[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
