[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55927-55928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23100]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0147]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Demonstrating the Substantial Equivalence of a New Tobacco 
Product: Responses to Frequently Asked Questions; 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availability of the draft guidance entitled ``Demonstrating the 
Substantial Equivalence of a New Tobacco Product: Responses to 
Frequently Asked Questions.'' This draft guidance provides responses to 
questions FDA has received on the Family Smoking Prevention and Tobacco 
Control Act's (Tobacco Control Act) provisions on new tobacco products 
and substantial equivalence, including questions on changes to 
packaging and labeling. This draft guidance is not final nor is it in 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 8, 2011.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov.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.
    Submit written requests for single copies of the draft guidance 
document entitled ``Demonstrating the Substantial Equivalence of a New 
Tobacco Product: Responses to Frequently Asked Questions'' 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.

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, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance provides responses to questions we have 
received on the Federal Food, Drug, and Cosmetic Act's (the FD&C Act) 
provisions on new tobacco products and

[[Page 55928]]

substantial equivalence (sections 905(j) and 910 of the FD&C Act, as 
amended by the Tobacco Control Act (21 U.S.C. 387e(j) and 387j)). In 
this draft guidance, FDA provides responses to questions related to the 
submission of 905(j) (substantial equivalence) reports in specific 
scenarios, including questions on whether changes to packaging and 
labeling and changes to additive specifications should be submitted in 
a 905(j) report to the Center for Tobacco Products. The draft guidance 
also provides information about discussing submissions.

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 
``Demonstrating the Substantial Equivalence of a New Tobacco Product: 
Responses to Frequently Asked Questions.'' 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 and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 
collections of information in sections 905(j) and 910 of the FD&C Act, 
as amended by the Tobacco Control Act have been approved under OMB 
control number 0910-0673; the collections of information in 21 CFR part 
25 have been approved under OMB control number 0910-0322.

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: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23100 Filed 9-8-11; 8:45 am]
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