2011-27530. Small Entity Compliance Guide: Required Warnings for Cigarette Packages and Advertisements; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.

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, [e-mail].

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.