
[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72900-72901]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28961]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1083]


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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[[Page 72901]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Civil Money Penalties for 
Tobacco Retailers: Responses to Frequently Asked Questions.'' This 
guidance provides information in response to questions that FDA has 
received regarding the issuance of civil money penalties for violations 
of regulations issued under the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) relating to tobacco products in retail outlets.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document 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 information on 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. Identify comments with the docket number 
found in brackets in the heading of this document.

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: gerie.voss@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance entitled ``Civil 
Money Penalties for Tobacco Retailers: Responses to Frequently Asked 
Questions.'' In this guidance, FDA addresses questions regarding the 
issuance of civil money penalties for violations of tobacco product 
regulations. In the Federal Register of February 8, 2013 (78 FR 9396), 
FDA announced the availability of the draft guidance of the same title. 
FDA received a few comments on the draft guidance and those comments 
were considered as the guidance was finalized. In addition, editorial 
changes were made to improve clarity.

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 this topic. 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 electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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 guidance document is available on the 
Internet at http://www.regulations.gov and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28961 Filed 12-3-13; 8:45 am]
BILLING CODE 4164-01-P


