[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
