[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46501-46504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19913]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1588]


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: Submit either electronic or written comments on the collection 
of information by November 13, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 13, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:

[[Page 46502]]

     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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-2013-N-1588 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 https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     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 https://www.regulations.gov. 
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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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.

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: Under the PRA (44 U.S.C. 3501-3520), 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 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

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) 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)) of the FD&C Act). 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

[[Page 46503]]

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.
    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.  [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.
    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.  [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).
    FDA estimates the burden of this collection of information as 
follows:

                                 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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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.             ..............  ..............  ..............  ..............          19,218
     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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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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[[Page 46504]]

 
    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...................
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    Total Hours Exemptions From   ..............  ..............  ..............  ..............          23,871
     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: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19913 Filed 9-12-18; 8:45 am]
 BILLING CODE 4164-01-P


