96-13981. ProMedica International; Withdrawal of Color Additive Petition

[Federal Register Volume 61, Number 108 (Tuesday, June 4, 1996)]
[Notices]
[Page 28213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13981]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94C-0312]


ProMedica International; Withdrawal 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 the 
withdrawal, without prejudice to future filing, of a color additive 
petition (CAP 4C0244) 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.

FOR FURTHER INFORMATION CONTACT: Mitchell A. Cheeseman, Center for Food 
Safety and Applied Nutrition (HFS-217), Food and Drug Administration, -
200 C St. SW., Washington, DC 20204, 202-418-3083.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of September 26, 1994 (59 FR 49074), FDA announced that a 
color additive petition (CAP 4C0244) had been filed by ProMedica 
International, 620 Newport Center Dr., suite 575, Newport Beach, CA 
92660. The petition proposed 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 opthalmic surgery. ProMedica International has now 
withdrawn the petition without prejudice to a future filing (21 CFR 
71.6(c)(2)).

    Dated: May 16, 1996.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 96-13981 Filed 6-3-96; 8:45 am]
BILLING CODE 4160-01-F