2011-16089. CooperVision, Inc.; Filing of Color Additive Petitions

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of petitions.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that CooperVision, Inc., has filed two petitions proposing that the color additive regulations be amended to provide for the safe use of 1,4-bis[4-(2-methacryloxyethyl)phenlyamino] anthraquinone (C.I. Reactive Blue 246) and 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247). The color additives are intended to be copolymerized with various monomers for use as colored contact lens materials.

FOR FURTHER INFORMATION CONTACT:

Regarding CAP 1C0291: Judith Kidwell, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1071.

Regarding CAP 1C0292: Teresa Croce, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1281.

SUPPLEMENTARY INFORMATION:

Under the Federal Food, Drug, and Cosmetic Act (section 721(d)(1) (21 U.S.C. 379e(d)(1))), notice is given that two color additive petitions (CAP 1C0291, Docket No. FDA-2011-C-0344 and CAP 1C0292, Docket No. FDA-2011-C-0463) have been filed by CooperVision, Inc., 6150 Stoneridge Mall Rd., Suite 370, Pleasanton, CA 94588. The petitions propose to amend the color additive regulations in 21 CFR part 73, subpart D, Medical Devices, to provide for the safe use of 1,4-bis[4-(2-methacryloxyethyl)phenstylamino]anthraquinone (C.I. Reactive Blue 246; CAS Reg. No. 121888-69-5) (CAP 1C0291) and 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247; CAS Reg. No. 109561-07-1) (CAP 1C0292). The color additives are intended to be copolymerized with various monomers for use as colored contact lens materials.

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: June 20, 2011.

Mitchell A. Cheeseman,

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