Notice2025-11959
Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
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Published
June 27, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act.
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 27617-27619]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11959]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0350]
Agency Information Collection Activities; Proposed Collection;
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, Agency, or we) 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 Reporting Harmful and
Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke
Under the Federal Food, Drug, and Cosmetic Act.
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 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-0350 for ``Reporting Harmful and Potentially Harmful
Constituents in Tobacco Products and Tobacco Smoke Under the Federal
Food, Drug, and Cosmetic Act.'' 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 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, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#e6b6b4a7b592878080a6808287c88e8e95c8818990"><span class="__cf_email__" data-cfemail="217173607255404747614745400f4949520f464e57">[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
[[Page 27618]]
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.
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-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.
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
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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
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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
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.
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.
Dated: June 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11959 Filed 6-26-25; 8:45 am]
BILLING CODE 4164-01-P
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