[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]



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:


    1. The authority citation for 21 CFR part 558 continues to read as 

    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]