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Rule

Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Paste

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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 Phoenix Scientific, Inc. The ANADA provides for the oral use of pyrantel pamoate paste for the removal and control of certain internal parasites in horses and ponies.

DATES:

This rule is effective March 20, 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:

Phoenix Scientific, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed ANADA 200-342 that provides for the use of Pyrantel Pamoate Paste for the removal and control of certain internal parasites in horses and ponies. Phoenix Scientific's Pyrantel Pamoate Paste is approved as a generic copy of Pfizer's STRONGID (pyrantel pamoate) Paste approved under NADA 129-831. The ANADA is approved as of January 22, 2003, and the regulations are amended in 21 CFR 520.2044 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 13627a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(1) 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 520

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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 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for

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

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2. Section 520.2044 is amended by revising paragraphs (a) and (b) to read as follows:

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Pyrantel pamoate paste.

(a) Specifications. (1) Each milliliter (mL) contains 180 milligrams (mg) pyrantel base (as pyrantel pamoate).

(2) Each mL contains 226 mg pyrantel base (as pyrantel pamoate).

(b) Sponsors. See sponsors in § 510.600(c) of this chapter.

(1) No. 000069 for use of product described in paragraph (a)(1) of this section.

(2) No. 059130 for use of product described in paragraph (a)(2) of this section.

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Dated: February 25, 2003.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

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[FR Doc. 03-6688 Filed 3-19-03; 8:45 am]

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