[Federal Register Volume 76, Number 15 (Monday, January 24, 2011)]
[Notices]
[Pages 4116-4117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1276]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0044]


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; Section 905(j) 
Reports: Demonstrating Substantial Equivalence for Tobacco Products.

DATES: Submit either electronic or written comments on the collection 
of information by March 25, 2011.

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: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr. PI50-400B, 
Rockville, MD 20850. 301-796-3794. [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.

Information Request Regarding Guidance for Industry and FDA Staff; 
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 
important new 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 authorizes FDA to establish the form 
for the submission of information related to

[[Page 4117]]

substantial equivalence (21 U.S.C. 387e(j)). 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.

Estimation of Burden

    FDA estimates the burden for this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
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                                                      Annual
        FD&C Act sections            Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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905(j) and 910(a)...............             150               1             150             360          54,000
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Total...........................  ..............  ..............  ..............  ..............          54,000
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There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA has based these estimates on information related to other 
regulated products and FDA's expectations regarding the tobacco 
industry's use of the 905(j) pathway to market their products. Table 1 
of this document 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. 387e(j) and 
387j(a)). FDA estimates that it will receive 150 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 54,000 hours.

    Dated: January 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1276 Filed 1-21-11; 8:45 am]
BILLING CODE 4160-01-P