[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Notices]
[Page 58358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-23058]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0125]


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: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Establishing That a Tobacco 
Product Was Commercially Marketed in the United States as of February 
15, 2007.'' This 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. The guidance includes a 
description of the types of evidence recommended to demonstrate that a 
tobacco product was commercially marketed in the United States as of 
February 15, 2007.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the 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, Document 
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002. 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 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: Annette Marthaler, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, Bldg. 
71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
1-877-287-1373, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Establishing That a Tobacco Product Was Commercially 
Marketed in the United States as of February 15, 2007.'' In this 
guidance, FDA provides recommendations on how a manufacturer can 
demonstrate that a tobacco product was commercially marketed (other 
than exclusively in test markets) in the United States as of February 
15, 2007. In the guidance document, FDA refers to tobacco products that 
were commercially marketed (other than exclusively in test markets) in 
the United States as of February 15, 2007, as grandfathered tobacco 
products. Grandfathered tobacco products are not considered new tobacco 
products and thus are not subject to the premarket requirements of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (section 910; 21 U.S.C. 
387j). A grandfathered tobacco product may serve as the predicate 
tobacco product in a 905(j) report (demonstrating substantial 
equivalence) for a new tobacco product (section 905(j)(1)A)(i) of the 
FD& C Act, 21 U.S.C. 387e(j)(1)(A)(i)). FDA recommends that information 
supporting a grandfather designation may include, among other things, 
dated copies of advertisements, dated catalog pages, and dated 
promotional material.
    In the Federal Register of April 25, 2011 (76 FR 22903), FDA 
announced the availability of the draft guidance of the same title. 
After considering the comments on the draft guidance, FDA made minor 
editorial changes to improve clarity.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on this topic. 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. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control number 0910-0775.

IV. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of 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, and will be posted to the docket at http://www.regulations.gov.

V. Electronic Access

    An electronic version of the guidance document is available on the 
Internet at http://www.regulations.gov and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23058 Filed 9-26-14; 8:45 am]
BILLING CODE 4160-01-P