[Federal Register Volume 62, Number 246 (Tuesday, December 23, 1997)]
[Rules and Regulations]
[Pages 66986-66987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33488]



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 increased 
rate of weight gain in broiler chickens raised in floor pens.
EFFECTIVE DATE:  December 23, 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 200-217 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 5 to 35 g/t and 
roxarsone 34 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 increased rate of 
weight gain in broiler chickens raised in floor pens.
    Alpharma Inc.'s ANADA 200-217 provides for using approved AMPROL 
HI-E<Register> (Merck's 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 200-217 is approved as a generic copy of 
Swisher Feed Div.'s NADA 39-284. The ANADA is approved as of December 
23, 1997, and the regulations are amended in 21

[[Page 66987]]

CFR 558.58(d)(1)(iii) to reflect the approval. The basis for approval 
is discussed in the freedom of information summary.
    This approval is for use of three Type A medicated articles to make 
combination drug Type C medicated feeds. One ingredient, roxarsone, is 
a Category II drug as defined in 21 CFR 558.3(b)(1)(ii). As provided in 
21 CFR 558.4(b), an approved form FDA 1900 is required to make Type C 
medicated feed from a Category II drug. Under section 512(m) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(m)), as amended by 
the Animal Drug Availability Act of 1996 (Pub. L. 104-250), medicated 
feed applications have been replaced by a requirement for feed mill 
licenses. Therefore, use of amprolium plus ethopabate, bacitracin zinc, 
and roxarsone Type A medicated articles to make Type C medicated feeds 
as provided in ANADA 200-217 is limited to manufacture in a licensed 
feed mill.
    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(a)(1) 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 5 to 35 plus 
roxarsone 34 (0.00375%)'' in the column ``Limitations'' by removing 
``No. 000004'' and adding in its place ``Nos. 000004 and 046573''.

    Dated: October 30, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-33488 Filed 12-22-97; 8:45 am]
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