Notice2022-17184
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exemptions From Substantial Equivalence Requirements for Tobacco Products
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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
August 10, 2022
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 87 Issue 153 (Wednesday, August 10, 2022)</title>
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[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48669-48671]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-17184]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1588]
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 September 9, 2022.
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 0910-0684. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#08585a495b7c696e6e486e6c692660607b266f677e"><span class="__cf_email__" data-cfemail="326260736146535454725456531c5a5a411c555d44">[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.
Exemptions From Substantial Equivalence Requirements for Tobacco
Products
OMB Control Number 0910-0684--Revision
On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act) (Pub. L. 111-31) was signed into law. The
Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding a chapter granting FDA important authority to
regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors.
The Consolidated Appropriations Act of 2022 (Pub. L. 117-103) (the
Appropriations Act), enacted on March 15, 2022, amended the definition
of the term ``tobacco product'' in section 201(rr) of the FD&C Act (21
U.S.C. 321(rr)) to include products that contain nicotine from any
source. As a result, non-tobacco nicotine (NTN) products that were not
previously subject to the FD&C Act (e.g., products containing synthetic
nicotine) are now subject to all of the tobacco product provisions in
the FD&C Act beginning on April 14, 2022, including the requirement of
premarket review for new tobacco products.
The FD&C Act, as amended by the Tobacco Control 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 (21 U.S.C. 387j(a)(2)(A)), 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
[[Page 48670]]
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 (21 U.S.C. 387e(j)(3)) 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; 42 U.S.C. 4332(2))
prepared in accordance with the requirements of Sec. 25.40 (21 CFR
25.40)).
The National Environmental Policy Act of 1969 (NEPA) (42 U.S.C.
4321-4347) states national environmental objectives and imposes upon
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 non-
excluded 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, 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).
Description of Respondents: The respondents to this collection of
information are tobacco product manufacturers defined as any person,
including any repacker or relabeler, who: (1) manufactures, fabricates,
assembles, processes, or labels a tobacco product; or (2) imports a
finished tobacco product for sale or distribution in the United States.
Section 1107.1(b) requires that the exemption request and
supporting information be submitted in an electronic format that FDA
can process, review, and archive. The exemption request and supporting
information must be legible and in English. These requirements ensure
that FDA can review the exemption request expeditiously and
appropriately. FDA provides information on its website on how
manufactures may provide electronic submissions and regulatory
correspondence, such as the exemption request and supporting
information, as well as the abbreviated report, to FDA (e.g.,
information on electronic media and methods of transmission). Steps on
how to prepare and the recommended structure of an exemption request
and abbreviated report can be found at: <a href="https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/exemption-substantial-equivalence">https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/exemption-substantial-equivalence</a>. Information on how to submit exemption requests and
abbreviated reports to the CTP Portal can be found here: <a href="https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal">https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal</a>.
FDA does not anticipate any need to submit an exemption request or
supporting information in a non-electronic format. However, a company
that is not able to submit the documentation in an electronic format
may submit a written request to the Center for Tobacco Products
document control center (<a href="https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/contact-ctp">https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/contact-ctp</a>).
In the Federal Register of February 25, 2022 (87 FR 10797), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment responsive to the four
information collection topics solicited was received. The comment
stated that the Agency should consider making the exemption request
pathway (section 905(j)(3) of the FD&C Act) more flexible for new
products, devices, and technology innovations.
FDA appreciates the comment and notes that although we may consider
the comment, these types of actions may necessitate guidance (as noted
in the comment). Currently, we believe that the exemption pathway is
providing applicants an efficient pathway to make additive changes to
their products and receive a marketing order. If the Agency decides to
consider revising the suggested actions, these types of actions would
need to be done pursuant to separate notice and comment procedures.
[[Page 48671]]
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
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Number of
21 CFR section and/or activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Sec. 1107.1(b); Optional 812 1 812 24 19,488
preparation of tobacco product
exemption from substantial
equivalence request; and Sec.
25.40; Preparation of an
environmental assessment.......
Sec. 1107.1(c); Preparation of 150 1 150 3 450
additional information for
tobacco product exemption from
substantial equivalence request
Abbreviated report submitted to 1,217 1 1,217 2 2,434
demonstrate: tobacco product is
modified under section
905(j)(3) of the FD&C Act,
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....................... .............. .............. .............. .............. 22,372
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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 812 exemption requests under
Sec. 1107.1(b) for 24 hours per response including EA for a total of
19,488 hours. 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 an exemption 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 1,217 respondents will prepare 1,217 responses
and each response will take approximately 2 hours to prepare an
abbreviated report, as required by section 905(j)(1)(A)(ii), for a
total of 2,434 hours. The estimates reflect a decrease of 1,217 hours
to account for a reduction in average response time for preparing an
abbreviated report. FDA provides a recommended format for applicants in
the exemption order letter that significantly reduces the burden hours
for preparing the abbreviated report. Therefore, FDA now estimates that
the hours for the collection of information associated with exemptions
from substantial equivalence requirements total 22,372 hours.
Although there may be year-to-year variability in the absolute
number of exemption requests submitted, FDA considers any trends in our
analysis, and the overall number of extension requests from
manufacturers of tobacco products has remained consistent.
Additionally, although manufacturers of NTN products are now subject to
all of the tobacco product provisions in the FD&C Act, including the
need to submit premarket submissions to FDA and obtain authorization
from the Agency to market their product, FDA expects to receive
premarket tobacco product applications for most currently marketed NTN
products. FDA does not expect to receive many exemption requests for
currently marketed NTN products. Thus, no additional adjustments to the
number of respondents in our burden estimate are needed for NTN
products as the current estimate accounts for some year-to-year
variability in the absolute number of exemption requests submitted.
Dated: August 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17184 Filed 8-9-22; 8:45 am]
BILLING CODE 4164-01-P
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