[Federal Register Volume 76, Number 124 (Tuesday, June 28, 2011)]
[Proposed Rules]
[Page 37690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-16089]



[[Page 37690]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket Nos. FDA-2011-C-0344 and FDA-2011-C-0463]


CooperVision, Inc.; Filing of Color Additive Petitions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petitions.

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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.
[FR Doc. 2011-16089 Filed 6-27-11; 8:45 am]
BILLING CODE 4160-01-P