[Federal Register Volume 59, Number 185 (Monday, September 26, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23774]


[[Page Unknown]]

[Federal Register: September 26, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94C-0312]

 

ProMedica International; 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 
ProMedica International has filed a petition proposing that the color 
additive regulations be amended to provide for the safe use of 
[phthalocyaninato(2-)] copper as a color additive in nonabsorbable 
polyvinylidene fluoride sutures intended for use in general and 
ophthalmic surgery.

DATES: Written comments on the petitioner's environmental assessment by 
October 26, 1994.

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: Mitchell Cheeseman, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3083.

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 4C0244) has been filed by ProMedica 
International, 620 Newport Center Dr., suite 575, Newport Beach, CA 
92660. The petition proposes to amend the color additive regulations in 
Sec. 74.3045 [Phthalocyaninato(2-)] copper (21 CFR 74.3045) to provide 
for the safe use of [phthalocyaninato(2-)] copper as a color additive 
in nonabsorbable polyvinylidene fluoride sutures intended for use in 
general and ophthalmic surgery.
    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 October 
26, 1994, 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: September 15, 1994.
Alan M. Rulis,
Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 94-23774 Filed 9-23-94; 8:45 am]
BILLING CODE 4160-01-F