Document ID: FDA-2009-D-0563-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products Under the Federal Food, Drug, and Cosmetic Act; Availability
Posted Date: 2009-11-27T05:00Z

[Federal Register: November 27, 2009 (Volume 74, Number 227)]
[Notices]               
[Page 62329-62330]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27no09-75]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0563]

 
Draft Guidance for Industry and Food and Drug Administration 
Staff; Preliminary Timetable for the Review of Applications for 
Modified Risk Tobacco Products Under the Federal Food, Drug, and 
Cosmetic Act; 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availability of a draft guidance entitled ``Preliminary Timetable for 
the Review of Applications for Modified Risk Tobacco Products under the 
Federal Food, Drug, and Cosmetic Act.'' This guidance is intended for 
manufacturers, retailers, importers, and FDA staff. The guidance 
describes FDA's current thinking regarding the appropriate preliminary 
timetable for its review of applications for Modified Risk Tobacco 
Products (MRTPs) under the Federal Food, Drug, and Cosmetic Act (the 
act), as modified by the Federal Smoking Prevention and Tobacco Control 
Act (Tobacco Control Act).

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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by February 25, 2010.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Preliminary Timetable for the Review of 
Applications for Modified Risk Tobacco Products under the Federal Food, 
Drug, and Cosmetic Act'' 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processing your request or include a fax number to which the draft 
guidance document may be sent. See the

[[Page 62330]]

SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.
    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. 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, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 240-276-1717, annette.marthaler@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Tobacco Control Act 
(Public Law 111-31) into law. The Tobacco Control Act amended the act 
(21 U.S.C. 301 et seq.) by, among other things, adding a new chapter 
granting FDA important new authority to regulate the manufacture, 
marketing, and distribution of tobacco products to protect the public 
health generally and to reduce tobacco use by minors.
    Section 911 of the act, as amended by the Tobacco Control Act, 
states: ``(a) No person may introduce or deliver for introduction into 
interstate commerce any modified risk tobacco product unless an order 
issued pursuant to subsection (g) is effective with respect to such 
product'' and ``(d) Any person may file with the Secretary an 
application for a modified risk tobacco product.* * *.'' Section 911(g) 
of the act provides the criteria under which the agency determines 
whether to issue an order that an MRTP may be commercially marketed. 
The Tobacco Control Act provides that, within 2 years and 9 months of 
the enactment of the Tobacco Control Act, the agency shall issue 
regulations or guidance regarding MRTP applications, and those 
regulations or guidance shall ``establish a reasonable timetable for 
the Secretary to review an application under this section.'' FDA is 
issuing this guidance to describe a preliminary timetable the agency 
intends to follow until such time as the agency issues more 
comprehensive guidance or regulations on MRTP applications. Pending 
further guidance or rulemaking, FDA intends to issue a decision on an 
MRTP application within 360 days of its receipt by FDA.

II. Significance of Guidance

    FDA is issuing this draft guidance document 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 
``Preliminary Timetable for the Review of Applications for Modified 
Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act.'' 
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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The guidance document and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

IV. 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: November 24, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28515 Filed 11-24-09; 4:15 pm]

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