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Rule

New Animal Drugs; Change of Sponsor

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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 12 approved new animal drug applications (NADAs) from A. H. Robins Co. to Fort Dodge Animal Health, Division of Wyeth.

DATES:

This rule is effective November 6, 2002.

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FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: lluther@cvm.fda.gov.

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SUPPLEMENTARY INFORMATION:

A. H. Robins Co., P.O. Box 518, Fort Dodge, IA 50501-0518, has informed FDA that it has transferred ownership of, and all rights and interest in, the following 12 approved NADAs to Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501:

NADA NumberProduct Name
034-879DOPRAM-V Injectable
038-838ROBAXIN-V Injectable
045-715ROBAXIN-V Tablets
091-065ROBIZONE-V
093-105ROBIZONE-V
098-640ROBIZONE Injectable 20%
101-777Robinul-V Injectable
106-111Telazol
136-651Guailaxin
141-003Derm-Otic Ointment
141-004Robamox-V
141-005Robamox-V Tablets

Accordingly, the agency is amending the regulations in 21 CFR 520.88b, 520.88f, 520.1380, 520.1720a, 522.775, 522.1066, 522.1085, 522.1380, 522.1720, 522.2470, and 524.1600a to reflect the transfer of ownership and to reflect current format.

Following this change of sponsorship, A. H. Robins Co. is no longer the sponsor of any approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for A. H. Robins Co.

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

, 522, 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

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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 520.1380

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7. Section 520.1720a

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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 522.775

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10. Section 522.1066

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11. Section 522.1085

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12. Section 522.1380

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13. Section 522.1720

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14. Section 522.2470

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PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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15. The authority citation for

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

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16. Section 524.1600a

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Dated: October 28, 2002.

Andrew J. Beaulieu,

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

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[FR Doc. 02-28156 Filed 11-5-02; 8:45 am]

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