[Federal Register Volume 75, Number 75 (Tuesday, April 20, 2010)]
[Notices]
[Pages 20606-20607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9134]
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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number to which the draft guidance document may be sent.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, [email protected].
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announced the availability of a draft guidance entitled ``Tobacco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,
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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]
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