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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 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 FDAs 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-201509-18/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, 2404027500.
You may submit comments on any guidance at any time see 21 CFR
10.115g5.
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
209930002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the guidance may be sent. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT:
Lauren Belcher or Courtney Smith, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD
209930002, 18772871373, email:
AskCTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background FDA is announcing the availability of a revised guidance for industry entitled Submission of Plans for Cigarette Packages and Cigarette Advertisements Revised. The Family Smoking Prevention and Tobacco Control Act
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Tobacco Control Act Pub. L. 11131
was enacted on June 22, 2009, and granted FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products.
The Tobacco Control Act also amended section 4 of the Federal Cigarette Labeling and Advertising Act FCLAA
to direct FDA to issue regulations requiring each cigarette package and advertisement to bear a new textual warning label statement accompanied by color graphics depicting the negative health consequences of smoking section 201 of the Tobacco Control Act. In enacting this legislation, Congress also provided that FDA may adjust the required warnings if FDA
found that such a change would promote greater public understanding of the risks associated with the use of tobacco products section 202 of the Tobacco Control Act. The Tobacco Control Act also modified the requirements of the FCLAA regarding the submission of cigarette plans for the random and equal display and distribution of required warnings on cigarette packages and quarterly rotation of required warnings in cigarette advertisements. It also requires that such cigarette plans be submitted to FDA for review and approval, rather than to the Federal Trade Commission.
In the Federal Register of March 18, 2020, FDA issued a final rule entitled Tobacco Products; Required Warnings for Cigarette Packages and Advertisements 85 FR 15638. The rule specifies the color graphics that must accompany the new textual warning label statements and establishes marketing requirements for cigarette packages and advertisements.
The marketing requirements include, among other things, submission of a cigarette plan that provides for the random and equal display and distribution of the required warnings on cigarette packages and quarterly rotation of the required warnings in cigarette advertisements, as described under section 4 of FCLAA.
On April 3, 2020, the final rule was challenged in the U.S. District Court for the Eastern District of Texas.1 On May 8, 2020, the Court granted a joint motion to govern proceedings in that case and postpone the effective date of the final rule by 120 days.2 On December 2, 2020, 1 R.J.

Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20cv 00176 E.D. Tex. filed April 3, 2020.
2 R.J. Reynolds Tobacco Co. et al., No. 6:20cv 00176 E.D. Tex. May 8, 2020 order granting joint motion and establishing schedule, Doc. No. 33.

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the same Court granted a new motion by Plaintiffs in the same case to postpone the effective date of the final rule by an additional 90 days.3 The new effective date of the final rule is January 14, 2022.
Pursuant to the court order, any obligation to comply with a deadline tied to the effective date of the final rule is similarly postponed, and those obligations and deadlines are now tied to the postponed effective date. As such, this revised guidance strongly encourages entities to submit cigarette plans to FDA as soon as possible after publication of the final rule, and in any event, by March 16, 2021.
FDA is issuing this guidance consistent with FDAs good guidance practices regulation 21 CFR 10.115.
The guidance represents the current thinking of FDA regarding the submission of plans for cigarette packages and cigarette advertisements.
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. Therefore, clearance by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 PRA 44 U.S.C. 3501
3521 is not required for this guidance.
The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR 1141.10 have been approved under 09100877.
III. Electronic Access Persons with access to the internet may obtain an electronic version of the guidance at either https
www.regulations.gov or https
www.fda.gov/tobacco-products/
products-guidance-regulations/rulesregulations-and-guidance.
Dated: February 8, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202103020 Filed 21221; 8:45 am BILLING CODE 416401P
3 R.J. Reynolds Tobacco Co. et al., No. 6:20cv 00176 E.D. Tex. May 8, 2020 order granting Plaintiffs motion and postponing effective date, Doc. No. 80.

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