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3,696 words·~17 min read·/register/2024/09/13/2024-20850·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2024-09-13.xml --- 89 178 Friday, September 13, 2024 Contents Agricultural Marketing Agricultural Marketing Service PROPOSED RULES Marketing Order: Raisins Produced from Grapes Grown in California, 74851-74866 2024-20079 Agriculture Agriculture Department See Agricultural Marketing Service Centers Disease Centers for Disease Control and Prevention NOTICES Award of a Sole Source Cooperative Agreement: Northwestern Provincial Health Office, Zambia, 74961-74962 2024-20790 Draft Hazard Review:

Wildland Fire Smoke Exposure among Farmworkers and Other Outdoor Workers, 74960-74961 2024-20763 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Hearings, Meetings, Proceedings, etc.: Medicare Program; Fiscal Year 2026 Applications for New Medical Services and Technologies Add-On Payments, 74962-74964 2024-20791 Children Children and Families Administration NOTICES Award of a Supplement: American Public Human Services Association for the Association of Administrators of the Interstate Compact on the Placement of Children in Washington, DC, 74964-74965 2024-20827 Civil Rights Civil Rights Commission NOTICES Meetings;

Sunshine Act, 74867 2024-20977 Coast Guard Coast Guard NOTICES Request for Membership Application: National Offshore Safety Advisory Committee, 74972-74973 2024-20804 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 74928-74930 2024-20841 2024-20842 Commodity Futures Commodity Futures Trading Commission NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Notification of Pending Legal Proceedings, 74930-74931 2024-20819 Consumer Product Consumer Product Safety Commission NOTICES Meetings; Sunshine Act, 74931 2024-21037 Energy Department Energy Department See Federal Energy Regulatory Commission NOTICES Hearings, Meetings, Proceedings, etc.: Environmental Management Site-Specific Advisory Board, Oak Ridge, 74931-74932 2024-20784 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans;

Approvals and Promulgations: New Hampshire; Ambient Air Quality Standards, 74834-74836 2024-20721 Pennsylvania; Attainment Plan for the Indiana Nonattainment Area for the 2010 1-Hour Sulfur Dioxide National Ambient Air Quality Standard, 74836-74847 2024-20598 Tennessee; Nitrogen Oxides SIP Call Alternative Monitoring and Domtar Paper Co., LLC, 74847-74850 2024-20668 NOTICES Environmental Impact Statements; Availability, etc., 74940 2024-20825 Recommendations of Specifications, Standards and Ecolabels for Federal Purchasing, 74940-74942 2024-20820 Export Import Export-Import Bank NOTICES Request to Increase the Amount of the Long-Term General Guarantee on the Interest of Secured Notes Issued by the Private Export Funding Corp., 74943 2024-20858 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 74948-74949 2024-20849 Privacy Act; Systems of Records, 74943-74948 2024-20847 2024-20848 Federal Deposit Federal Deposit Insurance Corporation NOTICES Meetings; Sunshine Act, 74949 2024-20921 Federal Energy Federal Energy Regulatory Commission NOTICES Application: Brookfield White Pine Hydro LLC, 74932-74933 2024-20832 Pacific Gas and Electric Co., Pacific Generation LLC, 74933 2024-20766 Change of Implementation Date: Electronic Tariff Filings, 74933 2024-20771 Combined Filings, 74933-74939 2024-20764 2024-20765 2024-20829 2024-20830 Environmental Assessments;

Availability, etc.: Village of Enosburg Falls, VT, 74939 2024-20767 Environmental Impact Statements; Availability, etc.: Alabama Power Co., 74937 2024-20833 Hearings, Meetings, Proceedings, etc.: Scott's Mill Hydro, LLC; Technical Conference, 74939 2024-20769 Request under Blanket Authorization: Florida Gas Transmission Co., LLC, 74934-74935 2024-20831 Tolling 60-Day Period for Action to Allow for Further Consideration: Unison Energy, LLC, Tiger Infrastructure Partners Fund III AIV U LP, 74934 2024-20770 Federal Highway Federal Highway Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 75010-75011 2024-20809 Federal Motor Federal Motor Carrier Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Road Test Requirement, 75011-75012 2024-20806 Federal Reserve Federal Reserve System NOTICES Change in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 74950 2024-20863 Formations of, Acquisitions by, and Mergers of Savings and Loan Holding Companies, 74949-74950 2024-20892 Federal Trade Federal Trade Commission NOTICES Petition to Reopen and Set Aside or Modify Order:

Coopharma, 74950-74960 2024-20811 Fish Fish and Wildlife Service NOTICES Permits; Applications, Issuances, etc.: Endangered and Threatened Species, 74977-74981 2024-20786 Food and Drug Food and Drug Administration RULES Guidance: Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements, 74831-74832 2024-20850 NOTICES Hearings, Meetings, Proceedings, etc.: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee, 74965-74966 2024-20889 New Drugs Regulatory Program Modernization:

Integrated Assessment of Marketing Applications and Integrated Review Documentation, 74966-74968 2024-20891 Withdrawal of Approval of Drug Application: Sandoz Inc., et al.; Correction, 74968-74969 2024-20873 Foreign Assets Foreign Assets Control Office RULES Reporting, Procedures and Penalties Regulations, 74832-74834 2024-20674 NOTICES Sanctions Action, 75012-75058 2024-20824 2024-20853 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See National Institutes of Health Homeland Homeland Security Department See Coast Guard NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Chemical-Terrorism Vulnerability Information, 74975-74977 2024-20828 Various Homeland Security Acquisitions Regulations Forms, 74974-74975 2024-20793 Hearings, Meetings, Proceedings, etc.: Data Privacy and Integrity Advisory Committee, 74973-74974 2024-20821 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service Internal Revenue Internal Revenue Service PROPOSED RULES Corporate Alternative Minimum Tax Applicable after 2022, 75062-75243 2024-20089 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: 2,4-Dichlorophenoxyacetic Acid from India, 74908-74910 2024-20861 2,4-Dichlorophenoxyacetic Acid from the People's Republic of China, 74906-74908 2024-20862 Carbazole Violet Pigment 23 from India, 74873-74875 2024-20860 Certain Cased Pencils from the People's Republic of China, 74894-74895 2024-20798 Certain Epoxy Resins from India, 74889-74891 2024-20887 Certain Epoxy Resins from Taiwan, 74896-74898 2024-20885 Certain Epoxy Resins from the People's Republic of China, 74891-74894 2024-20888 Certain Epoxy Resins from the Republic of Korea, 74912-74915 2024-20886 Certain Metal Lockers and Parts Thereof from the People's Republic of China, 74901-74904 2024-20780 Certain Steel Nails from the People's Republic of China, 74882-74884 2024-20760 Finished Carbon Steel Flanges from India, 74884-74887, 74899-74901 2024-20751 2024-20753 Glycine from India and the People's Republic of China, 74898-74899 2024-20754 Large Power Transformers from the Republic of Korea, 74869-74871 2024-20797 Light-Walled Rectangular Pipe and Tube from Mexico, 74916-74919 2024-20795 Light-Walled Rectangular Pipe and Tube from the People's Republic of China, 74875-74878, 74904-74906 2024-20772 2024-20773 Polyethylene Retail Carrier Bags from Malaysia, 74872-74873 2024-20777 Prestressed Concrete Steel Wire Strand from the United Arab Emirates, 74887-74888 2024-20801 Seamless Carbon and Alloy Steel Standard, Line, and Pressure Pipe from Ukraine, 74919-74921 2024-20749 Silicon Metal from Malaysia, 74910-74912 2024-20774 Stainless Steel Sheet and Strip in Coils from the Republic of Korea, 74915-74916 2024-20756 Steel Propane Cylinders from Thailand, 74878-74880 2024-20750 Utility Scale Wind Towers from Malaysia, 74867-74869 2024-20757 Utility Scale Wind Towers from the Republic of Korea, 74880-74882 2024-20778 International Trade Com International Trade Commission NOTICES Investigations;

Determinations, Modifications, and Rulings, etc.: Certain Hydrodermabrasion Systems and Components Thereof III, 74995-74996 2024-20789 Labor Department Labor Department See Occupational Safety and Health Administration Land Land Management Bureau NOTICES Application for Withdrawal Extension: Gallinas Peak and West Turkey Cone Electronic Sites, NM, 74982 2024-20787 Record of Decision: Approved Resource Management Plan Amendment for the Greenlink West Transmission Project, Clark, Esmeralda, Lyon, Mineral, Nye, Storey, and Washoe Counties, NV, 74981-74982 2024-20864 Millenium Millennium Challenge Corporation NOTICES Compact with the State of Belize, 74997-74998 2024-20752 Hearings, Meetings, Proceedings, etc., 74998-74999 2024-20755 National Institute National Institutes of Health NOTICES Hearings, Meetings, Proceedings, etc.:

Center for Scientific Review, 74969-74971 2024-20788 2024-20880 2024-20883 National Institute of Mental Health, 74969-74970 2024-20818 2024-20884 National Institute on Alcohol Abuse and Alcoholism, 74970-74971 2024-20881 National Institute on Minority Health and Health Disparities, 74970 2024-20882 National Oceanic National Oceanic and Atmospheric Administration NOTICES Hearings, Meetings, Proceedings, etc.: North Pacific Fishery Management Council, 74924-74926 2024-20823 South Atlantic Fishery Management Council, 74924 2024-20822 Taking or Importing of Marine Mammals:

Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico, 74921-74923 2024-20776 National Park National Park Service NOTICES Inventory Completion: Cape Girardeau County Sheriff's Office, Jackson, MO, 74990-74991 2024-20877 Indiana University, Bloomington, IN, 74982-74983 2024-20865 Madison County Coroner's Office, Fredericktown, MO, 74994-74995 2024-20868 Perry County Coroner's Office, Perryville, MO, 74994 2024-20879 San Bernardino County Museum, Redlands, CA, 74989-74990 2024-20867 Stoddard County Sheriff's Office, Bloomfield, MO, 74992 2024-20870 The University of Toledo, Toledo, OH, 74988-74989 2024-20874 U.S.

Army Corps of Engineers, Sacramento District, Sacramento, CA, 74992-74994 2024-20871 U.S. Department of the Interior, National Park Service, Fort Sumter and Fort Moultrie National Historical Park, Sullivan's Island, SC, 74987-74988 2024-20872 Western Washington University, Department of Anthropology, Bellingham, WA, 74984 2024-20869 Repatriation of Cultural Items: Turtle Bay Exploration Park, Redding, CA, 74988 2024-20876 U.S. Army Corps of Engineers, Sacramento District, Sacramento, CA, 74985-74987 2024-20878 University of California, Berkeley, Berkeley CA, 74983-74984, 74991-74992 2024-20866 2024-20875 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Hearings, Meetings, Proceedings, etc.:

Federal Advisory Council on Occupational Safety and Health, 74996-74997 2024-20808 Patent Patent and Trademark Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Patent Reexaminations, Supplemental Examinations, and Post Patent Submissions, 74926 2024-20807 Third-Party Submissions and Protests, 74927-74928 2024-20813 Pension Benefit Pension Benefit Guaranty Corporation NOTICES Requests for Nominations: Advisory Committee of the Pension Benefit Guaranty Corp., 74999 2024-20782 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances:

Patriot Day and National Day of Service and Remembrance (Proc. 10807), 74829-74830 2024-20982 Railroad Retirement Railroad Retirement Board NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 74999-75003 2024-20854 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 75004 2024-20846 Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Small Issuer Exemption from Registration under the Securities Act and its Attendant Form, 75003 2024-20845 Application: MA Specialty Credit Income Fund and MA Asset Management, LLC, 75003 2024-20851 Wellington Global Multi-Strategy Fund and Wellington Management Co. LLP, 75004 2024-20852 Self-Regulatory Organizations; Proposed Rule Changes: Cboe C2 Exchange, Inc., 75246-75293 2024-20462 Cboe EDGA Exchange, Inc., 75296-75343 2024-20467 Nasdaq GEMX, LLC, 75346-75393 2024-20469 Nasdaq PHLX LLC, 75396-75443 2024-20479 Small Business Small Business Administration NOTICES Disaster Declaration:

California, 75005-75007 2024-18974 2024-20775 Florida, 75005 2024-19830 Florida; Public Assistance Only, 75007 2024-19831 Iowa, 75006 2024-19535 New Hampshire, 75006 2024-19087 New York, 75004-75005 2024-20779 South Dakota, 75007-75008 2024-19540 Texas, 75008 2024-19533 West Virginia, 75007 2024-19713 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Foreign Service Officer Test Registration Form, 75008-75009 2024-20840 Surface Transportation Surface Transportation Board NOTICES Exemption:

Lease and Operation; Georges Creek Division Railroad, LLC, Eighteen Thirty Group, LLC, 75009 2024-20762 Lease Renewal; Iowa Northern Railway Co., North Central Iowa Rail Corridor, LLC, 75009-75010 2024-20855 Transportation Department Transportation Department See Federal Highway Administration See Federal Motor Carrier Safety Administration Treasury Treasury Department See Foreign Assets Control Office See Internal Revenue Service NOTICES Hearings, Meetings, Proceedings, etc.:

Financial Research Advisory Committee, 75058-75059 2024-20890 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: 35 Percent Exemption Request from 85/15 Reporting Requirement, 75059-75060 2024-20785 Child Care Provider Information—For the Child Care Subsidy Program, 75059 2024-20802 Separate Parts In This Issue Part II Treasury Department, Internal Revenue Service, 75062-75243 2024-20089 Part III Securities and Exchange Commission, 75246-75293 2024-20462 Part IV Securities and Exchange Commission, 75296-75343 2024-20467 Part V Securities and Exchange Commission, 75346-75393 2024-20469 Part VI Securities and Exchange Commission, 75396-75443 2024-20479 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. 89 178 Friday, September 13, 2024 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1141 [Docket No. FDA-2024-D-3742] Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements;

Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled “Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements.” This guidance describes FDA's enforcement policy for the final rule, “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements,” which established new required cigarette health warnings for cigarette packages and advertisements.

The guidance is intended to assist entities required to comply with the rule. DATES: The announcement of the guidance is published in the **Federal Register** on September 13, 2024. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time 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-2024-D-3742 for “Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at *https://www.regulations.gov* or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • 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.govinfo.gov/content/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, 240-402-7500.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Beth Buckler, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 877-287-1373, *AskCTP@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled “Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements.” This guidance describes FDA's enforcement policy for the final rule, “Tobacco Products;

Required Warnings for Cigarette Packages and Advertisements” (85 FR 15638, March 18, 2020; codified at 21 CFR part 1141), which established new required cigarette health warnings for cigarette packages and advertisements. The guidance is intended to assist entities required to comply with the rule. We are issuing this guidance consistent with our good guidance practices

(GGP)regulation (21 CFR 10.115). We are implementing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate (§ 10.115(g)(2)). We made this determination because FDA needs to communicate its enforcement policy in a timely manner given that the rule is now in effect due to developments in litigation, as explained below. Although this guidance document is being implemented immediately, it remains subject to comment in accordance with FDA's GGP regulation. In the **Federal Register** of March 18, 2020, FDA issued a final rule establishing new cigarette health warnings for cigarette packages and advertisements. The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) to require each cigarette package and advertisement to bear one of the new required warnings. The final rule specifies the 11 new textual warning label statements and accompanying color graphics. Additionally, the final rule requires the random and equal display and distribution of the required warnings for cigarette packages and quarterly rotation of the required warnings for cigarette advertisements in accordance with an FDA-approved plan (referred to as cigarette plans), consistent with the Tobacco Control Act. Pursuant to section 201(b) of the Tobacco Control Act, the rule was published with an effective date of June 18, 2021, 15 months after the date of publication of the final rule. On April 3, 2020, the final rule was challenged in the U.S. District Court for the Eastern District of Texas. 1 The District Court issued multiple orders postponing the effective date of the rule, the most recent of which postponed the effective date to November 6, 2023. 2 On December 7, 2022, the District Court issued an order vacating the rule. 3 On March 21, 2024, the U.S. Court of Appeals for the Fifth Circuit issued an opinion reversing the District Court and concluding that FDA's rule is consistent with the First Amendment. 4 The opinion remanded the case to the District Court for consideration of plaintiffs' remaining claims. A petition for rehearing en banc was denied on May 21, 2024, 5 and the court's mandate issued on May 29, 2024. 6 Accordingly, the rule is no longer vacated. Because the November 6, 2023, date in the District Court's most recent order postponing the rule's effective date has passed, the rule is now in effect. 1 *R.J. Reynolds Tobacco Co. et al.,* v. *United States Food and Drug Administration et al.,* No. 6:20-cv-00176 (E.D. Tex. filed April 3, 2020). 2 *R.J. Reynolds Tobacco Co.,* No. 6:20-cv-00176 (E.D. Tex. November 7, 2022) (order postponing effective date), Doc. No. 104. *See also* “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date,” 87 FR 72384 (November 25, 2022). 3 *R.J. Reynolds Tobacco Co.,* No. 6:20-cv-00176 (E.D. Tex. December 7, 2022) (opinion and order; final judgment), Docs. No. 106; 107. 4 *R.J. Reynolds Tobacco Co. et al.,* v. *United States Food and Drug Administration et al.,* No. 23-40076 (5th Cir. March 21, 2024) (panel opinion), Doc. No. 140-1. 5 *R.J. Reynolds Tobacco Co. et al.,* No. 23-40076 (5th Cir. May 21, 2024) (order denying petition for rehearing), Doc. No. 162-2. 6 *R.J. Reynolds Tobacco Co. et al.,* No. 23-40076 (5th Cir. May 29, 2024) (mandate), Doc. No. 163-2. FDA recognizes that some manufacturers, distributors, and retailers already may have begun to prepare to implement the rule's requirements. For instance, some manufacturers, distributors, and retailers already have submitted and obtained approval of cigarette plans. Even so, FDA recognizes that entities may need time to implement the rule's requirements. In the guidance, FDA sets out its enforcement policy for the final rule. As discussed in the guidance, FDA intends to exercise enforcement discretion and generally not enforce requirements of the final rule for 15 months after the issuance of this guidance, until December 12, 2025. FDA also intends to exercise enforcement discretion and generally not enforce requirements of the final rule for an additional 30 days, until January 12, 2026, with respect to products manufactured before December 12, 2025. These time periods are consistent with section 201(b) of the Tobacco Control Act and the effective date of the final rule upon its publication. As FDA recommended at the time of publication of the final rule, FDA recommends that entities that do not already have approved cigarette plans submit such plans as soon as possible, but in any event, within 5 months, by February 10, 2025. The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act

(PRA)(44 U.S.C. 3501-3521). The collections of information in 21 CFR 1141.10 have been approved under OMB control number 0910-0877. III. Electronic Access Persons with access to the internet may obtain an electronic version of the guidance at *https://www.regulations.gov, https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance,* or *https://www.fda.gov/regulatory-information/search-fda-guidance-documents.* Dated: September 10, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-20850 Filed 9-12-24; 8:45 am]

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