[Federal Register Volume 59, Number 52 (Thursday, March 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6225]


[[Page Unknown]]

[Federal Register: March 17, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558

 

New Animal Drugs for Use in Animal Feeds; Salinomycin

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 an abbreviated new animal drug 
application (ANADA) filed by Hoechst-Roussel Agri-Vet Co. The ANADA 
provides for making a Type A medicated article containing salinomycin 
used to make a Type C medicated broiler feed for the prevention of 
coccidiosis in broiler chickens.

EFFECTIVE DATE: March 17, 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: Hoechst-Roussel Agri-Vet Co., P.O. Box 2500, 
Somerville, NJ 08876-1258, filed ANADA 200-075 which provides for 
making a 30 grams (g) per pound salinomycin Type A medicated article 
used to make a Type C medicated broiler feed containing 40 to 60 g of 
salinomycin per ton. The feed is used for the prevention of coccidiosis 
caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati, E. 
necatrix, and E. tenella in broiler chickens.
    ANADA 200-075 for Hoechst-Roussel's salinomycin Type A article is 
as a generic copy of Agri-Bio Corp.'s Bio-Cox (salinomycin Type A 
article) in a new animal drug application (NADA 128-686). The ANADA is 
approved as of February 23, 1994, and the regulations are amended in 21 
CFR 558.550(a) to reflect the approval. The basis for approval is 
discussed in the freedom of information summary.
    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.
    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 
the 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 558.550 is amended by revising paragraph (a) to read as 
follows:


Sec. 558.550  Salinomycin.

    (a) Approvals. Type A medicated article with 30 grams of activity 
per pound from salinomycin sodium biomass: To 012799 in Sec. 510.600(c) 
of this chapter for use as in paragraph (b)(1)(i) of this section; to 
042835 in Sec. 510.600(c) of this chapter for use as in paragraph (b) 
of this section.
* * * * *

    Dated: March 10, 1994.
 Richard H. Teske,
 Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-6225 Filed 3-16-94; 8:45 am]
BILLING CODE 4160-01-F