Notice2025-18613
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
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 25, 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 184 (Thursday, September 25, 2025)</title>
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[Federal Register Volume 90, Number 184 (Thursday, September 25, 2025)]
[Notices]
[Pages 46215-46217]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18613]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0350]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reporting Harmful and
Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke
Under the Federal Food, Drug, and Cosmetic Act
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 27, 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 0910-0732. 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#bdedeffceec9dcdbdbfddbd9dc93d5d5ce93dad2cb"><span class="__cf_email__" data-cfemail="0d5d5f4c5e796c6b6b4d6b696c2365657e236a627b">[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.
Reporting Harmful and Potentially Harmful Constituents in Tobacco
Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic
Act
OMB Control Number 0910-0732--Extension
This information collection supports FDA regulations. Tobacco
products are governed by chapter IX of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (sections 900 through 920) (21 U.S.C. 387
through 21 U.S.C. 387t). The FD&C Act provides FDA with the authority
to regulate the manufacture, marketing, and distribution of cigarettes,
cigarette tobacco, roll-your-own (RYO) tobacco, and smokeless tobacco
products to protect the public health and to reduce tobacco use by
minors. FDA has the authority to issue regulations deeming other
products that meet the statutory definition of a tobacco product to be
subject to chapter IX of the FD&C Act (section 901(b) of the FD&C Act
(21 U.S.C. 387a(b)). In accordance with that authority, FDA issued a
rule deeming all products that meet the statutory definition of tobacco
product, except accessories of newly deemed tobacco products, to be
subject to FDA's tobacco product authority (81 FR 28974, May 10, 2016).
The definition of the term ``tobacco product'' in section 201(rr) of
the FD&C Act (21 U.S.C. 321(rr)) products that contain nicotine from
any source. As a result, non-
[[Page 46216]]
tobacco nicotine (NTN) products (e.g., products containing synthetic
nicotine) are subject to all of the tobacco product provisions in the
FD&C Act. Although NTN products are now subject to all of the tobacco
product provisions in the FD&C Act, including section 904 provisions of
the FD&C Act, FDA does not expect cigarettes, RYO tobacco, and
smokeless tobacco products, for which Form FDA 3787a-j was developed,
to also include NTN products.
Chapter IX of the FD&C Act applies to regulated tobacco products,
including sections 904(a)(3) and (c)(1) (21 U.S.C. 387d(a)(3) and
(c)(1)). Section 904(a)(3) of the FD&C Act requires the submission of
an initial report from each tobacco product manufacturer or importer,
or agents thereof, listing all constituents, including smoke
constituents as applicable, identified as a harmful and potentially
harmful constituent (HPHC) to health by FDA. Reports must be by brand
and by quantity in each brand and subbrand.
Section 904(c)(1) of the FD&C Act provides that manufacturers of
tobacco products not on the market as of June 22, 2009, must also
provide the information reportable under section 904(a)(3) of the FD&C
Act at least 90 days prior to introducing the product into interstate
commerce.\1\
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\1\ Note that section 904(c)(1) testing and reporting
requirements are separate from the requirements that must be
satisfied before a new tobacco product (sections 905 and 910 of the
FD&C Act (21 U.S.C. 387e and 387j)), or modified risk tobacco
product (section 911 of the FD&C Act (21 U.S.C. 387k)) may be
marketed.
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FDA has taken several steps to identify HPHCs to be reported under
section 904 of the FD&C Act, including issuing a guidance discussing
FDA's current thinking on the meaning of the term ``harmful and
potentially harmful constituent'' in the context of implementing the
HPHC list requirement under section 904(e) of the FD&C Act (76 FR 5387,
January 31, 2011, revised guidance issued August 2016). The guidance is
available on the internet at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/harmful-and-potentially-harmful-constituents-tobacco-products-used-section-904e-federal-food-drug">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/harmful-and-potentially-harmful-constituents-tobacco-products-used-section-904e-federal-food-drug</a>. The current established list of HPHCs also is available on the
internet at <a href="https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list">https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list</a> (77 FR 20034, April 3, 2012).
The purpose of the information collection is to collect statutorily
mandated information regarding HPHCs in certain tobacco products and
tobacco smoke, by brand and by quantity in each brand and subbrand.
To facilitate the submission of HPHC information, Forms FDA 3787a-
j, for cigarettes, smokeless tobacco products, and RYO tobacco
products, respectively, in both paper and electronic formats, are
available. Additionally, FDA is developing forms to facilitate the
submission of HPHC information for the deemed tobacco products. We
intend to model these forms on the current HPHC reporting forms (i.e.,
Forms FDA 3787a-j).
Manufacturers or importers, or their agents, will be able to submit
HPHC information either electronically through new web forms within the
Center for Tobacco Products (CTP) Portal Next Generation or in paper
format. The modernized web forms will streamline data entry and
submission for reporting HPHCs for cigarettes, smokeless tobacco
products, and RYO tobacco products. This process will be more efficient
than the current approach, which requires the use of the FDA's
eSubmitter Desktop Tool for data entry and the CTP Portal web
application for submission. With CTP Portal Next Generation, necessary
tasks will be completed directly within the web forms, making HPHC
submissions more user-friendly.
In the Federal Register of June 27, 2025 (90 FR 27617), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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 hours
respondents respondent responses per response
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Reporting for Section 904(c)(1) Products
1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
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Cigarette....................... 243 1 243 1.82 442
RYO............................. 10 1 10 0.43 4
Smokeless....................... 32 1 32 0.63 20
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Total....................... .............. .............. .............. .............. 466
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2. Testing of HPHC Quantities in Products
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Cigarette Filler and RYO........ 10 1 10 9.42 94
Smokeless....................... 32 1 32 12.06 386
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Total....................... .............. .............. .............. .............. 480
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3. Testing of HPHC Quantities in Mainstream Smoke
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Cigarette: ISO Regimen.......... 243 1 243 23.64 5,745
Cigarette: Health Canada Regimen 243 1 243 23.64 5,745
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Total....................... .............. .............. .............. .............. 11,490
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Total Section 904(c)(1) .............. .............. .............. .............. 12,436
Reporting Burden Hours.....
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 46217]]
We have revised our burden estimates to this information collection
request. Our burden estimates have been updated based on the assumption
that ``Each respondent represents a statutory tobacco product that
receives authorization from FDA for which manufacturers and importers
(or their agents), must report their product information to FDA under
section 904(c)(1) of the FD&C Act at least 90 days prior to delivery
for introduction into interstate commerce for all new products.'' Under
this assumption, the number of respondents is equal to the number of
total annual responses FDA estimated from previous submissions. This
assumption will facilitate future burden estimates, allow us to refine
the estimated burden to include only the products that need to report
HPHCs under section 904(c)(1) of the FD&C Act, and avoid data
suppression issues with disaggregated Alcohol and Tobacco Tax and Trade
Bureau data.
<bullet> Cigarette--section 904(c)(1) Reporting of Manufacturer/
Importer Company and Product Information by Completing Submission
Forms/Testing of HPHC is reflecting a reduction in 137 respondents from
380 to 243.
<bullet> Roll Your Own Tobacco Product--section 904(c)(1) Reporting
of Manufacturer/Importer Company and Product Information by Completing
Submission Forms is reflecting a reduction in 9 respondents from 19 to
10.
<bullet> Smokeless--section 904(c)(1) Reporting of Manufacturer/
Importer Company and Product Information by Completing Submission Forms
is reflecting an increase in 7 respondents from 25 to 32.
The cumulative changes to the estimated burden for this information
collection reflects an overall decrease of 6,727 burden hours and a
corresponding decrease of 139 responses.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18613 Filed 9-24-25; 8:45 am]
BILLING CODE 4164-01-P
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