[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Notices]
[Page 9396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02861]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-1083]
Draft Guidance for Industry and Food and Drug Administration
Staff; Civil Money Penalties for Tobacco Retailers: Responses to
Frequently Asked Questions; 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availability of a draft guidance for industry entitled ``Civil Money
Penalties for Tobacco Retailers: Responses to Frequently Asked
Questions.'' This draft guidance provides responses to questions FDA
has received regarding the issuance of civil money penalties for
violations of regulations issued under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) relating to tobacco products in retail outlets.
This draft guidance is not final nor is it in effect at this time.
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draft guidance before it begins work on the final version of the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 either electronic or written comments on the draft by
April 9, 2013.
ADDRESSES: Submit written requests for single copies of the guidance
entitled ``Civil Money Penalties for Tobacco Retailers: Responses to
Frequently Asked Questions'' 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
electronic access to the guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Gerie Voss, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1-877-287-1373, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance provides responses to questions FDA has
received regarding the issuance of civil money penalties for violations
of regulations issued under the FD&C Act relating to tobacco products
in retail outlets. In this draft guidance, FDA provides responses to
questions relating to civil money penalties for violations of the
requirement that tobacco products may not be sold or distributed in
violation of FDA's ``Regulations Restricting the Sale and Distribution
of Cigarettes and Smokeless Tobacco to Protect Children and
Adolescents'' (75 FR 13225, March 19, 2010, codified at 21 CFR part
1140). This draft guidance also provides additional information
regarding the complaint procedure used for civil money penalties.
II. Significance of Guidance
This draft guidance is being issued 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 ``Civil
Money Penalties for Tobacco Retailers: Responses to Frequently Asked
Questions.'' 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 either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.
IV. Electronic Access
An electronic version of the draft guidance document is available
on the Internet at http://www.regulations.gov and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: February 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02861 Filed 2-7-13; 8:45 am]
BILLING CODE 4160-01-P