[Federal Register Volume 62, Number 218 (Wednesday, November 12, 1997)]
[Rules and Regulations]
[Pages 60657-60658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29653]


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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 and Roxarsone

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 with bacitracin zinc and roxarsone 
Type A medicated articles to make Type C medicated broiler chicken 
feeds used as an aid in the prevention of coccidiosis and improved feed 
efficiency or improved feed efficiency and improved pigmentation.

EFFECTIVE DATE: November 12, 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, filed ANADA 200-214 that provides for 
combining approved amprolium plus ethopabate with bacitracin zinc and 
roxarsone Type A medicated articles to make Type C medicated broiler 
feeds. The Type C medicated feed containing amprolium 113.5 grams per 
ton (g/t) plus ethopabate 36.3 g/t with bacitracin zinc 10 to 50 g/t 
and roxarsone 15.4 to 45.4 g/t is used 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 for 
improved feed efficiency. The Type C medicated feed containing 
amprolium 113.5 g/t plus ethopabate

[[Page 60658]]

36.3 g/t with bacitracin zinc 10 g/t and roxarsone 30 to 45.4 g/t is 
used as an aid in the prevention of coccidiosis where severe exposure 
to coccidiosis from E. acervulina, E. maxima, and E. brunetti is likely 
to occur, and for improved feed efficiency and improved pigmentation.
    Alpharma Inc.'s ANADA 200-214 provides for combining approved 
AMPROL HI-E<Register> (Merck Research Laboratories' amprolium and 
ethopabate NADA 13-461), ALBAC<Register> (Alpharma Inc.'s bacitracin 
zinc ANADA 200-223), and 3-NITRO<Register> (Alpharma Inc.'s roxarsone 
NADA 7-891) Type A medicated articles to make the combination drug Type 
C medicated feeds.
    Alpharma Inc.'s ANADA 200-214 is approved as a generic copy of 
Hoffmann-LaRoche, Inc.'s NADA 105-758. The ANADA is approved as of 
November 12, 1997, and the regulations are amended 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 the table 
in paragraph (d)(1)(iii) in the entry for ``Bacitracin 10 to 50 plus 
roxarsone 15.4 to 45.4 (0.0017% to 0.005%)'' under ``Limitations'' by 
removing ``No. 000004'' both times it appears and adding in their place 
``Nos. 000004 and 046573'', and under ``Sponsor'' by removing 
``000004'' and adding in its place ``000004, 046573''.

    Dated: October 22, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-29653 Filed 11-10-97; 8:45 am]
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