
[Federal Register Volume 74, Number 82 (Thursday, April 30, 2009)]
[Notices]
[Page 19973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9868]


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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


