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Notice

Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents; Availability

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Information about this document as published in the Federal Register.

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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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Draft Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents.” The draft guidance is intended to help small entities comply with the final regulations restricting the sale and distribution of cigarettes and smokeless tobacco in order to protect children and adolescents.

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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 31, 2010.

ADDRESSES:

The draft guidance for industry entitled “Draft Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents” is available on the Internet at http://www.fda.gov/​TobaccoProducts/​GuidanceComplianceRegulatoryInformation/​default.htm, or a paper copy may be ordered free of charge by calling 1-877-287-1373.

Submit electronic comments 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.

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FOR FURTHER INFORMATION CONTACT:

Kathleen K. Quinn, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229, 240-276-1717, Kathleen.Quinn@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

I. Background

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31; 123 Stat. 1776) was enacted on June 22, 2009, amending the Federal Food, Drug, and Cosmetic Act (FFDCA) and providing FDA with the authority to regulate tobacco products. Section 102 of the Tobacco Control Act requires FDA to publish final regulations regarding cigarettes and smokeless tobacco which are identical in their provisions to the regulations promulgated by FDA in 1996 (1996 final regulations) on August 28, 1996 (61 FR 44396), with certain specified exceptions. In the Federal Register of March 19, 2010 (75 FR 13225), FDA published its final regulations entitled “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Start Printed Page 32792Protect Children and Adolescents,” at 21 CFR part 1140. The final regulations apply to manufacturers, distributors, and retailers who make, distribute, or sell cigarettes or smokeless tobacco products.

Beginning on June 22, 2010, these Federal regulations will prohibit retailers from selling cigarettes, cigarette tobacco, or smokeless tobacco to persons under the age of 18, and will require retailers to verify the age of all customers under the age of 27 by checking a photographic identification that includes the bearer's date of birth.

FDA is announcing the availability of a draft guidance document, which is intended to help small businesses comply with the requirements of the new regulations. FDA is soliciting comments on the draft guidance document and may amend the guidance document periodically as a result of comments received.

II. Significance of Guidance

FDA is issuing this draft guidance document 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 “Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents.” 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

The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed 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.

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.

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Dated: June 7, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-13922 Filed 6-7-10; 11:15 am]

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