[Federal Register Volume 76, Number 79 (Monday, April 25, 2011)]
[Notices]
[Pages 22903-22904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9939]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0125]
Draft Guidance for Industry and Food and Drug Administration
Staff; Establishing That a Tobacco Product Was Commercially Marketed in
the United States as of February 15, 2007; Availability; Agency
Information Collection Activities; Proposed Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Establishing That a Tobacco
Product Was Commercially Marketed in the United States as of February
15, 2007.'' This draft guidance provides information on how a
manufacturer may demonstrate that a tobacco product was commercially
marketed in the United States as of February 15, 2007. In this draft
guidance, FDA provides recommendations on the evidence that a
manufacturer may use to demonstrate that a tobacco product was
commercially marketed in the United States as of February 15, 2007.
This draft guidance is not final nor is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 24, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007'' to
the Center for Tobacco Products, Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850-3229. Send one self-addressed
adhesive label to assist that office in processing your request or
include a fax number to which the guidance document may be sent. See
the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance:
Annette Marthaler, Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-287-
1373, e-mail: [email protected].
With regard to the proposed collection of information: Jonna
Capezzuto, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-
796-3794, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance provides information on how a manufacturer may
establish that a tobacco product was commercially marketed in the
United States as of February 15, 2007. In this draft guidance, FDA
provides recommendations on the information that a manufacturer may use
to establish that a tobacco product was commercially marketed in the
United States on February 15, 2007, and is, therefore, a grandfathered
product not subject to premarket review requirements. In the draft
guidance document, FDA recommends that this information may include,
among other things, dated copies of advertisements, dated catalog
pages, and dated promotional material.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on
``Establishing That a Tobacco Product Was Commercially Marketed in the
United States as of February 15, 2007.'' It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.
III. Electronic Access
An electronic version of the draft guidance document is available
on the Internet at http://www.regulations.gov
[[Page 22904]]
and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
IV. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act (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 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.
Draft Guidance on Establishing That a Tobacco Product Was Commercially
Marketed in the United States as of February 15, 2007--(OMB Control
Number 0910-NEW)
This draft guidance provides information on how a manufacturer may
establish that a tobacco product was commercially marketed in the
United States as of February 15, 2007, and is, therefore, a
grandfathered product not subject to premarket review. The draft
guidance recommends that the manufacturer provide evidence that may
include, among other things, dated copies of advertisements, dated
catalog pages, dated promotional material, and dated bills of lading.
FDA recommends that the manufacturer submit as much information as
possible to demonstrate that the tobacco product was commercially
marketed in the United States as of February 15, 2007. FDA's estimate
of the number of respondents is based on the fact that requesting an
agency determination of the grandfathered status of a tobacco product
under the draft guidance is not required and also on indications of
interest in making such request. The number of hours is FDA's estimate
of how long it might take one to review, gather, and submit dated
information if making a request for an agency determination.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated One Time Reporting Burden \1\
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Annual
Activity Number of frequency per Total annual Hours per Total hours
respondents response responses response
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Submit evidence of commercial marketing in the United States as of 150 1 150 10 1,500
February 15, 2007.................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: April 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9939 Filed 4-22-11; 8:45 am]
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