[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: 94-3715]


[[Page Unknown]]

[Federal Register: February 18, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558

[Docket No. 93N-0471]

 

New Animal Drugs for Use in Animal Feeds; Maduramicin Ammonium 
With Chlortetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to remove those portions of the regulations that 
reflect approval of a new animal drug application (NADA) held by 
American Cyanamid Co. The NADA 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 Escherichia coli infections. In a notice published elsewhere in 
this issue of the Federal Register, FDA is withdrawing 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: In a notice published elsewhere in this 
issue of the Federal Register, FDA is withdrawing approval of NADA 140-
837 held by American Cyanamid Co., Agricultural Research Division, Box 
400, Princeton, NJ 08450. The sponsor requested withdrawal of approval 
of the NADA. The NADA provides for the use of 4.54 to 5.45 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. This document amends 21 CFR 558.128(c)(5)(xiii) and 
558.340(c)(2)(i) and (c)(2)(ii) to reflect the withdrawal of approval 
of the NADA.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).


Sec. 558.128  [Amended]

    2. Section 558.128 Chlortetracycline is amended by removing 
paragraph (c)(5)(xiii).


Sec. 558.340  [Amended]

    3. Section 558.340 Maduramicin ammonium is amended by removing and 
reserving paragraph (c)(2).

    Dated: February 10, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-3715 Filed 2-17-94; 8:45 am]
BILLING CODE 4160-01-F