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Rule

New Animal Drugs for Use in Animal Feeds; Diclazuril

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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 the use of approved, single-ingredient Type A medicated articles containing diclazuril and roxarsone to formulate two-way combination drug Type C medicated feeds for broiler chickens.

DATES:

This rule is effective March 3, 2004.

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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, e-mail: candres@cvm.fda.gov.

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SUPPLEMENTARY INFORMATION:

Alpharma Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed NADA 141-223 for use of CLINACOX (diclazuril) and 3-NITRO (roxarsone) Type A medicated articles to formulate two-way combination drug Type C medicated feeds for broiler chickens. The NADA is approved as of January 27, 2004, and the regulations are amended in 21 CFR 558.198 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 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 Division of Dockets Management (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 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 558.198 is amended in the table in paragraph (d)(1) by redesignating paragraphs (d)(1)(vi) and (d)(1)(vii) as paragraphs (d)(1)(vii) and (d)(1)(viii), respectively, and by adding new paragraph (d)(1)(vi) to read as follows:

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Diclazuril.
* * * * *

(d) * * *

(1) * * *

Diclazuril grams/tonCombination grams/tonIndications for useLimitationsSponsor
*         *         *         *         *         *         *
(vi) 0.91(1 ppm)Roxarsone 22.7 to 45.4Broiler chickens: As in item (i) of this table; for increased rate of weight gain, improved feed efficiency, and improved pigmentation.Feed continuously as the sole ration throughout growing period. Use as sole source of organic arsenic; drug overdose or lack of water may result in leg weakness. Not for use in hens producing eggs for human consumption. Withdraw 5 days before slaughter. Roxarsone provided by No. 046573 in § 510.600(c) of this chapter.046573
*         *         *         *         *         *         *
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Dated: February 23, 2004.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

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[FR Doc. 04-4654 Filed 3-2-04; 8:45 am]

BILLING CODE 4160-01-S