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Rule

New Animal Drugs; Change of Sponsor; Sulfaquinoxaline

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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 a change of sponsor for an approved new animal drug application (NADA) from Hess & Clark, Inc., to Phoenix Scientific, Inc.

DATES:

This rule is effective October 12, 2004.

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FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: david.newkirk@fda.gov.

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SUPPLEMENTARY INFORMATION:

Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511, has informed FDA that it has transferred ownership of , and all rights and interest in, the following three approved NADAs, to Phoenix Scientific, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503:

NADA NumberTrade Name
6-391S.Q. (sulfaquinoxaline) 40% Medicated Feed
6-677S.Q. (sulfaquinoxaline) 20% Solution
7-087Sulfaquinoxaline Solubilized

Accordingly, the agency is amending the regulations in 21 CFR 520.2325a and 558.586 to reflect the transfer of ownership and a current format.

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 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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[Amended]
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2. Section 520.2325a is amended in paragraph (a)(1) by removing “050749” and by adding in its place “059130”.

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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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4. Section 558.586 is amended by revising the section heading; by removing paragraphs (c) and (d); by redesignating paragraphs (e) and (f) as paragraphs (c) and (d); and by revising paragraph (a) and adding paragraph (b) to read as follows:

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Sulfaquinoxaline.

(a) Specifications. Type A medicated articles containing 40 percent sulfaquinoxaline.

(b) Approvals. See No. 059130 in § 510.600(c) of this chapter.

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Dated: September 27, 2004.

Steven D. Vaughn,

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

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[FR Doc. 04-22760 Filed 10-8-04; 8:45 am]

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