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Rule

New Animal Drugs; Change of Sponsor

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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 four new animal drug applications (NADAs) from PM Resources, Inc., to Virbac AH, Inc.

DATES:

This rule is effective July 9, 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: davidnewkirk@fda.gov.

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SUPPLEMENTARY INFORMATION:

PM Resources, Inc., 13001 St. Charles Rock Rd., Bridgeton, MO 63044, has informed FDA that it has transferred ownership of, and all rights and interest in, the following four approved NADAs to Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137:

Application No.21 CFR SectionTrade Name
NADA 007-076520.2325aSULFA-NOX (sulfaquinoxaline) Liquid
NADA 008-244520.2325aSULFA-NOX (sulfaquinoxaline) Concentrate
NADA 043-215524.900PURINA Grub-Kill (famphur)
NADA 092-150520.2045PURINA Horse & Colt Wormer (pyrantel tartrate)

Accordingly, the agency is amending the regulations in 21 CFR 520.2045, 520.2325a, and 524.900 to reflect the transfer of ownership.

Following these changes of sponsorship, PM Resources, Inc., is no longer the sponsor of an approved application. Accordingly, § 510.600(c) is being amended to remove the entries for PM Resources, 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

and 524

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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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2. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entry for “PM Resources, Inc.” and in the table in paragraph (c)(2) by removing the entry for “060594”.

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PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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3. The authority citation for

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

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4. Section 520.2045 is amended in paragraph (b)(2) by removing “060594” and by adding in its place “051311”.

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5. Section 520.2325a is amended in paragraph (a)(2) by removing “060594” and by adding in its place “051311”.

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PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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6. The authority citation for

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

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7. Section 524.900 is amended in paragraph (c) by removing “060594” and by adding in its place “051311”.

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Dated: June 18, 2004.

Steven D. Vaughn,

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

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[FR Doc. 04-15568 Filed 7-8-04; 8:45 am]

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