[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Page 12011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Demonstrating the Substantial Equivalence of a New Tobacco 
Product: Responses to Frequently Asked Questions; Guidance for 
Industry; 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 for industry entitled ``Demonstrating the 
Substantial Equivalence of a New Tobacco Product: Responses to 
Frequently Asked Questions.'' This guidance provides information in 
response to questions that FDA has received from manufacturers on 
demonstrating the substantial equivalence of a new tobacco product, 
including questions on when a modification to the label requires a 
premarket submission and review by FDA.

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 ``Demonstrating the Substantial Equivalence of a New 
Tobacco Product: Responses to Frequently Asked Questions'' 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, <a href="/cdn-cgi/l/email-protection#a0e3f4f0f2c5c7d5ccc1d4c9cfced3e0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="0a495e5a586f6d7f666b7e636564794a6c6e6b24626279246d657c">[email protected]</span></a>, email: 
<a href="/cdn-cgi/l/email-protection#8eefe0e0ebfafaeba0e3effcfae6efe2ebfccee8eaefa0e6e6fda0e9e1f8"><span class="__cf_email__" data-cfemail="89e8e7e7ecfdfdeca7e4e8fbfde1e8e5ecfbc9efede8a7e1e1faa7eee6ff">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Demonstrating the Substantial Equivalence of a New Tobacco 
Product: Responses to Frequently Asked Questions.'' In this guidance, 
FDA addresses questions from manufacturers on demonstrating the 
substantial equivalence of a new tobacco product. In the Federal 
Register of September 9, 2011 (76 FR 55927), FDA announced the 
availability of the draft guidance of the same title. After carefully 
reviewing and considering comments and information submitted in 
response to the draft guidance, which covered a range of topics on 
demonstrating the substantial equivalence of a new tobacco product, FDA 
is finalizing this guidance on many of the topics, including 
modifications to labels and changes to product quantity and intends to 
address the other topics in future regulatory documents.

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 refers to previously approved information collections 
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 (21 U.S.C. 
387e(j) and 387j), 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.

IV. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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

    Persons with access to the Internet may obtain the document at 
either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: February 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05023 Filed 3-4-15; 8:45 am]
 BILLING CODE 4164-01-P


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