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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 two new animal drug applications (NADAs) and three abbreviated new animal drug applications (ANADAs) from Delmarva Pharmaceuticals, Inc., to Virbac AH, Inc.

DATES:

This rule is effective September 29, 2003.

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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: dnewkirk@cvm.fda.gov.

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SUPPLEMENTARY INFORMATION:

Delmarva Laboratories, Inc., 1500 Huguenot Rd., suite 106, Midlothian, VA 23113, has informed FDA that it has transferred ownership of, and all rights and interest in, the following two approved NADAs and three approved ANADAs to Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137:

Application No.21 CFR SectionTrade Name
NADA 065-492520.88fROBAMOX V (amoxicillin trihydrate) Tablets
NADA 065-495520.88bROBAMOX V (amoxicillin trihydrate)
ANADA 200-071522.900EUTHASOL Solution
ANADA 200-291520.447CLINSOL (clindamycin hydrochloride) Liquid
ANADA 200-316520.446CLINTABS (clindamycin hydrochloride) Tablets
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Accordingly, the agency is amending the regulations in §§ 520.88b, 520.88f, 520.446, 520.447, and 522.900 to reflect the transfer of ownership.

Following these changes of sponsorship, Delmarva Laboratories, Inc., is no longer the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for Delmarva Laboratories, 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 522

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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

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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 520.88b

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5. Section 520.88f

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6. Section 520.446

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7. Section 520.447

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PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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8. The authority citation for

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

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9. Section 522.900

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Dated: September 15, 2003.

Steven D. Vaughn,

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

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[FR Doc. 03-24492 Filed 9-26-03; 8:45 am]

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