[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Draft Guidance for Industry and Food and Drug Administration 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availability of a draft guidance entitled ``Establishing That a Tobacco 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 This draft guidance provides information on how a 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 In this draft 
guidance, FDA provides recommendations on the evidence that a 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This draft guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 24, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Establishing That a Tobacco Product Was 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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]
BILLING CODE 4160-01-P