Document ID: FDA-2012-D-1083-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; Civil Responses to Frequently Asked
Posted Date: 2013-02-08T05:00Z

[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Notices]
[Page 9396]
From the Federal Register Online via the Government Printing 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Draft Guidance for Industry and Food and Drug Administration 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availability of a draft guidance for industry entitled ``Civil Money 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 This draft guidance provides responses to questions FDA 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This draft guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the 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, gerie.voss@fda.hhs.gov.

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