[Federal Register Volume 59, Number 188 (Thursday, September 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24148]
[[Page Unknown]]
[Federal Register: September 29, 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 a supplemental new animal drug
application (NADA) filed by Agri-Bio Corp. The supplemental NADA
provides for expanding the use of a currently approved Type A medicated
article containing salinomycin in order to make Type C medicated quail
feeds for the prevention of coccidiosis in quail.
EFFECTIVE DATE: September 29, 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: Agri-Bio Corp., P.O. Box 897, Gainesville,
GA 30503, is the sponsor of currently approved NADA 128-686. The NADA
provides for use of a Type A medicated article containing 30 grams (g)
of salinomycin sodium activity per pound to make Type C medicated feeds
containing 40 to 60 g of the drug per ton (g/ton) for the prevention of
coccidiosis in broiler chickens caused by certain Eimeria species. The
firm has filed a supplemental NADA which provides for expanding the use
of the above-mentioned Type A medicated article to make Type C
medicated quail feeds at a drug concentration of 50 g/ton for the
prevention of coccidiosis in quail caused by E. dispersa and E.
lettyae. The supplemental NADA is approved as of September 1, 1994, and
the regulations are amended in 21 CFR 558.550(b) 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.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food-
producing animals does not qualify for marketing exclusivity because
the application does not contain reports of new clinical or field
investigations (other than bioequivalence or residue studies) and new
human food safety studies (other than bioequivalence or residue
studies) essential to the approval of the supplement and conducted or
sponsored by the applicant.
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
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 adding new paragraph (b)(2) to
read as follows:
Sec. 558.550 Salinomycin.
* * * * *
(b) * * *
(2) Quail--(i)(a) Amount per ton. Salinomycin 50 grams.
(b) Indications for use. For the prevention of coccidiosis caused
by E. dispersa and E. lettyae.
(c) Limitations. Feed continuously as sole ration. Not approved for
use with pellet binders. May be fatal if accidentally fed to adult
turkeys or horses.
(ii) [Reserved]
* * * * *
Dated: September 21, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 94-24148 Filed 9-28-94; 8:45 am]
BILLING CODE 4160-01-F
