[Federal Register Volume 74, Number 221 (Wednesday, November 18, 2009)]
[Notices]
[Page 59560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-27629]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-C-0543]
Sauflon Pharmaceuticals Ltd.; Filing of Color Additive Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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.
[FR Doc. E9-27629 Filed 11-17-09; 8:45 am]
BILLING CODE 4160-01-S