[Federal Register Volume 61, Number 91 (Thursday, May 9, 1996)]
[Rules and Regulations]
[Pages 21075-21076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11514]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Halofuginone 
Hydrobromide, Bacitracin Methylene Disalicylate

AGENCY: Food and Drug Administration, HHS.


[[Page 21076]]


ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Hoechst-Roussel Agri-Vet Co. The NADA provides for 
using approved single ingredient Type A medicated articles to make Type 
C medicated turkey feeds containing halofuginone hydrobromide and 
bacitracin methylene disalicylate.

EFFECTIVE DATE: May 9, 1996
FOR FURTHER INFORMATION CONTACT: James F. McCormack, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1607.

SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., Route 202-206, 
P.O. Box 2500, Somerville, NJ 08876-1258, has filed NADA 140-919, which 
provides for use of approved Stenorol<Register> (2.72 grams of 
halofuginone hydrobromide per pound of Type A article) and approved 
BMD<Register> (30, 50, or 60 grams of bacitracin methylene disalicylate 
per pound) to make Type C medicated turkey feeds containing 1.36 to 
2.72 grams per ton (g/t) halofuginone hydrobromide and 10 to 50 g/t 
bacitracin methylene disalicylate, for prevention of coccidiosis in 
growing turkeys caused by Eimeria adenoeides, E. meleagrimitis, and E. 
gallopavonis, and for increased rate of weight gain.

    The NADA 140-919 is approved as of May 9, 1996, and the regulations 
are amended in Sec. 558.265(c)(2)(ii) (21 CFR 558.265(c)(2)(ii)) to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.

    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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.

    This approval is for use of single ingredient Type A medicated 
articles to make Type C medicated feeds. Halofuginone hydrobromide is a 
Category II drug which, as provided in Sec. 558.4, requires an approved 
form FDA 1900 for making a Type C medicated feed. Therefore, use of 
halofuginone hydrobromide and bacitracin methylene disalicylate Type A 
medicated articles to make a combination drug Type C medicated feed as 
provided in NADA 140-919 requires an approved form FDA 1900.
    The agency has determined under 21 CFR 25.24(d)(1)(ii) 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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval for use in 
food-producing animals qualifies for 3 years of marketing exclusivity 
beginning May 9, 1996, because the application contains reports of new 
clinical or field investigations (other than bioequivalence or residue 
studies) essential to the approval and conducted or sponsored by the 
applicant.

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: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

    2. Section 558.265 is amended by adding new paragraph (c)(2)(ii) to 
read as follows:


Sec. 558.265  Halofuginone hydrobromide.

* * * * *
    (c) *  *  *
    (2) *  *  *
    (ii) Amount per ton. Halofuginone hydrobromide 1.36 to 2.72 grams 
plus bacitracin methylene disalicylate 10 to 50 grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for 
increased rate of weight gain in growing turkeys.
    (B) Limitations. Feed continuously as sole ration. Withdraw 7 days 
before slaughter. Do not feed to laying chickens or water fowl. Keep 
out of lakes, ponds, and streams. Halofuginone is toxic to fish and 
aquatic life. Halofuginone is an irritant to eyes and skin. Avoid 
contact with skin, eyes, or clothing.

    Dated: April 26, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-11514 Filed 5-8-96; 8:45 am]
BILLING CODE 4160-01-F