[Federal Register Volume 59, Number 196 (Wednesday, October 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25230]


[[Page Unknown]]

[Federal Register: October 12, 1994]


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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; Halofuginone 
Hydrobromide

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 the approval of a supplemental new animal 
drug application (NADA) filed by Roussel-Uclaf. The supplemental NADA 
provides for use of halofuginone hydrobromide (Stenorol) in the feed of 
replacement cage laying chickens and replacement broiler breeder 
chickens for the prevention of coccidiosis.

EFFECTIVE DATE: October 12, 1994.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center For 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Roussel-Uclaf, Division Agro-Veterinaire, 
163 Avenue Gambetta, 75020, Paris, France, is the sponsor of NADA 130-
951, represented by Hoechst-Roussel Agri-Vet Co., P.O. Box 2500, Rt. 
202-206, Somerville, NJ 08876-1258. The NADA provides for use of 
halofuginone hydrobromide (Stenorol) Type A medicated article to make 
Type C medicated broiler feed used for the prevention of coccidiosis. 
The sponsor filed a supplemental application which provides for the use 
of 2.72 grams per ton (3 parts per million) halofuginone hydrobromide 
for replacement cage layers and replacement broiler breeders for the 
prevention of coccidiosis. The supplemental NADA is approved as of 
October 12, 1994 and the regulations are amended in 21 CFR 558.265(c) 
to reflect the approval. The basis for approval is discussed in the 
freedom of information summary.
    This approval is for use of a Type A medicated article to make a 
Type C medicated feed. Halofuginone hydrobromide is a Category II drug 
that, as provided in 21 CFR 558.4, requires an approved form FDA 1900 
for making a Type C medicated feed. Therefore, use of a halofuginone 
hydrobromide Type A article to make a Type C medicated feed as in NADA 
130-951, as supplemented, requires an approved form FDA 1900.
    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, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, from 9 a.m. to 4 p.m., Monday 
through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), the approval of this 
supplemental application qualifies for 3 years of marketing exclusivity 
beginning October 12, 1994 because the supplemental application 
contains reports of new clinical or field investigations (other than 
bioequivalence or residue studies) or human food safety studies (other 
than bioequivalence or residue studies) essential to the approval of 
the supplemental application and conducted or sponsored by the 
applicant.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment and that an environmental 
impact statement is not required. The agency's finding of no 
significant impact and the evidence supporting that finding, contained 
in an environmental assessment, may be seen in the Dockets Management 
Branch (address above) between 9 a.m. and 4 p.m., Monday through 
Friday.

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)(3) to 
read as follows:


Sec. 558.265  Halofuginone hydrobromide.

* * * * *
    (c) * * *
    (3) It is used in feed for replacement cage laying chickens and 
replacement broiler breeder chickens as follows:
    (i) Amount per ton. 2.72 grams.
    (A) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati/E. 
mitis, and E. brunetti.
    (B) Limitations. Feed continuously as sole ration to replacement 
cage laying chickens until 20 weeks of age. Feed continuously as sole 
ration to replacement broiler breeder chickens until 16 weeks of age. 
Withdraw 4 days before slaughter. Do not feed to laying chickens or 
water fowl. Halofuginone hydrobromide is toxic to fish and aquatic 
life. Keep out of lakes, ponds, and streams. Halofuginone hydrobromide 
is an irritant to eyes and skin. Avoid contact with skin, eyes, and 
clothing.
    (ii) [Reserved]

    Dated: October 4, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-25230 Filed 10-11-94; 8:45 am]
BILLING CODE 4160-01-F