[Federal Register Volume 65, Number 175 (Friday, September 8, 2000)]
[Rules and Regulations]
[Pages 54411-54412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23053]


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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; Monensin 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 use of approved 
single-ingredient monensin and roxarsone Type A medicated articles to 
make two-way combination drug Type C medicated feed used as an aid in 
the prevention of coccidiosis and for increased rate of weight gain, 
improved feed efficiency, and improved pigmentation in replacement 
chickens.

DATES: This rule is effective September 8, 2000.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug

[[Page 54412]]

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 141-139 that provides for use of 
Coban (45 or 60 grams per pound (g/lb) of monensin as 
monensin sodium) and 3-Nitro (45.4, 90, 227, or 360 g/lb 
roxarsone) Type A medicated articles to make combination Type C 
medicated feeds for replacement chickens intended for use as caged 
layers. The Type C medicated feeds contain 90 to 110 g/ton monensin and 
22.7 to 45.4 g/ton roxarsone, and they are used as an aid in the 
prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. 
acervulina, E. brunetti, E. mivati, and E. maxima, and for increased 
rate of weight gain, improved feed efficiency, and improved 
pigmentation. The NADA is approved as of June 28, 2000, and the 
regulations in 21 CFR 558.355 are 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 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:

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 558.355 is amended by adding paragraph (f)(4)(iv) to 
read as follows:


Sec. 558.355  Monensin.

* * * * *
    (f) * * *
    (4) * * *
    (iv) Amount per ton. Monensin, 90 to 110 grams, plus roxarsone, 
22.7 to 45.4 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima, and for increased rate of weight gain, improved 
feed efficiency, and improved pigmentation.
    (b) Limitations. Feed continuously as sole ration. Use as sole 
source of organic arsenic. Withdraw 5 days before slaughter. Do not 
feed to laying chickens. Do not feed to chickens over 16 weeks of age. 
Poultry should have access to drinking water at all times. Drug 
overdosage
    or lack of water may result in leg weakness or paralysis. As 
monensin sodium provided by 000986; roxarsone as provided by 046573 in 
Sec. 510.600(c) of this chapter.
* * * * *

    Dated: July 25, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-23053 Filed 9-7-00; 8:45 am]
BILLING CODE 4160-01-F