[Federal Register Volume 78, Number 244 (Thursday, December 19, 2013)]
[Notices]
[Pages 76838-76840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30137]


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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; Tobacco Products, Exemptions From Substantial 
Equivalence Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the

[[Page 76839]]

proposed collection of certain information by the Agency. Under the 
Paperwork Reduction Act of 1995 (the 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 February 18, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [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 (the 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, a manufacturer must submit a 
premarket application to FDA, and FDA must issue an order finding that 
the new product may be introduced or delivered for introduction into 
interstate commerce (section 910 of the FD&C Act (21 U.S.C. 387j)). An 
order under section 910 is not required, however, if a manufacturer 
submits a report under section 905(j) of the FD&C Act (21 U.S.C. 
387e(j) demonstrating the new tobacco product's substantial equivalence 
to an appropriate predicate product, and FDA issues an order finding 
the new product to be substantially equivalent to the predicate product 
and in compliance with the requirements of the FD&C Act.
    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 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; (2) a report demonstrating substantial equivalence 
is not necessary 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 company 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.  25.40.
    The National Environmental Policy Act (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

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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.  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 1107.1(d) provides that FDA may rescind an exemption where 
necessary to protect the public health.
    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 pursuant to 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
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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21 CFR 1107.1(b): Preparation of             500               1             500              12           6,000
 tobacco product exemption from
 substantial equivalence request
21 CFR 1107.1(c): Preparation of             150               1             150               3             450
 additional information for
 tobacco product exemption from
 substantial equivalence request
21 CFR 25.40: Preparation of an              500               1             500              12           6,000
 environmental assessment.......
Section 905(j)(1)(A)(ii) of the              750               1             750               3           2,250
 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 product, and
 modifications are covered by
 exemptions granted by Secretary
 pursuant to section 905(j)(3)..
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    Total.......................  ..............  ..............  ..............  ..............          14,700
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that 500 requests for exemption will be submitted 
annually, and that it will take approximately 12 hours to prepare an 
exemption request. FDA also estimates that up to 30 percent (150) of 
the initial requests for information may require 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. 
FDA also estimates that 750 manufacturers will take approximately 12 
hours to prepare and submit an EA under part 25 in accordance with the 
requirements of Sec.  25.40, as referenced in Sec.  1107.1(b)(9).
    FDA estimates that 750 respondents will take 3 hours to prepare a 
report under section 905(j)(1)(A)(ii) of the FD&C Act, which requires a 
manufacturer to submit a report at least 90 days prior to making an 
introduction or delivery into interstate commerce for commercial 
distribution of a tobacco product. The report will contain the 
manufacturer's basis that the tobacco product is modified within the 
meaning of section 905(j)(3) of the FD&C Act, the modifications are to 
a product that is commercially marketed and compliant with the FD&C 
Act, the modifications are covered by exemptions granted pursuant to 
section 905(j)(3), and a listing of actions taken to comply with any 
applicable requirements of section 907 of the FD&C Act. FDA's estimates 
are based on experience with and information on other FDA-regulated 
products and indications from industry.

    Dated: December 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30137 Filed 12-18-13; 8:45 am]
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