[Federal Register Volume 90, Number 180 (Friday, September 19, 2025)]
[Notices]
[Pages 45221-45223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-18183]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0378]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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 https://www.reginfo.gov/public/do/PRAMain. 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 0910-0684. 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,
[email protected].
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 45222]]
Exemptions From Substantial Equivalence Requirements for Tobacco
Products
OMB Control Number 0910-0684 Extension
This information collection supports Food and Drug Administration
regulations. 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).
In the Federal Register of June 27, 2025 (90 FR 27623), 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:
[[Page 45223]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average burden
21 CFR section and activity Number of responses per Total annual per response Total hours
respondents respondent \2\ responses (in 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...................
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Total Hours Exemptions .............. .............. .............. .............. 17,190
From 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
years.
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 an Abbreviated
Report, as required by section 905(j)(1)(A)(ii) of the FD&C Act, with
each report taking approximately 2 hours to prepare 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 years.
Our estimated burden for the information collection reflects an
overall decrease of 5,182 hours and 1,161 total respondents. We
attribute this adjustment to the number of submissions we received over
the past 3 years. Therefore, FDA now estimates the burden for
exemptions from substantial equivalence requirements is 17,190 hours.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18183 Filed 9-18-25; 8:45 am]
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