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Notice

Biocompatibles UK Ltd.; Filing of Color Additive Petition

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.

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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.

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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.

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Dated: March 5, 2010.

Mitchell A. Cheeseman,

Acting Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.

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[FR Doc. 2010-6177 Filed 3-19-10; 8:45 am]

BILLING CODE 4160-01-S