[Federal Register Volume 59, Number 249 (Thursday, December 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-32060]


[[Page Unknown]]

[Federal Register: December 29, 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

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 abbreviated new 
animal drug application (ANADA) filed by Hoechst-Roussel Agri-Vet Co. 
The supplemental ANADA provides for using an additional concentration 
of salinomycin Type A medicated articles to make Type C medicated 
broiler feeds.

EFFECTIVE DATE: December 29, 1994.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-142), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-2701.

SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., P.O. Box 2500, 
Somerville, NJ 08876-1258, filed supplemental ANADA 200-075 which 
provides for using 60 grams per pound (g/lb) salinomycin sodium Type A 
medicated articles in addition to 30 g/lb articles to make Type C 
medicated broiler feeds. The Type C feeds contain 40 to 60 g per ton 
(g/t) salinomycin sodium activity fed to broiler chickens for 
prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. 
acervulina, E. maxima, E. brunetti and E. mivati. The supplement is 
approved as of October 14, 1994, and the regulations are amended in 
Sec. 558.550(a) (21 CFR 558.550(a)) to reflect the approval.
    Approval of supplemental ANADA 200-075 is based on stability data 
submitted with the supplement. Additional safety or efficacy data were 
not required. Therefore, a freedom of information summary as provided 
by part 20 (21 CFR, part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 
514.11(e)(2)(ii)) is not required.
    This ANADA is for use of a single ingredient Type A medicated 
article to make a Type C medicated feed. The firm has several approved 
ANADA's for use of this Type A medicated article in combination with 
other approved Type A medicated articles to make Type C medicated 
feeds. If a Category II drug as in Sec. 558.4 is used in combination 
with this product to make a Type C medicated feed, an approved Form FDA 
1900 is required.
    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).

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


Sec. 558.550  Salinomycin.

    (a) Approvals. Type A medicated articles--30 or 60 grams of 
salinomycin activity per pound from salinomycin sodium biomass:
    (1) To 042835 in Sec. 510.600(c) of this chapter for use of 30 
grams per pound as in paragraph (b) of this section.
    (2) To 012799 for use of 30 and 60 grams per pound as in paragraphs 
(b)(1)(i), (b)(1)(iii) through (b)(1)(xiv), and (b)(3)(i) through 
(b)(3)(ii) of this section.
* * * * *

    Dated: December 16, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-32060 Filed 12-28-94; 8:45 am]
BILLING CODE 4160-01-F