Notice2026-10187
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Required Warnings for Cigarette Packages and Advertisements
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 21, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 91 Issue 98 (Thursday, May 21, 2026)</title>
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[Federal Register Volume 91, Number 98 (Thursday, May 21, 2026)]
[Notices]
[Pages 29964-29966]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10187]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-6076]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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: Submit written comments (including recommendations) on the
collection of information by June 22, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0877. Also include the FDA docket
number found in brackets in the heading of this document.
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#a0f0f2e1f3d4c1c6c6e0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="0e5e5c4f5d7a6f68684e686a6f2066667d20696178">[email protected]</span></a>.
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.
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,
[[Page 29965]]
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.
In the Federal Register of December 19, 2025, FDA published a 60-
day notice requesting public comment on the proposed information
collection and associated burden estimates. FDA received two PRA
related public comments on the 60-day notice for this information
collection. One commenter supported the extension, agreed that the
collection is necessary for FDA's public health mission, and found the
burden estimates reasonable. The second commenter supported the
required warnings but questioned whether FDA's collection of ``consumer
data'' was necessary and expressed concern about potential burden.
(Comment) One commenter supported the proposed extension of this
information collection, stating that the collection appears necessary
for FDA's public health mission and implementation of statutorily
required warning plans. The commenter also indicated that the burden
estimates are reasonable and appropriately reflect recent submission
trends.
(FDA Response) FDA agrees that this information collection is
necessary to implement statutory and regulatory requirements for
cigarette packages and advertisements, including the submission of
warning plans required under section 4 of the Federal Cigarette
Labeling and Advertising Act and 21 CFR 1141.10(g). FDA's burden
estimates are based on the Agency's experience with similar submissions
and available data on industry activity. Based on this comment, FDA has
not made any changes to the burden estimates or methodology.
(Comment) The second commenter supported the requirement for
cigarette health warnings but questioned whether FDA's collection of
``consumer data'' is necessary and expressed concern about potential
burden associated with such data collection.
(FDA Response) FDA agrees that this information collection is
necessary to support required warnings for cigarette packages and
advertisements. However, FDA disagrees with the commenter's concern
regarding ``consumer data.'' This information collection does not
involve the collection of data from consumers. Rather, it requires
manufacturers, distributors, and certain retailers to submit plans
describing how they will comply with statutory and regulatory
requirements for the display and rotation of required warnings. The
burden estimates reflect only the reporting and recordkeeping
activities associated with preparing, submitting, and maintaining these
plans. Based on this comment, FDA has not made any changes to the
burden estimates or methodology.
FDA considered all comments received in response to the 60-day
notice and determined that no revisions to the information collection
or burden estimates are warranted.
FDA's burden estimates, discussed below, reflect consideration of
the comments received in response to the 60-day notice as well as
updated data on recent submission activity. These burden estimates
reflect only industry reporting and recordkeeping activities associated
with plan submission and maintenance, and do not include any collection
of information from individual consumers. The following estimates
reflect only the reporting and recordkeeping burden for manufacturers,
distributors, and retailers associated with preparing, submitting, and
maintaining cigarette warning plans.
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,
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 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.
[[Page 29966]]
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 Burden \1\ \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.
FDA estimates that 51 recordkeepers will keep a total of about 77
(rounded) 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, 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 3,381 hours annually (3,150 hours for reporting + 231 hours for
recordkeeping). Independently of the public comments received, FDA has
adjusted its burden estimate based on updated submission data, 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 responses and a corresponding decrease of
7,986 annual hours. We attribute this adjustment to a decrease in the
number of submissions we received over the last few years. These
updated estimates are consistent with the scope of this information
collection as described above and do not reflect any changes made in
response to public comments.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10187 Filed 5-20-26; 8:45 am]
BILLING CODE 4164-01-P
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