Notice2025-23474
Agency Information Collection Activities; Proposed Collection; Comment Request; Required Warnings for Cigarette Packages and Advertisements
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Published
December 19, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 the collection of information entitled, "Required Warnings for Cigarette Packages and Advertisements."
Full Text
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<title>Federal Register, Volume 90 Issue 242 (Friday, December 19, 2025)</title>
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[Federal Register Volume 90, Number 242 (Friday, December 19, 2025)]
[Notices]
[Pages 59533-59535]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23474]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-6076]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Required Warnings for Cigarette Packages and
Advertisements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 the collection of information entitled,
``Required Warnings for Cigarette Packages and Advertisements.''
DATES: Either electronic or written comments on the collection of
information must be submitted by February 17, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 17, 2026. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2025-N-6076 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Required Warnings for Cigarette
Packages and Advertisements.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
[[Page 59534]]
FOR FURTHER INFORMATION CONTACT: Amber Barrett, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#4a1a180b193e2b2c2c0a2c2e2b64222239642d253c"><span class="__cf_email__" data-cfemail="f5a5a7b4a681949393b5939194db9d9d86db929a83">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
Required Warnings for Cigarette Packages and Advertisements--21 CFR
part 1141
OMB Control Number 0910-0877--Extension
This information collection supports Food and Drug Administration
(FDA) regulations and guidance. Tobacco products are governed by
chapter IX of the Federal Food, Drug, and Cosmetic Act (sections 900
through 920) (21 U.S.C. 387 through 21 U.S.C. 387t).
On March 18, 2020, FDA issued a final rule establishing new
cigarette health warnings for cigarette packages and advertisements
entitled ``Tobacco Products; Required Warnings for Cigarette Packages
and Advertisements'' (85 FR 15638; <a href="https://www.federalregister.gov/d/2020-05223">https://www.federalregister.gov/d/2020-05223</a>). 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 label statements. The Tobacco Control Act
amended section 4 of the Federal Cigarette Labeling and Advertising Act
of 1965 (FCLAA) (15 U.S.C. 1333) to require each cigarette package and
advertisement to bear one of the new required warnings. The 2020 final
rule specifies the 11 new textual warning label statements and
accompanying color graphics.
Section 4(c) of the FCLAA and 21 CFR 1141.10(g) sets forth the
specific marketing requirements relating to the random and equal
display and distribution of required warnings on cigarette packaging
and quarterly rotation of required warnings in alternating sequence in
cigarette advertising and requires the submission of plans outlining
how the cigarette packaging and advertising will comply with such
requirements. FDA must review and approve cigarette plans in advance of
any person displaying or distributing cigarette packages or
advertisements for products that are required to carry the required
warnings, and a record of the FDA-approved plan must be established and
maintained by the tobacco product manufacturer.
To implement these statutory requirements, cigarette plans will be
reviewed by FDA upon submission by respondents. FDA published an
updated guidance document in September 2024, entitled ``Submission of
Plans for Cigarette Packages and Cigarette Advertisements (Revised)''
which describes cigarette plans information, format and submission
(<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-plans-cigarette-packages-and-cigarette-advertisements-revised">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-plans-cigarette-packages-and-cigarette-advertisements-revised</a>). Pursuant to section 201(b) of the Tobacco
Control Act, FDA finalized the ``Required Warnings for Cigarette
Packages and Advertisements'' rule with an effective date of June 18,
2021, 15 months after the date of publication.
Litigation is pending regarding the validity of the final rule. See
R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug
Administration et al., No. 6:20-cv-00176 (E.D. Tex.), 25-40137 (5th
Cir.); and Philip Morris USA Inc. et al. v. United States Food and Drug
Administration et al., No. 2:24-cv-00143 (S.D. Ga.). FDA will provide
updates regarding submission of cigarette plans as they are available.
Visit FDA's website <a href="https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/cigarette-labeling-and-health-warning-requirements">https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/cigarette-labeling-and-health-warning-requirements</a> for updates.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average burden
21 CFR part 1141 and activity Number of responses per Total annual per response Total hours
respondents respondent responses (hours)
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Original Submission (Initial 17 1 17 150 2,550
Plan)..........................
Supplement...................... 8 1 8 75 600
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Total....................... .............. .............. .............. .............. 3,150
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimates are based on FDA's experience with information
collections for other tobacco product plans (i.e., smokeless and
cigars, consolidated under OMB control number 0910-0671) and 2023
Treasury Alcohol and Tobacco Tax and Trade Bureau (TTB) data.
FDA estimates up to 17 entities are affected annually. We estimate
these 17 entities will submit initial plans, and it will take an
average of 150 hours per
[[Page 59535]]
respondent to prepare and submit a plan for packaging and advertising
for a total of 2,550 hours. We estimate that about half of respondents
will submit a supplement each year. FDA estimates it will take
respondents half the time per response to prepare and submit a
supplement to an approved plan. We estimate receiving 8 supplements per
year at 75 hours per response for a total of 600 hours. FDA estimates
that the total annual hours for submitting initial plans and
supplements will be 3,150. Based on a review of the information
collection since our last request for OMB approval, our reporting
burden estimate has reduced from 11,100 to 3,150 hours annually.
Section 1141.10(g)(4) establishes that each tobacco product
manufacturer required to randomly and equally display and distribute
warnings on cigarette packages or quarterly rotate warnings in
cigarette advertisements in accordance with an FDA-approved plan under
section 4 of the FCLAA and 21 CFR part 1141 must maintain a copy of the
FDA-approved plan (approved under Sec. 1141.10(g)(3)). This copy of
such FDA-approved plan must be available for inspection and copying by
officers or employees of FDA. This subsection requires that the FDA-
approved plan must be retained while in effect and for a period of not
less than 4 years from the date it was last in effect.
Table 2--Estimated Annual Recordkeeping Burden1 2
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Average burden
Number of Number of Total annual per
21 CFR part 1141 and activity recordkeepers records per records recordkeeping Total hours
recordkeeper (hours)
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Original Submission (Initial 51 1.5 77 3 231
Plan) Records..................
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Total....................... .............. .............. .............. .............. 231
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Numbers are rounded to the nearest whole number.
FDA estimates that 51 recordkeepers will keep a total of about 76.5
(rounded to 77) records at 3 hours per record for a total of 231 hours.
As stated previously, these estimates are based on FDA's experience
with information collections for other tobacco product plans (i.e.,
smokeless and cigars, consolidated under OMB control number 0910-0671).
Based on our estimates for the submission of one-time, initial plans
and supplements (i.e., that all respondents will submit one-time,
initial plans and about half of respondents will submit supplements to
FDA-approved plans), we estimate that each recordkeeper will keep an
average of 1.5 records.
FDA concludes that the required warnings for cigarette packages and
cigarette advertisements in Sec. 1141.10 are not subject to review by
OMB because they do not constitute a ``collection of information''
under the PRA (44 U.S.C. 3501-3520). Rather, these labeling statements
are a ``public disclosure'' of information originally supplied by the
federal government to the recipient for the purpose of ``disclosure to
the public'' (5 CFR 1320.3(c)(2)).
FDA estimates that the total burden for this information collection
is 3,981 hours annually (3,150 hours for reporting + 231 hours for
recordkeeping). We have adjusted our burden estimate, which has
resulted in a decrease to the currently approved burden. Our estimated
reporting burden for the information collection reflects an overall
decrease of 76 annual respondents and a corresponding decrease of 7,386
annual hours. We attribute this adjustment to a decrease in the number
of submissions we received over the last few years.
Brian Fahey,
Associate Commissioner for Legislation.
[FR Doc. 2025-23474 Filed 12-18-25; 8:45 am]
BILLING CODE 4164-01-P
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