
[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Notices]
[Pages 34756-34758]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14253]


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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; Tobacco Products, 
Exemptions From Substantial Equivalence Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 34757]]

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 
18, 2014.

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 oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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.

Tobacco Products, Exemptions From Substantial Equivalence 
Requirements--(OMB Control Number 0910-0684)--Extension

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 
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 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).
    In the Federal Register of December 19, 2013 (78 FR 76838), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of

[[Page 34758]]

information. Six comment submissions were received, some of which 
included multiple comments.
    (Comment) Regarding the clarity of information collected, several 
comments indicated some confusion between the information being 
collected and the information needed to support an exemption request.
    (Response) Section 1107.1(a) sets out the general requirements for 
requesting an exemption, but a manufacturer will need to determine how 
to meet the requirements for any of its new products that use the 
pathway. FDA intends to consider issuing a regulation or guidance to 
further clarify terms as experience is gained with the pathway.
    (Comment) A few comments questioned the quality of the information 
being requested.
    (Response) We disagree that the information required in an 
exemption request is not sufficient. We believe the information 
requested is what FDA needs to make a determination on an exemption 
request. Furthermore, several commenters also agreed with the 
sufficiency of the information needed to support an exemption request.
    (Comment) Many comments addressed the accuracy of FDA's estimate of 
the burden for requesting a modification to an exemption request and 
questioned whether this burden was underestimated. Additionally, there 
was reference to the submittal of duplicative information.
    (Response) FDA disagrees with these comments. We believe the burden 
estimates are appropriate and reflect the information needed by FDA 
when reviewing an exemption request. FDA also disagrees that there is 
duplicative information requested. The regulations implement the 
requirements of the FD&C Act for the exemption pathway to market. The 
commenters may be referring to the other notification and reporting 
requirements related to additives, such as those in section 904(c) of 
the FD&C Act (21 U.S. C. 387d(c)), but those requirements are not in 
the scope of this information collection.
    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
                                Activity                                     Number of     responses per   Total annual    per response     Total hours
                                                                            respondents     respondent       responses      (in hours)
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21 CFR 1107.1(b): Preparation of tobacco product exemption from                      500               1             500              12           6,000
 substantial equivalence request........................................
21 CFR 1107.1(c): Preparation of additional information for tobacco                  150               1             150               3             450
 product exemption from substantial equivalence request.................
21 CFR 25.40: Preparation of an environmental assessment................             500               1             500              12           6,000
Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report               750               1             750               3           2,250
 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 covered by exemptions granted
 by Secretary pursuant to section 905(j)(3).............................
                                                                         -------------------------------------------------------------------------------
    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 (21 U.S.C. 
387g). FDA's estimates are based on experience with and information on 
other FDA-regulated products and indications from industry.

    Dated: June 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14253 Filed 6-17-14; 8:45 am]
BILLING CODE 4164-01-P


