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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 25 approved new animal drug applications (NADAs) from American Cyanamid to Fort Dodge Animal Health.

DATES:

This rule is effective December 24, 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:

American Cyanamid, Division of American Home Products, P.O. Box 1339, Fort Dodge, IA 50501, has informed FDA that it has transferred ownership of, and all rights and interest in, the following 25 approved NADAs to Fort Dodge Animal Health, Division of American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501:

NADA NumberTrade Name
006-084SULMET Drinking Water Solution
008-774SULMET Solution Injectable
011-582VETAMOX Soluble Powder
011-644FELAC
013-957S.E.Z. Drinking Water 6.25%
015-160Sodium Sulfachloropyrazine Solution
033-342PROBAN Cythioate Tablets 30 mg
033-606PROBAN Oral Liquid
033-653S.E.Z. Drinking Water Solution
033-654S.E.Z. Oblets 15 g
033-655S.E.Z. Intravenous Solution
047-033S.E.Z. C-R Oblets 15 g
055-012AUREOMYCIN Sulmet Soluble Powder
055-018AUREOMYCIN Tablets 25 mg
055-020AUREOMYCIN Soluble Powder
055-039AUREOMYCIN Soluble Oblets
065-071AUREOMYCIN Soluble Powder
065-269POLYOTIC Soluble Powder
065-270POLYOTIC Oblets
065-313BACIFERM Soluble 50
065-440AUREOMYCIN Soluble Powder Concentrate
065-441POLYOTIC Soluble Powder Concentrate
122-271SULMET Oblets
122-272SULMET Soluble Powder
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140-844TRAMISOL Pour-On

Accordingly, the agency is amending the regulations in 21 CFR 520.44, 520.154c, 520.445a, 520.445b, 520.445c, 520.530, 520.531, 520.2184, 520.2240a, 520.2240b, 520.2260a, 520.2261a, 520.2261b, 520.2345c, 520.2345d, 522.940, 522.2240, 522.2260, and 524.1240 to reflect the transfer of ownership and to reflect current format.

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

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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[Amended]
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4. Section 520.44

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5. Section 520.154c

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6. Section 520.445a

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7. Section 520.445b

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[Amended]
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8. Section 520.445c

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[Amended]
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9. Section 520.530

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10. Section 520.531

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11. Section 520.2184

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12. Section 520.2240a

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13. Section 520.2240b

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14. Section 520.2260a

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15. Section 520.2261a

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16. Section 520.2261b

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17. Section 520.2345c

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18. Section 520.2345d

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PART 522—IMPLANTATION OR INJECTABLE 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 522.940

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21. Section 522.2240

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22. Section 522.2260

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PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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23. The authority citation for

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

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24. Section 524.1240

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Dated: November 8, 2002.

Steven D. Vaughn,

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

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[FR Doc. 02-32345 Filed 12-23-02; 8:45 am]

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