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Rule

New Animal Drugs for Use in Animal Feeds; Salinomycin, Chlortetracycline, and Roxarsone

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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 an abbreviated new animal drug application (ANADA) filed by Pennfield Oil Co. The ANADA provides for the use of single-ingredient Type A medicated articles containing salinomycin, chlortetracycline, and roxarsone to make three-way combination drug Type C medicated feeds for broiler chickens.

DATES:

This rule is effective July 10, 2003.

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FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: lluther@cvm.fda.gov.

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SUPPLEMENTARY INFORMATION:

Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, filed ANADA 200-355 for use of PENNCHLOR (chlortetracycline), salinomycin, and roxarsone Type A medicated articles to make three-way combination drug Type C medicated feeds for broiler chickens. Pennfield Oil Co.'s ANADA 200-355 is approved as a generic copy of Alpharma, Inc.'s NADA 140-867. The ANADA is approved as of March 31, 2003, and the regulations are amended in 21 CFR 558.550 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 Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 Start Printed Page 41067a.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 558.550 is amended by adding paragraph (a)(3); and in paragraph (d)(1)(xv)(

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Salinomycin.

(a) * * *

(3) To 053389 for use as in paragraph (d)(1)(xv) of this section.

* * * * *
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Dated: June 26, 2003.

Andrew J. Beaulieu,

Acting Director, Center for Veterinary Medicine.

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[FR Doc. 03-17409 Filed 7-9-03; 8:45 am]

BILLING CODE 4160-01-S