Notice2025-11955
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission
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
June 27, 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 information collection associated with tobacco health document submissions.
Full Text
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<title>Federal Register, Volume 90 Issue 122 (Friday, June 27, 2025)</title>
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[Federal Register Volume 90, Number 122 (Friday, June 27, 2025)]
[Notices]
[Pages 27640-27642]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11955]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0351]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Tobacco Health Document Submission
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 information collection associated with
tobacco health document submissions.
DATES: Either electronic or written comments on the collection of
information must be submitted by August 26, 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 August 26, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is 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-0351 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Tobacco Health Document
Submission.'' 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
[[Page 27641]]
``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.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#4c1c1e0d1f382d2a2a0c2a282d6224243f622b233a"><span class="__cf_email__" data-cfemail="0b5b594a587f6a6d6d4b6d6f6a25636378256c647d">[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.
Tobacco Health Document Submission
OMB Control Number 0910-0654--Extension
This information collection supports FDA guidance. The Federal
Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to regulate the
manufacture, marketing, and distribution of tobacco products to protect
the public health generally and to reduce tobacco use by minors.
Section 904(a)(4) of the FD&C Act ((21 U.S.C. 387d(a)(4)) requires
each tobacco product manufacturer or importer, or agent thereof, to
submit all documents developed after June 22, 2009, ``that relate to
health, toxicological, behavioral, or physiologic effects of current or
future tobacco products, their constituents (including smoke
constituents), ingredients, components, and additives'' (herein
referred to as ``tobacco health documents'' or ``health documents'').
The guidance document ``Health Document Submission Requirements for
Tobacco Products (Revised)'' (2023) (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-health-document-submission">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-health-document-submission</a>) requests tobacco health document submissions from
manufacturers and importers of tobacco products based on statutory
requirements and compliance dates.\1\ As indicated in the guidance, all
manufacturers and importers of tobacco products are now subject to the
FD&C Act and are required to comply with section 904(a)(4), which
requires immediate and ongoing submission of health documents developed
after June 22, 2009 (the date of enactment of the Family Smoking
Prevention and Tobacco Control Act (Pub. L. 111-31)). However, FDA
generally does not intend to enforce the requirement at this time with
respect to all such health documents, so long as a specified set of
documents, those developed between June 23, 2009, and December 31,
2009, are provided at least 90 days prior to the delivery for
introduction of tobacco products into interstate commerce. Thereafter,
manufacturers should preserve all health documents, including those
that relate to products for further manufacturing and those developed
after December 31, 2009, for future submission to FDA. All Agency
guidance documents are issued in accordance with our good guidance
practice regulations in 21 CFR 10.115, which provide for public comment
at any time.
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\1\ FDA announced the availability of a guidance on this
collection in the Federal Register on April 20, 2010 (75 FR 20606)
[revised December 5, 2016 (81 FR 87565), August 10, 2017 (82 FR
37459), and March 20, 2023 (88 FR 16636)].
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FDA has been collecting the information submitted pursuant to
section 904(a)(4) of the FD&C Act through a facilitative electronic
form and through a paper form (Form FDA 3743) for those individuals who
choose not to use the electronic method. You may access the electronic
and paper forms on our website, at <a href="https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal">https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal</a> and <a href="https://www.fda.gov/media/78652/download">https://www.fda.gov/media/78652/download</a>, respectively. In addition to the
electronic and paper forms, FDA issued the guidance on this collection
to assist persons making tobacco health document submissions. For
further assistance, FDA has provided a technical guide, embedded hints,
and a web tutorial on the electronic portal via <a href="http://www.fda.gov/media/78631/download?attachment">www.fda.gov/media/78631/download?attachment</a>, <a href="https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal#what%20can">https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal#what%20can</a>, and <a href="https://www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions">https://www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions</a>.
In this information collection, FDA is proposing to continue its
compliance plan and request all manufacturers and importers of tobacco
products, if not previously submitted, at least 90 days prior to the
delivery for introduction into interstate commerce. Thereafter,
manufacturers should preserve all health documents, including those
that relate to products for further manufacturing and those developed
after December 31, 2009, for future submission to FDA.
FDA estimates the burden of this collection of information as
follows:
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Table 1--Estimated Annual Reporting Burden
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Number of Average
Activity Number of responses per Total annual burden per Total
respondents respondent responses response hours
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Tobacco Health Document Submissions 10 3.2 32 50 1,600
and Form FDA 3743..................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA estimates that a tobacco health document submission as required
by section 904(a)(4) of the FD&C Act, will take approximately 50 hours
per submission based on FDA experience. We anticipate documents will be
submitted annually for a total of 10 respondents. FDA estimates the
total annual reporting burden to be 1,600 hours.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: June 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11955 Filed 6-26-25; 8:45 am]
BILLING CODE 4164-01-P
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