[Federal Register Volume 62, Number 223 (Wednesday, November 19, 1997)]
[Rules and Regulations]
[Page 61627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30409]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Amprolium Plus 
Ethopabate With Bacitracin Zinc

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 using 
approved amprolium plus ethopabate and bacitracin zinc Type A medicated 
articles to make Type C medicated feeds used for prevention of 
coccidiosis in broiler and replacement chickens and improved feed 
efficiency in broiler chickens.

EFFECTIVE DATE: November 19, 1997.
FOR FURTHER INFORMATION CONTACT: Jeffrey M. Gilbert, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1602.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, is sponsor of ANADA 200-205 that provides for 
combining approved amprolium plus ethopabate and bacitracin zinc Type A 
medicated articles to make Type C medicated feeds for broilers 
containing amprolium 113.5 grams per ton (g/t) plus ethopabate 36.3 g/t 
and bacitracin zinc 4 to 50 g/t. The Type C medicated feed is used: (1) 
As an aid in the prevention of coccidiosis where severe exposure to 
coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is 
likely to occur in broiler chickens and replacement chickens where 
immunity to coccidiosis is not desired, and for increased rate of 
weight gain in broiler chickens raised in floor pens; (2) as an aid in 
the prevention of coccidiosis where severe exposure to coccidiosis from 
Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; and 
(3) for improved feed efficiency in broiler chickens.
    Alpharma Inc.'s ANADA 200-205 is approved as a generic copy of 
Hoffmann-LaRoche, Inc.'s NADA 114-794. The ANADA is approved as of 
September 19, 1997, and the regulations are amended in the table in 21 
CFR 558.58(d)(1)(iii) 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33 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. 558.58  [Amended]

    2. Section 558.58 Amprolium and ethopabate is amended in paragraph 
(d)(1)(iii) in the table in the entry for ``Bacitracin 4 to 50'' in the 
columns ``Limitations'' and ``Sponsor''by removing ``000004'' and 
adding in its place ``000004 and 046573''.

    Dated: October 30, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-30409 Filed 11-18-97; 8:45 am]
BILLING CODE 4160-01-F