designation period.

(d) Notice to submitters. The CFPB shall provide a submitter with prompt written notice of receipt of a request or appeal encompassing its business information whenever required in accordance with paragraph (e) of this section. Such written notice shall either describe the exact nature of the business information requested or provide copies of the records or portions of records containing the business information. When notification of a voluminous number of submitters is required, notification may be made by posting or publishing the notice in a place reasonably likely to accomplish it.

(e) When notice is required. (1) The CFPB shall provide a submitter with notice of receipt of a request or appeal whenever:

(i) The information has been designated in good faith by the submitter as information considered protected from disclosure under Exemption 4; or

(ii) The CFPB has reason to believe that the information may be protected from disclosure under Exemption 4.

(2) The notice requirements of this paragraph (e) shall not apply if:

(i) The CFPB determines that the information is exempt under the FOIA;

(ii) The information lawfully has been published or otherwise made available to the public;

(iii) Disclosure of the information is required by statute (other than the FOIA) or by a regulation issued in accordance with the requirements of Executive Order 12600 (3 CFR, 1988 Comp., p. 235); or

(iv) The designation made by the submitter under paragraph (e)(1)(i) of this section appears obviously frivolous, except that, in such a case, the CFPB shall, within a reasonable time prior to a specified disclosure date, give the submitter written notice of any final decision to disclose the information.

(f) Opportunity to object to disclosure before release. (1) Through the notice described in paragraph (d) of this section, the CFPB shall delay any release in order to afford a submitter ten (10) business days from the date of the notice to provide the CFPB with a detailed statement of any objection to disclosure. Such statement shall specify all grounds for withholding any of the information under any exemption of the FOIA and, in the case of Exemption 4, shall demonstrate why the information is considered to be a trade secret or commercial or financial information that is privileged or confidential. In the event that a submitter fails to respond to the notice within the time specified in it, the submitter shall be considered to have no objection to disclosure of the information. Information provided by a submitter pursuant to this paragraph (f) may itself be subject to disclosure under the FOIA.

(2) When notice is given to a submitter under this section, the requester shall be advised that such notice has been given to the submitter. The requester shall be further advised that a delay in responding to the request may be considered a denial of access to records and that the requester may proceed with an administrative appeal or seek judicial review, if appropriate. However, the requester will be invited to agree to a voluntary extension of time so that the CFPB may review the submitter's objection to disclose, if any.

(g) Notice of intent to disclose. The CFPB shall consider a submitter's objections and specific grounds for nondisclosure prior to determining whether to disclose business information. Whenever the CFPB decides to disclose business information over the objection of a submitter, the CFPB shall forward to the submitter a written notice which shall include:

(1) A statement of the reasons for which the submitter's disclosure objections were not sustained;

(2) A description of the business information to be disclosed; and

(3) A specified disclosure date which is not less than ten (10) business days after the notice of the final decision to release the requested information has been mailed to the submitter. Except as otherwise prohibited by law, a copy of the disclosure notice shall be forwarded to the requester at the same time.

(h) Notice to submitter of FOIA lawsuit. Whenever a requester brings suit seeking to compel disclosure of business information, the CFPB shall promptly notify the submitter of that business information of the existence of the suit.

(i) Notice to requester of business information. The CFPB shall notify a requester whenever it provides the submitter with notice and an opportunity to object to disclosure; whenever it notifies the submitter of its intent to disclose the requested information; and whenever a submitter files a lawsuit to prevent the disclosure of the information.

§ 1070.21 Administrative appeals.

(a) Grounds for administrative appeals. A requester may appeal an initial determination of the CFPB, including for the following reasons:

(1) To deny access to records in whole or in part (as provided in § 1070.18(b));

(2) To assign a particular fee category to the requester (as provided in § 1070.22(b));

(3) To deny a request for a reduction or waiver of fees (as provided in § 1070.22(e));

(4) That no records exist that are responsive to the request (as provided in § 1070.18(b)); or

(5) To deny a request for expedited processing (as provided in § 1070.17(e)).

(b) Time limits for filing administrative appeals. An appeal, other than an appeal of a denial of expedited processing, must be postmarked or submitted electronically on a date that is within ninety (90) calendar days after the date the initial determination is sent to the requester or the date of the letter transmitting the last records released, whichever is later. An appeal of a denial of expedited processing must be made within ten (10) days of the date of the initial determination letter to deny expedited processing (see § 1070.17).

(c) Form and content of administrative appeals. In order to ensure a timely response to an appeal, the appeal shall be made in writing as follows:

(1) If appeal is submitted by mail or delivery service, it shall be addressed to and submitted to the officer specified in paragraph (e) of this section at the address set forth in § 1070.14(b). The appeal shall be labeled “Freedom of Information Act Appeal.”

(2) If an appeal is submitted by electronic means, it shall be addressed to the officer specified in paragraph (e) of this section and submitted as set forth on the CFPB's website, http://www.consumerfinance.gov. The appeal shall be labeled “Freedom of Information Act Appeal.”

(3) The appeal shall set forth contact information for the requester, including, to the extent available, a mailing address, telephone number, or email address at which the CFPB may contact the requester regarding the appeal; and

(4) The appeal shall specify the applicable request tracking number, the date of the initial request, and the date of the letter of initial determination, and, where possible, enclose a copy of the initial request and the initial determination being appealed.

(d) Processing of administrative appeals. The FOIA office will record the date that appeals are received. The receipt of the appeal will be acknowledged by the CFPB and the requester will be advised of the date the appeal was received, the appeal tracking number, and the expected date of response.

(e) Determinations to grant or deny administrative appeals. The General Counsel is authorized to and shall decide whether to affirm the initial determination (in whole or in part), to reverse the initial determination (in whole or in part) or to remand the initial determination to the Chief FOIA Officer for further action and shall notify the requester of this decision in writing within twenty (20) business days after the date of receipt of the appeal, unless extended pursuant to § 1070.16(d).

(1) If it is decided that the appeal is to be denied (in whole or in part) the requester shall be:

(i) Notified in writing of the denial;

(ii) Notified of the reasons for the denial, including which of the FOIA exemptions were relied upon;

(iii) Notified of the name and title or position of the official responsible for the determination on appeal;

(iv) Provided with a statement that judicial review of the denial is available in the United States District Court for the judicial district in which the requester resides or has a principal place of business, the judicial district in which the requested records are located, or the District of Columbia in accordance with 5 U.S.C. 552(a)(4)(B); and

(v) Provided with notification that dispute resolution services are available to the requester as a non-exclusive alternative to litigation through the Office of Government Information Services in accordance with 5 U.S.C. 552(h)(3). Dispute resolution is a voluntary process. If the CFPB agrees to participate in the dispute resolution services provided by the Office of Governmental Information Services, it will actively engage as a partner to the process in an attempt to resolve the dispute.

(2) If the initial determination is reversed on appeal, the requester shall be so notified and the request shall be processed promptly in accordance with the decision on appeal.

(3) If the initial determination is remanded on appeal to the Chief FOIA Officer for further action, the requester shall be so notified and the request shall be processed in accordance with the decision on appeal. The remanded request shall be treated as a new request received by the CFPB as of the date when the General Counsel transmits the remand notification to the requester. The procedures and deadlines set forth in this subpart for processing, deciding, responding to, and filing administrative appeals of new FOIA requests shall apply to the remanded request.

(f) Adjudication of administrative appeals of requests in litigation. An appeal ordinarily will not be adjudicated if the request becomes a matter of FOIA litigation.

§ 1070.22 Fees for processing requests for CFPB records.

(a) In general. The CFPB shall determine whether and to what extent to charge a requester fees for processing a FOIA request, for the services and in the amounts set forth in this paragraph (a), by determining an appropriate fee category for the requester (as set forth in paragraph (b) of this section) and then by charging the requester those fees applicable to the assigned category (as set forth in paragraph (c) of this section), unless circumstances exist (as described in paragraph (d) of this section) that render fees inapplicable or unless the requester has requested and the CFPB has granted a reduction in or waiver of fees (as set forth in paragraph (e) of this section).

(1) The CFPB shall charge a requester fees for the cost of copying or printing records at the rate of $0.10 per page.

(2) The CFPB shall charge a requester for all time spent by its employees searching for records that are responsive to a request. The CFPB shall charge the requester fees for search time as follows:

(i) The CFPB shall charge for search time at the salary rate(s) (basic pay plus sixteen (16) percent) of the employee(s) who conduct the search. However, the CFPB shall charge search fees at the rate of $9.00 per fifteen (15) minutes of search time whenever only administrative/clerical employees conduct a search and at the rate of $23.00 per fifteen (15) minutes of search time whenever only professional/executive employees conduct a search. Search charges shall also include transportation of employees and records necessary to the search at actual cost. Fees may be charged for search time even if the search does not yield any responsive records, or if records are exempt from disclosure.

(ii) The CFPB shall charge the requester for the actual direct costs of conducting an electronic records search, including computer search time, runs, and output. The CFPB shall also charge for time spent by computer operators or programmers (at the rates set forth in paragraph (a)(2)(i) of this section) who conduct or assist in the conduct of an electronic records search.

(3) The CFPB shall charge a requester for time spent by its employees examining responsive records to determine whether any portions of such record are exempt from disclosure, pursuant to the FOIA exemptions of 5 U.S.C. 552(b). The CFPB shall also charge a requester for time spent by its employees redacting any such exempt information from a record and preparing a record for release to the requester. The CFPB shall charge a requester for time spent reviewing records at the salary rate(s) (i.e., basic pay plus sixteen (16) percent) of the employees who conduct the review. However, the CFPB shall charge review fees at the rate of $9.00 per fifteen (15) minutes of search time whenever only administrative/clerical employees review records and at the rate of $23.00 per fifteen (15) minutes of search time whenever only professional/executive employees review records. Fees shall be charged for review time even if records ultimately are not disclosed.

(4) Fees for all services provided shall be charged whether or not copies are made available to the requester for inspection. However, no fee shall be charged for monitoring a requester's inspection of records.

(5) Other services and materials requested which are not covered by this part nor required by the FOIA are chargeable at the actual cost to the CFPB. This includes, but is not limited to:

(i) Certifying that records are true copies; or

(ii) Sending records by special methods such as express mail, etc.

(b) Categories of requesters. (1) For purposes of assessing fees as set forth in this section, each requester shall be assigned to one of the following categories:

(i) Commercial user refers to one who seeks information for a use or purpose that furthers the commercial, trade, or profit interests of the requester or the person on whose behalf the request is made, which can include furthering those interests through litigation. The CFPB's decision to place a requester in the commercial use category will be made on a case-by-case basis based on how the requester will use the information.

(ii) Educational institution refers to any school that operates a program of scholarly research. A requester in this fee category must show that the request is made in connection with his or her role at the educational institution. Agencies may seek verification from the requester that the request is in furtherance of scholarly research and agencies will advise requesters of their placement in this category.

Example 1 to paragraph (b)(1)(ii). A request from a professor of geology at a university for records relating to soil erosion, written on letterhead of the Department of Geology, would be presumed to be from an educational institution.

Example 2 to paragraph (b)(1)(ii). A request from the same professor of geology seeking drug information from the Food and Drug Administration in furtherance of a murder mystery he is writing would not be presumed to be an institutional request, regardless of whether it was written on institutional stationery.

Example 3 to paragraph (b)(1)(ii). A student who makes a request in furtherance of their coursework or other school-sponsored activities and provides a copy of a course syllabus or other reasonable documentation to indicate the research purpose for the request, would qualify as part of this fee category.

(iii) Non-commercial scientific institution refers to an institution that is not operated on a “commercial user” basis as that term is defined in paragraph (b)(2)(i) of this section, and which is operated solely for the purpose of conducting scientific research, the results of which are not intended to promote any particular product or industry.

(iv) Representative of the news media refers to any person or entity that gathers information of potential interest to a segment of the public, uses its editorial skills to turn the raw materials into a distinct work, and distributes that work to an audience. In this paragraph (b)(1)(iv), the term “news” means information that is about current events or that would be of current interest to the public. Examples of news-media entities are television or radio stations broadcasting to the public at large and publishers of periodicals (but only if such entities qualify as disseminators of “news”) who make their products available for purchase by or subscription by or free distribution to the general public. Other examples of news media entities include online publications and websites that regularly deliver news content to the public. These examples are not all-inclusive. Moreover, as methods of news delivery evolve (for example, the adoption of the electronic dissemination of newspapers through telecommunications services), such alternative media shall be considered to be news-media entities. A freelance journalist shall be regarded as working for a news-media entity if the journalist can demonstrate a solid basis for expecting publication through that entity, whether or not the journalist is actually employed by the entity. A publication contract would present a solid basis for such an expectation; the CFPB may also consider the past publication record of the requester in making such a determination.

(v) Other requester refers to a requester who does not fall within any of the categories described in paragraphs (b)(1)(i) through (iv) of this section.

(2) Within twenty (20) calendar days of its receipt of a request, the CFPB shall make a determination as to the proper fee category to apply to a requester. The CFPB shall inform the requester of the determination in the request acknowledgment letter, or if no such letter is required, in another writing. Where the CFPB has reasonable cause to doubt the use to which a requester will put the records sought, or where that use is not clear from the request itself, the CFPB should seek additional clarification before assigning the request to a specific category.

(3) If the CFPB assigns to a requester a fee category, then the requester shall have the right to submit an appeal of the CFPB's determination in accordance with § 1070.21. The CFPB shall communicate this appeal right as part of its written notification to the requester of an adverse fee category determination. The requester shall label its appeal request “Appeal of Fee Category Determination.”

(c) Fees applicable to each category of requester. The following fee schedule applies uniformly throughout the CFPB to requests processed under the FOIA. Specific levels of fees are prescribed for each category of requester defined in paragraph (b) of this section.

(1) Commercial users shall be charged the full direct costs of searching for, reviewing, and duplicating the records they request. Moreover, when a request is received for disclosure that is primarily in the commercial interest of the requester, the CFPB is not required to consider a request for a waiver or reduction of fees based upon the assertion that disclosure would be in the public interest. The CFPB may recover the cost of searching for and reviewing records even if there is ultimately no disclosure of records or no records are located.

(2) Educational and non-commercial scientific institution requesters shall be charged only for the cost of duplicating the records they request, except that the CFPB shall provide the first one hundred (100) pages of duplication free of charge.

(3) Representatives of the news media shall be charged only for the cost of duplicating the records they request, except that the CFPB shall provide them with the first one hundred (100) pages of duplication free of charge.

(4) Other requesters who do not fit any of the categories described in paragraphs (c)(1) through (3) of this section shall be charged the full direct cost of searching for and duplicating records that are responsive to the request, except that the CFPB shall provide the first one hundred (100) pages of duplication and the first two hours of search time free of charge. The CFPB may recover the cost of searching for records even if there is ultimately no disclosure of records, or no records are located. Requests from persons for records about themselves filed in the CFPB's systems of records shall continue to be treated under the fee provisions of the Privacy Act of 1974, 5 U.S.C. 552a, which permit fees only for duplication, after the first one hundred (100) pages are furnished free of charge.

(d) Other circumstances when fees are not charged. In the following situations the CFPB may not charge a requester certain FOIA processing fees.

(1) If the cost of collecting a fee would be equal to or greater than the total FOIA processing fee, then the CFPB shall not charge a requester any FOIA processing fees.

(2) If the total search and review fees are less than $250, then the CFPB shall not charge a requester any search and review fees.

(3) If the CFPB has waived or reduced FOIA processing fees in accordance with paragraph (e) of this section, then the CFPB shall not charge the portion of the FOIA processing fees that has been waived or reduced.

(4) If the CFPB fails to comply with any time limit under § 1070.15 or § 1070.21, then the CFPB shall not assess search fees or if the requester is a representative of the news media or an educational or noncommercial scientific institution, then the CFPB shall not assess duplication fees, unless:

(i) A court has determined that exceptional circumstances, as defined by the FOIA, exist; or

(ii) The CFPB has determined that unusual circumstances apply to the processing of the request; and

(A) Provided timely written notice to the requester of the unusual circumstances in accordance with § 1070.16(d);

(B) Determined that more than 5,000 pages are necessary to respond to the request; and

(C) Discussed with the requester via mail, email, or telephone (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request.

(5) If the CFPB determines, as a matter of administrative discretion, that waiving or reducing the fees would serve the interest of the United States Government.

(e) Waiver or reduction of fees. (1) A requester shall be entitled to receive from the CFPB a waiver or reduction in the fees otherwise applicable to a FOIA request whenever the requester:

(i) Requests such waiver or reduction of fees in writing as part of the FOIA request;

(ii) Labels the request for waiver or reduction of fees “Fee Waiver or Reduction Requested” on the FOIA request; and

(iii) Demonstrates that the fee reduction or waiver request that a waiver or reduction of the fees is in the public interest because:

(A) Furnishing the information is likely to contribute significantly to public understanding of the operations or activities of the government; and

(B) Furnishing the information is not primarily in the commercial interest of the requester.

(2) To determine whether the requester has satisfied the requirements of paragraph (e)(1)(iii)(A) of this section, the CFPB shall consider the following factors:

(i) The subject of the requested records must concern identifiable operations or activities of the Federal government, with a connection that is direct and clear, and not remote or attenuated.

(ii) The disclosable portions of the requested records must be meaningfully informative about government operations or activities in order to be “likely to contribute” to an increased public understanding of those operations or activities. The disclosure of information that already is in the public domain, in either a duplicative or a substantially similar form, is not as likely to contribute to the public's understanding.

(iii) The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester. A requester's expertise in the subject area and ability and intention to effectively convey information to the public shall be considered. It shall be presumed that a representative of the news media will satisfy this consideration.

(iv) The public's understanding of the subject in question, as compared to the level of public understanding existing prior to the disclosure, must be enhanced by the disclosure to a significant extent.

(3) To determine whether the requester has satisfied the requirements of paragraph (e)(1)(iii)(B) of this section, the CFPB shall consider the following factors:

(i) The CFPB shall consider any commercial interest of the requester (with reference to the definition of “commercial user” in paragraph (b)(1)(i) of this section), or of any person on whose behalf the requester may be acting, that would be furthered by the requested disclosure. Requesters shall be given an opportunity in the administrative process to provide explanatory information regarding this consideration.

(ii) A fee waiver or reduction is justified where the public interest standard is satisfied and that public interest is greater in magnitude than that of any identified commercial interest in disclosure. The CFPB ordinarily shall presume that where a news media requester has satisfied the public interest standard, the public interest will be the interest primarily served by disclosure to that requester. Disclosure to data brokers or others who merely compile and market government information for direct economic return shall not be presumed to primarily serve the public interest.

(4) Where only some of the records to be released satisfy the requirements for a waiver of fees, a waiver shall be granted for those records.

(5) If the CFPB denies a request to reduce or waive fees, then the CFPB shall advise the requester, in the denial notification letter, that the requester may incur fees if the CFPB proceeds to process the request. The notification letter shall also advise the requester that the CFPB will not proceed to process the request further unless the requester, in writing, directs the CFPB to do so and either agrees to pay any fees that may apply to processing the request or specifies an upper limit that the requester is willing to pay to process the request. If the CFPB does not receive this written direction and agreement/specification within thirty (30) calendar days of the date of the denial notification letter, then the CFPB shall deem the request to be withdrawn.

(6) If the CFPB denies a request to reduce or waive fees, then the requester shall have the right to submit an appeal of the denial determination in accordance with § 1070.21. The CFPB shall communicate this appeal right as part of its written notification to the requester denying the fee reduction or waiver request. The requester should label its appeal request “Appeal for Fee Reduction/Waiver.”

(f) Advance notice and prepayment of fees. (1) The CFPB shall notify a requester of the estimated fees for processing a request and provide a breakdown of the fees attributable to search, review, and duplication, when the estimated fees are $250 or more and:

(i) The fees exceed the limit set by the requester;

(ii) The requester did not specify a limit; or

(iii) The CFPB has denied a request for a reduction or waiver of fees.

(2) The requester must provide an agreement to pay the estimated fees; however, the requester shall also be given an opportunity to reformulate the request in an attempt to reduce fees.

(3) If the fees are estimated to exceed $1000, the requester must pre-pay such amount prior to the processing of the request, or provide satisfactory assurance of full payment if the requester has a history of prompt payment of FOIA fees. The requester shall also be given an opportunity to reformulate the request in such a way as to lower the applicable fees.

(4) The CFPB reserves the right to request prepayment after a request is processed and before documents are released.

(5) If a requester has previously failed to pay a fee within thirty (30) calendar days of the date of the billing, the requester shall be required to pay the full amount owed plus any applicable interest and to make an advance payment of the full amount of the estimated fee before the CFPB begins to process a new request or the pending request.

(6) When the CFPB acts under paragraphs (f)(1) through (5) of this section, the statutory time limits of twenty (20) days (excluding Saturdays, Sundays, and legal public holidays) from receipt of initial requests or appeals, plus extensions of these time limits, shall begin only after fees have been paid, a written agreement to pay fees has been provided, or a request has been reformulated.

(g) Form of payment. Payment may be tendered as set forth on the CFPB's website, http://www.consumerfinance.gov.

(h) Charging interest. The CFPB may charge interest on any unpaid bill starting on the 31st day following the date of billing the requester. Interest charges will be assessed at the rate provided in 31 U.S.C. 3717 and will accrue from the date of the billing until payment is received by the CFPB. The CFPB will follow the provisions of the Debt Collection Act of 1982 (Pub. L. 97-365, 96 Stat. 1749), as amended, and its administrative procedures, including the use of consumer reporting agencies, collection agencies, and offset.

(i) Aggregating requests. Where the CFPB reasonably believes that a requester or a group of requesters acting together is attempting to divide a request into a series of requests for the purpose of avoiding fees, the CFPB may aggregate those requests and charge accordingly. The CFPB may presume that multiple requests of this type made within a thirty (30) day period have been made in order to avoid fees. Where requests are separated by a longer period, the CFPB will aggregate them only where there exists a solid basis for determining that aggregation is warranted under all the circumstances involved. Multiple requests involving unrelated matters will not be aggregated.

§ 1070.23 Authority and responsibilities of the Chief FOIA Officer.

(a) Chief FOIA Officer. The Director authorizes the Chief FOIA Officer to act upon all requests for agency records, with the exception of determining appeals from the initial determinations of the Chief FOIA Officer, which will be decided by the General Counsel. The Chief FOIA officer shall, subject to the authority of the Director:

(1) Have CFPB-wide responsibility for efficient and appropriate compliance with the FOIA;

(2) Monitor implementation of the FOIA throughout the CFPB and keep the Director, the General Counsel, and the Attorney General appropriately informed of the CFPB's performance in implementing the FOIA;

(3) Recommend to the Director such adjustments to agency practices, policies, personnel and funding as may be necessary to improve the Chief FOIA Officer's implementation of the FOIA;

(4) Review and report to the Attorney General, through the Director, at such times and in such formats as the Attorney General may direct, on the CFPB's performance in implementing the FOIA;

(5) Facilitate public understanding of the purposes of the statutory exemptions of the FOIA by including concise descriptions of the exemptions in both the CFPB's handbook and the CFPB's annual report on the FOIA, and by providing an overview, where appropriate, of certain general categories of CFPB records to which those exemptions apply;

(6) Designate one or more FOIA Public Liaisons;

(7) Offer Training to Bureau staff regarding their responsibilities under the FOIA;

(8) Serve as the primary Bureau liaison with the Office of Government Information Services and the Office of Information Policy; and

(9) Maintain and update, as necessary and in accordance with the requirements of this subpart, the CFPB's FOIA website, including its e-FOIA Library.

(b) FOIA Public Liaisons. FOIA Public Liaisons shall report to the Chief FOIA Officer and shall serve as supervisory officials to whom a requester can raise concerns about the service the requester has received from the CFPB's FOIA office, following an initial response from the FOIA office staff. FOIA Public Liaisons shall be responsible for assisting in reducing delays, increasing transparency and understanding of the status of requests, and assisting in the resolution of disputes.

Subpart C—Disclosure of CFPB Information in Connection with Legal Proceedings
§ 1070.30 Purpose and scope; definitions.

(a) This subpart sets forth the procedures to be followed with respect to subpoenas, court orders, or other requests or demands for any CFPB information, whether contained in the files of the CFPB or acquired by a CFPB employee as part of the performance of that employee's duties or by virtue of employee's official status.

(b) This subpart does not apply to requests for official information made pursuant to subparts B, D, and E of this part.

(c) This subpart does not apply to requests for information made in the course of adjudicating claims against the CFPB by CFPB employees (present or former) or applicants for CFPB employment for which jurisdiction resides with the U.S. Equal Employment Opportunity Commission, the U.S. Merit Systems Protection Board, the Office of Special Counsel, the Federal Labor Relations Authority, or their successor agencies, or a labor arbitrator operating under a collective bargaining agreement between the CFPB and a labor organization representing CFPB employees.

(d) This subpart is intended only to inform the public about CFPB procedures concerning the service of process and responses to subpoenas, summons, or other demands or requests for official information or action and is not intended to and does not create, and may not be relied upon to create any right or benefit, substantive or procedural, enforceable at law by a party against the CFPB or the United States.

(e) For purposes of this subpart:

(1) Demand means a subpoena or order for official information, whether contained in CFPB records or through testimony, related to or for possible use in a legal proceeding.

(2) Legal proceeding encompasses all pre-trial, trial, and post-trial stages of all judicial or administrative actions, hearings, investigations, or similar proceedings before courts, commissions, boards, grand juries, arbitrators, or other judicial or quasi-judicial bodies or tribunals, whether criminal, civil, or administrative in nature, and whether foreign or domestic. This phrase includes all stages of discovery as well as formal or informal requests by attorneys, their agents, or others involved in legal proceedings.

(3) Official Information means all information of any kind, however stored, that is in the custody and control of the CFPB or was acquired by CFPB employees, or former employees as part of their official duties or because of their official status while such individuals were employed by or served on behalf of the CFPB. Official information also includes any information acquired by CFPB employees or former employees while such individuals were engaged in matters related to consumer financial protection functions prior to the employees' transfer to the CFPB pursuant to Subtitle F of the Consumer Financial Protection Act of 2010.

(4) Request means any request for official information in the form of testimony, affidavits, declarations, admissions, responses to interrogatories, document production, inspections, or formal or informal interviews, during the course of a legal proceeding, including pursuant to the Federal Rules of Civil Procedure, the Federal Rules of Criminal Procedure, or other applicable rules of procedure.

(5) Testimony means a statement in any form, including personal appearances before a court or other legal tribunal, interviews, depositions, telephonic, televised, or videographed statements or any responses given during discovery or similar proceeding in the course of litigation.

§ 1070.31 Service of subpoenas, court orders, and other demands for CFPB information or action.

(a) Except in cases in which the CFPB is represented by legal counsel who have entered an appearance or otherwise given notice of their representation, only the General Counsel is authorized to receive and accept subpoenas or other demands or requests directed to the CFPB or its employees, whether civil or criminal in nature, for:

(1) Records of the CFPB;

(2) Official information including, but not limited to, testimony, affidavits, declarations, admissions, responses to interrogatories, or informal statements, relating to material contained in the files of the CFPB or which any CFPB employee acquired in the course and scope of the performance of his or her official duties;

(3) Garnishment or attachment of compensation of current or former employees; or

(4) The performance or non-performance of any official CFPB duty.

(b) Documents described in paragraph (a) of this section should be served upon the General Counsel, Consumer Financial Protection Bureau, 1700 G Street NW, Washington, DC 20552. Service must be effected as provided in applicable rules and regulations governing service in Federal judicial and administrative proceedings. Acceptance of such documents by the General Counsel does not constitute a waiver of any defense that might otherwise exist with respect to service under the Federal Rules of Civil or Criminal Procedure or other applicable laws or regulations.

(c) In the event that any demand or request described in paragraph (a) of this section is sought to be delivered to a CFPB employee other than in the manner prescribed in paragraph (b) of this section, such employee shall decline service and direct the server of process to these regulations. If the demand or request is nonetheless delivered to the employee, the employee shall immediately notify, and deliver a copy of that document to, the General Counsel.

(d) The CFPB is not an agent for service for, or otherwise authorized to accept on behalf of its employees, any subpoenas, orders, or other demands or requests, which are not related to the employees' official duties.

(e) Copies of any subpoenas, orders, or other demands or requests that are directed to former employees of the CFPB in connection with the performance of official CFPB duties shall also be served upon the General Counsel. The CFPB shall not, however, serve as an agent for service for the former employee, nor is the CFPB otherwise authorized to accept service on behalf of its former employees. If the demand involves their official duties as CFPB employees, former employees who receive subpoenas, orders, or similar compulsory process should also notify, and deliver a copy of the document to, the General Counsel.

§ 1070.32 Testimony and production of documents prohibited unless approved by the General Counsel.

(a) Unless authorized by the General Counsel, no employee or former employee of the CFPB shall, in response to a demand or a request provide oral or written testimony by deposition, declaration, affidavit, or otherwise concerning any official information.

(b) Unless authorized by the General Counsel, no employee or former employee shall, in response to a demand or request, produce any document or any material acquired as part of the performance of that employee's duties or by virtue of that employee's official status.

§ 1070.33 Procedure when testimony or production of documents is sought; general.

(a) If, as part of a proceeding in which the United States or the CFPB is not a party, official information is sought through a demand for testimony, CFPB records, or other material, the party seeking such information must (except as otherwise required by Federal law or authorized by the General Counsel) set forth in writing:

(1) The title and forum of the proceeding, if applicable;

(2) A detailed description of the nature and relevance of the official information sought;

(3) A showing that other evidence reasonably suited to the requester's needs is not available from any other source; and

(4) If testimony is requested, the intended use of the testimony, a general summary of the desired testimony, and a showing that no document could be provided and used in lieu of testimony.

(b) To the extent he or she deems necessary or appropriate, the General Counsel may also require from the party seeking such information a plan of all reasonably foreseeable demands, including but not limited to the names of all employees and former employees from whom testimony or discovery will be sought, areas of inquiry, expected duration of proceedings requiring oral testimony, identification of potentially relevant documents, or any other information deemed necessary to make a determination. The purpose of this requirement is to assist the General Counsel in making an informed decision regarding whether testimony, the production of documents, or the provision of other information should be authorized.

(c) The General Counsel may consult or negotiate with an attorney for a party, or the party if not represented by an attorney, to refine or limit a request or demand so that compliance is less burdensome.

(d) The General Counsel will notify the CFPB employee and such other persons as circumstances may warrant of his or her decision regarding compliance with the request or demand.

§ 1070.34 Procedure when response to demand is required prior to receiving instructions.

(a) If a response to a demand described in § 1070.33 is required before the General Counsel renders a decision, the CFPB will request that the appropriate CFPB attorney or an attorney of the Department of Justice, as appropriate, take steps to stay, postpone, or obtain relief from the demand pending decision. If necessary, the attorney will:

(1) Appear with the employee upon whom the demand has been made;

(2) Furnish the court or other authority with a copy of the regulations contained in this subpart;

(3) Inform the court or other authority that the demand has been, or is being, as the case may be, referred for the prompt consideration of the appropriate CFPB official; and

(4) Request the court or authority to stay the demand pending receipt of the requested instructions.

(b) In the event that an immediate demand for production or disclosure is made in circumstances which would preclude the proper designation or appearance of an attorney of the CFPB or the Department of Justice on the employee's behalf, the employee, if necessary, shall request from the demanding court or authority a reasonable stay of proceedings for the purpose of obtaining instructions from the General Counsel.

§ 1070.35 Procedure in the event of an adverse ruling.

If a stay of, or other relief from, the effect of a demand made pursuant to §§ 1070.33 and 1070.34 is declined or not obtained, or if the court or other judicial or quasi-judicial authority declines to stay the effect of the demand made pursuant to §§ 1070.33 and 1070.34, or if the court or other authority rules that the demand must be complied with irrespective of the General Counsel's instructions not to produce the material or disclose the information sought, the employee upon whom the demand has been made shall decline to comply with the demand citing this subpart and United States ex rel. Touhy v. Ragen, 340 U.S. 462 (1951).

§ 1070.36 Considerations in determining whether the CFPB will comply with a demand or request.

(a) In deciding whether to comply with a demand or request, CFPB officials and attorneys shall consider, among other pertinent considerations:

(1) Whether such compliance would be unduly burdensome or otherwise inappropriate under the applicable rules of discovery or the rules of procedure governing the case or matter in which the demand arose;

(2) Whether the number of similar requests would have a cumulative effect on the expenditure of CFPB resources;

(3) Whether compliance is appropriate under the relevant substantive law concerning privilege or disclosure of information;

(4) The public interest;

(5) The need to conserve the time of CFPB employees for the conduct of official business;

(6) The need to avoid spending time and money of the United States for private purposes;

(7) The need to maintain impartiality between private litigants in cases where a substantial government interest is not implicated;

(8) Whether compliance would have an adverse effect on performance by the CFPB of its mission and duties;

(9) The need to avoid involving the CFPB in controversial issues not related to its mission;

(10) Whether compliance would interfere with supervisory examinations, compromise the CFPB's supervisory functions or programs, or undermine public confidence in supervised financial institutions; and

(11) Whether compliance would interfere with the CFPB's ability to monitor for risks to consumers in the offering or provision of consumer financial products and services.

(b) Among those demands and requests in response to which compliance will not ordinarily be authorized are those with respect to which any of the following factors, inter alia, exist:

(1) Compliance would violate a statute or applicable rule of procedure;

(2) Compliance would violate a specific regulation or Executive order;

(3) Compliance would reveal information properly classified in the interest of national security;

(4) Compliance would reveal confidential or privileged commercial or financial information or trade secrets without the owner's consent;

(5) Compliance would compromise the integrity of the deliberative processes of the CFPB;

(6) Compliance would not be appropriate or necessary under the relevant substantive law governing privilege;

(7) Compliance would reveal confidential information; or

(8) Compliance would interfere with ongoing investigations or enforcement proceedings, compromise constitutional rights, or reveal the identity of a confidential informant.

(c) The CFPB may condition disclosure of official information pursuant to a request or demand on the entry of an appropriate protective order.

§ 1070.37 Prohibition on providing expert or opinion testimony.

(a) Except as provided in this section, and subject to 5 CFR 2635.805, CFPB employees or former employees shall not provide opinion or expert testimony based upon information which they acquired in the scope and performance of their official CFPB duties, except on behalf of the CFPB or the United States or a party represented by the CFPB, or the Department of Justice, as appropriate.

(b) Any expert or opinion testimony by a former employee of the CFPB shall be excepted from paragraph (a) of this section where the testimony involves only general expertise gained while employed at the CFPB.

(c) Upon a showing by the requester of exceptional need or unique circumstances and that the anticipated testimony will not be adverse to the interests of the United States, the General Counsel may, consistent with 5 CFR 2635.805, exercise his or her discretion to grant special, written authorization for CFPB employees, or former employees, to appear and testify as expert witnesses at no expense to the United States.

(d) If, despite the final determination of the General Counsel, a court of competent jurisdiction or other appropriate authority orders the appearance and expert or opinion testimony of a current or former CFPB employee, that person shall immediately inform the General Counsel of such order. If the General Counsel determines that no further legal review of or challenge to the court's order will be made, the CFPB employee, or former employee, shall comply with the order. If so directed by the General Counsel, however, the employee, or former employee, shall decline to testify.

7. Revise subpart E to read as follows: Subpart E—Privacy Act Sec. 1070.50 Purpose and scope; definitions. 1070.51 Authority and responsibilities of the Chief Privacy Officer. 1070.52 Fees. 1070.53 Request for access to records. 1070.54 CFPB procedures for responding to a request for access. 1070.55 Special procedures for medical records. 1070.56 Request for amendment of records. 1070.57 CFPB review of a request for amendment of records. 1070.58 Appeal of adverse determination of request for access or amendment. 1070.59 Restrictions on disclosure. 1070.60 Exempt records. 1070.61 Training; rules of conduct; penalties for non-compliance. 1070.62 Preservation of records. 1070.63 Use and collection of Social Security numbers. Subpart E—Privacy Act
§ 1070.50 Purpose and scope; definitions.

(a) This subpart implements the provisions of the Privacy Act of 1974, 5 U.S.C. 552a (the Privacy Act). The regulations apply to all records maintained by the CFPB and which are retrieved by an individual's name or personal identifier. The regulations set forth the procedures for requests for access to, or amendment of, records concerning individuals that are contained in systems of records maintained by the CFPB. These regulations should be read in conjunction with the Privacy Act, which provides additional information about this topic.

(b) For purposes of this subpart, the following definitions apply:

(1) The term Chief Privacy Officer means the Chief Information Officer of the CFPB or any CFPB employee to whom the Chief Information Officer has delegated authority to act under this part;

(2) The term guardian means the parent of a minor, or the legal guardian of any individual who has been declared to be incompetent due to physical or mental incapacity or age by a court of competent jurisdiction;

(3) Individual means a citizen of the United States or an alien lawfully admitted for permanent residence;

(4) Maintain includes maintain, collect, use, or disseminate;

(5) Record means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, his education, financial transactions, medical history, and criminal or employment history and that contains his name or the identifying number, symbol, or other identifying particular assigned to the individual, such as a finger or voiceprint or a photograph;

(6) Routine use means the disclosure of a record that is compatible with the purpose for which it was collected;

(7) System of records means a group of any records under the control of an agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual; and

(8) Statistical record means a record in a system of records maintained for statistical research or reporting purposes only and not used in whole or in part in making any determination about an identifiable individual, except as provided by 13 U.S.C. 8.

§ 1070.51 Authority and responsibilities of the Chief Privacy Officer.

The Chief Privacy Officer is authorized to:

(a) Develop, implement, and maintain an organization-wide privacy program;

(b) Respond to requests for access to, accounting of, or amendment of records contained in a system of records maintained by the CFPB;

(c) Approve the publication of new systems of records and amend existing systems of record; and

(d) File any necessary reports related to the Privacy Act.

§ 1070.52 Fees.

(a) Copies of records. The CFPB shall provide the requester with copies of records requested pursuant to § 1070.53 at the same cost charged for duplication of records under § 1070.22.

(b) No fee. The CFPB will not charge a fee if:

(1) Total charges associated with a request are less than $5; or

(2) The requester is a CFPB employee or former employee, or an applicant for employment with the CFPB, and the request pertains to that employee, former employee, or applicant.

§ 1070.53 Request for access to records.

(a) Procedures for making a request for access to records. An individual's requests for access to records that pertain to that individual (or to the individual for whom the requester serves as guardian) may be submitted to the CFPB in writing as follows:

(1) If submitted by mail or delivery service, the request shall be labeled “Privacy Act Request” and shall be addressed to the Chief Privacy Officer, Consumer Financial Protection Bureau, 1700 G Street NW, Washington, DC 20552.

(2) If submitted by electronic means, the request shall be labeled “Privacy Act Request” and the request shall be submitted as set forth at the CFPB's website, http://www.consumerfinance.gov.

(b) Content of a request for access to records. A request for access to records shall include:

(1) A statement that the request is made pursuant to the Privacy Act;

(2) The name of the system of records that the requester believes contains the record requested, or a description of the nature of the record sought in detail sufficient to enable CFPB personnel to locate the system of records containing the record with a reasonable amount of effort;

(3) Whenever possible, a description of the nature of the record sought, the date of the record or the period in which the requester believes that the record was created, and any other information that might assist the CFPB in identifying the record sought (e.g., maiden name, dates of employment, account information, etc.);

(4) Information necessary to verify the requester's identity pursuant to paragraph (c) of this section; and

(5) The mailing or email address where the CFPB's response or further correspondence should be sent.

(c) Verification of identity. To obtain access to the CFPB's records pertaining to a requester, the requester shall provide proof to the CFPB of the requester's identity as provided in paragraphs (c)(1) and (2) of this section.

(1) In general, the following will be considered adequate proof of a requester's identity:

(i) A photocopy of two forms of identification, including one form of identification that bears the requester's photograph, and one form of identification that bears the requester's signature;

(ii) A photocopy of a single form of identification that bears both the requester's photograph and signature; or

(iii) A statement swearing or affirming the requester's identity and to the fact that the requester understands the penalties provided in 5 U.S.C. 552a(i)(3).

(2) Notwithstanding paragraph (c)(1) of this section, a designated official may require additional proof of the requester's identity before action will be taken on any request, if such official determines that it is necessary to protect against unauthorized disclosure of information in a particular case. In addition, if a requester seeks records pertaining to an individual in the requester's capacity as that individual's guardian, the requester shall be required to provide adequate proof of the requester's legal relationship before action will be taken on any request.

(d) Request for accounting of previous disclosures. An individual may request an accounting of previous disclosures of records pertaining to that individual in a system of records as provided in 5 U.S.C. 552a(c). Such requests should conform to the procedures and form for requests for access to records set forth in paragraphs (a) and (b) of this section.

§ 1070.54 CFPB procedures for responding to a request for access.

(a) Acknowledgment and response. The CFPB will provide written acknowledgement of the receipt of a request within twenty (20) business days from the receipt of the request and will, where practicable, respond to each request within that twenty (20) day period. When a full response is not practicable within the twenty (20) day period, the CFPB will respond as promptly as possible.

(b) Disclosure. (1) When the CFPB discloses information in response to a request, the CFPB will make the information available for inspection and copying during regular business hours as provided in § 1070.13, or the CFPB will mail it or email it to the requester, if feasible, upon request.

(2) The requester may bring with him or her anyone whom the requester chooses to see the requested material. All visitors to the CFPB's buildings must comply with the applicable security procedures.

(c) Denial of a request. If the CFPB denies a request made pursuant to § 1070.53, it will inform the requester in writing of the reason(s) for denial and the procedures for appealing the denial.

§ 1070.55 Special procedures for medical records.

If an individual requests medical or psychological records pursuant to § 1070.53, the CFPB will disclose them directly to the requester unless the CFPB determines that such disclosure could have an adverse effect on the requester. If the CFPB makes that determination, the CFPB shall provide the information to a licensed physician or other appropriate representative that the requester designates, who shall disclose those records to the requester in a manner he or she deems appropriate.

§ 1070.56 Request for amendment of records.

(a) Procedures for making request. (1) If an individual wishes to amend a record that pertains to that individual in a system of records, that individual may submit a request in writing to the Chief Privacy Officer, as set forth in § 1070.53(a). The request shall be labeled “Privacy Act Amendment Request.”

(2) A request for amendment of a record must:

(i) Identify the name of the system of records that the requester believes contains the record for which the amendment is requested, or a description of the nature of the record in detail sufficient to enable CFPB personnel to locate the system of records containing the record with a reasonable amount of effort;

(ii) Specify the portion of that record requested to be amended; and

(iii) Describe the nature and reasons for each requested amendment.

(3) When making a request for amendment of a record, the CFPB will require a requester to verify his or her identity under the procedures set forth in § 1070.53(c), unless the requester has already done so in a related request for access or amendment.

(b) Burden of proof. In a request for amendment of a record, the requester bears the burden of proving by a preponderance of the evidence that the record is not accurate, relevant, timely, or complete.

§ 1070.57 CFPB review of a request for amendment of records.

(a) Time limits. The CFPB will acknowledge a request for amendment of records within ten (10) business days after it receives the request. In the acknowledgment, the CFPB may request additional information necessary for a determination on the request for amendment. The CFPB will make a determination on a request to amend a record promptly.

(b) Contents of response to a request for amendment. When the CFPB responds to a request for amendment, the CFPB will inform the requester in writing whether the request is granted or denied, in whole or in part. If the CFPB grants the request, it will take the necessary steps to amend the record and, when appropriate and possible, notify prior recipients of the record of its action. If the CFPB denies the request, in whole or in part, it will inform the requester in writing:

(1) Why the request (or portion of the request) was denied;

(2) That the requester has a right to appeal; and

(3) How to file an appeal.

§ 1070.58 Appeal of adverse determination of request for access or amendment.

(a) Appeal. A requester may appeal a denial of a request made pursuant to § 1070.53 or § 1070.56 within ten (10) business days after the CFPB notifies the requester that it has denied the request.

(b) Content of appeal. A requester may submit an appeal in writing as set forth in § 1070.53(a). The appeal shall be addressed to the General Counsel and labeled “Privacy Act Appeal.” The appeal must also:

(1) Specify the background of the request; and

(2) Provide reasons why the requester believes the denial is in error.

(c) Determination. The General Counsel will make a determination as to whether to grant or deny an appeal within thirty (30) business days from the date it is received, unless the General Counsel extends the time for good cause.

(1) If the General Counsel grants an appeal regarding a request for amendment, he or she will take the necessary steps to amend the record and, when appropriate and possible, notify prior recipients of the record of its action.

(2) If the General Counsel denies an appeal, he or she will inform the requester of such determination in writing, including the reasons for the denial, and the requester's right to file a statement of disagreement and to have a court review its decision.

(d) Statement of disagreement. (1) If the General Counsel denies an appeal regarding a request for amendment, a requester may file a concise statement of disagreement with the denial. The CFPB will maintain the requester's statement with the record that the requester sought to amend and any disclosure of the record will include a copy of the requester's statement of disagreement.

(2) When practicable and appropriate, the CFPB will provide a copy of the statement of disagreement to any prior recipients of the record.

§ 1070.59 Restrictions on disclosure.

The CFPB will not disclose any record about an individual contained in a system of records to any person or agency without the prior written consent of that individual unless the disclosure is authorized by 5 U.S.C. 552a(b). Disclosures authorized by 5 U.S.C. 552a(b) include disclosures that are compatible with one or more routine uses that are contained within the CFPB's Systems of Records Notices, which are available on the CFPB's website, at http://www.consumerfinance.gov.

§ 1070.60 Exempt records.

(a) Exempt systems of records. Pursuant to 5 U.S.C. 552a(k)(2), the CFPB exempts the systems of records listed in paragraphs (a)(1) through (4) of this section from 5 U.S.C. 552a(c)(3), (d), (e)(1), (e)(4)(G)-(H), and (f), and §§ 1070.53 through 1070.59, to the extent that such systems of records contain investigatory materials compiled for law enforcement purposes, provided, however, that if any individual is denied any right, privilege, or benefit to which he or she would otherwise be entitled under Federal law, or for which he or she would otherwise be eligible as a result of the maintenance of such material, such material shall be disclosed to such individual, except to the extent that the disclosure of such material would reveal the identity of a source who furnished information to the CFPB under an express promise that the identity of the source would be held in confidence:

(1) CFPB.002 Depository Institution Supervision Database.

(2) CFPB.003 Non-Depository Institution Supervision Database.

(3) CFPB.004 Enforcement Database.

(4) CFPB.005 Consumer Response System.

(b) Information compiled for civil actions or proceedings. This subpart does not permit an individual to have access to any information compiled in reasonable anticipation of a civil action or proceeding.

§ 1070.61 Training; rules of conduct; penalties for non-compliance.

(a) Training. The Chief Privacy Officer shall institute a training program to instruct CFPB employees and contractor personnel covered by 5 U.S.C. 552a(m), who are involved in the design, development, operation, or maintenance of any CFPB system of records, on a continuing basis with respect to the duties and responsibilities imposed on them and the rights conferred on individuals by the Privacy Act, the regulations in this subpart, and any other related regulations. Such training shall provide suitable emphasis on the civil and criminal penalties imposed on the CFPB and the individual employees or contractor personnel by the Privacy Act for non-compliance with specified requirements of the Act as implemented by the regulations in this subpart.

(b) Rules of conduct. The following rules of conduct are applicable to employees of the CFPB (including, to the extent required by the contract or 5 U.S.C. 552a(m), Government contractors and employees of such contractors), who are involved in the design, development, operation or maintenance of any system of records, or in maintaining any records, for or on behalf of the CFPB.

(1) The head of each office of the CFPB shall be responsible for assuring that employees subject to such official's supervision are advised of the provisions of the Privacy Act, including the criminal penalties and civil liabilities provided therein, and the regulations in this subpart, and that such employees are made aware of their individual and collective responsibilities to protect the security of personal information, to assure its accuracy, relevance, timeliness and completeness, to avoid unauthorized disclosure either orally or in writing, and to ensure that no system of records is maintained without public notice.

(2) Employees of the CFPB involved in the design, development, operation, or maintenance of any system of records, or in maintaining any record shall:

(i) Collect no information of a personal nature from individuals unless authorized to collect it to achieve a function or carry out a responsibility of the CFPB;

(ii) Collect information, to the extent practicable, directly from the individual to whom it relates;

(iii) Inform each individual asked to supply information, on the form used to collect the information or on a separate form that can be retained by the individual of—

(A) The authority (whether granted by statute, or by executive order of the President) which authorizes the solicitation of the information and whether disclosure of such information is mandatory or voluntary;

(B) The principal purpose or purposes for which the information is intended to be used;

(C) The routine uses which may be made of the information, as published pursuant to 5 U.S.C. 552a(e)(4)(D); and

(D) The effects on the individual, if any, of not providing all or any part of the requested information;

(iv) Not collect, maintain, use or disseminate information concerning an individual's religious or political beliefs or activities or membership in associations or organizations, unless expressly authorized by statute or by the individual about whom the record is maintained or unless pertinent to and within the scope of an authorized law enforcement activity;

(v) Advise their supervisors of the existence or contemplated development of any record system which is capable of retrieving information about individuals by individual identifier;

(vi) Assure that no records maintained in a CFPB system of records are disseminated without the permission of the individual about whom the record pertains, except when authorized by 5 U.S.C. 552a(b);

(vii) Maintain and process information concerning individuals with care in order to ensure that no inadvertent disclosure of the information is made either within or without the CFPB;

(viii) Prior to disseminating any record about an individual to any person other than an agency, unless the dissemination is made pursuant to 5 U.S.C. 552a(b)(2), make reasonable efforts to assure that such records are accurate, complete, timely, and relevant for agency purposes; and

(ix) Assure that an accounting is kept in the prescribed form, of all dissemination of personal information outside the CFPB, whether made orally or in writing, unless disclosed under 5 U.S.C. 552 or subpart B of this part.

(3) The head of each office of the CFPB shall, at least annually, review the record systems subject to their supervision to ensure compliance with the provisions of the Privacy Act of 1974 and the regulations in this subpart.

§ 1070.62 Preservation of records.

The CFPB will preserve all correspondence pertaining to the requests that it receives under this part, as well as copies of all requested records, until disposition or destruction is authorized by title 44 of the United States Code or the National Archives and Records Administration's General Records Schedule 14. Records will not be disposed of or destroyed while they are the subject of a pending request, appeal, proceeding, or lawsuit.

§ 1070.63 Use and collection of Social Security numbers.

The CFPB will ensure that employees authorized to collect information are aware:

(a) That individuals may not be denied any right, benefit, or privilege as a result of refusing to provide their Social Security numbers, unless the collection is authorized either by a statute or by a regulation issued prior to 1975; and

(b) That individuals requested to provide their Social Security numbers must be informed of:

(1) Whether providing Social Security numbers is mandatory or voluntary;

(2) Any statutory or regulatory authority that authorizes the collection of Social Security numbers; and

(3) The uses that will be made of the numbers.

Dated: August 30, 2018. Mick Mulvaney, Acting Director, Bureau of Consumer Financial Protection.
[FR Doc. 2018-19384 Filed 9-11-18; 8:45 am] BILLING CODE 4810-AM-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2016-5909; Special Conditions No. 25-626A-SC] Special Conditions: The Boeing Company (Boeing), Model 787-8, 787-9, and 787-10 Series Airplanes; Dynamic Test Requirements for Single-Occupant, Oblique (Side-Facing) Seats With or Without Airbag Devices or 3-Point Restraints AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Amended final special conditions; request for comments.

SUMMARY:

These amended special conditions are issued for the Boeing Model 787-8, 787-9, and 787-10 series airplanes. This amendment states that the Boeing Model 787-8, 787-9, and 787-10 series airplanes oblique (side-facing) seats may be installed at an angle of 18 to 45 degrees to the airplane centerline and may include a 3-point or airbag restraint system, or both, for occupant restraint and injury protection. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These design features are oblique (side-facing) single-occupant seats equipped with airbag devices or 3-point restraints. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for these design features. These special conditions contain the additional safety standards the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES:

This action is effective on Boeing on September 12, 2018. Send comments on or before October 29, 2018.

ADDRESSES:

Send comments identified by Docket No. FAA-2016-5909 using any of the following methods:

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

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

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

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

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

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

FOR FURTHER INFORMATION CONTACT:

John Shelden, Airframe and Cabin Safety Section, AIR-675, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3214; email [email protected]

SUPPLEMENTARY INFORMATION:

The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. The FAA, therefore, finds it unnecessary to delay the effective date and finds that good cause exists for making these special conditions effective upon publication in the Federal Register.

Comments Invited

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

Background

On November 22, 2017, Boeing applied for a change to Type Certificate No. T00021SE for the installation of oblique (side-facing) passenger seats with or without airbag devices or 3-point restraints in the Boeing Model 787-8, 787-9, and 787-10 series airplanes. The Boeing Model 787-8, 787-9, and 787-10 series airplanes are twin-engine, transport category airplanes with a maximum certified passenger capacity of up to 440, and a maximum takeoff weight of approximately 476,000 lbs.

Type Certification Basis

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Boeing must show that the Model 787-8, 787-9, and 787-10 series airplanes, as changed, continue to meet the applicable provisions of the regulations listed in Type Certificate No. T00021SE or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Boeing Model 787-8, 787-9, and 787-10 series airplanes because of novel or unusual design features, special conditions are prescribed under the provisions of § 21.16.

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

In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 787-8, 787-9, and 787-10 series airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.

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

Novel or Unusual Design Features

The business-class seating configuration Boeing proposes is novel or unusual due to the seat installation at 30 degrees to the airplane centerline, the airbag-system installation, and the seat/occupant interface with the surrounding furniture that introduces occupant alignment and loading concerns. The proposed business-class seating configuration is also beyond the limits of current acceptable equivalent-level-of-safety findings. These oblique (side-facing) seats may be installed at an angle of 18 to 45 degrees to the airplane centerline and may include a 3-point or airbag restraint system, or both, for occupant restraint and injury protection.

The existing regulations do not provide adequate or appropriate safety standards for occupants of oblique-angled seats with airbag systems. To provide a level of safety that is equivalent to that afforded occupants of forward- and aft-facing seats, additional airworthiness standards, in the form of special conditions, are necessary. These special conditions supplement part 25 and, more specifically, supplement §§ 25.562 and 25.785.

The requirements contained in these special conditions consist of both test conditions and injury pass/fail criteria.

Discussion

The FAA has been conducting and sponsoring research on appropriate injury criteria for oblique (side-facing) seat installations. However, the FAA research program is not complete and we may update these criteria as we obtain further research results. To reflect current research findings, the FAA issued policy statement PS-ANM-25-03-R1 to update injury criteria for fully side-facing seats, and policy statement PS-AIR-25-27, to define injury criteria for oblique (side-facing) seats.

The proposed Boeing Model 787-8, 787-9, and 787-10 series airplanes business-class seat installation is novel such that the current Boeing Model 787-8, 787-9, and 787-10 series airplanes certification basis does not adequately address protection of the occupant's neck and spine for seat configurations that are positioned at an angle greater than 18 degrees from the airplane centerline. The FAA issued special conditions No. 25-580-SC for Model 787-9 airplanes on April 14, 2015, and special conditions No. 25-626-SC for certain Model 787-9 airplanes on July 27, 2016. These special conditions contained injury criteria for oblique seats based on the best knowledge the FAA had at the time. These special conditions for oblique seat installations do not adequately address oblique seats, reflecting the current research results, with or without 3-point or airbag restraint systems. Therefore, Boeing's proposed configuration will require amended special conditions.

The installation of passenger seats at angles of 18 to 45 degrees to the airplane centerline are unique due to the seat/occupant interface with the surrounding furniture that introduces occupant alignment/loading concerns with or without the installation of a 3-point or airbag restraint system, or both. On-going research has invalidated previously released special conditions for oblique (side-facing) seat installations. These updated special conditions further address potential injuries to the occupant's neck and spine. As a result, these special conditions replace special conditions 25-580-SC and 25-626-SC.

FAA-sponsored research has found that an un-restrained flailing of the upper torso, even when the pelvis and torso are nearly aligned, can produce serious spinal and torso injuries. At lower impact severities, even with significant misalignment between the torso and pelvis, these injuries did not occur. Tests with an FAA H-III anthropomorphic test device (ATD) have identified a level of lumbar spinal tension corresponding to the no-injury impact severity. This level of tension is included as a limit in the special conditions. The spine tension limit selected is conservative with respect to other aviation injury criteria since it corresponds to a no-injury loading condition.

As noted in the special conditions for each airbag restraint system, because an airbag restraint system is essentially a single use device, there is the potential that it could deploy under crash conditions that are not sufficiently severe as to require head injury protection from the airbag restraint system. Since an actual crash is frequently composed of a series of impacts before the airplane comes to rest, this could render the airbag restraint system useless if a larger impact follows the initial impact. This situation does not exist with energy absorbing pads or upper torso restraints, which tend to provide protection according to the severity of the impact. Therefore, the installation of the airbag restraint system should be such that the airbag restraint system will provide protection when it is required, and will not expend its protection when it is not needed.

Because these airbag restraint systems may or may not activate during various crash conditions, the injury criteria listed in these special conditions and in § 25.562 must be met in an event that is slightly below the activation level of the airbag restraint system. If an airbag restraint system is included with the oblique seats, the system must meet the requirements in one of the airbag (inflatable restraint) special conditions applicable to the Boeing Model 787-8, 787-9, and 787-10 series airplanes.

These amended special conditions will provide head injury criteria, neck injury criteria, spine injury criteria, and body-to-wall contact criteria. They contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

Applicability

As discussed above, these special conditions are applicable to the Boeing Model 787-8, 787-9, and 787-10 series airplanes. Should Boeing apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

Conclusion

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

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

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and recordkeeping requirements.

Authority Citation

The authority citation for these special conditions is as follows:

Authority:

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

The Special Conditions

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Boeing Boeing Model 787-8, 787-9, and 787-10 series airplanes.

Side-Facing Seats Special Conditions

In addition to the requirements of § 25.562:

1. Head Injury Criteria

Compliance with § 25.562(c)(5) is required, except that, if the ATD has no apparent contact with the seat/structure but has contact with an airbag, a head-injury criterion (HIC) unlimited score in excess of 1000 is acceptable, provided the HIC15 score (calculated in accordance with 49 CFR 571.208) for that contact is less than 700.

2. Body-to-Wall/Furnishing Contact

If a seat is installed aft of structure (e.g., an interior wall or furnishing) that does not provide a homogenous contact surface for the expected range of occupants and yaw angles, then additional analysis and/or test(s) may be required to demonstrate that the injury criteria are met for the area that an occupant could contact. For example, if different yaw angles could result in different airbag performance, then additional analysis or separate test(s) may be necessary to evaluate performance.

3. Neck Injury Criteria

The seating system must protect the occupant from experiencing serious neck injury. The assessment of neck injury must be conducted with the airbag device activated, unless there is reason to also consider that the neck-injury potential would be higher for impacts below the airbag-device deployment threshold.

a. The Nij (calculated in accordance with 49 CFR 571.208) must be below 1.0, where Nij = Fz/Fzc + My/Myc, and Nij critical values are:

i. Fzc = 1,530 lb for tension ii. Fzc = 1,385 lb for compression iii. Myc = 229 lb-ft in flexion iv. Myc = 100 lb-ft in extension

b. In addition, peak Fz must be below 937 lb in tension and 899 lb in compression.

c. Rotation of the head about its vertical axis, relative to the torso, is limited to 105 degrees in either direction from forward-facing.

d. The neck must not impact any surface that would produce concentrated loading on the neck.

4. Spine and Torso Injury Criteria

a. The lumbar spine tension (Fz) cannot exceed 1,200 lb.

b. Significant concentrated loading on the occupant's spine, in the area between the pelvis and shoulders during impact, including rebound, is not acceptable. During this type of contact, the interval for any rearward (X direction) acceleration exceeding 20g must be less than 3 milliseconds as measured by the thoracic instrumentation specified in 49 CFR part 572, subpart E filtered in accordance with SAE International (SAE) recommended practice J211/1, “Instrumentation for Impact Test—Part 1-Electronic Instrumentation.”

c. The occupant must not interact with the armrest or other seat components in any manner significantly different than would be expected for a forward-facing seat installation.

5. Pelvis Criteria

Any part of the load-bearing portion of the bottom of the ATD pelvis must not translate beyond the edges of the seat bottom seat-cushion supporting structure.

6. Femur Criteria

Axial rotation of the upper leg (about the z-axis of the femur per SAE Recommended Practice J211/1) must be limited to 35 degrees from the nominal seated position. Evaluation during rebound does not need to be considered.

7. ATD and Test Conditions

Longitudinal tests conducted to measure the injury criteria above must be performed with the FAA Hybrid III ATD, as described in SAE 1999-01-1609, “A Lumbar Spine Modification to the Hybrid III ATD for Aircraft Seat Tests.” The tests must be conducted with an undeformed floor, at the most-critical yaw cases for injury, and with all lateral structural supports (e.g. armrests or walls) installed.

Note:

Boeing must demonstrate that the installation of seats via plinths or pallets meets all applicable requirements. Compliance with the guidance contained in policy memorandum PS-ANM-100-2000-00123, “Guidance for Demonstrating Compliance with Seat Dynamic Testing for Plinths and Pallets,” dated February 2, 2000, is acceptable to the FAA.

8. Inflatable Airbag Restraint Systems Special Conditions

If inflatable airbag restraint systems are installed, the airbag systems must meet the requirements in one of the airbag (inflatable restraint) special conditions applicable to the Boeing Model 787-8, 787-9 and 787-10 series airplanes.

Issued in Des Moines, Washington, on September 5, 2018. Victor Wicklund, Manager, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service.
[FR Doc. 2018-19753 Filed 9-11-18; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2016-4136; Special Conditions No. 25-621A-SC] Special Conditions: The Boeing Company (Boeing), Model 777 Series Airplanes; Dynamic Test Requirements for Single Occupant Oblique Seats, With or Without Airbag Devices or 3-Point Restraints AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Amended final special conditions; request for comments.

SUMMARY:

These amended special conditions are issued for the Boeing Model 777 series airplanes. This amendment states that the Boeing Model 777 series airplanes oblique (side-facing) seats may be installed at an angle of 18 to 45 degrees to the airplane centerline and may include a 3-point or airbag restraint system, or both, for occupant restraint and injury protection. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These design features are oblique (side-facing) single-occupant passenger seats equipped with or without airbag devices or 3-point restraints. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES:

This action is effective on The Boeing Company on September 12, 2018. Send comments on or before October 29, 2018.

ADDRESSES:

Send comments identified by Docket No. FAA-2016-4136 using any of the following methods:

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

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

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

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

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

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

FOR FURTHER INFORMATION CONTACT:

John Shelden, Airframe and Cabin Safety Section, AIR-675, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3214; email [email protected]

SUPPLEMENTARY INFORMATION:

The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. The FAA therefore finds it unnecessary to delay the effective date and finds that good cause exists for making these special conditions effective upon publication in the Federal Register.

Comments Invited

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

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

Background

On November 22, 2017, Boeing applied for an amendment to Type Certificate No. T00001SE for the installation of oblique (side-facing) passenger seats with or without airbag devices or 3-point restraints in the Boeing Model 777 series airplanes. The Boeing Model 777 series airplanes are twin-engine, transport category airplanes with a maximum certified passenger capacity of up to 550 and a maximum takeoff weight of approximately 775,000 lbs.

Type Certification Basis

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Boeing must show that the Model 777 series airplanes meet the applicable provisions of the regulations listed in Type Certificate No. T00001SE, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Boeing Model 777 series airplanes because of novel or unusual design features, special conditions are prescribed under the provisions of § 21.16.

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

In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 777 series airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.

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

Novel or Unusual Design Features

The business-class seating configuration Boeing proposes is novel or unusual due to the seat installation at 30 degrees to the airplane centerline, the airbag-system installation, and the seat/occupant interface with the surrounding furniture that introduces occupant alignment and loading concerns. The proposed business-class seating configuration is also beyond the limits of current acceptable equivalent-level-of-safety findings. These oblique (side-facing) seats may be installed at an angle of 18 to 45 degrees to the airplane centerline and may include a 3-point or airbag restraint system, or both, for occupant restraint and injury protection.

The existing regulations do not provide adequate or appropriate safety standards for occupants of oblique-angled seats with airbag systems. To provide a level of safety that is equivalent to that afforded occupants of forward- and aft-facing seats, additional airworthiness standards, in the form of special conditions, are necessary. These special conditions supplement part 25 and, more specifically, supplement §§ 25.562 and 25.785.

The requirements contained in these special conditions consist of both test conditions and injury pass/fail criteria.

Discussion

The FAA has been conducting and sponsoring research on appropriate injury criteria for oblique (side-facing) seat installations. However, the FAA research program is not complete and we may update these criteria as we obtain further research results. To reflect current research findings, the FAA issued policy statement PS-ANM-25-03-R1 to update injury criteria for fully side-facing seats, and policy statement PS-AIR-25-27, to define injury criteria for oblique (side-facing) seats.

The proposed Boeing Model 777 series airplanes business-class seat installation is novel such that the current Boeing Model 777 series airplanes certification basis does not adequately address protection of the occupant's neck and spine for seat configurations that are positioned at an angle greater than 18 degrees from the airplane centerline. The FAA issued special conditions No. 25-569-SC for Model 777-300ER airplanes on September 25, 2014, and special conditions No. 25-621-SC for certain Model 777-300ER airplanes on August 3rd, 2016. These special conditions contained injury criteria for oblique seats based on the best knowledge the FAA had at the time. These special conditions for oblique seat installations do not adequately address oblique seats, reflecting the current research results, with or without 3-point or airbag restraint systems. Therefore, Boeing's proposed configuration will require amended special conditions.

The installation of passenger seats at angles of 18 to 45 degrees to the airplane centerline are unique due to the seat/occupant interface with the surrounding furniture that introduces occupant alignment/loading concerns with or without the installation of a 3-point or airbag restraint system, or both. On-going research has invalidated previously released special conditions for oblique (side-facing) seat installations. These updated special conditions further address potential injuries to the occupant's neck and spine. As a result, these special conditions replace special conditions 25-569-SC and 25-621-SC.

FAA-sponsored research has found that an un-restrained flailing of the upper torso, even when the pelvis and torso are nearly aligned, can produce serious spinal and torso injuries. At lower impact severities, even with significant misalignment between the torso and pelvis, these injuries did not occur. Tests with an FAA H-III anthropomorphic test device (ATD) have identified a level of lumbar spinal tension corresponding to the no-injury impact severity. This level of tension is included as a limit in the special conditions. The spine tension limit selected is conservative with respect to other aviation injury criteria since it corresponds to a no-injury loading condition.

As noted in the special conditions for each airbag restraint system, because an airbag restraint system is essentially a single use device, there is the potential that it could deploy under crash conditions that are not sufficiently severe as to require head injury protection from the airbag restraint system. Since an actual crash is frequently composed of a series of impacts before the airplane comes to rest, this could render the airbag restraint system useless if a larger impact follows the initial impact. This situation does not exist with energy absorbing pads or upper torso restraints, which tend to provide protection according to the severity of the impact. Therefore, the installation of the airbag restraint system should be such that the airbag restraint system will provide protection when it is required, and will not expend its protection when it is not needed.

Because these airbag restraint systems may or may not activate during various crash conditions, the injury criteria listed in these special conditions and in § 25.562 must be met in an event that is slightly below the activation level of the airbag restraint system. If an airbag restraint system is included with the oblique seats, the system must meet the requirements in one of the airbag (inflatable restraint) special conditions applicable to the Boeing Model 777 series airplanes.

These amended special conditions will provide head injury criteria, neck injury criteria, spine injury criteria, and body-to-wall contact criteria. They contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

Applicability

As discussed above, these special conditions are applicable to the Boeing Model 777 series airplane. Should Boeing apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

Conclusion

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

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and recordkeeping requirements.

Authority Citation

The authority citation for these special conditions is as follows:

Authority:

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

The Special Conditions

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Boeing Model 777 series airplanes.

Side-Facing Seats Special Conditions

In addition to the requirements of § 25.562:

1. Head Injury Criteria (HIC)

Compliance with § 25.562(c)(5) is required, except that, if the ATD has no apparent contact with the seat/structure but has contact with an airbag, a HIC unlimited score in excess of 1,000 is acceptable, provided the HIC15 score for that contact (calculated in accordance with 49 CFR 571.208) is less than 700.

2. Body-to-Wall/Furnishing Contact

If a seat is installed aft of structure (e.g., interior wall or furnishings) that does not provide a homogenous contact surface for the expected range of occupants and yaw angles, then additional analysis and tests may be required to demonstrate that the injury criteria are met for the area which an occupant could contact. For example, different yaw angles could result in different airbag device performance, then additional analysis or separate tests may be necessary to evaluate performance.

3. Neck Injury Criteria

The seating system must protect the occupant from experiencing serious neck injury. The assessment of neck injury must be conducted with the airbag device activated, unless there is a reason to also consider that the neck-injury potential would be higher for impacts below the airbag-device deployment threshold.

a. The Nij, calculated in accordance with 49 CFR 571.208, must be below 1.0, where Nij = Fz/Fzc + My/Myc, and Nij critical values are:

i. Fzc = 1,530 lbs for tension ii. Fzc = 1,385 lbs for compression iii. Myc = 229 lb-ft in flexion iv. Myc = 100 lb-ft in extension

b. In addition, peak upper-neck Fz must be below 937 lbs. in tension and 899 lbs. in compression.

c. Rotation of the head about its vertical axis, relative to the torso is limited to 105 degrees in either direction from forward-facing.

d. The neck must not impact any surface that would produce concentrated loading on the neck.

4. Spine and Torso Injury Criteria:

a. The lumbar spine tension (Fz) cannot exceed 1,200 lbs.

b. Significant concentrated loading on the occupant's spine, in the area between the pelvis and shoulders during impact, including rebound, is not acceptable. During this type of contact, the interval for any rearward (X direction) acceleration exceeding 20 g must be less than 3 milliseconds as measured by the thoracic instrumentation specified in 49 CFR part 572, subpart E, filtered in accordance with SAE recommended practice J211/1, “Instrumentation for Impact Test-Part 1—Electronic Instrumentation.”

c. The occupant must not interact with the armrest or other seat components in any manner significantly different than would be expected for a forward-facing seat installation.

5. Pelvis Criteria

Any part of the load-bearing portion of the bottom of the ATD pelvis must not translate beyond the edges of the seat bottom seat-cushion supporting structure.

6. Femur Criteria

Axial rotation of the upper leg (about the z-axis of the femur per SAE Recommended Practice J211/1) must be limited to 35 degrees from the nominal seated position. Evaluation during rebound does not need to be considered.

7. ATD and Test Conditions

Longitudinal tests conducted to measure the injury criteria above must be performed with the FAA Hybrid III ATD, as described in SAE 1999-01-1609, “A Lumbar Spine Modification to the Hybrid III ATD for Aircraft Seat Tests.” The tests must be conducted with an undeformed floor, at the most-critical yaw cases for injury, and with all lateral structural supports (e.g., armrests or walls) installed.

Issued in Des Moines, Washington, on September 5, 2018. Victor Wicklund, Manager, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service.
[FR Doc. 2018-19752 Filed 9-11-18; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Part 744 [Docket No. 180718671-8671-01] RIN 0694-AH57 Addition of Certain Entities to the Entity List, Revision of Entries on the Entity List and Removal of Certain Entities From the Entity List Correction

In rule document 2018-18766 beginning on page 44821 in the issue of Tuesday, September 4, 2018, make the following correction:

1. On page 44824, in the third column, amendatory instruction number 2e is corrected to read as follows:

“2. * * *

e. Under Russia,

i. By removing the entity “Joint Stock Company Mikron”;

ii. By adding in alphabetical order two entities “Joint Stock Company (JSC) NIIME” and “PJSC Mikron”;

2. On page 44825, in the table, under the country heading for Hong Kong, the Joinus Freight Systems entry should read as follows:

Joinus Freight Systems (H.K.) Limited, a.k.a., the following two aliases: For all items subject to the EAR. (See § 744.11 of the EAR) Presumption of denial 81 FR 14958, 3/21/16. 83 FR [Insert FR Page Number] 9/4/2018. -JFS Global Logistics; and -Joinus Freight Systems Global Logistics Limited Unit 07-07, 25F, Tower B, Regent Centre, 63 Wo Yi Hop Road, Kwai Chung, N.T. Hong Kong and Units 801-803 and 805, Park Sun Building, No. 97-107 Wo Yi Hop Road, Kwai Chung, Hong Kong

3. On page 44826, in the table, under the country heading for Russia, the PJSC Mikron entry should read as follows:

PJSC Mikron, 1st Zapadniy Proezd 12/1, Zelenograd, Russia, 124460 For all items subject to the EAR. (See § 744.11 of the EAR) Presumption of denial 81 FR 61601, 9/7/16. 83 FR [Insert FR Page Number] 9/4/2018.
[FR Doc. C2-2018-18766 Filed 9-11-18; 8:45 am] BILLING CODE 1301-00-D
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 110 [Docket No. FDA-2011-N-0920] Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; partial withdrawal.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is removing instruction 13 from the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food) regulation. Instruction 13 directs the Federal Register to remove and reserve as of September 17, 2018, the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (Human Food CGMP) regulation. Removal of instruction 13 is necessary because the compliance dates for certain facilities subject to the modernized current good manufacturing practice requirements in the Preventive Controls for Human Food regulation have been extended. Retaining the Human Food CGMP regulation will maintain the status quo while these facilities prepare for compliance with the new CGMP requirements and will avoid an unintended gap in public health protection.

DATES:

Effective September 12, 2018, FDA withdraws amendatory instruction 13 on page 56144 of the final rule published at 80 FR 55908 at 56144 on September 17, 2015. Submit either electronic or written comments by October 12, 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 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 12, 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-2011-N-0920 for “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” Received comments, those filed in a timely manner (see ADDRESSES), 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:

Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166.

SUPPLEMENTARY INFORMATION:

Table of Contents I. Background and Discussion II. Legal Authority III. Analysis of Environmental Impact IV. Paperwork Reduction Act of 1995 I. Background and Discussion

In the Federal Register of September 17, 2015, FDA published the final rule, “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (80 FR 55908; the “rule establishing part 117”). Among other things, in the final rule establishing part 117 (21 CFR part 117), we modernized and placed in part 117, subpart B the longstanding current good manufacturing practice requirements (CGMPs) codified in part 110 (21 CFR part 110). We staggered the compliance dates for part 117 based on business size. We also instructed the Federal Register to remove and reserve part 110 effective September 17, 2018, the latest of the staggered compliance dates, which we treated as a conforming amendment (see instruction number 13 at 80 FR 55908 at 56144).

Subsequently, in a final rule published in the Federal Register of August 24, 2016 (81 FR 57784; the “compliance date final rule”), among other things, we extended by up to 16 months the part 117 compliance dates for certain facilities, to address concerns about the practicality of compliance, consider changes to the regulatory text, and better align compliance dates across various rules. The compliance date final rule extended the part 117 compliance dates for the following establishments, as set out in table 1:

Table 1—Facilities That Received Extended Part 117 Compliance Dates Compliance date announced in final rule establishing part 117 Compliance date with extension as announced in compliance date final rule Facility solely engaged in packing and/or holding activities on produce RACs, that is: • a very small business September 17, 2018 January 27, 2020. • a small business September 18, 2017 January 28, 2019. • not a small or very small business September 19, 2016 January 26, 2018. Facility that would qualify as a secondary activities farm except for ownership of the facility, that is: • a very small business September 17, 2018 January 27, 2020. • a small business September 18, 2017 January 28, 2019. • not a small or very small business September 19, 2016 January 26, 2018. Facilities that would qualify as a farm if it did not color RACs, that is: a very small business September 17, 2018 January 27, 2020. a small business September 18, 2017 January 28, 2019. not a small or very small business September 19, 2016 January 26, 2018.

A small business is a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees. A very small business is a business (including any subsidiaries and affiliates) averaging less than $1 million, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed or held without sale (e.g., held for a fee). (See § 117.3.)

After issuing the compliance date final rule, FDA announced that as a matter of enforcement policy it did not intend to enforce certain part 117 requirements for certain facilities, including some of the facilities in table 1 whose compliance dates had been extended by the compliance date final rule. See the January 2018 guidance entitled “Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs” (https://www.fda.gov/downloads/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm590661.pdf). The present rulemaking does not change the policies contained in this guidance.

As mentioned above, in the final rule establishing part 117 we instructed the Federal Register to remove and reserve part 110, effective September 17, 2018, which at the time was the latest of the staggered compliance dates. The goal was to have firms subject to the Human Food CGMP regulation until the Preventive Controls for Human Food regulation took its place, leaving no gap in public health protection. However, in the compliance date final rule we extended the compliance dates for part 117 by up to 16 months but failed to revise the previous instruction to remove part 110. Without the current action, the small and very small facilities described in table 1 will not be subject to any CGMPs until, respectively, January 28, 2019, and January 27, 2020. However, FDA's intent always has been that part 110 would remain unchanged and in effect until all establishments have reached the date when they must be in compliance with part 117. Therefore, we are amending the rule establishing part 117 to remove the instruction to the Federal Register to remove and reserve part 110. We intend to remove part 110 in a separate action after all establishments have reached their compliance dates for the part 117 CGMPs.

When FDA conducts rulemaking, it normally does so using notice-and-comment procedures established under the Administrative Procedure Act (APA) and FDA regulations. These procedures allow the public an opportunity to participate in Agency rulemaking by submitting written comments on proposed rules. FDA considers these comments as it finalizes rules. (5 U.S.C. 553(b) and (c); § 10.40 (21 CFR 10.40.)) The APA, however, does not require an agency to use notice-and-comment procedures in all rulemaking. For example, the APA provides that Agencies shall not use notice-and-comment procedures, and shall proceed with a final rule, when the Agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to public interest, and incorporates the finding and a brief statement of reasons therefor in the rules issued. (5 U.S.C. 553(b)(B).) Likewise, FDA's regulations provide that the requirements of notice and public procedure do not apply when the Commissioner of Food and Drugs determines for good cause that they are impracticable, unnecessary, or contrary to the public interest, in which case, the notice issuing the regulation will state the reasons for the determination, and provide an opportunity for comment to determine whether the regulation should subsequently be modified or revoked. (§ 10.40(e)(1).) Pursuant to this regulation, FDA requests comments on the timing for the removal of part 110.

In this instance, for several reasons, FDA finds good cause for issuing this final rule without notice and comment.

Notice and comment are unnecessary because this final rule is a minor and technical repair of an obvious oversight in the compliance date final rule, maintains the CGMP regulatory status quo for industry, affirms FDA's plan for transitioning from part 110 to part 117 as outlined in the rule establishing part 117, and is not expected to generate public concern. FDA is addressing the gap in CGMP regulatory coverage from September 17, 2018, to January 27, 2020, by issuing a narrowly tailored amendment to remove instruction 13 from the rule to establish part 117. The result of this amendment will be that the part 110 CGMPs will continue in effect for establishments that have not reached their part 117 compliance date. This action will serve to correct an obvious oversight made in the compliance date final rule. FDA does not anticipate public concern with this action. The Agency previously sought public comment on its proposal to remove part 110 in coordination with the compliance dates for part 117 and received no comments that disagreed. The present continuation and planned eventual removal of part 110 is a repeat of what was previously proposed without public objection. Furthermore, it is clear from the rule establishing part 117 that we intended for facilities to remain subject to part 110 until their part 117 compliance date (80 FR 55908 at 56127). Thus, we do not believe there was ever any reasonable expectation on the part of the establishments listed in table 1 that they would not be continuously subject to CGMPs. For these various reasons, we have determined that notice and comment is unnecessary.

FDA finds further good cause for issuing this final rule without notice and comment because notice and comment are contrary to the public interest and impracticable. There could be negative public health implications if there were a temporal gap in CGMP coverage; for example, there have been outbreaks associated with the types of facilities still subject to part 110 (e.g., listeria in cantaloupe). Many of the establishments listed in table 1 are not required to comply with the replacement CGMPs in part 117 until January 2019 or January 2020, depending on business size. This means that these establishments would have no applicable CGMP requirements for 4 to 16 months. CGMP requirements have existed for all human food manufacturers since at least 1970 (see 34 FR 6977) and serve as a significant basis for FDA's determination of what constitutes an insanitary food production environment that may result in food that is injurious to public health under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(4)), among other authorities. It would be contrary to the public interest to allow the temporal gap in CGMP coverage.

To summarize, a gap in CGMP coverage would leave FDA without a primary tool to execute its function of ensuring that food manufacturing establishments follow basic food safety practices, potentially endangering the public health, in order to provide the public an opportunity to comment on a non-controversial technical matter. For these reasons, we are issuing this amendment to the final rule establishing part 117 without prior notice and comment. (5 U.S.C. 553(b)(3)(B)).

In addition, we find good cause for this amendment to the rule establishing part 117 to become effective on the date of publication. The APA allows an effective date less than 30 days after publication as provided by the Agency for good cause found and published within the rule (5 U.S.C. 553(d)(3)). As provided at 80 FR 55908, September 17, 2015, the amendment removing part 110 was to take effect on September 17, 2018. In order to continue part 110 for an interim period, this final rule needs to be effective on or before September 16, 2018, and therefore it is not possible for this rule to take effect 30 days after publication in the Federal Register. As previously described, in order to prevent a gap in CGMP coverage for certain establishments, an immediate effective date is necessary to remove, before September 17, 2018, the instruction to remove and reserve part 110. Further, because the facilities' responsibility to comply with CGMP requirements remains unchanged, this rule places no burden on affected parties for which they would need a reasonable time to prepare. Therefore, the Commissioner finds good cause under 5 U.S.C. 553(d)(3) and § 10.40(c)(4)(ii) for this amendment to become effective on the date of publication.

II. Legal Authority

We are issuing this final rule removing instruction number 13 of the rule to establish part 117 under the same authority for which the rule containing instruction number 13 was originally issued. That analysis may be found in section II, “Legal Authority,” of the rule to establish part 117 (80 FR 55908 at 55917 to 55920).

III. Analysis of Environmental Impact

FDA has determined that the removal of instruction 13 will not change the status quo and, therefore, is not a major Federal action significantly affecting the quality of the human environment within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4321 et seq.). Therefore, neither an environmental assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 110

Food packaging, Foods.

Therefore, in FR Rule Doc. No. 2015-21920, published September 17, 2015, at 80 FR 55908-56168, amendatory instruction 13 in the third column on page 56144 is withdrawn. Dated: September 7, 2018. Scott Gottlieb, Commissioner of Food and Drugs.
[FR Doc. 2018-19855 Filed 9-11-18; 8:45 am] BILLING CODE 4164-01-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 60, 61, and 63 [EPA-R06-OAR-2016-0091; FRL-9982-62—Region 6] New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants; Delegation of Authority to New Mexico AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule; delegation of authority.

SUMMARY:

The New Mexico Environment Department (NMED) has submitted updated regulations for receiving delegation and approval of a program for the implementation and enforcement of certain New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) for all sources (both Title V and non-Title V sources). These updated regulations apply to certain NSPS promulgated by the EPA and amended between September 24, 2013 and January 15, 2017; certain NESHAP promulgated by the EPA and amended between January 1, 2011 and January 15, 2017; and other NESHAP promulgated by the EPA and amended between August 30, 2013 and January 15, 2017, as adopted by the NMED. The delegation of authority under this action does not apply to sources located in Bernalillo County, New Mexico, or to sources located in areas defined as Indian Country. The EPA is providing notice that it is updating the delegation of certain NSPS to NMED, and taking final action to approve the delegation of certain NESHAP to NMED.

DATES:

This rule is effective on October 12, 2018.

ADDRESSES:

The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2016-0091. All documents in the docket are listed on the http://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 either electronically through http://www.regulations.gov or in hard copy at the EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733.

FOR FURTHER INFORMATION CONTACT:

Mr. Rick Barrett (6MM-AP), (214) 665-7227; email: [email protected]

SUPPLEMENTARY INFORMATION:

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

Table of Contents I. Background II. Response to Comment III. What does this action do? IV. What is the authority for delegation? V. What criteria must New Mexico's programs meet to be approved? VI. How did NMED meet the NSPS and NESHAP program approval criteria? VII. What is being delegated? VIII. What is not being delegated? IX. How will statutory and regulatory interpretations be made? X. What authority does the EPA have? XI. What information must NMED provide to the EPA? XII. What is the EPA's oversight role? XIII. Should sources submit notices to the EPA or NMED? XIV. How will unchanged authorities be delegated to NMED in the future? XV. Final Action XVI. Statutory and Executive Order Reviews I. Background

On April 13, 2018, EPA published a direct final rule and accompanying proposal approving the updated delegation of authority for implementation and enforcement of NSPS and NESHAPs for all sources (both part 70 and non-part 70 sources) to the NMED. The direct final rule and proposal were published without prior proposal because EPA anticipated no relevant adverse comments. See 83 FR 15964 and 83 FR 16027, respectively. EPA stated in the direct final rule that if we receive relevant adverse comments by May 14, 2018, we would publish a timely withdrawal in the Federal Register, and all public comments received would be addressed in a subsequent final rule based on the proposed rule.

EPA received an adverse comment on May 14, 2018, and accordingly withdrew the direct final rule on June 5, 2018, pursuant to sections 111 and 112 of the CAA. See 83 FR 25936. The comment and our response to that comment follows below.

II. Response to Comment

Comment: EPA received an anonymous adverse comment in response to the proposed rulemaking. The comment includes several personal observations and statements critical of New Mexico's ability to maintain and oversee its air quality programs. The commenter recommends that the proposed update to New Mexico's NESHAP delegation not be approved until EPA investigates the commenter's allegations and New Mexico has addressed the alleged deficiencies. See Docket for the entire comment.

EPA's Response: We thank the commenter for the comment. Section 112(l) of the Act and EPA's implementing regulations at 40 CFR part 63, subpart E primarily govern EPA's actions on State requests for delegation of authority to implement and enforce the NESHAP program. CAA section 112(l)(5)(B) states that EPA shall disapprove a NESHAP program submitted by a State if we find that adequate resources are not available to implement the program. See also 40 CFR 63.91(d)(3)(iii). Several concerns expressed by the commenter relate to the adequacy of resources (including the lack of technically experienced and qualified staff) maintained by the NMED Air Quality Bureau. NMED provided EPA with a response to those comments that included a description of current resources and experience within the Air Quality Bureau. See Docket for NMED's response. In addition, consistent with 40 CFR 63.91(d)(2), New Mexico's delegation update request included a reference to its previous demonstration and a reaffirmation that the up-front approval criteria for delegation are still being met. Based on this information as well as discussions with the Compliance and Enforcement Division and the Criminal Investigation Division within EPA Region 6, we have not identified sufficient information to support the necessary finding for disapproval of the requested NESHAP delegation update. The remainder of the commenter's concerns (e.g., meeting the requirements of EPA's compliance monitoring plan) relate to matters that are more appropriately addressed as part of our oversight responsibilities. EPA oversees NMED's decisions to ensure the delegated authorities are being adequately implemented and enforced. We integrate oversight of the delegated authorities into the existing mechanisms and resources for oversight currently in place. If, during oversight, we determine that NMED made decisions which decreased the stringency of the delegated standards, then NMED would be required to take corrective actions and the source(s) affected by the decisions will be notified, as required by 40 CFR 63.91(g)(1)(ii). Our oversight authorities allow us to initiate withdrawal of the program delegation if the corrective actions taken are insufficient.

III. What does this action do?

The EPA is providing notice that it is approving NMED's request updating the delegation for the implementation and enforcement of certain NSPS. The EPA is also taking final action to approve NMED's request updating the delegation of certain NESHAP. With this delegation, NMED has the primary responsibility to implement and enforce the delegated standards. See sections VII and VIII, below, for a discussion of which standards are being delegated and which are not being delegated.

IV. What is the authority for delegation?

Upon the EPA's finding that the procedures submitted by a State for the implementation and enforcement of standards of performance for new sources located in the State are adequate, Section 111(c)(1) of the Clean Air Act (CAA) authorizes the EPA to delegate its authority to implement and enforce such standards. The new source performance standards are codified at 40 CFR part 60.

Section 112(l) of the CAA and 40 CFR part 63, subpart E, authorize the EPA to delegate authority for the implementation and enforcement of emission standards for hazardous air pollutants to a State that satisfies the statutory and regulatory requirements in subpart E. The hazardous air pollutant standards are codified at 40 CFR parts 61 and 63.

V. What criteria must New Mexico's programs meet to be approved?

In order to receive delegation of NSPS, a State must develop and submit to the EPA a procedure for implementing and enforcing the NSPS in the state, and their regulations and resources must be adequate for the implementation and enforcement of the NSPS. The EPA initially approved New Mexico's program for the delegation of NSPS on June 6, 1986 (51 FR 20648). The EPA reviewed the laws of the State and the rules and regulations of the New Mexico Environmental Improvement Division (now the NMED) and determined the State's procedures, regulations and resources adequate for the implementation and enforcement of the Federal standards. The NSPS delegation was most recently updated on February 2, 2015 (80 FR 5475). This action notifies the public that the EPA is updating NMED's delegation to implement and enforce certain additional NSPS.

Section 112(l)(5) of the CAA requires the EPA to disapprove any program submitted by a State for the delegation of NESHAP standards if the EPA determines that:

(A) The authorities contained in the program are not adequate to assure compliance by the sources within the State with respect to each applicable standard, regulation, or requirement established under section 112;

(B) adequate authority does not exist, or adequate resources are not available, to implement the program;

(C) the schedule for implementing the program and assuring compliance by affected sources is not sufficiently expeditious; or

(D) the program is otherwise not in compliance with the guidance issued by the EPA under section 112(l)(2) or is not likely to satisfy, in whole or in part, the objectives of the CAA.

In carrying out its responsibilities under section 112(l), the EPA promulgated regulations at 40 CFR part 63, subpart E setting forth criteria for the approval of submitted programs. For example, in order to obtain approval of a program to implement and enforce Federal section 112 rules as promulgated without changes (straight delegation), a State must demonstrate that it meets the criteria of 40 CFR 63.91(d). 40 CFR 63.91(d)(3) provides that interim or final title V program approval will satisfy the criteria of 40 CFR 63.91(d).1

1 Some NESHAP standards do not require a source to obtain a title V permit (e.g., certain area sources that are exempt from the requirement to obtain a title V permit). For these non-title V sources, the EPA believes that the State must assure the EPA that it can implement and enforce the NESHAP for such sources. See 65 FR 55810, 55813 (Sept. 14, 2000).

The NESHAP delegation was most recently approved on February 2, 2015 (80 FR 5475).

VI. How did NMED meet the NSPS and NESHAP program approval criteria?

As to the NSPS standards in 40 CFR part 60, NMED adopted the Federal standards via incorporation by reference. The NMED regulations are, therefore, at least as stringent as the EPA's rules. See 40 CFR 60.10(a). Also, in the EPA initial approval of NSPS delegation, we determined that the State developed procedures for implementing and enforcing the NSPS in the State, and that the State's regulations and resources are adequate for the implementation and enforcement of the Federal standards. See 51 FR 20648 (June 6, 1986).

As to the NESHAP standards in 40 CFR parts 61 and 63, as part of its Title V submission NMED stated that it intended to use the mechanism of incorporation by reference to adopt unchanged Federal section 112 standards into its regulations. This commitment applied to both existing and future standards as they applied to part 70 sources. The EPA's final interim approval of New Mexico's Title V operating permits program delegated the authority to implement certain NESHAP, effective December 19, 1994 (59 FR 59656). On November 26, 1996, the EPA promulgated final full approval of the State's operating permits program, effective January 27, 1997 (61 FR 60032). These interim and final title V program approvals satisfy the upfront approval criteria of 40 CFR 63.91(d). Under 40 CFR 63.91(d)(2), once a state has satisfied the up-front approval criteria, it needs only to reference the previous demonstration and reaffirm that it still meets the criteria for any subsequent submittals for delegation of the section 112 standards. NMED has affirmed that it still meets the up-front approval criteria. With respect to non-Title V sources, the EPA has previously approved delegation of NESHAP authorities to NMED after finding adequate authorities to implement and enforce the NESHAP for non-Title V sources. See 68 FR 69036 (December 11, 2003).

VII. What is being delegated?

By letter dated January 22, 2016, the EPA received a request from NMED to update its NSPS delegation and NESHAP delegation. With certain exceptions noted in section VIII below, NMED's request included NSPS in 40 CFR part 60, as amended between September 24, 2013 and September 15, 2015; NESHAP in 40 CFR part 61, as amended between January 1, 2011 and September 15, 2015; and NESHAP in 40 CFR part 63, as amended between August 30, 2013 and September 15, 2015.

By letter dated June 9, 2017, the EPA received a request from NMED to update its NSPS delegation and NESHAP delegation. With certain exceptions noted in section VIII below, NMED's request included NSPS in 40 CFR part 60, as amended between September 15, 2015 and January 15, 2017; NESHAP in 40 CFR part 61, as amended between September 15, 2015 and January 15, 2017; and NESHAP in 40 CFR part 63, as amended between September 15, 2015 and January 15, 2017. This action is being taken in response to NMED's requests noted above.

VIII. What is not being delegated?

All authorities not affirmatively and expressly delegated by this action are not delegated. These include the following part 60, 61 and 63 authorities listed below:

• 40 CFR part 60, subpart AAA (Standards of Performance for New Residential Wood Heaters);

• 40 CFR part 60, subpart QQQQ (Standards of Performance for New Residential Hydronic Heaters and Forced-Air Furnaces);

• 40 CFR part 61, subpart B (National Emission Standards for Radon Emissions From Underground Uranium Mines);

• 40 CFR part 61, subpart H (National Emission Standards for Emissions of Radionuclides Other Than Radon From Department of Energy Facilities);

• 40 CFR part 61, subpart I (National Emission Standards for Radionuclide Emissions From Federal Facilities Other Than Nuclear Regulatory Commission Licensees and Not Covered by Subpart H);

• 40 CFR part 61, subpart K (National Emission Standards for Radionuclide Emissions From Elemental Phosphorus Plants);

• 40 CFR part 61, subpart Q (National Emission Standards for Radon Emissions From Department of Energy facilities);

• 40 CFR part 61, subpart R (National Emission Standards for Radon Emissions From Phosphogypsum Stacks);

• 40 CFR part 61, subpart T (National Emission Standards for Radon Emissions From the Disposal of Uranium Mill Tailings);

• 40 CFR part 61, subpart W (National Emission Standards for Radon Emissions From Operating Mill Tailings); and

• 40 CFR part 63, subpart J (National Emission Standards for Polyvinyl Chloride and Copolymers Production).

In addition, the EPA regulations provide that we cannot delegate to a State any of the Category II authorities set forth in 40 CFR 63.91(g)(2). These include the following provisions: § 63.6(g), Approval of Alternative Non-Opacity Standards; § 63.6(h)(9), Approval of Alternative Opacity Standards; § 63.7(e)(2)(ii) and (f), Approval of Major Alternatives to Test Methods; § 63.8(f), Approval of Major Alternatives to Monitoring; and § 63.10(f), Approval of Major Alternatives to Recordkeeping and Reporting. Also, some Part 61 and Part 63 standards have certain provisions that cannot be delegated to the States. Furthermore, no authorities are delegated that require rulemaking in the Federal Register to implement, or where Federal overview is the only way to ensure national consistency in the application of the standards or requirements of CAA section 112. Finally, this action does not delegate any authority under section 112(r), the accidental release program.

All inquiries and requests concerning implementation and enforcement of the excluded standards in the State of New Mexico should be directed to the EPA Region 6 Office.

In addition, this delegation to NMED to implement and enforce certain NSPS and NESHAP authorities does not extend to sources or activities located in Indian country, as defined in 18 U.S.C. 1151. Under this definition, the EPA treats as reservations, trust lands validly set aside for the use of a Tribe even if the trust lands have not been formally designated as a reservation. Consistent with previous Federal program approvals or delegations, the EPA will continue to implement the NSPS and NESHAP in Indian country because NMED has not submitted information to demonstrate authority over sources and activities located within the exterior boundaries of Indian reservations and other areas in Indian country.

IX. How will statutory and regulatory interpretations be made?

In approving the NSPS delegation, NMED will obtain concurrence from the EPA on any matter involving the interpretation of section 111 of the CAA or 40 CFR part 60 to the extent that implementation or enforcement of these provisions have not been covered by prior EPA determinations or guidance. See 51 FR 20649 (June 6, 1986).

In approving the NESHAP delegation, NMED will obtain concurrence from the EPA on any matter involving the interpretation of section 112 of the CAA or 40 CFR parts 61 and 63 to the extent that implementation or enforcement of these provisions have not been covered by prior EPA determinations or guidance.

X. What authority does the EPA have?

We retain the right, as provided by CAA section 111(c)(2), to enforce any applicable emission standard or requirement under section 111.

We retain the right, as provided by CAA section 112(l)(7) and 40 CFR 63.90(d)(2), to enforce any applicable emission standard or requirement under section 112. In addition, the EPA may enforce any federally approved State rule, requirement, or program under 40 CFR 63.90(e) and 63.91(c)(1)(i). The EPA also has the authority to make decisions under the General Provisions (subpart A) of parts 61 and 63. We are delegating to NMED some of these authorities, and retaining others, as explained in sections V and VI above. In addition, the EPA may review and disapprove State determinations and subsequently require corrections. See 40 CFR 63.91(g)(1)(ii). EPA also has the authority to review NMED's implementation and enforcement of approved rules or programs and to withdraw approval if we find inadequate implementation or enforcement. See 40 CFR 63.96.

Furthermore, we retain any authority in an individual emission standard that may not be delegated according to provisions of the standard. Also, listed in footnote 2 of the part 63 delegation table at the end of this rule are the authorities that cannot be delegated to any State or local agency which we therefore retain.

Finally, we retain the authorities stated in the original delegation agreement. See 51 FR 20648-20650 (June 6, 1986).

XI. What information must NMED provide to the EPA?

NMED must provide any additional compliance related information to EPA, Region 6, Office of Enforcement and Compliance Assurance, within 45 days of a request under 40 CFR 63.96(a). In receiving delegation for specific General Provisions authorities, NMED must submit to EPA Region 6, on a semi-annual basis, copies of determinations issued under these authorities. See 40 CFR 63.91(g)(1)(ii). For 40 CFR part 63 standards, these determinations include: Section 63.1, Applicability Determinations; Section 63.6(e), Operation and Maintenance Requirements—Responsibility for Determining Compliance; Section 63.6(f), Compliance with Non-Opacity Standards—Responsibility for Determining Compliance; Section 63.6(h), Compliance with Opacity and Visible Emissions Standards—Responsibility for Determining Compliance; Sections 63.7(c)(2)(i) and (d), Approval of Site-Specific Test Plans; Section 63.7(e)(2)(i), Approval of Minor Alternatives to Test Methods; Section 63.7(e)(2)(ii) and (f), Approval of Intermediate Alternatives to Test Methods; Section 63.7(e)(iii), Approval of Shorter Sampling Times and Volumes When Necessitated by Process Variables or Other Factors; Sections 63.7(e)(2)(iv), (h)(2), and (h)(3), Waiver of Performance Testing; Sections 63.8(c)(1) and (e)(1), Approval of Site-Specific Performance Evaluation (Monitoring) Test Plans; Section 63.8(f), Approval of Minor Alternatives to Monitoring; Section 63.8(f), Approval of Intermediate Alternatives to Monitoring; Section 63.9 and 63.10, Approval of Adjustments to Time Periods for Submitting Reports; Section 63.10(f), Approval of Minor Alternatives to Recordkeeping and Reporting; and Section 63.7(a)(4), Extension of Performance Test Deadline.

XII. What is the EPA's oversight role?

The EPA oversees NMED's decisions to ensure the delegated authorities are being adequately implemented and enforced. We will integrate oversight of the delegated authorities into the existing mechanisms and resources for oversight currently in place. If, during oversight, we determine that NMED made decisions that decreased the stringency of the delegated standards, then NMED shall be required to take corrective actions and the source(s) affected by the decisions will be notified. See 40 CFR 63.91(g)(1)(ii) and 63.91(b). Our oversight authorities allow us to initiate withdrawal of the program delegation if the corrective actions taken are insufficient.

XIII. Should sources submit notices to the EPA or NMED?

Sources located outside the boundaries of Bernalillo County and outside of Indian country should submit all information required pursuant to the delegated authorities in the Federal NSPS and NESHAP (40 CFR parts 60, 61 and 63) directly to the NMED at the following address: New Mexico Environment Department, P.O. Box 5469, Santa Fe, New Mexico 87502-5469. The NMED is the primary point of contact with respect to delegated NSPS and NESHAP authorities. Sources do not need to send a copy to the EPA. The EPA Region 6 waives the requirement that notifications and reports for delegated authorities be submitted to the EPA in addition to NMED in accordance with 40 CFR 63.9(a)(4)(ii) and 63.10(a)(4)(ii).2 For those authorities not delegated, sources must continue to submit all appropriate information to the EPA.

2 This waiver only extends to the submission of copies of notifications and reports; EPA does not waive the requirements in delegated standards that require notifications and reports be submitted to an electronic database (e.g., 40 CFR part 63, subpart HHHHHHH).

XIV. How will unchanged authorities be delegated to NMED in the future?

In the future, NMED will only need to send a letter of request to update their delegation to EPA, Region 6, for those NSPS which they have adopted by reference. The EPA will amend the relevant portions of the Code of Federal Regulations showing which NSPS standards have been delegated to NMED. Also, in the future, NMED will only need to send a letter of request for approval to EPA, Region 6, for those NESHAP regulations that NMED has adopted by reference. The letter must reference the previous up-front approval demonstration and reaffirm that it still meets the up-front approval criteria. We will respond in writing to the request stating that the request for delegation is either granted or denied. A Federal Register action will be published to inform the public and affected sources of the delegation, indicate where source notifications and reports should be sent, and to amend the relevant portions of the Code of Federal Regulations showing which NESHAP standards have been delegated to NMED.

XV. Final Action

We are approving the request by the NMED for the updated delegation of certain NSPS to NMED, and taking final action to approve the delegation of certain NESHAP to NMED, for all sources (both Title V and non-Title V sources). These updated regulations apply to certain NSPS promulgated by the EPA at 40 CFR part 60, as amended between September 24, 2013 and January 15, 2017; certain NESHAP promulgated by the EPA at 40 CFR part 61, as amended between January 1, 2011 and January 15, 2017; and other NESHAP promulgated by the EPA at 40 CFR part 63, as amended between August 30, 2013 and January 15, 2017, as adopted by the NMED (See the amendatory language at the end of this document for the specific standards delegated). The delegation of authority under this action does not apply to sources located in Bernalillo County, New Mexico, or to sources located in areas defined as Indian Country.

XVI. Statutory and Executive Order Reviews

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866. This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it 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). The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

The delegation 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 as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state request to receive delegation of certain Federal standards, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing delegation submissions, EPA's role is to approve submissions, provided that they meet the criteria of the Clean Air Act. This action is not subject to the 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. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this 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. 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 13, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule 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 40 CFR Part 60

Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements.

40 CFR Part 61

Environmental protection, Administrative practice and procedure, Air pollution control, Arsenic, Benzene, Beryllium, Hazardous substances, Intergovernmental relations, Mercury, Reporting and recordkeeping requirements, Vinyl chloride.

40 CFR Part 63

Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Intergovernmental relations, Reporting and recordkeeping requirements.

Authority:

42 U.S.C. 7401 et seq

Dated: September 6, 2018. Wren Stenger, Director, Multimedia Division, Region 6.

40 CFR parts 60, 61, and 63 are amended as follows:

PART 60—[AMENDED] 1. The authority citation for part 60 continues to read as follows: Authority:

42 U.S.C. 7401 et seq.

Subpart A—General Provisions 2. Section 60.4 is amended by revising paragraphs (b)(33) and (e)(1) to read as follows:
§ 60.4 Address.

(b) * * *

(33) State of New Mexico: New Mexico Environment Department, P.O. Box 5469, Santa Fe, New Mexico 87502-5469. Note: For a list of delegated standards for New Mexico (excluding Bernalillo County and Indian country), see paragraph (e)(1) of this section.

(e) * * *

(1) New Mexico. The New Mexico Environment Department has been delegated all part 60 standards promulgated by the EPA, except subpart AAA—Standards of Performance for New Residential Wood Heaters; and subpart QQQQ—Standards of Performance for New Residential Hydronic Heaters and Forced-Air Furnaces, as amended in the Federal Register through January 15, 2017.

PART 61—[AMENDED] 3. The authority citation for part 61 continues to read as follows: Authority:

42 U.S.C. 7401 et seq.

Subpart A—General Provisions 4. Section 61.04 is amended by revising paragraphs (b)(33) and (c)(6)(iii) to read as follows:
§ 61.04 Address.

(b) * * *

(33) State of New Mexico: New Mexico Environment Department, P.O. Box 5469, Santa Fe, New Mexico 87502-5469. For a list of delegated standards for New Mexico (excluding Bernalillo County and Indian country), see paragraph (c)(6) of this section.

(c) * * *

(6) * * *

(iii) New Mexico. The New Mexico Environment Department (NMED) has been delegated the following part 61 standards promulgated by the EPA, as amended in the Federal Register through January 15, 2017. The (X) symbol is used to indicate each subpart that has been delegated. The delegations are subject to all of the conditions and limitations set forth in Federal law and regulations.

Delegation Status for National Emission Standards for Hazardous Air Pollutants (Part 61 Standards) for New Mexico [Excluding Bernalillo County and Indian Country] Subpart Source category NMED 1 A General Provisions X B Radon Emissions From Underground Uranium Mines C Beryllium X D Beryllium Rocket Motor Firing X E Mercury X F Vinyl Chloride X G (Reserved) H Emissions of Radionuclides Other Than Radon From Department of Energy Facilities I Radionuclide Emissions From Federal Facilities Other Than Nuclear Regulatory Commission Licensees and Not Covered by Subpart H J Equipment Leaks (Fugitive Emission Sources) of Benzene X K Radionuclide Emissions From Elemental Phosphorus Plants L Benzene Emissions From Coke By-Product Recovery Plants X M Asbestos X N Inorganic Arsenic Emissions From Glass Manufacturing Plants X O Inorganic Arsenic Emissions From Primary Copper Smelters X P Inorganic Arsenic Emissions From Arsenic Trioxide and Metallic Arsenic Production Facilities X Q Radon Emissions From Department of Energy Facilities R Radon Emissions From Phosphogypsum Stacks S (Reserved) T Radon Emissions From the Disposal of Uranium Mill Tailings U (Reserved) V Equipment Leaks (Fugitives Emission Sources) X W Radon Emissions From Operating Mill Tailings X (Reserved) Y Benzene Emissions From Benzene Storage Vessels X Z-AA (Reserved) BB Benzene Emissions From Benzene Transfer Operations X CC-EE (Reserved) FF Benzene Waste Operations X 1 Program delegated to New Mexico Environment Department (NMED).
PART 63—[AMENDED]
5. The authority citation for part 63 continues to read as follows: Authority:

42 U.S.C. 7401 et seq.

Subpart E—Approval of State Programs and Delegation of Federal Authorities 6. Section 63.99 is amended by revising paragraph (a)(32)(i) to read as follows:
§ 63.99 Delegated Federal authorities.

(a) * * *

(32) * * *

(i) The following table lists the specific part 63 standards that have been delegated unchanged to the New Mexico Environment Department for all sources. The “X” symbol is used to indicate each subpart that has been delegated. The delegations are subject to all of the conditions and limitations set forth in Federal law and regulations. Some authorities cannot be delegated and are retained by the EPA. These include certain General Provisions authorities and specific parts of some standards. Any amendments made to these rules after January 15, 2017 are not delegated.

Delegation Status for Part 63 Standards—State of New Mexico [Excluding Indian Country] Subpart Source category NMED 1 2 ABCAQCB 1 3 A General Provisions X X D Early Reductions X X F Hazardous Organic NESHAP (HON)—Synthetic Organic Chemical Manufacturing Industry (SOCMI) X X G HON—SOCMI Process Vents, Storage Vessels, Transfer Operations and Wastewater X X H HON—Equipment Leaks X X I HON—Certain Processes Negotiated Equipment Leak Regulation X X J Polyvinyl Chloride and Copolymers Production (4) (4) K (Reserved) L Coke Oven Batteries X X M Perchloroethylene Dry Cleaning X X N Chromium Electroplating and Chromium Anodizing Tanks X X O Ethylene Oxide Sterilizers X X P (Reserved) Q Industrial Process Cooling Towers X X R Gasoline Distribution X X S Pulp and Paper Industry X X T Halogenated Solvent Cleaning X X U Group I Polymers and Resins X X V (Reserved) W Epoxy Resins Production and Non-Nylon Polyamides Production X X X Secondary Lead Smelting X X Y Marine Tank Vessel Loading X X Z (Reserved) AA Phosphoric Acid Manufacturing Plants X X BB Phosphate Fertilizers Production Plants X X CC Petroleum Refineries X X DD Off-Site Waste and Recovery Operations X X EE Magnetic Tape Manufacturing X X FF (Reserved) GG Aerospace Manufacturing and Rework Facilities X X HH Oil and Natural Gas Production Facilities X X II Shipbuilding and Ship Repair Facilities X X JJ Wood Furniture Manufacturing Operations X X KK Printing and Publishing Industry X X LL Primary Aluminum Reduction Plants X X MM Chemical Recovery Combustion Sources at Kraft, Soda, Sulfide, and Stand-Alone Semichemical Pulp Mills X X NN Wool Fiberglass Manufacturing Area Sources X OO Tanks-Level 1 X X PP Containers X X QQ Surface Impoundments X X RR Individual Drain Systems X X SS Closed Vent Systems, Control Devices, Recovery Devices and Routing to a Fuel Gas System or a Process X X TT Equipment Leaks—Control Level 1 X X UU Equipment Leaks—Control Level 2 Standards X X VV Oil—Water Separators and Organic—Water Separators X X WW Storage Vessels (Tanks)—Control Level 2 X X XX Ethylene Manufacturing Process Units Heat Exchange Systems and Waste Operations X X YY Generic Maximum Achievable Control Technology Standards X X ZZ-BBB (Reserved) CCC Steel Pickling—HCI Process Facilities and Hydrochloric Acid Regeneration X X DDD Mineral Wool Production X X EEE Hazardous Waste Combustors X X FFF (Reserved) GGG Pharmaceuticals Production X X HHH Natural Gas Transmission and Storage Facilities X X III Flexible Polyurethane Foam Production X X JJJ Group IV Polymers and Resins X X KKK (Reserved) LLL Portland Cement Manufacturing X X MMM Pesticide Active Ingredient Production X X NNN Wool Fiberglass Manufacturing X X OOO Amino/Phenolic Resins X X PPP Polyether Polyols Production X X QQQ Primary Copper Smelting X X RRR Secondary Aluminum Production X X SSS (Reserved) TTT Primary Lead Smelting X X UUU Petroleum Refineries—Catalytic Cracking Units, Catalytic Reforming Units and Sulfur Recovery Plants X X VVV Publicly Owned Treatment Works (POTW) X X WWW (Reserved) XXX Ferroalloys Production: Ferromanganese and Silicomanganese X X AAAA Municipal Solid Waste Landfills X X CCCC Nutritional Yeast Manufacturing X X DDDD Plywood and Composite Wood Products X 5 X 5 EEEE Organic Liquids Distribution X X FFFF Misc. Organic Chemical Production and Processes (MON) X X GGGG Solvent Extraction for Vegetable Oil Production X X HHHH Wet Formed Fiberglass Mat Production X X IIII Auto and Light Duty Truck (Surface Coating) X X JJJJ Paper and other Web (Surface Coating) X X KKKK Metal Can (Surface Coating) X X MMMM Misc. Metal Parts and Products (Surface Coating) X X NNNN Surface Coating of Large Appliances X X OOOO Fabric Printing Coating and Dyeing X X PPPP Plastic Parts (Surface Coating) X X QQQQ Surface Coating of Wood Building Products X X RRRR Surface Coating of Metal Furniture X X SSSS Surface Coating for Metal Coil X X TTTT Leather Finishing Operations X X UUUU Cellulose Production Manufacture X X VVVV Boat Manufacturing X X WWWW Reinforced Plastic Composites Production X X XXXX Rubber Tire Manufacturing X X YYYY Combustion Turbines X X ZZZZ Reciprocating Internal Combustion Engines (RICE) X X AAAAA Lime Manufacturing Plants X X BBBBB Semiconductor Manufacturing X X CCCCC Coke Ovens: Pushing, Quenching and Battery Stacks X X DDDDD Industrial/Commercial/Institutional Boilers and Process Heaters X 6 X 6 EEEEE Iron Foundries X X FFFFF Integrated Iron and Steel X X GGGGG Site Remediation X X HHHHH Miscellaneous Coating Manufacturing X X IIIII Mercury Cell Chlor-Alkali Plants X X JJJJJ Brick and Structural Clay Products Manufacturing X 7 (7) KKKKK Clay Ceramics Manufacturing X 7 (7) LLLLL Asphalt Roofing and Processing X X MMMMM Flexible Polyurethane Foam Fabrication Operation X X NNNNN Hydrochloric Acid Production, Fumed Silica Production X X OOOOO (Reserved) PPPPP Engine Test Facilities X X QQQQQ Friction Products Manufacturing X X RRRRR Taconite Iron Ore Processing X X SSSSS Refractory Products Manufacture X X TTTTT Primary Magnesium Refining X X UUUUU Coal and Oil-Fired Electric Utility Steam Generating Units X 8 X 8 VVVVV (Reserved) WWWWW Hospital Ethylene Oxide Sterilizers X X XXXXX (Reserved) YYYYY Electric Arc Furnace Steelmaking Area Sources X X ZZZZZ Iron and Steel Foundries Area Sources X X AAAAAA (Reserved) BBBBBB Gasoline Distribution Bulk Terminals, Bulk Plants, and Pipeline Facilities X X CCCCCC Gasoline Dispensing Facilities X X DDDDDD Polyvinyl Chloride and Copolymers Production Area Sources X X EEEEEE Primary Copper Smelting Area Sources X X FFFFFF Secondary Copper Smelting Area Sources X X GGGGGG Primary Nonferrous Metals Area Source: Zinc, Cadmium, and Beryllium X X HHHHHH Paint Stripping and Miscellaneous Surface Coating Operations at Area Sources X X IIIIII (Reserved) JJJJJJ Industrial, Commercial, and Institutional Boilers Area Sources X X KKKKKK (Reserved) LLLLLL Acrylic and Modacrylic Fibers Production Area Sources X X MMMMMM Carbon Black Production Area Sources X X NNNNNN Chemical Manufacturing Area Sources: Chromium Compounds X X OOOOOO Flexible Polyurethane Foam Production and Fabrication Area Sources X X PPPPPP Lead Acid Battery Manufacturing Area Sources X X QQQQQQ Wood Preserving Area Sources X X RRRRRR Clay Ceramics Manufacturing Area Sources X X SSSSSS Glass Manufacturing Area Sources X X TTTTTT Secondary Nonferrous Metals Processing Area Sources X X UUUUUU (Reserved) VVVVVV Chemical Manufacturing Area Sources X X WWWWWW Plating and Polishing Operations Area Sources X X XXXXXX Metal Fabrication and Finishing Area Sources X X YYYYYY Ferroalloys Production Facilities Area Sources X X ZZZZZZ Aluminum, Copper, and Other Nonferrous Foundries Area Sources X X AAAAAAA Asphalt Processing and Asphalt Roofing Manufacturing Area Sources X X BBBBBBB Chemical Preparation Industry Area Sources X X CCCCCCC Paints and Allied Products Manufacturing Area Sources X X DDDDDDD Prepared Feeds Areas Sources X X EEEEEEE Gold Mine Ore Processing and Production Area Sources X X FFFFFFF—GGGGGGG (Reserved) HHHHHHH Polyvinyl Chloride and Copolymers Production Major Sources X X 1 Authorities which may not be delegated include: § 63.6(g), Approval of Alternative Non-Opacity Emission Standards; § 63.6(h)(9), Approval of Alternative Opacity Standards; § 63.7(e)(2)(ii) and (f), Approval of Major Alternatives to Test Methods; § 63.8(f), Approval of Major Alternatives to Monitoring; § 63.10(f), Approval of Major Alternatives to Recordkeeping and Reporting; and all authorities identified in the subparts (e.g., under “Delegation of Authority”) that cannot be delegated. 2 Program delegated to New Mexico Environment Department (NMED) for standards promulgated by the EPA, as amended in the Federal Register through January 15, 2017. 3 Program delegated to Albuquerque-Bernalillo County Air Quality Control Board (ABCAQCB) for standards promulgated by the EPA, as amended in the Federal Register through September 13, 2013. 4 The NMED was previously delegated this subpart on February 9, 2004 (68 FR 69036). The ABCAQCB has adopted the subpart unchanged and applied for delegation of the standard. The subpart was vacated and remanded to the EPA by the United States Court of Appeals for the District of Columbia Circuit. See Mossville Environmental Action Network v. EPA, 370 F. 3d 1232 (D.C. Cir. 2004). Because of the D.C. Court's holding this subpart is not delegated to NMED or ABCAQCB at this time. 5 This subpart was issued a partial vacatur by the United States Court of Appeals for the District of Columbia Circuit. See 72 FR 61060 (October 29, 2007). 6 Final Rule. See 76 FR (March 21, 2011), as amended at 78 FR 7138 (January 31, 2013); 80 FR 72807 (November 20, 2015). Note that the ABCAQCB has not yet applied for updated delegation of these standards. 7 Final Promulgated Rule adopted by the EPA. See 80 FR 65470 (October 26, 2015). Note that Part 63 Subpart KKKKK was amended to correct minor typographical errors. See 80 FR 75817 (December 4, 2015). Note that the ABCAQCB has not yet applied for updated delegation of these standards. 8 Final Rule. See 77 FR 9304 (February 16, 2012), as amended 81 FR 20172 (April 6, 2016). Final Supplemental Finding that it is appropriate and necessary to regulate HAP emissions from Coal- and Oil-fired EUSGU Units. See 81 FR 24420 (April 25, 2016). Note that the ABCAQCB has not yet applied for updated delegation of these standards.
[FR Doc. 2018-19801 Filed 9-11-18; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0705; FRL-9982-22] Metschnikowia Fructicola Strain NRRLY-27328; Exemption From the Requirement of a Tolerance AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes an exemption from the requirement of a tolerance for residues of Metschnikowia fructicola strain NRRL Y-27328 in or on the stone fruit group (group 12-12); the small fruit vine climbing subgroup, except fuzzy kiwifruit (subgroup 13-07F); and the low growing berry subgroup (subgroup 13-07G) when used in accordance with label directions and good agricultural practices. Interregional Research Project Number 4 (IR-4) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Metschnikowia fructicola strain NRRL Y-27328 under FFDCA.

DATES:

This regulation is effective September 12, 2018. Objections and requests for hearings must be received on or before November 13, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

The docket for this action, identified by docket identification (ID) EPA-HQ-OPP-2017-0705, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]

SUPPLEMENTARY INFORMATION:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

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

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

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID EPA-HQ-OPP-2017-0705 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 13, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0705, by one of the following methods:

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

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

Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

In the Federal Register of March 21, 2018 (83 FR 12311) (FRL-9974-76), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7E8560) by IR-4, Rutgers, The State University of New Jersey, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the microbial pesticide Metschnikowia fructicola strain NRRL Y-27328 in or on stone fruit group 12-12; small fruit vine climbing, except fuzzy kiwifruit subgroup 13-07F; and low growing berry subgroup 13-07G. That document referenced a summary of the petition prepared by the petitioner IR-4 and available in the docket via http://www.regulations.gov. There were no comments received in response to the notice of filing.

III. Final Rule A. EPA's Safety Determination

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of a particular pesticide's residues and other substances that have a common mechanism of toxicity.”

EPA evaluated the available toxicological and exposure data on Metschnikowia fructicola strain NRRL Y-27328 and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Safety Determination for Metschnikowia fructicola strain NRRL Y-27328.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.

The available data demonstrated that Metschnikowia fructicola strain NRRL Y-27328 is not significantly toxic, pathogenic, or infective via any route of exposure. Although there may be some exposure to residues when Metschnikowia fructicola strain NRRL Y-27328 is used on certain food commodities in accordance with label directions and good agricultural practices, there is a lack of concern due to the lack of potential for adverse effects. EPA also determined that retention of the Food Quality Protection Act (FQPA) safety factor was not necessary as part of the qualitative assessment conducted for Metschnikowia fructicola strain NRRL Y-27328.

Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Metschnikowia fructicola strain NRRL Y-27328. Therefore, an exemption from the requirement of a tolerance is established for residues of Metschnikowia fructicola strain NRRL Y-27328 in or on the stone fruit group (group 12-12); the small fruit vine climbing subgroup, except fuzzy kiwifruit (subgroup 13-07F); and the low growing berry subgroup (subgroup 13-07G) when used in accordance with label directions and good agricultural practices.

B. Analytical Enforcement Methodology

An analytical method is not required because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.

IV. Statutory and Executive Order Reviews

This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, EPA has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

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

V. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

Dated: August 16, 2018. Richard P. Keigwin, Jr., Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

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

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

2. Add § 180.1358 to subpart D to read as follows:
§ 180.1358 Metschnikowia fructicola strain NRRL Y-27328; exemption from the requirement of a tolerance.

Residues of Metschnikowia fructicola strain NRRL Y-27328 are exempt from the requirement of a tolerance in or on the food commodities included in the following crop groups and subgroups when this pesticide chemical is used in accordance with label directions and good agricultural practices: Fruit, stone group 12-12; Fruit, small fruit vine climbing, except fuzzy kiwifruit, subgroup 13-07F; and Berry, low growing subgroup 13-07G.

[FR Doc. 2018-19870 Filed 9-11-18; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 300 [EPA-HQ-SFUND-2005-0011; FRL-9983-63—Region 1] National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the Old Southington Landfill Superfund Site AGENCY:

Environmental Protection Agency.

ACTION:

Final rule.

SUMMARY:

The Environmental Protection Agency (EPA) Region 1 announces the deletion of the Old Southington Landfill Superfund Site (Site) located in Southington, Connecticut, from the National Priorities List (NPL). The NPL, promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of Connecticut, through the Connecticut Department of Energy and Environmental Protection (CTDEEP), have determined that all appropriate response actions under CERCLA, other than operation and maintenance, monitoring, and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund.

DATES:

This action is effective September 12, 2018.

ADDRESSES:

Docket: EPA has established a docket for this action under Docket Identification No. EPA-HQ-SFUND-2005-0011. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information is not publicly available, i.e., 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 either electronically through http://www.regulations.gov or in hard copy at the Site information repositories. Locations, contacts, phone numbers and viewing hours are:

U.S. EPA Region 1—New England, Superfund Records Center, 5 Post Office Square, Suite 100, Boston, MA 02109, Phone: 617-918-1440, Hours: Monday-Friday: 9:00 a.m.-5:00 p.m., Saturday and Sunday—Closed.

Southington Public Library, 255 Main Street, Southington, CT, Phone: 860-628-0947, Hours: Monday-Thursday 9:00 a.m.-9:00 p.m., Friday-Saturday 9:00 a.m.-5:00 p.m., and Sunday Closed.

FOR FURTHER INFORMATION CONTACT:

Almerinda Silva, Remedial Project Manager, U.S. Environmental Protection Agency, Region I, OSRR 07-4, 5 Post Office Square, Boston, MA 02109-3912. Telephone (617) 918-1246, Email [email protected].

SUPPLEMENTARY INFORMATION:

The site to be deleted from the NPL is: the Old Southington Landfill Superfund Site located at Old Turnpike Road, Southington, Connecticut. A Notice of Intent to Delete for this Site was published in the Federal Register (83 FR 34513) on July 20, 2018.

The closing date for comments on the Notice of Intent to Delete was August 20, 2018. No public comments were received. Therefore, a responsiveness summary was not prepared and not placed in the docket, EPA-HQ-SFUND-2005-0011, on www.regulations.gov, nor in the local repositories listed above. EPA still believes the deletion action is still appropriate.

EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Deletion from the NPL does not preclude further remedial action. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system. Deletion of a site from the NPL does not affect responsible party liability in the unlikely event that future conditions warrant further actions.

List of Subjects in 40 CFR Part 300

Environmental protection, Air pollution control, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, and Water supply.

Dated: September 4, 2018. Alexandra Dapolito Dunn, Regional Administrator, Region 1.

For reasons set out in the preamble, 40 CFR part 300 is amended as follows:

PART 300—NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION CONTINGENCY PLAN 1. The authority citation for part 300 continues to read as follows: Authority:

33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626, 77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., p. 193.

Appendix B to Part 300—[Amended] 2. Table 1 of appendix B to part 300 is amended by removing the listing under Connecticut for “Old Southington Landfill”.
[FR Doc. 2018-19874 Filed 9-11-18; 8:45 am] BILLING CODE 6560-50-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 170817779-8161-02] RIN 0648-XG472 Fisheries of the Exclusive Economic Zone Off Alaska; Yellowfin Sole for Vessels Participating in the BSAI Trawl Limited Access Fishery in the Bering Sea and Aleutian Islands Management Area AGENCY:

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

ACTION:

Temporary rule; closure.

SUMMARY:

NMFS is prohibiting directed fishing for yellowfin sole in the Bering Sea and Aleutian Islands management area (BSAI) for vessels participating in the BSAI trawl limited access fishery. This action is necessary to prevent exceeding the 2018 allocation of yellowfin sole total allowable catch for vessels participating in the BSAI trawl limited access fishery in the BSAI.

DATES:

Effective 1200 hrs, Alaska local time (A.l.t.), September 7, 2018, through 2400 hrs, A.l.t., December 31, 2018.

FOR FURTHER INFORMATION CONTACT:

Steve Whitney, 907-586-7228.

SUPPLEMENTARY INFORMATION:

NMFS manages the groundfish fishery in the BSAI according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (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 allocation of yellowfin sole total allowable catch for vessels participating in the BSAI trawl limited access fishery in the BSAI is 18,351 metric tons (mt) as established by the final 2018 and 2019 harvest specifications for groundfish in the BSAI (83 FR 8365, February 27, 2018). In accordance with § 679.20(d)(1)(iii), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2018 allocation of yellowfin sole total allowable catch allocated as a directed fishing allowance for vessels participating in the BSAI trawl limited access fishery in the BSAI will soon be reached. Consequently, NMFS is prohibiting directed fishing for yellowfin sole for vessels participating in the BSAI trawl limited access fishery in the BSAI.

While this closure remains in effect, 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 yellowfin sole by vessels fishing in the BSAI trawl limited access fishery in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of September 6, 2018.

The acting 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: September 7, 2018. Margo B. Schulze-Haugen, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
[FR Doc. 2018-19821 Filed 9-7-18; 4:15 pm] BILLING CODE 3510-22-P
83 177 Wednesday, September 12, 2018 Proposed Rules DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 927 [Doc. No. AMS-SC-18-0049; SC18-927-2 PR] Pears Grown in Oregon and Washington; Decreased Assessment Rate for Processed Pears AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Proposed rule.

SUMMARY:

This proposed rule would implement a recommendation from the Processed Pear Committee (Committee) to decrease the assessment rate established for “summer/fall” varieties of pears for canning for the 2018-2019 and subsequent fiscal periods. The assessment rate would remain in effect indefinitely unless modified, suspended, or terminated.

DATES:

Comments must be received by October 12, 2018.

ADDRESSES:

Interested persons are invited to submit written comments concerning this proposed rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or internet: http://www.regulations.gov. Comments should reference the document number and the date and page number of this issue of the Federal Register and will be available for public inspection in the Office of the Docket Clerk during regular business hours, or can be viewed at: http://www.regulations.gov. All comments submitted in response to this rule will be included in the record and will be made available to the public. Please be advised that the identity of the individuals or entities submitting the comments will be made public on the internet at the address provided above.

FOR FURTHER INFORMATION CONTACT:

Dale Novotny, Marketing Specialist, or Gary Olson, Regional Director, Northwest Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (503) 326-2724, Fax: (503) 326-7440, or Email: [email protected] or [email protected] Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected]

SUPPLEMENTARY INFORMATION:

This action, pursuant to 5 U.S.C. 553, proposes an amendment to regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Order No. 927, as amended (7 CFR part 927), regulating the handling of pears grown in Oregon and Washington. Part 927, (referred to as “the Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of growers, handlers, and processors operating within the area of production, and a public member.

The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 13563 and 13175. This proposed rule falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this proposed 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).

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the Order now in effect, Oregon and Washington pear handlers are subject to assessments. Funds to administer the Order are derived from such assessments. It is intended that the assessment rate would be applicable to all assessable “summer/fall” varieties of pears specifically used for canning for the 2018-2019 fiscal period, and continue until amended, suspended, or terminated.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

The Order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The Committee members are familiar with the Committee's needs and with the costs of goods and services in their local area and are in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting where all directly affected persons have an opportunity to participate and provide input.

This proposed rule would decrease the assessment rate from $8.00, the rate that was established for the 2017-2018 and subsequent fiscal periods, to $7.15 per ton of “summer/fall” varieties of pears for canning handled for the 2018-2019 and subsequent fiscal periods. The assessment rate for “winter” and “other” pears for processing would remain unchanged at $0.00. The Committee met on May 30, 2018, and unanimously recommended 2018-2019 fiscal period expenditures of $693,472. In comparison, last year's budgeted expenditures were $800,150. The Committee also unanimously recommended an assessment rate of $7.15 per ton of “summer/fall” varieties of pears for canning handled. The proposed assessment rate of $7.15 per ton is $0.85 lower than the $8.00 per ton rate currently in effect. The Committee recommended the lower assessment rate to balance assessment revenue with its budgeted expenditures and to maintain its monetary reserve at levels authorized in the Order.

The major expenditures recommended by the Committee for the 2018-2019 fiscal period include $495,000 for promotion and paid advertising, $136,172 for research, $15,000 for market access programs, $25,000 for administrative and management services, and $22,300 for Committee expenses. In comparison, these major expense categories for the 2017-2018 fiscal period were budgeted at $591,030, $147,694, $14,576, $25,000, and $21,850; respectively.

The assessment rate recommended by the Committee was derived by considering anticipated expenses, expected shipments, and the amount of funds available in the authorized reserve. The quantity of assessable “summer/fall” pears for canning for the 2018-2019 fiscal period is estimated at 100,000 tons. Thus, the proposed $7.15 per ton should provide handler assessments of $715,000. This amount would be adequate to cover budgeted expenses of $693,472, with any excess funds used to make a small contribution to the Committee's monetary reserve. Funds in the reserve (currently $497,565) would be kept within the maximum permitted by § 927.42(a) of approximately one fiscal period's expenses.

The assessment rate proposed in this rule would continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee, or other available information.

Although this assessment rate would be in effect for an indefinite period, the Committee would continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA would evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's budget for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA.

Initial Regulatory Flexibility Analysis

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

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

There are approximately 1,500 growers of pears for processing in the production area and approximately 43 handlers of processed pears subject to regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

According to data from USDA National Agricultural Statistics Service (NASS), the Committee, and the industry for the 2016-2017 season (the most recent complete season of record) the average f.o.b. price for Oregon-Washington processed Bartlett pears (the only variety used for canning in the production area) was approximately $390.50 per ton. Total shipments for that period were approximately 103,020 tons. Using the number of handlers, and assuming a normal distribution, the majority of handlers would have average annual receipts of less than $7,500,000 ($390.50 per ton times 103,020 tons equals $40,229,310 divided by 43 handlers equals $935,565 per handler).

In addition, based on data from the Committee, the industry produced 103,020 tons of processed pears in the production area during the 2016-2017 season, with an average grower price of $360 per ton. Based on the average grower price, production, and the total number of Oregon-Washington processed pear growers reported by the Committee (1,500), and assuming a normal distribution, the average annual grower revenue is below $750,000 ($360 per ton times 103,020 tons equals $37,087,200 divided by 1,500 growers equals $24,725 per grower). Thus, the majority of Oregon and Washington processed pear handlers and growers may be classified as small entities.

This proposal would decrease the assessment rate collected from handlers for the 2018-2019 and subsequent fiscal periods from $8.00 per ton to $7.15 per ton of Oregon and Washington “summer/fall” pears for canning handled. The Committee unanimously recommended 2018-2019 fiscal period expenditures of $693,472 and the $7.15 per ton assessment rate. The proposed assessment rate of $7.15 per ton is $0.85 lower than the rate in effect for the 2017-2018 fiscal period. The quantity of assessable “summer/fall” pears for canning for the 2018-2019 fiscal period is estimated at 100,000 tons. Thus, the proposed $7.15 per ton rate should provide $715,000 in assessment income. Income derived from handler assessments should be adequate to cover budgeted expenses, with any excess funds to be carried over in the Committee's monetary reserve to be used in subsequent years.

The major expenditures recommended by the Committee for the 2018-2019 fiscal period include $495,000 for promotion and paid advertising, $136,172 for research, $15,000 for market access programs, $25,000 for administrative and management services, and $22,300 for Committee expenses. In comparison, these major expense categories for the 2017-2018 fiscal period were budgeted at $591,030, $147,694, $14,576, $25,000, and $21,850, respectively.

The proposed lower assessment rate is necessary to balance assessment revenue with the Committee's 2018-2019 fiscal period budgeted expenditures and to maintain its monetary reserve at levels authorized in the Order.

Prior to arriving at this budget and assessment rate, the Committee considered the benefits and costs related to maintaining the current assessment rate of $8.00 per ton and establishing other assessment rates. However, leaving the assessment rate unchanged would generate more revenue than required to meet the Committee's 2018-2019 fiscal period budgeted expenses of $693,472, and would add a large amount of excess funds to the Committee's already sufficient monetary reserve. Based on estimated shipments, the recommended assessment rate of $7.15 per ton should provide $715,000 in assessment income. The Committee determined assessment revenue would be adequate to fully cover budgeted expenditures for the 2018-2019 fiscal period, with a small amount of excess funds to be added to the Committee's monetary reserve. Reserve funds would be kept within the amount authorized in the Order.

A review of historical information and preliminary information pertaining to the upcoming fiscal year indicates that the average grower price for the 2018-2019 season should be approximately $296 per ton of pears for processing. Therefore, the estimated assessment revenue for the 2018-2019 fiscal period as a percentage of total grower revenue would be about 2.4 percent ($7.15 per ton assessment divided by $296 per ton grower price).

This proposed action would decrease the assessment obligation imposed on handlers for the 2018-2019 and subsequent fiscal periods. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, decreasing the assessment rate would reduce the burden on handlers, and may reduce the burden on producers.

The Committee's meetings were widely publicized throughout the Oregon and Washington processed pear industry. All interested persons were invited to attend the meetings and participate in Committee deliberations on all issues. Like all Committee meetings, the May 30, 2018, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and information collection impacts of this action on small businesses.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189. No changes in those requirements would be necessary because of this action. Should any changes become necessary, they would be submitted to OMB for approval.

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

AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

List of Subjects in 7 CFR Part 927

Marketing agreements, Pears, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, 7 CFR part 927 is proposed to be amended as follows:

PART 927—PEARS GROWN IN OREGON AND WASHINGTON 1. The authority citation for 7 CFR part 927 continues to read as follows: Authority:

7 U.S.C. 601-674.

2. In § 927.237 revise the intro paragraph text and paragraph (a) to read as follows:
§ 927.237 Assessment rate.

On and after July 1, 2018, the following base rates of assessment for pears for processing are established for the Processed Pear Committee:

(a) $7.15 per ton for any or all varieties or subvarieties of pears for canning classified as “summer/fall” excluding pears for other methods of processing;

Dated: September 6, 2018. Bruce Summers, Administrator, Agricultural Marketing Service.
[FR Doc. 2018-19683 Filed 9-11-18; 8:45 am] BILLING CODE 3410-02-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 310 [Docket No. FDA-2017-N-6924] RIN 0910-AH47 Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is proposing to repeal a regulation that requires an FDA-approved new drug application (NDA) or abbreviated new drug application (ANDA) for any drug product that is sterilized by irradiation (the irradiation regulation). Repealing the irradiation regulation would mean that over-the-counter (OTC) drug products that are generally recognized as safe and effective, that are not misbranded, and that comply with all applicable regulatory requirements can be marketed legally without an NDA or ANDA, even if they are sterilized by irradiation. FDA is proposing to take this action because the irradiation regulation is out of date and unnecessary. The technology of controlled nuclear radiation for sterilization of drugs is now well understood, and our regulations require that OTC drugs be manufactured in compliance with current good manufacturing practices (CGMPs). Appropriate and effective sterilization of drugs, including by irradiation, is adequately addressed by the CGMP requirements. This action is part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.

DATES:

Submit either electronic or written comments on the proposed rule by November 13, 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 November 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 13, 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-2017-N-6924 for “Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation.” Received comments, those filed in a timely manner (see ADDRESSES), 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:

Sudha Shukla, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5198, Silver Spring, MD 20993-0002, 301-796-3345.

SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary II. Background and Discussion A. The History of the Irradiation Regulation B. Sterilization by Irradiation C. The OTC Drug Monograph System and Current Good Manufacturing Practices D. Conclusion III. Legal Authority IV. Proposed Effective Date V. Economic Analysis of Impacts VI. Analysis of Environmental Impact VII. Paperwork Reduction Act of 1995 VIII. Federalism IX. Consultation and Coordination With Indian Tribal Governments X. References I. Executive Summary

This proposed rule would repeal the irradiation regulation, which provides that any drug sterilized by irradiation is a new drug. This action, if finalized, would mean that OTC drugs marketed pursuant to the OTC Drug Review that are generally recognized as safe and effective, that are not misbranded, and that comply with all applicable regulatory requirements can be marketed legally without an FDA-approved NDA or ANDA, even if the drugs are sterilized by irradiation. FDA is taking this action because the Agency no longer concludes that drugs sterilized by irradiation are necessarily new drugs. The technology of controlled nuclear radiation for sterilization of drugs is now well understood. In addition, drugs that are marketed pursuant to the OTC Drug Review must be manufactured in compliance with CGMPs. Appropriate and effective sterilization of drugs, including by irradiation, is adequately addressed by the CGMP requirements. Repealing the irradiation regulation would eliminate a requirement that is no longer necessary, and will not diminish public health protections.

The estimated one-time costs of this rule range from $120 to $150. Avoiding the unnecessary preparation and review of a premarket drug application will generate an estimated one-time cost savings that range from about $395,000 to $2,076,000. Over 10 years with a 7 percent discount rate, the annualized net cost savings range from $0.05 million to $0.28 million, with a primary estimate of $0.06 million; with a 3 percent discount rate, the annualized net cost savings range from $0.04 million to $0.24 million, with a primary estimate of $0.05 million. Over an infinite horizon, we assume that one sponsor will benefit from this deregulatory action every 10 years; the present value of the net cost savings over the infinite horizon range from $0.83 million to $4.37 million with a 7 percent discount rate and from $1.58 million to $8.30 million with a 3 percent discount rate.

II. Background and Discussion

On February 24, 2017, E.O. 13777, “Enforcing the Regulatory Reform Agenda” (https://www.thefederalregister.org/fdsys/pkg/FR-2017-03-01/pdf/2017-04107.pdf) was issued. One of the provisions in the E.O. requires Agencies to evaluate existing regulations and make recommendations to the Agency head regarding their repeal, replacement, or modification, consistent with applicable law. As part of this initiative, FDA is proposing to repeal the irradiation regulation as specified in this rule.

In addition, in a citizen petition dated August 14, 2014, Richard O. Wood of The Wood Burditt Group LLC requested that the irradiation regulation be revoked. FDA has responded to Mr. Wood's citizen petition. A copy of the response is available at: https://www.regulations.gov under Docket No. FDA-2014-P-1784.

A. The History of the Irradiation Regulation

In the November 29, 1955, issue of the Federal Register, FDA issued a statement of interpretation relating to the sterilization of drugs by irradiation (20 FR 8747 to 8748).1 In the statement, FDA explained that there was an interest in the utilization of newly developed sources of radiation for the sterilization of drugs. The Agency went on to state that it was necessary in the interest of protecting the public health to establish by adequate investigations that the irradiation treatment does not cause the drug to become unsafe or otherwise unsuitable for use. For this reason, all drug products sterilized by irradiation would be regarded as new drugs within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which would mean that an effective new drug application would be required for such products.

1 Available at: https://www.loc.gov/item/fr020231/. A month later, this provision was included at § 3.45 in the republication of chapter 21 of the Code of Federal Regulations in the Federal Register. See 20 FR 9525 at 9554 (December 20, 1955), available at: http://cdn.loc.gov/service/ll/fedreg/fr020/fr020246/fr020246.pdf. In 1975, FDA republished and re-codified the rule at 21 CFR 200.30. See 40 FR 13996 at 13997 (March 27, 1975), available at: https://www.loc.gov/item/fr040060/.

In 1996, FDA proposed to revise the statement and consolidate it with similar provisions into a single list of drugs that have been determined by previous rulemaking procedures to be new drugs within the meaning of section 201(p) of the FD&C Act (61 FR 29502 at 29503 to 29504 (June 11, 1996)). The Agency proposed to remove any existing background information describing the Agency's basis for determination of new drug status from the regulatory text.

In 1997, FDA finalized these provisions, now located in 21 CFR 310.502, entitled “Certain drugs accorded new drug status through rulemaking procedures.” (62 FR 12084 at 12084 (March 14, 1997).) Paragraph 310.502(a) sets forth a list of drugs that have been determined by rulemaking procedures to be “new drugs” within the meaning of section 201(p) of the FD&C Act. Included on the list is sterilization of drugs by irradiation (§ 310.502(a)(11) (21 CFR 310.502(a)(11)). Because this regulation reflects an FDA determination that the drugs on the list are “new drugs,” an NDA or ANDA must be submitted and approved by FDA before they can be marketed legally. For a non-prescription drug that could otherwise be legally marketed without an approved NDA or ANDA in effect pursuant to the OTC Drug Review, the effect of § 310.502(a)(11) is that, if the drug is sterilized by irradiation, an approved NDA or ANDA is necessary.

B. Sterilization by Irradiation

Since the paragraph now reflected at § 310.502(a)(11) was published in 1955, the technology of controlled nuclear radiation for sterilization of drugs has become well understood. Gamma ray irradiation has been recognized as a method of sterilizing drug products for half a century (Refs. 1 and 2). Electron beam and x-ray irradiation are also recognized methods for sterilizing drugs (Ref. 1).

Information and data on whether a particular drug can safely and effectively be sterilized by irradiation are available in the scientific literature (Ref. 1). The United States Pharmacopeial Convention (USP) has provided guidance on irradiation sterilization of drug products since 1965 (Refs. 1 and 3). This includes chapter <1229> on “Sterilization of Compendial Articles,” which sets forth principles that may be applied to the sterilization of compendial and non-compendial drug products, and chapter <1229.10> on “Radiation Sterilization,” which sets forth guidelines on validation of sterilization by irradiation (Refs. 3 and 4). The American National Standards Institute, the Association for the Advancement of Medical Instrumentation, ASTM International, and the International Organization for Standardization (ISO) have also published standards on the irradiation of medical products, including drugs (Ref. 1). ISO standard 11137, which sets forth several methods that can be used to determine the appropriate radiation dose for health care products, was first published in 1984 2 (Ref. 1).

2 ISO 11137-1 specifies standards for the development, validation, and routine control of a radiation sterilization process for medical devices, while ISO 11137-2 specifies dose establishment and dose audit methods and defines product family approaches for dose establishment and dose audits. Additional target sterilization doses are covered in ISO Technical Information Report (TIR) 13004. Neither ISO 11137-2 nor TIR 13004 is explicitly limited to medical devices. In addition, both ISO 11137-2 and ISO TIR 13004 reference ISO 11137-1 as “indispensable for the application of this document.” This implies that the concepts in ISO 11137-1 may be applied to sterilization of drug products.

USP chapter <1229.10> states that the methods set forth in ISO 11137 typically guide the choice of radiation dose (Ref. 3). Relevant factors include a drug's pre-sterilization level of microbial contamination (sometimes referred to as its bioburden) and the desired sterility assurance level (Ref. 1). Once the dose is selected, USP General Chapter <1229.10> states that all materials exposed to radiation, especially the drug product and its primary container, should be evaluated for immediate and long-term effects, and “[p]roduct stability, safety, and functionality should be confirmed over the product's intended use period” (Ref. 3). Among the advantages of sterilizing drug products by irradiation is that due to radiation's high penetrability, drug products can be irradiated after they are placed in their final containers (Ref. 1). Known as terminal sterilization, this provides a greater degree of sterilization assurance than aseptic processing and, where feasible, its use is preferable to relying solely on aseptic processing to ensure sterility (Ref. 5). Other advantages to irradiation sterilization of drugs include low chemical reactivity; the very low rise in temperature associated with radiation, which allows for its use on heat-sensitive products; that irradiation sterilization has fewer process variables than other methods, which translates into fewer sterility rejections; and that radiation does not leave behind any sterilant residuals (Refs. 1 and 6).

C. The OTC Drug Monograph System and Current Good Manufacturing Practices

The OTC Drug Review was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States before May 11, 1972. As set forth in 21 CFR 330.10, it is a multiphase public rulemaking process (each phase requiring a Federal Register publication) resulting in the establishment of monographs for OTC therapeutic drug classes. OTC drug monographs, which can be found in Title 21, chapter I, subchapter D of the Code of Federal Regulations, cover acceptable ingredients, doses, formulations, other conditions, and labeling for certain OTC drugs. A company can legally make and market an OTC product that meets each of the conditions contained in an applicable monograph and, in addition, each of the general conditions set forth in § 330.1. Among the general conditions that apply to all drug products marketed under the OTC Drug Review is the requirement set forth in § 330.1(a) that they be manufactured in compliance with current good manufacturing practices, as established by parts 210 and 211 of this chapter. The CGMP requirements in parts 210 and 211 encompass sterilization, including by irradiation.3

3 We note that sterilization is not generally a condition specifically covered by OTC monographs. Currently, the monograph for ophthalmic drug products at 21 CFR part 349 is the only monograph that incorporates a sterility condition. There are, however, OTC products covered by a monograph or tentative final monograph that are not required to be sterile, but which manufacturers may choose to sterilize. These may include consumer and healthcare antiseptics, such as consumer hand washes, body washes, and hand rubs, first aid antiseptics, health care personnel hand washes and hand rubs, surgical hand scrubs and rubs, and patient preoperative skin preparations. In 2013, FDA asked manufacturers to voluntarily revise the product labels for topical antiseptics to indicate whether the product is manufactured as a sterile or nonsterile product (Ref. 7).

In 1955, when the determination with respect to drugs sterilized by irradiation (now reflected in § 310.502(a)(11)) was made, neither the OTC drug monograph system nor the CGMP requirements existed. The authorizing legislation that the CGMP regulations implement, section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), was enacted in 1962 (Drug Amendments of 1962, October 10, 1962, Pub. L. 87-781, Title I, sec. 101), and the first CGMP regulations followed in 1963 (Part 133—Drugs; Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding, 28 FR 6385 (June 20, 1963) available at: https://www.loc.gov/item/fr028120/). The regulations creating procedures for establishing OTC drug monographs were issued in 1972 (37 FR 9464 (May 11, 1972)) available at: https://www.loc.gov/item/fr037092/). Because of these subsequent statutes and regulations, § 310.502(a)(11) can be revoked and manufacturers will still be obligated to ensure that, if they use radiation: (1) The drug products that they purport to be sterile are in fact sterile and (2) their use of radiation does not have a detrimental effect on their drug products' identity, strength, quality, purity, or stability.

CGMP regulations require manufacturers to take steps to ensure that sterile drug products are free of objectionable microorganisms. (See, e.g., 21 CFR 211.28(a), 211.42(b) and (c), 211.67(a), 211.84(c), 211.110(a), 211.113(b), 211.165(b), 211.167(a).) The CGMP regulations also include provisions that ensure that irradiation or any other sterilization processes do not have a detrimental effect on a drug product's identity, strength, quality, purity, or stability. (See, e.g., 21 CFR 211.22, 211.25(b), 211.68, 211.100, 211.160(b), 211.165, 211.166.)

Numerous records relating to the manufacture of the drug product must be maintained and made available for inspection (21 CFR part 211, subpart J). FDA conducts inspections at manufacturing facilities, including irradiation facilities, to ensure that the CGMP regulations are followed. Inspection findings are reviewed and, when appropriate, action may be recommended against manufacturers observed to be out of compliance.

Choosing the sterilization process that is suitable for a particular drug product is the responsibility of the manufacturer and is an important part of pharmaceutical development. To guide them in choosing an appropriate method of sterilization and otherwise complying with the CGMP requirements, manufacturers can turn to voluntary consensus standards that are widely-known by industry and recognized by FDA for the development, validation, and routine control of the sterilization of drugs by irradiation. As noted previously in this document, ISO publishes standards that address the different doses of radiation that are appropriate depending on the type and amount of microbiological contamination and the necessary degree of sterility assurance (Ref. 3). These include the following:

• ISO 11137-1:2006: Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices;

• ISO 11137-2:2013: Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose;

• ISO 11137-3:2006: Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects; and

• ISO/TS 13004:2013: Sterilization of health care products—Substantiation of selected sterilization dose: Method VDmaxSD.

• The USP also provides guidance on irradiation sterilization, including in chapter <1229.10>, which specifically addresses the topic (Ref. 3).

D. Conclusion

We propose the repeal of § 310.502(a)(11) because the Agency no longer concludes that drugs sterilized by irradiation are necessarily new drugs. The technology of controlled nuclear radiation for sterilization of drugs is now well understood and sterilization is a manufacturing process that is adequately addressed by the regulations governing the OTC drug monograph system and CGMPs.

III. Legal Authority

FDA is issuing this proposed rule under the drugs and general administrative provisions of the FD&C Act (sections 201, 301, 501, 502, 503, 505, 510, 701, 702, and 704 (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371, 372, and 374)) and under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264). The FD&C Act gives us the authority to issue and enforce regulations designed to help ensure that drug products are safe, effective, and manufactured according to current good manufacturing practices, while section 361 of the PHS Act gives us the authority to issue and enforce regulations designed to prevent the introduction, transmission, or spread of communicable diseases.

IV. Proposed Effective Date

Any final rule that results from this proposed rule will be effective 30 days after the date of the final rule's publication in the Federal Register.

V. Economic Analysis of Impacts

We have examined the impacts of the proposed rule under E.O. 12866, E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). EOs 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). E.O. 13771 requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” We believe that this proposed rule is not a significant regulatory action as defined by E.O. 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because few entities will be affected and the net effect will be cost savings to affected firms, we propose to certify that the proposed rule, if finalized, will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $150 million, using the most current (2017) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

Table 1 summarizes our estimate of the annualized costs and benefits of the proposed rule.

Table 1—Summary of Benefits, Costs and Distributional Effects of the Rule [$ million] Category Primary estimate Low
  • estimate
  • High
  • estimate
  • Units Year
  • dollars
  • Discount rate
  • (%)
  • Period covered
  • (years)
  • Notes
    Benefits: Annualized, Monetized $millions/year $0.06 $0.05 $0.28 2016 7 10 Benefits are cost savings. 0.05 0.04 0.24 2016 3 10 Benefits are cost savings. Annualized Quantified 2016 7 10 2016 3 10 Qualitative Costs: Annualized Monetized $millions/year 0.00 0.00 0.00 2016 7 10 Costs total less than $100. 0.00 0.00 0.00 2016 3 10 Costs total less than $100. Annualized Quantified 2016 7 10 2016 3 10 Qualitative Transfers: Federal Annualized Monetized $millions/year 0.14 0.14 0.14 2016 7 10 User Fee. 0.12 0.12 0.12 2016 3 10 User Fee. From: To: Other Annualized Monetized $millions/year 2016 7 10 2016 3 10 From: To: Effects: State, Local or Tribal Government: None
  • Small Business: None
  • Wages: None
  • Growth: None
  • Because the proposed rule will repeal an outdated regulation and generate net cost savings, we consider this action a deregulatory action under E.O. 13771. Table 2 presents a summary of the E.O. 13771 impacts of the proposed rule over an infinite horizon. For this estimate, we assume that one sponsor will benefit from this deregulatory action every 10 years.

    Table 2—E.O. 13771 Summary [In $ millions 2016 dollars, over an infinite horizon] Primary
  • (7%)
  • Lower bound
  • (7%)
  • Upper bound
  • (7%)
  • Primary
  • (3%)
  • Lower bound
  • (3%)
  • Upper bound
  • (3%)
  • Present Value of Costs $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 Present Value of Cost Savings 0.97 0.83 4.37 1.84 1.58 8.30 Present Value of Net Costs (0.97) (0.83) (4.37) (1.84) (1.58) (8.30) Annualized Costs $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 Annualized Cost Savings $0.07 $0.06 $0.31 $0.06 $0.05 $0.25 Annualized Net Costs (0.07) (0.06) (0.31) (0.06) (0.05) (0.25)

    We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full analysis of economic impacts is available in the docket for this proposed rule (Ref. 8) and at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

    VI. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) and 25.31(a) 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.

    VII. Paperwork Reduction Act of 1995

    This proposed rule refers to previously approved collections of information 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). The collections of information resulting from compliance with CGMPs have been approved under OMB control number 0910-0139.

    VIII. Federalism

    We have analyzed this proposed rule in accordance with the principles set forth in E.O. 13132. We have determined that this proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the E.O. and, consequently, a federalism summary impact statement is not required.

    IX. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the principles set forth in E.O. 13175. We have tentatively determined that the rule does not contain policies that would 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. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action.

    X. References

    The following references are on display in the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at 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. Jacobs, G., “Validation of the Radiation Sterilization of Pharmaceuticals.” In: J. Agalloco and F. J. Carleton (eds.), Validation of Pharmaceutical Processes (3rd Ed.) Informa USA, New York, 2007. 2. Microbiology Sub-Committee, Radiation Sterilization Task Force, Parenteral Drug Association, Technical Report No. 11, “Sterilization of Parenterals by Gamma Radiation,” Journal of Parenteral Science and Technology, 42 (3S), 1988, available at: https://store.pda.org/ProductCatalog/Product.aspx?ID=1170. 3. United States Pharmacopeial Convention (USP 40), Radiation Sterilization <1229.10>, 2017. 4. United States Pharmacopeial Convention (USP 40), Sterilization of Compendial Articles <1229>, 2017. 5. FDA Guidance for Industry on “Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice,” September 2004; available at https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070342.pdf. 6. United States Pharmacopeial Convention (USP 40), Sterilization and Sterility Assurance of Compendial Articles <1211>, 2017. 7. FDA Drug Safety Communication, “FDA Requests Label Changes and Single-Use Packaging for Some Over-the-Counter Topical Antiseptic Products to Decrease Risk of Infection,” November 13, 2013; available at https://www.fda.gov/Drugs/DrugSafety/ucm374711.htm. 8. FDA Preliminary Regulatory Impact Analysis, Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation; https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. List of Subjects in 21 CFR Part 310

    Administrative practice and procedure, Drugs, Labeling, Medical devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 310 be amended as follows:

    PART 310—NEW DRUGS 1. The authority citation for part 310 continues to read as follows: Authority:

    21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-1; 42 U.S.C. 216, 241, 242(a), 262.

    2. In § 310.502, revise paragraph (a) introductory text and remove and reserve paragraph (a)(11) to read as follows:
    § 310.502 Certain drugs accorded new drug status through rulemaking procedures.

    (a) The drugs listed in this paragraph have been determined by rulemaking procedures to be new drugs within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act. An approved new drug application under section 505 of the Federal Food, Drug, and Cosmetic Act and part 314 of this chapter is required for marketing the following drugs:

    (11) [Reserved]

    Dated: September 7, 2018. Scott Gottlieb, Commissioner of Food and Drugs.
    [FR Doc. 2018-19845 Filed 9-11-18; 8:45 am] BILLING CODE 4164-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 261 [EPA-R10-RCRA-2018-0538; SW-FRL-9982-05—Region 10] Hazardous Waste Management System; Proposed Exclusion for Identifying and Listing Hazardous Waste AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule and request for comment.

    SUMMARY:

    The Environmental Protection Agency (also, “the Agency” or “we” in this preamble) is proposing to grant a petition submitted by Sandvik Special Metals (Sandvik), in Kennewick, Washington to exclude (or “delist”) up to 1,500 cubic yards of F006 wastewater treatment sludge per year from the list of federal hazardous wastes.

    The Agency is proposing to grant the petition based on an evaluation of waste-specific information provided by Sandvik. This proposed decision, if finalized, conditionally excludes the petitioned waste from the requirements of hazardous waste regulations under the Resource Conservation and Recovery Act.

    We conclude that Sandvik's petitioned waste is nonhazardous with respect to the original federal listing criteria and that there are no other factors (including additional constituents) other than those for which the waste was listed that would warrant retaining the waste as a hazardous waste. Subject to state-only requirements within the state of Washington, or federally-authorized or state-only requirements in other states where the subject wastes may be disposed of, Sandvik's petitioned waste may be disposed of in a Subtitle D landfill which is permitted, licensed, or registered by a State to manage industrial solid waste.

    DATES:

    Comments must be received on or before October 12, 2018. Requests for an informal hearing must reach the EPA by September 27, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R10-RCRA-2018-0538 by one of the following methods:

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

    Mail: To Dr. David Bartus, Office of Air and Waste, EPA, Region 10, 1200 6th Avenue, Suite 155, OAW-150, Seattle, Washington 98101.

    Hand Delivery: To Dr. David Bartus, Office of Air and Waste, EPA, Region 10, 1200 6th Avenue, Suite 155, OAW-150, Seattle, Washington 98101. Such deliveries are only accepted during normal hours of operation. Please contact David Bartus at (206) 553-2804.

    Instructions: Direct your comments to Docket ID No. EPA-R10-RCRA-2018-0538. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through www.regulations.gov or email. The www.regulations.gov website is an “anonymous access” system, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through www.regulations.gov your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any physical media you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

    Any person may request an informal hearing on this proposed decision by filing a request with Timothy Hamlin, Director, Office of Air and Waste, EPA, Region 10, 1200 6th Ave., Suite 155, OAW-150, Seattle, Washington 98101. The request must contain the information prescribed in 40 Code of Federal Regulations CFR 260.20(d).

    Docket: All documents in the docket are listed in the www.regulations.gov index. Although listed in the index, some information may not be 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 form. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the RCRA Records Center, 16th floor, U.S. EPA, Region 10, 1200 6th Avenue, Suite 155, OAW-150, Seattle, Washington 98101. This facility is open from 8:30 a.m. to 4:00 p.m., Monday through Friday, excluding legal holidays. We recommend you telephone David Bartus at (206) 553-2804 before visiting the Region 10 office. The public may copy material from the regulatory docket at 15 cents per page.

    FOR FURTHER INFORMATION, CONTACT:

    Dr. David Bartus, EPA, Region 10, 1200 6th Avenue, Suite 155, OAW-150, Seattle, Washington 98070; telephone number: (206) 553-2804; fax number (206) 553-8509; email address: [email protected].

    As discussed in Section V below, the Washington State Department of Ecology is evaluating Sandvik's petition under state authority. Information on Ecology's action may be found at https://fortress.wa.gov/ecy/publications/SummaryPages/1804023.html.

    SUPPLEMENTARY INFORMATION:

    The information in this section is organized as follows:

    I. Overview Information II. Background A. What is a listed waste? B. What is a delisting petition? C. What factors must the EPA consider in deciding whether to grant a delisting petition? III. EPA's Evaluation of the Waste Information and Data A. What waste did Sandvik petition EPA to delist? B. How does Sandvik generate the waste? C. How did Sandvik sample and analyze the waste? D. What were the results of Sandvik's analysis of the waste? E. How did the EPA evaluate the risk of delisting this waste? F. What did the EPA conclude about Sandvik's waste? IV. Conditions for Exclusion A. When would the EPA finalize the proposed delisting exclusion? B. How will Sandvik manage the waste if it is delisted? C. What are the maximum allowable concentrations of hazardous constituents in the waste? D. How frequently must Sandvik test the waste? E. What data must Sandvik submit? F. What happens if Sandvik's waste fails to meet the conditions of the exclusion? G. What must Sandvik do if the process changes? V. How would this action affect states? VI. Statutory and Executive Order Reviews I. Overview Information

    The EPA is proposing to grant the petition submitted by Sandvik Special Metals (Sandvik) located in Kennewick, Washington to exclude or delist an annual volume of up to 1,500 cubic yards of F006 wastewater treatment sludge from the lists of hazardous waste set forth in 40 Code of Federal Regulations CFR 261.31. Sandvik claims that the petitioned waste does not meet the criteria for which the EPA listed it, and that there are no additional constituents or factors which could cause the waste to be hazardous.

    Based on our review described in section III, we agree with the petitioner that the waste is nonhazardous. We reviewed the description of the process which generates the waste and the analytical data submitted by Sandvik. We believe that the petitioned waste does not meet the criteria for which the waste was listed, and that there are no other factors which might cause the waste to be hazardous.

    II. Background A. What is a listed waste?

    The EPA published an amended list of hazardous wastes from nonspecific and specific sources on January 16, 1981, as part of its final and interim final regulations implementing § 3001 of Resource Conservation and Recovery Act (RCRA). The EPA has amended this list several times and published it in 40 CFR 261.31 and 261.32.

    We list these wastes as hazardous because: (1) They typically and frequently exhibit one or more of the characteristics of hazardous wastes identified in subpart C of part 261 (that is, ignitability, corrosivity, reactivity, and toxicity) or (2) they meet the criteria for listing contained in § 261.11(a)(2) or (3).

    B. What is a delisting petition?

    Individual waste streams may vary depending on raw materials, industrial processes, and other factors. Thus, while a waste described in the regulations generally is hazardous, a specific waste from an individual facility meeting the listing description may not be hazardous.

    A procedure to exclude or delist a waste is provided in 40 CFR 260.20 and 260.22 which allows a person or a facility to submit a petition to the EPA or to an authorized state demonstrating that a specific waste from a particular generating facility is not hazardous.1

    1 Washington State has promulgated regulations at WAC 173-303-910(3) corresponding to the cited federal regulation. However, Washington State has not received final authorization to implement these regulations in lieu of the federal program. As such, they are effective concurrent with 40 CFR 260.20 and 260.22 on a state-only basis.

    In a delisting petition, the petitioner must show that a waste does not meet any of the criteria for listed wastes in 40 CFR 261.11 and that the waste does not exhibit any of the hazardous waste characteristics of ignitability, reactivity, corrosivity, or toxicity. The petitioner must present sufficient information for us to decide whether any factors in addition to those for which the waste was listed warrant retaining it as a hazardous waste. (See § 260.22, 42 U.S.C. 6921(f) and the background documents for the listed wastes.)

    If a delisting petition is granted, the generator remains obligated under RCRA to confirm that the waste remains nonhazardous according to the conditions of the delisting.

    C. What factors must EPA consider in deciding whether to grant a delisting petition?

    In reviewing this petition, we considered the original listing criteria and the additional factors required by the Hazardous and Solid Waste Amendments of 1984 (HSWA). See § 222 of HSWA, 42 U.S.C. 6921(f), and 40 CFR 260.22(d)(2)-(4). We evaluated the petitioned waste against the listing criteria and factors cited in § 261.11(a)(2) and (3).

    Besides considering the criteria in 40 CFR 260.22(a), 261.11(a)(2) and (3), 42 U.S.C. 6921(f), and in the background documents for the listed wastes, the EPA must consider any factors (including additional constituents) other than those for which we listed the waste if these additional factors could cause the waste to be hazardous.

    Our proposed decision to grant the petition to delist the waste from Sandvik's Kennewick, Washington facility is based on our evaluation of the waste for factors or criteria which could cause the waste to be hazardous. These factors included: (1) Whether the waste is considered acutely toxic; (2) the toxicity of the constituents; (3) the concentration of the constituents in the waste; (4) the tendency of the constituents to migrate and to bioaccumulate; (5) the persistence in the environment of any constituents once released from the waste; (6) plausible and specific types of management of the petitioned waste; (7) the quantity of waste produced; and (8) waste variability.

    The EPA must also consider as hazardous wastes mixtures containing listed hazardous wastes and wastes derived from treating, storing, or disposing of listed hazardous waste. See 40 CFR 261.3(a)(2)(iv) and (c)(2)(i), called the “mixture” and “derived-from” rules, respectively. Mixture and derived-from wastes are also eligible for exclusion but remain hazardous until excluded.

    III. EPA's Evaluation of the Waste Information and Data A. What waste did Sandvik petition the EPA to delist?

    On April 27, 2018, Sandvik petitioned the EPA to exclude an annual volume of up to 1,500 cubic yards of F006 wastewater treatment sludges generated at its facility located in Kennewick, Washington from the list of hazardous wastes contained in 40 CFR 261.31. F006 is defined in § 261.31 as “Wastewater treatment sludges from electroplating operations . . .” Sandvik claims that the petitioned waste does not meet the criteria for which F006 was listed (i.e., cadmium, hexavalent chromium, nickel and complexed cyanide) and that there are no other factors which would cause the waste to be hazardous.

    B. How does Sandvik generate the waste?

    Sandvik Special Metals fabricates specialty titanium and zirconium tubing for the aeronautical, medical and nuclear industries. The filter cake waste material that is the subject of this delisting action is the combined end waste from the wastewater treatment facility (WWTF) that manages F006 chemical etching wastes, and a separate coolant process waste stream associated with Sandvik's manufacturing process. A detailed description of the processes which contribute to the filter cake, including the wastewater treatment and the manufacturing processes, associated alloys and process materials, is provided below.

    Titanium and zirconium alloys are the main raw materials for the manufacturing process, with titanium being used for most products and zirconium being used only on special orders for the nuclear industry. In recent years, zirconium accounted for less than one percent of the total production, however, zirconium has accounted for up to 10 to 20 percent of the production volume historically. The manufacturing processes meet strict industry standards for Sandvik customers and are consistent at the Kennewick facility.

    The standard tube making process for titanium (Ti) and zirconium (Zr) alloyed tubing includes three main steps. See Figure 1 in Sandvik's delisting petition. The alloys used in the process arrive at the Kennewick facility in the form of large diameter rough tubing (either extrusions or Trex [which is an extrusion that has been reduced once]) from one of two suppliers, Sandvik SZ in Sweden or ATI in Oregon. In the first tube-making process, the extrusions or Trex go through multiple cold pilger steps to reduce the diameter size of the tubing into seamless hollow metal tubing. The cold pilgering process uses roll dies (presses) and a tapered mandrel (the rod that supports the inside of the tube during formation) to reduce the size of the tubing cross section. A fatty acid coolant/lubricant is used to manage heat generation during the process. The number of cold pilgering steps is dependent on the available starting materials and final tube size. After each cold pilger step, the interior of the tube is cleaned in a hot alkaline solution to remove the fatty acid coolant/lubricant used in the forming process, resulting in the generation of an alkaline rinsing solution that is discharged to the WWTF and a small amount of used fatty acid coolant/lubricant, which is pumped to an underground storage tank and then batch transferred to the WWTF.

    The second step in the tube forming process is a high temperature anneal step performed to relieve stress on the metal that can make it brittle after cold forming. Annealing also improves the homogeneity of the metal and can improve the ductile and toughness properties. No waste is generated during the annealing process.

    During the third step, after annealing, the hollows, or final tubes are rotary straightened and cleaned in the hot alkaline solution again to remove the straightening lubrication. The cleaned hollows are open dip etched in an acidic solution to remove a small amount of metal from both the outer diameter (OD) and inner diameter (ID) surfaces. The acidic waste and rinse water from the hollow etch process is discharged to the WWTF. This acid etch step is the basis for application of the F006 listing to Sandvik's WWTF sludge, as discussed in the following section.

    If the next pass is to produce a smaller OD or thinner wall hollow, the above three-step process is repeated until the desired sizing is accomplished resulting in a final tube.

    C. How is Sandvik's waste captured by the F006 listing definition?

    The listing definition for F006 waste at 40 CFR 261.31 states that the source definition of F006 wastes include:

    Wastewater treatment sludges from electroplating operations except from the following processes: (1) Sulfuric acid anodizing of aluminum; (2) tin plating on carbon steel; (3) zinc plating (segregated basis) on carbon steel; (4) aluminum or zinc-aluminum plating on carbon steel; (5) cleaning/stripping associated with tin, zinc and aluminum plating on carbon steel; and (6) chemical etching and milling of aluminum.

    The EPA promulgated an interpretive rule (51 FR 43350 (December 2, 1986)) clarifying the scope of the EPA Hazardous Waste No. F006 contained in the list of hazardous wastes from non-specific sources of Subpart D of Part 261. This interpretive rule established that:

    The F006 listing is (and always has been) therefore, inclusive of wastewater treatment sludges from only the following processes: (1) Common and precious metals electroplating, except tin, zinc (segregated basis), aluminum, and zinc-aluminum plating on carbon steel; (2) anodizing, except sulfuric acid anodizing of aluminum; (3) chemical etching and milling, except when performed on aluminum; and (4) cleaning and stripping, except when associated with tin, zinc, and aluminum plating on carbon steel.

    Because the Sandvik production process that results in generation of the candidate WWTF sludge includes chemical etching other than that performed on aluminum, Sandvik's WWTF sludge meets the definition of F006 listed waste.

    D. How did Sandvik sample and analyze the petitioned waste?

    Sandvik conducted a detailed chemical analysis of their WWTF sludge according to a written sampling and analysis plan (SAP), provided as Attachment 2 to the delisting petition. This SAP included the following key elements:

    • A description of the manufacturing and wastewater treatment processes relevant to the petitioned waste;

    • An initial identification of Constituents of Potential Concern (COPCs) potentially present in the petitioned waste based on manufacturing and wastewater treatment processes;

    • Development of sampling strategies to address variations and periodic fluctuations in the manufacturing and wastewater treatment processes, including obtaining representative samples to account for variations of alloys used in the manufacturing process and addition of coolant/lubricant into the filter cake.

    • The proposed methodology for evaluating the resulting data with respect to anticipated delisting decision criteria; and

    • A Quality Assurance Project Plan (QAPP) documenting the required quality and quantity of the data necessary for decisions based on them to be within an acceptable degree of uncertainty.

    Sandvik's SAP identified an initial list of COPCs based on a consideration of constituents included in the F006 hazardous waste listing and present in the manufacturing and wastewater treatment materials and processes. See Section 2 and Table 5 of Attachment 2 in Sandvik's delisting petition. Additionally, the list of COPCs included impurities and other constituents listed in the alloys and in the process and wastewater treatment chemical Safety Data Sheets (SDS).2 Constituents were then evaluated based on historical detections in the filter cake waste and compared to constituents listed in the following RCRA regulations, as applicable to the Kennewick facility and this specific filter cake waste:

    2 SDS constituent reporting requirements are typically ingredients which have been determined to be health hazards, and which comprise 1% or greater of the composition, except chemicals identified as carcinogens which are listed if the concentrations are 0.1% or greater. In addition, chemicals <1% (<0.1% for carcinogens) are reported if they could be released from the product at a concentration that would exceed an established Occupational Safety and Health Administration (OHSA) exposure limit. SDSs are prepared in accordance with OHSA (29 CFR 1910.1200(g)) and the Global Harmonization System.

    • Constituent for which F006 was listed (40 CFR part 261 Appendix VII; WAC 173-303-082) or listed as a Land Disposal Restriction (LDR) constituent subject to treatment for F006 or identified as a constituent for which an LDR Universal Treatment Standard has been established (40 CFR 268.40 and 268.48; WAC 173-303-140) with the exception of cyanide. Cyanide was not retained as a COPC because there is no documented use of cyanide at the Kennewick facility and it was not detected in historical filter cake samples.

    • Constituent has been historically detected in filter cake and was present on the Toxicity Characteristics List (40 CFR 261.24; WAC 173-303-090 Part 8), Hazardous Constituents List (40 CFR part 261 Appendix VIII; WAC 173-303-9905), and/or Groundwater Monitoring List (40 CFR part 264 Appendix IX; WAC 173-303-110(7)).

    • According to the alloy composition, constituent could potentially be present in the filter cake and is listed on the Toxicity Characteristics List (40 CFR 261.24; WAC 173-303-090(8)), Hazardous Constituents List (40 CFR part 261 Appendix VIII; WAC 173-303-9905), and/or the Groundwater Monitoring List (40 CFR part 264 Appendix IX; WAC 173-303-110 Part 7).

    A constituent was not retained as a COPC if it was not:

    • Listed on potentially relevant regulatory lists; or

    • There was no documented Kennewick facility use of the constituent, or it was a minor constituent in wastewater treatment material, not detected in historical filter cake samples, or converted to another COPC in the wastewater treatment process (i.e., hydrofluoric acid is present as fluoride in the filter cake).

    Based on this analysis, Sandvik's SAP proposed the following list of COPCs: Arsenic; Barium; Cadmium; Chromium (including hexavalent chromium); Cobalt; Copper; Fluoride; 3 Lead; Nickel; Silver; Tin; Vanadium; and Zinc. Details of Sandvik's identification of COPCs can be found in Table 5 in Attachment 2 to the delisting petition.

    3 Fluoride does not meet the criteria set forth in Section 3.1 but is included in the final list of COPCs as requested by the EPA during a 17 April 2017 teleconference.

    The objectives of the waste characterization sampling conducted by Sandvik were as follows:

    • To supplement the existing historical data set with total and TCLP data for the identified COPCs;

    • To collect samples that are representative of process variations that include processing of two different alloy materials (titanium and zirconium) and the periodic addition of the waste coolant/lubricant to the filter cake waste;

    • To assess acute toxicity effects of wastes in accordance with the Washington State Department of Ecology's 80-12, Part A protocol,4 and

    4 This sampling requirement is in place to satisfy state-only requirements of Ecology's dangerous waste program. This requirement is considered broader in scope than the federally authorized program.

    • To generate a representative data set that can be used in the Delisting Risk Assessment Software (DRAS) modeling.

    To achieve these objectives, Sandvik collected six (6) representative samples over three (3) sampling events that included the following scope of work:

    • Each event included the collection of one filter cake sample with the used coolant/lubricant waste stream and one filter cake sample without the used coolant/lubricant waste stream;

    • Since titanium raw materials are present at higher weight composition percentages than zirconium, four filter cake samples (two with coolant and two without coolant) events were obtained when only titanium alloys were being run in the manufacturing process; and

    • To account for the use of zirconium, two samples (one with coolant and one without coolant) were obtained while zirconium alloys were also being run in the manufacturing process in addition to titanium alloys.5

    5 The zirconium product requirements are more sensitive to contamination. As such, the tanks and mills are flushed prior to zirconium production. The titanium product requirements are not as sensitive; therefore, following zirconium production, the same acids and coolant/lubricants are used during titanium production.

    All samples were analyzed for total and TCLP COPCs, where applicable. If chromium was detected at a concentration above the laboratory practical quantitation limit (PQL), a sample from the same sampling event was analyzed for hexavalent chromium. If chromium was not detected above the PQL, no additional testing was performed. This approach to sampling for chromium was used for both total and TCLP sampling.

    One sample with the coolant/lubricant and one sample without the coolant/lubricant was analyzed to assess acute toxicity via bioassay as part of the first titanium-only sampling events. This combination of the filter cake production characteristics is expected to be the most conservative choice for bioassay testing, given the higher number of impurities in the titanium alloy. Additional details of Sandvik's waste characterization sampling activities are provided in Attachment 2 to the delisting petition.

    D. What were the results of Sandvik's analysis of its waste?

    Sandvik provided results of their waste characterization activities in Attachment 3 to the delisting petition entitled “Sampling Results and Data Evaluation Report.” As part of its overall delisting petition submission, Sandvik submitted a signed statement certifying that information in the petition, including their submission of waste characterization data and description of the associated sampling and analysis activities, is true, accurate and complete, and the responsibilities of the signatory of the delisting petition. See 40 CFR 260.22(i)(12).

    Sandvik conducted its first sampling event on July 31, 2017, followed by two additional sampling events on August 31 and September 25, 2017. Two representative samples of the WWTF filter cake were collected during each event, one with the used coolant/lubricant waste stream and one without, for a total of six filter cake samples. Of these six samples, four were collected when only titanium alloys were being run in the manufacturing process, and two when zirconium was also being run. Each sample was a composite sample collected from four separate locations within each filter cake collection bin used to collect the filter cake following the filter press. Sandvik's delisting petition states that according to facility representatives, the filter cake generation durations and resulting volumes within the filter press during each sampling event were typical for facility operations. Additional details of Sandvik's waste characterization sampling activities can be found in Section 3 of the SAP (Attachment 2 of the delisting petition).

    Sandvik performed a quality assurance/quality control review of each laboratory report, with complete results of the data validation review detailed in Appendix C of the SAP. While this review identified one constituent (arsenic) from one sampling round where the data do not fully satisfy the data quality objectives set forth in Sandvik's quality control standards, Sandvik concludes that the data are nevertheless generally suitable for their intended decision-making function. This constituent and sampling round are discussed further below.

    Based on the results of filter cake characterization sampling, Sandvik concluded that all constituents other than hexavalent chromium should be retained as constituents of concern for further evaluation. Sandvik's deletion of hexavalent chromium from the list of COPCs is based on hexavalent chromium not being detected in any of the filter cake total or TCLP analysis according to the sampling methodology described above.

    Sandvik compared their 2017 waste characterization sampling results to historical total and TCLP results available for several of the COPCs. The range of recent COPC results was consistent with historical results except for fluoride. Historical total fluoride concentrations of 67,500 mg/kg and 42,000 mg/kg from 1991 and 1997, respectively, were several orders of magnitude higher than recent concentrations; the highest recent concentration was 907 mg/kg. Sandvik indicates that it has progressively reduced the amount of etching in its process at the Kennewick facility, which would result in a decline in hydrofluoric acid use and fluoride in the filter cake. In addition, the collection method of the historical samples as well as the production and wastewater treatment system operations at the time of historical sampling are unknown. As a result, the 2017 samples are considered to be more representative of typical conditions for fluoride for current and future operations at the Kennewick facility.

    Overall, totals concentrations from the three 2017 sampling events were within the range of historical results. In addition to fluoride, as discussed in the previous paragraph, one 2017 maximum nickel sample (425 mg/kg) exceeded the historical maximum nickel sample of 392 mg/kg. The 2017 totals samples also exceeded historical maximum concentrations for arsenic, barium, chromium, and silver, but none of these constituents had a difference of more than one order of magnitude between the 2017 and historic samples. Because most historical concentrations are from 20 or more years ago and production and collection methods are unknown, the 2017 COPC results obtained from implementation of the SAP were considered more reliable and used for the subsequent data evaluation.

    Sandvik also compared the 2017 waste characterization sampling result to the toxicity characteristic (TC) regulatory standard for those waste constituents for which regulatory standards have been established. Based on this comparison, Sandvik concluded that the candidate wastes do not exhibit the toxicity characteristic. Although Sandvik did not explicitly evaluate their candidate wastes for the characteristics of ignitability, reactivity or corrosivity, the EPA agrees that process knowledge provides an adequate demonstration that the wastes in question do not exhibit the enumerated characteristics.

    E. How did the EPA evaluate the risk of delisting this waste?

    For this delisting determination, we assumed that the waste would be disposed in a Subtitle D landfill and we considered transport of waste constituents through ground water, surface water and air. We evaluated Sandvik's analysis of petitioned waste using the Agency's Delisting Risk Assessment Software (DRAS) to predict the concentration of hazardous constituents that might be released from the petitioned waste and to determine if the waste would pose a threat to human health and the environment. The DRAS software and associated documentation can be found at www.epa.gov/hw/hazardous-waste-delisting-risk-assessment-software-dras.

    To predict the potential for release to groundwater from landfilled wastes and subsequent routes of exposure to a receptor, the DRAS uses dilution attenuation factors derived from the EPA's Composite Model for leachate migration with Transformation Products. From a release to ground water, the DRAS considers routes of exposure to a human receptor of ingestion of contaminated groundwater, inhalation from groundwater while showering and dermal contact from groundwater while bathing.

    From a release to surface water by erosion of waste from an open landfill into storm water run-off, DRAS evaluates the exposure to a human receptor by fish ingestion and ingestion of drinking water. From a release of waste particles and volatile emissions to air from the surface of an open landfill, DRAS considers routes of exposure of inhalation of volatile constituents, inhalation of particles, and air deposition of particles on residential soil and subsequent ingestion of the contaminated soil by a child. The technical support document and the user's guide to DRAS are included in the docket.

    Sandvik documented the input parameters used in their DRAS analysis, as summarized below:

    Table 1—Sandvik Delisting DRAS Input DRAS input parameter Value Assumptions Waste Management Unit Type Landfill Waste planned for disposal in the Finley Buttes Municipal Landfill, Boardman, Oregon. Waste Volume—annual generation 1,500 cubic yards/year Conservative estimation value based on facility-specific information. Waste Management Unit Active Life 20 years Selected based on the DRAS default value. Target risk—carcinogenic risk level 1×10−5 Based on risk ranges in the EPA's RCRA Delisting Technical Support Document (2008). Target risk—health quotient 1.0 Based on risk ranges in the EPA's RCRA Delisting Technical Support Document (2008).

    At a target cancer risk of 1×10−5 and a target hazard quotient of 1.0, the DRAS program determined maximum allowable concentrations for each constituent in both the waste and the leachate at an annual waste volume of 1,500 cubic yards. Sandvik used the maximum estimated annual waste volume and the maximum reported total and estimated leachate concentrations as inputs to estimate the constituent concentrations in the ground water, soil, surface water or air. The following table documents the constituent-specific maximum total and TCLP sample results used as input to the DRAS analysis, and the resulting modeling results from DRAS. The EPA notes that it has independently conducted its own DRAS modeling run, and has verified the modeling results documented by Sandvik in its delisting petition.

    Table 2—Sampling Data and DRAS Modeling Results Constituent of
  • concern
  • Maximum observed
  • concentration 1
  • Total 1
  • (mg/kg)
  • TCLP
  • (mg/L) 4
  • Modeling results Total concentrations Limiting
  • concentration
  • (mg/kg) 2
  • Limiting pathway 3 TCLP concentration Limiting
  • concentration
  • (mg/L) 2
  • Limiting pathway 3
    Arsenic 4.77 0.05 U 9,840 Fish Ingestion 0.042 GW Ingestion. Barium 24.1 0.05 U 21,300,000 Fish Ingestion 176 MCL. Cadmium 15.0 0.05 U 37,100 Fish Ingestion 0.451 MCL. Chromium 44.3 0.05 U 77,500 Air Particulate Inhalation 9.54 MCL. Cobalt 291 0.255 103,000 Air Particulate Inhalation 1.06 GW Ingestion. Copper 26.2 0.057 3,790,000 Fish Ingestion 120 MCL. Fluoride 907 114 1,490,000,000 Soil 194 GW Ingestion. Lead 11.1 0.05 U 8,870,000 Air Particulate Inhalation 2.95 MCL. Nickel 425 0.466 3,870,000 Air Particulate Inhalation 66.4 GW Ingestion. Silver 5.76 0.05 U 3,830,000 Fish Ingestion 38.8 GW Ingestion. Tin 268 0.05 U 14,900,000,000 Soil 192,000,000 GW Ingestion. Vanadium 1,500 0.05 U 124,000,000 Soil 16.9 GW Ingestion. Zinc 69.4 0.233 9,810,000 Fish ingestion 992 GW Ingestion. 1 Maximum concentration obtained during implementation of the 2017 Sampling and Analysis Plan (Geosyntec, 2017). 2 The Limiting Concentration is the lowest risk-based concentration developed in DRAS for the potential receptor pathways and specified target risk levels. See text in Section IV.C for the EPA's consideration of limiting concentrations exceeding 1,000,000 mg/kg for total concentrations or 1,000,000 mg/L for TCLP concentrations. 3 The Limiting Pathway is the corresponding potential receptor pathway for the Limiting Concentration. 4 For detected constituents, the maximum analytical result was used. For non-detect constituents (annotated with a “U”), the practical quantitation limit (PQL) was used. 5Note: Italicized cells indicate exceedance of COPC Concentration Input over the Limiting Concentration in the DRAS modeling.
    F. What did the EPA conclude about Sandvik's waste?

    The maximum reported concentrations of the hazardous constituents found in this waste are presented in the table above. The table also presents the maximum allowable concentrations. Except for the groundwater pathway for arsenic, the concentrations of all constituents in both the waste and the leachate are below the allowable concentrations.

    For arsenic, the maximum reported concentration was undetected at a value of 0.05 mg/L, a value slightly higher than the maximum allowable TCLP concentration of 0.042 mg/L. The EPA's review of the corresponding laboratory reports indicate that the laboratory reported sample results from the July 31, 2017 characterization sampling round as non-detect based on a practical quantitation limit of 0.05 mg/L. Subsequent laboratory reports for the August 31, 2017 and October 4, 2017 characterization rounds, however, reported TCLP arsenic results as non-detect at a level of 0.001 mg/L, based on a lower method detection limit rather a practical quantitation limit. Since the total arsenic results for all characterization samples are both low and consistent, ranging from 2.02 to 4.77 mg/kg, the EPA believes that the TCLP arsenic results for the July 31, 2017 results are not likely to be materially different than lower non-detect results for the August 31, 2017 and October 4, 2017 sample results. Also, based on the difference in arsenic concentrations from the totals analysis (detected at low levels) and the TCLP samples (non-detect), arsenic appears to be relatively immobile in the filter cake. Therefore, the EPA concludes that even though the TCLP arsenic data from the August 31, 2017, laboratory report does not explicitly document satisfaction of the 0.042 mg/L TCLP arsenic delisting criterion, the overall data set clearly supports a conclusion that the TCLP arsenic results do not exceed the maximum allowable concentration of 0.042 mg/L from any of the characterization sampling rounds, and that this arsenic data quality issue is not a sufficient basis to disqualify Sandvik's waste from being delisted. If the EPA approves Sandvik's delisting petition, Sandvik must ensure that any required periodic verification sampling and analysis meet appropriate data quality standards to address this issue.

    We, therefore, conclude that Sandvik's wastewater treatment sludge is not a substantial or potential hazard to human health and the environment when disposed of in a Subtitle D landfill. Further, the data presented by Sandvik in their petition supports the EPA's conclusion that the petitioned waste does not exhibit any hazardous characteristic, and that there are no other factors that would warrant retaining the waste as hazardous. On this basis, we propose to grant the Sandvik's petition to delist this waste. If this exclusion is finalized, and subject to the conditions of the final delisting, Sandvik must dispose of this waste in a Subtitle D landfill permitted or licensed by a state and will remain obligated to verify that the waste continues to meet the allowable concentrations set forth here. Sandvik must also continue to demonstrate that the waste does not exhibit any hazardous characteristics pursuant to 40 CFR part 261 Subpart C.

    IV. Conditions for Exclusion A. When would the EPA finalize the proposed delisting exclusion?

    HSWA specifically requires the EPA to provide notice and an opportunity for comment before granting or denying a final exclusion. Thus, EPA will not make a final decision or grant an exclusion until it has addressed all timely public comments on today's proposal, including any at public hearings.

    Since this rule would reduce the existing requirements for persons generating hazardous wastes, the regulated community does not need a six-month period to come into compliance in accordance with § 3010 of RCRA as amended by HSWA.

    B. How will Sandvik manage the waste if it is delisted?

    If the petitioned waste is delisted, Sandvik must dispose of it in a Subtitle D landfill which is permitted, licensed, or registered by a state to manage industrial waste.

    C. What are the maximum allowable concentrations of hazardous constituents in the waste?

    Concentrations measured in the waste of the following constituents must not exceed the concentrations in Table 3 below. The EPA notes that for barium, chromium, and silver, the DRAS model output predicts a maximum concentration in an extract of the waste that exceeds the toxicity characteristic regulatory designation level (TC Limit) for that constituent. Since wastes that are a candidate for delisting cannot exhibit a characteristic, the fourth column in Table 3 caps the maximum TCLP concentration of the waste at the toxicity characteristic regulatory level for barium, chromium and silver. These capped levels for the maximum TCLP concentration are the enforceable decision criteria for demonstrating that the waste meets delisting criteria.

    Table 3—Verification Constituents and Compliance Concentrations Constituent Total
  • concentration DRAS model
  • (mg/kg)
  • TCLP
  • concentration DRAS model
  • (mg/l)
  • TCLP
  • concentration DRAS model capped at TC limit
  • (mg/l)
  • Arsenic 9,840 0.042 0.042 Barium N/A 176 100 Cadmium 37,100 0.451 0.451 Chromium 77,500 9.54 5.00 Cobalt 103,000 1.06 1.06 Copper N/A 120 120 Fluoride N/A 194 194 Lead N/A 2.95 2.95 Nickel N/A 66.4 66.4 Silver N/A 38.8 5.00 Vanadium N/A 16.9 16.9 Zinc N/A 992 992

    The EPA notes that in multiple instances the maximum allowable total constituent concentrations provided by the DRAS model exceed 100% of the waste—these DRAS results are an artifact of the risk calculations that do not have physical meaning. In instances where DRAS predicts a maximum constituent greater than 100 percent of the waste (that is, greater than 1,000,000 mg/kg or mg/L, respectively, for total and TCLP concentrations), the EPA is not requiring Sandvik to perform sampling and analysis for that constituent and sampling type (total or TCLP). In these instances, the corresponding entry in Table 3 above is “N/A.”

    D. How frequently must Sandvik test the waste?

    Sandvik must analyze a representative sample of the wastewater treatment sludges on an annual basis to demonstrate that the constituents of concern in the petitioned waste do not exceed the concentrations of concern in section IV.C above. Sandvik must use methods with sufficient analytical sensitivity and appropriate quality control procedures. SW-846 Method 1311 must be used for generation of the leachate extract used in the testing of the subject waste. SW-846 Method 1311 is incorporated by reference in 40 CFR 260.11.

    A total analysis of the waste (accounting for any filterable liquids and the dilution factor inherent in the TCLP method) may be used to estimate the TCLP concentration as provided for in section 1.2 of Method 1311. The EPA is not requiring Sandvik to use Method 1330 for extraction of wastes, since Method 1330 is applicable to API separator sludges, rag oils, slop oil emulsions, and other oil wastes derived from petroleum refining, which are fundamentally different wastes than those proposed by Sandvik for delisting.

    E. What data must Sandvik submit?

    Sandvik must submit the data obtained through annual verification testing to U.S. EPA Region 10, Office of Air and Waste, 1200 6th Avenue, Suite 155, OAW-150, Seattle, Washington 98101 upon each anniversary of the effective date of this exclusion. Sandvik must submit sampling data from both titanium and zirconium manufacturing processes provided both of these materials have been in production and contributed to candidate wastes within the three (3) month period prior to each anniversary of the effective date of this delisting. If both materials are not in production with the specified three-month period, then only data from that material in production need be submitted.

    Sandvik must compile, summarize, and maintain on-site for a minimum of five years, records of analytical data required by this rule, and operating conditions relevant to those data analytical data. Sandvik must make those records available for inspection. All data must be accompanied by a signed copy of the certification statement in 40 CFR 260.22(i)(12).

    F. What happens if Sandvik fails to meet the conditions of the exclusion?

    If Sandvik violates the terms and conditions established in the exclusion, the Agency may start procedures to withdraw the exclusion.

    If the verification testing of the waste does not demonstrate compliance with the delisting concentrations described in section IV.C above, or other data (including but not limited to leachate data or groundwater monitoring data from the final land disposal facility) relevant to the delisted waste indicates that any constituent is at a concentration in waste above specified delisting verification concentrations in Table 3, Sandvik must notify the Agency within 10 days of first possessing or being made aware of the data. The exclusion will be suspended and the waste managed as hazardous until Sandvik has received written approval from the EPA to continue the exclusion. Sandvik may provide sampling results which support the continuation of the delisting exclusion.

    The EPA has the authority under RCRA and the Administrative Procedures Act, 5 U.S.C. 551 (1978) et seq. to reopen a delisting decision if we receive new information indicating that the conditions of this exclusion have been violated, or are otherwise not being met.

    G. What must Sandvik do if the process changes?

    If Sandvik significantly changes the manufacturing or treatment process or the chemicals used in the manufacturing or treatment process, Sandvik may not handle the wastewater treatment sludge generated from the new process under this exclusion until it has demonstrated to the EPA that the waste meets the concentrations set forth in section IV.C and that no new hazardous constituents listed in Appendix VIII of 40 CFR part 261 have been introduced. Sandvik must manage wastes generated after the process change as hazardous waste until Sandvik has received written notice from the EPA that the demonstration has been accepted.

    V. How would this action affect the states?

    Because the EPA is proposing to issue this exclusion under the federal RCRA delisting regulations, only states subject to federal RCRA delisting provisions will be affected. This exclusion may not be effective in states which have received authorization from the EPA to make their own delisting decisions.

    The EPA allows states to impose their own non-RCRA regulatory requirements that are more stringent than the EPA's, under § 3009 of RCRA. These more stringent requirements may include a provision that prohibits a federally issued exclusion from taking effect in the state. We urge petitioners to contact the state regulatory authority to establish the status of their wastes under the state law.

    The EPA has also authorized some states to administer a delisting program in place of the federal program, that is, to make state delisting decisions. Therefore, this exclusion does not apply in those authorized states. If Sandvik manages the waste in any state with delisting authorization, Sandvik must obtain delisting authorization or other determination from the receiving state before it can manage the waste as nonhazardous in that state.

    While Washington State has received final authorization to implement most of its dangerous waste program regulations in lieu of the federal program, including the listing and identification of F006 wastes (See 51 FR 3782 (January 30, 1986), it has not been authorized to implement its delisting regulations program in lieu of the federal program. The EPA notes that Washington State has provisions in the Washington Administrative Code (WAC) 173-303-910(3) similar to the federal provisions upon which this delisting is based. These provisions are in effect as a matter of state law. Thus, Sandvik must seek approval from Washington State at the state level in addition to this proposed delisting.

    VI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

    A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

    This proposed action is exempt from review by the Office of Management and Budget because it is a rule of particular applicability, not general applicability. The proposed action approves a delisting petition under RCRA for the petitioned waste at a particular facility.

    B. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs

    This proposed action is not an Executive Order 13771 regulatory action because actions such as approval of delisting petitions under RCRA are exempted under Executive Order 12866.

    C. Paperwork Reduction Act

    This proposed action does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) because it only applies to a particular facility.

    D. Regulatory Flexibility Act

    E. Because this rule is of particular applicability relating to a particular facility, it is not subject to the regulatory flexibility provision of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).

    F. Unfunded Mandates Reform Act

    This proposed action does not contain any unfunded mandate as described in the Unfunded Mandates Reform Act (2 U.S.C. 1531-1538) and does not significantly or uniquely affect small governments. The action imposes no new enforceable duty on any state, local, or tribal governments or the private sector.

    G. Executive Order 13132: Federalism

    This proposed action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

    H. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

    This proposed action does not have tribal implications as specified in Executive Order 13175. This proposed action applies only to a particular facility on non-tribal land. Thus, Executive Order 13175 does not apply to this action.

    I. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

    This proposed action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This proposed action's health and risk assessments using the Agency's Delisting Risk Assessment Software (DRAS), which considers health and safety risks to children, are described in section III.E above. The technical support document and the user's guide for DRAS are included in the docket.

    J. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use

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

    K. National Technology Transfer and Advancement Act

    This proposed action does not involve technical standards as described by the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note).

    L. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

    The EPA believes that this proposed action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples. The EPA has determined that this proposed action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. The Agency's risk assessment, as described in section III.E above, did not identify risks from management of this material in an authorized, solid waste landfill (e.g. RCRA Subtitle D landfill, commercial/industrial solid waste landfill, etc.). Therefore, the EPA believes that any populations in proximity of the landfills used by this facility should not be adversely affected by common waste management practices for this delisted waste.

    M. Congressional Review Act

    This proposed action is exempt from the Congressional Review Act (5 U.S.C. 801 et seq.) because it is a rule of particular applicability.

    List of Subjects in 40 CFR Part 261

    Environmental protection, Hazardous waste, Recycling, and Reporting and recordkeeping requirements.

    Dated: August 21, 2018. Jan Hastings, Deputy Director, Office of Air and Waste.

    For the reasons set out in the preamble, the EPA proposes to amend 40 CFR part 261 as follows:

    PART 261—IDENTIFICATION AND LISTING OF HAZARDOUS WASTE 1. The authority citation for part 261 continues to read as follows: Authority:

    42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y) and 6938.

    2. Amend Table 1 of Appendix IX to Part 261 by adding the following waste stream entry “Sandvik Special Metals” in alphabetical order to read as follows: Appendix IX to Part 261—Wastes Excluded Under §§ 260.20 and 260.22 Table 1—Wastes Excluded From Non-Specific Sources Facility Address Waste description *         *         *         *         *         *         * Sandvik Special Metals Kennewick, Washington Wastewater treatment sludges, F006, generated at Sandvik Special Metals (Sandvik) facility in Kennewick, Washington at a maximum annual rate of 1,500 cubic yards per year. The sludge must be disposed of in a Subtitle D landfill which is licensed, permitted, or otherwise authorized by a state to accept the delisted wastewater treatment sludge. The exclusion becomes effective as of [the date of final publication]. 1. Delisting Levels: (A) The constituent concentrations in a representative sample of the waste must not exceed the following levels: Total concentrations (mg/kg): Arsenic—9,840; Cadmium—37,100; Chromium—77,500; Cobalt—103,000. TCLP Concentrations (mg/l in the waste extract): Arsenic—0.042; Barium—100; Cadmium—0.451; Chromium—5.00; Cobalt—1.06; Copper—120; Fluoride—194; Lead—2.95; Nickel—66.4; Silver—5.00; Vanadium—16.9; Zinc—992. 2. Annual Verification Testing: To verify that the waste does not exceed the delisting concentrations specified in Section 1.A, Sandvik must collect and analyze one representative waste sample with coolant on an annual basis no later than each anniversary of the effective date of this delisting using methods with appropriate detection concentrations and elements of quality control. If both titanium and zirconium products have been in production and contributed to candidate wastes within the three-month period prior to each anniversary of the effective date of this delisting, samples of waste from both manufacturing processes must be collected for that reporting cycle. Otherwise, sampling only of that material in production within the specified three-month period is required. Sampling data must be provided to the EPA no later 60 days following each anniversary of the effective date of this delisting, or such later date as the EPA may agree to in writing. Sandvik must conduct all verification sampling according to a written sampling plan and associated quality assurance project plan that ensures analytical data are suitable for their intended use, which must be made available to the EPA upon request. Sandvik's annual submission must also include a certification that all wastes satisfying the delisting concentrations in Condition 1.A have been disposed of in a Subtitle D landfill which is licensed, permitted, or otherwise authorized by a state to accept the delisted wastewater treatment sludge. 3. Changes in Operating Conditions: Sandvik must notify the EPA in writing if it significantly changes the manufacturing process, the chemicals used in the manufacturing process, the treatment process, or the chemicals used in the treatment process. Sandvik must handle wastes generated after the process change as hazardous until it has demonstrated that the wastes continue to meet the delisting concentrations in section 1.C, demonstrated that no new hazardous constituents listed in 40 CFR part 261 Appendix VIII have been introduced into the manufacturing process or waste treatment process, and it has received written approval from the EPA that it may continue to manage the waste as non-hazardous. 4. Data Submittals: Sandvik must submit the data obtained through verification testing or as required by other conditions of this rule to the Director, Office of Air and Waste, U.S. EPA Region 10, 1200 6th Avenue Suite 155, OAW-150, Seattle, Washington, 98070 or his or her equivalent. The annual verification data and certification of proper disposal must be submitted within 60 days after each anniversary of the effective date of this delisting exclusion, or such later date as the EPA may agree to in writing. Sandvik must compile, summarize, and maintain on-site for a minimum of five years, records of analytical data required by this rule, and operating conditions relevant to those data. Sandvik must make these records available for inspection. All data must be accompanied by a signed copy of the certification statement in 40 CFR 260.22(i)(12). If Sandvik fails to submit the required data within the specified time or maintain the required records on-site for the specified time, the EPA may, at its discretion, consider such failure a sufficient basis to reopen the exclusion as described in paragraph 5. 5. Reopener Language—(A) If, any time after disposal of the delisted waste, Sandvik possesses or is otherwise made aware of any data relevant to the delisted waste indicating that any constituent is at a higher than the specified delisting concentration, then Sandvik must report such data, in writing, to the Director, Office of Air and Waste, EPA, Region 10, or his or her equivalent, within 10 days of first possessing or being made aware of that data. (B) Based on the information described in paragraph (A) and any other information received from any source, the EPA will make a preliminary determination as to whether the reported information requires Agency action to protect human health or the environment. Further action may include suspending, or revoking the exclusion, or other appropriate response necessary to protect human health and the environment. (C) If the EPA determines that the reported information does require Agency action, the EPA will notify Sandvik in writing of the actions it believes are necessary to protect human health and the environment. The notice shall include a statement of the proposed action and a statement providing Sandvik with an opportunity to present information as to why the proposed Agency action is not necessary or to suggest an alternative action. Sandvik shall have 30 days from the date of the EPA's notice to present the information. (D) If after 30 days Sandvik presents no further information or after a review of any submitted information, the EPA will issue a final written determination describing the Agency actions that are necessary to protect human health or the environment. Any required action described in the EPA's determination shall become effective immediately, unless the EPA provides otherwise. *         *         *         *         *         *         *
    [FR Doc. 2018-19595 Filed 9-11-18; 8:45 am] BILLING CODE 6560-50-P
    83 177 Wednesday, September 12, 2018 Notices DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Doc. No. AMS SC-18-0056; SC18-981-4] Notice of Request for Approval of New Information Collection for Almonds Grown in California (Marketing Order No. 981) AGENCY:

    Agricultural Marketing Service, USDA.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice announces the Agricultural Marketing Service's (AMS) intention to request approval for ballots and a petition form used to collect nominations of members and alternates to serve on the Board. Once approved, the forms would be merged with other forms the Board and AMS uses to collect information under Federal Marketing Order No. 981, Almonds Grown in California.

    DATES:

    Comments on this notice must be received by November 13, 2018.

    Additional Information: Contact Andrew Hatch, Supervisory Marketing Specialist, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Stop 0237, Washington, DC 20250-0237; (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected]

    Small businesses may request information on this notice by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; telephone (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected]

    Comments: Comments are welcome and should reference OMB No. 0581-NEW and the Marketing Order for Almonds Grown in California, Marketing Order No. 981, and the date and page number of this issue of the Federal Register. Comments may be submitted by mail to the Docket Clerk, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Stop 0237, Room 1406-S, Washington, DC 20250-0237; Fax: (202) 720-8938; or submitted online at http://www.regulations.gov. All comments received will be available for public inspection in the Office of the Docket Clerk during regular USDA business hours or they can be viewed at www.regulations.gov.

    SUPPLEMENTARY INFORMATION:

    Title: Almonds Grown in California, Marketing Order No. 981.

    OMB Number: 0581-NEW.

    Expiration Date of Approval: This is a NEW collection.

    Type of Request: Approval of New Information Collection.

    Abstract: Under the Agricultural Marketing Agreement Act of 1937 (AMAA), as amended (7 U.S.C. 601-674), fresh fruits, vegetables and specialty crop industries can create marketing order programs that provide an opportunity for producers, in a specified production area, to work together to solve marketing problems. The Secretary of Agriculture is authorized to oversee the marketing order operations and to consider the issuance of regulations recommended by a committee of representatives from each commodity industry.

    The Almond Marketing Order, as amended, (7 CFR part 981), hereinafter referred to as the “Order” regulates the handling of almonds grown in California. The Order authorizes research and promotion activities, as well as quality regulations, and provides for the establishment of the Almond Board of California (Board).

    The Board locally administers the Order with USDA oversight. Board members and alternates are appointed by USDA from nominations submitted by industry members to the Board. The Board conducts the nomination process with a petition form completed by individual growers and handlers to nominate themselves or others. Industry members then complete ballots to vote on those individuals whose names would be submitted to USDA for consideration for appointment to the Board. Only authorized employees of the Board, and authorized representatives of the USDA, including AMS, Specialty Crops Program's regional and headquarters staff have access to information provided on the forms.

    Requesting public comments on the ballots and petition form described below is part of the process to obtain approval of the forms by the Office of Management and Budget (OMB). These forms have been designated OMB No. 0581-NEW. The forms include Independent Grower Ballot (ABC-15), Independent Handler Ballot (ABC-16), Cooperative Grower Ballot (ABC-17), Cooperative Handler Ballot (ABC-18), and Grower Petition (ABC-19). Once approved by OMB, USDA will request permission to merge the ballots and petition form into OMB No. 0581-0178 Vegetable and Specialty Crops collection that includes other forms related to the Order.

    Estimate of Burden: Public reporting burden for this collection of information is estimated to average 5.03 minutes per response.

    Respondents: Almond producers and handlers.

    Estimated Number of Respondents: 677.

    Estimated Number of Responses: 677.

    Estimated Number of Responses per Respondent: 1.

    Estimated Total Annual Burden on Respondents: 56.83 hours.

    Comments: Comments are invited on: (1) Whether the proposed collection of the information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on 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.

    All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

    Dated: September 7, 2018. Bruce Summers, Administrator, Agricultural Marketing Service.
    [FR Doc. 2018-19827 Filed 9-11-18; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request September 7, 2018.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by October 12, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725-17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such person are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Office of the Chief Financial Officer

    Title: Request to Change FEHB Enrollment or to Receive Plan Brochures for Spouse Equity/Temporary Continuation of Coverage Enrollees/Direct Pay Annuitants (DPRS 2809).

    OMB Control Number: 0505-0024.

    Summary of Collection: Title 5, U.S. Code, Chapter 89, sections 8905 and 8905a specifies the opportunities and conditions under which a retiree, survivor annuitant, separated employee, former spouse or former dependent child of a retiree, employee, or separated employee is eligible to change enrollment in the Federal Employees Health Benefits (FEHB) Program. DPRS-2809 is completed by the enrollee to make an open season enrollment change.

    Need and Use of the Information: The DPRS-2809 is administered by the U.S. Department of Agriculture's National Finance Center (NFC) for use by separated employees or former spouses and former dependent children of active or separated employees. NFC determines whether all conditions permitting change in enrollment are met and implements the enrollment change. NFC also informs the FEHB carriers of the action. If this information were not collected, NFC could not comply with the provisions of title 5, U.S. Code, Chapter 89.

    Description of Respondents: Individuals.

    Number of Respondents: 25,000.

    Frequency of Responses: Reporting: Other (One time).

    Total Burden Hours: 18,750.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2018-19820 Filed 9-11-18; 8:45 am] BILLING CODE 3410-KS-P
    DEPARTMENT OF AGRICULTURE Rural Utilities Service Announcement of Disaster Assistance Grant Application Deadlines and Funding Levels AGENCY:

    Rural Utilities Service, USDA.

    ACTION:

    Notice of funds availability.

    SUMMARY:

    As part of the Bipartisan Budget Act of 2018, Public Law 115-123, dated February 9, 2018, the Rural Utilities Service's Water and Environmental Programs (WEP) received $165,475,000 in supplemental grant funding of which $163,475,000 is available for repairs to drinking water systems and sewer and solid waste disposal systems impacted by Hurricanes Harvey, Irma, and Maria. States impacted include: Florida, Georgia, South Carolina, Texas, and the territories of Puerto Rico and Virgin Islands.

    DATES:

    Unless otherwise specified in this Notice, applications will be accepted on a continual basis until funds are exhausted.

    ADDRESSES:

    Entities wishing to apply for assistance, or that are in need of further information, should contact the USDA Rural Development State Office in the State where the project is located. A list of the USDA Rural Development State Offices addresses and telephone numbers is as follows:

    Note:

    Telephone numbers are not toll-free.

    Florida/Virgin Islands USDA Rural Development State Office, 4440 NW 25th Place, P.O. Box 147010, Gainesville, FL 32614-7010, (352) 338-3400/TDD (352) 338-3499. Georgia USDA Rural Development State Office, Stephens Federal Building, 355 E Hancock Avenue, Athens, GA 30601-2768, (706) 546-2162/TDD (706) 546-2034. South Carolina USDA Rural Development State Office, Strom Thurmond Federal Building, 1835 Assembly Street, Room 1007, Columbia, SC 29201, (803) 765-5163/TDD (803) 765-5697. Texas USDA Rural Development State Office, Federal Building, Suite 102, 101 South Main, Temple, TX 76501, (254) 742-9700/TDD (254) 742-9712. Puerto Rico USDA Rural Development State Office, IBM Building, Suite 601, 654 Munos Rivera Avenue, San Juan, PR 00918-6106, (787) 766-5095/TDD (787) 766-5332. FOR FURTHER INFORMATION CONTACT:

    Main point of contact: Derek Jones, Community Programs Specialist, Water and Environmental Programs, Rural Utilities Service, Rural Development, U.S. Department of Agriculture.

    Phone: (202) 720-9640.

    Fax: (202) 690-0649.

    Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995, the information collection requirements associated with the Program, as covered in this Notice, have been approved by the Office of Management Budget (OMB) under OMB Control Number 0572-0121.

    Overview

    Federal Agency Name: Rural Utilities Service (“RUS,” an Agency of USDA in the Rural Development mission area).

    Solicitation Opportunity Title: Announcement of Disaster Assistance Grant Application Deadlines and Funding Levels.

    Announcement Type: Notice of Funds Availability.

    Catalog of Federal Domestic Assistance (CFDA) Number: The CFDA number for this Notice is 10.760.

    Dates: Unless otherwise specified in this Notice, applications will be accepted on a continual basis until funds are exhausted.

    A. Program Description

    This program is designed to provide supplemental grant funding for repairs to drinking water systems and sewer and solid waste disposal systems impacted by Hurricanes Harvey, Irma, and Maria in the states of Florida, Georgia, South Carolina, Texas, and the territories of Puerto Rico and Virgin Islands.

    Details on eligible applicants and projects may be found in the relevant regulations listed in Section B, Eligibility Information below.

    The applicable Statutory or Regulatory authority for this action includes:

    • Bipartisan Budget Act of 2018, Public Law 115-123, Rural Utilities Service Rural Water and Waste Disposal Program Account.

    • 2 CFR parts 200 and 400, uniform Federal grant awards regulations.

    B. Federal Award Description—Disaster Assistance Grants

    The Bipartisan Budget Act of 2018, Public Law 115-123, dated February 9, 2018, enables USDA Rural Development to provide: WEP $165,475,000 in supplemental grant funding of which $163,475,000 is available for repairs to drinking water systems and sewer and solid waste disposal systems impacted by Hurricanes Harvey, Irma, and Maria in the states of Florida, Georgia, South Carolina, Texas, and the territories of Puerto Rico and Virgin Islands.

    C. Eligibility Information

    1. Applicant eligibility. An eligible Applicant must:

    (i) Be either a Public Body, a Nonprofit Corporation, or an Indian tribe.

    (ii) Be eligible to receive a Federal loan or grant under Federal law.

    (iii) Certify in writing, and the Agency shall determine and document, that (1) the Applicant is unable to finance the proposed project from their own resources or through commercial credit at reasonable rates and terms, or as applicable, (2) the applicant made repairs by utilizing their own resources or by obtaining commercial credit and as a result is experiencing financial hardship that is impacting its operations and its customers.

    (iv) Have the legal authority necessary for owning, constructing, operating, and maintaining the facility or service to be repaired or replaced and for obtaining security for the proposed grant. The Applicant shall be responsible for operating, maintaining, and managing the facility, and providing for its continued availability and use at reasonable user rates and charges. The Applicant shall retain this responsibility even though the facility may be operated, maintained, or managed by a third party under contract or management agreement. Applicants must submit evidence of legal authority before grant approval/obligation

    (v) Demonstrate that they possess the technical, managerial, and financial capability necessary to consistently comply with pertinent Federal and State laws and requirements.

    (vi) Be current on the repayment of all debts at the time they are due.

    2. Eligible facilities. An eligible facility must serve a rural area. The term rural or rural area means a city, town, or unincorporated area that has a population of no more than 50,000 in habitants. Projects funded by the Agency may be located in non-rural areas. However, grant funds may be used to repair only that portion of the facility serving and benefiting rural areas, regardless of project location, that has a population up to 50,000.

    3. State nonmetropolitan median household income (MHI) according to the American Community Survey (ACS) five-year data (2006-2010). An income survey may also be conducted to determine rural area income if the ACS sample size is insufficient and/or does not accurately represent the city or town's median household income. If the MHI of the population being served is less than the poverty or 80% of State Non-metro median household grant, then the project may qualify for up to 100% grant. If MHI is between 80% SNMHI and 100%, then the project may qualify for up to 75% grant. If SNMHI is over 100%, then the project is limited to 45% grant. If the project does not qualify for 100% grant, then the system may supplement the funding from applicant contribution and/or other funding sources. Median household income is according to the American Community Survey (ACS) five-year data (2006-2010).

    4. Eligible grant purposes. Grant funds may only be used to repair damages to drinking water systems or sewer and solid waste disposal systems caused by Hurricanes Harvey, Irma, or Maria. If repairs to a system are not economically feasible or cost-effective due to the extent of the damage caused by a hurricane, WEP will consider replacement (as opposed to repair) on a case-by-case basis.

    For such repairs and replacements already made to restore service, grants may be awarded to reimburse applicants for expenses incurred by the applicant. These expenses must have been incurred within two years from the date of the covered hurricane. Reimbursement must be justified by a clear demonstration of financial hardship to the system or its customers due to the use of its own funds or commercial credit to make such repairs or replacement. There shall be no reimbursement for repairs or replacements made or financed through the use of other Federal funds such as Federal Emergency Management Agency, Environmental Protection Agency, or other Federal source of assistance used for repairs or replacement, or through insurance proceeds

    D. Application and Submission Information

    1. Address to Request Application Package. The packages will be submitted to the USDA Rural Development State Office in the State where the project is located as listed in the ADDRESSES section of this Notice. Applicants can also apply through RUS' website for online applications, RDApply. The RDApply website link is as follows: https://rdapply.usda.gov.

    2. Content and Form of Application Submission. Applicants will be required to submit the following items to the processing office, upon notification from the processing office to proceed with further development of the full application. The forms below are available on the RD website: (https://forms.sc.egov.usda.gov/eForms/welcomeAction.do?Home):

    i. Form RD 442-7, “Operating Budget” or similar form.

    ii. Form RD 1910-11, “Application Certification, Federal Collection Policies for Consumer or Commercial Debts;”

    iii. Form RD 400-1, “Equal Opportunity Agreement;”

    iv. Form RD 400-4, “Assurance Agreement;”

    v. Form AD-1047, “Certification Regarding Debarment, Suspension and other Responsibility Matters;”

    vii. Form AD-1049, “Certification regarding Drug-Free Workplace Requirements (Grants) Alternative I For Grantees Other Than Individuals;”

    viii. Certifications for Contracts, Grants, and Loans (Regarding Lobbying); and

    ix. Certification regarding prohibited tying arrangements. Applicants that provide electric service must provide the Agency a certification that they will not require users of a water or waste facility financed under this Notice to accept electric service as a condition of receiving water assistance.

    3. Dun and Bradstreet Universal Systems (DUNS) Number and System for Award Management (SAM). Dun and Bradstreet Data Universal Numbering System (DUNS) and System for Awards Management (SAM) Grant applicants must obtain a Dun and Bradstreet Data Universal Numbering System (DUNS) number and register in the System for Award Management (SAM) prior to submitting an application pursuant to 2 CFR 25.200(b). In addition, an entity applicant must maintain registration in SAM at all times during which it has an active Federal award or an application or plan under consideration by the Agency. Similarly, all recipients of Federal financial assistance are required to report information about first-tier subawards and executive compensation in accordance to 2 CFR part 170. So long as an entity applicant does not have an exception under 2 CFR 170.110(b), the applicant must have the necessary processes and systems in place to comply with the reporting requirements should the applicant receive funding. See 2 CFR 170.200(b). An applicant, unless excepted under 2 CFR 25.110(b), (c), or (d), is required to:

    i. Be registered in SAM before submitting its application;

    ii. Provide a valid DUNS number in its application; and

    iii. Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by a Federal awarding agency.

    The Federal awarding agency may not make a federal award to an applicant until the applicant has complied with all applicable DUNS and SAM requirements and, if an applicant has not fully complied with the requirements by the time the Federal awarding agency is ready to make a Federal award, the Federal awarding agency may determine that the applicant is not qualified to receive a Federal award and use that determination as a basis for making a Federal award to another applicant. As required by the Office of Management and Budget (OMB), all grant applications must provide a DUNS number when applying for Federal grants, on or after October 1, 2003. Organizations can receive a DUNS number at no cost by calling the dedicated toll-free number at 1-866-705-5711 or via internet at http://fedgov.dnb.com/webform. Additional information concerning this requirement can be obtained on the Grants.gov website at http://www.grants.gov. Similarly, applicants may register for SAM at https://www.sam.gov or by calling 1-866-606-8220. The applicant must provide documentation that they are registered in SAM and their DUNS number. If the applicant does not provide documentation that they are registered in SAM and their DUNS number, the application will not be considered for funding.

    You will need the following information when requesting a DUNS number:

    i. Legal Name of the Applicant;

    ii. Headquarters name and address of the Applicant;

    iii. The names under which the Applicant is doing business as (dba) or other name by which the organization is commonly recognized;

    iv. Physical address of the Applicant;

    v. Mailing address (if separate from headquarters and/or physical address) of the Applicant;

    vi. Telephone number;

    vii. Contact name and title; and

    viii. Number of employees at the physical location.

    4. Submission Dates and Times. Unless otherwise specified in this Notice, applications will be accepted on a rolling basis until funds are exhausted.

    5. Intergovernmental Review. The following program is subject to the provisions of Executive Order 12372 which requires intergovernmental consultation with State and local officials, pursuant to 2 CFR part 415, subpart C, as a covered program.

    6. Funding Restrictions. Grant funds may not be used to finance:

    i. Repairs or replacement of facilities not directly impacted by Hurricanes Harvey, Irma, or Maria;

    ii. Facilities which are not modest in size, design, and cost;

    iii. Grant finder's fees;

    iv. Any portion of the cost of a facility which does not serve a rural area as defined in this Notice;

    v. That portion of project costs normally provided by a business or industrial user, such as wastewater pretreatment;

    vi. Rental for the use of equipment or machinery owned by the applicant; or

    vii. Other purposes not directly related to operating and maintenance of the facility being repaired or replaced.

    E. Application Review Information

    Within 15 days of receiving your application, RUS will send you a letter of acknowledgment. Your application will be reviewed for completeness to determine if you included all of the items required. If your application is incomplete or ineligible, RUS will return it to you with an explanation. Applicants may resubmit applications deemed incomplete or ineligible after revising them in accordance with RUS explanation.

    1. Criteria. In the event demand for funding is greater than the amount of funds available, a priority ranking scoring system will be used to determine which projects are funded. When ranking eligible applications for consideration for limited funds, Agency officials will consider the priority items met by each application and the degree to which those priorities are met. Points will be awarded as indicated below. This is a new grant program. Some guidelines historically utilized in other grant programs informed the development of the point system.

    Priorities Points i. Population: The proposed project will serve an area with a rural population: a. Not in excess of 1,500 30 b. More than 1,500 and not in excess of 3,000 20 c. More than 3,000 and not in excess of 5,000 15 d. Over 5,000 0 ii. Income: The median household income of population to be served by the proposed project is: a. Not in excess of 70 percent of the statewide nonmetropolitan median household income 30 b. More than 70 percent and not in excess of 80 percent of the statewide nonmetropolitan median household income 20 c. More than 80 percent and not in excess of 90 percent of the statewide nonmetropolitan median household income 10 d. More than 90 percent of the statewide nonmetropolitan Median household income 0 iii. Health Priorities: a. Needed to alleviate an emergency situation, correct unanticipated diminution in quantity or deterioration in quality of a water supply, or to meet Safe Drinking Water Act requirements which pertain to a water system. 25 b. Required to correct inadequacies of a wastewater disposal system, or to meet health standards which pertain to a wastewater disposal system. 25 c. Required to meet administrative orders issued to Correct local, State or Federal solid waste violations 15 iv Other Priorities: a. Applicant is a public body or Indian Tribe 5 b. Amount of other than RUS funds committed to the project: A. 50% or more 15 B. 20% to 49% 10 C. 5%-19% 5 D. Less than 5% 0 c. The utility has not been able to secure the funds needed for repairs from its own resources or from commercial credit 15 d. The proposed project will serve an area that has an unreliable quality or supply of drinking water 10

    The RUS Administrator may assign up to 15 additional points that will be considered in the total points. These points will be added to address items such as geographic distribution of funds, the highest priority projects within the jurisdiction, and emergency conditions caused by the hurricanes. The Administrator may delegate the authority to assign these points to National Office staff.

    2. Review and Selection Process. All applications will be processed and scored in the State Office and then reviewed for funding priority at the National Office. RUS will rank all qualifying applications by their final score. Applications will be selected for funding, based on the highest scores. Each applicant will be notified in writing of the score its application receives and whether it was approved for funding.

    F. Federal Award Administration Information

    1. Federal Review Notices. RUS generally notifies by mail those applicants whose projects were approved for funding. However, the receipt of an approval letter does not serve to authorize the applicant to commence performance under the grant. RUS follows the approval letter with a grant agreement containing terms and conditions for the grant. Applicants selected for funding will complete and return grant agreement, which outlines the terms and conditions of the grant award and other forms as required.

    2. Administrative and National Policy. The items listed in Section A of this notice, and Departmental and other regulations including 2 CFR parts 180, 182, 200, 400, 421 and any successor regulations implementing the appropriate administrative and national policy requirements of this grant program, which include but are not limited to:

    i. SF-270, “Request for Advance or Reimbursement,” will be completed by the Non-Federal Entity and submitted to either the State or National office no more frequently than monthly.

    ii. Upon receipt of a properly completed SF-270, the funds will be requested through the field office terminal system. Ordinarily, payment will be made within 30 days after receipt of a proper request for reimbursement.

    iii. Non-Federal Entities may use women- and minority-owned banks (a bank which is owned at least 50 percent by women or minority group members) for the deposit and disbursement of funds.

    3. Reporting.

    i. Any change in the scope of the project or any other significant change in the project must be reported to and approved by the approval official by written amendment to the grant agreement. Any change not approved may be cause for termination of the grant.

    ii. Non-Federal Entities shall constantly monitor performance to ensure that time schedules are being met, projected work by time periods is being accomplished, and other performance objectives are being achieved. The Non-Federal Entity will provide project reports to the Agency as follows:

    iii. SF-425, “Financial Status Report (short form),” and a project performance activity report will be required of all Non-Federal Entities on a quarterly basis, due 30 days after the end of each quarter.

    iv. A final project performance report will be required with the last SF-425 due 90 days after the end of the last quarter in which the project is completed.

    v. Financial reporting. The Non-Federal Entity will provide an audit report or financial statements to the Agency as follows:

    vi. Non-Federal Entities expending $750,000 or more Federal funds per fiscal year will submit an audit conducted in accordance with 2 CFR part 200. The audit will be submitted within nine months after the Non-Federal Entity's fiscal year. Additional audits may be required if the project period covers more than one fiscal year.

    vii. Non-Federal Entities expending less than $750,000 will provide annual financial statements covering the grant period, consisting of the organization's statement of income and expense and balance sheet signed by an appropriate official of the organization. Financial statements will be submitted within 90 days after the Non-Federal Entity's fiscal year.

    G. Federal Awarding Contacts

    Main point of contact: Derek Jones, Community Programs Specialist, Water and Environmental Programs, Rural Utilities Service, Rural Development, U.S. Department of Agriculture.

    Phone: (202) 720-9640.

    Fax: (202) 690-0649.

    Email: [email protected].

    H. Other Information

    1. Civil Rights. Programs referenced in this Notice are subject to applicable Civil Rights Laws. These laws include the Equal Credit Opportunity Act, Title VI of the Civil Rights Act of 1964, Title VIII of the Civil Rights Act of 1968, as amended in 1988, and Section 504 of the Rehabilitation Act of 1973.

    2. Non-Discrimination Statement. In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program. Political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

    Persons with disabilities who require alternative means of communication for program information (e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

    To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at: http://www.ascr.usda.gov/complaint_filing_cust.html, and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of a complaint form, call, (866) 632-9992. Submit your completed form or letter to USDA by:

    1. Mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410;

    2. Fax: (202) 690-7442; or

    3. Email at: [email protected]

    USDA is an equal opportunity provider, employer, and lender.

    Dated: September 6, 2018. Christopher A. McLean, Acting Administrator, Rural Utilities Service.
    [FR Doc. 2018-19784 Filed 9-11-18; 8:45 am] BILLING CODE 3410-15-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 2059] Reorganization and Expansion of Foreign-Trade Zone 135 Under Alternative Site Framework; Palm Beach, Florida

    Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:

    Whereas, the Foreign-Trade Zones (FTZ) Act provides for “. . . the establishment . . . of foreign-trade zones in ports of entry of the United States, to expedite and encourage foreign commerce, and for other purposes,” and authorizes the Foreign-Trade Zones Board to grant to qualified corporations the privilege of establishing foreign-trade zones in or adjacent to U.S. Customs and Border Protection ports of entry;

    Whereas, the Board adopted the alternative site framework (ASF) (15 CFR 400.2(c)) as an option for the establishment or reorganization of zones;

    Whereas, the Port of Palm Beach District, grantee of Foreign-Trade Zone 135, submitted an application to the Board (FTZ Docket B-12-2018, docketed February 9, 2018) for authority to reorganize and expand under the ASF with a service area of Palm Beach County, Martin County and St. Lucie County (with the exception of Sites 1 through 4 of FTZ 218, which are located in St. Lucie County), in and adjacent to the West Palm Beach Customs and Border Protection port of entry, and FTZ 135's existing Sites 1, 4, 5, 6 and 8 would be categorized as magnet sites and Sites 2, 3, 7, 9, 10, 11 and 12 would be categorized as usage-driven sites;

    Whereas, notice inviting public comment was given in the Federal Register (83 FR 7451-7452, February 21, 2018) and the application has been processed pursuant to the FTZ Act and the Board's regulations; and,

    Whereas, the Board adopts the findings and recommendations of the examiner's report, and finds that the requirements of the FTZ Act and the Board's regulations are satisfied;

    Now, therefore, the Board hereby orders:

    The application to reorganize and expand FTZ 135 under the ASF is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, to the Board's standard 2,000-acre activation limit for the zone, to an ASF sunset provision for magnet sites that would terminate authority for Sites 4, 5, 6 and 8 if not activated within five years from the month of approval, and to an ASF sunset provision for usage-driven sites that would terminate authority for Sites 2, 3, 7, 9, 10, 11 and 12 if no foreign-status merchandise is admitted for a bona fide customs purpose within three years from the month of approval.

    Dated: September 6, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, Alternate Chairman, Foreign-Trade Zones Board.
    [FR Doc. 2018-19851 Filed 9-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 2058] Approval of Subzone Status; Driftwood LNG, LLC, Sulphur, Louisiana

    Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:

    Whereas, the Foreign-Trade Zones (FTZ) Act provides for “. . . the establishment. . . of foreign-trade zones in ports of entry of the United States, to expedite and encourage foreign commerce, and for other purposes,” and authorizes the Foreign-Trade Zones Board to grant to qualified corporations the privilege of establishing foreign-trade zones in or adjacent to U.S. Customs and Border Protection ports of entry;

    Whereas, the Board's regulations (15 CFR part 400) provide for the establishment of subzones for specific uses;

    Whereas, the Lake Charles Harbor & Terminal District, grantee of Foreign-Trade Zone 87, has made application to the Board for the establishment of a subzone at the facility of Driftwood LNG, LLC, located in Sulphur, Louisiana (FTZ Docket B-31-2018, docketed May 17, 2018);

    Whereas, notice inviting public comment has been given in the Federal Register (83 FR 23633, May 22, 2018) and the application has been processed pursuant to the FTZ Act and the Board's regulations; and,

    Whereas, the Board adopts the findings and recommendations of the examiner's memorandum, and finds that the requirements of the FTZ Act and the Board's regulations are satisfied;

    Now, therefore, the Board hereby approves subzone status at the facility of Driftwood LNG, LLC, located in Sulphur, Louisiana (Subzone 87G), as described in the application and Federal Register notice, subject to the FTZ Act and the Board's regulations, including Section 400.13.

    Dated: September 6, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance Alternate Chairman Foreign-Trade Zones Board.
    [FR Doc. 2018-19850 Filed 9-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 2060] Reorganization of Foreign-Trade Zone 158 Under Alternative Site Framework; Vicksburg/Jackson, Mississippi

    Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:

    Whereas, the Foreign-Trade Zones (FTZ) Act provides for “. . . the establishment . . . of foreign-trade zones in ports of entry of the United States, to expedite and encourage foreign commerce, and for other purposes,” and authorizes the Foreign-Trade Zones Board to grant to qualified corporations the privilege of establishing foreign-trade zones in or adjacent to U.S. Customs and Border Protection ports of entry;

    Whereas, the Board adopted the alternative site framework (ASF) (15 CFR Sec. 400.2(c)) as an option for the establishment or reorganization of zones;

    Whereas, the Greater Mississippi Foreign-Trade Zone, Inc., grantee of Foreign-Trade Zone 158, submitted an application to the Board (FTZ DocketB-22-2018, docketed April 10, 2018) for authority to reorganize under the ASF with a service area of Claiborne, Hinds, Madison, Marshall, Pontotoc, Rankin, Tate, Warren and Washington Counties, Mississippi and portions of Lee and Tishomingo Counties, Mississippi, in and adjacent to the Vicksburg and Greenville (Mississippi), Memphis (Tennessee) and Huntsville (Alabama) Customs and Border Protection ports of entry, and FTZ 158's existing Sites 2, 10, 11, 14, 15, 16, 17 and 18 would be categorized as magnet sites;

    Whereas, notice inviting public comment was given in the Federal Register (83 FR 17144, April 18, 2018) and the application has been processed pursuant to the FTZ Act and the Board's regulations; and,

    Whereas, the Board adopts the findings and recommendations of the examiner's report, and finds that the requirements of the FTZ Act and the Board's regulations are satisfied;

    Now, therefore, the Board hereby orders:

    The application to reorganize FTZ 158 under the ASF is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, to the Board's standard 2,000-acre activation limit for the zone, and to an ASF sunset provision for magnet sites that would terminate authority for Sites 10, 11, 14, 15, 16, 17 and 18 if not activated within five years from the month of approval.

    Dated: September 6, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, Alternate Chairman, Foreign-Trade Zones Board.
    [FR Doc. 2018-19843 Filed 9-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 2057] Reorganization of Foreign-Trade Zone 105 Under Alternative Site Framework Providence, Rhode Island

    Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:

    Whereas, the Foreign-Trade Zones (FTZ) Act provides for “. . . the establishment . . . of foreign-trade zones in ports of entry of the United States, to expedite and encourage foreign commerce, and for other purposes,” and authorizes the Foreign-Trade Zones Board to grant to qualified corporations the privilege of establishing foreign-trade zones in or adjacent to U.S. Customs and Border Protection ports of entry;

    Whereas, the Board adopted the alternative site framework (ASF) (15 CFR Sec. 400.2(c)) as an option for the establishment or reorganization of zones;

    Whereas, the Rhode Island Commerce Corporation, grantee of Foreign-Trade Zone 105, submitted an application to the Board (FTZ Docket B-4-2018, docketed January 25, 2018) for authority to reorganize under the ASF with a service area of the Counties of Bristol, Kent, Newport, Providence and Washington, Rhode Island, in and adjacent to the Providence Customs and Border Protection port of entry, and FTZ 105's existing Sites 1, 2 and 3 would be categorized as magnet sites;

    Whereas, notice inviting public comment was given in the Federal Register (83 FR 4466, January 31, 2018) and the application has been processed pursuant to the FTZ Act and the Board's regulations; and,

    Whereas, the Board adopts the findings and recommendations of the examiner's report, and finds that the requirements of the FTZ Act and the Board's regulations are satisfied;

    Now, therefore, the Board hereby orders:

    The application to reorganize FTZ 105 under the ASF is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, to the Board's standard 2,000-acre activation limit for the zone, and to an ASF sunset provision for magnet sites that would terminate authority for Sites 2 and 3 if not activated within five years from the month of approval.

    Dated: September 6, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance Alternate Chairman, Foreign-Trade Zones Board.
    [FR Doc. 2018-19846 Filed 9-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 2061] Reorganization of Foreign-Trade Zone 179 Under Alternative Site Framework, Madawaska, Maine

    Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:

    Whereas, the Foreign-Trade Zones (FTZ) Act provides for “. . . the establishment . . . of foreign-trade zones in ports of entry of the United States, to expedite and encourage foreign commerce, and for other purposes,” and authorizes the Foreign-Trade Zones Board to grant to qualified corporations the privilege of establishing foreign-trade zones in or adjacent to U.S. Customs and Border Protection ports of entry;

    Whereas, the Board adopted the alternative site framework (ASF) (15 CFR Sec. 400.2(c)) as an option for the establishment or reorganization of zones;

    Whereas, the Madawaska Foreign-Trade Zone Corporation, grantee of Foreign-Trade Zone 179, submitted an application to the Board (FTZ DocketB-5-2018, docketed January 25, 2018) for authority to reorganize under the ASF with a service area of the towns of Fort Kent, Frenchville, Grand Isle, Madawaska, St. Agatha and Van Buren, Maine, in and adjacent to the Madawaska Customs and Border Protection port of entry, and FTZ 179's existing Site 1 would be removed;

    Whereas, notice inviting public comment was given in the Federal Register (83 FR 4466, January 31, 2018), and the application has been processed pursuant to the FTZ Act and the Board's regulations; and,

    Whereas, the Board adopts the findings and recommendations of the examiner's report, and finds that the requirements of the FTZ Act and the Board's regulations are satisfied;

    Now, therefore, the Board hereby orders:

    The application to reorganize FTZ 179 under the ASF is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, and to the Board's standard 2,000-acre activation limit for the zone.

    Dated: September 6, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, Alternate Chairman, Foreign-Trade Zones Board.
    [FR Doc. 2018-19844 Filed 9-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-122-855] Polyethylene Terephthalate Resin From Canada: Notice of Rescission of Antidumping Duty Administrative Review; 2017-2018 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) is rescinding its administrative review of polyethylene terephthalate resin from Canada for the period or review (POR) May 1, 2017, through April 30, 2018.

    DATES:

    Applicable September 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Karine Gziryan, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4081.

    SUPPLEMENTARY INFORMATION:

    Background

    On May 1, 2018, Commerce published in the Federal Register a notice of “Opportunity to Request Administrative Review” of the antidumping duty order on polyethylene terephthalate resin from Canada for the POR.1 On May 31, 2018, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213(b), Commerce received a timely request from Compagnie Selenis Canada (Selenis) to conduct an administrative review.2

    1See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 83 FR 19047 (May 1, 2018).

    2See Letter from Selenis, “Administrative Review of the Antidumping Duty Order on Polyethylene Terephthalate Resin from Canada: Request for Review,” dated May 31, 2018.

    Pursuant to this request and in accordance with 19 CFR 351.221(c)(1)(i), on July 12, 2018, Commerce published a notice of initiation of an administrative review of the antidumping duty order on polyethylene terephthalate resin from Canada.3 On July 18, 2018, Commerce issued its antidumping duty questionnaire to Selenis. On August 3, 2018, Selenis withdrew its request for an administrative review.4

    3See Initiation of Antidumping and Countervailing Duty Administrative Review, 83 FR 32270 (July 12, 2018) (Initiation Notice).

    4See Letter from Selenis, “Administrative Review of the Antidumping Duty Order on Polyethylene Terephthalate Resin from Canada: Withdrawal of Request for Review,” dated August 3, 2018.

    Rescission of Review

    Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review if the party that requested the review withdraws its request within 90 days of the publication date of the notice of initiation of the requested review. Selenis withdrew its review request before the 90-day deadline, and no other party requested an administrative review of the antidumping duty order. Therefore, in accordance with 19 CFR 351.213(d)(1), we are rescinding this administrative review in its entirety.

    Assessment

    Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries of polyethylene terephthalate resin from Canada. Antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, during the period May 1, 2017, through April 30, 2018, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions to CBP 41 days after the date of publication of this notice in the Federal Register.

    Notification to Importers

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

    Notification Regarding Administrative Protective Order

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

    This notice is published in accordance with section 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).

    Dated: September 6, 2018. James Maeder, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2018-19831 Filed 9-11-18; 8:45 am] BILLING CODE 3510-DS-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION Credit Union Advisory Council Meeting AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    Under the Federal Advisory Committee Act (FACA), this notice sets forth the announcement of a public meeting of the Credit Union Advisory Council (CUAC or Council) of the Bureau of Consumer Financial Protection (Bureau). The notice also describes the functions of the Council.

    DATES:

    The meeting date is Thursday, September 27, 2018, from approximately 9:30 a.m. to 4 p.m. eastern daylight time.

    ADDRESSES:

    The meeting location is the Bureau of Consumer Financial Protection, 1700 G Street NW, Washington, DC 20552.

    FOR FURTHER INFORMATION CONTACT:

    Crystal Dully, Outreach and Engagement Associate, Consumer Advisory Board and Councils Office, External Affairs, at 202-435-9588, [email protected] If you require this document in an alternative electronic format, please contact [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Section 2 of the CUAC Charter provides that pursuant to the executive and administrative powers conferred on the Bureau of Consumer Financial Protection by section 1012 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), the Director established the Credit Union Advisory Council under agency authority.

    Section 3 of the CUAC Charter states: “The purpose of the Advisory Council is to advise the Bureau in the exercise of its functions under the federal consumer financial laws as they pertain to community banks with total assets of $10 billion or less.”

    II. Agenda

    The Credit Union Advisory Council will discuss policy issues related to financial technology.

    Persons who need a reasonable accommodation to participate should contact [email protected], 202-435-9EEO, 1-855-233-0362, or 202-435-9742 (TTY) at least ten business days prior to the meeting or event to request assistance. The request must identify the date, time, location, and title of the meeting or event, the nature of the assistance requested, and contact information for the requester. The Bureau will strive to provide, but cannot guarantee that accommodation will be provided for late requests.

    Written comments will be accepted from interested members of the public and should be sent to [email protected], a minimum of seven (7) days in advance of the meeting. The comments will be provided to the CUAC members for consideration.

    Individuals who wish to join the Credit Union Advisory Council must RSVP via this link https://consumer-financial-protection-bureau.forms.fm/september-27-advisory-board-and-council-meeting by noon, September 26, 2018. Members of the public must RSVP by the due date.

    III. Availability

    The Council's agenda will be made available to the public on Wednesday September 12, 2018, via consumerfinance.gov. Individuals should express in their RSVP if they require a paper copy of the agenda.

    A recording and summary of this meeting will be available after the meeting on the Bureau's website consumerfinance.gov.

    Dated: September 6, 2018. Kirsten Sutton, Chief of Staff, Bureau of Consumer Financial Protection.
    [FR Doc. 2018-19788 Filed 9-11-18; 8:45 am] BILLING CODE 4810-AM-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION Community Bank Advisory Council Meeting AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    Under the Federal Advisory Committee Act (FACA), this notice sets forth the announcement of a public meeting of the Community Bank Advisory Council (CBAC or Council) of the Bureau of Consumer Financial Protection (Bureau). The notice also describes the functions of the Council.

    DATES:

    The meeting date is Thursday, September 27, 2018, from approximately 9:30 a.m. to 4:00 p.m. eastern daylight time.

    ADDRESSES:

    The meeting location is the Bureau of Consumer Financial Protection, 1700 G Street NW, Washington, DC 20552.

    FOR FURTHER INFORMATION CONTACT:

    Crystal Dully, Outreach and Engagement Associate, Consumer Advisory Board and Councils Office, External Affairs, at 202-435-9588, [email protected]. If you require this document in an alternative electronic format, please contact [email protected].

    SUPPLEMENTARY INFORMATION: I. Background

    Section 2 of the CBAC Charter provides that pursuant to the executive and administrative powers conferred on the Bureau of Consumer Financial Protection by section 1012 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), the Director established the Community Bank Advisory Council under agency authority.

    Section 3 of the CBAC Charter states: “The purpose of the Advisory Council is to advise the Bureau in the exercise of its functions under the federal consumer financial laws as they pertain to community banks with total assets of $10 billion or less.”

    II. Agenda

    The Community Bank Advisory Council will discuss policy issues related to financial technology.

    Persons who need a reasonable accommodation to participate should contact [email protected], 202-435-9EEO, 1-855-233-0362, or 202-435-9742 (TTY) at least ten business days prior to the meeting or event to request assistance. The request must identify the date, time, location, and title of the meeting or event, the nature of the assistance requested, and contact information for the requester. CFPB will strive to provide, but cannot guarantee that accommodation will be provided for late requests.

    Written comments will be accepted from interested members of the public and should be sent to [email protected], a minimum of seven (7) days in advance of the meeting. The comments will be provided to the CBAC members for consideration.

    Individuals who wish to join the Community Bank Advisory Council must RSVP via this link https://consumer-financial-protection-bureau.forms.fm/september-27-advisory-board-and-council-meeting by noon, September 26, 2018. Members of the public must RSVP by the due date.

    III. Availability

    The Council's agenda will be made available to the public on Wednesday September 26, 2018, via consumerfinance.gov. Individuals should express in their RSVP if they require a paper copy of the agenda.

    A recording and summary of this meeting will be available after the meeting on the Bureau's website consumerfinance.gov.

    Dated: September 6, 2018. Kirsten Sutton, Chief of Staff, Bureau of Consumer Financial Protection.
    [FR Doc. 2018-19787 Filed 9-11-18; 8:45 am] BILLING CODE 4810-AM-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION Consumer Advisory Board Subcommittee Meetings AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    Under the Federal Advisory Committee Act (FACA), this notice sets forth the announcement of a public meeting of the Consumer Advisory Board (CAB or Board) of the Bureau of Consumer Financial Protection (Bureau). The notice also describes the functions of the Board.

    DATES:

    The meeting date is Thursday, September 27, 2018, from approximately 9:30 a.m. to 4:00 p.m. eastern daylight time.

    FOR FURTHER INFORMATION CONTACT:

    Crystal Dully, Outreach and Engagement Associate, Advisory Board and Councils Office, External Affairs, at 202-435-9588, [email protected]. If you require this document in an alternative electronic format, please contact [email protected].

    SUPPLEMENTARY INFORMATION: I. Background

    Section 3 of the Charter of the Consumer Advisory Board states that:

    The purpose of the Board is outlined in section 1014(a) of the Dodd-Frank Act, which states that the Board shall “advise and consult with the Bureau in the exercise of its functions under the Federal consumer financial laws” and “provide information on emerging practices in the consumer financial products or services industry, including regional trends, concerns, and other relevant information.

    To carry out the Board's purpose, the scope of its activities shall include providing information, analysis, and recommendations to the Bureau. The Board will generally serve as a vehicle for market intelligence and expertise for the Bureau. Its objectives will include identifying and assessing the impact on consumers and other market participants of new, emerging, and changing products, practices, or services.

    II. Agenda

    The Consumer Advisory Board will discuss policy issues related to financial technology.

    Persons who need a reasonable accommodation to participate should contact [email protected], 202-435-9EEO, 1-855-233-0362, or 202-435-9742 (TTY) at least ten business days prior to the meeting or event to request assistance. The request must identify the date, time, location, and title of the meeting or event, the nature of the assistance requested, and contact information for the requester. CFPB will strive to provide, but cannot guarantee that accommodation will be provided for late requests.

    Written comments will be accepted from interested members of the public and should be sent to [email protected], a minimum of seven (7) days in advance of the meeting. The comments will be provided to the CAB members for consideration.

    Individuals who wish to join the Consumer Advisory Board must RSVP via this link https://consumer-financial-protection-bureau.forms.fm/september-27-advisory-board-and-council-meeting by noon, September 26, 2018. Members of the public must RSVP by the due date.

    III. Availability

    The Board's agenda will be made available to the public on Wednesday, September 26, 2018, via consumerfinance.gov. Individuals should express in their RSVP if they require a paper copy of the agenda.

    A recording and summary of this meeting will be available after the meeting on the Bureau's website consumerfinance.gov.

    Dated: September 6, 2018. Kirsten Sutton, Chief of Staff, Bureau of Consumer Financial Protection.
    [FR Doc. 2018-19789 Filed 9-11-18; 8:45 am] BILLING CODE 4810-AM-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2018-ICCD-0094] Agency Information Collection Activities; Comment Request; Grantee Reporting Form—Rehabilitation Services Administration (RSA) Annual Payback Report AGENCY:

    Office of Special Education and Rehabilitative Services (OSERS), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before November 13, 2018.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2018-ICCD-0094. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 550 12th Street SW, PCP, Room 9088, Washington, DC 20202-0023.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Karen Holliday, 202-245-7318.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Grantee Reporting Form—Rehabilitation Services Administration (RSA) Annual Payback Report.

    OMB Control Number: 1820-0617.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: Individuals or Households; Private Sector.

    Total Estimated Number of Annual Responses: 11,790.

    Total Estimated Number of Annual Burden Hours: 4,858.

    Abstract: Under Section 302 of the Rehabilitation Act of 1973, as amended by the Workforce Innovation and Opportunity Act (WIOA), hereafter referred to as “The Act,” the RSA provides Long-Term Training grants to academic institutions to support scholarship assistance to scholars. Scholars who receive scholarships under this program are required to work within the public rehabilitation program, such as with a State vocational rehabilitation agency, or an agency or organization that has a service arrangement with a State vocational rehabilitation agency, in qualified employment fields, which include rehabilitation counseling, administration, supervision, teaching or research in vocational rehabilitation, supported employment, or independent living rehabilitation of individuals with disabilities, especially individuals with significant disabilities. The scholar is required to work two years in such settings for every year of full-time scholarship support. The service obligation for the scholar who matriculated part time, is based on the equivalent total of actual academic years of training received. The program regulations at 34 CFR 386.33-386.36 and 386.40-386.43 detail the payback provisions and the RSA scholars' requirements to comply with them.

    Section 302 (b)(2)(C) of the Act requires that data on the employment of scholars are accurate, including tracking of scholars' employment status and location of former scholars supported under the RLTT grants in order to ensure that scholars are meeting the payback requirements.

    In addition to meeting the requirement that all scholars be tracked, the data collected will provide performance data relevant to the rehabilitation fields and degrees pursued by RSA scholars, as well as the funds owed and the rehabilitation work completed by them. These data are used to assess program effectiveness and efficiency, and to meet the reporting requirements of the Government Performance and Results Act (GPRA).

    RSA is requesting a revision of the currently approved collection for grantees (Institutions of Higher Education) to submit an Annual Payback Report through the online RSA Management Information System (MIS). To collect the needed data, RSA created the revised Payback Information Management System (PIMS). Through the PIMS grantees, scholars and employers report data electronically.

    Dated: September 6, 2018. Tomakie Washington, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-19745 Filed 9-11-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY [OE Docket No. PP-82-6] Application To Amend Presidential Permit; Vermont Electric Power Company, Inc., as Agent for the Joint Owners in the Highgate Interconnection Facilities AGENCY:

    Office of Electricity, DOE.

    ACTION:

    Notice of application.

    SUMMARY:

    Vermont Electric Power Company, Inc. (“VELCO”), as operating-and-management agent for the Joint Owners of the Highgate Interconnection Facilities (the “Highgate Joint Owners”) filed an application to amend PP-82, issued on May 14, 1985 and amended on March 1, 1994, September 3, 2003, February 7, 2005, May 3, 2016 and January 8, 2018. VELCO requested that DOE reflect changes in ownership of the Highgate Interconnection Facilities and transfer the ownership interests in the Highgate Interconnection Facilities from two of the Highgate Joint Owners to the third Highgate Joint Owner.

    DATES:

    Comments or motions to intervene must be submitted on or before October 12, 2018.

    ADDRESSES:

    Comments or motions to intervene should be addressed as follows: Office of Electricity (OE-20), U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585.

    FOR FURTHER INFORMATION CONTACT:

    Christopher Lawrence (Program Office) at 202-586-5260, or by email to [email protected]; Christopher Drake (Program Attorney) at 202-586-2919, or by email to [email protected]

    SUPPLEMENTARY INFORMATION:

    The construction, operation, maintenance, and connection of facilities at the international border of the United States for the transmission of electric energy between the United States and a foreign country is prohibited in the absence of a Presidential permit issued pursuant to Executive Order (E.O.) 10485, as amended by E.O. 12038.

    On August 13, 2018, VELCO filed an application with DOE, as required by 10 CFR 205.322, requesting that DOE amend PP-82-5 to reflect a change in names and ownership interests and authorize, under Article 10 of PP-82-5, the transfer of the Highgate Interconnection Facilities so that Vermont Transco LLC (Transco) will acquire 100% of the ownership interest in the facility from the two other Highgate Joint Owners: the Town of Stowe Electric Department and the City of Burlington Electric Department. Transco would then become sole owner of the Highgate Interconnection Facilities.

    The international transmission facilities authorized by Presidential Permit No. PP-82, as amended, include a back-to-back converter station in Highgate, Vermont, and a 345 kilovolt (kV) transmission line extending approximately 7.5 miles from the converter station to the United States-Canada border in Franklin, Vermont. VELCO does not propose to make any physical changes to the Highgate Interconnection Facilities, but rather asks the Department to amend the permit to reflect the change in ownership of the Highgate Transmission Facility.

    Procedural Matters: Any person may comment on this application by filing such comment at the address provided above. Any person seeking to become a party to this proceeding must file a motion to intervene at the address provided above in accordance with Rule 214 of the Federal Energy Regulatory Commission's Rules of Practice and Procedure (18 CFR 385.214). Two copies of each comment or motion to intervene should be filed with DOE on or before the date listed above.

    Additional copies of such motions to intervene also should be filed directly with Mr. Colin Owyang, Vice President, General Counsel & Corporate Secretary, Vermont Electric Power Company, Inc., 366 Pinnacle Ridge Road, Rutland, VT 05701, [email protected] AND Margaret H. Claybour, Esq., Van Ness Feldman, LLP, 1050 Thomas Jefferson Street NW, Suite 700, Washington, DC 20007-3877, [email protected]

    Before a Presidential permit may be granted or amended, DOE must determine that the proposed action will not adversely impact the reliability of the U.S. electric power supply system. In addition, DOE will consider the environmental impacts of the proposed action (i.e., granting the Presidential permit or amendment, with any conditions and limitations, or denying the permit) according to the standards of the National Environmental Policy Act of 1969, as amended. DOE also must obtain the favorable recommendation of the Secretary of State and the Secretary of Defense before taking final action on a Presidential permit application.

    Copies of this application will be made available, upon request, for public inspection and copying at the address provided above. In addition, the application may be reviewed or downloaded electronically at http://energy.gov/oe/services/electricity-policy-coordination-and-implementation/international-electricity-regulatio-2. Upon reaching the home page, select “Pending Applications.”

    Signed in Washington, DC, on August 31, 2018. Christopher A. Lawrence, Program and Management Analyst, Office of Electricity.
    [FR Doc. 2018-19842 Filed 9-11-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY State Energy Advisory Board; Teleconference AGENCY:

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

    ACTION:

    Notice of open teleconference.

    SUMMARY:

    This notice announces a teleconference call of the State Energy Advisory Board (STEAB). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.

    DATES:

    Thursday, September 20, 2018, from 3 p.m. to 4 p.m. (EDT). To receive the call-in number and passcode, please contact the Board's Designated Federal Officer at the address or phone number listed below.

    FOR FURTHER INFORMATION CONTACT:

    Michael Li, Senior Policy Advisor, Office of Energy Efficiency and Renewable Energy, US Department of Energy, 1000 Independence Ave. SW, Washington, DC 20585. Phone number 202-287-5718, and email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: To make recommendations to the Assistant Secretary for the Office of Energy Efficiency and Renewable Energy regarding goals and objectives, programmatic and administrative policies, and to otherwise carry out the Board's responsibilities as designated in the State Energy Efficiency Programs Improvement Act of 1990 (Pub. L. 101-440).

    Tentative Agenda: Discuss logistics and recommendations from STEAB to the Assistant Secretary for the Office of Energy Efficiency and Renewable Energy.

    Public Participation: The meeting is open to the public. Written statements may be filed with the Board either before or after the meeting. Members of the public who wish to make oral statements pertaining to agenda items should contact Michael Li at the address or telephone number listed above. Requests to make oral comments must be received five days prior to the meeting; reasonable provision will be made to include requested topic(s) on the agenda. The Chair of the Board is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business.

    Signed in Washington, DC, on September 6, 2018. Latanya Butler, Deputy Committee Management Officer.
    [FR Doc. 2018-19828 Filed 9-11-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Biological and Environmental Research Advisory Committee AGENCY:

    Office of Science, Department of Energy.

    ACTION:

    Notice of Open Meeting.

    SUMMARY:

    This notice announces a meeting of the Biological and Environmental Research Advisory Committee (BERAC). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.

    DATES:

    Thursday, October 18, 2018; 8:30 a.m.—5:30 p.m. and Friday, October 19, 2018; 8:30 a.m.—12:30 p.m.

    ADDRESSES:

    Hilton Washington DC/Rockville Hotel & Meeting Center, 1750 Rockville Pike, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Tristram West, Designated Federal Officer, BERAC, U.S. Department of Energy, Office of Science, Office of Biological and Environmental Research, SC-23/Germantown Building, 1000 Independence Avenue SW, Washington, DC 20585-1290. Phone 301-903-5155; fax (301) 903-5051 or email: [email protected] The most current information concerning this meeting can be found on the website: http://science.energy.gov/ber/berac/meetings/.

    SUPPLEMENTARY INFORMATION:

    Purpose of the Committee: To provide advice on a continuing basis to the Director, Office of Science of the Department of Energy, on the many complex scientific and technical issues that arise in the development and implementation of the Biological and Environmental Research Program.

    Tentative Agenda Topics • News from the Office of Science • News from the Office of Biological and Environmental Research (BER) • News from the Biological Systems Science and Climate and Environmental Sciences Divisions • Workshop briefings • Subcommittee briefing • Science talks • New business • Public comment

    Public Participation: The day and a half meeting is open to the public. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any of the items on the agenda, you should contact Tristram West at [email protected] (email) or 301-903-5051 (fax). You must make your request for an oral statement at least five business days before the meeting. Reasonable provision will be made to include the scheduled oral statements on the agenda. The Chairperson of the Committee will conduct the meeting to facilitate the orderly conduct of business. Public comment will be limited to five minutes each.

    Minutes: The minutes of this meeting will be available for public review and copying within 45 days at the BERAC website: http://science.energy.gov/ber/berac/meetings/berac-minutes/.

    Signed in Washington, DC on September 6, 2018. Latanya Butler, Deputy Committee Management Officer.
    [FR Doc. 2018-19830 Filed 9-11-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY [Case No. CR-007] Energy Conservation Program: Decision and Order Granting a Waiver to ITW Food Equipment Group, LLC From the Department of Energy Commercial Refrigeration Equipment Test Procedure AGENCY:

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

    ACTION:

    Notice of decision and order.

    SUMMARY:

    The U.S. Department of Energy (DOE) gives notice of a Decision and Order (Case No. CR-007) that grants to ITW Food Equipment Group, LLC (ITW) a waiver from specified portions of the DOE test procedure for determining the energy consumption of commercial refrigerators, freezers, and refrigerator-freezers (collectively, “commercial refrigeration equipment”). Under the Decision and Order, ITW is required to test and rate specified basic models of its commercial refrigeration equipment in accordance with a specified method.

    DATES:

    The Decision and Order is effective on September 12, 2018. The Decision and Order will terminate in conjunction with any future updates to the test procedure for commercial refrigeration equipment located in 10 CFR part 431, subpart C, appendix B. At such time, ITW must use the relevant test procedure for this equipment for any testing to demonstrate compliance with standards, and any other representations of energy use.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Lucy deButts, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 287-1604. Email: [email protected]

    Ms. Jennifer Tiedeman, U.S. Department of Energy, Office of the General Counsel, Mail Stop GC-33, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585-0103. Telephone: (202) 287-6111. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    In accordance with Title 10 of the Code of Federal Regulations (10 CFR 431.401(f)(2)), DOE gives notice of the issuance of its Decision and Order as set forth below. The Decision and Order grants ITW a waiver from the applicable test procedure in 10 CFR part 431, subpart C, appendix B for specified basic models of commercial refrigeration equipment, provided that ITW tests and rates such equipment using the alternate test procedure specified in the Decision and Order. ITW's representations concerning the energy consumption of the specified basic models must be based on testing consistent with the provisions and restrictions in the alternate test procedure set forth in the Decision and Order, and the representations must fairly disclose the test results. Distributors, retailers, and private labelers are held to the same requirements when making representations regarding the energy consumption of this equipment. 42 U.S.C. 6314(d).

    Consistent with 10 CFR 431.401(j), not later than November 13, 2018, any manufacturer currently distributing in commerce in the United States equipment employing a technology or characteristic that results in the same need for a waiver from the applicable test procedure must submit a petition for waiver. Manufacturers not currently distributing such equipment in commerce in the United States must petition for and be granted a waiver prior to the distribution in commerce of that equipment in the United States. Manufacturers may also submit a request for interim waiver pursuant to the requirements of 10 CFR 431.401.

    Signed in Washington, DC, on September 6, 2018. Annamaria Garcia, Director of Weatherization and Intergovernmental Programs, Energy Efficiency and Renewable Energy. Case #CR-007 Decision and Order I. Background and Authority

    The Energy Policy and Conservation Act of 1975 (EPCA),1 Public Law 94-163 (42 U.S.C. 6291-6317, as codified), among other things, authorizes DOE to regulate the energy efficiency of a number of consumer products and industrial equipment. Title III, Part C 2 of EPCA established the Energy Conservation Program for Certain Industrial Equipment, which sets forth a variety of provisions designed to improve energy efficiency for certain types of industrial equipment. This equipment includes commercial refrigeration equipment, the focus of this document. (42 U.S.C. 6311(a)(1)(E))

    1 All references to EPCA in this document refer to the statute as amended through EPS Improvement Act of 2017, Public Law 115-115 (January 12, 2018).

    2 For editorial reasons, upon codification in the U.S. Code, Part C was redesignated as Part A-1.

    Under EPCA, DOE's energy conservation program consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of the Act include definitions (42 U.S.C. 6311), energy conservation standards (42 U.S.C. 6313), test procedures (42 U.S.C. 6314), labeling provisions (42 U.S.C. 6315), and the authority to require information and reports from manufacturers (42 U.S.C. 6316).

    The Federal testing requirements consist of test procedures that manufacturers of covered equipment must use as the basis for: (1) Certifying to DOE that their equipment complies with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6316(a); 42 U.S.C. 6295(s)), and (2) making representations about the efficiency of that equipment (42 U.S.C. 6314(d)). Similarly, DOE must use these test procedures to determine whether the equipment complies with relevant standards promulgated under EPCA. (42 U.S.C. 6316(a); 42 U.S.C. 6295(s))

    Under 42 U.S.C. 6314, EPCA sets forth the criteria and procedures DOE is required to follow when prescribing or amending test procedures for covered equipment. EPCA requires that any test procedures prescribed or amended under this section must be reasonably designed to produce test results which reflect energy efficiency, energy use or estimated annual operating cost of covered equipment during a representative average use cycle or period of use and requires that test procedures not be unduly burdensome to conduct. (42 U.S.C. 6314(a)(2)) The test procedure for commercial refrigeration equipment is contained in the Code of Federal Regulations (CFR) at 10 CFR part 431, subpart C, appendix B, “Amended Uniform Test Method for the Measurement of Energy Consumption of Commercial Refrigerators, Freezers, and Refrigerator-Freezers.”

    Under 10 CFR 431.401, any interested person may submit a petition for waiver from DOE's test procedure requirements. DOE will grant a waiver from the test procedure requirements if DOE determines either that the basic models for which the waiver was requested contain a design characteristic that prevents testing of the basic models according to the prescribed test procedures, or that the prescribed test procedures evaluate the basic models in a manner so unrepresentative of their true energy or water consumption characteristics as to provide materially inaccurate comparative data. 10 CFR 431.401(a)(1). DOE may grant the waiver, subject to conditions, including adherence to alternate test procedures. 10 CFR 431.401(f)(2).

    II. ITW's Petition for Waiver: Assertions and Determinations

    By letter dated December 20, 2016 (and supplemented on May 3, 2017), ITW submitted a petition for waiver and application for interim waiver for certain basic models of commercial refrigeration equipment that are required to be tested according to DOE's test procedure at 10 CFR part 431, subpart C, appendix B. Specifically, ITW requested a waiver for certain Innopod temperature-controlled grocery and general merchandise system (Innopod) basic models of commercial refrigeration equipment. On July 19, 2017, DOE published a notice that announced receipt of ITW's petition for waiver (hereafter “notice of petition for waiver”), and granted an interim waiver to ITW. 82 FR 33081.

    DOE's current test procedure references Air-Conditioning and Refrigeration Institute (ARI) Standard 1200-2006 and Air-Conditioning, Heating, and Refrigeration Institute (AHRI) Standard 1200 (I-P)-2010, which further references American National Standards Institute/American Society of Heating, Refrigerating and Air-Conditioning Engineers (ANSI/ASHRAE) Standard 72 (incorporated by reference at 10 CFR 431.63(c) and (d)). ITW asserted that the current test procedures do not account for the unique operating characteristics of its Innopod basic models, including floating suction temperatures for individual compartments, different typical door-opening cycles, and a high-temperature “ambient” compartment. ITW asserted that its petition meets both conditions of 10 CFR 431.401(f)(2) for granting waivers, namely that (1) the basic models contain one or more design characteristics that prevent testing according to the prescribed test procedures; and (2) the prescribed test procedures evaluate the basic models in a manner so unrepresentative of its true energy consumption as to provide materially inaccurate comparative data. ITW submitted to DOE an alternate test procedure that it stated allows for testing its specified Innopod basic models.

    ITW's petition recommended an alternate test using an “inverse refrigeration load” test, various calculations to account for refrigeration system and component energy consumption, and adjustments to the door opening requirements based on typical use in the field to accommodate for the basic models' multiple thermally separated, temperature controlled compartments supplied with refrigerant from a single condensing unit. ITW's recommended refrigeration system calculations rely on the current calculations and assumptions used for testing remote condensing commercial refrigeration equipment in accordance with the DOE test procedure.

    As noted in the notice of petition for waiver, DOE granted ITW an interim waiver and required that ITW test and rate the specified basic models according to an alternate procedure. The alternate procedure granted by DOE was similar to that requested by ITW, but with minor modifications. Those modifications included clarifications of how ITW should determine the basic models and adjust certain aspects of the requested alternate test procedure regarding ambient test conditions, reference to the current version of the AHRI 1200 industry standard, and clarifications to certain calculations. 82 FR 33081, 33083-33084. DOE received no comments in response to the notice of petition for waiver.

    DOE understands that absent a waiver, the basic models identified by ITW in its petition cannot be tested and rated for energy consumption on a basis representative of their true energy consumption characteristics. DOE has reviewed the recommended procedure suggested by ITW and concludes that it will allow for the accurate measurement of the energy use of the equipment, while alleviating the testing problems associated with ITW's implementation of DOE's applicable commercial refrigeration equipment test procedure for the specified Innopod basic models. However, as in the interim test procedure waiver, DOE has clarified how ITW should determine basic models, as discussed in this notice, and adjusted certain aspects of the requested alternate test procedure regarding ambient test conditions, referenced industry standards, and calculations.

    In this Decision and Order, DOE requires that ITW test and rate specific basic models of commercial refrigeration equipment according to the alternate test procedure specified in this Decision and Order, which is identical to that provided by DOE in the interim waiver.

    In its petition, ITW sought a test procedure waiver for certain basic models. This Decision and Order is applicable only to the basic models listed and does not extend to any other basic models. ITW may request that the scope of this waiver be extended to include additional basic models that employ the same technology as those listed in this waiver. 10 CFR 431.401(g). ITW may also submit another petition for waiver from the test procedure for additional basic models that employ a different technology and meet the criteria for test procedure waivers. 10 CFR 431.401(a)(1).

    DOE notes that it may modify the waiver at any time upon DOE's determination that the factual basis underlying the petition for waiver is incorrect, or upon a determination that the results from the alternate test procedure are unrepresentative of the basic models' true energy consumption characteristics. 10 CFR 431.401(k)(1). Likewise, ITW may request that DOE rescind or modify the waiver if the company discovers an error in the information provided to DOE as part of its petition, determines that the waiver is no longer needed, or for other appropriate reasons. 10 CFR 431.401(k)(2). As set forth above, the test procedure specified in this Decision and Order is not the same as the test procedure offered by ITW. If ITW believes that the alternate test method it suggested provides representative results and is less burdensome than the test method required by this Decision and Order, ITW may submit a request for modification under 10 CFR 431.401(k)(2) that addresses the concerns that DOE has specified with that procedure. ITW may also submit another less burdensome alternative test procedure not expressly considered in this notice under the same provision.

    III. Order

    After careful consideration of all the material submitted by ITW in this matter, it is ordered that:

    (1) ITW must, as of the date of publication of this Order in the Federal Register, test and rate the following ITW basic models as set forth in paragraph (2) below:

    30-XX-X5-AAAAR, 30-XX-X5-AAARA, 30-XX-X5-AAARR, 30-XX-X5-AAAFA, 30-XX-X5-AAAFR, 30-XX-X5-AARAA, 30-XX-X5-AARAR, 30-XX-X5-AARRA, 30-XX-X5-AARRR, 30-XX-X5-AARFA, 30-XX-X5-AARFR, 30-XX-X5-AAFAA, 30-XX-X5-AAFAR, 30-XX-X5-AAFRA, 30-XX-X5-AAFRR, 30-XX-X5-AAFFA, 30-XX-X5-AAFFR, 30-XX-X5-ARAAA, 30-XX-X5-ARAAR, 30-XX-X5-ARARA, 30-XX-X5-ARARR, 30-XX-X5-ARAFA, 30-XX-X5-ARAFR, 30-XX-X5-ARRAA, 30-XX-X5-ARRAR, 30-XX-X5-ARRRA, 30-XX-X5-ARRRR, 30-XX-X5-ARRFA, 30-XX-X5-ARRFR, 30-XX-X5-ARFAA, 30-XX-X5-ARFAR, 30-XX-X5-ARFRA, 30-XX-X5-ARFRR, 30-XX-X5-ARFFA, 30-XX-X5-ARFFR, 30-XX-X5-AFAAA, 30-XX-X5-AFAAR, 30-XX-X5-AFARA, 30-XX-X5-AFARR, 30-XX-X5-AFAFA, 30-XX-X5-AFAFR, 30-XX-X5-AFRAA, 30-XX-X5-AFRAR, 30-XX-X5-AFRRA, 30-XX-X5-AFRRR, 30-XX-X5-AFRFA, 30-XX-X5-AFRFR, 30-XX-X5-AFFAA, 30-XX-X5-AFFAR, 30-XX-X5-AFFRA, 30-XX-X5-AFFRR, 30-XX-X5-RAAAA, 30-XX-X5-RAAAR, 30-XX-X5-RAARA, 30-XX-X5-RAARR, 30-XX-X5-RAAFA, 30-XX-X5-RAAFR, 30-XX-X5-RARAA, 30-XX-X5-RARAR, 30-XX-X5-RARRA, 30-XX-X5-RARRR, 30-XX-X5-RARFA, 30-XX-X5-RARFR, 30-XX-X5-RAFAA, 30-XX-X5-RAFAR, 30-XX-X5-RAFRA, 30-XX-X5-RAFRR, 30-XX-X5-RAFFA, 30-XX-X5-RAFFR, 30-XX-X5-RRAAA, 30-XX-X5-RRAAR, 30-XX-X5-RRARA, 30-XX-X5-RRARR, 30-XX-X5-RRAFA, 30-XX-X5-RRAFR, 30-XX-X5-RRRAA, 30-XX-X5-RRRAR, 30-XX-X5-RRRRA, 30-XX-X5-RRRFA, 30-XX-X5-RRFAA, 30-XX-X5-RRFAR, 30-XX-X5-RRFRA, 30-XX-X5-RRFFA, 30-XX-X5-RFAAA, 30-XX-X5-RFAAR, 30-XX-X5-RFARA, 30-XX-X5-RFARR, 30-XX-X5-RFAFA, 30-XX-X5-RFAFR, 30-XX-X5-RFRAA, 30-XX-X5-RFRAR, 30-XX-X5-RFRRA, 30-XX-X5-RFRFA, 30-XX-X5-RFFAA, 30-XX-X5-RFFAR, 30-XX-X5-RFFRA, 30-XX-X5-FAAAA, 30-XX-X5-FAAAR, 30-XX-X5-FAARA, 30-XX-X5-FAARR, 30-XX-X5-FAAFA, 30-XX-X5-FAAFR, 30-XX-X5-FARAA, 30-XX-X5-FARAR, 30-XX-X5-FARRA, 30-XX-X5-FARRR, 30-XX-X5-FARFA, 30-XX-X5-FARFR, 30-XX-X5-FAFAA, 30-XX-X5-FAFAR, 30-XX-X5-FAFRA, 30-XX-X5-FAFRR, 30-XX-X5-FRAAA, 30-XX-X5-FRAAR, 30-XX-X5-FRARA, 30-XX-X5-FRARR, 30-XX-X5-FRAFA, 30-XX-X5-FRAFR, 30-XX-X5-FRRAA, 30-XX-X5-FRRAR, 30-XX-X5-FRRRA, 30-XX-X5-FRRFA, 30-XX-X5-FRFAA, 30-XX-X5-FRFAR, 30-XX-X5-FRFRA, 30-XX-X5-FFAAA, 30-XX-X5-FFAAR, 30-XX-X5-FFARA, 30-XX-X5-FFARR, 30-XX-X5-FFRAA, 30-XX-X5-FFRAR, 30-XX-X5-FFRRA, 30-XX-X4A-AAAR, 30-XX-X4A-AARA, 30-XX-X4A-AARR, 30-XX-X4A-ARAA, 30-XX-X4A-ARAR, 30-XX-X4A-ARRA, 30-XX-X4A-ARRR, 30-XX-X4A-AFAA, 30-XX-X4A-AFAR, 30-XX-X4A-AFRA, 30-XX-X4A-AFRR, 30-XX-X4A-RAAA, 30-XX-X4A-RAAR, 30-XX-X4A-RARA, 30-XX-X4A-RARR, 30-XX-X4A-RRAA, 30-XX-X4A-RRAR, 30-XX-X4A-RRRA, 30-XX-X4A-RFAA, 30-XX-X4A-RFAR, 30-XX-X4A-RFRA, 30-XX-X4A-FAAA, 30-XX-X4A-FAAR, 30-XX-X4A-FARA, 30-XX-X4A-FARR, 30-XX-X4A-FRAA, 30-XX-X4A-FRAR, 30-XX-X4A-FRRA, 30-XX-X4A-FFAA, 30-XX-X4A-FFAR, 30-XX-X4A-FFRA, 30-XX-X4B-AAAR, 30-XX-X4B-AARA, 30-XX-X4B-AARR, 30-XX-X4B-AAFA, 30-XX-X4B-AAFR, 30-XX-X4B-ARAA, 30-XX-X4B-ARAR, 30-XX-X4B-ARRA, 30-XX-X4B-ARRR, 30-XX-X4B-ARFA, 30-XX-X4B-ARFR, 30-XX-X4B-AFAA, 30-XX-X4B-AFAR, 30-XX-X4B-AFRA, 30-XX-X4B-AFRR, 30-XX-X4B-AFFA, 30-XX-X4B-AFFR, 30-XX-X4B-RAAA, 30-XX-X4B-RAAR, 30-XX-X4B-RARA, 30-XX-X4B-RARR, 30-XX-X4B-RAFA, 30-XX-X4B-RAFR, 30-XX-X4B-RRAA, 30-XX-X4B-RRAR, 30-XX-X4B-RRRA, 30-XX-X4B-RRFA, 30-XX-X4B-RFAA, 30-XX-X4B-RFAR, 30-XX-X4B-RFRA, 30-XX-X4B-RFFA, 30-XX-XX-3-AAR, 30-XX-XX-3-ARA, 30-XX-XX-3-ARR, 30-XX-XX-3-RAA, 30-XX-XX-3-RAR, and 30-XX-XX-3-RRA.

    (2) The applicable method of test for the ITW basic models listed in paragraph (1) is the test procedure for commercial refrigeration equipment prescribed by DOE at 10 CFR part 431, subpart C, appendix B, with the following modifications:

    For the purpose of testing and rating, the Ambient (75 °F) compartment is treated as a Medium (Refrigerator at 75 °F) compartment. All volume and energy consumption calculations will be included within the Medium (Refrigerator 38 °F) category and summed with other Medium (Refrigerator 38 °F) compartment(s) calculations. Compartments that are convertible between ambient and refrigerator temperature ranges shall be tested at the refrigerator temperature (38 °F). Compartments that are convertible between refrigerator and freezer (0 °F) temperature ranges shall be tested at both temperatures.

    BILLING CODE 6450-01-P EN12SE18.000 EN12SE18.001 BILLING CODE 6450-01-C

    (3) Representations. ITW may make representations about the energy use of the specified basic models of its commercial refrigeration equipment for compliance, marketing, or other purposes only to the extent that such equipment has been tested in accordance with the provisions above and such representations fairly disclose the results of such testing in accordance with 10 CFR part 429, subpart B.

    (4) This waiver shall remain in effect consistent with the provisions of 10 CFR 431.401.

    (5) This waiver is issued on the condition that the statements, representations, and documentation provided by the petitioner are valid. If ITW makes any modifications to the controls or configurations of these basic models, the waiver will no longer be valid and ITW will either be required to use the current Federal test method or submit a new application for a test procedure waiver. DOE may revoke or modify this waiver at any time if it determines the factual basis underlying the petition for waiver is incorrect, or the results from the alternate test procedure are unrepresentative of the basic models' true energy consumption characteristics. Likewise, ITW may request that DOE rescind or modify the waiver if ITW discovers an error in the information provided to DOE as part of its petition, determines that the waiver is no longer needed, or for other appropriate reasons.

    (6) Granting of this waiver does not release a petitioner from the certification requirements set forth at 10 CFR part 429.

    Signed in Washington, DC, on September 6, 2018.

    Annamaria Garcia, Director of Weatherization and Intergovernmental Programs Energy Efficiency and Renewable Energy.
    [FR Doc. 2018-19852 Filed 9-11-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Electricity Advisory Committee AGENCY:

    Office of Electricity, Department of Energy.

    ACTION:

    Notice of Open Meeting.

    SUMMARY:

    This notice announces a meeting of the Electricity Advisory Committee. The Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.

    DATES:

    Wednesday, October 17, 2018, 12:00 p.m.—6:00 p.m. EST; Thursday, October 18, 2018, 8:00 a.m.—12:15 p.m. EST.

    ADDRESSES:

    The meeting will be held at the National Rural Electric Cooperative Association, 4301 Wilson Blvd., Arlington, VA 22203.

    FOR FURTHER INFORMATION CONTACT:

    Lawrence Mansueti, Office of Electricity, U.S. Department of Energy, Forrestal Building, Room 8G-017, 1000 Independence Avenue SW, Washington, DC 20585; Telephone: (202) 586-2588 or Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose of the Committee: The Electricity Advisory Committee (EAC) was re-established in July 2010, in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C., App. 2, to provide advice to the U.S. Department of Energy (DOE) in implementing the Energy Policy Act of 2005, executing the Energy Independence and Security Act of 2007, and modernizing the nation's electricity delivery infrastructure. The EAC is composed of individuals of diverse backgrounds and selected for their technical expertise and experience, established records of distinguished professional service, and their knowledge of issues that pertain to electricity.

    Tentative Agenda: The meeting of the EAC is expected to include panels or presentations on institutional perspectives on grid resilience, an update related to FERC, case studies in operations and scale relating to emerging technologies addressing megawatt-scale storage, and the grid modernization MYPP peer review. Additionally, the meeting is expected to include an update on the programs and initiatives of the DOE's Office of Electricity and an update on the activities of the Smart Grid Subcommittee and the Energy Storage Subcommittee.

    Tentative Agenda: October 17, 2018 12:00 p.m.-1:00 p.m. Registration 1:00 p.m.-1:15 p.m. Welcome, Introductions, Developments since the July 2018 Meeting 1:15 p.m.-1:30 p.m. Update on the DOE Office of Electricity (OE) Programs and Initiatives 1:30 p.m.-2:30 p.m. FERC Update 2:30 p.m.-2:45 p.m. Break 2:45 p.m.-3:15 p.m. Presentation: Institutional Perspectives on Grid Resilience 3:15 p.m.-5:15 p.m. Panel Session: Institutional Perspectives on Grid Resilience 5:15 p.m.-5:30 p.m. Break 5:30 p.m.-5:55 p.m. Ethics Briefing 5:55 p.m.-6:00 p.m. Wrap-up and Adjourn Day 1 Tentative Agenda: October 18, 2018 8:00 a.m.-10:30 a.m. Presentation and Panel: Approaching Megawatt-Scale Storage Through Emerging Technologies: Case Studies in Operations and Scale 10:30 a.m.-10:45 a.m. Break 10:45 a.m.-11:15 a.m. Presentation on Grid Modernization MYPP Peer Review 11:15 a.m.-11:35 a.m. Smart Grid Subcommittee Update 11:35 a.m.-12:00 p.m. Energy Storage Subcommittee Update 12:00 p.m.-12:10 p.m. Public Comments 12:10 p.m.-12:15 p.m. Wrap-up and Adjourn

    The meeting agenda may change to accommodate EAC business. For EAC agenda updates, see the EAC website at: http://energy.gov/oe/services/electricity-advisory-committee-eac.

    Public Participation: The EAC welcomes the attendance of the public at its meetings. Individuals who wish to offer public comments at the EAC meeting may do so on Thursday, October 18, 2018, but must register at the registration table in advance. Approximately 10 minutes will be reserved for public comments. Time allotted per speaker will depend on the number who wish to speak but is not expected to exceed three minutes. Anyone who is not able to attend the meeting, or for whom the allotted public comments time is insufficient to address pertinent issues with the EAC, is invited to send a written statement to Mr. Lawrence Mansueti.

    You may submit comments, identified by: “Electricity Advisory Committee Open Meeting,” through any of the following methods:

    Mail/Hand Delivery/Courier: Lawrence Mansueti, Office of Electricity, U.S. Department of Energy, Forrestal Building, Room 8G- 017, 1000 Independence Avenue SW, Washington, DC 20585.

    Email: [email protected] Include “Electricity Advisory Committee Open Meeting” in the subject line of the message.

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Instructions: All submissions received must include the agency name and identifier. All comments received will be posted without change to http://energy.gov/oe/services/electricity-advisory-committee-eac, including any personal information provided.

    Docket: For access to the docket, to read background documents or comments received, go to http://energy.gov/oe/services/electricity-advisory-committee-eac.

    The following electronic file formats are acceptable: Microsoft Word (.doc), Corel Word Perfect (.wpd), Adobe Acrobat (.pdf), Rich Text Format (.rtf), plain text (.txt), Microsoft Excel (.xls), and Microsoft PowerPoint (.ppt). If you submit information that you believe to be exempt by law from public disclosure, you must submit one complete copy, as well as one copy from which the information claimed to be exempt by law from public disclosure has been deleted. You must also explain the reasons why you believe the deleted information is exempt from disclosure.

    DOE is responsible for the final determination concerning disclosure or nondisclosure of the information and for treating it in accordance with the DOE's Freedom of Information regulations (10 CFR 1004.11).

    Note:

    Delivery of the U.S. Postal Service mail to DOE may be delayed by several weeks due to security screening. DOE, therefore, encourages those wishing to comment to submit comments electronically by email. If comments are submitted by regular mail, the Department requests that they be accompanied by a CD or diskette containing electronic files of the submission.

    Minutes: The minutes of the EAC meeting will be posted on the EAC web page at http://energy.gov/oe/services/electricity-advisory-committee-eac. They can also be obtained by contacting Mr. Lawrence Mansueti at the address above.

    Signed in Washington, DC on September 6, 2018. Latanya Butler, Deputy Committee Management Officer.
    [FR Doc. 2018-19829 Filed 9-11-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP17-101-000] Transcontinental Gas Pipe Line Company, LLC; Notice of Revised Schedule for Environmental Review of the Northeast Supply Enhancement Project

    This notice identifies the Federal Energy Regulatory Commission (FERC or Commission) staff's revised schedule for the completion of the final environmental impact statement (EIS) for Transcontinental Gas Pipe Line Company, LLC's (Transco) Northeast Supply Enhancement Project. The first notice of schedule, issued on January 3, 2018, identified September 17, 2018 as the final EIS issuance date. Staff has revised the schedule for issuance of the final EIS based on the current status of Transco's General Conformity review and feasible mitigation options. The forecasted schedule for the final EIS is also based upon Transco providing complete and timely responses to any future data requests. In addition, the schedule assumes that the cooperating agencies will provide input on their areas of responsibility on a timely basis.

    Schedule for Environmental Review Issuance of Notice of Availability of the final EIS—January 25, 2019 90-day Federal Authorization Decision Deadline—April 25, 2019

    If a schedule change becomes necessary, an additional notice will be provided so that the relevant agencies are kept informed of the project's progress.

    Additional Information

    In order to receive notification of the issuance of the EIS and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC website (www.ferc.gov). Using the “eLibrary” link, select “General Search” from the eLibrary menu, enter the selected date range and “Docket Number” excluding the last three digits (i.e., CP17-101-000), and follow the instructions. For assistance with access to eLibrary, the helpline can be reached at (866) 208-3676, TTY (202) 502-8659, or at [email protected] The eLibrary link on the FERC website also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rule makings.

    Dated: September 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-19815 Filed 9-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13318-003] Swan Lake North Hydro LLC; Notice of Anticipated Schedule of Final Order for Swan Lake North Pumped Storage Hydroelectric Project

    On October 28, 2015, Swan Lake North Hydro LLC filed an application requesting authorization to construct and operate the Swan Lake North Pumped Storage Hydroelectric Project. The project would be located 11 miles northeast of Klamath Falls, in Klamath County, Oregon.

    In accordance with Title 41 of the Fixing America's Surface Transportation Act, enacted on December 4, 2015, agencies are to publish completion dates for all federal environmental reviews and authorizations. This notice identifies the Commission's anticipated schedule for issuance of the final order for the Project, which is based on the anticipated date of issuance of the final Environmental Impact Statement. Accordingly, we currently anticipate issuing a final order for the Project no later than:

    Issuance of Final Order—April 30, 2019

    If a schedule change becomes necessary for the final order, an additional notice will be provided so that interested parties and government agencies are kept informed of the Project's progress.

    Dated: September 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-19813 Filed 9-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL18-197-000] City of Oakland, California v. Pacific Gas and Electric Company; Notice of Complaint

    Take notice that on September 5, 2018, pursuant to sections 206 and 306 of the Federal Power Act, 16 U.S.C. 824e and 825e, and Rules 206 and 207 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 and 385.207, City of Oakland, California (Complainant) filed a formal complaint against Pacific Gas and Electric Company (Respondent) alleging that the Respondent's provision of power and transmission service to the Complainant failed to comply with the requirements of the Federal Power Act, as more fully explained in the complaint.

    The Complainant certifies that copies of the complaint were served on the contacts for the Respondent as listed on the Commission's list of Corporate Officials.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainant.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5 p.m. Eastern Time on September 25, 2018.

    Dated: September 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-19809 Filed 9-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14884-000] Midwest Energy Recycling, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications

    On July 17, 2018, Midwest Energy Recycling, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Yellow Medicine County Pumped Storage Project to be located near the Minnesota River and the City of Granite Falls, in Yellow Medicine County, Minnesota. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.

    The proposed project would consist of the following all new facilities: (1) A circular 100-acre rockfill embankment (upper reservoir) having a total storage capacity of 3,300 acre-feet with a maximum pond elevation level of 1089 feet mean sea level (msl); (2) a 2,400-foot by 1,425-foot rectangular lower reservoir with a total storage capacity of 3,300 acre-feet and water surface elevation between minus (−) 1,320 and minus 1,420 feet msl; (3) a 100-foot outside diameter, 18-foot inside diameter “morning glory” in configuration reinforced concrete intake located in the upper reservoir; (4) a vertical 2,500-foot-long, 18-foot-diameter steel penstock connected to the intake at the upper reservoir and ending in a bifurcation before the powerhouse located at the lower reservoir; (5) a 200-foot-long, 70-foot-wide, 130-foot-high reinforced concrete powerhouse containing two 333-megawatt (MW) reversible pump turbine units with a total plant rating of 666 MW; (6) a 240-foot-long, 50-foot-wide, 40-foot-high transformer gallery; (7); a 200 to 1,000-foot-long, 345-kilovolt transmission line extending from the transformer gallery to an existing substation (the point of interconnection); and (8) appurtenant facilities. The estimated annual generation of the Yellow Medicine County Pumped Storage Project would be 1,450 gigawatt-hours.

    Applicant Contact: Mr. Douglas A. Spaulding, P.E., Nelson Energy, 8441 Wayzata Boulevard, Suite 101 Golden Valley, MN 55426; phone: (952) 544-8133.

    FERC Contact: Sergiu Serban; phone: (202) 502-6211.

    Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 Days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.

    The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The first page of any filing should include docket number P-14884-000.

    More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-14884) in the docket number field to access the document. For assistance, contact FERC Online Support.

    Dated: September 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-19814 Filed 9-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP18-533-000] Texas Eastern Transmission, LP; Notice of Intent To Prepare an Environmental Assessment for the Proposed Line 1-N Abandonment Project and Request for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the Line 1-N Abandonment Project involving construction and operation of facilities by Texas Eastern Transmission, LP (Texas Eastern) in Harrison and Marion Counties, Texas. The Commission will use this EA in its decision-making process to determine whether to authorize the project.

    This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies about issues regarding the project. The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from its action whenever it considers the issuance of an authorization. NEPA also requires the Commission to discover concerns the public may have about proposals. This process is referred to as “scoping.” The main goal of the scoping process is to focus the analysis in the EA on the important environmental issues. By this notice, the Commission requests public comments on the scope of the issues to address in the EA. To ensure that your comments are timely and properly recorded, please submit your comments so that the Commission receives them in Washington, DC on or before 5 p.m. Eastern Time on October 6, 2018.

    You can make a difference by submitting your specific comments or concerns about the project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the EA. Commission staff will consider and address all filed comments during the preparation of the EA.

    If you sent comments on this project to the Commission before the opening of this docket on July 24, 2018, you will need to file those comments in Docket No. CP18-533-000 to ensure they are considered as part of this proceeding.

    This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this proposed project and encourage them to comment on their areas of concern.

    If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the proposed facilities. The company would seek to negotiate a mutually acceptable easement agreement. You are not required to enter into an agreement. However, if the Commission approves the project, that approval conveys with it the right of eminent domain. Therefore, if you and the company do not reach an easement agreement, the pipeline company could initiate condemnation proceedings in court. In such instances, compensation would be determined by a judge in accordance with state law.

    Texas Eastern provided landowners with a fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” This fact sheet addresses a number of typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. It is also available for viewing on the FERC website (www.ferc.gov).

    Public Participation

    For your convenience, there are three methods you can use to submit your comments to the Commission. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or [email protected] Please carefully follow these instructions so that your comments are properly recorded.

    (1) You can file your comments electronically using the eComment feature, which is located on the Commission's website (www.ferc.gov) under the link to Documents and Filings. Using eComment is an easy method for submitting brief, text-only comments on a project;

    (2) You can file your comments electronically by using the eFiling feature, which is located on the Commission's website (www.ferc.gov) under the link to Documents and Filings. With eFiling, you can provide comments in a variety of formats by attaching them as a file with your submission. New eFiling users must first create an account by clicking on “eRegister.” You will be asked to select the type of filing you are making; a comment on a particular project is considered a “Comment on a Filing”; or

    (3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket number (CP18-533-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426.

    Summary of the Proposed Project

    Texas Eastern proposes to abandon a portion of its lateral Line 1-N and related facilities, in Harrison and Marion Counties, Texas. Specifically, Texas Eastern is requesting approval to abandon in place and by removal a total of approximately 30 miles of 8-inch, 10-inch, and 12-inch-diameter lateral pipeline; abandon by removal all of the facilities at Metering and Regulating (M&R) Station 70191; and abandon by removal all aboveground appurtenances on each of the 8-inch, 10-inch and 12-inch-diameter pipeline segments.

    According to Texas Eastern, the project would eliminate the need for operating and maintenance expenditures on facilities that have not been used to provide service for over a year and are not necessary to meet Texas Eastern's firm service obligations. The project would not impact the daily design capacity of, or the operating conditions on, Texas Eastern's system, and it would not impact service for Texas Eastern's existing shippers.

    The general location of the project facilities is shown in appendix 1.1

    1 The appendices referenced in this notice will not appear in the Federal Register. Copies of appendices were sent to all those receiving this notice in the mail and are available at www.ferc.gov using the link called “eLibrary” or from the Commission's Public Reference Room, 888 First Street NE, Washington, DC 20426, or call (202) 502-8371. For instructions on connecting to eLibrary, refer to the last page of this notice.

    Land Requirements for Construction

    The project would temporarily affect approximately 6 acres of land within the existing right-of-way. Following abandonment, Texas Eastern would revegetate temporary work areas in accordance with its Erosion and Sedimentation Control Plan. Texas Eastern would retain and continue to maintain the pipeline right-of-way following abandonment activities.

    The EA Process

    The EA will discuss impacts that could occur as a result of the construction and operation of the proposed project under these general headings:

    • Geology and soils;

    • land use;

    • water resources, fisheries, and wetlands;

    • cultural resources;

    • vegetation and wildlife;

    • air quality and noise;

    • endangered and threatened species;

    • public safety; and

    • cumulative impacts.

    Commission staff will also evaluate reasonable alternatives to the proposed project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.

    The EA will present Commission staffs' independent analysis of the issues. The EA will be available in the public record through eLibrary.2 Commission staff will consider and address all comments on the EA before making recommendations to the Commission. To ensure Commission staff have the opportunity to address your comments, please carefully follow the instructions in the Public Participation section, beginning on page 2.

    2 For instructions on connecting to eLibrary, refer to the last page of this notice.

    With this notice, the Commission is asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of this project to formally cooperate in the preparation of the EA.3 Agencies that would like to request cooperating agency status should follow the instructions for filing comments provided under the Public Participation section of this notice.

    3 The Council on Environmental Quality regulations addressing cooperating agency responsibilities are at Title 40, Code of Federal Regulations, Part 1501.6.

    Consultation Under Section 106 of the National Historic Preservation Act

    In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, the Commission is are using this notice to initiate consultation with the applicable State Historic Preservation Office (SHPO), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.4 Commission staff will define the project-specific Area of Potential Effects (APE) in consultation with the SHPO as the project develops. On natural gas facility projects, the APE at a minimum encompasses all areas subject to ground disturbance (examples include construction right-of-way, contractor/pipe storage yards, compressor stations, and access roads). The EA for this project will document findings on the impacts on historic properties and summarize the status of consultations under section 106.

    4 The Advisory Council on Historic Preservation's regulations are at Title 36, Code of Federal Regulations, Part 800. Those regulations define historic properties as any prehistoric or historic district, site, building, structure, or object included in or eligible for inclusion in the National Register of Historic Places.

    Environmental Mailing List

    The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; Native American Tribes; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project. Commission staff will update the environmental mailing list as the analysis proceeds to ensure that information related to this environmental review is sent to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project.

    As stated above, the EA will be available in the public record through the Commission's eLibrary, under the Docket Number CP18-533-000.

    Additional Information

    Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at www.ferc.gov using the “eLibrary” link. Click on the eLibrary link, click on “General Search” and enter the docket number in the “Docket Number” field, excluding the last three digits (i.e., CP18-533). Be sure you have selected an appropriate date range. For assistance, please contact FERC Online Support at [email protected] or (866) 208-3676, or for TTY, contact (202) 502-8659. The eLibrary link also provides access to the texts of all formal documents issued by the Commission, such as orders, notices, and rulemakings.

    In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Finally, public sessions or site visits will be posted on the Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: September 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-19806 Filed 9-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14872-000] Peterson Machinery Sales; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications

    On March 19, 2018, Peterson Machinery Sales filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act, proposing to study the feasibility of the Hubbardston Hydroelectric Project (project) to be located on the Fish Creek, near Hubbardston, in Ionia County, Michigan. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.

    The proposed project would be located at the site of an existing, non-operational hydroelectric project previously operated by Hope Renewable Energy, LLC without a Commission license. The proposed run-of-river project will involve rehabilitation and upgrade of the following existing facilities: (1) A 60-acre, 600-acre-foot reservoir with normal surface elevation of 850 feet mean sea level; (2) a 350-foot-long, 25 to 30-foot-high combination dam and spillway incorporating a 80-foot-long, 12-foot-wide intake channel; (3) a 30-foot-long, 20-foot-wide, 25-foot-high powerhouse containing two Francis turbines and associated generators with a combined installed capacity of 400 kilowatts; (4) a 600-foot-long tailrace; and (5) appurtenant facilities. The estimated average annual generation of the project would be 3,500 megawatt-hours that would be conveyed from the powerhouse to the grid via a transmission line owned by Consumers Energy.

    Applicant Contact: Charles R. Peterson, 804 Gila Bend Highway, Casa Grande, Arizona 85122, phone (231) 649-8706.

    FERC Contact: Sergiu Serban, (202) 502-6211.

    Deadline for filing comments, applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.

    The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The first page of any filing should include docket number P-14872-000.

    More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's website at http://www.ferc.gov/docs-filing/elibary.asp. Enter the docket number (P-14872) in the docket number field to access the document. For assistance, contact FERC Online Support.

    Dated: September 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-19812 Filed 9-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [EG18-95-000, EG18-96-000, EG18-97-000, EG18-98-000, EG18-99-000, EG18-100-000, EG18-101-000, EG18-102-000, FC18-6-000, FC18-7-000] Langdon Renewables, LLC, Rush Springs Energy Storage, LLC, Origis Energy, Palmer's Creek Wind Farm, LLC, Meadowlark Wind I LLC, Foard City Wind, LLC, Torrecillas Wind Energy, LLC, Holloman Lessee LLC, Solfuture Gestion, S.L.U., Glicinia Instalaciones Fotovoltaicas, S.L.U.; Notice of Effectiveness of Exempt Wholesale Generator and Foreign Utility Company Status

    Take notice that during the month of August 2018, the status of the above-captioned entities as Exempt Wholesale Generators or Foreign Utility Companies became effective by operation of the Commission's regulations. 18 CFR 366.7(a)(2018).

    Dated: September 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-19808 Filed 9-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

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

    Docket Numbers: EC18-151-000.

    Applicants: Breckinridge Wind Project, LLC, Carousel Wind Farm, LLC, Cottonwood Wind Project, LLC, Golden Hills North Wind, LLC, Golden Hills Interconnection, LLC, Kingman Wind Energy I, LLC, Kingman Wind Energy II, LLC, Mountain View Solar, LLC, NextEra Energy Bluff Point, LLC, Ninnescah Wind Energy, LLC, Rush Springs Wind Energy, LLC, NEP US SellCo, LLC, NEP Renewables Holdings, LLC.

    Description: Joint Application for Authorization Under Section 203 of the Federal Power Act of Breckinridge Wind Project, LLC, et al.

    Filed Date: 9/5/18.

    Accession Number: 20180905-5102.

    Comments Due: 5 p.m. ET 9/26/18.

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

    Docket Numbers: ER18-2379-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: 3rd Rev ISA SA No. 3837; 2nd Rev CSA SA No. 3838; Queue #X4-048/Y2-089/AA1-077 to be effective 8/6/2018.

    Filed Date: 9/5/18.

    Accession Number: 20180905-5101.

    Comments Due: 5 p.m. ET 9/26/18.

    Docket Numbers: ER18-2380-000.

    Applicants: California Independent System Operator Corporation.

    Description: § 205(d) Rate Filing: 2018-09-05 Dispatch Operating Target Clarification Amendment to be effective 11/6/2018.

    Filed Date: 9/6/18.

    Accession Number: 20180906-5000.

    Comments Due: 5 p.m. ET 9/27/18.

    Docket Numbers: ER18-2381-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Annual Calculation of the Cost of New Entry value (“CONE”) for each Local Resource Zone (“LRZ”) in the MISO Region of Midcontinent Independent System Operator, Inc.

    Filed Date: 9/5/18.

    Accession Number: 20180905-5136.

    Comments Due: 5 p.m. ET 9/26/18.

    Docket Numbers: ER18-2382-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: Revisions to Attachment AP to Remove References to SPP as Regional Entity to be effective 9/1/2018.

    Filed Date: 9/5/18.

    Accession Number: 20180905-5137.

    Comments Due: 5 p.m. ET 9/26/18.

    Docket Numbers: ER18-2383-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: Bylaws and Membership Agreement Revisions to Remove References to SPP RE to be effective 9/1/2018.

    Filed Date: 9/5/18.

    Accession Number: 20180905-5147.

    Comments Due: 5 p.m. ET 9/26/18.

    Docket Numbers: ER18-2384-000.

    Applicants: Ameren Illinois Company.

    Description: Notice of Cancellation of Rate Schedule No. 43 of Ameren Illinois Company.

    Filed Date: 9/5/18.

    Accession Number: 20180905-5148.

    Comments Due: 5 p.m. ET 9/26/18.

    Docket Numbers: ER18-2385-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 607R33 Westar Energy, Inc. NITSA NOA to be effective 9/27/2018.

    Filed Date: 9/6/18.

    Accession Number: 20180906-5059.

    Comments Due: 5 p.m. ET 9/27/18.

    Docket Numbers: ER18-2386-000.

    Applicants: NRG REMA LLC.

    Description: Compliance filing: Notice of Succession for Reactive Service Rate Schedule to be effective 8/21/2018.

    Filed Date: 9/6/18.

    Accession Number: 20180906-5060.

    Comments Due: 5 p.m. ET 9/27/18.

    Docket Numbers: ER18-2387-000.

    Applicants: GenOn Mid-Atlantic, LLC.

    Description: Compliance filing: Notice of Succession for Reactive Service Rate Schedules to be effective 8/21/2018.

    Filed Date: 9/6/18.

    Accession Number: 20180906-5061.

    Comments Due: 5 p.m. ET 9/27/18.

    Docket Numbers: ER18-2388-000.

    Applicants: GenOn Energy Management, LLC.

    Description: Tariff Cancellation: Notice of Cancellation to be effective 8/21/2018.

    Filed Date: 9/6/18.

    Accession Number: 20180906-5062.

    Comments Due: 5 p.m. ET 9/27/18.

    Docket Numbers: ER18-2389-000.

    Applicants: GenOn Energy Management, LLC.

    Description: Tariff Cancellation: Notices of Cancellation to be effective 8/21/2018.

    Filed Date: 9/6/18.

    Accession Number: 20180906-5063.

    Comments Due: 5 p.m. ET 9/27/18.

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

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

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

    Dated: September 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-19805 Filed 9-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER18-2361-000] Enel Green Power Hilltopper Wind, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Enel Green Power Hilltopper Wind, LLC`s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 26, 2018.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: September 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-19810 Filed 9-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP18-542-000] KO Transmission Company; Notice of Amendment

    Take notice that on August 24, 2018, KO Transmission Company (KOT), 139 East 4th Street, Cincinnati, Ohio, filed an application under section 7(c) of the Natural Gas Act and Part 157 of the Commission's regulations requesting authorization to amend its Certificate of Public Convenience and Necessity issued on April 22, 1998, in Docket No. CP97-720-000 1 in order to properly reflect the capacity acquired in that proceeding. KOT further requests authorization to amend its certificated capacity north of the Foster Station to reflect current operating capacity, all as more fully set forth in the request which is on file with the Commission and opens to public inspection. The filing may be viewed on the web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at [email protected] or call toll-free, (886) 208-3676 or TYY, (202) 502-8659.

    1 KO Transmission Company, 83 FERC ¶ 62,066 (1998).

    Any questions regarding the proposed amendment should be directed to Lance Stotts, Administrator, KO Transmission Company, 4720 Piedmont Row Drive, Room 864, Charlotte, North Carolina 28210; telephone (704)731-4360; email [email protected]

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: complete its environmental analysis (EA) and place it into the Commission's public record (eLibrary) for this proceeding, or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's EA.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 5 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    Comment Date: 5 p.m., September 27, 2018.

    Dated: September 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-19807 Filed 9-11-18; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2018-0576; FRL-9982-39] Pesticide Product Registration; Receipt of Applications for New Uses AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.

    DATES:

    Comments must be received on or before October 12, 2018.

    ADDRESSES:

    Submit your comments, identified by the Docket Identification (ID) Number and the File Symbol or EPA Registration Number of interest as shown in the body of this document, by one of the following methods:

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

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

    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:

    Robert McNally, Biopesticides and Pollution Prevention Division (7511P), main telephone number: (703) 305-7090, email address: [email protected]; or Michael Goodis, Registration Division (7505P), main telephone number: (703) 305-7090, email address: [email protected] The mailing address for each contact person is: Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. As part of the mailing address, include the contact person's name, division, and mail code. The division to contact is listed at the end of each application summary.

    SUPPLEMENTARY INFORMATION:

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

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

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

    B. 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. Registration Applications

    EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications.

    III. New Uses

    1. EPA Registration Numbers: 264-1143 and 264-1141. Docket ID number: EPA-HQ-OPP-2013-0226. Applicant: Bayer CropScience LP, P.O. Box 12014, 2 TW Alexander Dr., Research Triangle Park, NC 27709. Active ingredient: Flupyradifurone. Product type: Insecticide. Proposed use: tobacco. Contact: RD.

    2. File Symbol: 92331-E. Docket ID number: EPA-HQ-OPP-2018-0521. Applicant: Eden Research plc, 6 Priory Ct., Priory Court Business Park, Poulton, Cirencester, GL7 5JB, United Kingdom (c/o SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192). Active ingredient: Thymol. Product type: Fungicide and nematocide. Proposed use: For manufacturing or formulating of products to be used on grapes (table, wine, and raisin), fruiting vegetables, and cucurbits. Contact: BPPD.

    3. File Symbol: 92331-G. Docket ID number: EPA-HQ-OPP-2018-0519. Applicant: Eden Research plc, 6 Priory Ct., Priory Court Business Park, Poulton, Cirencester, GL7 5JB, United Kingdom (c/o SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192). Active ingredient: Eugenol. Product type: Fungicide. Proposed use: For manufacturing or formulating of products to be used on grapes (table, wine, and raisin). Contact: BPPD.

    4. File Symbol: 92331-R. Docket ID numbers: EPA-HQ-OPP-2018-0519 and EPA-HQ-OPP-2018-0521. Applicant: Eden Research plc, 6 Priory Ct., Priory Court Business Park, Poulton, Cirencester, GL7 5JB, United Kingdom (c/o SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192). Active ingredients: Thymol, eugenol, and geraniol. Product type: Fungicide. Proposed use: Grapes (table, wine, and raisin). Contact: BPPD.

    5. File Symbol: 92331-U. Docket ID number: EPA-HQ-OPP-2018-0521. Applicant: Eden Research plc, 6 Priory Ct., Priory Court Business Park, Poulton, Cirencester, GL7 5JB, United Kingdom (c/o SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192). Active ingredients: Thymol and geraniol. Product type: Nematocide. Proposed use: Fruiting vegetables and cucurbits. Contact: BPPD.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: August 14, 2018. Delores Barber, Director, Information Technology and Resources Management Division, Office of Pesticide Programs.
    [FR Doc. 2018-19869 Filed 9-11-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2018-0097; FRL-9983-06] Certain New Chemicals or Significant New Uses; Statements of Findings for April to July 2018 AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    Section 5(g) of the Toxic Substances Control Act (TSCA) requires EPA to publish in the Federal Register a statement of its findings after its review of TSCA section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to premanufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) submitted to EPA under TSCA section 5. This document presents statements of findings made by EPA on TSCA section 5(a) notices during the period from April 1, 2018 to July 31, 2018.

    FOR FURTHER INFORMATION CONTACT:

    For technical information contact: Greg Schweer, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-8469; 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?

    This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitters of the PMNs addressed in this action.

    B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0097, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    II. What action is the Agency taking?

    This document lists the statements of findings made by EPA after review of notices submitted under TSCA section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. This document presents statements of findings made by EPA during the period from April 1, 2018 to July 31, 2018.

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

    TSCA section 5(a)(3) requires EPA to review a TSCA section 5(a) notice and make one of the following specific findings:

    • The chemical substance or significant new use presents an unreasonable risk of injury to health or the environment;

    • The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the chemical substance or significant new use;

    • The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects and the chemical substance or significant new use may present an unreasonable risk of injury to health or the environment;

    • The chemical substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance; or

    • The chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

    Unreasonable risk findings must be made without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant under the conditions of use. The term “conditions of use” is defined in TSCA section 3 to mean “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”

    EPA is required under TSCA section 5(g) to publish in the Federal Register a statement of its findings after its review of a TSCA section 5(a) notice when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to PMNs, MCANs, and SNUNs submitted to EPA under TSCA section 5.

    Anyone who plans to manufacture (which includes import) a new chemical substance for a non-exempt commercial purpose and any manufacturer or processor wishing to engage in a use of a chemical substance designated by EPA as a significant new use must submit a notice to EPA at least 90 days before commencing manufacture of the new chemical substance or before engaging in the significant new use.

    The submitter of a notice to EPA for which EPA has made a finding of “not likely to present an unreasonable risk of injury to health or the environment” may commence manufacture of the chemical substance or manufacture or processing for the significant new use notwithstanding any remaining portion of the applicable review period.

    IV. Statements of Administrator Findings Under TSCA Section 5(a)(3)(C)

    In this unit, EPA provides the following information (to the extent that such information is not claimed as Confidential Business Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this period, EPA has made findings under TSCA section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:

    • EPA case number assigned to the TSCA section 5(a) notice.

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

    • Website link to EPA's decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA section 5(a)(3)(C).

    EPA Case Number: J-18-0002-0003; Chemical identity: Saccharomyces cerevisiae modified (generic name); website link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-90.

    EPA Case Number: P-18-0142; Chemical identity: Alkanoic acid, alkyl-, alkyl ester, polymer with substituted alkenoates, alkenoic acid, alkyl peroxoate-initiated; polymer exemption flag (generic name); website link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-91.

    EPA Case Number: P-16-0510; Chemical identity: Oxirane, 2-methyl-, polymer with oxirane, bis[2-[(1-oxo-2-propen-1-yl)amino]propyl] ether (CASRN: 1792208-65-1); website link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-92.

    Authority:

    15 U.S.C. 2601 et seq.

    Dated: September 4, 2018. Greg Schweer, Chief, New Chemicals Management Branch, Chemical Control Division, Office of Pollution Prevention and Toxics.
    [FR Doc. 2018-19873 Filed 9-11-18; 8:45 am] BILLING CODE 6560-50-P
    FARM CREDIT SYSTEM INSURANCE CORPORATION Regular Meeting; Farm Credit System Insurance Corporation Board AGENCY:

    Farm Credit System Insurance Corporation.

    ACTION:

    Notice, regular meeting.

    SUMMARY:

    Notice is hereby given of the regular meeting of the Farm Credit System Insurance Corporation Board (Board).

    DATES:

    The meeting of the Board will be held at the offices of the Farm Credit Administration in McLean, Virginia, on September 19, 2018, from 10:00 a.m. until such time as the Board concludes its business.

    FOR FURTHER INFORMATION CONTACT:

    Dale Aultman, Secretary to the Farm Credit System Insurance Corporation Board, (703) 883-4009, TTY (703) 883-4056, [email protected]

    ADDRESSES:

    Farm Credit System Insurance Corporation, 1501 Farm Credit Drive, McLean, Virginia 22102. Submit attendance requests via email to [email protected] See SUPPLEMENTARY INFORMATION for further information about attendance requests.

    SUPPLEMENTARY INFORMATION:

    Parts of this meeting of the Board will be open to the public (limited space available), and parts will be closed to the public. Please send an email to [email protected] at least 24 hours before the meeting. In your email include: name, postal address, entity you are representing (if applicable), and telephone number. You will receive an email confirmation from us. Please be prepared to show a photo identification when you arrive. If you need assistance for accessibility reasons, or if you have any questions, contact Dale Aultman, Secretary to the Farm Credit System Insurance Corporation Board, at (703) 883-4009. The matters to be considered at the meeting are:

    Closed Session

    • Confidential Report on System Performance

    Open Session A. Approval of Minutes

    • June 14, 2018 (Open and Closed)

    B. Business Reports

    • Quarterly Financial Reports

    • Report on Insured and Other Obligations

    • Quarterly Report on Annual Performance Plan

    C. New Business

    • Annual Performance Plan FY 2020-2021

    • Proposed 2020 and 2021 Budgets

    • Insurance Fund Progress Review and Setting of Premium Range Guidance for 2019

    Dated: September 7, 2018 Dale Aultman, Secretary, Farm Credit System Insurance Corporation Board.
    [FR Doc. 2018-19849 Filed 9-11-18; 8:45 am] BILLING CODE 6710-01-P
    FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority AGENCY:

    Board of Governors of the Federal Reserve System.

    SUMMARY:

    Notice is hereby given of temporary approval of revisions to the mandatory Consolidated Financial Statements for Holding Companies (FR Y-9C; OMB No. 7100-0128) by the Board of Governors of the Federal Reserve System (Board) pursuant to the authority delegated to the Board by the Office of Management and Budget (OMB), per OMB Regulations on Controlling Paperwork Burdens on the Public. The temporary approval is valid until March 31, 2019.

    DATES:

    The revisions are applicable as of June 30, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, the OMB delegated to the Board authority under the Paperwork Reduction Act (PRA) to temporarily approve a revision to a collection of information without providing opportunity for public comment if the Board determines that a change in an existing collection must be instituted quickly and that public participation in the approval process would defeat the purpose of the collection or substantially interfere with the Board's ability to perform its statutory obligation.

    The Board's delegated authority requires that the Board, after temporarily approving a collection, publish a notice soliciting public comment. The Board will publish a notice in the future inviting comment on these actions.

    Final approval under OMB delegated authority of the temporary revision of the following reports:

    Report title: Consolidated Financial Statements for Holding Companies.

    Agency form number: FR Y-9C, FR Y-9LP, FR Y-9SP, FR Y-9ES, and FR Y-9CS.

    OMB control number: 7100-0128.

    Effective Date: June 30, 2018.

    Frequency: Quarterly and semiannually.

    Respondents: Bank holding companies, savings and loan holding companies, securities holding companies, and U.S. intermediate holding companies (collectively, holding companies (HCs)).

    Estimated number of respondents: FR Y-9C (non-advanced approaches holding companies): 638; FR Y-9C (advanced approaches holding companies): 18; FR Y-9LP: 775; FR Y-9SP: 3,837 FR Y-9ES: 82; FR Y-9CS: 236.

    Estimated average hours per response: FR Y-9C (non-advanced approaches holding companies): 46.29 hours; FR Y-9C (advanced approaches holding companies HCs): 47.54 hours; FR Y-9LP: 5.27 hours; FR Y-9SP: 5.40 hours; FR Y-9ES: 0.50 hours; FR Y-9CS: 0.50 hours.

    Estimated annual burden hours: FR Y-9C (non-advanced approaches holding companies): 118,132 hours; FR Y-9C (advanced approaches holding companies): 3,423 hours; FR Y-9LP: 16,337 hours; FR Y-9SP: 41,440 hours; FR Y-9ES: 41 hours; FR Y-9CS: 472 hours.

    General description of report: The FR Y-9 family of reporting forms continues to be the primary source of financial data on HCs that examiners rely on between on-site inspections. Financial data from these reporting forms is used to detect emerging financial problems, review performance, conduct pre-inspection analysis, monitor and evaluate capital adequacy, evaluate HC mergers and acquisitions, and analyze an HC's overall financial condition to ensure the safety and soundness of its operations. The FR Y-9C, FR Y-9LP, and FR Y-9SP serve as standardized financial statements for the consolidated holding company. The Board requires HCs to provide standardized financial statements to fulfill the Board's statutory obligation to supervise these organizations. The FR Y-9ES is a financial statement for HCs that are Employee Stock Ownership Plans. The Board uses the FR Y-9CS (a free-form supplement) to collect additional information deemed to be critical and needed in an expedited manner. HCs file the FRY-9C on a quarterly basis, the FR Y-9LP quarterly, the FR Y-9SP semiannually, the FR Y-9ES annually, and the FR Y-9CS on a schedule that is determined when this supplement is used.

    Legal Authorization and confidentiality: The FR Y-9 family of reports is authorized by section 5(c) of the Bank Holding Company Act (12 U.S.C. 1844(c)), section 10 of Home Owners' Loan Act (12 U.S.C. 1467a(b)) and section 618 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) (12 U.S.C. 1850a(c)(1)), and section 165 of the Dodd-Frank Act (12 U.S.C. 5365). The obligation of covered institutions to report this information is mandatory.

    With respect to FR Y-9LP, FR Y-9SP, FR Y-ES, and FR Y-9CS, the information collected would generally not be accorded confidential treatment. If confidential treatment is requested by a respondent, the Board will review the request to determine if confidential treatment is appropriate.

    With respect to FR Y-9C, Schedule HI's item 7(g) “FDIC deposit insurance assessments,” Schedule HC-P's item 7(a) “Representation and warranty reserves for 1-4 family residential mortgage loans sold to U.S. government agencies and government sponsored agencies,” and Schedule HC-P's item 7(b) “Representation and warranty reserves for 1-4 family residential mortgage loans sold to other parties” are considered confidential. Such treatment is appropriate because the data is not publicly available and the public release of this data is likely to impair the Board's ability to collect necessary information in the future and could cause substantial harm to the competitive position of the respondent. Thus, this information may be kept confidential under exemptions (b)(4) of the Freedom of Information Act, which exempts from disclosure “trade secrets and commercial or financial information obtained from a person and privileged or confidential” (5 U.S.C. 552(b)(4)), and (b)(8) of the Freedom of Information Act, which exempts from disclosure information related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions (5 U.S.C. 552(b)(8)).

    Current Actions: The Economic Growth, Regulatory Relief, and Consumer Protection Action (EGRRCPA), enacted on May 24, 2018, amended various provisions of banking law to eliminate or reduce statutory and regulatory requirements on certain banking organizations. EGRRCPA, among other things, provides that state member banks and other depository institutions may only be required to assign a heightened risk weight to a “high volatility commercial real estate” (HVCRE) exposure if such exposure is an “HVCRE ADC Loan,” as defined in section 214 of EGRRCPA. Section 202 of EGRRCPA also amended the statutory definition of “brokered deposits.” The current instructions for reporting HVCRE and brokered deposits in the FR Y-9C are inconsistent with these provisions of EGRRCPA.

    In order to avoid the regulatory burden associated with different definitions for HVCRE exposures and brokered deposits within a single organization, the Board has amended the FR Y-9C instructions to permit bank holding companies, savings and loan holding companies, and intermediate holding companies of foreign banks to report HVCRE and brokered deposits on the FR Y-9C report in a manner consistent with their subsidiary depository institution(s).

    In order for the FR Y-9C to reflect sections 202 and 214 of EGRRCPA, which became effective immediately when EGRRCPA was signed on May 24, 2018, the Board cannot comply with the normal clearance process and still receive the June 30, 2018, financial data in a timely manner. Therefore, the Board has determined that the revisions to the FR Y-9C described above must be instituted quickly and public participation in the approval process would substantially interfere with the Board's ability to perform its statutory obligations arising from EGRRCPA.

    Board of Governors of the Federal Reserve System, September 6, 2018. Michele Taylor Fennell, Assistant Secretary of the Board.
    [FR Doc. 2018-19676 Filed 9-11-18; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 8, 2018.

    A. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272:

    1. Veritex Holdings, Inc., Dallas, Texas; to acquire Green Bancorp, Inc., and thereby indirectly acquire Green Bank, National Association, both of Houston, Texas.

    Board of Governors of the Federal Reserve System, September 7, 2018. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2018-19826 Filed 9-11-18; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority AGENCY:

    Board of Governors of the Federal Reserve System.

    SUMMARY:

    Notice is hereby given of temporary approval of revisions to the mandatory Complex Institution Liquidity Monitoring Report (FR 2052a; OMB No. 7100-0361) by the Board of Governors of the Federal Reserve System (Board) pursuant to the authority delegated to the Board by the Office of Management and Budget (OMB), per OMB Regulations on Controlling Paperwork Burdens on the Public. The temporary approval is valid until March 31, 2019.

    DATES:

    The revisions are applicable as of June 30, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, OMB delegated to the Board authority under the Paperwork Reduction Act (PRA) to temporarily approve a revision to a collection of information without providing opportunity for public comment if the Board determines that a change in an existing collection must be instituted quickly and that public participation in the approval process would defeat the purpose of the collection or substantially interfere with the Board's ability to perform its statutory obligation.

    The Board's delegated authority requires that the Board, after temporarily approving a collection, publish a notice soliciting public comment. The Board will publish a notice in the future inviting comment on these actions.

    Final approval under OMB delegated authority of the temporary revision of the following report:

    Report title: Complex Institution Liquidity Monitoring Report.

    Agency form number: FR 2052a.

    OMB control number: 7100-0361.

    Effective Date: June 30, 2018.

    Frequency: Monthly, and each business day (daily).

    Respondents: U.S. bank holding companies (BHCs), U.S. savings and loan holding companies (SLHCs), and foreign banking organizations (FBOs) with U.S. assets.

    Estimated number of respondents: Monthly, 40; Daily, 12.

    Estimated average hours per response: Monthly, 120; Daily, 220.

    Estimated annual burden hours: 717,600.

    General description of report: The FR 2052a is used to monitor the overall liquidity profile of institutions supervised by the Board. These data provide detailed information on the liquidity risks within different business lines (e.g., financing of securities positions, prime brokerage activities). In particular, these data serve as part of the Board's supervisory surveillance program in its liquidity risk management area and provide timely information on firm-specific liquidity risks during periods of stress. Analyses of systemic and idiosyncratic liquidity risk issues are then used to inform the Board's supervisory processes, including the preparation of analytical reports that detail funding vulnerabilities.

    Legal authorization and confidentiality: The Board's Legal Division has determined that the FR 2052a is authorized pursuant to section 5 of the Bank Holding Company Act (12 U.S.C. 1844), section 8 of the International Banking Act (12 U.S.C. 3106), and section 165 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) (12 U.S.C. 5365) and are mandatory. Section 5(c) of the Bank Holding Company Act authorizes the Board to require BHCs to submit reports to the Board regarding their financial condition. Section 8(a) of the International Banking Act subjects FBOs to the provisions of the Bank Holding Company Act. Section 165 of the Dodd-Frank Act requires the Board to establish prudential standards for certain BHCs and FBOs, which include liquidity requirements.

    Financial institution information required by the FR 2052a is collected as part of the Board's supervisory process. Therefore, such information is entitled to confidential treatment under Exemption 8 of the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)(8)). In addition, the institution information provided by each respondent would not be otherwise available to the public and its disclosure could cause substantial competitive harm. Accordingly, it is entitled to confidential treatment under the authority of exemption 4 of the FOIA (5 U.S.C. 552(b)(4)), which protects from disclosure trade secrets and commercial or financial information.

    Current Actions: The Economic Growth, Regulatory Relief, and Consumer Protection Act (EGRRCPA), enacted on May 24, 2018, amended various provisions of banking law to eliminate or reduce statutory and regulatory requirements on certain banking organizations. Section 403 of EGRRCPA provides that the federal banking agencies shall treat certain municipal obligations as “high quality liquid assets” (HQLA) for purposes of their liquidity regulations, and must amend those regulations to reflect this new treatment within 90 days of the enactment of EGRRCPA. The federal banking agencies, on August 22, 2018, issued an interim final rule 1 amending their liquidity regulations (the “Liquidity IFR'). The current FR 2052a instructions are inconsistent with the provisions of EGRRCPA. The Board has revised the FR 2052a to provide that respondents are permitted to report investment grade municipal obligations as HQLA, consistent with EGRRCPA and the Liquidity IFR. In order for the FR 2052a to reflect section 403 of EGRRCPA, which became effective immediately when EGRRCPA was signed on May 24, 2018, the Board cannot comply with the normal clearance process and still receive the June 30, 2018, financial data in a timely manner. Therefore, the Board has determined that the revision to the FR 2052a described above must be instituted quickly and public participation in the approval process would substantially interfere with the Board's ability to perform its statutory obligations arising from EGRRCPA.

    1 Press Release, Board of Governors of the Federal Reserve System, Agencies issue final rule regarding the treatment of certain municipal securities as high-quality liquid assets (August 22, 2018), available at https://www.federalreserve.gov/newsevents/pressreleases/bcreg20180822a.htm.

    Board of Governors of the Federal Reserve System, September 6, 2018. Michele Taylor Fennell, Assistant Secretary of the Board.
    [FR Doc. 2018-19675 Filed 9-11-18; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Board Meeting; 77 K St. NE, Washington, DC; 10th Floor; September 17, 2018; 8:30 a.m. Open Session 1. Approval of the Minutes of the August 27, 2018 Board Meeting 2. Monthly Reports (a) Participant Activity (b) Investment Policy (c) Legislative Report 3. FY 19 Budget Review and Approval 4. Vendor Risk Management Update 5. Capital Market and L Fund Update 6. IT Update Closed Session

    Information covered under 5 U.S.C. 552b(c)(4) and (c)(9)(B).

    CONTACT PERSON FOR MORE INFORMATION:

    Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.

    Dated: September 7, 2018. Dharmesh Vashee, Deputy General Counsel, Federal Retirement Thrift Investment Board.
    [FR Doc. 2018-19833 Filed 9-11-18; 8:45 am] BILLING CODE 6760-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0908] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by October 12, 2018.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0581. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected].

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees OMB Control Number 0910-0581—Extension

    Sponsors are required to monitor studies evaluating new drugs, biologics, and devices (21 CFR 312.50 and 312.56 for drugs and biologics, and 21 CFR 812.40 and 812.46 for devices). Various individuals and groups play different roles in clinical trial monitoring. One such group is a data monitoring committee (DMC), appointed by a sponsor to evaluate the accumulating outcome data in some trials. A clinical trial DMC is a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials. The DMC advises the sponsor regarding the continuing safety of current trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial.

    The guidance document referenced in this document is intended to assist sponsors of clinical trials in determining when a DMC is needed for monitoring a study and how such committees should operate. The guidance addresses the roles, responsibilities, and operating procedures of DMCs and describes certain reporting and recordkeeping responsibilities, including the following: (1) Sponsor reporting to FDA on DMC recommendations related to safety; (2) standard operating procedures (SOPs) for DMCs; (3) DMC meeting records; (4) sponsor notification to the DMC regarding waivers; and (5) DMC reports based on meeting minutes to the sponsor.

    1. Sponsor Reporting to FDA on DMC Recommendations Related to Safety

    The requirement of the sponsor to report DMC recommendations related to serious adverse events in an expedited manner in clinical trials of new drugs (§ 312.32(c) (21 CFR 312.32(c))) would not apply when the DMC recommendation is related to an excess of events not classifiable as serious. Nevertheless, the Agency recommends in the guidance that sponsors inform FDA about all recommendations related to the safety of the investigational product whether or not the adverse event in question meets the definition of “serious.”

    2. SOPs for DMCs

    In the guidance, FDA recommends that sponsors establish procedures to do the following things:

    • Assess potential conflicts of interest of proposed DMC members;

    • Ensure that those with serious conflicts of interest are not included in the DMC;

    • Provide disclosure to all DMC members of any potential conflicts that are not thought to impede objectivity and, thus, would not preclude service on the DMC;

    • Identify and disclose any concurrent service of any DMC member on other DMCs of the same, related, or competing products;

    • Ensure separation, and designate a different statistician to advise on the management of the trial, if the primary trial statistician takes on the responsibility for interim analysis and reporting to the DMC; and

    • Minimize the risks of bias that are associated with an arrangement under which the primary trial statistician takes on the responsibility for interim analysis and reporting to the DMC, if it appears infeasible or highly impractical for any other statistician to take over responsibilities related to trial management.

    3. DMC Meeting Records

    The Agency recommends in the guidance that the DMC or the group preparing the interim reports to the DMC maintain all meeting records. This information should be submitted to FDA with the clinical study report (21 CFR 314.50(d)(5)(ii)).

    4. Sponsor Notification to the DMC Regarding Waivers

    The sponsor must report to FDA certain serious and unexpected adverse events in drugs and biologics trials (§ 312.32) and unanticipated adverse device effects in the case of device trials (21 CFR 812.150(b)(1)). The Agency recommends in the guidance that sponsors notify DMCs about any waivers granted by FDA for expedited reporting of certain serious events.

    5. DMC Reports of Meeting Minutes to the Sponsor

    The Agency recommends in the guidance that DMCs should issue a written report to the sponsor based on the DMC meeting minutes. Reports to the sponsor should include only those data generally available to the sponsor. The sponsor may convey the relevant information in this report to other interested parties, such as study investigators. Meeting minutes or other information that include discussion of confidential data would not be provided to the sponsor.

    Description of the Respondents: The submission and data collection recommendations described in this document affect sponsors of clinical trials and DMCs.

    Burden Estimate: Table 1 of this document provides the burden estimate of the annual reporting burden for the information to be submitted in accordance with the guidance. Table 2 of this document provides the burden estimate of the annual recordkeeping burden for the information to be maintained in accordance with the guidance. Table 3 of this document provides the burden estimate of the annual third-party disclosure burden for the information to be submitted in accordance with the guidance.

    Reporting, Recordkeeping, and Third-Party Disclosure Burdens: Based on information from FDA review divisions, FDA estimates there are approximately 740 clinical trials with DMCs regulated by the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health. FDA estimates that the average length of a clinical trial is 2 years, resulting in an annual estimate of 370 clinical trials. Because FDA has no information on which to project a change in the use of DMCs, FDA estimates that the number of clinical trials with DMCs will not change significantly. For purposes of this information collection, FDA estimates that each sponsor is responsible for approximately 10 trials, resulting in an estimated 37 sponsors that are affected by the guidance annually.

    Based on information provided to FDA by sponsors that have typically used DMCs for the kinds of studies for which this guidance recommends them, FDA estimates that the majority of sponsors have already prepared SOPs for DMCs, and only a minimum amount of time is necessary to revise or update them for use for other clinical studies. FDA receives very few requests for waivers regarding expedited reporting of certain serious events; therefore, FDA has estimated one respondent per year to account for the rare instance a request may be made. Based on FDA's experience with clinical trials using DMCs, FDA estimates that the sponsor on average would issue two interim reports per clinical trial to the DMC. FDA estimates that the DMCs would hold two meetings per year per clinical trial resulting in the issuance of two DMC reports of meeting minutes to the sponsor. One set of both of the meeting records should be maintained per clinical trial.

    The “Average Burden per Response” and “Average Burden per Recordkeeping” are based on FDA's experience with comparable recordkeeping and reporting provisions applicable to FDA regulated industry. The “Average Burden per Response” includes the time the respondent would spend reviewing, gathering, and preparing the information to be submitted to the DMC, FDA, or the sponsor. The “Average Burden per Recordkeeping” includes the time to record, gather, and maintain the information.

    The information collection provisions in the guidance for 21 CFR 312.30, 312.32, 312.38, 312.55, and 312.56 have been approved under OMB control number 0910-0014; 21 CFR 314.50 has been approved under OMB control number 0910-0001; and 21 CFR 812.35 and 812.150 have been approved under OMB control number 0910-0078.

    In the Federal Register of May 31, 2018 (83 FR 25015), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

    We estimate the burden of the information collection as follows:

    Table 1—Estimated Annual Reporting Burden 1 Section of guidance/reporting activity Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Average burden
  • per response
  • Total hours
    5. Sponsor reporting to FDA on DMC recommendations related to safety 37 1 37 0.50 (30 minutes) 18.5 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 2—Estimated Annual Recordkeeping Burden 1 Section of guidance/recordkeeping activity Number of
  • recordkeepers
  • Number of
  • records per
  • recordkeeper
  • Total annual
  • responses
  • Average
  • burden per
  • recordkeeping
  • Total hours
    4.1. and 6.4 SOPs for DMCs 37 1 37 8 296 4.4.3.2. DMC meeting records 370 1 370 2 740 Total 1,036 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 3—Estimated Annual Third-Party Disclosure Burden 1 Section of guidance/disclosure activity Number of
  • respondents
  • Number of
  • disclosures
  • per
  • respondent
  • Total annual
  • disclosures
  • Average burden
  • per disclosure
  • Total hours
    4.4.1.2. Sponsor notification to the DMC regarding waivers 1 1 1 0.25 (15 minutes) 0.25 4.4.3.2. DMC reports of meeting minutes to the sponsor 370 2 740 1 740 Total 740.25 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.

    Dated: September 6, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-19799 Filed 9-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1960] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by October 12, 2018.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0291 and title “MedWatch: The Food and Drug Administration Medical Products Reporting Program.” Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected].

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    MedWatch: The FDA Medical Products Reporting Program OMB Control Number 0910-0291—Revision

    This information collection supports FDA's MedWatch safety information and adverse event reporting program. Members of the public use FDA's MedWatch system to report adverse events, product problems, errors with the use of a human medical product, or when evidence of therapeutic failure is suspected or identified in clinical use. To ensure the marketing of safe and effective products, it is critical that postmarketing adverse outcomes and product problems are reported for all FDA-regulated human healthcare products, including drugs (prescription and nonprescription), biologics, medical devices, dietary supplements, and other special nutritional products (e.g. infant formula and medical foods), and cosmetics. To facilitate reporting on human medical products (except vaccines) during their postapproval and marketed lifetimes, we have developed three forms (collectively known as the MedWatch forms). Form FDA 3500 is intended to be used for voluntary (i.e., not mandated by law or regulation) reporting by healthcare professionals; Form FDA 3500A is used for mandatory reporting (i.e., required by law or regulation); and Form FDA 3500B is written in plain language and is intended to be used for voluntary reporting (i.e., not mandated by law or regulation) by consumers (i.e., patients and their caregivers). Information collected by the forms is used to assess and evaluate risks associated with FDA-regulated products, enabling us to take appropriate action to reduce, mitigate, or eliminate the public's exposure to the risk through regulatory and public health interventions.

    I. Background A. Authorizing Statutes and Codified Regulations

    The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b, 355, 360i, 360l, and 393) and the Public Health Service Act (42 U.S.C. 262) require FDA to collect mandatory adverse event reports from regulated industry on medical products once they have been approved for marketing, enabling the Agency to monitor the safety of drugs, biologics, medical devices, and dietary supplements. Postmarket reporting for medical foods, infant formula, cosmetics, and tobacco products is done voluntarily.

    Requirements regarding mandatory reporting of adverse events or product problems are codified at parts 310, 314, 600, and 803 (21 CFR parts 310, 314, 600, and 803), specifically §§ 310.305, 314.80, 314.98, 600.80, 803.30, 803.50, 803.53, 803.56, and specified in sections 503B, 760, and 761 of the FD&C Act (21 U.S.C. 353b, 379aa, and 379aa-1). Mandatory reporting of adverse reactions for human cells, tissues, and cellular- and tissue-based products (HCT/Ps) is codified at § 1271.350 (21 CFR 1271.350).

    B. Voluntary Reporting: Form FDA 3500

    Voluntary reporting of adverse events is completed using Form FDA 3500 and may be used by healthcare professionals to submit all reports not mandated by Federal law or regulation. Individual health professionals are not required by law or regulation to submit reports to the Agency or the manufacturer with the exception of Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1). Reports for vaccines are not submitted via MedWatch or MedWatch forms, but are submitted to the Vaccines Adverse Event Reporting System, which is jointly administered by FDA and the Centers for Disease Control and Prevention and approved under OMB control number 0910-0308.

    Hospitals are not required by Federal law or regulation to submit reports associated with drug products, biological products, or special nutritional products. However, hospitals and other user facilities are required by Federal law to report medical device-related deaths and serious injuries. Under Federal law and regulation, section 761(b)(1) of the FD&C Act, a dietary supplement manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA any serious adverse event report it receives regarding use of the dietary supplement in the United States. However, FDA bears the burden to gather and review evidence that a dietary supplement may be adulterated under section 402 of the FD&C Act (21 U.S.C. 342) after that product is marketed. Therefore, the Agency depends on the voluntary reporting by health professionals, and especially by consumers, of suspected serious adverse events and product quality problems associated with the use of dietary supplements. All dietary supplement reports were previously received by the Agency on paper versions of Form FDA 3500 (or Form FDA 3500B) (by mail or Fax). Currently, electronic reports may be sent to the Agency via an online submission route called the Safety Reporting Portal (https://www.safetyreporting.hhs.gov/ approved under OMB control number 0910-0645). In that case, Form FDA 3500 (or Form FDA 3500B) is not used.

    Form FDA 3500 may be used to report to the Agency serious adverse events, product problems, and product use errors and therapeutic failures. The form is provided in both paper and electronic formats. Reporters may mail or Fax paper forms to the Agency (a fillable PDF version of the form is available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf) or reporters may electronically submit a report via the MedWatch Online Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/). Reporting is supported for drugs, non-vaccine biologicals, medical devices, special nutritional products, cosmetics, and non-prescription (over-the-counter (OTC)) human drug products marketed without an approved application. The paper form may also be used to submit reports about tobacco products and dietary supplements. Electronic reports for tobacco products and dietary supplements may be submitted to the Agency via an online submission route called the Safety Reporting Portal (https://www.safetyreporting.hhs.gov/).

    C. Mandatory Reporting: Form FDA 3500A 1. Drug and Biological Products

    In sections 505(b) and (j), 503B, and 704 (21 U.S.C. 355(b) and (j), 353B, and 374) of the FD&C Act, Congress has required that important safety information relating to all human drug products be made available to FDA so that it can take appropriate action to protect the public health when necessary. Section 702 of the FD&C Act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the FD&C Act. These statutory requirements regarding mandatory reporting have been codified by FDA under parts 310 and 314 (drugs) and 600 (biological products). Mandatory reporting of adverse reactions for HCT/Ps has been codified in § 1271.350.

    2. OTC Monograph Drug Products and Dietary Supplements

    Section 760 of the FD&C Act provides for mandatory safety reporting for non-prescription human drug products marketed without an approved application as described in the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462), which became law on December 22, 2006. The law requires manufacturers, packers, and distributors of nonprescription, OTC human drug products marketed without an approved application (OTC monograph drug products) to submit reports of adverse experiences from domestic sources. The law also requires reports of serious adverse events to be submitted to FDA by manufacturers of dietary supplements.

    3. Postmarketing Safety Reports—Changes in Format Starting in June 2018

    Current requirements specify that postmarketing adverse experience reports must be submitted on paper on Form FDA 3500A (or the CIOMS) (Council for International Organizations of Medical Sciences) I form for serious, unexpected adverse experiences from a foreign source). For the last several years the Agency has accepted electronic submissions in lieu of the paper Form FDA 3500A on the condition they are submitted in a manner that the Agency can process, review, and archive. On June 10, 2014, the Agency issued a final rule entitled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements” (79 FR 33072) that requires electronic submission of all mandatory postmarketing safety reports, including individual case safety reports. Entities with mandatory reporting obligations under parts 310 and 314 (drugs) and 600 (biological products) and specified under section 760 of the FD&C Act must implement this rule within 1 year of the issuance date (by June 10, 2015). For more information see: https://www.thefederalregister.org/fdsys/pkg/FR-2014-06-10/pdf/2014-13480.pdf.

    4. Medical Device Products

    Section 519 of the FD&C Act (21 U.S.C. 360i) requires manufacturers and importers of devices intended for human use to establish and maintain records, make reports, and provide information, as the Secretary of Health and Human Services may, by regulation, reasonably be required to provide assurance that such devices are not adulterated or misbranded and to otherwise assure its safety and effectiveness. The Safe Medical Devices Act of 1990 (Pub. L. 101-629), signed into law on November 28, 1990, amends section 519 of the FD&C Act. The amendment requires that user facilities such as hospitals, nursing homes, ambulatory surgical facilities, and outpatient treatment facilities report deaths related to medical devices to FDA and to the manufacturer, if known. Serious illnesses and injuries are to be reported to the manufacturer or to FDA if the manufacturer is not known. These statutory requirements regarding mandatory reporting have been codified by FDA under part 803. Part 803 mandates the use of Form FDA 3500A for reporting to FDA on medical devices. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), signed into law October 26, 2002, amended section 519 of the FD&C Act. The MDUFMA amendment (section 303) required FDA to revise the MedWatch forms to facilitate the reporting of information relating to reprocessed single-use devices, including the name of the reprocessor and whether the device has been reused.

    D. Voluntary Reporting by Consumers: Form FDA 3500B

    Form FDA 3500B was developed for voluntary reporting by consumers (i.e. patients and their caregivers) to submit reports not mandated by Federal law or regulation. Individual patients or their caregivers are not required by law or regulation to submit reports to the Agency or the manufacturer.

    FDA supports and encourages direct reporting to the Agency by consumers and healthcare professionals of suspected serious adverse outcomes and other product problems associated with human medical products, (https://www.fda.gov/Safety/ReportaProblem/default.htm). FDA has further encouraged voluntary reporting by requiring inclusion of the MedWatch toll-free phone number or the MedWatch internet address on all outpatient drug prescriptions dispensed, as mandated by section 17 of the Best Pharmaceuticals for Children Act (Pub. L. 107-109).

    On March 25, 2008, section 906 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) amended section 502(n) of the FD&C Act (21 U.S.C. 352(n)) and mandated that published direct-to-consumer advertisements for prescription drugs include the following statement printed in conspicuous text (this includes vaccine products): “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.”

    Most private vendors of consumer medication information, the drug product-specific instructions dispensed to consumers at outpatient pharmacies, remind patients to report “side effects” to FDA and provide contact information to permit reporting via the MedWatch process. For this reporting FDA has created Form FDA 3500B, a modified version of Form FDA 3500 tailored for consumers and written in plain language (in conformance with the Plain Writing Act of 2010 (Pub. L. 111-274), https://www.thefederalregister.org/fdsys/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf).

    Form FDA 3500B evolved from several iterations of draft versions, with input from human factors experts, from other regulatory agencies, and with extensive input from consumer advocacy groups and the general public. Form FDA 3500B may be used to report to the Agency adverse events, product problems, and product use errors. The form is provided in both paper and electronic formats. Reporters may mail or Fax paper forms to the Agency (a fillable PDF version of the form is available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf) or electronically submit a report via the MedWatch Online Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/, approved under OMB control number 0910-0645). Reporting is supported for drugs, non-vaccine biologicals, medical devices, special nutritional products, cosmetics, and non-prescription OTC human drug products marketed without an approved application. The paper form may also be used to submit reports about tobacco products and dietary supplements. Electronic reports for tobacco products and dietary supplements may be submitted to the Agency via an online submission route called the Safety Reporting Portal (https://www.safetyreporting.hhs.gov/, approved under OMB control number 0910-0645).

    II. Proposed Modification to Existing Forms FDA 3500, 3500A, and 3500B A. General Changes

    The proposed modifications to Form FDA 3500 and Form FDA 3500A reflect changes that will bring the form into conformity, since the previous OMB authorization in 2015, with current regulations, rules, and guidances and fall into three categories: (1) Regulatory driven revisions, (2) work improvements for the Center, and (3) report processing improvements. We also welcome comments about translation of Form FDA 3500B (consumer) into Spanish and other languages. Lastly, formatting modifications are being proposed to several fields to enhance the quality, utility, and clarity of the information.

    B. Changes Proposed for Form FDA 3500

    In section A, we are revising the heading of A3 to “Current Gender” followed by check boxes next to the following options “Female”, “Male”, “Intersex”, “Transgender”, “Prefer not to disclose.”

    In section B, we are revising B1 to “Type of Report (check all that apply)”. In section B2, we are removing “(Devices)” from the last option. We are also splitting section B6 into two questions: “B6.a. Relevant Test (please included dates)” and “B6.b. Relevant Laboratory Data (please included dates).”

    In section C, we are adding question C2 “Do you have a picture of the product?”

    In section D1, we are adding the question “Does this report involve cosmetics, dietary supplements or food?” followed by a checkbox for “Yes.” In section D4, we are adding the question “Is therapy still on-going?” This question is important for pharmacovigilance and the current form does not allow the reporter to be specific. The current form does not allow the reporter to be specific. It is proposed to combine boxes D6 and D7 and change the title to “Product Type” (check all that apply).

    In section E, we are adding question E9 “Was this device serviced by a third-party servicer?” followed by a checkbox for “Yes” and a checkbox for “No.”

    C. Changes Proposed for Form FDA 3500A

    In section A, we are revising the heading of A3 to “Current Gender” followed by check boxes next to the options “Female”, “Male”, “Intersex”, “Transgender”, “Prefer not to disclose”.

    In section B, we are revising the heading for BI to now read “Type of Report (check all that apply)”. In section B2, we are removing “(Devices)” from the last option. Section B6 is being split into two questions: “B6.a. Relevant Test (please include dates)” and “B6.b. Relevant Laboratory Data (please include dates),”

    In section C, we are combining boxes C6 and C7 and changing the title to “Product Type” (check all that apply).

    In section D, we are adding a new question “Was this device serviced by a third party?” followed by a checkbox for “Yes” and a checkbox for “No.”

    In section F, we are changing the revising the heading of F10 to “Adverse Event Problem” and splitting the “Patient Code” box into two fields entitled “Patient Outcome Code” and “Patient Severity Code.” We are also splitting the “Device Code” field into two fields entitled “Device Code” and “Component Code.”

    In section G, question G1 will now include “or Compounding Outsourcing Facility” after (and Manufacturing Site for Devices.)” In section G5, we are adding two new options entitled “PreANDA” and “Compounded Product” followed by a check box for “Yes,” and making consistent changes within section G6 by replacing “If IND,” to “Give Protocol #.”

    In section H1, we are adding a check box to indicate whether a summary report is included followed by a field in which to indicate “Number of Events Summarized” and an open field in which to add text. We are renaming section H6 to “Adverse Event Problem” and splitting “Patient Code” into two fields entitled “Patient Outcome Code” and “Patient Severity Code.” We are also splitting “Device Code” into two fields entitled “Device Code” and “Component Code.” In section H6, we are renaming the headings as follows: (1) “Method” to “Type of Investigation” (2) “Results” to “Investigation Findings” and (3) “Conclusions” to “Investigation Conclusion.” Finally, H10 is becoming a field entitled “Additional Manufacturer Narrative,” and we are adding field H11 entitled “Corrected Data.”

    D. Changes Proposed for Form FDA 3500B

    On page 1, we are removing the text “nutrition products, such as vitamins and minerals, herbal remedies, infant formulas, and medical foods.” We are also going to number each of the questions included.

    In section A, for the question “Did any of the following happen?” we are removing “Devices)” from the last option. We are also revising the question “List any relevant tests or laboratory data if you know them. (Include dates)” as two separate questions: “List any relevant tests (Include dates)”; and “List any relevant laboratory data (Include dates)” with corresponding date fields for “relevant tests” and “laboratory data.”

    In section B, we are asking whether respondents have a picture of the product. Also in section B, we are adding the questions “Does this report involve cosmetics, dietary supplements, or food?” and “Is therapy still on-going?” These questions pertain to pharmacovigilance and the current form does not allow for such specificity. We are also adding the question, “Was the product compounded by a pharmacy or an outsourcing facility?” Following the question, “Is the Product Compounded?” we are adding a check box for “Yes” and a checkbox for “No.” We are also adding checkboxes within the field “Product Type (check all that apply)” to correspond with selections for “Over-the-Counter, Generic and Biosimilar.” Finally, we are revising “Name of the . . .” to “Name(s) of the . . .” for clarity.

    In section C, we are separating “Other identifying information” into two fields; hoping this improves reporting. New fields will be entitled (1) “Model number” (2) “Catalog number” (3) “Lot number” (4) Serial number” (5) “UDI Number and (6) “Expiration Date.”

    In section D we are changing the terminology from “Sex” to “Current Gender” followed by corresponding check boxes next to the options “Female”, “Male”, “Intersex”, “Transgender”, “Prefer not to disclose”.

    In section E, we are revising the question “If you do NOT want your identity disclosed to the manufacturer, place an `X' in this box:” to read “If you do NOT want your identity disclosed to the manufacturer/compounder, place an `X' in this box:”

    III. Public Comment

    In the Federal Register of March 16, 2018 (83 FR 11756), we published a 60-day notice requesting public comment on the proposed collection of information. A number of comments were received and are discussed in the following paragraphs.

    General comments included suggestions that the MedWatch program be better advertised to physicians and other medical healthcare professionals as well as patients. Also, that the forms use terminology more familiar to healthcare providers and consumers. For example, using `Medication error' or `Medication error/product use error' instead of `Product use error' to ensure respondents are aware that MedWatch forms can be used to report medication errors. Other comments suggested revisions that might improve or otherwise clarify instructions. Finally, some comments pertained to the advantages of electronic reporting.

    More specific comments included a suggestion to add a question to section A of Form FDA 3500 related to pregnancy. While we agree that documenting pregnancy status is important, we do not plan on adding an additional checkbox for pregnancy at this time. Previously (in 2005), we proposed adding checkboxes for both “Product Used During Pregnancy” and “Product Used During Breast Feeding.” However we received comments expressing concern that these new data fields introduced divergence from International Council on Harmonisation standards and appeared to duplicate information usually provided in the narrative section and in coded adverse event terms. At the same time, we ask readers to note that pregnancy status can be captured in field B7 under “other relevant history.”

    Another comment suggested adding “Physician Assistant” to the drop down “Occupation” menu in section G of Form FDA 3500. We appreciate this suggestion and will implement the revision.

    We also received comment that some users have experienced “timing out” while completing Form FDA 3500B online and requested that any time limit for completing online forms be extended. We were not aware of this issue and will investigate to see whether it relates to the online functionality of the form. If so, we will make the necessary adjustments.

    While we are especially appreciative of the comments received in response to our notice, we continue to welcome feedback at all times regarding ways we might improve the MedWatch Program and the associated forms. In addition to the revisions discussed previously, on our own initiative we are now including burden associated with written submissions under § 329.100(c)(2) (21 CFR 329.100(c)(2)) that request a temporary waiver from the electronic reporting requirements associated with postmarket adverse drug events under section 760 of the FD&C Act. While we expect few such waiver requests, we retain a placeholder for one respondent annually, and we estimate it takes 1 hour to complete the request.

    We therefore estimate the burden for the information collection as follows.

    Table 1—Estimated Annual Reporting Burden 1 FDA center or 21 CFR section and/or FDA form Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • Total hours
    Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research: Form 3500 14,727 1 14,727 0.66 (40 minutes) 9,720 Form 3500A (§§ 310.305, 314.80, 314.98, 600.80, and 1271.350) 599 98 58,702 1.21 71,029 Form 3500A (§ 310.305 outsourcing facilities) 50 2 100 1.21 121 Center for Devices and Radiological Health: Form 3500 5,233 1 5,233 0.66 (40 minutes) 3,454 Form 3500A (part 803) 2,277 296 673,992 1.21 815,530 Center for Food Safety and Applied Nutrition: Form 3500 1,793 1 1,793 0.66 (40 minutes) 1,183 Form 3500A 1,659 1 1,659 1.21 2,007 Center for Tobacco Products: Form 3500 39 1 39 0.66 (40 minutes) 26 All Centers: Form 3500B 13,750 1 13, 750 0.46 (28 minutes) 6,325 Written requests for temporary waiver under § 329.100(c)(2): 1 1 1 1 1 Total 909,396 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    While we retain the currently approved estimate for the information collection, as noted previously we have added burden associated with written submissions under § 329.100.

    Dated: September 4, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-19742 Filed 9-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3010] Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient; Public Workshop; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshop; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled “Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient.” This public workshop is intended to discuss potential candidate biomarkers to determine organ transplant patients' immunologic risk for organ rejection or tolerance. The public workshop will include discussion of the biomarker qualification process and how it could be used to develop biomarkers for use in clinical trials in transplantation, to develop new drugs to address unmet needs, and in clinical practice to guide patient treatment selection. Speakers will be patients who will provide perspective on the challenges of living with a transplant, managing immunosuppression and perspectives on tolerability, adherence, and risk that may inform patient-reported outcome (PRO) and patient-focused drug development.

    DATES:

    The public workshop will be held on September 27, 2018, from 8:30 a.m. to 6 p.m. and September 28, 2018, from 8 a.m. to 12:30 p.m. Submit either electronic or written comments on this public workshop by November 19, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information.

    ADDRESSES:

    The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, sections B and C), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    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 November 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 19, 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-3010 for “Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient.” Received comments, those filed in a timely manner (see ADDRESSES), 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:

    Derek Alberding or Ramou Pratt, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-0963, [email protected], or 301-796-3928, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing a public workshop entitled “Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient.” This public workshop is intended for academic experts, industry, healthcare providers, patients, other U.S. Government Agencies, and other stakeholders.

    II. Topics for Discussion at the Public Workshop

    Presentations and discussions will cover identifying potential candidate biomarkers that could:

    • Be considered for the biomarker qualification process

    • be used in identifying patients at high immunologic risk or low immunologic risk

    • be used in clinical trials to develop drugs to address unmet individual needs in transplantation

    • be used to make appropriate immunosuppressive regimen treatment decisions

    In addition, patient speakers will provide perspectives on:

    • Challenges of living with a transplant,

    • managing immunosuppression, and

    • tolerability, adherence, and risk of therapy.

    The goal of these presentations is to inform PRO and patient-focused drug development.

    III. Participating in the Public Workshop

    Registration: Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by September 14, 2018, midnight Eastern Time. To register, please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone to [email protected]

    Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. We will let registrants know if registration closes before the day of the public workshop.

    If you need special accommodations due to a disability, please contact Derek Alberding or Ramou Pratt (see FOR FURTHER INFORMATION CONTACT) no later than September 13, 2018.

    Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by September 14, 2018. All requests to make oral presentations must be received by September 10, 2018. If selected for presentation, any presentation materials must be emailed to [email protected] (see FOR FURTHER INFORMATION CONTACT) no later than September 19, 2018. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

    Streaming Webcast of the Public Workshop: This public workshop will also be webcast at https://collaboration.fda.gov/ebtd092018/.

    If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

    Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/Drugs/NewsEvents/ucm605761.htm.

    Dated: September 6, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-19816 Filed 9-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3308] Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; establishment of a public docket; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

    DATES:

    The meeting will be held on October 10, 2018, from 8 a.m. to 1 p.m.

    ADDRESSES:

    FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-3308. The docket will close on October 9, 2018. Submit either electronic or written comments on this public meeting by October 9, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 9, 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.

    Comments received on or before October 1, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA.

    You may submit comments as follows:

    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-3308 for “Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), 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.” FDA 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 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 the 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:

    Lauren D. Tesh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, email: [email protected]; or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: The committee will discuss biologics license application 761088 for CT-P10, a proposed biosimilar to Genentech, Inc.'s RITUXAN (rituximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are for the treatment of adult patients with (1) relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma (NHL) as a single agent; (2) previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to CT-P10 in combination with chemotherapy, as single-agent maintenance therapy; and (3) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before October 1, 2018, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 24, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 25, 2018.

    Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

    For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Lauren D. Tesh (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: September 6, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-19741 Filed 9-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4853] Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register.

    FOR FURTHER INFORMATION CONTACT:

    Angela Hoague, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver Spring, MD 20993-0002, 301-348-3915, [email protected].

    SUPPLEMENTARY INFORMATION:

    The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111-148) on March 23, 2010. The BPCI Act amended the PHS Act and created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by the BPCI Act, describes the requirements for a BLA for a proposed biosimilar product or a proposed interchangeable product (351(k) BLA). Section 351(l) of the PHS Act, also added by the BPCI Act, describes certain procedures for exchanging patent information and resolving patent disputes between a 351(k) BLA applicant and the holder of the BLA reference product. If a 351(k) applicant is served with a complaint for a patent infringement described in section 351(l)(6) of the PHS Act, the applicant is required to provide the FDA with notice and a copy of the complaint within 30 days of service. FDA is required to publish notice of a complaint received under section 351(l)(6)(C) of the PHS Act in the Federal Register.

    FDA received notice of the following complaint under section 351(l)(6)(C) of the PHS Act: Genentech, Inc. and City of Hope v. Amgen Inc., 1:18-cv-00924-GMS (D. Del., filed July 2, 2018).

    FDA has only a ministerial role in publishing notice of a complaint received under section 351(l)(6)(C) of the PHS Act, and does not perform a substantive review of the complaint.

    Dated: September 6, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-19811 Filed 9-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0429] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on “Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products.”

    DATES:

    Submit either electronic or written comments on the collection of information by November 13, 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 November 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 13, 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-2012-D-0429 for “Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products.” Received comments, those filed in a timely manner (see ADDRESSES), 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:

    Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products OMB Control Number 0910-0731—Extension

    The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) offers tobacco product manufacturers several pathways to obtain an order from FDA to authorize the marketing of a new tobacco product before it may be introduced or delivered into interstate commerce. To provide assistance with these pathways to market products, FDA will meet with tobacco product manufacturers, importers, researchers, and investigators (or their representatives) when appropriate. This guidance is intended to assist persons who seek meetings with FDA relating to their research to inform the regulation of tobacco products, or to support the development or marketing of tobacco products. The original guidance issued in 2012 was revised for updating and clarity in July 2016.

    In the guidance, the Agency discusses, among other things:

    • What information FDA recommends persons include in a meeting request;

    • How and when to submit a request; and

    • What information FDA recommends persons submit prior to a meeting.

    This guidance describes two collections of information: (1) The submission of a meeting request containing certain information and (2) the submission of an information package in advance of the meeting. The purpose of this proposed information collection is to allow FDA to conduct meetings with tobacco manufacturers, importers, researchers, and investigators in an effective and efficient manner. FDA issued this guidance and the revisions consistent with FDA's good guidance practices regulations (21 CFR 10.115).

    Meeting Requests: The guidance sets forth FDA's recommendations for materials to be included in a request for a meeting with FDA to discuss the research and development of tobacco products. In the guidance, FDA recommends that the following information be included in the meeting request:

    1. Product name and FDA-assigned Submission Tracking Number (if applicable);

    2. Product category (e.g., cigarettes, smokeless tobacco) (if applicable);

    3. Product use (indicate for consumer use or for further manufacturing);

    4. Contact information for the authorized point of contact for the company requesting the meeting;

    5. The topic of the meeting being requested (e.g., a new tobacco product application, an application for permission to market a modified risk tobacco product, or investigational use of a new tobacco product);

    6. A brief statement of the purpose of the meeting, which could include a discussion of the types of studies or data to be discussed at the meeting, the general nature of the primary questions to be asked, and where the meeting fits in the overall product development plans;

    7. A preliminary list of the specific objectives/outcomes expected from the meeting;

    8. A preliminary proposed agenda, including an estimate of the time needed and a designated speaker for each agenda item;

    9. A preliminary list of specific questions, grouped by discipline (e.g., chemistry, clinical, nonclinical);

    10. A list of all individuals who will attend the meeting on behalf of the tobacco product manufacturer, importer, researcher, or investigator, including titles and responsibilities;

    11. The date on which the meeting information package will be received by FDA; and

    12. Suggested format of the meeting (e.g., conference call, in-person meeting at FDA offices, video conference, or written response) and suggested dates and times for the meeting. Meetings are usually scheduled for 1 hour.

    This information will be used by the Agency to: (1) Determine the utility of the meeting, (2) identify Agency staff necessary to discuss proposed agenda items, and (3) schedule the meeting.

    Meeting Information Packages: An individual submitting a meeting information package to FDA in advance of a meeting should provide summary information relevant to the product and supplementary information pertaining to any issue raised by the individual or FDA to be discussed at the meeting. As stated in the guidance, FDA recommends that meeting information packages generally include updates of information that was submitted with the meeting request and, as applicable:

    1. Product composition and design data summary;

    2. Manufacturing and process control data summary;

    3. Nonclinical data summary;

    4. Clinical data summary;

    5. Behavioral and product use data summary;

    6. User and nonuser perception data summary; and

    7. Investigational plans for studies and surveillance of the tobacco product, including a summary of proposed study protocols containing the following information (as applicable):

    a. Study objective(s);

    b. Study hypotheses;

    c. Study design;

    d. Study population (inclusion/exclusion criteria, comparison group(s));

    e. Human subject protection information, including Institutional Review Board information;

    f. Primary and secondary endpoints (definition and success criteria);

    g. Sample size calculation;

    h. Data collection procedures;

    i. Duration of follow up and baseline and follow up assessments, and

    j. Data analysis plan(s).

    The purpose of the information package is to provide Agency staff the opportunity to adequately prepare for the meeting, including the review of relevant data concerning the product. In the Agency's experience, reviewing such information is critical to achieving a productive meeting. If the information package was previously submitted in the meeting request, it should be revised, as applicable, so that the information reflects the most current and accurate information available.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    Meeting Requests Combining and Sending Meeting Request Letters for Manufacturers, Importers, and Researchers 83 1 83 10 830 Meeting Information Packages Combining and Submitting Meeting Information Packages for Manufacturers, Importers, and Researchers 83 1 83 18 1,494 Total 2,324 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's estimate of the number of respondents for meeting requests in table 1 is based on the number of meeting requests received and projected over the next 3 years. FDA estimates that 83 preapplication meetings will be requested.

    The hours per response for combining and sending meeting request letters are estimated at 10 hours each, and the total burden hours for meeting requests are expected to be 830 hours. Based on FDA's experience, the Agency expects it will take respondents this amount of time to prepare, gather, copy, and submit brief statements about the product and a description of the purpose and details of the meeting.

    FDA's estimates that 83 respondents will compile meeting information packages and submit to FDA at 18 hours per response. Based on FDA's experience, the Agency expects that it will take respondents 1,494 hours (83 respondents × 18 hours) to gather, copy, and submit brief statements about the product, a description of the details of the anticipated meeting, and data and information that generally would already have been generated for the planned research and/or product development.

    The total number of burden hours for this collection of information is estimated to be 2,324 hours (830 hours to prepare and submit meeting requests and 1,494 hours to prepare and submit information packages).

    Our estimated burden for the information collection reflects an overall increase of 16 respondents and 448 hours. We attribute this adjustment to an increase in the number of industry meetings as the premarket tobacco application compliance deadlines will come due in the next 3 years.

    Dated: September 4, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-19743 Filed 9-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Healthcare Delivery and Methodologies Integrated Review Group; Clinical Management of Patients in Community-based Settings Study Section.

    Date: September 27-28, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Warwick Denver, 1776 Grant Street, Denver, CO 80203.

    Contact Person: Martha L Hare, Ph.D., RN, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3154, MSC 7770, Bethesda, MD 20892, (301) 451-8504, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Hypertension and Microcirculation.

    Date: October 2, 2018.

    Time: 8:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW, Washington, DC 20015.

    Contact Person: Katherine M. Malinda, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4140, MSC 7814, Bethesda, MD 20892, 301-435-0912, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Dental, Microbiology and Oral Biology.

    Date: October 3, 2018.

    Time: 12:00 p.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Baljit S Moonga, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7806, Bethesda, MD 20892, 301-435-1777, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR-17-094: Maximizing Investigators' Research Award (R35).

    Date: October 10-11, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Capital View, 2850 South Potomac Avenue, Arlington, VA 22202.

    Contact Person: Jonathan Arias, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5170, MSC 7840, Bethesda, MD 20892, 301-435-2406, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: September 6, 2018. David D. Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-19796 Filed 9-11-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Biobehavioral Regulation, Learning and Ethology Study Section.

    Date: October 4-5, 2018.

    Time: 8:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Zoe, Fisherman's Wharf, 425 North Point Street, San Francisco, CA 94133.

    Contact Person: Unja Hayes, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301-827-6830, [email protected].

    Name of Committee: Genes, Genomes, and Genetics Integrated Review Group; Prokaryotic Cell and Molecular Biology Study Section.

    Date: October 4-5, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Kinzie Hotel, 20 West Kinzie Street, Chicago, IL 60654.

    Contact Person: Luis Dettin, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2208, Bethesda, MD 20892, 301-451-1327, [email protected].

    Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Motor Function, Speech and Rehabilitation Study Section.

    Date: October 4, 2018.

    Time: 8:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Westin Georgetown, 2350 M Street NW, Washington, DC 20037.

    Contact Person: Biao Tian, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3166, MSC 7848, Bethesda, MD 20892, 301-402-4411, [email protected].

    Name of Committee: Vascular and Hematology Integrated Review Group; Atherosclerosis and Inflammation of the Cardiovascular System Study Section.

    Date: October 11-12, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854.

    Contact Person: Natalia Komissarova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5207, MSC 7846, Bethesda, MD 20892, 301-435-1206, [email protected].

    Name of Committee: Risk, Prevention and Health Behavior Integrated Review Group; Psychosocial Development, Risk and Prevention Study Section.

    Date: October 11-12, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Fairmont Washington, DC, 2401 M Street NW, Washington, DC 20037.

    Contact Person: Anna L. Riley, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3114, MSC 7759, Bethesda, MD 20892, 301-435-2889, [email protected].

    Name of Committee: Immunology Integrated Review Group; Hypersensitivity, Autoimmune, and Immune-mediated Diseases Study Section.

    Date: October 11-12, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites Alexandria Old Town, 1900 Diagonal Road, Alexandria, VA 22314.

    Contact Person: Deborah Hodge, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4207 MSC 7812, Bethesda, MD 20892, 301-435-1238, [email protected].

    Name of Committee: Risk, Prevention and Health Behavior Integrated Review Group; Behavioral Medicine, Interventions and Outcomes Study Section.

    Date: October 11-12, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Baltimore Marriott Waterfront, 700 Aliceanna Street, Baltimore, MD 21202.

    Contact Person: Lee S. Mann, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3224, MSC 7808, Bethesda, MD 20892, 301-435-0677, [email protected].

    Name of Committee: Digestive, Kidney and Urological Systems Integrated Review Group; Hepatobiliary Pathophysiology Study Section.

    Date: October 11-12, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Jianxin Hu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2156, Bethesda, MD 20892, 301-827-4417, [email protected].

    Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Neural Oxidative Metabolism and Death Study Section.

    Date: October 11-12, 2018.

    Time: 8:00 a.m. to 2:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Crystal Gateway Marriott, 1700 Jefferson Davis Highway, Arlington, VA 22202.

    Contact Person: Carol Hamelink, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4192, MSC 7850, Bethesda, MD 20892, (301) 213-9887, [email protected].

    Name of Committee: Immunology Integrated Review Group; Innate Immunity and Inflammation Study Section.

    Date: October 11-12, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Sheraton Grand at Wild Horse Pass, 5594 W Wild Horse Pass Boulevard, Phoenix, AZ 85226.

    Contact Person: Tina McIntyre, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4202, MSC 7812, Bethesda, MD 20892, 301-594-6375, [email protected].

    Name of Committee: Digestive, Kidney and Urological Systems Integrated Review Group; Xenobiotic and Nutrient Disposition and Action Study Section.

    Date: October 11, 2018.

    Time: 8:00 a.m. to 8:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852.

    Contact Person: Martha Garcia, Ph.D., Scientific Reviewer Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2186, Bethesda, MD 20892, 301-435-1243, [email protected]

    Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Pathogenic Eukaryotes Study Section.

    Date: October 11-12, 2018.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Tera Bounds, DVM, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3198, MSC 7808, Bethesda, MD 20892, 301-435-2306, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: September 6, 2018. David D. Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-19793 Filed 9-11-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Child Health and Human Development Initial Review Group; Reproduction, Andrology, and Gynecology Subcommittee.

    Date: October 5, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda Downtown 7355 Wisconsin Ave., Bethesda, MD 20814.

    Contact Person: Dennis E. Leszczynski, Ph.D., Scientific Review Administrator Division of Scientific Review National Institute of Child Health and Human Development, NIH, 6710B Rockledge Drive, Bethesda, MD 20892, (301) 435-2717, [email protected]

    Name of Committee: National Institute of Child Health and Human Development Initial Review Group; Developmental Biology Subcommittee.

    Date: October 11, 2018.

    Time: 8:00 a.m. to 5:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites at the Chevy Chase Pavilion 4300 Military Road NW, Washington, DC 20015.

    Contact Person: Cathy J. Wedeen, Ph.D., Scientific Review Officer Division of Scientific Review, OD, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, DHHS 6710B Rockledge Drive, Bethesda, MD 20892, 301-435-6878, [email protected]

    Name of Committee: National Institute of Child Health and Human Development Initial Review Group; Function, Integration, and Rehabilitation Sciences Subcommittee.

    Date: October 12, 2018.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites, 4300 Military Rd. NW, Washington, DC 20015.

    Contact Person: Joanna Kubler-Kielb, Ph.D., Scientific Review Officer Scientific Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development 6710B Rockledge Drive, Bethesda, MD 20892, 301-435-6916, [email protected]

    Name of Committee: National Institute of Child Health and Human Development Initial Review Group Pediatrics Subcommittee.

    Date: October 12, 2018.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Rita Anand, Ph.D., Scientific Review Officer Division of Scientific Review, National Institute of Child Health and Human Development, NIH, 6710B Rockledge Drive, Bethesda, MD 20892, (301) 496-1487, [email protected]

    Name of Committee: National Institute of Child Health and Human Development Initial Review Group; Health, Behavior, and Context Subcommittee.

    Date: October 15, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Kimberly L. Houston, MD, Scientific Review Officer, Eunice Kennedy Shriver National Institute of Children Health and Human Development, 6710B Rockledge Drive, Room 2127B Bethesda, MD 20892, 301-827-4902, [email protected]

    Name of Committee: National Institute of Child Health and Human Development Initial Review Group; Obstetrics and Maternal-Fetal Biology Subcommittee.

    Date: October 26, 2018.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814,

    Contact Person: Peter Zelazowski, Ph.D., Scientific Review Officer National Institutes of Health NICHD, SRB, 6710B Rockledge Drive Bethesda, MD 20892, 301-435-6902, [email protected]

    Name of Committee: National Institute of Child Health and Human Development Initial Review Group; Biobehavioral and Behavioral Sciences Subcommittee.

    Date: October 29, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Minki Chatterji, Scientific Review Officer, Scientific Review Branch, Eunice Kennedy Shriver National Institute, of Child Health and Human Development, NIH, DHHS 6710B Rockledge Drive, Rm. 2121D, Bethesda, MD 20892-7501, 301-827-5435, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS)
    Dated: September 6, 2018. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-19795 Filed 9-11-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Initial Review Group; Kidney, Urologic and Hematologic Diseases D Subcommittee.

    Date: October 16-18, 2018.

    Time: 5:00 p.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Barbara A. Woynarowska, Ph.D., Scientific Review Administrator, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7007, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 402-7172, [email protected].

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Initial Review Group; Digestive Diseases and Nutrition C Subcommittee.

    Date: October 17-19, 2018.

    Time: 6:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Maria E. Davila-Bloom, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7017, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-7637, [email protected]

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Initial Review Group; Diabetes, Endocrinology and Metabolic Diseases B Subcommittee.

    Date: October 24-26, 2018.

    Time: 5:30 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Capital View, 2850 South Potomac Avenue, Arlington, VA 22202.

    Contact Person: John F. Connaughton, Ph.D., Chief, Scientific Review Branch, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7007, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-7797, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS)
    Dated: September 6, 2018. David D. Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-19794 Filed 9-11-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA-4383-DR; Docket ID FEMA-2018-0001] Wisconsin; Major Disaster and Related Determinations AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    This is a notice of the Presidential declaration of a major disaster for the State of Wisconsin (FEMA-4383-DR), dated August 10, 2018, and related determinations.

    DATES:

    The declaration was issued August 10, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given that, in a letter dated August 10, 2018, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”), as follows:

    I have determined that the damage in certain areas of the State of Wisconsin resulting from severe storms, straight-line winds, and flooding during the period of June 15 to June 19, 2018, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”). Therefore, I declare that such a major disaster exists in the State of Wisconsin.

    In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.

    You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, with the exception of projects that meet the eligibility criteria for a higher Federal cost-sharing percentage under the Public Assistance Alternative Procedures Pilot Program for Debris Removal implemented pursuant to section 428 of the Stafford Act.

    Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, David G. Samaniego, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.

    The following areas of the State of Wisconsin have been designated as adversely affected by this major disaster:

    Ashland, Bayfield, Burnett, Clark, Douglas, and Iron Counties for Public Assistance.

    All areas within the State of Wisconsin are eligible for assistance under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.

    Brock Long, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2018-19783 Filed 9-11-18; 8:45 am] BILLING CODE 9111-11-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA-3399-EM; Docket ID FEMA-2018-0001] Hawaii; Amendment No. 1 to Notice of an Emergency Declaration AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice amends the notice of an emergency declaration for State of Hawaii (FEMA-3399-EM), dated August 22, 2018, and related determinations.

    DATES:

    This change occurred on August 24, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.

    SUPPLEMENTARY INFORMATION:

    The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Willie G. Nunn, of FEMA is appointed to act as the Federal Coordinating Officer for this emergency.

    This action terminates the appointment of William Roche as Federal Coordinating Officer for this emergency.

    The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.

    Brock Long, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2018-19779 Filed 9-11-18; 8:45 am] BILLING CODE 9111-11-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-6050-N-02] Relief From HUD Requirements Available During Calendar Year (CY) 2018 to Public Housing Agencies To Assist With Recovery and Relief Efforts on Behalf of Families Affected by Presidentially-Declared Major Disasters AGENCY:

    Office of the Assistant Secretary for Public and Indian Housing, HUD.

    ACTION:

    Notice.

    SUMMARY:

    This Notice advises the public that HUD, in order to more effectively and expeditiously respond to Presidentially-declared Major Disaster Declarations (MDD), is establishing for CY 2018 an expedited process for the review of requests for relief from HUD regulatory and/or administrative requirements (“HUD requirements”) for public housing agencies (PHAs) that are located in counties that are included in MDDs. PHAs located in areas covered by MDDs issued for which a related disaster occurs during 2018 may request waivers of HUD requirements and receive expedited review of such requests utilizing the flexibilities and expedited waiver process set out by this Notice.

    DATES:

    Applicable: September 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Shelia Bethea, Office of Field Operations, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4112, Washington, DC 20410-5000, telephone number 202-402-8120. Persons with hearing or speech impairments may access this number via TTY by calling the Federal Information Relay Service at 800-877-8339.

    SUPPLEMENTARY INFORMATION:

    I. Background Information

    On several occasions in recent years, after Presidential disaster declarations, HUD has published notices to announce waivers and flexibilities available to PHAs, Tribes, and Tribally Designated Housing Entities located in areas covered by MDDs.1 In the interest of expediting HUD's ability to provide administrative relief to PHAs in MDD declaration areas, based on HUD's past experience, HUD is publishing this Notice on waivers and flexibilities that will be made available to PHAs on an expedited basis following MDDs. The Notice is organized as follows:

    1 See, Regulatory and Administrative Waivers Granted for Public and Indian Housing Programs to Assist with Recovery and Relief in Hurricane Katrina Disaster Areas, 70 FR 57716 (October 3, 2005); Regulatory and Administrative Waivers Granted for Public and Indian Housing Programs to Assist with Recovery and Relief in Hurricane Rita Disaster Areas; and Additional Administrative Relief for Hurricane Katrina, 70 FR 66222 (November 1, 2005); Extension of Regulatory and Administrative Waivers Granted for Public and Indian Housing Programs to Assist With Recovery and Relief in Hurricanes Katrina, Rita, and Wilma Disaster Areas, 71 FR 78022 (December 27, 2006); Regulatory and Administrative Waivers Granted for Public and Indian Housing Programs to Assist with Recovery and Relief in Hurricane Wilma Disaster Areas, 71 FR 12988 (March 13, 2006); Regulatory and Administrative Waivers Granted for Public and Indian Housing Programs to Assist with Recovery and Relief in Superstorm Sandy Disaster Areas, 77 FR 71439 (November 30, 2012); and Relief From HUD Requirements Available to PHAs to Assist With Recovery and Relief Efforts on Behalf of Families Affected by Hurricanes Harvey, Irma, Maria and Future Natural Disasters Where Major Disaster Declarations Might be Issued in 2017, 82 FR 46821 (October 6, 2017).

    • Section II describes the flexibilities that are currently available to MDD PHAs under statutes and/or regulations. MDD PHAs may avail themselves of these flexibilities, following the process described in Section IV of the Notice.

    • Section III describes certain HUD requirements that, if waived, may facilitate an MDD PHA's ability to participate in relief and recovery efforts. An MDD PHA may request a waiver of a HUD requirement not listed in Section IV and receive expedited review of the request if the MDD PHA demonstrates that the waiver is needed to assist in its relief and recovery efforts. An MDD PHA may not adopt any requested waiver prior to receiving HUD approval.

    • Section V States that a Finding of No Significant Impact (FONSI) with respect to the environment has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)).

    Waiver requests approved by HUD pursuant to this Notice will be published in the Federal Register and will identify the MDD PHAs receiving such approvals. The process that HUD will use in assessing applications for waivers and flexibilities is covered below:

    This Notice applies only during CY 2018.

    II. Flexibilities That Are Available to MDD PHAs During CY 2018

    HUD is exercising discretionary authority consistent with 24 CFR 5.110 to provide relief from the requirements described in this section. Upon notification to HUD and appropriate documentation of good cause, or upon HUD approval, as noted below, relief will be granted to MDD PHAs. Relief from the requirements must benefit families affected by the disasters, for example by enabling MDD PHA staff to focus on relief and recovery efforts. Unless otherwise stated, the deadline for requesting waivers is 4 months after the initial MDD.

    A. 24 CFR 905.306 (Extension of deadline for obligation and expenditure of Capital Funds). Section 9(j)(1) of the United States Housing Act of 1937 (1937 Act) requires PHAs to obligate Capital Funds not later than 24 months after the date on which the funds became available, or the date on which the PHA accumulates adequate funds to undertake modernization, substantial rehabilitation, or new construction of units, plus the period of any extension approved under section 9(j)(2) of the Act. Section 9(j)(5)(A) of the 1937 Act requires a PHA to expend Capital Funds not later than 4 years after the date on which the funds become available for obligation, plus the period of any extension approved under section 9(j)(2). Section 9(j)(2) of the 1937 Act authorizes the Secretary to extend the time period for the obligation of Capital Funds for such period as the Secretary determines necessary if the Secretary determines that the failure of the PHA to obligate assistance in a timely manner is attributable to an event beyond the control of the PHA. The authority for extension of the section 9(j) obligation and extension deadlines for an event beyond the control of the PHA made in this Notice is also found in the implementing regulation at 24 CFR 905.306 (d)(5).

    B. 24 CFR 984.105(d) (Family Self-Sufficiency minimum program size). 24 CFR 984.105(d) defines the circumstances under which a PHA may, upon HUD approval, operate a program that is smaller than the required program size. HUD has determined, based on its past experience with MDDs, that a major disaster may hinder a PHA's ability to operate a program that meets minimum program size requirements. As a result, upon the submission to HUD of a certification (as defined in 24 CFR 984.103) that the MDD PHA is unable to operate a program that meets minimum program size requirements due to the major disaster, HUD will grant an exemption from the minimum program size requirement for a period of 24 months from the effective date of this Notice.

    C. 24 CFR 990.145(b) (Public housing dwelling units with approved vacancies). Section 990.145 lists the categories of vacant public housing units that are eligible to receive operating subsidy and are therefore considered to be “approved vacancies.” Under Section 990.145(b), a PHA shall receive operating subsidy for units that are vacant due to a declared disaster, subject to prior HUD approval, on a project-by-project basis. If an MDD PHA has a unit that has been vacated due to a Presidentially-declared disaster, then the MDD PHA, with HUD approval, may treat the unit as an “approved vacancy.” Upon the request of an MDD PHA and HUD approval, on a case-by-case basis, such units may be considered approved vacancies for a period not to exceed 12 months from the date of HUD approval.

    III. HUD Requirements That May Be Waived

    For an MDD PHA, HUD will review requests for waivers of HUD requirements on an expedited basis. This section lists requirements for waivers, requests for which HUD anticipates receiving. An MDD PHA may also request a waiver of a HUD requirement not listed in this section and receive expedited review of the request if the MDD PHA documents that the waiver is needed for relief and recovery purposes. This documentation need not be in writing if HUD determines that providing written documentation is impracticable.

    PHAs must note that commonly sought waivers such as waiving inspection or income verification requirements entirely cannot be granted. PHAs should go through the hierarchy of verifying income as found in PIH 2017-12 if sources of income are difficult to find. Similarly, while the requirement for HQS inspections cannot be waived, HUD can consider variations to the acceptability criteria to HQS in case of disaster (under the authority of 982.401(a)(4)).

    HUD expects that any waiver granted pursuant to this Notice will benefit families affected by disasters by, for example, enabling MDD PHA staff to focus on relief and recovery efforts.

    An MDD PHA seeking a waiver of a HUD requirement listed below or of any other HUD requirement needed to assist the MDD PHA in its relief and recovery efforts must submit a waiver request pursuant to the process that will be provided in a further Notice. HUD will not approve an MDD PHA's or other recipient's request to waive a fair housing, civil rights, labor standards, or environmental requirement. The request must be submitted to HUD not later 4 months following the date of the relevant disaster declaration.

    A. 24 CFR 5.801(c) and 5.801(d)(1) (Uniform financial reporting standards; Filing of financial reports; Reporting compliance dates). Section 5.801 establishes uniform financial reporting standards (UFRS) for PHAs (and other entities). Section 5.801(c) requires that PHAs submit financial information in accordance with 24 CFR 5.801(b) annually, not later than 60 days after the end of the fiscal year of the reporting period. Section 5.801(d)(1) requires that PHAs submit their unaudited financial statements not later than 60 calendar days after the end of their fiscal year and that PHAs submit their audited financial statements not later than 9 months after the end of their fiscal year. HUD is willing to consider requests to extend these reporting deadlines.

    For MDD PHAs with a deadline to submit only audited financial information in accordance with 24 CFR 5.801(b) and (d) within 6 months after the date of the disaster related to the MDD, HUD is willing to consider a request to waive the due date. For MDD PHAs with a deadline to submit unaudited financial information in accordance with 24 CFR 5.801(b) and (d) within 4 months before and up to 6 months after the date of the disaster related to the MDD, HUD is willing to consider a request to waiver the due date. For these PHAs, HUD also is willing to consider a request to waive the due date of the audited financial information. For situations beyond a PHA's control, HUD is willing to consider requests from the MDD PHAs with financial submission due dates that fall outside these dates.

    The deadline for submission of financial information in accordance with 24 CFR 5.801(b) and the deadline for submission of unaudited financial statement may be extended to 180 calendar days, and the deadline for submission of audited financial statements may be extended to 13 months.

    B. 24 CFR 902 (Public Housing Assessment System). Part 902 sets out the indicators by which HUD measures the performance of a PHA. The indicators measure a PHA's physical condition, financial condition, management operations, and Capital Fund obligation and occupancy.

    For MDD PHAs with FYE dates within 4 months before and up to 10 months after the date of the disaster related to the MDD, HUD is willing to consider a request to waive the physical inspection and scoring of public housing projects, as required under 24 CFR 902. For situations beyond the PHA's control, HUD is willing to consider requests from MDD PHAs with a FYE date that falls outside these dates.

    C. 24 CFR 905.322(b) (Fiscal closeout). Section 905.322(b) establishes deadlines for the submission of an Actual Development Cost Certificate (ADCC) and an Actual Modernization Cost Certificate (AMCC). Specifically, the ADCC must be submitted 12 months from the date of completion/termination of a modernization activity, and the AMCC must be submitted not later than 12 months from the activity's expenditure deadline. Upon request from an MDD PHA, HUD may extend these deadlines by 12 months.

    D. 24 CFR 905.314(b)-(c) (Cost and other limitations; Maximum project cost; Total Development Cost (TDC) limit). 42 U.S.C. 1437d(b) requires HUD to calculate total development costs, which may not be exceeded “unless the Secretary provides otherwise, and in any case may not exceed 110 per centum of such amount unless the Secretary for good cause determines otherwise.” Section 905.314(b)-(c) establishes the calculation of maximum project cost and the calculation of total development cost. To facilitate the use of Capital Funds for repairs and construction for needed housing in the disaster areas, HUD is willing to consider waiving the TDC and housing cost cap limits for all work funded by the Capital Grant (Capital Grant Funds with undisbursed balances and HOPE VI funds) until the next issuance of TDC levels. MDD PHAs that request to waive this provision and receive approval to do so must strive to keep housing costs reasonable given local market conditions, based upon the provisions outlined in 2 CFR part 200.

    E. 24 CFR 905.314(j) (Cost and other limitations; Types of labor). This section establishes that non-high performer PHAs may use force account labor for modernization activities only when the use of force account labor for such activities has been included in a Board-approved Capital Fund Program 5-Year Action Plan. HUD may waive this requirement to allow for the use of force account labor for modernization activities even if this activity has not been included in the non-high performer MDD PHA's 5-Year Action Plan. Should HUD waive this requirement, the waiver will be in effect for a period not to exceed 12 months from the date of HUD approval.

    F. 24 CFR 905.400(i)(5) (Capital Fund Formula; Limitation of Replacement Housing Funds to New Development). Section 905.400 describes the Capital Fund formula. Section 905.400(i)(5) limits the use of replacement housing funds to the development of new public housing. To help address housing needs because of the displacement caused by a disaster, HUD is willing to consider waiving 905.400(i)(5) to allow all Capital Fund Replacement Housing Factor Grants with undisbursed balances to be used for public housing modernization. Should HUD waive this requirement, the waiver will be in effect for funds obligated within 12 months from the date of HUD approval.

    G. 24 CFR 960.202(c)(1) (Tenant selection policies) and 982.54(a) (Administrative plan). Section 960.202(c)(1) provides that public housing tenant selection policies must be duly adopted and implemented. Section 982.54(a) provides that a PHA's Section 8 administrative plan must be formally adopted by the PHA Board of Commissioners or other authorized PHA officials. For temporary revisions to an MDD PHA's public housing tenant selection policies or Section 8 administrative plan that an MDD PHA wishes to put into place to address circumstances unique to relief and recovery efforts, HUD is willing to consider requests to waive the requirements for formal approval. Any waiver request must include documentation that an MDD PHA's Board of Commissioners or an authorized MDD PHA official supports the waiver request and must identify the temporary revisions, which shall be effective for a period not to exceed 12 months from the date of HUD's approval. Additionally, any waiver request would be limited to revisions that do not constitute a significant amendment or modification to the PHA plan; pursuant to Section 5A(g) of the 1937 Act, HUD cannot waive the approval by the board or other authorized PHA officials if the proposed revision would constitute a significant amendment or modification to the PHA plan. Finally, HUD cannot waive any terms within a PHA's own plan or state law requiring the approval of the board or authorized PHA officials.

    H. 24 CFR 982.206(a)(2) (Waiting List; Opening and closing; Public notice). This section describes where a PHA must provide public notice when it opens its waiting list for tenant-based assistance. HUD is willing to consider a request from an MDD PHA that wishes, in lieu of the requirement to provide notice in a local newspaper of general circulation, to provide public notice via its Website, at any of its offices, and/or in a voice-mail message, for any opening of the waiting list for tenant-based assistance that occurs within a period not to exceed 12 months from the date of HUD approval. MDD PHAs, that request a waiver of this requirement and receive HUD approval, must comply with applicable fair housing and other civil rights requirements when they provide public notice. For example, an MDD PHA that chooses to provide public notice at its offices must consider the impact on persons with disabilities, who may have difficulty visiting the office in person. Similarly, an MDD PHA that chooses to provide public notice via voice-mail message must consider how it will reach persons with hearing impairments and persons with limited English proficiency. HUD maintains the requirement that an MDD PHA must also provide the public notice in minority media. Any notice must comply with HUD's fair housing requirements.

    I. 24 CFR 982.503(c) (HUD approval of exception payment standard amount). 24 CFR 982.503(c) authorizes HUD to approve an exception payment standard amount that is higher than 110 percent of the published fair market rent (FMR). Typically, a PHA must provide data about the local market to substantiate the need for an exception payment standard. In a natural disaster situation, however, the typical data sources fail to capture conditions on the ground. In these cases, HUD considers the most recently available data on the rental market, prior to the disaster, then estimates the number of households seeking housing units in the wake of the disaster to arrive at an emergency exception payment standard amount. In the event of a disaster, HUD will consider, based on this data, whether exception payment standard amounts up to 150 percent of the FMR have a good cause justification even in the absence of supporting data. If so, an MDD PHA may request this payment standard. Upon approval by HUD, an exception payment standard adopted pursuant to this Notice may be adopted for any Housing Assistance Payments (HAP) contract entered as of the effective date of this Notice. HUD intends for these exception payment standards to remain in effect until HUD implements changes to the FMRs in the affected areas. MDD PHAs are reminded that increased per-family costs resulting from the use of exception payment standards may result in a reduction in the number of families assisted or may require other cost-saving measures for an MDD PHA to stay within its funding limitations.

    J. 24 CFR 982.401(d) (Housing quality standards; Space and security). This section establishes a standard for adequate space for an Housing Choice Voucher-assisted family. Specifically, it requires that each dwelling unit have at least 1 bedroom or living/sleeping room for each 2 persons. HUD is willing to consider a request from an MDD PHA that wishes to waive this requirement to house families displaced due to the severe storms and flooding. Should the waiver be granted, it will be in effect only for HAPs entered into during the 12-month period following the date of HUD approval, and then only with the written consent of the family. For any family occupying a unit pursuant to this waiver, the waiver will be in effect for the initial lease term.

    K. 24 CFR 982.633(a) (Occupancy of home). This section establishes the requirement that PHAs may make HAP for homeownership assistance only while a family resides in their home and must stop HAP no later than the month after a family moves out. HUD is willing to consider a request from an MDD PHA wishing to waive this requirement to allow families displaced from their homes located in areas affected by MDD(s) to comply with mortgage terms or make necessary repairs. A PHA requesting a waiver of this type must show good cause by demonstrating that the family is not already receiving assistance from another source. Note: An MDD PHA that wishes in addition to request a waiver of the requirement at § 982.312 that a family be terminated from the program if they have been absent from their home for 180 consecutive calendar days must do so separately.

    L. 24 CFR 984.303(d) (Contract of participation; contract extension). Part 984 establishes the requirements for the Section 8 and Public Housing Family Self-Sufficiency (FSS) Program. Section 984.303(d) authorizes a PHA to extend a family's contract of participation for a period not to exceed 2 years, upon a finding of good cause, for any family that requests such an extension in writing. HUD is willing to consider a request from an MDD PHA that wishes to extend family contracts for up to 3 years, if such extensions are merited based on circumstances deriving from MDDs. Any waiver granted pursuant to this request will be in effect for requests made to the MDD PHA during a period not to exceed 12 months from the date of HUD approval.

    M. 24 CFR part 985 (Section 8 Management Assessment Program (SEMAP)). Part 985 sets out the requirements by which Section 8 tenant-based assistance programs are assessed. For an MDD PHA that has a SEMAP score due during CY 2018, HUD is willing to consider a request to carry forward the last SEMAP score received by the PHA.

    N. Notice PIH 2012-10, Section 8(c) (Verification of the Social Security Number (SSN)). PHAs are required to transmit form HUD-50058 not later than 30 calendar days following receipt of an applicant's or participant's SSN documentation. HUD is willing to consider a request to extend this requirement to 90 calendar days, for a period not to exceed 12 months from the date of HUD approval.

    O. Notice PIH 2012-7, Section 9 and 4. HUD will not process a Special Application Center (SAC) application that is incomplete or deficient on a substantial item (e.g., supporting information required under 24 CFR sections 970.7(a)(1)-(17) (environmental review must still be performed)). HUD is willing to consider a request to waive this for MDD PHAs to allow these PHAs to apply for tenant protection vouchers (TPVs) after the submission of a SAC application based on imminent health and safety issues (in accordance with PIH Notice 2018-09).

    P. 24 CFR 970.15(b)(1)(ii). For Section 18 demolition applications (and disposition applications) justified by location obsolescence, in addition to accepting an environmental review performed by HUD under 24 CFR part 50, for MDD PHAs, HUD is willing to accept an environmental review performed under 24 CFR part 58 if HUD determines the part 58 review indicates the environmental conditions jeopardize the suitability of the site or a portion of the site and its housing structures for residential use.

    Q. 24 CFR 970.15(b)(2) and PIH 2012-7, Section 14. For Section 18 demolition applications (and disposition applications) justified by obsolescence, HUD generally shall not consider a program of modifications to be cost-effective if the costs of such programs exceed 62.5 percent of TDC for elevator structures and 57.14 percent of TDC for all other types of structures in effect at the time the application is submitted to HUD. In addition, HUD requires that PHAs support rehabilitation cost-estimate by a list of specific and detailed work-items identified on form HUD-52860-B and other criteria outlined in PIH Notice 2012-7, Section 14. HUD is willing to consider requests to waive these requirements if MDD PHAs submit other evidence (e.g., insurance adjuster reports, condemnation orders from local municipalities, and photographs) that support the MDD PHA's certification that a program of modifications is not cost-effective.

    R. Notice PIH 2012-7, Section 14. HUD approves Section 18 demolition applications and disposition applications justified by physical obsolescence. HUD is willing to consider requests to waive these criteria for MDD PHAs if they submit other evidence (e.g., insurance adjuster reports, photographs) that support the MDD PHA's certification that a program of modifications is not cost-effective.

    IV. Notification and Expedited Waiver Process During CY 2018—Instructions

    HUD has developed a checklist (Attachment A to this Notice) that an MDD PHA must complete and submit to take advantage of the provisions identified in this Notice and the expedited review of waiver requests. Each provision on the checklist indicates the documentation that must accompany the MDD PHA's submission. Each request for a waiver (Section 3 of the checklist) must include a good-cause justification stating why the waiver is needed for the PHA's relief and recovery efforts.

    To complete the checklist, take the following steps:

    1. Download the checklist to your computer, saving the document with the following filename: FR-6050-N-02. Your Agency's HA Code (e.g., FR-050-N02.MI001). HUD will consider other methods of submission as needed.

    2. Complete the section titled Information about Requesting Agency. This section must be complete. An official of the MDD PHA must sign where indicated. If the information about the requesting agency is incomplete or the checklist has not been signed, then the checklist will be returned without review.

    3. Complete Sections 1, 2, and/or 3 of the checklist, as applicable, noting the documentation (if any) that accompanies each provision.

    4. Address an email to both [email protected] and your Field Office Public Housing Director. In the subject line, type “PHA Name—PHA Code—MDD Disaster Relief—Month and Year”.

    5. Attach the completed checklist, letter of justification, and supporting documentation as applicable to your email.

    6. Click “Send.”

    Checklists and any supporting documentation or information must be submitted not later than 4 months following the MDD. Requests submitted after that time period will not be considered except in special cases outside of the agency's control.

    V. Finding of No Significant Impact

    A Finding of No Significant Impact (FONSI) with respect to the environment has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The FONSI is available for public inspection between 8 a.m. and 5 p.m. weekdays in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW, Room 10276, Washington, DC 20410-0500. Due to security measures at the HUD Headquarters building, an advance appointment to review the docket file must be scheduled by Calling the Regulations Division at 202-708-3055 (this is not a toll-free number). Hearing- or speech-impaired individuals may access this number through TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).

    Dated: September 5, 2018. Danielle Bastarache, Deputy Assistant Secretary. BILLING CODE 4210-67-P EN12SE18.002 EN12SE18.003 EN12SE18.004 EN12SE18.005 EN12SE18.006
    [FR Doc. 2018-19708 Filed 9-11-18; 8:45 am] BILLING CODE 4210-67-C
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLORB00000.L10200000.BS0000.LXSSH1060000.18X.HAG 18-0149] Notice of Public Meetings for the Southeast Oregon Resource Advisory Council AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management's (BLM), Southeast Oregon Resource Advisory Council (RAC) will meet as indicated below.

    DATES:

    The Southeast Oregon RAC will meet Thursday, October 11, and Friday, October 12, 2018 from 8 a.m. to 5 p.m. Pacific Daylight Time each day. A half-hour comment period, during which the public may address the RAC, will begin at 4 p.m. Friday, October 12. The final agenda will be posted online at https://www.blm.gov/get-involved/resource-advisory-council/near-you/oregon-washington/southeast-oregon-rac at least one week prior to the meeting.

    ADDRESSES:

    This meeting will be held at the Harney County Chamber of Commerce, 484 N Broadway, Burns, OR 97720.

    FOR FURTHER INFORMATION CONTACT:

    Larisa Bogardus, Public Affairs Officer, 1301 S G Street, Lakeview, Oregon 97630; (541) 947-6811; [email protected] Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1(800) 877-8339 to contact the above individual during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    The meeting Thursday, October 11, will consist of working sessions that pertain to the Lakeview Resource Management Plan Amendment (RMP-A) and the Southeast Oregon (Vale) RMP-A. The meeting Friday, October 12, will include discussions about potential management approaches for the draft alternatives for the Lakeview District's RMP-A; development of interstate fuel breaks to protect against wildfire; a discussion of potential comments to submit regarding the draft alternatives proposed for the Southeast Oregon RMP-A; a report on the 2018 Fire Season; a presentation by the State of Oregon Department of Fish and Wildlife regarding their wolf management plan and how it applies to Federal lands; and any other business that may reasonably come before the RAC.

    The 15-member Southeast Oregon RAC was chartered and appointed by the Secretary of the Interior. Their diverse perspectives are represented in commodity, conservation, and general interests. They provide advice to the BLM and US Forest Service resource managers regarding management plans and proposed resource actions on public land in southeast Oregon. All meetings are open to the public in their entirety. Information to be distributed to the RAC is requested prior to the start of each meeting.

    Before including your address, phone number, email address, or other personal identifying information in your comments, please be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee we will be able to do so.

    Authority:

    43 CFR 1784.4-2.

    Jeff Krauss, Acting Assistant Director, Communications.
    [FR Doc. 2018-19839 Filed 9-11-18; 8:45 am] BILLING CODE 4310-33-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLAK940000.L14100000.BX0000.18X.LXSS001L0100] Filing of Plats of Survey: Alaska AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of official filing.

    SUMMARY:

    The plats of survey of lands described in this notice are scheduled to be officially filed in the Bureau of Land Management (BLM), Alaska State Office, Anchorage, Alaska. The surveys, which were executed at the request of the U.S. Fish and Wildlife Service and the BLM, are necessary for the management of these lands.

    DATES:

    The BLM must receive protests by October 12, 2018.

    ADDRESSES:

    You may obtain a copy of the plats from the Alaska Public Information Center at the BLM Alaska State Office, 222 W. 7th Avenue, Anchorage, AK 99513, upon required payment. You may view the plats at this location at no cost. Please use this address when filing written protests.

    FOR FURTHER INFORMATION CONTACT:

    Douglas N. Haywood, Chief, Branch of Cadastral Survey, Alaska State Office, Bureau of Land Management, 222 W 7th Avenue, Anchorage, AK 99513; 907-271-5481; [email protected] People who use a telecommunications device for the deaf may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    The lands surveyed are:

    U.S. Survey No. 14489, accepted August 30, 2018.

    U.S. Survey No. 14495, accepted August 30, 2018.

    Seward Meridian, Alaska T. 1 N, R. 20 W, accepted June 22, 2018 T. 1 N, R. 21 W, accepted June 22, 2018 T. 2 N, R. 18 W, accepted June 22, 2018 T. 2 N, R. 19 W, accepted June 22, 2018 T. 2 N, R. 20 W, accepted June 22, 2018 T. 2 N, R. 21 W, accepted June 22, 2018 T. 3 N, R. 17 W, accepted June 22, 2018 T. 3 N, R. 18 W, accepted June 22, 2018 T. 3 N, R. 19 W, accepted June 22, 2018 T. 3 N, R. 20 W, accepted June 22, 2018 T. 4 N, R. 18 W, accepted June 22, 2018 T. 4 N, R. 19 W, accepted June 22, 2018 T. 4 N, R. 20 W, accepted June 22, 2018 T. 4 N, R. 21 W, accepted June 22, 2018 T. 1 S, R. 21 W, accepted June 22, 2018 T. 40 S, R. 57 W, accepted June 29, 2018 T. 40 S, R. 58 W, accepted July 2, 2018

    A person or party who wishes to protest one or more plats of survey identified above must file a written notice of protest with the State Director for the BLM in Alaska. The notice of protest must identify the plat(s) of survey that the person or party wishes to protest. You must file the notice of protest before the scheduled date of official filing for the plat(s) of survey being protested. The BLM will not consider any notice of protest filed after the scheduled date of official filing. A notice of protest is considered filed on the date it is received by the State Director for the BLM in Alaska during regular business hours; if received after regular business hours, a notice of protest will be considered filed the next business day. A written statement of reasons in support of a protest, if not filed with the notice of protest, must be filed with the State Director for the BLM in Alaska within 30 calendar days after the notice of protest is filed.

    If a notice of protest against a plat of survey is received prior to the scheduled date of official filing, the official filing of the plat of survey identified in the notice of protest will be stayed pending consideration of the protest. A plat of survey will not be officially filed until the dismissal or resolution of all protests of the plat.

    Before including your address, phone number, email address, or other personal identifiable information in a notice of protest or statement of reasons, you should be aware that the documents you submit, including your personal identifiable information, may be made publicly available in their entirety at any time. While you can ask the BLM to withhold your personal identifiable information from public review, we cannot guarantee that we will be able to do so.

    Authority:

    43 U.S.C. Chap. 3.

    Douglas N. Haywood, Chief Cadastral Surveyor, Alaska.
    [FR Doc. 2018-19890 Filed 9-11-18; 8:45 am] BILLING CODE 4310-JA-P
    INTERNATIONAL TRADE COMMISSION [Investigation Nos. 731-TA-1422-1423 (Preliminary)] Strontium Chromate From Austria and France; Institution of Anti-Dumping Duty Investigations and Scheduling of Preliminary Phase Investigations AGENCY:

    United States International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping duty investigation Nos. 731-TA-1422-1423 (Preliminary) pursuant to the Tariff Act of 1930 (“the Act”) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of strontium chromate from Austria and France, provided for in subheadings 2841.50.91 and 3212.90.00 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value. Unless the Department of Commerce (“Commerce”) extends the time for initiation, the Commission must reach a preliminary determination in antidumping duty investigations in 45 days, or in this case by October 22, 2018. The Commission's views must be transmitted to Commerce within five business days thereafter, or by October 29, 2018.

    DATES:

    September 5, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Kristina Lara (202) 205-3386, Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (https://www.usitc.gov). The public record for these investigations may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov.

    SUPPLEMENTARY INFORMATION:

    Background.—These investigations are being instituted, pursuant to section 733(a) of the Tariff Act of 1930 (19 U.S.C. 1673b(a)), in response to a petition filed on September 5, 2018, by WPC Technologies, Oak Creek, Wisconsin.

    For further information concerning the conduct of these investigations and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and B (19 CFR part 207).

    Participation in the investigations and public service list.—Persons (other than petitioners) wishing to participate in the investigations as parties must file an entry of appearance with the Secretary to the Commission, as provided in sections 201.11 and 207.10 of the Commission's rules, not later than seven days after publication of this notice in the Federal Register. Industrial users and (if the merchandise under investigation is sold at the retail level) representative consumer organizations have the right to appear as parties in Commission antidumping duty investigations. The Secretary will prepare a public service list containing the names and addresses of all persons, or their representatives, who are parties to these investigations upon the expiration of the period for filing entries of appearance.

    Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and BPI service list.—Pursuant to section 207.7(a) of the Commission's rules, the Secretary will make BPI gathered in these investigations available to authorized applicants representing interested parties (as defined in 19 U.S.C. 1677(9)) who are parties to the investigations under the APO issued in the investigations, provided that the application is made not later than seven days after the publication of this notice in the Federal Register. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

    Conference.—The Commission's Director of Investigations has scheduled a conference in connection with these investigations for 9:30 a.m. on Wednesday, September 26, 2018, at the U.S. International Trade Commission Building, 500 E Street SW, Washington, DC. Requests to appear at the conference should be emailed to [email protected] (DO NOT FILE ON EDIS) on or before September 24, 2018. Parties in support of the imposition of antidumping duties in these investigations and parties in opposition to the imposition of such duties will each be collectively allocated one hour within which to make an oral presentation at the conference. A nonparty who has testimony that may aid the Commission's deliberations may request permission to present a short statement at the conference.

    Written submissions.—As provided in sections 201.8 and 207.15 of the Commission's rules, any person may submit to the Commission on or before October 1, 2018, a written brief containing information and arguments pertinent to the subject matter of the investigations. Parties may file written testimony in connection with their presentation at the conference. All written submissions must conform with the provisions of section 201.8 of the Commission's rules; any submissions that contain BPI must also conform with the requirements of sections 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's Handbook on E-Filing, available on the Commission's website at https://edis.usitc.gov, elaborates upon the Commission's rules with respect to electronic filing.

    In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.

    Authority:

    These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.12 of the Commission's rules.

    By order of the Commission.

    Issued: September 6, 2018. Lisa Barton, Secretary to the Commission.
    [FR Doc. 2018-19790 Filed 9-11-18; 8:45 am] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE [OMB Number 1121-0249] Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection: Mortality in Correctional Institutions (State Prisons) AGENCY:

    Bureau of Justice Statistics, Department of Justice.

    ACTION:

    60-day notice.

    SUMMARY:

    The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting an extension to an existing information collection to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

    DATES:

    Comments are encouraged and will be accepted for 60 days until November 13, 2018.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments, especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Mary Cowhig, Statistician, 810 Seventh Street NW, Washington, DC 20531 (email: [email protected]; telephone: 202-353-4982).

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Bureau of Justice Statistics, including whether the information will have practical utility; —Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection

    1. Type of Information Collection: Extension of a currently approved collection.

    2. The Title of the Form/Collection: Mortality in Correctional Institutions (State Prisons) (MCI-State Prisons).

    3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: The MCI-State Prisons collection currently includes the following forms:

    NPS-4: Annual Summary of Inmate Deaths in State Prisons. This form is sent to the 50 state DOCs to collect the number of state prisoner deaths in a calendar year.

    NPS-4A: State Prison Inmate Death Report Form. Annually, this form is sent to the 50 state DOCs to collect details about each state prisoner death.

    The applicable component within the Department of Justice is the Bureau of Justice Statistics (BJS), in the Office of Justice Programs.

    BJS proposes to transfer the MCI-Jails information collection from the currently approved OMB collection under control number 1121-0094, where it was bundled with the Annual Survey of Jails and the Survey of Jails in Indian Country collections in 2015, to this collection (OMB Control Number 1121-0249, expiration 03/31/2019) to form one mortality collection program.

    The combined mortality collection would include the 50 state departments of corrections (DOCs) plus approximately 3,000 local jail jurisdictions and would collect data on the number and nature of inmate deaths in the custody of state correctional facilities.

    Prior to 2015, BJS collected mortality data from both state prisons and local jails under the OMB Control Number 1121-0249. In 2015, the Mortality in Correctional Institutions (Jails) (MCI-Jails) portion of the collection was bundled with the Annual Survey of Jails (ASJ) and the Survey of Jails in Indian Country (SJIC) in an attempt to consolidate the response burden placed on jails. However, the overlap among these three collections is small, both in terms of jails covered in each and context collected:

    • MCI-Jails requests annual data from about 3,000 jail jurisdictions on deaths, the confined population as of December 31, average daily population (ADP), number of holds for other jurisdictions, and number of admissions.

    • The ASJ samples approximately 900 local jails, and provides data to estimate the number and characteristics of local jail inmates nationwide. The ASJ collects population information, including the number of confined inmates, number of individuals supervised in the community by local jails, average daily population, and the number of holds for other authorities as of June 30. The ASJ also obtains data on inmate movements, including the number of admissions and discharges; facility characteristics, including rated and peak capacities and staffing; and inmate characteristics, including race and ethnicity, sex, age group (adult or juvenile), primary offense, and conviction status.

    • The SJIC collects data from Indian country jails that are not part of either the ASJ or the MCI-Jails collections. The SJIC collects information from confinement facilities, detention centers, jails, and other facilities operated by tribal authorities or the Bureau of Indian Affairs.

    Although there is some duplication in data collected by the ASJ and MCI-Jails, the reference dates are different and the ASJ is a sample, whereas MCI-Jails is a full enumeration of jail jurisdictions. Due to seasonal fluctuations in jail populations, and fewer inmates held at year-end (December 31), the ASJ uses the last weekday in June as its reference date. MCI-Jails uses December 31 as its reference date, and more importantly, uses ADP from January 1 to December 31 as the denominator in calculating mortality rates, which is consistent with the time period represented by the numerator, the number of deaths in a calendar year.

    The following forms are proposed to be transferred from OMB Control Number 1121-0094 to OMB Control Number 1121-0249:

    CJ-9: Death Report on Inmates under Jail Jurisdiction. This form goes to all jail jurisdictions that are operated by a county or city. Jail administrators are requested to complete the form if their facilities had one or more deaths in a calendar year.

    CJ-10: Death Report on Inmates in Private and Multi-Jurisdictional Jails. This form goes to all confinement facilities administered by two or more local governments (regional jails) and privately owned or operated confinement facilities. Jail administrators are requested to complete the form if their facilities had one or more deaths in a calendar year.

    CJ-9A: Annual Summary on Inmates under Jail Jurisdiction. This form goes to county and city jail jurisdictions. The form collects the number of male and female deaths in custody in a calendar year, the number of males and females confined as of December 31, the number of male and female admissions during the year, the average daily population by sex, and the number of persons confined on behalf of other agencies.

    CJ-10A: Annual Summary on Inmates in Private and Multi-Jurisdictional Jails. This form goes to confinement facilities administered by two or more local governments (regional jails) and to privately owned or operated facilities. The form collects the same information as Form CJ-9A.

    4. Affected public who will be asked or required to respond, as well as a brief abstract: The combined MCI for prisons and jails would collect annual data from the 50 state departments of corrections and roughly 3,000 jail jurisdictions on the number and nature of deaths in their custody.

    5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:

    Data supplier and form Reporting method Number of data suppliers Number of
  • responses
  • Average
  • reporting
  • time
  • (in minutes)
  • Total burden
  • (in hours,
  • rounded to
  • whole number)
  • Verification calls (local jails) Telephone 3,000 3,000 9 450 CJ-9A, CJ-10A jail annual summary Online, mail 3,000 2,900 15 725 CJ-9, CJ-10 jail death report Online, mail 3,000 1,000 30 500 Data quality follow-up (local jails) Telephone, email 3,000 350 10 58 Total, MCI-Jails 1,733 Verification calls (state prisons) Telephone 50 50 9 8 NPS-4A, state prison death report Online, mail 50 3,500 30 1,750 NPS-4, state prison annual summary Online, mail 50 50 5 4 Data quality follow-up (state prisons) Telephone, email 50 420 10 70 Total, MCI-State Prisons 1,832 Total Burden 3,565

    The estimated total burden hours associated with this combined jail and state prison mortality collection for report year 2018 is 3,565. This is a transfer of 1,733 hours from the jail mortality collection to the state prison mortality collection. When the state prison mortality collection was last approved in 2016, the total burden estimate was 1,723 hours. The state prison portion is now estimated at 1,832 burden hours due to an increase in the expected number of individual death reports. Based on the average number of death reports received over the most recent 10-year period, BJS expects to receive about 3,500 state prison and 1,000 jail death reports per year.

    If additional information is required, contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.

    Dated: September 7, 2018. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2018-19802 Filed 9-11-18; 8:45 am] BILLING CODE 4410-18-P
    NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (18-067)] NASA Aerospace Safety Advisory Panel; Meeting AGENCY:

    National Aeronautics and Space Administration (NASA).

    ACTION:

    Notice of meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.

    DATES:

    Thursday, October 11, 2018, 10:45 a.m. to 12 p.m., Central Time.

    ADDRESSES:

    NASA Johnson Space Center, Building 1, Room 966, 2101 NASA Parkway, Houston, TX 77058.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Evette Whatley, Aerospace Safety Advisory Panel Administrative Officer, NASA Headquarters, Washington, DC 20546, (202) 358-4733, or email at [email protected] .

    SUPPLEMENTARY INFORMATION:

    The Aerospace Safety Advisory Panel (ASAP) will hold its Fourth Quarterly Meeting for 2018. This discussion is pursuant to carrying out its statutory duties for which the Panel reviews, identifies, evaluates, and advises on those program activities, systems, procedures, and management activities that can contribute to program risk. Priority is given to those programs that involve the safety of human flight. The agenda will include:

    • Updates on the Exploration Systems Development • Updates on the Commercial Crew Program • Updates on the International Space Station Program

    The meeting will be open to the public up to the seating capacity of the room. Seating will be on a first-come basis. This meeting is also available telephonically. Any interested person may call the USA toll free conference call number (888) 566-6575; pass code 3391926. Attendees will be required to sign a visitor's register and to comply with NASA security requirements, including the presentation of a valid picture ID, before receiving an access badge. Any member of the public desiring to attend the ASAP 2018 Fourth Quarterly Meeting at the Johnson Space Center must provide their full name and company affiliation (if applicable) to Ms. Stephanie Castillo at [email protected] or by fax 281-483-2200 or telephone 281-483-3341 by October 1, 2018. Foreign Nationals attending the meeting will be required to provide a copy of their passport and visa, in addition to providing the following information by September 18, 2018: Full name; gender; date/place of birth; citizenship; visa information (number, type, expiration date); passport information (number, country, expiration date); employer/affiliation information (name of institution, address, country, telephone); and title/position of attendee. Additional information may be requested. Permanent Residents should provide this information: Green card number and expiration date. Persons with disabilities who require assistance should indicate this. Photographs will only be permitted during the first 10 minutes of the meeting.

    At the beginning of the meeting, members of the public may make a verbal presentation to the Panel on the subject of safety in NASA, not to exceed 5-minutes in length. To do so, members of the public must contact Ms. Evette Whatley at [email protected] or at (202) 358-4733 at least 48 hours in advance. Any member of the public is permitted to file a written statement with the Panel at the time of the meeting. Verbal presentations and written comments should be limited to the subject of safety in NASA. It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants.

    Patricia Rausch, Advisory Committee Management Officer, National Aeronautics and Space Administration.
    [FR Doc. 2018-19803 Filed 9-11-18; 8:45 am] BILLING CODE 7510-13-P
    NATIONAL SCIENCE FOUNDATION Advisory Committee for Cyberinfrastructure; Notice of Meeting

    In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:

    Name and Committee Code: Advisory Committee for Cyberinfrastructure (25150).

    Date and Time: October 2, 2018; 10:00 a.m.-6:00 p.m.; October 3, 2018; 8:00 a.m.-2:30 p.m.

    Place: National Science Foundation, 2415 Eisenhower Avenue, Room E3430, Alexandria, VA 22314.

    Type of Meeting: Open.

    Contact Person: Amy Friedlander, CISE, Division of Advanced Cyberinfrastructure, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314; Telephone: 703-292-8970.

    Minutes: May be obtained from the contact person listed above.

    Purpose of Meeting: To advise NSF on the impact of its policies, programs and activities in the ACI community. To provide advice to the Director/NSF on issues related to long-range planning.

    Agenda: Updates on NSF wide ACI activities.

    Dated: September 6, 2018. Crystal Robinson, Committee Management Officer.
    [FR Doc. 2018-19782 Filed 9-11-18; 8:45 am] BILLING CODE 7555-01-P
    NATIONAL SCIENCE FOUNDATION Notice of Antarctic Meteorite Collection, Documentation, and Curation Plan Received Under the Antarctic Conservation Act of 1978 AGENCY:

    National Science Foundation.

    ACTION:

    Notice of Antarctic Meteorite Collection, Documentation, and Curation Plan Received.

    SUMMARY:

    On March 31, 2003, the National Science Foundation (NSF) issued a final rule that authorized the collection of meteorites in Antarctica for scientific purposes only. In addition, the regulations provide requirements for appropriate collection, handling, documentation, and curation of Antarctic meteorites to preserve their scientific value. These regulations implement the Antarctic Conservation Act of 1978, as amended by the Antarctic Science, Tourism and Conservation Act of 1996, and Article 7 of the Protocol on Environmental Protection to the Antarctic Treaty. The NSF is required to publish notice of the availability of Meteorite Collection, Documentation, and Curation Plans received under the Antarctic Conservation Act of 1978. This is the required notice.

    DATES:

    Interested parties are invited to submit written data, comments, or views with respect to this plan by September 27, 2018. This plan may be inspected by interested parties at the Permit Office, address below.

    ADDRESSES:

    Comments should be addressed to Permit Office, Office of Polar Programs, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314.

    FOR FURTHER INFORMATION CONTACT:

    Nature McGinn, ACA Permit Officer, at the above address, 703-292-8030, or [email protected]

    SUPPLEMENTARY INFORMATION:

    An Antarctic meteorite collection, documentation, and curation plan has been received from Ralph Harvey and James Karner of Case Western University.

    Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation.
    [FR Doc. 2018-19823 Filed 9-11-18; 8:45 am] BILLING CODE 7555-01-P
    NATIONAL SCIENCE FOUNDATION Sunshine Act Meetings; National Science Board

    The National Science Board, pursuant to NSF regulations (45 CFR part 614), the National Science Foundation Act, as amended, (42 U.S.C. 1862n-5), and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice of RESCHEDULING a meeting for the transaction of National Science Board business.

    FEDERAL REGISTER CITATION OF ORIGINAL ANNOUNCEMENT:

    83 FR 43710, published on August 27, 2018. The teleconference meeting was originally scheduled for Thursday, August 30, 2018, from 3:00-4:00 p.m. EDT.

    FEDERAL REGISTER CITATION OF POSTPONEMENT:

    83 FR 44675, published on August 30, 2018.

    NEW TIME AND DATE OF MEETING:

    This closed teleconference meeting of the National Science Board has been rescheduled and will be held on Tuesday, September 18, 2018, from 4:00-5:00 p.m. EDT.

    CONTACT PERSON FOR MORE INFORMATION:

    Brad Gutierrez, [email protected], 703-292-7000. Please refer to the National Science Board website for additional information. Meeting information and schedule updates (time, place, subject matter, and status of meeting) may be found at http://www.nsf.gov/nsb/meetings/notices.jsp#sunshine.

    Chris Blair, Executive Assistant, National Science Board Office.
    [FR Doc. 2018-19927 Filed 9-10-18; 4:15 pm] BILLING CODE 7555-01-P
    NATIONAL SCIENCE FOUNDATION Notice of Permit Modification Received Under the Antarctic Conservation Act of 1978 AGENCY:

    National Science Foundation.

    ACTION:

    Notice of Permit Modification Request.

    SUMMARY:

    The National Science Foundation (NSF) is required to publish a notice of requests to modify permits issued to conduct activities regulated under the Antarctic Conservation Act of 1978. This is the required notice of a requested permit modification.

    DATES:

    Interested parties are invited to submit written data, comments, or views with respect to this permit application by October 12, 2018. Permit applications may be inspected by interested parties at the Permit Office, address below.

    ADDRESSES:

    Comments should be addressed to Permit Office, Office of Polar Programs, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314.

    FOR FURTHER INFORMATION CONTACT:

    Nature McGinn, ACA Permit Officer, at the above address, 703-292-8030, or [email protected]

    SUPPLEMENTARY INFORMATION:

    The National Science Foundation, as directed by the Antarctic Conservation Act of 1978 (Pub. L. 95-541), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed regulations for the establishment of a permit system for various activities in Antarctica and designation of certain animals and certain geographic areas a requiring special protection. The regulations establish such a permit system to designate Antarctic Specially Protected Areas.

    1. Description of Permit Modification Requested: NSF issued a permit (ACA 2018-012) to Jay J. Rotella on October 16, 2017. The issued permit allows the permit holder to continue long-term studies of Weddell seal populations in Erebus Bay and the McMurdo Sound region to evaluate how temporal variation in the marine environment affects individual life histories and population dynamics of a long-lived mammal. These studies may require the permit holder and agents to enter into six ASPAs in the area. Research involves capture and release of up to 675 Weddell seal pups at one to four days after birth for flipper tagging per year. A recent modification to this permit, dated November 22, 2017, permitted the permit holder to increase the total take of Weddell seal pups for flipper tagging from 675 to 1000.

    Now the permit holder proposes a modification to the permit to increase the number of takes allocated to certain permitted activities to reflect the same increases authorized earlier this year in NMFS Permit No. 21158-02. The take increases from those allowed under the ACA permit, as originally issued, would be as follows: Increase from 515 to 800 pups, flipper tagged once; increase from 10 to 20 pups, flipper tagged twice; increase from 285 to 385 adults, flipper tagged once; increase from 1325 to 1800 adults, harassment takes (4 per animal); increase from 675 to 910 pups, harassment takes (4 per animal); increase from 10 to 35 adults, salvage parts and vibrissae samples (3 per animal). These proposed changes would set the total number of takes of Weddell seal pups for flipper tagging to 970. The permit holder has also requested that a documentary film crew be allowed to accompany and film the permit holder and agents as they conduct the permitted activities this season.

    Location: Erebus Bay, McMurdo Sound; ASPA 137, North-West White Island, McMurdo Sound; ASPA 155, Cape Evans; ASPA 121, Cape Royds; ASPA 157, Backdoor Bay, Cape Royds, Ross Island; ASPA 158, Hut Point, Ross Island; ASPA 161, Terra Nova Bay, Ross Sea.

    Dates of Permitted Activities: October 1, 2018—September 30, 2022.

    2. Description of Permit Modification Requested: The Foundation issued a permit (ACA 2018-013) to Linnea Pearson on October 16, 2017. The issued permit allows the permit holder to handle Weddell seal pups per year for the purposes of studying the thermoregulatory strategies by which the pups maintain euthermia in air and in water and examine the development of diving capability as the animals prepare for independent foraging. Each of the ten seal pups, separated into two cohorts of five each, were to be handled at four time points between one and eight weeks of age. Flipper-mounted ime/depth recorder tags were to be attached to 1-week-old seal pups and removed from the pups at 7-8 weeks of age. At the 3-week time point, accelerometer tags were to be attached to the dorsal pelage of the pups and then removed at 7-8 weeks of age. VHF radio transmitters were allowed to be attached to the seal pups dorsal, caudal pelage after molting. The collection of a single whisker by plucking from each seal pup was allowed at 7-8 weeks of age. Protocols not requiring sedation (mass, morphometrics, core and surface temperatures, metabolic rates) and protocols requiring anesthesia (body composition, biopsies, blood volume analysis) were to be conducted on the first cohort of five pups at all four time points. The sedative midazolam was to be used alone on 1-week-old pups in the first cohort, while a combination of midazolam and butorphanol was allowed for use in the first cohort at 3, 5, and 7-8 weeks of age time points. A combination of midazolam and ketamine could have been used on 7-8-week-old pups, if deemed necessary. Metabolic and morphometric measurements were to be conducted on a second, separate cohort of five pups at each of the four time points. Sedation of seal pups in the second cohort, with a combination of midazolam and butorphanol, was only allowed for study animals at 3 weeks of age for the purposes of attaching an accelerometer tag. The permit holder was also allowed to conduct behavioral observations, imaging, and may disturb up to 350 Weddell seals. An additional seven Weddell seal pups, 15 Weddell seal adult females, and 20 crabeater seals were allowed to be disturbed during procedures on study animals. Up to two pup mortalities were requested per year, not to exceed three over the course of two field seasons. The permit holder was also allowed to collect tissues from Weddell seals (any age or gender) found dead from natural causes.

    Now the applicant proposes a modification to the permit to allow the following: Sedation of all seal pups at all time points using midazolam with or without butorphanol (and continue to have the option of using midazolam in combination with ketamine at 7-8 weeks of age); collection of blood samples from seal pups in the second cohort, at all four time points, while the pups are under sedation; use of a cannulated biopsy needle for muscle tissue sampling of seal pups in the first cohort (rather than a dermal biopsy punch), at all four time points; attachment of a flipper-mounted VHF transmitter tag to seal pups in both cohorts at 3 weeks of age, on the flipper opposite the one with the time/depth tag attached, with removal at the final time point; attachment of accelerometer tags to the dorsal pelage of 1-week-old pups in both cohorts with removal of the tags at 3 weeks of age; administration of antibiotics to treat local or systemic infections in seal pups involved in the study; and increased takes of seal pups and adult females such that a total of 12 pups would be handled for study purposes compared with 10 in the original permit (six pups in each cohort compared with five in the original permit) and a total of 12 adult females, the mothers of the pups, would be disturbed during the handling of the pups (10 in the original permit). The permit holder has also requested a modification of NMFS Permit No. 21006.

    Location: Erebus Bay, McMurdo Sound; ASPA 121, Cape Royds.

    Dates of Permitted Activities: October 1, 2018—September 30, 2020.

    3. Description of Permit Modification Requested: The Foundation issued a permit (ACA 2017-005) to David Ainley on July 27, 2016. The issued permit allows the permit holder and agents to enter three Antarctic Specially Protected Areas (ASPAs); observe Adelie penguins; mark and measure penguin nests; attach tags, flipper bands, and special instruments to penguins; take small feather samples; and weigh and measure penguin chicks and adults. The permitted activities also include maintaining a webcam just inside the boundary of the Cape Royds ASPA.

    Now the permit holder proposes a modification to the permit to attach a miniature video camera to adult Adelie penguins (n=40) to document activities during diving. The permit holder also proposes to engage the services of experienced pilots to operate remotely piloted aircraft systems (RPAS) to capture video imagery of penguin colonies for the purposes of census and quantifying habitat characteristics. The RPAS operations would occur within the boundaries of ASPA 121, Cape Royds, and ASPA 124, Cape Crozier.

    Location: ASPA 121, Cape Royds; ASPA 124, Cape Crozier; ASPA 105, Beaufort Island; Cape Bird (outside ASPA boundary).

    Dates of Permitted Activities: October 1, 2018—February 5, 2020.

    Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation.
    [FR Doc. 2018-19822 Filed 9-11-18; 8:45 am] BILLING CODE 7555-01-P
    NATIONAL SCIENCE FOUNDATION Advisory Committee for Environmental Research and Education Notice of Meeting

    In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:

    Name and Committee Code: Advisory Committee for Environmental Research and Education (9487).

    Date and Time: October 24, 2018; 9:00 a.m.-5:30 p.m. (EDT); October 25, 2018; 9:00 a.m.-3:00 p.m. (EDT).

    Place: National Science Foundation, 2415 Eisenhower Avenue, Room E 2020, Alexandria, VA 22314.

    Type of Meeting: Open.

    Contact Person: Dr. Leah Nichols, Staff Associate, Office of Integrative Activities/Office of Director/National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314; (Email: [email protected]/. Telephone: (703) 292-2983).

    Minutes: May be obtained from https://www.nsf.gov/ere/ereweb/minutes.jsp.

    Purpose of Meeting: To provide advice, recommendations, and oversight concerning support for environmental research and education.

    Agenda: Approval of minutes from past meeting. Updates on agency support for environmental research and activities. Discussion with NSF Director and Assistant Directors. Plan for future advisory committee activities. Updated agenda will be available at https://www.nsf.gov/ere/ereweb/minutes.jsp.

    Dated: September 6, 2018. Crystal Robinson, Committee Management Officer.
    [FR Doc. 2018-19781 Filed 9-11-18; 8:45 am] BILLING CODE 7555-01-P
    NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Computing and Communication Foundations; Notice of Meeting

    In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:

    Name and Committee Code: Proposal review panel for Computing and Communication Foundations (#1192)—Expeditions in Computing Division—Year 2 Site Visit at Cornell University.

    Date and Time: September 12, 2018; 7:00 p.m.-9:00 p.m.; September 13, 2018; 8:00 a.m.-9:00 p.m.; September 14, 2018: 8:30 a.m.-3:30 p.m.

    Place: BU George Sherman Union, Metcalf Hall, 775 Commonwealth Ave., Boston, MA 02215.

    Type of Meeting: Part-Open.

    Contact Person: Sylvia Spengler, Expeditions in Computing Program, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314; Telephone 703/292-8930.

    Purpose of Meeting: Site visit to assess the progress of the EIC Award: CCF-1522054, “Collaborative Research: CompSustNet: Expanding the Horizons of Computational Sustainability,” and to provide advice and recommendations concerning further NSF support for the project.

    Agenda Wednesday, September 12, 2018 7:00 p.m.-9:00 p.m.: Closed Evening briefing to discuss the Expeditions award and forthcoming site visit. Thursday, September 13, 2018 8:00 a.m.-12:30 p.m.: Open Presentations by Awardee Institution, faculty staff and students, to Site Team and NSF Staff. Discussions, question and answer sessions. 1:30 p.m.-2:00 p.m.: Closed NSF Staff and Panelists deliberation. 2:00 p.m.-5:00 p.m.: Open Continued presentations by Awardee Institution. Response and feedback to presentations by Site Team and NSF Staff. Discussions, question and answer sessions. Draft report on education and research activities. Complete written site visit report with preliminary recommendations. 6:00 p.m.-9:00 p.m.: Closed NSF Staff and Panelists working dinner. Friday, September 14, 2018 8:30 a.m.-10:30 a.m.: Open Expeditions PIs responses to issues raised by panelists. 10:30 a.m.-2:30 p.m.: Closed Panelists prepare site visit report. 2:30 p.m.-3:30 p.m.: Open Presentation of site visit report to Expeditions leadership team.

    Reason For Closing: Topics to be discussed and evaluated during closed portions of the site review will include information of a proprietary or confidential nature, including technical information; and information on personnel. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act.

    Dated: September 6, 2018. Crystal Robinson, Committee Management Officer.
    [FR Doc. 2018-19780 Filed 9-11-18; 8:45 am] BILLING CODE 7555-01-P
    NATIONAL SCIENCE FOUNDATION Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978 AGENCY:

    National Science Foundation.

    ACTION:

    Notice of permit applications received.

    SUMMARY:

    The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of permit applications received.

    DATES:

    Interested parties are invited to submit written data, comments, or views with respect to this permit application by October 12, 2018. This application may be inspected by interested parties at the Permit Office, address below.

    ADDRESSES:

    Comments should be addressed to Permit Office, Office of Polar Programs, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314.

    FOR FURTHER INFORMATION CONTACT:

    Nature McGinn, ACA Permit Officer, at the above address, 703-292-8030, or [email protected]

    SUPPLEMENTARY INFORMATION:

    The National Science Foundation, as directed by the Antarctic Conservation Act of 1978 (Pub. L. 95-541, 45 CFR 671), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed regulations for the establishment of a permit system for various activities in Antarctica and designation of certain animals and certain geographic areas a requiring special protection. The regulations establish such a permit system to designate Antarctic Specially Protected Areas.

    Application Details Permit Application: 2019-005 1. Applicant: Bill Davis, VP Operations, Quark Expeditions, 3131 Elliot Avenue, Suite 250, Seattle, WA 98121.

    Activity for Which Permit is Requested: Waste Management. The applicant is seeking a waste management permit associated with the operation of the i/b Kapitan Khlebnikov in the Antarctic Peninsula region. The vessel will complete multiple cruises and multiple landings per cruise. Maximum passengers taken ashore at any one time will be limited to 100 persons. Quark would offer activities including shore excursions by Zodiac or helicopter, sightseeing by helicopter, visits to the Snow Hill emperor penguin colony, polar plunges, and vessel-supported short overnight stays (camping). The applicant also proposes to operate a small, battery-operated remotely piloted aircraft system (RPAS) consisting, in part, of a quadcopter equipped with a camera to collect footage for commercial and educational purposes. Mitigation measures would be in place to reduce the risk of non-native species introductions and the risk of spills or releases to the environment. Waste generated during small boat and shore-based activities would be returned to the vessels for proper disposal.

    For vessel-supported short overnight stays (camping): Camping would be away from vegetated sites and at least 150m from wildlife concentrations or lakes, protected areas, historical sites, and scientific stations. Tents would be pitched on snow, ice, or bare smooth rock, at least 15m from the high-water line. No food, other than emergency rations, would be brought onshore and all wastes, including human waste, would be collected and returned to the ship for proper disposal. Campers would be limited to 30 passengers plus staff, except at the following sites where campers are limited to 60 passengers plus staff: Damoy Point/Dorian Bay, Danco Island, Pleneau Island, Leith Cove, and Rongé Island. The ratio of staff to passengers would be 1:10. Camping would include overnight stays of any duration, but in accordance with the visitor site guidelines for each site.

    For remotely piloted aircraft systems (RPAS) operation: The quadcopter would not be flown over wildlife, or over Antarctic Specially Protected Areas or Historic Sites and Monuments. The RPAS would only be operated by pilots with adequate experience. Several measures would be taken to prevent against loss of the quadcopter including painting the them a highly visible color; only flying when the wind is calm; flying for only 15 minutes at a time to maintain adequate battery charge; having a flotation device for operations over water, and an “auto go home” feature in case of loss of control link or low battery; having an observer on the lookout for wildlife, people, and other hazards; and ensuring that the separation between the operator and quadcopter does not exceed a maximum distance of 300 meters.

    Location: Snow Hill Island; Antarctic Peninsula region. For camping: Damoy Point/Dorian Bay, Danco Island, Rongé Island, Errera Channel, Paradise Bay, Andvord Bay, Pleneau Island, Argentine Islands (Winter Island by Wordie House), Hovgaard Island, Orne Harbour, Leith Cove, Prospect Point, Portal Point, Skontorp Cove, Horseshoe Island, Stony Point, Lefevre-Utile, the Naze.

    Dates of Permitted Activities: October 1, 2018-March 31, 2019.

    Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation.
    [FR Doc. 2018-19824 Filed 9-11-18; 8:45 am] BILLING CODE 7555-01-P
    NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-346, 50-440, 50-334 and 50-412; NRC-2018-0187, NRC-2018-0192, and NRC-2018-0193] FirstEnergy Nuclear Operating Company (FENOC) and FirstEnergy Nuclear Generation, LLC, Beaver Valley Power Station, Units 1 and 2, Davis-Besse Nuclear Power Station, Unit No. 1, Perry Nuclear Power Plant, Unit No. 1 AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Exemption; issuance.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption in response to a July 19, 2017 request from FirstEnergy Nuclear Operating Company (FENOC) and FirstEnergy Nuclear Generation, LLC (collectively, the licensee), as supplemented by letters dated March 16, 2018, and May 2, 2018. The exemption is from the NRC definition for a physical barrier regarding the construction standards for the fence bracket angle. The exemption allows the licensee to apply a fence topper bracket angle of zero degrees (or vertical) at specific locations on the protected area fence at each facility, in lieu of the 30 to 45 degree fence bracket angle required by Commission regulations. All other construction standards contained in the Commission regulations for a physical barrier fence topper remain applicable.

    DATES:

    The exemption was issued on September 6, 2018.

    ADDRESSES:

    Please refer to Docket IDs. NRC-2018-0187, NRC-2018-0192, and NRC-2018-0193 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0187, NRC-2018-0192, and NRC-2018-0193. Address questions about dockets in Regulations.gov to Jennifer Borges, telephone: 301-287-9127; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] For the convenience of the reader, the ADAMS accession numbers are provided in a table in the “Availability of Documents” section of this document.

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

    FOR FURTHER INFORMATION CONTACT:

    Bhalchandra K. Vaidya, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3308; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The NRC is making the documents identified below available to interested persons through one or more of the following methods, as indicated. To access documents related to this action, see ADDRESSES section of this document.

    Document ADAMS
  • Accession No.
  • FirstEnergy Nuclear Operating Company—Exemption Request for a Physical Barrier Requirement. Dated July 19, 2017 ML17200D139 FirstEnergy Nuclear Operating Company—Response to Request For Additional Information Regarding Exemption Request for a Physical Barrier Requirement. Dated March 16, 2018 ML18078A033 FirstEnergy Nuclear Operating Company—Response to Request For Additional Information Regarding Exemption Request for a Physical Barrier Requirement. Dated May 2, 2018 ML18122A133 U.S. Nuclear Regulatory Commission—FENOC FLEET—Beaver Valley Power Station, Unit Nos. 1 and 2; Davis-Besse Nuclear Power Station, Unit No. 1; and Perry Nuclear Power Plant, Unit No. 1—Environmental Assessment and Finding of No Significant Impact Related to Exemption Request for a Physical Barrier Requirement ML18130A760,
  • ML18130A849,
  • ML18130A820
  • The text of the exemption is attached.

    Dated at Rockville, Maryland, this 7th day of September 2018.

    For the Nuclear Regulatory Commission.

    Bhalchandra K. Vaidya, Project Manager, Plant Licensing Branch III, Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation.
    Attachment—Exemption NUCLEAR REGULATORY COMMISSION Docket Nos. 50-334, 50-412, 50-346, 50-440 FirstEnergy Nuclear Operating Company (FENOC) Exemption I. Background

    FirstEnergy Nuclear Operating Company (FENOC) and FirstEnergy Nuclear Generation, LLC (collectively, the licensee), are the holders of the following operating licenses: (1) Renewed Facility Operating License No. DPR-66, and No. NPF-73, at Beaver Valley Power Station, Units 1 and 2 (BVPS), issued on November 5, 2009; (2) Renewed Facility Operating License No. NPF-3 at Davis-Besse Nuclear Power Station (DBNPS), Unit No. 1, issued on December 8, 2015; and (3) Facility Operating License No. NPF-58 at Perry Nuclear Power Plant (PNPP), Unit No. 1, issued on November 13, 1986. The licenses provide, among other things, that the facilities are subject to all rules, regulations, and orders of the NRC now or hereafter in effect.

    II. Request/Action

    Pursuant to 10 CFR 73.5, “Specific exemptions,” by letter dated July 19, 2017 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML17200D139), FENOC requested a specific partial exemption from one physical barrier construction standard described in 10 CFR 73.2, “Definitions” for fences. The Commission requirement for a protected area physical barrier is stated in 10 CFR 73.55(e)(8)(i) which requires, in part, that: “The protected area perimeter must be protected by physical barriers that are designed and constructed to . . . ” to limit access, etc. The construction standards for a physical barrier are defined in 10 CFR 73.2.

    The regulation in 10 CFR 73.2 requires, in part, that fences must be constructed of No. 11 American wire gauge, or heavier wire fabric, topped by three strands or more of barbed wire or similar material on brackets angled inward or outward between 30 and 45 degrees from the vertical. Currently, some of the barbed wire bracketing on top of the protected area physical barrier fencing does not meet this design criteria specified in 10 CFR, Section 73.2.

    The requested partial exemption would allow the licensees to configure the bracket topper supporting three strands of barbed-wire or similar material at the vertical orientation (or 0 degrees) only at specific locations along the protected area perimeter fence at each facility, as specified in the licensees' supplemental letter dated March 16, 2018 (ADAMS Accession No. ML18078A033).

    III. Discussion

    Pursuant to 10 CFR 73.5, “Specific exemptions,” the Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security, and are otherwise in the public interest.

    In the request dated July 19, 2017, FENOC states, in part, that brackets on the top of physical barrier fencing are currently oriented vertically on gates, near gates, near interfaces with buildings, and on corners. BVPS, DBNPS, and PNPP have similar configurations while DBNPS has vertical brackets on top of fences near the intrusion detection system (lDS). The FENOC exemption request is limited to specific portions of the protected area perimeter fence where the licensee prefers to orient the bracket topper on the protected area fence at a vertical orientation, in lieu of the inward or outward, 45 to 30 degree angular construction standard stated in the 10 CFR 73.2.

    In Section 4.0 of the submittal dated July 19, 2017, FENOC states that the basis for this exemption is that the vertical configuration of the brackets on and near gates, near interfaces with buildings, on corners, and near the IDS, of the protected area fence does not have an adverse impact on the site protective strategies and will continue to protect against the design basis threat of radiological sabotage. FENOC further states that because the vertical barbed wire will maintain the plant's physical security, the underlying purpose of the regulation is met. The limited protected area fence sections where the configuration does not meet the current regulatory requirement is a small portion of the entire protected area perimeter fence. Consultation of design drawings and protected area site walk-downs estimates this portion to be approximately 6 percent or less for each of the three sites. Finally, in Chapter 6, Section 6.2, of the BVPS, DBNPS, and PNPP Physical Security Plans, the licensee states that the 45 to 30 degree angular requirement for the fence topping may not be met at locations such as gates and buildings.

    In the supplemental submission dated March 16, 2018, to NRC staff Request for Additional Information (RAI) No. 2, the licensee stated that the technical basis for the FENOC request for exemption from this requirement is that the vertical bracket configuration is limited to locations on gates, near gates, near interfaces with buildings, and on corners where the licensee prefers to increase the tension that can be applied to the three strands of barbed-wire. The licensee goes on to state that “DBNPS also has vertical brackets in two locations adjacent to the IDS where physical separation clearance is required.” In the supplemental submission dated May 2, 2018 (ADAMS Accession No. ML18122A133), to NRC staff request for Follow-up RAI No. 1, the licensee stated that the outward angular fence bracket requirement would interfere with the effective operation of the IDS in that it would result in an unacceptable frequency of false alarms and would reduce the sensitivity of the detection capability to an unacceptable level.

    The licensee further states in the supplemental response dated March 16, 2018, that “other than the DBNPS locations near the IDS, the vertical bracket configuration at the other locations described in the exemption request is preferred to maintain sufficient tension in the barbed wire strands.” The licensee goes on to state that the vertical bracket configuration is preferred because greater barbed wire tension can be applied when using vertical brackets as opposed to angular brackets on the end of fence runs (which includes on top of gates, adjacent to gates, and adjacent to buildings). Angular corner arms do not provide a good tension point in the barbed wire.

    In the supplemental submission dated March 16, 2018, in response to NRC staff RAI No. 3, the licensee stated that the vertical bracket configuration has no impact to adversary or responder timelines in the protective strategies for the FENOC fleet. This is due to site-specific evaluations that determined the limiting perimeter barrier fence scenarios are most similar to a configuration illustrated in Regulatory Issue Summary 2003-06, or the use of mechanical breaching utilizing the same configuration. The licensee also stated that whether or not the fence toppings are vertical or angled makes no difference to the protective strategy limiting timelines.

    A. The Exemption Is Authorized by Law

    This exemption would allow the application of a 0 degree (or vertical/upward) fence topper bracket angle at specific locations at BVPS Units 1 and 2, DBNPS, and PNPP. As stated above, 10 CFR 73.5 allows the NRC to grant exemptions from the requirements of 10 CFR part 73. The fence topper bracket angle that will be applied at BVPS, DBNPS, and PNPP does not conform to the fence topper bracket angle of inward or outward, between 30 and 45 degrees that is explicitly defined in 10 CFR 73.2; however, the NRC staff has determined that the construction standard applied at each of the three facilities and as described in the Chapter 6, Section 6.2 of the BVPS, DBNPS, and PNPP Physical Security Plans does not negatively impact the capability of the physical protection program at each facility meet the requirements of 10 CFR 73.55(b). Therefore, granting the licensee's proposed exemption would not result in a violation of the Atomic Energy Act of 1954, as amended, or the Commission's regulations. Accordingly, the granting of the partial exemption request from the requirements of 10 CFR 73.2 is authorized by law.

    B. The Exemption Will Not Endanger Life or Property

    The objectives of 10 CFR 73.55(e) for physical barriers and the construction standards for fences contained in the 10 CFR 73.2 definition are to ensure that licensees provide physical barriers that are adequately designed and constructed to perform their intended physical protection program function. Further, all other construction materials and components required for a fence as defined in 10 CFR 73.2 are currently in place and are maintained at the affected FENOC facilities as stated. In addition, the level of protection offered by the requested bracket configuration has been accounted for by the licensee as part of the facility physical protection program. Finally, based on the above discussion, the NRC staff has concluded that the use of physical barriers as described in the BVPS, DBNPS, and PNPP security plans would provide adequate protection against the design basis threat of radiological sabotage, if effectively implemented. Therefore, the NRC staff has determined that this exemption would not endanger life or property.

    C. The Exemption Would Not Endanger Common Defense and Security

    The partial exemption would allow the licensee to apply a fence topper bracket angle of 0 degrees (or vertical) at specific locations in lieu of the required inward or outward angle of 30 to 45 degrees. In Section 4.0 of the submittal dated July 19, 2017, the licensee states that the vertical configuration of the brackets on and near gates, near interfaces with buildings, on corners, and near the IDS, of the protected area fence does not have an adverse impact on the site protective strategies and will continue to protect against the design basis threat of radiological sabotage. Because the vertical barbed wire will maintain the plant's physical security, the NRC staff finds that the underlying purpose of the regulation is met. The licensee is required to develop and maintain a physical protection program that maintains the capability to detect, assess, interdict, and neutralize all threats up to and including the design basis threat of radiological sabotage. Therefore, the NRC staff has determined that this exemption would not endanger common defense and security.

    D. Exemption Is Otherwise in the Public Interest

    Based on its evaluation of licensee's request for an exemption to allow vertical barbed wire fence toppings in limited protected area sections (on and near gates, near interfaces with buildings, on corners, and near the IDS) as described in the licensee's submission dated March 16, 2018, the NRC staff has determined that the partial exemption would maintain the physical security of the sites and would not have an adverse effect on public interest. Therefore, the NRC staff has determined that this exemption is otherwise in the public interest.

    E. Environmental Considerations

    In accordance with 10 CFR 51.31(a), the Commission has determined that the granting of this exemption will not have a significant effect on the quality of the human environment as discussed in the NRC staff's Finding of No Significant Impact and associated Environmental Assessment published in Federal Register on September 4, 2018 (83 FR 44914, 83 FR 44923, and 83 FR 44927), the NRC staff finds that the proposed exemption would not significantly affect plant safety, would not have a significant adverse effect on the probability of an accident occurring, and would not have any significant radiological and non-radiological impacts. Therefore, the NRC concludes that the proposed action will not have a significant effect on the quality of the human environment. Accordingly, the NRC has determined not to prepare an environmental impact statement for the proposed action

    V. Conclusion

    Accordingly, the Commission has determined that pursuant to 10 CFR 73.5, the exemption is authorized by law, will not endanger life or property, is consistent with the common defense and security, and is otherwise in the public interest. Therefore, the Commission hereby grants FENOC a partial exemption from the requirements of 10 CFR 73.2 for a fence bracket to be angled inward or outward between 30 and 45 degrees, to allow the fence bracket angular orientation of 0 degrees (or vertical/upward) at BVPS, DBNPS, and PNPP at only those locations specifically identified by the licensee in the supplemental response dated March 16, 2018, to NRC staff RAI No.1, explicitly, “site layouts with the locations and descriptions of the protected area physical barrier fencing sections topped with vertically-oriented brackets containing barbed wire or similar material are provided in Figures 1, 2, and 3 for BVPS, DBNPS, and PNPP, respectively.” All other construction and design requirements apply to the specified locations as stated in 10 CFR 73.2. Additionally, all construction and design requirements for a physical barrier as stated in 10 CFR 73.2, remain applicable to all other facility locations not specified in Figures 1, 2, and 3, for BVPS, DBNPS, and PNPP, respectively as specified in the supplemental response to NRC staff RAI No. 1, dated March 16, 2018.

    Dated at Rockville, Maryland, this 6th day of September, 2018.

    For the Nuclear Regulatory Commission.

    Kathryn M. Brock, Acting Director, Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation.
    [FR Doc. 2018-19848 Filed 9-11-18; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2018-0093] Guidance About Administrative Licensing Procedures AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Draft NUREG; request for comments.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is revising its guidance about administrative licensing procedures and agency policies for reviewing nuclear materials licensing requests. The NRC is requesting public comment on draft NUREG-1556, Volume 20, “Consolidated Guidance About Materials Licenses: Guidance About Administrative Licensing Procedures.” The document has been updated from the original version to include information on updated regulatory requirements, safety culture, security of radioactive materials, protection of sensitive information, and changes in regulatory policies and practices. This document is intended for use by the NRC staff when reviewing NRC materials licensing requests.

    DATES:

    Submit comments by October 15, 2018. Comments received after this date will be considered if it is practical to do so, but the NRC is only able to assure consideration of comments received on or before this date.

    ADDRESSES:

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

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0093. Address questions about NRC dockets to Jennifer Borges; telephone: 301-287-9127; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Mail comments to: May Ma, Program Management, Announcements, and Editing (PMAE), Office of Administration, Mail Stop: TWFN-7-A60M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

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

    FOR FURTHER INFORMATION CONTACT:

    Anthony McMurtray, Office of Nuclear Material Safety and Safeguards; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2746; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Accessing Information and Submitting Comments A. Accessing Information

    Please refer to Docket ID NRC-2018-0093 when contacting the NRC about the availability of information regarding this document. You may access publicly-available information related to this action by the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0093.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The draft NUREG-1556, Volume 20, Revision 1, is available in ADAMS under Accession Number ML18240A014.

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

    The draft NUREG-1556, Volume 20, Revision 1, is also available on the NRC's public website at http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/ under “Consolidated Guidance About Materials Licenses (NUREG-1556).”

    B. Submitting Comments

    Please include Docket ID NRC-2018-0093 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.

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

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

    II. Additional Information

    NUREG-1556, Volume 20, Revision 1 provides guidance to NRC management and staff regarding administrative licensing procedures and agency policies for reviewing NRC materials licensing requests. The purpose of this notice is to provide the public with an opportunity to review and provide comments on draft NUREG-1556, Volume 20, Revision 1, “Consolidated Guidance About Materials Licenses: Guidance About Administrative Licensing Procedures.” These comments will be considered in the final version or subsequent revisions.

    Dated at Rockville, Maryland, this 6th day of September 2018.

    For the Nuclear Regulatory Commission.

    Daniel S. Collins, Director, Division of Materials Safety, Security, State and Tribal Programs, Office of Nuclear Material Safety and Safeguards.
    [FR Doc. 2018-19755 Filed 9-11-18; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2016-0098] Disposition of Information Related to the Time Period That Safety-Related Structures, Systems, or Components Are Installed AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Draft regulatory issue summary; withdrawal.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is withdrawing draft regulatory issue summary, “Disposition of Information Related to the Time Period that Safety-Related Structures, Systems or Components are Installed,” which was published for public comment in the Federal Register on May 17, 2016. This document is being withdrawn because public interactions to date between NRC staff and industry have adequately communicated the issues identified by the staff to the industry. The NRC will continue to follow up on these issues via the reactor oversight process.

    DATES:

    The effective date of the withdrawal of the draft regulatory issue summary is September 12, 2018.

    ADDRESSES:

    Please refer to Docket ID NRC-2016-0098 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2016-0098. Address questions about NRC dockets to Jennifer Borges; telephone: 301-287-9127; email: [email protected]. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]. The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in this document.

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

    FOR FURTHER INFORMATION CONTACT:

    John Thompson, Office of Nuclear Reactor Regulation, telephone: 301-415-1011, email: [email protected], and Eric Thomas, Office of Nuclear Reactor Regulation, telephone: 301-415-6772, email: [email protected]. Both are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    SUPPLEMENTARY INFORMATION:

    On September 14, 2017, NRC's Committee for the Review of Generic Requirements (CRGR) held a public meeting (Meeting No. 447) with industry to discuss this Regulatory Issue Summary (RIS). The meeting minutes are available in ADAMS at ML17276B156. Based on industry concerns expressed during the public meeting, the CRGR recommended that NRC staff cease efforts to further develop and issue the RIS.

    Dated at Rockville, Maryland, this 6th day of September 2018.

    For the Nuclear Regulatory Commission.

    Robert B. Elliott, Chief, Operating Experience Branch, Division of Inspection and Regional Support, Office of Nuclear Reactor Regulation.
    [FR Doc. 2018-19800 Filed 9-11-18; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2015-0027] Information Collection: NRC Form 7, Application for NRC Export/Import License, Amendment, Renewal or Consent Request(s) AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Notice of submission to the Office of Management and Budget; request for comment.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, “NRC Form 7, Application for NRC Export/Import License, Amendment, Renewal or Consent Request(s).”

    DATES:

    Submit comments by October 12, 2018.

    ADDRESSES:

    Submit comments directly to the OMB reviewer at: OMB Office of Information and Regulatory Affairs (3150-0027), Attn: Desk Officer for the Nuclear Regulatory Commission, 725 17th Street NW, Washington, DC 20503; email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2015-0027 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    Federal rulemaking website: Go to http://www.regulations.gov and search for Docket ID: NRC-2015-0027. A copy of the collection of information and related instructions may be obtained without charge by accessing Docket ID NRC-2015-0027 on this website.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The supporting statement and Application for NRC Export or Import License, Amendment, Renewal, or Consent Request(s) are available in ADAMS under Accession Nos. ML18180A163 and ML18179A369.

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

    NRC's Clearance Officer: A copy of the collection of information and related instructions may be obtained without charge by contacting the NRC's Clearance Officer, David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: [email protected]

    B. Submitting Comments

    The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at http://www.regulations.gov and entered into ADAMS. Comment submissions are not routinely edited to remove identifying or contact information.

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

    II. Background

    Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the NRC recently submitted a request for renewal of an existing collection of information to OMB for review entitled, NRC Form 7, “NRC Form 7, Application for NRC Export/Import License, Amendment, Renewal or Consent Request(s).” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    The NRC published a Federal Register notice with a 60-day comment period on this information collection on April 26, 2018, pp. 18356-18357. No comments were received.

    1. The title of the information collection: NRC Form 7, Application for NRC Export/Import License, Amendment, Renewal or Consent Request(s).

    2. OMB approval number: 3150-0027.

    3. Type of submission: Extension.

    4. The form number if applicable: NRC Form 7.

    5. How often the collection is required or requested: On occasion.

    6. Who will be required or asked to respond: Any person in the U.S. who wishes to export or import (a) nuclear material and equipment subject to the requirements of a specific license; (b) amend a license; (c) renew a license; (d) obtain consent to export Category 1 quantities of materials listed in Appendix P to 10 CFR part 110; or (5) request an exemption from a licensing requirement under Part 110.

    7. The estimated number of annual responses: 85.

    8. The estimated number of annual respondents: 85.

    9. An estimate of the total number of hours needed annually to comply with the information collection requirement or request: 204.

    10. Abstract: Persons in the U.S. wishing to export or import nuclear material or equipment, who are required to obtain a specific license, amendment, license renewal, obtain consent to export Category 1 quantities of byproduct material listed in Appendix P to 10 CFR part 110 or request an exemption from a licensing requirement under Part 110. The NRC Form 7 application will be reviewed by the NRC and by the Executive Branch, and if applicable statutory, regulatory, and policy considerations are satisfied, the NRC will issue an export, import, amendment or renewal license.

    Dated at Rockville, Maryland, on September 7, 2018.

    For the Nuclear Regulatory Commission.

    David C. Cullison, NRC Clearance Officer, Office of the Chief Information Officer.
    [FR Doc. 2018-19859 Filed 9-11-18; 8:45 am] BILLING CODE 7590-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84047; File No. SR-NASDAQ-2017-128] Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing of Amendment No. 3 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 3, To List and Trade Shares of the Western Asset Total Return ETF September 6, 2018. I. Introduction

    On December 20, 2017, The Nasdaq Stock Market LLC (“Nasdaq”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 1 and Rule 19b-4 thereunder,2 a proposed rule change to list and trade shares (“Shares”) of the Western Asset Total Return ETF (“Fund”), a series of Legg Mason ETF Investment Trust (“Trust”), under Nasdaq Rule 5735 (Managed Fund Shares). The proposed rule change was published for comment in the Federal Register on January 9, 2018.3 On February 21, 2018, pursuant to Section 19(b)(2) of the Act,4 the Commission designated a longer period within which to approve the proposed rule change, disapprove the proposed rule change, or institute proceedings to determine whether to disapprove the proposed rule change.5 On April 6, 2018, the Commission instituted proceedings under Section 19(b)(2)(B) of the Act to determine whether to approve or disapprove the proposed rule change.6 On July 3, 2018, the Commission designated a longer period for Commission action on the proceedings to determine whether to approve or disapprove the proposed rule change.7 On July 30, 2018, the Exchange filed Amendment No. 1 to the proposed rule change, which replaced and superseded the proposed rule change in its entirety. On August 27, 2018, the Exchange filed Amendment No. 2 to the proposed rule change, which replaced and superseded the proposed rule change, as modified by Amendment No. 1, in its entirety. On September 5, 2018, the Exchange filed Amendment No. 3 to the proposed rule change, which replaced and superseded the proposed rule change, as modified by Amendment Nos. 1 and 2, in its entirety.8 The Commission has received no comments on the proposed rule change. The Commission is publishing notice of the filing of Amendment No. 3 to solicit comment from interested persons and is approving the proposed rule change, as modified by Amendment No. 3, on an accelerated basis.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3See Securities Exchange Act Release No. 82439 (Jan. 3, 2018), 83 FR 1062 (“Notice”).

    4 15 U.S.C. 78s(b)(2).

    5See Securities Exchange Act Release No. 82757, 83 FR 8532 (Feb. 27, 2018). The Commission designated April 9, 2018, as the date by which the Commission shall approve or disapprove, or institute proceedings to determine whether to disapprove, the proposed rule change.

    6See Securities Exchange Act Release No. 83007, 83 FR 15883 (Apr. 12, 2018) (“OIP”). The Commission designated July 8, 2018, as the date by which the Commission shall approve or disapprove the proposed rule change.

    7See Securities Exchange Act Release No. 83588, 83 FR 31827 (Jul. 9, 2018). The Commission extended the date by which the Commission shall approve or disapprove the proposed rule change to September 6, 2018.

    8 In Amendment No. 3, the Exchange: (1) Provided that the Fund's investments in ABS/Private MBS (as defined below) (excluding, for the purposes of the rule filing, CDOs (as defined below)) would be limited to 20% of the weight of the fixed income portion of the Fund's portfolio, and that the Fund's holdings in CDOs would be limited to 10% of the Fund's total assets; (2) clarified the types of Debt (as defined below) in which the Fund may invest, and that, for purposes of the proposed rule change, bank loans would be classified as Debt rather than fixed income securities and would not meet the generic requirements for fixed income securities set forth in Nasdaq Rule 5735(b)(1)(B) but would instead comply with the alternative limitations proposed for Debt holdings of the Fund as further described below; (3) stated that the Fund would not invest more than 20% of its total assets in Debt that is unsecured and subordinated; (4) stated that, for purposes of the proposed rule change, in applying the generic requirements for fixed income securities set forth in Nasdaq Rule 5735(b)(1)(B), the terms “fixed income weight of the portfolio” and “weight of the fixed income portion of the portfolio” would be interpreted to include all fixed income securities and Debt held by the Fund as well as derivatives held by the Fund that provide exposure to fixed income securities or Debt; (5) stated that no more than 10% of the Fund's total assets would be invested in exchange-listed securities and Exchange-Traded Derivatives (as defined below) that are listed and traded on an exchange that is not an ISG (as defined below) member or does not have a comprehensive surveillance sharing agreement (“CSSA”) with the Exchange; (6) clarified that, for purposes of the proposed rule change, Fixed-Income Related Warrants (as defined below) are treated as fixed income securities and would be subject to and comply with the generic listing requirements for fixed income securities rather than the requirements applicable to equity securities; (7) clarified the types of derivatives in which the Fund may invest and the reference assets for such derivatives; (8) stated that the Fund expects that it will primarily issue and redeem Creation Units (as defined below) for cash, that orders to create or redeem Creation Units must be received from 9 a.m., E.T., to 10 a.m., E.T. on a given business day, in order to receive the NAV (as defined below) determined on the business day the order was placed, and that when the Fund permits Creation Units to be issued in-kind, the Fund will cause to be published by the National Securities Clearing Corporation, on each business day, at or before 9 a.m., E.T., the identity and the required number of each deposit security and the amount of the cash component, if any, to be included in the Fund Deposit (as defined below); (9) provided additional information about sources of price information for the Fund's proposed holdings; (10) provided additional justification as to why the listing and trading of the Shares is consistent with the Act even though certain of the Fund's proposed holdings would not meet the generic listing standards for Managed Fund Shares set forth in Nasdaq Rule 5735(b)(1); and (11) made other clarifications, corrections, and technical changes.

    II. Exchange's Description of the Proposal, as Modified by Amendment No. 3 A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    The Exchange proposes to list and trade the Shares of the Fund under Nasdaq Rule 5735, which governs the listing and trading of Managed Fund Shares 9 on the Exchange. The Fund will be an exchange-traded fund (“ETF”) that is actively-managed. The Shares will be offered by the Trust, which was established as a Maryland statutory trust on June 8, 2015.10 The Exchange notes that other actively-managed, broad market fixed-income ETFs have been previously approved by the SEC prior to the adoption of “generic” listing standards for actively-managed ETFs.11 The Trust is registered with the Commission as an investment company under the 1940 Act and has filed a registration statement on Form N-1A (“Registration Statement”) with the Commission with respect to the Fund.12 The Fund will be a series of the Trust. The Fund intends to qualify each year as a regulated investment company (“RIC”) under Subchapter M of the Internal Revenue Code of 1986, as amended.

    9 A Managed Fund Share is a security that represents an interest in a company, which is registered under the Investment Company Act of 1940 (15 U.S.C. 80a-1) (the “1940 Act”) and organized as an open-end investment company or similar entity, that invests in a portfolio of securities selected by its investment adviser consistent with the company's investment objective and policies. In contrast, an open-end investment company that issues Index Fund Shares, listed and traded on the Exchange under Nasdaq Rule 5705, seeks to provide investment results that correspond generally to the price and yield performance of a specific foreign or domestic stock index, fixed income securities index or combination thereof.

    10 The Commission has issued an order, upon which the Trust may rely, granting certain exemptive relief under the 1940 Act. See Investment Company Act Release No. 32391 (December 13, 2016) (File No. 812-14547) (the “Exemptive Relief”). In addition, on December 6, 2012, the staff of the Commission's Division of Investment Management (“Division”) issued a no-action letter (“No-Action Letter”) relating to the use of derivatives by actively-managed ETFs. See No-Action Letter dated December 6, 2012 from Elizabeth G. Osterman, Associate Director, Office of Exemptive Applications, Division of Investment Management. The No-Action Letter stated that the Division would not recommend enforcement action to the Commission under applicable provisions of and rules under the 1940 Act if actively-managed ETFs operating in reliance on specified orders (which include the Exemptive Relief) invest in options contracts, futures contracts or swap agreements provided that they comply with certain representations stated in the No-Action Letter.

    11See, e.g., Securities Exchange Act Release Nos. 76719 (December 21, 2015), 80 FR 80859 (December 28, 2015) (SR-NYSEArca-2015-73) (granting approval for the listing of shares of the Guggenheim Total Return Bond ETF); 66321 (February 3, 2012), 77 FR 6850 (February 9, 2012) (SR-NYSEArca-2011-95) (granting approval for the listing of shares of the PIMCO Total Return Exchange Traded Fund (now known as the PIMCO Active Bond Exchange-Traded Fund)); and 72666 (July 24, 2014), 79 FR 44224 (July 30, 2014) (SR-NYSEArca-2013-122) (granting approval to the use of derivatives by the PIMCO Total Return Exchange Traded Fund); see also infra notes 84 and 102.

    12See Post-Effective Amendment No. 53 to the Registration Statement on Form N-1A for the Trust (File Nos. 333-206784 and 811-23096) as filed on July 30, 2018. The Trust will file additional amendments to the Registration Statement as necessary to conform to the representations in this filing. The descriptions of the Fund and the Shares contained herein are based, in part, on information in the Registration Statement.

    Legg Mason Partners Fund Advisor, LLC will be the investment manager (“Manager”) 13 to the Fund. Western Asset Management Company, LLC will serve as the sub-adviser to the Fund (the “Sub-Adviser”) 14 and Western Asset Management Company Limited in London (“Western Asset London”), Western Asset Management Company Pte. Ltd. in Singapore (“Western Asset Singapore”) and Western Asset Management Company Ltd in Japan (“Western Asset Japan”) will each serve as the sub-sub-advisers to the Fund (collectively, the “Sub-Sub-Advisers” and each, a “Sub-Sub-Adviser”). 15 Hereinafter, references to “Sub-Adviser” or “Sub-Advisers” include the Sub-Adviser and each applicable Sub-Sub-Adviser. Legg Mason Investor Services, LLC (the “Distributor”) will be the distributor of the Fund's Shares. The Manager, each of the Sub-Advisers and the Distributor are wholly-owned subsidiaries of Legg Mason, Inc. (“Legg Mason”). An entity that is not affiliated with Legg Mason, and which is named in the Registration Statement, will act as the administrator, accounting agent, custodian, and transfer agent to the Fund.

    13 Legg Mason Partners Fund Advisor, LLC describes its role as “investment manager” rather than as “investment adviser” in applicable Fund-related documents, including the Registration Statement, in its investment management agreement with the Fund and in connection with its annual approval process by the board of trustees for the Trust (the “Board”). As a result, the defined term “Manager” is used in this filing with respect to a proposed rule change instead of the term “investment adviser,” which is the term used by certain other investment advisers to ETFs in their filings with respect to proposed rule changes under Rule 19b-4 of the Act.

    14 The Sub-Adviser is responsible for the day-to-day management of the Fund and, as such, typically makes all decisions with respect to portfolio holdings regardless of where the instruments are traded. The Manager has ongoing oversight responsibility.

    15 Each of the Sub-Sub-Advisers provides advisory services to the Fund relating to the Fund's investments. Sub-Sub-Advisers advise primarily on instruments traded in the region in which the Sub-Sub-Adviser is located, but they may advise on portfolio instruments held by the Fund that are traded in other regions. Western Asset London generally advises on the Fund's portfolio holdings in non-U.S. and non-Asian investment instruments and currencies (including through ETFs and derivative instruments that provide exposure to those instruments and currencies); Western Asset Japan generally advises on the Fund's portfolio holdings in Japanese investment instruments and currencies (including through ETFs and derivative instruments that provide exposure to those instruments and currencies); and Western Asset Singapore generally advises on the Fund's portfolio holdings in non-Japan, Asian investment instruments and currencies (including through ETFs and derivative instruments that provide exposure to those instruments and currencies).

    Paragraph (g) of Rule 5735 provides that if the investment adviser to the investment company issuing Managed Fund Shares is affiliated with a broker-dealer, such investment adviser shall erect and maintain a “fire wall” between the investment adviser and the broker-dealer with respect to access to information concerning the composition and/or changes to such investment company's portfolio.16 In addition, paragraph (g) further requires that personnel who make decisions on the investment company's portfolio composition must be subject to procedures designed to prevent the use and dissemination of material, non-public information regarding the investment company's portfolio.

    16 An investment adviser to an investment company is required to be registered under the Investment Advisers Act of 1940 (the “Advisers Act”). The Manager and the Sub-Advisers, as registered investment advisers, and their related personnel are subject to the provisions of Rule 204A-1 under the Advisers Act relating to codes of ethics. Rule 204A-1 requires investment advisers (such as the Manager and the Sub-Advisers) to adopt a code of ethics that reflects the fiduciary nature of the relationship to clients as well as compliance with other applicable securities laws. Accordingly, procedures designed to prevent the communication and misuse of non-public information by the Manager and the Sub-Advisers must be consistent with the Advisers Act and Rule 204A-1 thereunder. In addition, Rule 206(4)-7 under the Advisers Act makes it unlawful for an investment adviser (such as the Manager and the Sub-Advisers) to provide investment advice to clients unless such investment adviser has (i) adopted and implemented written policies and procedures reasonably designed to prevent violation, by the investment adviser and its supervised persons, of the Advisers Act and the Commission rules adopted thereunder; (ii) implemented, at a minimum, an annual review regarding the adequacy of the policies and procedures established pursuant to subparagraph (i) above and the effectiveness of their implementation; and (iii) designated an individual (who is a supervised person) responsible for administering the policies and procedures adopted under subparagraph (i) above.

    Rule 5735(g) is similar to Nasdaq Rule 5705(b)(5)(A)(i); however, paragraph (g) in connection with the establishment and maintenance of a “fire wall” between the investment adviser and the broker-dealer reflects the applicable investment company's portfolio, not an underlying benchmark index, as is the case with index-based funds. None of the Manager or any of the Sub-Advisers is a broker-dealer, but each is affiliated with the Distributor, a broker-dealer, and has implemented and will maintain a fire wall with respect to its broker-dealer affiliate regarding access to information concerning the composition and/or changes to the portfolio.

    In addition, personnel who make decisions on the Fund's portfolio composition will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding the Fund's portfolio. In the event (a) the Manager or any of the Sub-Advisers registers as a broker-dealer or becomes newly affiliated with a broker-dealer, or (b) any new investment adviser or any new sub-adviser to the Fund is a registered broker-dealer or becomes affiliated with another broker-dealer, it will implement and maintain a fire wall with respect to its relevant personnel and/or such broker-dealer affiliate, as applicable, regarding access to information concerning the composition and/or changes to the Fund's portfolio and will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding such portfolio.

    Western Asset Total Return ETF Principal Investments

    The investment objective of the Fund will be to seek to maximize total return, consistent with prudent investment management and liquidity needs. Although the Fund may invest in securities and Debt (as defined below) of any maturity, the Fund will normally maintain an effective duration as set forth in the prospectus.17 Effective duration seeks to measure the expected sensitivity of market price to changes in interest rates, taking into account the anticipated effects of structural complexities (for example, some bonds can be prepaid by the issuer).

    17 The effective duration of the Fund may fall outside of its expected range due to market movements. If this happens, the Sub-Advisers will take action to bring the Fund's effective duration back within its expected range within a reasonable period of time.

    Under Normal Market Conditions,18 the Fund will seek to achieve its investment objective by investing at least 80% of its assets in a portfolio comprised of U.S. or foreign fixed income securities; U.S. or foreign Debt (as defined below); 19 ETFs 20 that provide exposure to such U.S. or foreign fixed income securities, Debt or other Principal Investments (defined below); derivatives 21 that (i) provide exposure to such U.S. or foreign fixed income securities, Debt and other Principal Investments, (ii) are used to risk manage the Fund's holdings, and/or (iii) are used to enhance returns, such as through covered call strategies; 22 U.S. or foreign equity securities of any type acquired in reorganizations of issuers of fixed income securities or Debt held by the Fund (“Work Out Securities”); 23 U.S. or foreign non-convertible preferred securities (other than trust preferred securities, which the Fund may invest in, but which are treated as fixed income securities 24 ) (“Non-Convertible Preferred Securities”); 25 warrants,26 comprised of: Warrants on U.S. or foreign fixed income securities (“Fixed-Income Related Warrants”) and warrants on U.S. or foreign equity securities (“Equity-Related Warrants”), both fixed income and equity securi