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New Animal Drugs for Use in Animal Feeds; Monensin and Tylosin Phosphate

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Food and Drug Administration, HHS.


Final rule.


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. The NADA provides for use of approved, single-ingredient monensin and tylosin phosphate Type A medicated articles to make two-way combination Type C medicated feeds used as an aid in the prevention of coccidiosis, for increased rate of weight gain, and improved feed efficiency in broiler chickens. Technical corrections are also being made.


This rule is effective September 5, 2000.

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

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Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 141-164 that provides for use of Coban® (44, 45, or 60 grams per pound (g/lb) of monensin activity as monensin sodium) and Tylan® (10 g/lb of tylosin phosphate) Type A medicated articles to make combination Type C medicated broiler chicken feeds. The combination Type C medicated feeds contain 90 to 110 g/ton monensin and 4 to 50 g/ton tylosin phosphate and are used as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, for increased rate of weight gain, and improved feed efficiency in broiler chickens. The NADA is approved as of July 3, 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.

Also, 21 CFR 558.625 is being revised by updating the address for Dockets Management Branch in paragraph (a) and by moving paragraph (f)(1)(vi)(e) to precede paragraph (f)(2), correcting a sequence error in the format of this paragraph.

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.

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List of Subjects in 21 CFR Part 558

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to

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1. The authority citation for

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

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2. Section 558.355 is amended by adding paragraph (f)(1)(xxviii) to read as follows:

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(f) * * *

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(xxviii) Amount per ton. Monensin, 90 to 110 grams, plus tylosin phosphate, 4 to 50 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, for increased rate of weight gain, and improved feed efficiency.

(b) Limitations. Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. As monensin sodium and tylosin phosphate provided by No. 000986 in § 510.600(c) of this chapter.

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3. Section 558.625

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Dated: August 23, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

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[FR Doc. 00-22572 Filed 9-1-00; 8:45 am]