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Rule

New Animal Drugs for Use in Animal Feeds; Decoquinate and Monensin

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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 decoquinate and monensin Type A medicated articles to make two-way combination drug Type B and Type C medicated feeds used for prevention of coccidiosis and improved feed efficiency in cattle fed in confinement for slaughter.

DATES:

This rule is effective December 29, 2000.

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FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7578.

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SUPPLEMENTARY INFORMATION:

Alpharma Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed NADA 141-148 that provides for use of DECCOX® (27.2 gram per pound (g/lb) decoquinate) and Rumensin® (20, 30, 45, 60, 80, or 90.7 g/lb monensin activity as monensin sodium) Type A medicated articles to make two-way combination Type B and Type C medicated feeds. The Type C medicated feeds contain 13.6 to 27.2 g/ton decoquinate and 5 to 30 g/ton monensin, and are used for prevention of coccidiosis caused by Eimeria bovis and E. zuernii, and improved feed efficiency in cattle fed in confinement for slaughter. The NADA is approved as of November 16, 2000, and the regulations in 21 CFR 558.195 and 558.355 are amended to reflect the approval. The basis for 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 Start Printed Page 82913a.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 the Center for Veterinary Medicine,

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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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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 558.195 is amended in the table in paragraph (d) by adding an entry following “13.6 to 27.2 (0.0015 to 0.003 pct)” and before “Chlortetracycline approximately 400” to read as follows:

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Decoquinate.
* * * * *

(d) * * *

Decoquinate in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
 *         *         *         *         *       *        *
Monensin 5 to 30Cattle fed in confinement for slaughter; for prevention of coccidiosis caused by Eimeria bovis and E. zuernii, and improved feed efficiency.Feed only to cattle fed in confinement for slaughter. Feed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb body weight per day and 50 to 360 mg of monensin per head per day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Also see (c)(1) of this paragraph and § 558.355(d)(8). Monensin as monensin sodium provided by 000986 in § 510.600(c) of this chapter.046573
 *         *         *         *         *       *        *
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3. Section 558.355 is amended by adding paragraph (f)(7) to read as follows:

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Monensin.
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(f) * * *

(7) Monensin may also be used in combination with decoquinate as in § 558.195.

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Dated: December 20, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

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[FR Doc. 00-33217 Filed 12-28-00; 8:45 am]

BILLING CODE 4160-01-F