# Sauflon Pharmaceuticals Ltd.; Filing of Color Additive Petition
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice.
**SUMMARY:**
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.
**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.
**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 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.
Dated: November 10, 2009.
Laura M. Tarantino,
Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.