[Federal Register Volume 63, Number 49 (Friday, March 13, 1998)]
[Notices]
[Page 12473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6570]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98C-0158]


Linvatec 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 
Linvatec 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 
to color absorbable meniscal tacks made from poly(L-lactic acid).

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 8C0255) has been filed by Linvatec Corp., 
P.O. Box 2917, Largo, FL 33779-2917. 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 to color 
absorbable meniscal tacks made from poly(L-lactic acid).
    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: March 2, 1998.
 Alan M. Rulis,
 Director, Office of Premarket Approval, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 98-6570 Filed 3-12-98; 8:45 am]
BILLING CODE 4160-01-F