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Rule

New Animal Drugs; Change of Sponsor

Document Details

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 a change of sponsor for an approved abbreviated new animal drug application (ANADA) from Equi Aid Products, Inc., to Farnam Companies, Inc.

DATES:

This rule is effective August 7, 2002.

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FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-101), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail: lluther@cvm.fda.gov.

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SUPPLEMENTARY INFORMATION:

Equi Aid Products, Inc., 1517 West Knudsen Dr., Phoenix, AZ 85027, has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-168 for CW 48 (pyrantel tartrate) Type A medicated article to Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-3928. Accordingly, the agency is amending the regulations in § 558.485 (21 CFR 558.485) to reflect the transfer of ownership.

Following this change of sponsorship, Equi Aid Products, Inc., is no longer the sponsor of any approved application. Accordingly, § 510.600(c) is amended to remove the entries for Equi Aid Products, Inc.

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

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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 510—NEW ANIMAL DRUGS

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1. The authority citation for

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Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

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[Amended]
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2. Section 510.600

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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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3. The authority citation for

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

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[Amended]
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4. Section 558.485

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Dated: July 17, 2002.

Alan Rudman,

Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

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[FR Doc. 02-19861 Filed 8-6-02; 8:45 am]

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