[Federal Register Volume 59, Number 63 (Friday, April 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7725]


[[Page Unknown]]

[Federal Register: April 1, 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 Methylene Disalicylate

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 methylene disalicylate.

EFFECTIVE DATE: April 1, 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, has filed ANADA 200-081. 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) 
salinomycin sodium activity, 45.4 g/t roxarsone, and 4 to 50 g/t 
bacitracin methylene disalicylate, for 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 salinomycin alone; and for increased rate of weight 
gain.
    ANADA 200-081 is approved as a generic copy of Agri-Bio's NADA 135-
321. ANADA 200-081 is approved as of April 1, 1994. The regulations are 
amended in 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 21 CFR 558.4, requires an approved form FDA 
1900 for making a Type C medicated feed. Therefore, use of salinomycin, 
roxarsone, and bacitracin methylene disalicylate Type A medicated 
articles to make Type C medicated feeds as provided in ANADA 200-081 
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. to 4 p.m., 
Monday through Friday.
    FDA 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).

    2. Section 558.550 Salinomycin is amended by revising paragraph 
(a)(2) to read as follows:


Sec. 558.550  Salinomycin.

    (a) * * *
    (2) To 012799 for use as in paragraphs (b)(1)(i), (b)(1)(iv), and 
(b)(3)(i) of this section.
* * * * *

    Dated: March 25, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-7725 Filed 3-31-94; 8:45 am]
BILLING CODE 4160-01-F