Notice2025-18186
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
September 19, 2025
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 90 Issue 180 (Friday, September 19, 2025)</title>
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[Federal Register Volume 90, Number 180 (Friday, September 19, 2025)]
[Notices]
[Pages 45218-45220]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18186]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0351]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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 October 20, 2025.
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 0910-0654. Also include the FDA docket
number found in brackets in the heading of this document.
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#603032213314010606200604014e0808134e070f16"><span class="__cf_email__" data-cfemail="08585a495b7c696e6e486e6c692660607b266f677e">[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.
[[Page 45219]]
Tobacco Health Document Submission
OMB Control Number 0910-0654--Revision
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="http://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-health-document-submission">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\ We updated the guidance to
reflect revised references to current FDA websites, which we will
publish upon OMB approval. 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="http://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal">www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal</a> and <a href="http://www.fda.gov/media/78652/download">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="http://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal#what%20can">www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal#what%20can</a>, and <a href="http://www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions">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.
In the Federal Register of June 27, 2025 (90 FR 27640), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Tobacco Health Document Submissions and Form FDA 3743.............. 10 3.2 32 50 1,600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Since the publication of the 60-day Federal Register notice, FDA
discovered that we erroneously omitted the discussion of the removal of
a line item from the burden chart. As such, 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. To derive the number of respondents for this provision,
FDA assumes that very few manufacturers or importers, or agents
thereof, would have health documents to submit. We anticipate 32
document submissions will be submitted on an annual basis by 10
respondents for an average of 3.2 submissions per respondent. We
anticipate that manufacturers without additional documents have already
completed their notification through a single FDA Form 3743 submission.
Conversely, our experience shows that manufacturers with additional
documents generally make multiple submissions. FDA estimates the annual
reporting burden for these manufacturers to be 1,600 hours.
FDA has adjusted its burden estimate by removing estimates of
burden associated with tobacco health document submissions for NTN
products because the compliance period for initial submission from NTN
manufacturers has passed. This has resulted in a decrease of 200 hours
and 100 respondents. With this revision, all tobacco product
manufacturers are now accounted for under the single tobacco health
document submissions
[[Page 45220]]
information collection activity listed in Table 1.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18186 Filed 9-18-25; 8:45 am]
BILLING CODE 4164-01-P
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