Notice2025-11950
Agency Information Collection Activities; Proposed Collection; Comment Request; Exemptions From Substantial Equivalence Requirements for Tobacco Products
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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 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 "Exemptions From Substantial Equivalence Requirements for Tobacco Products."
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 27623-27625]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11950]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0378]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Exemptions From Substantial Equivalence Requirements
for 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 ``Exemptions From Substantial Equivalence
Requirements for Tobacco Products.''
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-0378 for ``Exemptions From Substantial Equivalence
Requirements for 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 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#a2f2f0e3f1d6c3c4c4e2c4c6c38ccacad18cc5cdd4"><span class="__cf_email__" data-cfemail="0c5c5e4d5f786d6a6a4c6a686d2264647f226b637a">[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
[[Page 27624]]
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.
Exemptions From Substantial Equivalence Requirements for Tobacco
Products
OMB Control Number 0910-0684--Extension
This information collection supports Food and Drug Administration
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.
Tobacco products are governed by chapter IX of the FD&C Act
(sections 900 through 920) (21 U.S.C. 387 through 387t). Section
201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended, defines a
tobacco product as ``any product made or derived from tobacco or
containing nicotine from any source that is intended for human
consumption, including any component, part, or accessory of a tobacco
product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product).''
The FD&C Act, requires that before a new tobacco product may be
introduced or delivered for introduction into interstate commerce, the
new tobacco product must undergo premarket review by FDA. FDA must
issue an order authorizing the commercial distribution of the new
tobacco product or find the product exempt from the requirements of
substantial equivalence under section 910(a)(2)(A) of the FD&C Act,
before the product may be introduced into commercial distribution.
FDA has established a pathway for manufacturers to request
exemptions from the substantial equivalence requirements of the FD&C
Act in Sec. 1107.1 (21 CFR 1107.1) of the Agency's regulations. As
described in Sec. 1107.1(a), FDA may exempt tobacco products that are
modified by adding or deleting a tobacco additive, or increasing or
decreasing the quantity of an existing tobacco additive, from the
requirement of demonstrating substantial equivalence if the Agency
determines that: (1) the modification would be a minor modification of
a tobacco product that can be sold under the FD&C Act, (2) a report
demonstrating substantial equivalence is not necessary to ensure that
permitting the tobacco product to be marketed would be appropriate for
the protection of public health, and (3) an exemption is otherwise
appropriate.
Section 1107.1(b) states that a request for exemption under section
905(j)(3) of the FD&C Act may be made only by the manufacturer of a
legally marketed tobacco product for a minor modification to that
tobacco product and that the manufacturer must submit the request and
all information supporting it to FDA. The request must be made in an
electronic format that FDA can process, review, and archive (or a
written request must be made by the manufacturer explaining in detail
why the manufacturer cannot submit the request in an electronic format
and requesting an alternative means of submission to the electronic
format).
An exemption request must contain: (1) The manufacturer's address
and contact information; (2) identification of the tobacco product(s);
(3) a detailed explanation of the purpose for the modification; (4) a
detailed description of the modification, including a statement as to
whether the modification involves adding or deleting a tobacco
additive, or increasing or decreasing the quantity of the existing
tobacco additive; (5) a detailed explanation of why the modification is
a minor modification of a tobacco product that can be sold under the
FD&C Act; (6) a detailed explanation of why a report under section
905(j)(1) of the FD&C Act intended to demonstrate substantial
equivalence is not necessary to ensure that permitting the tobacco
product to be marketed would be appropriate for protection of the
public health; (7) a certification (i.e., a signed statement by a
responsible official of the company) summarizing the supporting
evidence and providing the rationale for the official's determination
that the modification does not increase the tobacco product's appeal to
or use by minors, toxicity, addictiveness, or abuse liability; (8)
other information justifying an exemption; and (9) an environmental
assessment (EA) under Part 25 (21 CFR part 25) prepared in accordance
with the requirements of Sec. 25.40.
The National Environmental Policy Act of 1969 (NEPA) (42 U.S.C.
4321-4347) states national environmental objectives and imposes on each
Federal Agency the duty to consider the environmental effects of its
actions. Section 102(2)(C) of NEPA requires the preparation of an
environmental impact statement for every major Federal action that will
significantly affect the quality of the human environment.
The FDA NEPA regulations are contained in part 25. All applications
for exemption from substantial equivalence require the submission of an
EA. An EA provides information that is used to determine whether an FDA
action could result in a significant environmental impact. Section
25.40(a) and (c) specifies the content requirements for EAs for
nonexcluded actions.
The information required by Sec. 1107.1(b) is submitted to FDA so
FDA can determine whether an exemption from substantial equivalence to
the product is appropriate for the protection of the public health.
Section 1107.1(c) states that FDA will review the information submitted
and determine whether to grant or deny an exemption based on whether
the criteria in section 905(j)(3) of the FD&C Act are met. FDA may
request additional information if necessary, to make a determination
and may consider the exemption request withdrawn if the information is
not provided within the requested timeframe.
This collection of information also contains a requirement that a
manufacturer submit a report (referred to as an ``abbreviated report'')
at least 90 days prior to making an introduction or delivery for
introduction into interstate commerce for commercial distribution of a
tobacco product. Section 905(j)(1)(A)(ii) of the FD&C Act states that
if an exemption has been requested and granted, a report must be
submitted to FDA that demonstrates that the tobacco product is modified
within the meaning of section 905(j)(3), the modifications are to a
product that is commercially marketed and in compliance with the
requirements of the FD&C Act, and all of the modifications are covered
by exemptions granted by the Secretary of Health and Human Services
(the Secretary) under section 905(j)(3).
FDA estimates the burden of this collection of information as
follows:
[[Page 27625]]
Table 1--Estimated Annual Reporting Burden \1\
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Average
Number of Number of Total annual burden per
21 CFR section and activity respondents responses per responses response (in Total hours
respondent \2\ hours)
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Sec. 1107.1(b) Optional Preparation of Tobacco Product Exemption From Substantial Equivalence Request
Including Sec. 25.40 Preparation of an Environmental Assessment
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Sec. 1107.1(b)--Preparation of 682 1 682 24 16,368
tobacco product exemption from
substantial equivalence request
and Sec. 25.40--Preparation
of an environmental assessment.
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Total Hours (Sec. .............. .............. .............. .............. 16,368
1107.1(b)).................
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Sec. 1107.1(c) Preparation of Additional Information for Tobacco Product Exemption From Substantial
Equivalence Request
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Sec. 1107.1(c)--Preparation of 150 1 150 3 450
additional information for
tobacco product exemption from
substantial equivalence request
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Total Hours (Sec. .............. .............. .............. .............. 450
1107.1(c)).................
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Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report submitted to demonstrate tobacco product
is modified under section 905(j)(3), modifications are to a product that is commercially marketed and compliant,
and modifications covered by exemptions granted by Secretary under section 905(j)(3)
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Abbreviated report submitted to 186 1 186 2 372
demonstrate tobacco product is
modified under section
905(j)(3), modifications are to
a product that is commercially
marketed and compliant, and
modifications covered by
exemptions granted by Secretary
under section 905(j)(3)........
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Total Hours (section .............. .............. .............. .............. 372
905(j)(1)(A)(ii)) of the
FD&C Act...................
Total Hours Exemptions From .............. .............. .............. .............. 17,190
Substantial Equivalence
Requirements...............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA estimates that we will receive 682 exemption requests under
Sec. 1107.1(b) for 24 hours per response including EA for a total of
16,368 hours. We have reduced the number of respondents from 812 to 682
based on the average number of applications received during the past 3
fiscal years. Since an EA is required for each Sec. 1107.1(b)
(Optional Preparation of Tobacco Product Exemption From Substantial
Equivalence Request), the burden per response for EAs (12 hours) has
been combined with the 12 hours for a substantial equivalence request
for a total of 24 hours per response.
FDA further estimates that we will receive 150 submissions
requiring additional information in support of the initial exemption
request, and it is expected that it will take an average of 3 hours to
prepare the additional information for a total of 450 hours.
FDA estimates that 186 respondents will prepare 186 responses and
each response will take approximately 2 hours to prepare, as required
by section 905(j)(1)(A)(ii) of the FD&C Act, for a total of 372 hours.
We have reduced the number of respondents as required by section
905(j)(1)(A)(ii) (abbreviated reports) from 1,217 to 186 based on the
average authorizations issued during the past 3 fiscal years. This
collection of information requires a manufacturer to submit a report at
least 90 days prior to making an introduction or delivery for
introduction into interstate commerce for commercial distribution of a
tobacco product. Section 905(j)(1)(A)(ii) of the FD&C Act states that
if an exemption has been requested and granted, the manufacturer must
submit to FDA a report that demonstrates that the tobacco product is
modified within the meaning of section 905(j)(3), the modifications are
to a product that is commercially marketed and in compliance with the
requirements of the FD&C Act, and all the modifications are covered by
exemptions granted by the Secretary under section 905(j)(3).
Our estimated burden for the information collection reflects an
overall decrease of 5,182 hours and 1,161 respondents. We attribute
this adjustment to the number of submissions we received over the past
few years. Therefore, FDA now estimates the burden for exemptions from
substantial equivalence requirements is 17,190 hours.
Dated: June 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11950 Filed 6-26-25; 8:45 am]
BILLING CODE 4164-01-P
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