[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]
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