99-13980. Genzyme Surgical Products Corp.; Filing of Color Additive Petition

[Federal Register Volume 64, Number 106 (Thursday, June 3, 1999)]
[Notices]
[Pages 29871-29872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13980]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99C-1455]


Genzyme Surgical Products Corp.; 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 
Genzyme Surgical Products Corp. has filed a petition proposing that the 
color additive regulations be amended to provide for the safe use of 
D&C Violet No. 2 as a color additive in absorbable sutures prepared 
from homopolymers of glycolide for general surgery. The petitioner also 
proposes that the nomenclature polyglactin 910 (glycolic-lactic acid 
polyester) be revised to the generic nomenclature-copolymers of 90 
percent glycolide and 10 percent L-lactide.

FOR FURTHER INFORMATION CONTACT:  Ellen M. Waldron, Center for Food 
Safety and Applied Nutrition (HFS-217), 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 9C0266) has been filed by Genzyme Surgical 
Products Corp., 600 Airport Rd., Fall River, MA 02720. The petition 
proposes to amend the color additive regulations in Sec. 74.3602  D&C 
Violet No. 2  (21 CFR 74.3602) to provide for the safe use of D&C 
Violet No. 2 as a color additive in absorbable sutures prepared from 
homopolymers of glycolide for general surgery. The

[[Page 29872]]

petitioner also proposes that the nomenclature polyglactin 910 
(glycolic-lactic acid polyester) be revised to the generic nomenclature 
90 percent glycolide and 10 percent L-lactide.
    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 5, 1999.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 99-13980 Filed 6-2-99; 8:45 am]
BILLING CODE 4160-01-F