[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]
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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.
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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