[Federal Register Volume 76, Number 206 (Tuesday, October 25, 2011)]
[Notices]
[Pages 66074-66075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27530]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0568]


Small Entity Compliance Guide: Required Warnings for Cigarette 
Packages and Advertisements; 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 guidance for industry entitled ``Required Warnings 
for Cigarette Packages and Advertisements--Small Entity Compliance 
Guide'' for a final rule published in the Federal Register on June 22, 
2011. This small entity compliance guide (SECG) is intended to set 
forth in plain language the requirements of the regulation and to help 
small businesses understand and comply with the regulation.

DATES: Submit either electronic or written comments on the SECG at any 
time.

ADDRESSES: Submit written requests for single copies of the SECG 
entitled ``Required Warnings for Cigarette Packages and 
Advertisements--Small Entity Compliance Guide'' 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 guidance document.

[[Page 66075]]

    Submit electronic comments on the 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 Voss, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 877-287-1373, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 22, 2011 (76 FR 36628), FDA issued 
a final rule regarding required warnings for use on cigarette packages 
and in cigarette advertisements. FDA examined the economic implications 
of the final rule as required by the Regulatory Flexibility Act (5 
U.S.C. 601-612) and determined that the rule would have a significant 
economic impact on a substantial number of small entities. In 
compliance with section 212 of the Small Business Regulatory 
Enforcement Fairness Act (Public Law 104-121), FDA is making available 
this SECG stating in plain language the legal requirements of the June 
22, 2011, final rule, set forth in 21 CFR part 1141, establishing 
requirements for graphic health warnings on cigarette packages and in 
cigarette advertisements.
    FDA is issuing this SECG as level 2 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG 
represents the Agency's current thinking on this topic. 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 statutes and 
regulations.

II. Comments

    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.

III. Electronic Access

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

    Dated: October 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-27530 Filed 10-24-11; 8:45 am]
BILLING CODE 4160-01-P