[Federal Register Volume 63, Number 21 (Monday, February 2, 1998)]
[Notices]
[Page 5387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2497]



[[Page 5387]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98C-0041]


Ethicon, Inc.; 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 
Ethicon, Inc., has filed a petition proposing that the color additive 
regulations be amended to provide for the safe use of 
[phthalocyaninato(2-)] copper in coloring nonabsorbable sutures for 
general and opthalmic surgery made from a blend of poly(vinylidene 
fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene).

DATES: Written comments on the petitioner's environmental assessment by 
March 4, 1998.

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

FOR FURTHER INFORMATION CONTACT: Ellen M. Waldron, Center for Food 
Safety and Applied Nutrition (HFS-215), 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(d)(1) (21 U.S.C. 379e(d)(1)), notice is given that a 
color additive petition (CAP 8C0253) has been filed by Ethicon, Inc., 
P.O. Box 151, Somerville, NJ 08876-0151. 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 in coloring nonabsorbable sutures 
for general and opthalmic surgery made from a blend of poly(vinylidene 
fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene).
    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 March 
4, 1998, 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: January 15, 1998.
Laura M. Tarantino,
Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 98-2497 Filed 1-30-98; 8:45 am]
BILLING CODE 4160-01-F