[Federal Register Volume 59, Number 64 (Monday, April 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7884]


[[Page Unknown]]

[Federal Register: April 4, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558

 

New Animal Drugs for Use in Animal Feeds; Bambermycins

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 approval of a new animal drug application 
(NADA) filed by Hoechst-Roussel Agri-Vet Co. The NADA provides for 
expanding the use of currently approved bambermycins-containing Type A 
medicated articles to make Type C medicated feeds for increased rate of 
weight gain in pasture cattle.

EFFECTIVE DATE: April 4, 1994.

FOR FURTHER INFORMATION CONTACT: Warner J. Caldwell, Center for 
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1638.

SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., Rt. 202-206 
North, P.O. Box 2500, Somerville, NJ 08876-1258, has filed NADA 141-
034. The NADA provides for expanding the use of currently approved 2-, 
4-, and 10-gram-per-pound bambermycins-containing Type A medicated 
articles to make Type C medicated feeds for increased rate of weight 
gain in pasture cattle (as in related NADA 44-759 which covers broiler 
chickens, growing-finishing swine, growing turkeys, and cattle fed in 
confinement for slaughter). The NADA is approved as of March 4, 1994, 
and the regulations are amended in Sec. 558.95(b) (21 CFR 558.95(b)) to 
reflect the approval.
    As provided in 21 CFR 558.4(a) and (d), bambermycins are Category I 
drugs, which as the sole drug ingredient, do not require an approved 
Form FDA 1900 for making Type C medicated feeds as in approved NADA 
141-034 and in Sec. 558.95, as amended herein.
    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, between 9 a.m. and 4 p.m., 
Monday through Friday.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning March 4, 1994, because the application contains reports of 
new clinical or field investigations (other than bioequivalence or 
residue studies) and, in the case of food-producing animals, human food 
safety studies (other than bioequivalence or residue studies) essential 
to the approval of the application and conducted or sponsored by the 
applicant. The 3 years of marketing exclusivity applies only to the 
claim of increased rate of weight gain in pasture cattle for which the 
application is being approved.
    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 558.95 is amended by adding new paragraph (b)(4)(ii) to 
read as follows:


Sec. 558.95  Bambermycins.

* * * * *
    (b) * * *
    (4) * * *
    (ii) Amount per ton. 4 to 20 grams.
    (a) Indications for use. For increased rate of weight gain.
    (b) Limitations. Feed continuously to pasture cattle (slaughter, 
stocker, and feeder) at a rate of 10 to 20 milligrams of bambermycins 
per head per day in at least 1 pound and not more than 10 pounds of 
Type C medicated feed. Not for use in animals intended for breeding.
* * * * *

    Dated: March 25, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-7884 Filed 4-1-94; 8:45 am]
BILLING CODE 4160-01-F