Notice2026-03098
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
Primary source
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Published
February 18, 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 32 (Wednesday, February 18, 2026)</title>
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[Federal Register Volume 91, Number 32 (Wednesday, February 18, 2026)]
[Notices]
[Pages 7499-7500]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03098]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2652]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Regulations
Restricting the Sale and Distribution of Cigarettes and Smokeless
Tobacco To Protect Children and Adolescents
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 March 20, 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 0910-0312. 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#550507140621343333153331347b3d3d267b323a23"><span class="__cf_email__" data-cfemail="eebebcafbd9a8f8888ae888a8fc086869dc0898198">[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.
Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco To Protect Children and Adolescents--21 CFR Part 1140
OMB Control Number 0910-0312--Extension
This information collection supports FDA regulatory requirements
contained in part 1140 (21 CFR part 1140) authorized under Chapter IX
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 9) and
associated agency guidance. Regulations in part 1140 establish
permissible forms of labeling and advertising for cigarettes or
smokeless tobacco and include
[[Page 7500]]
reporting requirements directing persons to notify FDA if they intend
to use a form of advertising or labeling that is not addressed in the
regulations. Section 1140.30(a)(2) requires tobacco product
manufacturers, distributors, and retailers to notify FDA if they intend
to use advertising or labeling for cigarettes or smokeless tobacco in a
medium that is not listed in section 1140.30(a)(1). The notice shall
describe the medium and discuss the extent to which the advertising or
labeling may be seen by persons younger than 18 years of age. The
notifications must be made 30 days prior to the use of such media.
We allow electronic and written submission of these notifications.
Respondents can mail notifications as prescribed in section
1140.30(a)(2) to FDA. Instructions providing clarification on how to
format the notification may be found in the guidance document entitled
''Compliance with Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To Protect Children and Adolescents''
(2013) (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-regulations-restricting-sale-and-distribution-cigarettes-and-smokeless-tobacco-protect">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-regulations-restricting-sale-and-distribution-cigarettes-and-smokeless-tobacco-protect</a>).
In the Federal Register of August 22, 2024 (90 FR 41085), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received four comments. Two comments
were responsive to the Paperwork Reduction Act (PRA) information
collection topics solicited. Two comments were not responded to the PRA
and will not be addressed here.
The comments generally supported FDA's collection of information.
The comments supported FDA's maintaining oversight related to youth
tobacco access through the regulatory provision related to this
collection, encouraged the FDA to enhance transparency of this
collection by clearly providing better explanation about how retailer
and manufacturer data is analyzed and used for enforcement or policy
interventions, and recommended expanding digital tools and providing
plain language guidance materials in multiple languages to minimize
administrative burden and help retailers understand submission
requirements.
The comments also believed FDA has underestimated burden and
suggested that there were ways to improve the collection by providing
standardized submission templates, clearer definitions of unlisted
media, illustrative examples, clarification of material changes
requiring new notices, and different ways to provide supporting
documentation. The comments believe FDA should provide target review
and timelines and should implement an electronic submission portal,
accept machine-readable attachments, allow consolidated annual or
semiannual notification, provide a fillable submission template, and
establish a safe-harbor correction window.
In response, FDA thanks the commenters and agrees that this
information collection has practical utility and is necessary for the
proper performance of FDA's functions. Regarding burden estimates, FDA
encourages detailed information be submitted and acknowledges burden
for each respondent to the collection could vary and that it may take
some respondents longer to complete the requirements than others. FDA
tries to minimize burden by efficiently collecting information without
compromising FDA's ability to identify and address violations by
providing options to comply and allowing both electronic and mail
submission of information. FDA believes that the average burden
estimates per response are sufficient. FDA is always open to improve
the quality, utility, and clarity of information we collect, and offers
guidance regarding the types of information that should be included
with a cover letter describing the information. FDA also provides a
clear list of media that should be provided and options for providing
supporting documentation and notes that any notification returned to
the submitter is not intended to imply that prior approval is required
before use of a medium.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
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Number of Total Average
Activity Number of responses per annual burden per Total
respondents respondent responses response hours
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1140.30(a)(2)--Notification of other advertising 4 1 4 1 4
or labeling medium..............................
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Total........................................ ............ .............. .......... ........... 4
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden hour estimates for this collection of information were
based on submissions regarding cigarette and smokeless tobacco product
advertising expenditures. FDA has received 12 such notifications to
date since 2022. Based on a review of the information collection and
the number of notifications received since 2022, FDA estimates that
approximately four respondents will submit an annual notice of
alternative advertising, and the Agency has estimated it should take
one hour to provide such notice. Therefore, our estimated burden for
the information collection reflects an overall decrease of 21 hours and
a corresponding decrease of 21 responses.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03098 Filed 2-17-26; 8:45 am]
BILLING CODE 4164-01-P
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