[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]


-----------------------------------------------------------------------

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Draft Guidance for Industry: Compliance With Regulations 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availability of a draft guidance for industry entitled ``Draft Guidance 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 The draft guidance is intended to help small 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 31, 2010.

ADDRESSES:  The draft guidance for industry entitled ``Draft Guidance 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