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Notice

Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions; Availability

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions.” This draft guidance provides responses to questions FDA has received regarding the issuance of civil money penalties for violations of regulations issued under the Federal Food,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 This draft guidance is not final nor is it in effect at this time.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft by April 9, 2013.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.

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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.

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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This draft guidance provides responses to questions FDA has received regarding the issuance of civil money penalties for violations of regulations issued under the FD&C Act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.

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Dated: February 4, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2013-02861 Filed 2-7-13; 8:45 am]

BILLING CODE 4160-01-P