
[Federal Register: December 28, 2009 (Volume 74, Number 247)]
[Notices]               
[Page 68629]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de09-80]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0600]

 
Draft Guidance for Industry on Tobacco Health Document 
Submission; 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availability of a draft guidance document entitled ``Tobacco Health 
Document Submission.'' The draft guidance is intended to assist persons 
making certain document submissions to FDA under the Family 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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 January 22, 2010.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Tobacco Health Document Submission'' to 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include a fax number to which the draft guidance document may be sent.
    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. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: May Nelson, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 240-276-1717, May.Nelson@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, 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 904(a)(4) of the act, as amended by the Tobacco Control 
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 
accessibility of submitted documents. Therefore, FDA does not intend to 
enforce the December 22, 2009, deadline provided you submit by April 
30, 2009, all documents described in section 904(a)(4) of the act 
developed between June 23, 2009, and March 31, 2010.

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 
``Tobacco Health Document Submission.'' 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 draft 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. Paperwork Reduction Act of 1995

    This draft guidance contains proposed collections of information 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
As required by the PRA, FDA has published an analysis of, among other 
information collections, the information collection concerning the 
submission of tobacco health documents (74 FR 45219, September 1, 2009, 
as corrected by 74 FR 47257, September 15, 2009) and will submit them 
for OMB approval.

V. 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 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-30657 Filed 12-22-09; 8:45 am]

BILLING CODE 4160-01-S
