Document ID: FDA-2011-D-0147-0022
Agency: fda
Document Type: Notice
Title: Demonstrating the Substantial Equivalence of a New Tobacco
Product: Responses to Frequently Asked Questions; Second Edition;
Guidance for Industry; Availability
Posted Date: 2015-09-08T04:00Z

[Federal Register Volume 80, Number 173 (Tuesday, September 8, 2015)]
[Notices]
[Pages 53810-53811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22494]

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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; Second Edition; 
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 a second 
edition of the guidance for industry entitled ``Demonstrating the 
Substantial Equivalence of a New Tobacco Product: Responses to 
Frequently Asked Questions''. FDA is issuing the second edition to 
provide further information on demonstrating substantial equivalence 
(SE) of a new tobacco product, including demonstrating SE when the new 
tobacco product has: A modified label that renders it distinct from, 
but has identical characteristics to, a valid predicate product; or a 
change in product quantity from, but where the per weight composition 
is identical to, a valid predicate product.

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

ADDRESSES: All communications in response to this notice should be 
identified with Docket No. FDA-2011-D-0147. 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.

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, CTPRegulations@fda.hhs.gov, or 
annette.marthaler@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of the second edition of the 
guidance for industry entitled ``Demonstrating the Substantial 
Equivalence of a New Tobacco Product: Responses to Frequently Asked 
Questions'' (second edition SE FAQ guidance). We are issuing this 
guidance consistent with our good guidance practices regulation (21 CFR 
10.115).
    In September 2011, FDA issued draft guidance responding to 
frequently asked questions covering a range of topics on demonstrating 
the SE of a new tobacco product (September 9, 2011, 76 FR 55927). In 
March 2015, FDA issued a final guidance on many of the topics included 
in the September 2011 draft ((March 5, 2015, 80 FR 12011) (March 2015 
FAQ guidance)). In May 2015, FDA announced that an interim enforcement 
policy would be in effect while it considered comments submitted on the 
March 2015 FAQ guidance. This interim enforcement policy will continue 
to be in effect for 30 days from the date of issuance of the

[[Page 53811]]

second edition SE FAQ guidance. Based on the comments received on the 
September 2011 draft guidance and the March 2015 final guidance, we are 
now issuing the second edition FAQ final guidance.
    The second edition FAQ guidance describes FDA's current thinking on 
whether and when a change to a tobacco product's label, product 
quantity in the package, additives, or specifications renders that 
product a ``new tobacco product'' subject to premarket review. It 
explains that a manufacturer may submit streamlined SE reports for 
certain modifications to labels and changes to product quantity. The 
guidance also explains FDA's plans and processes for review of the 
streamlined SE reports. Finally, this guidance responds to several 
questions that have been raised about the SE process more generally.
    The guidance represents the current thinking of FDA on this topic. 
It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies 
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved information 
collections. 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, 
respectively), as amended by the Tobacco Control Act (Pub. L. 111-31), 
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.

III. Comments

A. General Information About Submitting 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.

B. Public Availability of Comments

    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. As a matter of Agency 
practice, FDA generally does not post comments submitted by individuals 
in their individual capacity on http://www.regulations.gov. This is 
determined by information indicating that the submission is written by 
an individual, for example, the comment is identified with the category 
``Individual Consumer'' under the field titled ``Category (Required),'' 
on the ``Your Information'' page on http://www.regulations.gov. For 
this document, however, FDA will not be following this general 
practice. Instead, FDA will post on http://www.regulations.gov comments 
to this docket that have been submitted by individuals in their 
individual capacity. If you wish to submit any information under a 
claim of confidentiality, please refer to 21 CFR 10.20.

C. Information Identifying the Person Submitting the Comment

    Please note that your name, contact information, and other 
information identifying you will be posted on http://www.regulations.gov if you include that information in the body of your 
comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the body of your comment on http://www.regulations.gov along with your state/province and country (if 
provided), the name of your representative (if any), and the category 
identifying you (e.g., individual, consumer, academic, industry). For 
written submissions submitted to the Division of Dockets Management, 
FDA will post the body of your comments on http://www.regulations.gov, 
but you can put your name and/or contact information on a separate 
cover sheet and not in the body of your comments.

IV. Electronic Access

    Persons with access to the Internet may obtain an electronic 
version of the guidance at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: August 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22494 Filed 9-4-15; 8:45 am]
BILLING CODE 4164-01-P