[Federal Register Volume 64, Number 95 (Tuesday, May 18, 1999)]
[Rules and Regulations]
[Page 26844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12395]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Fenbendazole
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Hoechst Roussel Vet. The supplemental NADA
provides for revised feeding instructions for using fenbendazole in
Type C medicated swine feeds to allow for restricted feeding of sows.
EFFECTIVE DATE: May 18, 1999.
FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7578.
SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, 30 Independence Blvd.,
P.O. Box 4915, Warren, NJ 07059, filed supplemental NADA 131-675 for
fenbendazole Type C medicated swine feeds. The supplemental NADA
provides for increasing the concentration of fenbendazole in Type C
medicated swine feeds from 10 to 80 grams per ton (g/t) to 10 to 300 g/
t to be fed at 9 milligrams per kilogram (mg/kg) (4.08 mg per pound
(lb)) over a 3- to 12-day period. The supplement is approved as of
April 16, 1999, and the regulations in 21 CFR 558.258(c)(1)(i) are
amended to reflect that fenbendazole Type C medicated swine feeds
contain 10 to 300 g/t fenbendazole and are fed at 9 mg/kg body weight
(4.08 mg/lb) over a 3- to 12-day period.
The supplemental NADA approval provides for clarification of the
amount of drug fed to the animals for treatment. No additional safety
or effectiveness data were required. Therefore, a freedom of
information summary is not 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. 558.258 [Amended]
2. Section 558.258 Fenbendazole is amended in paragraph (c)(1)(i)
introductory text by removing ``10 to 80'' and adding in its place ``10
to 300''.
Dated: May 4, 1999.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 99-12395 Filed 5-17-99; 8:45 am]
BILLING CODE 4160-01-F
