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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 25 approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) from Bimeda, Inc., to Cross Vetpharm Group Ltd.

DATES:

This rule is effective January 31, 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:

Bimeda, Inc., 291 Forest Prairie Rd., LeSueur, MN 56058, has informed FDA that it has transferred ownership of, and all rights and interest in, the following 25 approved NADAs and ANADAs to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland.

NADA NumberTrade Name
010-092GALLIMYCIN 50
010-346COMBUTHAL Powder
012-123ERYTHRO-100, -200; GALLIMYCIN Injectable
035-157GALLIMYCIN 100; GALLIMYCIN 500
035-455ERYTHRO-36 Dry; GALLIMYCIN-36 Dry
035-456GALLIMYCIN-36 Sterile
038-241ERYTHRO (High Lev)/Zoalene Plus Arsanilic Acid
038-242ERYTHRO (Low Lev)/Amp Plus Etho
038-624PRO-GALLIMYCIN-10
038-661SPECTAM Water Soluble Concentrate
041-955Erythromycin Medicated Premix
044-756TEVCODYNE
055-059TEVCOCIN Tablets
093-515SPECTAM Tablets
095-218Dexamethasone Tablets, 0.25 mg
100-128Supersweet Medipak TYLAN 10
101-690ERYTHRO-100 Injection
107-506CARBAM Tablets
118-032CARBAM PALATABS
118-979BUTATRON Gel
120-615SUSTAIN III Bolus
126-504Nitrofurazone Ointment
200-050Neomycin 325 Soluble Powder
200-103Penicillin G Potassium, USP
200-144Oxytetracycline HCl Soluble Powder; TETROXY

Accordingly, the agency is amending the regulations in 21 CFR 520.390a, 520.540b, 520.622a, 520.823, 520.1484, 520.1660d, 520.1696b, 520.1720a, 520.1720d, 520.2123a, 520.2123b, 520.2260b, 522.820, 522.2444b, 524.1580b, 526.820, 558.248, and 558.625 to reflect the transfer of ownership.

Following this change of sponsorship, Bimeda, Inc., is no longer the sponsor of any approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for Bimeda, 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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, 522, 524, and 526

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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 520.390a

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5. Section 520.540b

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6. Section 520.622a

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7. Section 520.823

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8. Section 520.1484

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9. Section 520.1660d

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10. Section 520.1696b

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11. Section 520.1720a

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12. Section 520.1720d

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13. Section 520.2123a

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14. Section 520.2123b

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15. Section 520.2260b

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PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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16. The authority citation for

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

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17. Section 522.820

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18. Section 522.2444b

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PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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19. The authority citation for

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

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20. Section 524.1580b

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PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

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21. The authority citation for

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

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22. Section 526.820

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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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23. The authority citation for

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Authority: 21 U.S.C. 360b, 371.

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24. Section 558.248

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25. Section 558.625

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Dated: January 6, 2003.

Steven D. Vaughn,

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

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[FR Doc. 03-2295 Filed 1-30-03; 8:45 am]

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