Document ID: FDA-2009-D-0600-0012
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Tobacco Health Document Submission; Availability
Posted Date: 2010-04-20T04:00Z

[Federal Register: April 20, 2010 (Volume 75, Number 75)]
[Notices]               
[Page 20606-20607]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ap10-70]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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 guidance entitled ``Tobacco Health Document 
Submission.'' The guidance document is intended to assist persons 
making certain document submissions to FDA under the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act).

DATES:  Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES:  Submit written requests for single copies of the 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number to which the draft guidance document may be sent. See the 
SUPPLEMENTARY INFORMATION section for information on 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:  Beth Buckler, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 1-877-287-1373, Beth.Buckler@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 28, 2009 (74 FR 68629), FDA 
announced the availability of a draft guidance entitled ``Tobacco 
Health Document Submission.'' The agency considered received comments 
as it finalized this guidance. The guidance document is intended to 
assist persons making certain document submissions to FDA under the 
Tobacco Control Act (Public Law 111-31).
    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,

[[Page 20607]]

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, 2010, all documents described 
in section 904(a)(4) of the act developed between June 22, 2009 and 
December 31, 2009.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 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 guidance contains information collection provisions that 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 
collection(s) of information in this guidance was approved under OMB 
control number 0910-0654.

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: April 15, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9134 Filed 4-16-10; 11:15 am]
BILLING CODE 4160-01-S