[Federal Register Volume 59, Number 34 (Friday, February 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3714]


[[Page Unknown]]

[Federal Register: February 18, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 93N-0471]

 

American Cyanamid Co.; Withdrawal of Approval of NADA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA) held by American Cyanamid Co. 
The NADA provides for the use of maduramicin ammonium in combination 
with chlortetracycline in the feed of broiler chickens for prevention 
of coccidiosis and as an aid in the reduction of mortality due to 
Escherichia coli infections. The firm requested the withdrawal of the 
approval of the NADA. In a final rule published elsewhere in this issue 
of the Federal Register, FDA is amending the regulations by removing 
the portion of the regulation which reflects approval of the NADA.

EFFECTIVE DATE: February 28, 1994.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville MD 20855, 301-594-0749.

SUPPLEMENTARY INFORMATION: American Cyanamid Co., Agricultural Research 
Division, Box 400, Princeton, NJ 08450, is the sponsor of NADA 140-837 
that provides for the use of 4.54 to 5.45 grams (g) per ton of 
maduramicin ammonium combination with 500 g per ton of 
chlortetracycline in the feed of broiler chickens for the prevention of 
coccidiosis and as an aid in the reduction of mortality due to E. coli 
infections. American Cyanamid requested withdrawal of the NADA 
approval.
     Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10) and redelegated to the Center for Veterinary 
Medicine (21 CFR 5.84), and in accordance with Sec. 514.115 Withdrawal 
of approval of applications (21 CFR 514.115), notice is given that 
approval of NADA 140-837 and all supplements and amendments thereto is 
hereby withdrawn, effective February 28, 1994.
     In a final rule published elsewhere in this issue of the Federal 
Register, FDA is amending 21 CFR 558.128(c)(5)(xiii) and 558.340(c)(2) 
to reflect withdrawal of the approval.

    Dated: February 9, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-3714 Filed 2-17-94; 8:45 am]
BILLING CODE 4160-01-F