Document ID: FDA-2010-C-0077-0001
Agency: fda
Document Type: Notice
Title: Filing of Color Additive Petition: Biocompatibles UK Ltd.
Posted Date: 2010-03-22T04:00Z

[Federal Register: March 22, 2010 (Volume 75, Number 54)]
[Notices]               
[Page 13556]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr10-67]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-C-0077]

 
Biocompatibles UK Ltd.; 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 
Biocompatibles UK Ltd., has filed a petition proposing that the color 
additive regulations be amended to provide for the safe use of C.I. 
Reactive Blue No. 4 [2-anthracenesulfonic acid, 1-amino-4-(3-((4,6-
dichloro-s-triazin-2-yl)amino)-4-sulfoanilino)-9,10-dihydro-9,10-dioxo, 
disodium salt] (CAS Reg. No. 4499-01-8) reacted with polyvinyl alcohol 
as a color additive in vascular embolization devices.

FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1071.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (sec. 721(d)(1) (21 U.S.C. 379e(d)(1))), notice is given that a 
color additive petition (CAP 0C0288) has been filed by Biocompatibles 
UK Ltd., c/o John Greenbaum, Generic Devices Consulting, Inc., 20310 
SW. 48th St, Southwest Ranches, FL 33332. The petition proposes to 
amend the color additive regulations in 21 CFR part 73, subpart D, 
Medical Devices, to provide for the safe use of C.I. Reactive Blue No. 
4 [2-anthracenesulfonic acid, 1-amino-4-(3-((4,6-dichloro-s-triazin-2-
yl)amino)-4-sulfoanilino)-9,10-dihydro-9,10-dioxo, disodium salt] (CAS 
Reg. No. 4499-01-8) reacted with polyvinyl alcohol as a color additive 
in vascular embolization devices.
    The agency has determined under 21 CFR 25.32(l) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: March 5, 2010.
Mitchell A. Cheeseman,
Acting Director, Office of Food Additive Safety, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 2010-6177 Filed 3-19-10; 8:45 am]
BILLING CODE 4160-01-S