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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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List of Subjects

21 CFR Part 510

  • Administrative practice and procedure
  • Animal drugs
  • Labeling
  • Reporting and recordkeeping requirements

21 CFR Parts 520, 522, 524, and 526

  • Animal drugs

21 CFR Part 558

  • Animal drugs
  • Animal feeds
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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, 21 CFR parts 510, 520, 522, 524, 526, and 558 are amended as follows:

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PART 510—NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 510 continues to read as follows:

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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 Names, addresses, and drug labeler codes of sponsors of approved applications is amended in the table in paragraph (c)(1) by removing the entry for “Bimeda, Inc.” and in the table in paragraph (c)(2) by removing the entry for “061133”.

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PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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3. The authority citation for 21 CFR part 520 continues to read as follows:

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

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4. Section 520.390a Chloramphenicol tablets is amended in paragraph (b)(2) by removing “061133” and by adding in its place “061623”.

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5. Section 520.540b Dexamethasone tablets and boluses is amended in paragraph (b)(2) by removing “061133” and by adding in its place “061623”.

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6. Section 520.622a Diethylcarbamazine citrate tablets is amended in paragraph (a)(3) by removing “061133” and by adding in its place “061623”.

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7. Section 520.823 Erythromycin phosphate is amended in paragraphs (b) by removing “061133” and by adding in its place “061623”.

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8. Section 520.1484 Neomycin sulfate soluble powder is amended in paragraph (b)(2) by removing “061133” and by adding in its place “061623”.

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9. Section 520.1660d Oxytetracycline hydrochloride soluble powder is amended in paragraph (b)(7) by removing “061133” and by adding in its place “061623”.

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10. Section 520.1696b Penicillin G potassium in drinking water is amended in paragraph (b) by removing “061133” and by adding in its place “061623”.

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11. Section 520.1720a Phenylbutazone tablets and boluses is amended in paragraph (b)(3) by Start Printed Page 4915removing “061133” and by adding in its place “061623”.

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12. Section 520.1720d Phenylbutazone gel is amended in paragraph (b) by removing “061133” and by adding in its place “No. 061623”.

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13. Section 520.2123a Spectinomycin dihydrochloride pentahydrate tablets is amended in paragraph (b) by removing “061133” and by adding in its place “061623”.

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14. Section 520.2123b Spectinomycin dihydrochloride pentahydrate soluble powder is amended in paragraph (b) by removing “061133” and by adding in its place “061623”.

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15. Section 520.2260b Sulfamethazine sustained-release boluses is amended in paragraphs (c)(1) and (e)(1) by removing “061133” and by adding in its place “061623”.

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PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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16. The authority citation for 21 CFR part 522 continues to read as follows:

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

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17. Section 522.820 Erythromycin injection is amended in paragraph (a) by removing “061133” and by adding in its place “No. 061623”.

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18. Section 522.2444b Sodium thiopental, sodium pentobarbital for injection is amended in paragraph (b) by removing “061133” and by adding in its place “061623”.

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PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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19. The authority citation for 21 CFR part 524 continues to read as follows:

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

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20. Section 524.1580b Nitrofurazone ointment is amended in paragraph (b) by removing “061133” and by adding in its place “061623”.

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PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

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21. The authority citation for 21 CFR part 526 continues to read as follows:

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

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22. Section 526.820 Erythromycin is amended in paragraph (b) by removing “061133” and by adding in its place “061623”.

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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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23. The authority citation for 21 CFR part 558 continues to read as follows:

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

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24. Section 558.248 Erythromycin thiocyanate is amended in paragraphs (a)(1) and (a)(2) by removing “061133” and by adding in its place “061623”; and in the table in paragraph (d)(1) in the “Sponsor” column by removing “061133” wherever it appears and by adding in its place “061623”.

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25. Section 558.625 Tylosin is amended in the table in paragraph (b)(39) by removing “061133” and by adding in its place “061623”.

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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]

BILLING CODE 4160-01-S