[Federal Register Volume 60, Number 160 (Friday, August 18, 1995)]
[Notices]
[Pages 43156-43157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20562]



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[[Page 43157]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95C-0211]


Pilkington Barnes Hind; 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 
Pilkington Barnes Hind has filed a petition proposing that the color 
additive regulations be amended to provide for the safe use of 2-[[2,5-
diethoxy-4-[(4-methylphenyl)thio]phenyl]azo]-1,3,5-benzenetriol to tint 
soft (hydrophilic) contact lenses.

DATES: Written comments on the petitioner's environmental assessment by 
September 18, 1995.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Diane E. Robertson, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3089.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (sec. 721(b)(5) (21 U.S.C. 379e(b)(5))), notice is given that a 
color additive petition (CAP 5C0246) has been filed by Pilkington 
Barnes Hind, 810 Kifer Rd., Sunnyvale, CA 94086-5200. The petition 
proposes to amend the color additive regulations in Sec. 73.3115
2-[[2,5-Diethoxy- 4-[(4-methylphenyl)thio]phenyl]azo]-1,3,5-
benzenetriol (21 CFR 73.3115) to provide for the safe use of the color 
additive to tint soft (hydrophilic) contact lenses.
    The potential environmental impact of this action is being 
reviewed. To encourage public participation consistent with regulations 
promulgated under the National Environmental Policy Act (40 CFR 
1501.4(b)), the agency is placing the environmental assessment 
submitted with the petition that is the subject of this notice on 
public display at the Dockets Management Branch (address above) for 
public review and comment. Interested persons may, on or before 
September 18, 1995, submit to the Dockets Management Branch (address 
above) written comments. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday. FDA will also place 
on public display any amendments to, or comments on, the petitioner's 
environmental assessment without further announcement in the Federal 
Register. If, based on its review, the agency finds that an 
environmental impact statement is not required and this petition 
results in a regulation, the notice of availability of the agency's 
finding of no significant impact and the evidence supporting that 
finding will be published with the regulation in the Federal Register 
in accordance with 21 CFR 25.40(c).

    Dated: August 7, 1995.
Alan M. Rulis,
Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 95-20562 Filed 8-17-95; 8:45 am]
BILLING CODE 4160-01-F