Notice2025-12413
Agency Information Collection Activities; Proposed Collection; Comment Request; Warning Plans for Certain Tobacco Products
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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
July 3, 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 information collection provisions associated with warning plans for certain tobacco products.
Full Text
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<title>Federal Register, Volume 90 Issue 126 (Thursday, July 3, 2025)</title>
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[Federal Register Volume 90, Number 126 (Thursday, July 3, 2025)]
[Notices]
[Pages 29559-29561]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12413]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0956]
Agency Information Collection Activities; Proposed Collection;
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 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 information collection provisions
associated with warning plans for certain tobacco products.
DATES: Either electronic or written comments on the collection of
information must be submitted by September 2, 2025.
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 September 2, 2025. 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-0956 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Warning Plans for Certain Tobacco
Products.'' 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
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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.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, 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#306062716344515656705654511e5858431e575f46"><span class="__cf_email__" data-cfemail="77272536240316111137111316591f1f0459101801">[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.
Warning Plans for Certain Tobacco Products
OMB Control Number 0910-0671--Revision
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). 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) 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 label
statements specified in 15 U.S.C. 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 labels must be rotated quarterly in advertisements for each brand
of smokeless tobacco product, also ``in accordance with a plan'' and
subject to approval by FDA. (15 U.S.C. 4402(b)(3)(A)). Similarly, all
cigar packages and advertisements bear one of six required warning
statements, which must be displayed on packaging and advertising for
each brand of cigars ``in accordance with a plan submitted by the
tobacco product manufacturer, importer, distributor, or retailer'' to,
and approved by, FDA. (21 CFR 1143.5).
To implement statutory requirements for smokeless tobacco products,
warning plans are reviewed by FDA, upon submission by respondents. (21
U.S.C. 4402(b)(C)(3)). 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 (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-warning-plans-cigarettes-and-smokeless-tobacco-products">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-warning-plans-cigarettes-and-smokeless-tobacco-products</a>). Submitters
may also visit a web page that describes the smokeless tobacco labeling
and warning statement requirements (<a href="https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/smokeless-tobacco-labeling-and-warning-statement-requirements">https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/smokeless-tobacco-labeling-and-warning-statement-requirements</a>). 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 <a href="https://ctpportal.fda.gov/ctpportal/login.jsp">https://ctpportal.fda.gov/ctpportal/login.jsp</a>, provides a secure online system for electronically
submitting documents and receiving messages from CTP.
FDA published a draft guidance for cigar warning plans entitled
``Submission of Warning Plans for Cigars'' in August of 2018, which
describes the information and format to be submitted for cigar plans
(<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-policy-certain-labeling-and-warning-statement-requirements-cigars-and-pipe-tobacco">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-policy-certain-labeling-and-warning-statement-requirements-cigars-and-pipe-tobacco</a>). However, the U.S. District Court
for the District of Columbia issued an order vacating the health
warning requirements for cigars and pipe tobacco set forth in 21 CFR
1143.3 and 1143.5 (Sec. Sec. 1143.3 and 1143.5) and remanding the
Final Deeming Rule's warning requirements for cigars and pipe tobacco
back to the Agency. See Order, Cigar Ass'n of Am. v. U.S. Food and Drug
Admin., No. 1:16-cv-01460 (D.D.C. September 11, 2020). Although the
requirement has been vacated, cigar and pipe tobacco firms may choose
to voluntarily comply with these health warning provisions.
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).
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..........
21 CFR part 1143 Cigar Warning Plans. 1 1 1 1 1
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Total............................ .............. .............. .............. .............. 121
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA's estimated total burden for warning plans for certain tobacco
products is 121 hours, since FDA is revising this collection to
incorporate the burden for cigar warning plans previously received
under OMB control number 0910-0768 (which covers the burden for tobacco
products subject to the Federal Food, Drug, and Cosmetic Act). Based on
a 2020 order vacating the health warning requirements for cigars and
pipe tobacco (set forth in Sec. Sec. 1143.3 and 1143.5) and remanding
the Final Deeming Rule's warning requirements for cigars and pipe
tobacco, FDA has replaced the burden previously attributed to this
activity with a placeholder of 1 hour, acknowledging that the
regulation remains effective.
In regard to 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 approximately 30 hours to complete per response,
for a total of 60 burden hours. Thus, the total burden for the
collection for smokeless tobacco warning plans 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. To date, FDA has received a total of
47 original smokeless warning plans, and a total of 33 supplements.
However, from 2022-2024, FDA only received one original smokeless
tobacco warning plan and a total of two 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.
Dated: June 26, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-12413 Filed 7-2-25; 8:45 am]
BILLING CODE 4164-01-P
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