[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]
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