
[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Notices]
[Pages 78974-78975]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30880]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1558]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry and Food and Drug Administration 
Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence 
for Tobacco Products

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 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 the information request 
regarding the guidance for industry and FDA staff entitled ``Section 
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco 
Products.''

DATES: Submit either electronic or written comments on the collection 
of information by February 25, 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, PRAStaff@fda.hhs.gov.

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

[[Page 78975]]

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.

Information Request Regarding Guidance for Industry and FDA Staff on 
Section 905(j) Reports: Demonstrating Substantial Equivalence for 
Tobacco Products (OMB Control Number 0910-0673--Extension)

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (the 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 new chapter granting FDA 
authority to regulate the manufacture, marketing, and distribution of 
tobacco products to protect the public health generally and to reduce 
tobacco use by minors. Section 905(j) of the FD&C Act (21 U.S.C. 
387e(j)) authorizes FDA to establish the form for the submission of 
information related to substantial equivalence. In a Level 1 guidance 
document issued under the Good Guidances Practices regulation (21 CFR 
10.115), FDA provides recommendations intended to assist persons 
submitting reports under section 905(j) of the FD&C Act and explains, 
among other things, FDA's interpretation of the statutory sections 
related to substantial equivalence.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                         FD&C act sections                              Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses       per response
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905(j)(1)(A)(i) and 910(a).........................................           1,000                1            1,000              360          360,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA has based these estimates on information it now has available 
from interactions with the industry, information related to other 
regulated products, and FDA's expectations regarding the tobacco 
industry's use of the section 905(j) pathway to market their products. 
Table 1 describes the annual reporting burden as a result of the 
implementation of the substantial equivalence requirements of sections 
905(j) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)). FDA estimates 
that it will receive 1,000 section 905(j) reports each year and that it 
will take a manufacturer approximately 360 hours to prepare a report of 
substantial equivalence for a new tobacco product. Therefore, FDA 
estimates the burden for submission of substantial equivalence 
information will be 360,000 hours.

    Dated: December 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30880 Filed 12-26-13; 8:45 am]
BILLING CODE 4160-01-P


