[Federal Register: August 17, 2005 (Volume 70, Number 158)]
[Notices]               
[Page 48426-48427]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au05-88]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2005C-0302, 2005C-0303, and 2005C-0304]

 
CIBA Vision Corp.; Filing of Color Additive Petitions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that CIBA 
Vision Corp. has filed three petitions proposing that the color 
additive regulations be amended to

[[Page 48427]]

provide for the safe use of Color Index (C.I.) Pigment Violet 19, C.I. 
Pigment Yellow 154, and C.I. Pigment Red 122 as color additives in 
contact lenses.

FOR FURTHER INFORMATION CONTACT:
    Regarding CAPs 5C0278 and 5C0280: Celeste Johnston, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1282.
    Regarding CAP 5C0279: Harold Woodall, Center for Food Safety and 
Applied Nutrition (HFS-206), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740-3835, 301-436-1259.

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 three 
color additive petitions (CAP 5C0278, Docket No. 2005C-0302; CAP 
5C0279, Docket No. 2005C-0303; CAP 5C0280, Docket No. 2005C-0304) have 
been filed by CIBA Vision Corp., 11460 Johns Creek Pkwy., Duluth, GA 
30097-1556. The petitions propose to amend the color additive 
regulations in 21 CFR part 73 to provide for the safe use of C.I. 
Pigment Violet 19 (CAP 5C0278), C.I. Pigment Yellow 154 (CAP 5C0279), 
and C.I. Pigment Red 122 (CAP 5C0280), as color additives 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: July 22, 2005.
Laura M. Tarantino,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 05-16332 Filed 8-16-05; 8:45 am]

BILLING CODE 4160-01-S