[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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