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Rule

Oral Dosage Form 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 the change of sponsor for a new animal drug application (NADA) from Merial Ltd., to Vétoquinol N.-A., Inc.

DATES:

This rule is effective April 18, 2000.

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FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0213.

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SUPPLEMENTARY INFORMATION:

Merial Ltd., 2100 Ronson Rd., Iseline, NJ 08830-3077, has informed FDA that it has transferred the ownership of, and all rights and interests in, the approved NADA 113-510 (phenylbutazone granules) to Vétoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J0K 1H0. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) and 520.1720b(b) to reflect the change of sponsor.

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 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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2. Section 510.600 is amended in the table in paragraph (c)(1) by alphabetically adding an entry for “Vétoquinol N.-A., Inc.,” and in the table in paragraph (c)(2) by numerically adding an entry for “059320” to read as follows:

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Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
 *          *          *          *          *          *          *  
Vetoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J0K 1H0059320
 *          *          *          *          *          *          *  

(2) * * *

Drug labeler codeFirm name and address
 *          *          *          *          *          *          *  
059320Vetoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J0K 1H0
 *          *          *          *          *          *          *  
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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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[Amended]
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4. Section 520.1720b

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Dated: March 17, 2000.

Claire M. Lathers,

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

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[FR Doc. 00-9573 Filed 4-17-00; 8:45 am]

BILLING CODE 4160-01-F