[Federal Register Volume 59, Number 131 (Monday, July 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16615]


[[Page Unknown]]

[Federal Register: July 11, 1994]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 558

 

Animal Drugs, Feeds, and Related Products; 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 two supplemental new animal 
drug applications (NADA's) filed by Hoechst-Roussel Agri-Vet Co. One 
supplemental NADA provides for use of fenbendazole granules, the other 
provides for use of a fenbendazole Type A medicated article to make 
Type C medicated feed, both products for use as dewormers for zoo and 
wildlife animals.

EFFECTIVE DATE: July 11, 1994.

FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for 
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0614.

SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., Rt. 202-206, 
P.O. Box 2500, Somerville, NJ 08876-1258, filed a supplement to NADA 
121-473 that provides for use of fenbendazole 22.2 percent granules to 
top dress feed, and a supplement to NADA 131-675 that provides for use 
of a fenbendazole Type A medicated article (4 percent, 8 percent, and 
20 percent) to make Type C medicated feed. The supplements provide for 
using 2.5 to 10 milligrams of fenbendazole per kilogram of body weight 
per day for 3 days for removal and control of internal parasites in zoo 
and wildlife animals.
    Supplemental NADA 121-473 is approved as of May 31, 1994, 
supplemental NADA 131-675 is approved as of July 11, 1994, and the 
regulations are amended in 21 CFR 520.905b and 558.258 to reflect the 
approvals.
    Approval of NADA 131-675 is for use of fenbendazole Type A 
medicated article to make Type C medicated feed. Fenbendazole is a 
Category II drug which, as provided in 21 CFR 558.4, requires an 
approved form FDA 1900 for making a Type C medicated feed. Therefore, 
use of fenbendazole Type A medicated articles to make Type C medicated 
feeds as in NADA 131-675 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 these applications may be seen in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 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)), these supplemental 
approvals qualify for a 3-year period of marketing exclusivity, for 
supplemental NADA 121-473 for this use beginning May 31, 1994, and for 
supplemental NADA 131-675 for this use beginning July 11, 1994, because 
new clinical or field investigations (other than bioequivalence or 
residue studies) conducted by the sponsor were required for the 
approvals.
    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

21 CFR Part 520

    Animal drugs.

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 parts 520 and 
558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

    2. Section 520.905b is amended by adding new paragraph (c)(3) to 
read as follows:


Sec. 520.905b  Fenbendazole granules.

* * * * *
    (c) * * *
    (3) Zoo and wildlife animals--(i) Amount. Ten milligrams per 
kilogram per day for 3 days.
    (ii) Indications for use. For control of internal parasites of 
Felidae and Ursidae as follows:
    (A) Lion (Panthera leo) and Tiger (Panthera tigris): Ascarid 
(Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma spp.).
    (B) Cheetah (Acinonyx jubatus): Ascarid (Toxocara cati, Toxascaris 
leonina).
    (C) Puma (Felis concolor), Panther (Panthera spp.), Leopard 
(Panthera pardus), Jaguar (Panthera onca): Ascarid (Toxocara cati, 
Toxascaris leonina), Hookworm (Ancylostoma spp.), Tapeworm (Taenia 
hydatigena, T. krabbei, T. taeniaeformis).
    (D) Black Bear (Ursus americanus): Ascarid (Baylisascaris 
transfuga, Toxascaris leonina), Hookworm (Ancylostoma caninum), 
Tapeworm (Taenia hydatigena, T. krabbei).
    (E) Polar Bear (Ursus maritimus) and Grizzly Bear (Ursus 
horribilis): Ascarid (Baylisascaris transfuga, Toxascaris leonina).
    (iii) Limitations. Top dress or mix with a small portion of food. 
Must be fully consumed prior to feeding. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian. Do not use 
14 days before or during the hunting season.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    3. 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).

    4. Section 558.258 is amended by adding new paragraph (c)(4) to 
read as follows:


Sec. 558.258  Fenbendazole.

* * * * *
    (c) * * *
    (4) Zoo and wildlife animals. For removal and control of internal 
parasites in hoofed zoo and wildlife animals as follows:
    (i) Feral swine (Suis scrofa): 3 milligrams per kilogram per day 
for 3 days. Treatment for kidney worm (Stephanurus dentatus), roundworm 
(Ascaris suum), nodular worm (Oesophagostomum dentatum).
    (ii) Ruminants (subfamily Antilopinae, Hippotraginae, Caprinae): 
2.5 milligrams per kilogram per day for 3 days. Treatment for small 
stomach worm (Trichostrongylus spp.), thread necked intestinal worm 
(Nematodirus spp.), barberpole worm (Haemonchus spp.), whipworm 
(Trichuris spp.).
    (iii) Rocky mountain bighorn sheep (Ovis c. canadensis): 10 
milligrams per kilogram per day for 3 days. Treatment and control of 
Protostrongylus spp.
    (iv) Limitations. Use as complete feed. Prior withdrawal of feed or 
water is not necessary. Retreatment may be required in 6 weeks. Consult 
your veterinarian for assistance in the diagnosis, treatment, and 
control of parasitism. Do not use 14 days before or during the hunting 
season.

    Dated: June 21, 1994.
 Stephen F. Sundlof,
 Director, Center for Veterinary Medicine.
[FR Doc. 94-16615 Filed 7-8-94; 8:45 am]
BILLING CODE 4160-01-F