[Federal Register Volume 66, Number 43 (Monday, March 5, 2001)]
[Rules and Regulations]
[Page 13238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5219]


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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 Tylosin

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 Elanco Animal Health. The supplemental NADA 
provides for use of monensin and tylosin single-ingredient Type A 
medicated articles to make combination drug Type C medicated feeds used 
for improved feed efficiency, prevention and control of coccidiosis, 
and reduction of the incidence of liver abscesses in cattle fed in 
confinement for slaughter.

DATES: This rule is effective March 5, 2001.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed 
supplemental NADA 104-646 that provides for use of RUMENSIN 
(20, 30, 45, 60, 80, or 90.7 grams per pound (g/lb) monensin activity 
as monensin sodium) and TYLAN (10, 40, or 100 g/lb tylosin 
phosphate) Type A medicated articles to make combination drug Type C 
medicated feeds for cattle fed in confinement for slaughter. The Type C 
medicated feeds contain 10 to 30 g/ton monensin and 8 to 10 g/ton 
tylosin, and are used for improved feed efficiency, prevention and 
control of coccidiosis caused by Eimeria bovis and E. zuernii, and 
reduction of the incidence of liver abscesses caused by Fusobacterium 
necrophorum and Actinomyces (Corynebacterium) pyogenes. The 
supplemental NADA is approved as of February 2, 2001, and the 
regulations are amended in 21 CFR 558.355 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)(3)(xii) to 
read as follows:


Sec. 558.355  Monensin.

* * * * *
    (f) * * *
    (3) * * *
    (xii) Amount per ton. Monensin, 10 to 30 grams; plus tylosin, 8 to 
10 grams.
    (a) Indications for use. For improved feed efficiency, prevention 
and control of coccidiosis due to Eimeria bovis and E. zuernii, and 
reduction of incidence of liver abscesses caused by Fusobacterium 
necrophorum and Actinomyces (Corynebacterium) pyogenes.
    (b) Limitations. Feed only to cattle being fed in confinement for 
slaughter. Feed continuously to provide 50 to 360 milligrams monensin 
per head per day. For prevention and control of coccidiosis, feed at a 
rate of 0.14 to 0.42 milligram monensin per pound of body weight per 
day, depending upon the severity of challenge, up to maximum of 360 
milligrams per head per day; and 60 to 90 milligram of tylosin per head 
per day.
* * * * *

    Dated: February 15, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation Center for Veterinary 
Medicine.
[FR Doc. 01-5219 Filed 3-2-01; 8:45 am]
BILLING CODE 4160-01-F