Document ID: FDA-2011-N-0121-0007
Agency: fda
Document Type: Notice
Title: Small Entity Compliance Guide; Further Amendments to General Regulations of the FDA to Incorporate Tobacco Products
Posted Date: 2012-03-28T04:00Z

[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Notices]
[Pages 18830-18831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7455]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0121]

Small Entity Compliance Guide: Further Amendments to General 
Regulations of the Food and Drug Administration To Incorporate Tobacco 
Products; 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 ``Further Amendments 
to General Regulations of the Food and Drug Administration to 
Incorporate Tobacco Products--Small Entity Compliance Guide'' for a 
final rule published in the Federal Register of February 2, 2012. 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 ``Further Amendments to General Regulations of the Food and 
Drug Administration to Incorporate Tobacco Products--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.

[[Page 18831]]

FOR FURTHER INFORMATION CONTACT: Gerie Voss, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 877-287-1373, gerie.voss@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of February 2, 2012 (77 FR 5171), FDA 
issued a final rule regarding further amendments to the general 
regulations of the FDA to incorporate tobacco products. 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 (Pub. L. 104-121), FDA is making 
available this SECG stating in plain language the legal requirements of 
the February 2, 2012, final rule, set forth in 21 CFR parts 1, 7, and 
16, amending the FDA's general regulations to ensure that tobacco 
products are subject to the same general requirements that apply to 
other FDA-regulated products.
    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. 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 the document at 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulation.gov.

    Dated: March 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-7455 Filed 3-27-12; 8:45 am]
BILLING CODE 4160-01-P