[Federal Register Volume 59, Number 81 (Thursday, April 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-10019]


[Federal Register: April 28, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Salinomycin, Roxarsone, 
and Bacitracin Zinc

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 using approved single ingredient Type A medicated articles 
to make Type C medicated broiler feeds containing salinomycin with 
roxarsone and bacitracin zinc.

EFFECTIVE DATE: April 28, 1994.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1602.

SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., P.O. Box 2500, 
Somerville, NJ 08876-1258, filed ANADA 200-086 for the use of 
salinomycin with roxarsone and bacitracin zinc. The ANADA provides for 
using approved single ingredient Type A medicated articles to make Type 
C medicated broiler feeds containing 40 to 60 grams per ton (g/t) of 
salinomycin sodium activity, 45.4 g/t of roxarsone, and 4 to 50 g/t of 
bacitracin zinc, for the prevention of coccidiosis in broiler chickens 
caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. 
brunetti, and E. mivati, including some field strains of E. tenella 
that are more susceptible to roxarsone combined with salinomycin than 
to salinomycin alone, and for increased rate of weight gain and 
improved feed efficiency.
    ANADA 200-086 is as a generic copy of Agri-Bio's NADA 137-536 and 
is approved as of April 27, 1994. The regulations are amended in 
Sec. 558.550 Salinomycin (21 CFR 558.550) to reflect the approval.
    This approval is for use of single ingredient Type A medicated 
articles to make Type C medicated feeds. Roxarsone is a Category II 
drug which, as provided in Sec. 558.4, requires an approved Form FDA 
1900 for making a Type C feed. Therefore, the use of salinomycin, 
roxarsone, and bacitracin zinc Type A medicated articles to make Type C 
medicated feeds as provided in ANADA 200-086 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 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 determined under 21 CFR 25.24(d)(1)(ii) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
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: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

Sec. 558.550  [Amended]

    2. Section 558.550 Salinomycin is amended in paragraph (a)(2) by 
adding ``(b)(1)(viii),'' after ``(b)(1)(vi)''.

    Dated: April 18,1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-10019 Filed 4-26-94; 8:45 am]
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