[Federal Register Volume 75, Number 168 (Tuesday, August 31, 2010)]
[Notices]
[Pages 53316-53317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21661]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0431]
Draft Guidance for Food and Drug Administration Staff and Tobacco
Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for
Tobacco Retailers; 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availability of a draft guidance entitled ``Civil Money Penalties and
No-Tobacco-Sale Orders for Tobacco Retailers.'' This guidance document
is intended to describe FDA's current policies with respect to civil
money penalties and no-tobacco-sale orders for retailers who violate
requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
relating to tobacco products, including the FD&C Act 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.'' When this
guidance document is final, several provisions in the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) that relate to
civil money penalties and no-tobacco-sale orders will become effective.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 1, 2010.
ADDRESSES: Submit written requests for single copies of the guidance
entitled ``Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco
Retailers'' 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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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.
FOR FURTHER INFORMATION CONTACT: Gerie A. Voss, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1-877-287-1373, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for FDA
Staff and tobacco retailers entitled ``Civil Money Penalties and No-
Tobacco-Sale Orders for Tobacco Retailers.'' On June 22, 2009,
President Obama signed the Tobacco Control Act (Public Law 111-31) into
law . The Tobacco Control Act grants FDA important new authority to
regulate the manufacture, marketing and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors.
Among its many provisions, the Tobacco Control Act authorizes FDA
to impose civil money penalties for violations of FD&C Act requirements
that relate to tobacco products (section 303(f)(9) of the FD&C Act (21
U.S.C. 333
[[Page 53317]]
(f)(9)). Of special interest to retailers, one of the FD&C Act's
requirements is that tobacco products may not be sold or distributed in
a manner that violates regulations issued under section 906(d) of the
FD&C Act, such as the ``Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless Tobacco to Protect Children
and Adolescents'' that were published by FDA in the Federal Register of
March 19, 2010 (75 FR 13225) (21 CFR part 1140). The Tobacco Control
Act also authorizes FDA to impose a no-tobacco-sale order on a retail
outlet for repeated violations of regulations issued under section
906(d) of the FD&C Act, and discusses a number of technical and
procedural issues relating to civil money penalties and no-tobacco-sale
orders.
The draft guidance document describes the penalty structure and
draft FDA policies with respect to civil money policies and no-tobacco-
sale orders. When this guidance is final, several Tobacco Control Act
provisions that relate to civil money penalties and no-tobacco-sale
orders will become effective (section 103(q)(3) of the Tobacco Control
Act).
II. Significance of Guidance
FDA is issuing this draft guidance document as a level 1 draft
guidance consistent with FDA's good guidance practices regulation
(Sec. 10.115 (21 CFR 10.115)). The draft guidance, when finalized,
will represent the agency's current thinking on ``Civil Money Penalties
and No-Tobacco-Sale Orders for Tobacco Retailers.'' 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 to the Division of Dockets Management
(See ADDRESSES), 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 draft guidance
at either http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.
Dated: August 26, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-21661 Filed 8-30-10; 8:45 am]
BILLING CODE 4160-01-S