[Federal Register Volume 65, Number 142 (Monday, July 24, 2000)]
[Rules and Regulations]
[Pages 45522-45523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18583]


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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 and 
Roxarsone

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 new animal drug application 
(NADA) filed by Alpharma, Inc. The NADA provides for using approved, 
single-ingredient salinomycin and roxarsone Type A medicated articles 
to make two-way combination Type C medicated feeds used for prevention 
of coccidiosis, increased rate of weight gain, improved feed 
efficiency, and improved pigmentation in roaster and replacement 
breeder and layer) chickens.

DATES: This rule is effective July 24, 2000.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-135 that provides for use of 
approved Bio-Cox (30 or 60 grams per pound (g/lb) of 
salinomycin activity) and 3-Nitro (45.4, 90, 227, or 360 g/lb 
roxarsone) Type A medicated articles to make combination Type C 
medicated feeds for use in roaster and replacement (breeder and layer) 
chickens. The combination Type C medicated feeds contain 40 to 60 g per 
ton (g/ton) salinomycin and 22.7 to 45.4 g/ton roxarsone, and they are 
used for the prevention of coccidiosis caused byEimeria tenella,E. 
necatrix,E. acervulina, E. maxima,E. brunetti, andE. mivati, and for 
increased rate of weight gain, improved feed efficiency, and improved 
pigmentation. The NADA is approved as of May 26, 2000, and the 
regulation in 21 CFR 558.550 is amended to reflect the approval. The 
basis of approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 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, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through 
Friday.
    The agency has determined under 21 CFR 25.33(a)(2) 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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

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:

[[Page 45523]]

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: 21 U.S.C. 360b, 371.


    2. Section 558.550 is amended by adding paragraph (d)(3)(iv) to 
read as follows:


Sec. 558.550  Salinomycin.

* * * * *
    (d) * * *
    (3) * * *
    (iv) Amount per ton. Salinomycin, 40 to 60 grams; and roxarsone, 
22.7 to 45.4 grams.
    (a) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella,E. necatrix,E. acervulina,E. brunetti,E. mivati, 
andE. maxima, and for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation.
    (b) Limitations. Feed continuously as sole ration. Discontinue use 
prior to sexual maturity. Do not feed to laying chickens. Use as sole 
source of organic arsenic. Poultry should have access to drinking water 
at all times. Drug overdosage or lack of water intake may result in leg 
weakness or paralysis. May be fatal if fed to adult turkeys or to 
horses. Withdraw 5 days before slaughter. Salinomycin as provided by 
No. 063238 and roxarsone as provided by No. 046573 in Sec. 510.600(c) 
of this chapter.
* * * * *

    Dated: July 7, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-18583 Filed 7-21-00; 8:45 am]
BILLING CODE 4160-01-F