[Federal Register Volume 67, Number 97 (Monday, May 20, 2002)]
[Notices]
[Pages 35551-35552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12546]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00C-1321]


Wesley Jessen Corp.; Filing of Color Additive Petition; Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is amending the filing 
notice for a color additive petition filed by Wesley Jessen, Corp. (now 
Ciba Vision Corp.), to indicate that the petitioned additive is more 
appropriately identified as mica coated with iron oxides or mica coated 
with titanium dioxide for use in contact lenses. The previous filing 
notice

[[Page 35552]]

indicated that the proposed additive was mica for use in contact 
lenses.

FOR FURTHER INFORMATION CONTACT: Aydin Orstan, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 202-418-3076.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of June 7, 2000 (65 FR 36148), FDA announced that a color 
additive petition (CAP 0C0271) had been filed by Wesley Jessen, Corp., 
333 East Howard Ave., Des Plaines, IL 60018 (now Ciba Vision Corp., 
11460 Johns Creek Pkwy., Duluth, GA 30097-1556). The petition proposed 
to amend the color additive regulations to provide for the safe use of 
mica to color contact lenses.
    During its review of the petition, the agency determined that the 
subject color additives are composite pigments, commonly known as 
pearlescent pigments, composed of mica coated with iron oxides or mica 
coated with titanium dioxide. Therefore, FDA is amending the filing 
notice of June 7, 2000, to state that the petition proposes that the 
color additive regulations in 21 CFR part 73 subpart D--Medical Devices 
be amended to provide for the safe use of mica coated with iron oxides 
or mica coated with titanium dioxide, collectively identified as mica-
based pearlescent pigments, 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: May 6, 2002.
Alan M. Rulis,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 02-12546 Filed 5-17-02; 8:45 am]
BILLING CODE 4160-01-S