Notices. Notice
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/register/2010/03/22/2010-6177A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4160-01-S 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. 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]
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- 21 CFR 73
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