[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Notices]
[Page 16424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-6794]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0277]


Draft Guidance for Industry: Compliance With Regulations 
Restricting the Sale and Distribution of Cigarettes and Smokeless 
Tobacco To Protect Children and Adolescents; 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availability of a revised draft guidance for industry entitled ``Draft 
Guidance for Industry: Compliance With Regulations Restricting the Sale 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.'' This revised draft guidance replaces the 
original draft guidance published in the Federal Register of June 9, 
2010 (75 FR 32791). The original draft guidance was revised to remove 
potential ambiguities and to address several issues not included in the 
original draft guidance. This revised draft guidance is intended to 
help small entities comply with the final rule entitled ``Regulations 
Restricting the Sale and Distribution of Cigarettes and Smokeless 
Tobacco 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 23, 2011.

ADDRESSES: The draft guidance for industry entitled ``Draft Guidance 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.

FOR FURTHER INFORMATION CONTACT: Office of Compliance and Enforcement, 
Center for Tobacco Products, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850-3229, 877-287-1373, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Pub. L. 111-31; 123 Stat. 1776) was enacted on June 22, 
2009, amending the Federal Food, Drug, and Cosmetic Act 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 issued by FDA on August 28, 1996 (61 FR 
44396), with certain specified exceptions. In the Federal Register of 
March 19, 2010 (75 FR 13225), FDA published a final rule entitled 
``Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco to Protect Children and Adolescents.'' The final 
regulations apply to manufacturers, distributors, and retailers who 
make, distribute, or sell cigarettes or smokeless tobacco products.
    As of June 22, 2010, these Federal regulations, among other things, 
prohibit retailers from selling cigarettes, cigarette tobacco, or 
smokeless tobacco to persons under the age of 18, and 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 announced the publication of the original draft guidance 
document on June 9, 2010 (75 FR 32791). This revised draft guidance 
replaces the original draft guidance. The original draft guidance was 
revised to remove potential ambiguities and to address several issues 
not included in the original draft guidance. This revised draft 
guidance is intended to help small entities comply with the final rule 
entitled ``Regulations Restricting the Sale and Distribution of 
Cigarettes and Smokeless Tobacco to Protect Children and Adolescents'' 
published on March 19, 2010. FDA is soliciting comments on the revised 
draft guidance document which replaces the original draft guidance 
document. FDA 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

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.

    Dated: March 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6794 Filed 3-22-11; 8:45 am]
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