[Federal Register: April 30, 2009 (Volume 74, Number 82)]
[Notices]
[Page 19973]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap09-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0198]
Small Entity Compliance Guide: Cochineal Extract and Carmine:
Declaration by Name on the Label of All Foods and Cosmetic Products
That Contain These Color Additives; 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 ``Cochineal Extract
and Carmine: Declaration by Name on the Label of All Foods and Cosmetic
Products That Contain These Color Additives--Small Entity Compliance
Guide.'' The small entity compliance guide (SECG) is being issued for a
final rule published in the Federal Register of January 5, 2009, and it
is intended to set forth in plain language the requirements of the
regulation and to help small businesses understand the regulation.
DATES: Submit written or electronic comments on the SECG at any time.
ADDRESSES: Submit written requests for single copies of the SECG to the
Division of Petition Review, Office of Food Additive Safety (HFS-265),
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or FAX
your request to 301-436-2972. Send one self-addressed adhesive label to
assist that office in processing your request. Submit written comments
on the SECG to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments on the SECG to http://www.regulations.gov.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
SECG.
FOR FURTHER INFORMATION CONTACT: James C. Wallwork, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1303.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 5, 2009 (74 FR 207), FDA issued
a final rule requiring the declaration of cochineal extract and carmine
by name on the label of all foods and cosmetic products that contain
these color additives. This final rule becomes effective January 5,
2011.
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 final rule may 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 January 5, 2009, final rule set
forth in 21 CFR parts 73 and 101 concerning cochineal extract and
carmine.
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) written or electronic comments regarding this SECG.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. The SECG and 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.cfsan.fda.gov/guidance.html.
Dated: April 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9868 Filed 4-29-09; 8:45 am]
BILLING CODE 4160-01-S