Document ID: FDA-2008-C-0098-0001
Agency: fda
Document Type: Notice
Title: Combe, Inc.; Filing of Color Additive Petition
Posted Date: 2008-02-25T05:00Z

[Federal Register: February 25, 2008 (Volume 73, Number 37)]
[Notices]               
[Page 10035]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe08-78]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-C-0098]

 
Combe, Inc.; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Combe, Inc., has filed a petition proposing that the color additive 
regulations be amended to increase the permitted use level of bismuth 
citrate as a color additive in cosmetics intended for coloring hair on 
the scalp.

DATES:  Submit written or electronic comments on the petitioner's 
environmental assessment by March 26, 2008.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Felicia M. Ellison, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1264.

SUPPLEMENTARY INFORMATION: Under section 721e(d)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), notice is given 
that a color additive petition (CAP 8C0286) has been filed by Combe, 
Inc., c/o EAS Consulting Group, LLC, 1940 Duke St., suite 200, 
Alexandria, VA 22314. The petition proposes to amend the color additive 
regulations in Sec.  73.2110 Bismuth citrate (21 CFR 73.2110) to 
increase the permitted use level of bismuth citrate as a color additive 
in cosmetics intended for coloring hair on the scalp.
    The potential environmental impact of this action is being 
reviewed. To encourage public participation consistent with regulations 
issued under the National Environmental Policy Act (40 CFR 1501.4(b)), 
the agency is placing the environmental assessment submitted with the 
petition that is the subject of this notice on public display at the 
Division of Dockets Management (see ADDRESSES) for public review and 
comment.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday. FDA will also place on public display any amendments 
to, or comments on, the petitioner's environmental assessment without 
further announcement in the Federal Register. If, based on its review, 
the agency finds that an environmental impact statement is not required 
and this petition results in a regulation, the notice of availability 
of the agency's finding of no significant impact and the evidence 
supporting that finding will be published with the regulation in the 
Federal Register in accordance with 21 CFR 25.51(b).
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

    Dated: February 15, 2008.
Laura M. Tarantino,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. E8-3416 Filed 2-22-08; 8:45 am]

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