[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36560-36562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14674]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5364]


Submission of Plans for Cigarette Packages and Cigarette 
Advertisements (Revised); Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a revised final guidance for industry entitled 
``Submission of Plans for Cigarette Packages and Cigarette 
Advertisements (Revised).'' This is a revision to the third edition of 
this final guidance, which issued in February 2021, and is intended to 
assist those required to submit cigarette plans for cigarette packages 
and cigarette advertisements by providing content, timing, and other 
recommendations related to those submissions. FDA is revising this 
guidance to reflect the May 21, 2021, court order that postponed the 
effective date of the final rule entitled ``Tobacco Products; Required 
Warnings for Cigarette Packages and Advertisements'' to July 13, 2022. 
Pursuant to the court order, 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 the recommended 
submission date, which is currently September 13, 2021.

[[Page 36561]]


DATES: The announcement of the revised final guidance is published in 
the Federal Register on July 12, 2021.

ADDRESSES: You may submit 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-2019-D-5364 for ``Submission of Plans for Cigarette Packages and 
Cigarette Advertisements (Revised).'' 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 office 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 may be sent. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Courtney Smith, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, 10903 
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 
1-877-287-1373, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised final guidance for 
industry entitled ``Submission of Plans for Cigarette Packages and 
Cigarette Advertisements (Revised).'' The Family Smoking Prevention and 
Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) 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 of 1965 (Pub. L. 89-92) (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

[[Page 36562]]

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, 
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\ On March 2, 2021, 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.\4\ On May 21, 2021, 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.\5\ The new 
effective date of the final rule is July 13, 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 September 13, 2021.
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    \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. et al., No. 6:20-cv-00176 (E.D. 
Tex. May 8, 2020) (order granting joint motion and establishing 
schedule), Doc. No. 33.
    \3\ R.J. Reynolds Tobacco Co. et al., No. 6:20-cv-00176 (E.D. 
Tex. December 2, 2020) (order granting Plaintiffs' motion and 
postponing effective date), Doc. No. 80.
    \4\ R.J. Reynolds Tobacco Co. et al., No. 6:20-cv-00176 (E.D. 
Tex. March 2, 2021) (order granting Plaintiffs' motion and 
postponing effective date), Doc. No. 89.
    \5\ R.J. Reynolds Tobacco Co. et al., No. 6:20-cv-00176 (E.D. 
Tex. May 21, 2021) (order granting Plaintiffs' motion and postponing 
effective date), Doc. No. 91.
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    FDA is issuing this guidance consistent with FDA's 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 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/products-guidance-regulations/rules-regulations-and-guidance, and https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

    Dated: June 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14674 Filed 7-9-21; 8:45 am]
BILLING CODE 4164-01-P