[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]
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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; Amprolium Plus
Ethopabate With Bacitracin Zinc
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 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