[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