[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Notices]
[Pages 26123-26125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11658]


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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: Fax written comments on the collection of information by July 5, 
2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 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.

Exemptions From Substantial Equivalence Requirements for Tobacco 
Products

OMB Control Number 0910-0684--Extension

    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 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, before the product may be 
introduced into commercial distribution (section 910 of the FD&C Act 
(21 U.S.C. 387j)).
    The Tobacco Control Act also gave FDA the authority to issue a 
regulation deeming all 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) (21 U.S.C. 387a(b))). On May 10, 2016, FDA issued 
that rule, extending FDA's tobacco product authority to all products 
that meet the definition of tobacco product in the law (except for 
accessories of newly regulated tobacco products), including electronic 
nicotine delivery systems, cigars, hookah, pipe tobacco, nicotine gels, 
dissolvables that were not already subject to the FD&C Act, and other 
tobacco products that may be developed in the future (81 FR 28974 at 
28976, May 10, 2016) (``the final deeming rule'')).
    FDA has established a pathway for manufacturers to request 
exemptions from the substantial equivalence requirements of the FD&C 
Act in Sec.  [thinsp]1107.1 (21 CFR 1107.1) of the Agency's 
regulations. As described in Sec.  [thinsp]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.

[[Page 26124]]

    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) prepared in accordance 
with the requirements of Sec.  [thinsp]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.
    FDA's 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.  [thinsp]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.
    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 September 13, 2018 (83 FR 46501) FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two PRA related comments were received, 
which inquired about how FDA formulated the PRA estimates. In response 
to the questions related to the PRA estimates, these estimates are 
based on our experience. To date, the annual number of exemption 
requests has been lower than the estimate of 812 respondents in this 
notice (https://www.accessdata.fda.gov/scripts/fdatrack/view/track.cfm?program=ctp&id=%20CTP-OS-total-exemption-from-SE-since-Program-Inception), but the Agency expects that the number of exemption 
requests could increase as applicants begin to submit such requests for 
tobacco products subject to the final deeming rule. The estimated 
number of respondents is intended to reflect that potential. As noted 
in the comments, the exemption request is anticipated to take less time 
than the other premarket applications, and FDA believes that 24 hours 
average burden per response reflects the experience to date.
    Along with commenting on the PRA estimates, these comments also 
state that the Agency should provide additional details on exemption 
requests and develop categories of exemptions. FDA appreciates these 
comments but notes that consideration of such new processes is outside 
the scope of the present information collection. FDA will continue to 
consider these comments as appropriate in future rulemakings.
    FDA estimates the burden of this collection of information as 
follows:

                                 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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21 CFR 1107.1(b)--Preparation of             812               1             812              24          19,488
 tobacco product exemption from
 substantial equivalence request
 and 21 CFR 25.40--Preparation
 of an environmental assessment.
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    Total Hours (Sec.             ..............  ..............  ..............  ..............          19,488
     1107.1(b)).................
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[[Page 26125]]

 
      Sec.   1107.1(c) Preparation of Additional Information for Tobacco Product Exemption From Substantial
                                               Equivalence Request
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21 CFR 1107.1(c)--Preparation of             244               1             244               3             732
 additional information for
 tobacco product exemption from
 substantial equivalence request
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    Total Hours (Sec.             ..............  ..............  ..............  ..............             732
     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             1217               1            1217               3           3,651
 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          ..............  ..............  ..............  ..............           3,651
     905(j)(1)(A)(ii)) of the
     FD&C Act...................
                                 -------------------------------------------------------------------------------
        Total Hours Exemptions    ..............  ..............  ..............  ..............          23,871
         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 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 SE request for a total of 24 
hours per response.
    FDA further estimates that we will receive 244 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 732 hours.
    FDA estimates that 1,217 respondents will prepare 1,217 responses 
and each response will take approximately 3 hours to prepare, as 
required by section 905(j)(1)(A)(ii) of the FD&C Act, for a total of 
3,651 hours.
    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). FDA 
estimates the total hours for exemptions from Substantial Equivalence 
Requirements will be 23,871 hours.
    FDA's estimates are based on full analysis of economic impacts and 
information gathered from other FDA-regulated products. Based on a 
review of the currently approved information collection, we have made 
no adjustments to our burden estimate.

    Dated: May 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11658 Filed 6-4-19; 8:45 am]
BILLING CODE 4164-01-P