Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing that Sauflon Pharmaceuticals Ltd. has filed a petition proposing that the color additive regulations be amended to provide for the safe use of disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate (CAS Reg. No. 70209-99-3) as a color additive in contact lenses.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Raphael A. Davy, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1272.End Further Info End Preamble Start Supplemental 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 8C0287) has been filed by Sauflon Pharmaceuticals Ltd., 49-53 York St., Twickenham, Middlesex, TW1 3LP, United Kingdom. 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 disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate (CAS Reg. No. 70209-99-3) as a color additive in contact lenses.
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.Start Signature
Dated: November 10, 2009.
Laura M. Tarantino,
Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.
[FR Doc. E9-27629 Filed 11-17-09; 8:45 am]
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