[Federal Register Volume 63, Number 244 (Monday, December 21, 1998)]
[Rules and Regulations]
[Page 70335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33636]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Chlortetracycline and
Monensin Sodium
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 reflect approval of an abbreviated new animal drug
application (ANADA) filed by Alpharma Inc. The ANADA provides for the
use of approved chlortetracycline Type A medicated articles and
monensin sodium Type A medicated articles in making Type C medicated
chicken feed used as an aid in the reduction of mortality due to E.
coli infections susceptible to such treatments and as an aid in the
prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E.
acervulina, E. maxima, E. brunetti, and E. mivati in broiler chickens.
EFFECTIVE DATE: December 21, 1998.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209.
SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, is the sponsor of ANADA 200-263 that provides
for the use of approved ChlorMaxTM Coban,
chlortetracycline Type A medicated articles and monensin sodium Type A
medicated articles) in making Type C medicated chicken feed used as an
aid in the reduction of mortality due to E. coli infections susceptible
to such treatments, and as an aid in the prevention of coccidiosis
caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E.
brunetti, and E. mivati in broiler chickens. The ANADA is approved as a
generic copy of Roche Vitamins, Inc.'s NADA 121-553,
Aureomycin-Coban. ANADA 200-263 is approved as of
September 21, 1998, and the regulations are amended in 21 CFR 558.355
to reflect the approval. The basis for approval is discussed in the
freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness
data and information submitted to support approval of this application
may be seen in the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(2) 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.
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: 21 U.S.C. 360b, 371.
Sec. 558.355 [Amended]
2. Section 558.355 Monensin is amended in paragraph (b)(11) by
removing ``(f)(1)(xviii)'' and adding in its place ``(f)(1)(xiv),
(xviii),'' and in paragraph (f)(1)(xiv)(b) by removing the phrase ``No.
063238'' and adding in its place ``Nos. 046573 and 063238''.
Dated: November 30, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-33636 Filed 12-18-98; 8:45 am]
BILLING CODE 4160-01-F
