# 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.