[Federal Register Volume 91, Number 11 (Friday, January 16, 2026)]
[Notices]
[Pages 2135-2136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-00792]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0956]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Warning Plans for
Certain Tobacco Products
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 February 17, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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 0910-0671. 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,
[email protected].
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.
Warning Plans for Certain Tobacco Products
OMB Control Number 0910-0671 Extension
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. 387u). Implementing regulations are found in 21 CFR
subchapter K (21 CFR parts 1100 through 1150). Section 3 of the
Comprehensive Smokeless Tobacco Health Education Act of 1986 (the
Smokeless Tobacco Act) (15 U.S.C. 4402) as amended by section 204 of
the Family Smoking Prevention and Tobacco Control Act (the Tobacco
Control Act), requires, among other things, that all smokeless tobacco
product packages and advertisements bear one of four required warning
statements (15 U.S.C. 4402(a)(1)). The warning statements specified in
4402(a)(1) must be randomly displayed on packaging and randomly
distributed ``in accordance with a plan submitted by the tobacco
product manufacturer, importer, distributor, or retailer'' to, and
approved by FDA (15 U.S.C. 4402(b)(3)(A)). Those statements must be
rotated quarterly in advertisements for each brand of smokeless tobacco
product, also ``in accordance with a plan'' submitted to and approved
by FDA (15 U.S.C. 4402(b)(3)(B)).
To implement statutory requirements for smokeless tobacco products,
warning plans are reviewed by FDA, upon submission by respondents (21
U.S.C. 4402(b)(3)(C)). FDA published a draft guidance entitled
``Submission of Warning Plans for Cigarettes and Smokeless Tobacco
Products'' on September 9, 2011, which describes the information and
format to be submitted for smokeless plans (www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-warning-plans-cigarettes-and-smokeless-tobacco-products). Submitters may also visit a
web page that describes the smokeless tobacco labeling and warning
statement requirements (www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/smokeless-tobacco-labeling-and-warning-statement-requirements). Additionally, FDA considers a
submission to be a supplement if the submitter is seeking approval of a
change to an FDA-approved warning plan. Warning plans can be submitted
either electronically or in paper format. The Center for Tobacco
Products (CTP) Portal, available at ctpportal.fda.gov/ctpportal/login.jsp, provides a secure online system for electronically
submitting documents and receiving messages from CTP.
In the Federal Register of July 3, 2025 (FR 90 29559), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments that were not PRA
related.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total
respondents respondent responses per response hours
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Submission of original rotational 1 1 1 60 60
plans for health warning statements
for smokeless tobacco products......
Supplement to approved plan for 2 1 2 30 60
smokeless tobacco products..........
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Total............................ .............. .............. .............. .............. 120
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on FDA's experience over the years, FDA retains the estimate
of 60 hours to complete an original rotational warning plan. FDA
estimates that preparing and submitting a supplement to an approved
plan will take half this time (30 hours).
Regarding smokeless tobacco warning plans, FDA estimates a total of
one respondent will submit a new original smokeless tobacco warning
plan per year, which will take approximately 60 hours to complete, for
a total of 60 burden hours. Additionally, FDA estimates a total of two
respondents will submit a supplement to an approved smokeless tobacco
warning plan, taking
[[Page 2136]]
approximately 30 hours to complete per response, for a total of 60
burden hours. Thus, the total burden for this collection is estimated
to be 120 hours.
FDA has adjusted its burden estimate, which has resulted in a
decrease of 60 hours and 2 respondents to the currently approved
burden. This adjusted burden estimate is based on historical trends for
smokeless tobacco warning plans. As of this OMB submission, FDA has
received a total of 47 original smokeless warning plans, and a total of
33 supplements. Generally, after receiving the initial influx of
original smokeless warnings plans, the number of annual warning plan
submissions has decreased, and FDA does not expect submissions to
increase at this time. Since publication of the 60-day notice, we
removed the cigar warning plan burden from this collection.
Brian Fahey,
Associate Commissioner for Legislation.
[FR Doc. 2026-00792 Filed 1-15-26; 8:45 am]
BILLING CODE 4164-01-P