[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
