[Federal Register: March 17, 1999 (Volume 64, Number 51)]
[Rules and Regulations]               
[Page 13069]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr99-7]

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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 
Virginiamycin

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 Elanco Animal Health, a Division of Eli Lilly and Co. 
The NADA provides for combining approved monensin and virginiamycin 
Type A medicated articles to make combination drug Type C medicated 
growing turkey feeds used for prevention of certain forms of 
coccidiosis and for increased rate of weight gain and improved feed 
efficiency.

EFFECTIVE DATE: March 17, 1999.

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: Elanco Animal Health, a Division of Eli 
Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285, filed 
NADA 141-110 that provides for combining approved monensin and 
virginiamycin Type A medicated articles to make combination drug Type C 
medicated growing turkey feeds containing 54 to 90 grams per ton (g/t) 
monensin and 10 to 20 g/t virginiamycin. The Type C medicated growing 
turkey feed is used for the prevention of coccidiosis caused by Eimeria 
meleagrimitis, E. adenoeides, and E. gallopavonis, and for increased 
rate of weight gain and improved feed efficiency. The NADA is approved 
as of January 29, 1999, and the regulations are amended in 21 CFR 
558.355 to reflect the approval.
     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.
     FDA 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.

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)(2)(iv) to 
read as follows:

Sec. 558.355   Monensin.

* * * * *
     (f) * * *
     (2) * * *
     (iv)  Amount per ton. Monensin, 54 to 90 grams, with 
virginiamycin, 10 to 20 grams.
     (a)  Indications for use. For the prevention of coccidiosis caused 
by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for 
increased rate of weight gain and improved feed efficiency in growing 
turkeys.
     (b)  Limitations. For growing turkeys only. Feed continuously as 
sole ration. Do not allow horses, other equines, mature turkeys, or 
guinea fowl access to feed containing monensin. Ingestion of monensin 
by horses, mature turkeys, and guinea fowl has been fatal. Some strains 
of turkey coccidia may be monensin tolerant or resistant. Monensin may 
interfere with development of immunity to turkey coccidiosis. 
Virginiamycin as provided by No. 000069 in Sec. 510.600(c) of this 
chapter.
* * * * *

    Dated: February 26, 1999.
 Stephen F. Sundlof,
 Director, Center for Veterinary Medicine.
[FR Doc. 99-6460 Filed 3-16-99; 8:45 am]
BILLING CODE 4160-01-F