
[Federal Register: December 21, 2009 (Volume 74, Number 243)]
[Notices]               
[Page 67877-67878]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21de09-41]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0588]

 
Guidance for Industry on the Timeframe for Submission of Tobacco 
Health Documents; 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 guidance entitled ``Timeframe for Submission of 
Tobacco Health Documents.'' This document provides written guidance to 
tobacco product manufacturers and importers on enforcement of the 
requirement to submit certain documents to FDA under the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act).

DATES: The guidance is final upon the date of publication. However, you 
may submit electronic or written comments on the guidance at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Timeframe for Submission of Tobacco Health 
Documents'' 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

[[Page 67878]]

electronic access to the guidance document.
    Submit electronic comments to http://www.regulations.gov. 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. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Michele Mital, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 240-276-1717, Michele.Mital@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 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.) 
by 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 904(a)(4) of the act requires each tobacco product 
manufacturer or importer, or agent thereof, to submit all documents 
developed after June 22, 2009, ``that relate to health, toxicological, 
behavioral, or physiologic effects of current or future tobacco 
products, their constituents (including smoke constituents), 
ingredients, components, and additives.'' Information required under 
section 904(a)(4) of the act must be submitted to FDA beginning 
December 22, 2009. FDA recognizes the challenges associated with the 
collection, review, organization, and production of documents. We also 
recognize that additional time may be necessary for the production of 
documents in a digital format, which FDA strongly encourages in order 
to improve the management and readability of submitted documents. 
Therefore, FDA does not intend to enforce the December 22, 2009, 
initial document submission deadline, provided that manufacturers and 
importers submit by April 30, 2010, all documents described in section 
904(a)(4) of the act developed between June 23, 2009, and March 31, 
2010. FDA is in the process of developing a draft guidance document 
that will explain the requirements of and recommendations for 
compliance with section 904(a)(4) of the act. We anticipate that the 
draft guidance document will be issued shortly.

II. Significance of Guidance

    FDA is issuing this guidance document as a level 1 guidance 
consistent with FDA's good guidance practices regulation (Sec.  10.115 
(21 CFR 10.115)). This guidance document is being implemented 
immediately without prior public comment, under Sec.  10.115(g)(2), 
because the agency has determined that prior public participation is 
not feasible or appropriate. This document provides guidance on 
statutory requirements that are due to take effect on December 22, 
2009, and so it is urgent that FDA explain its enforcement policy 
before that date.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written 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. 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: December 16, 2009.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning, and Budget.
[FR Doc. E9-30297 Filed 12-16-09; 4:15 pm]

BILLING CODE 4160-01-S
