[Federal Register Volume 59, Number 232 (Monday, December 5, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29855]


[[Page Unknown]]

[Federal Register: December 5, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558

 

New Animal Drugs for Use in Animal Feeds; Monensin and Bacitracin 
Methylene Disalicylate

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, Division of Eli Lily and Co. The 
NADA provides for use of two separately approved Type A medicated 
articles, one containing monensin sodium and the other containing 
bacitracin methylene disalicylate, to make combination Type C medicated 
feeds for the prevention of coccidiosis, for increased rate of weight 
gain and for improved feed efficiency in growing turkeys.

EFFECTIVE DATE: December 5, 1994.

FOR FURTHER INFORMATION CONTACT: James F. McCormack, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1602.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, Division of Eli Lilly 
and Co., Lilly Corporate Center, Indianapolis, IN 46285, has filed NADA 
140-937. The NADA provides for use of separately approved 45 and 60 
grams per pound (g/lb) monensin and 10, 25, 30, 40, 50, and 60 g/lb 
bacitracin methylene disalicylate Type A medicated articles to make 
Type C medicated feeds containing 54 to 90 g per ton (g/t) monensin and 
4 to 50 g/t bacitracin methylene disalicylate. The feed is used for the 
prevention of coccidiosis caused by Eimeria adenoeides, E. 
meleagrimitis, and E. gallopavonis, for increased rate of weight gain, 
and for improved feed efficiency in growing turkeys. The NADA is 
approved as of November 8, 1994, and the regulations are amended in 21 
CFR 558.355(f)(2) to reflect the approval. The basis for approval is 
discussed in the freedom of information summary.
    Certain limitations currently required on the monensin turkey feed 
labeling are not in the regulations. At this time, FDA is adding these 
limitations to the regulations.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857, from 9 a.m. to 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning November 8, 1994, because 
the application contains reports of new clinical or field 
investigations (other than bioequivalence or residue studies) or human 
food safety studies (other than bioequivalence or residue studies) 
essential to the approval and conducted or sponsored by the applicant.
    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 
the 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 558.355 is amended by redesignating paragraphs 
(f)(2)(ii) and (f)(2)(iii) as paragraphs (f)(2)(i)(a) and (f)(2)(i)(b), 
respectively, by revising newly redesignated paragraph (f)(2)(i)(b), 
and by adding new paragraph (f)(2)(ii) to read as follows:


Sec. 558.355  Monensin.

* * * * *
    (f) * * *
    (2) * * *
    (i) * * *
    (b) Limitations. For growing turkeys only; as monensin sodium; 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 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.
    (ii) Amount per ton. Monensin, 54 to 90 grams, and bacitracin 
methylene disalicylate, 4 to 50 grams.
    (a) Indications for use. For prevention of coccidiosis caused by 
Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, for 
increased rate of weight gain, and for improved feed efficiency.
    (b) Limitations. For growing turkeys only; as monensin sodium; 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 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. 
Bacitracin methylene disalicylate as provided by No. 046573 in 
Sec. 510.600(c) of this chapter.
 * * * * *

    Dated: November 18, 1994.
Richard H. Teske,
Deputy Director, Pre-market Review, Center for Veterinary Medicine.
[FR Doc. 94-29855 Filed 12-2-94; 8:45 am]
BILLING CODE 4160-01-F