Document ID: FDA-2014-D-0800-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Substantial Equivalence Reports;
Manufacturer Requests for Extensions or To Change the Predicate Tobacco Product; Availability
Posted Date: 2014-07-15T04:00Z

[Federal Register Volume 79, Number 135 (Tuesday, July 15, 2014)]
[Notices]
[Page 41292]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16562]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0800]

Draft Guidance for Industry on Substantial Equivalence Reports; 
Manufacturer Requests for Extensions or To Change the Predicate Tobacco 
Product; 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availability of a draft guidance entitled ``Substantial Equivalence 
Reports: Manufacturer Requests for Extensions or To Change the 
Predicate Tobacco Product.'' This draft guidance provides information 
to tobacco product manufacturers about FDA's policies on manufacturer 
requests for extensions of time to respond to deficiencies that FDA has 
identified, and manufacturer requests to change the predicate tobacco 
product, in substantial equivalence (SE) reports.

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 on 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 15, 2014.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Center for Tobacco Products, Food and Drug 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 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: 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: CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for tobacco 
product manufacturers entitled ``Substantial Equivalence Reports: 
Manufacturer Requests for Extensions or To Change the Predicate Tobacco 
Product.'' During the review of an SE report, the Center for Tobacco 
Products (CTP) may issue a scientific advice/information letter or 
preliminary finding letter to a manufacturer highlighting deficiencies 
of the SE report (deficiency letter). In response to those letters, 
some manufacturers have requested an extension of time to respond to 
the deficiencies or have indicated they may change the predicate 
tobacco product identified in the SE report. In this draft guidance, 
FDA provides information to tobacco product manufacturers about CTP's 
policies on manufacturer requests for extensions of time to respond to 
deficiencies CTP has identified, and manufacturer requests to change 
the predicate tobacco product.
    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 
``Substantial Equivalence Reports: Manufacturer Requests for Extensions 
or To Change the Predicate Tobacco Product.'' 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 statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. 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 have 
been approved under OMB control number 0910-0673.

III. 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.

IV. Electronic Access

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

    Dated: July 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16562 Filed 7-14-14; 8:45 am]
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