[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]
-----------------------------------------------------------------------
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Draft Guidance for Industry: Compliance With Regulations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.
-----------------------------------------------------------------------
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availability of a revised draft guidance for industry entitled ``Draft
Guidance for Industry: Compliance With Regulations Restricting the Sale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 This revised draft guidance replaces the
original draft guidance published in the Federal Register of June 9,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 The original draft guidance was revised to remove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original draft guidance. This revised draft guidance is intended to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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 23, 2011.
ADDRESSES: The draft guidance for industry entitled ``Draft Guidance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]
BILLING CODE P