Document ID: FDA-2009-C-0543-0001
Agency: fda
Document Type: Notice
Title: Sauflon Pharmaceuticals Ltd.; Filing of Color Additive Petition
Posted Date: 2009-11-18T05:00Z

[Federal Register: November 18, 2009 (Volume 74, Number 221)]
[Notices]               
[Page 59560]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no09-61]                         

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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