Document ID: FDA-2013-N-1588-0017
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Exemptions From
Substantial Equivalence Requirements for Tobacco Products
Posted Date: 2022-08-10T04:00Z

[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48669-48671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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: 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, 
[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.

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: https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/exemption-substantial-equivalence. Information on how to submit exemption requests and 
abbreviated reports to the CTP Portal can be found here: https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal.
    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 (https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/contact-ctp).
    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)........
                                 -------------------------------------------------------------------------------
    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