[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]
BILLING CODE 4160-01-F
