[Federal Register Volume 75, Number 110 (Wednesday, June 9, 2010)]
[Notices]
[Pages 32791-32792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13922]
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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Draft Guidance for Industry: Compliance With Regulations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availability of a draft guidance for industry entitled ``Draft Guidance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 The draft guidance is intended to help small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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 31, 2010.
ADDRESSES: The draft guidance for industry entitled ``Draft Guidance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.
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, [email protected].
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
[[Page 32792]]
Protect 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.
Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13922 Filed 6-7-10; 11:15 am]
BILLING CODE 4160-01-S