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Start Printed Page 4914
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.
Start Further InfoFOR 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.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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 Number Trade Name 010-092 GALLIMYCIN 50 010-346 COMBUTHAL Powder 012-123 ERYTHRO-100, -200; GALLIMYCIN Injectable 035-157 GALLIMYCIN 100; GALLIMYCIN 500 035-455 ERYTHRO-36 Dry; GALLIMYCIN-36 Dry 035-456 GALLIMYCIN-36 Sterile 038-241 ERYTHRO (High Lev)/Zoalene Plus Arsanilic Acid 038-242 ERYTHRO (Low Lev)/Amp Plus Etho 038-624 PRO-GALLIMYCIN-10 038-661 SPECTAM Water Soluble Concentrate 041-955 Erythromycin Medicated Premix 044-756 TEVCODYNE 055-059 TEVCOCIN Tablets 093-515 SPECTAM Tablets 095-218 Dexamethasone Tablets, 0.25 mg 100-128 Supersweet Medipak TYLAN 10 101-690 ERYTHRO-100 Injection 107-506 CARBAM Tablets 118-032 CARBAM PALATABS 118-979 BUTATRON Gel 120-615 SUSTAIN III Bolus 126-504 Nitrofurazone Ointment 200-050 Neomycin 325 Soluble Powder 200-103 Penicillin G Potassium, USP 200-144 Oxytetracycline 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.
Start List of SubjectsList 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
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:
End Amendment Part Start PartPART 510—NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for 21 CFR part 510 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment Part Start PartPART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part3. The authority citation for 21 CFR part 520 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]4. Section 520.390a Chloramphenicol tablets is amended in paragraph (b)(2) by removing “061133” and by adding in its place “061623”.
End Amendment PartStart Amendment Part[Amended]5. Section 520.540b Dexamethasone tablets and boluses is amended in paragraph (b)(2) by removing “061133” and by adding in its place “061623”.
End Amendment PartStart Amendment Part[Amended]6. Section 520.622a Diethylcarbamazine citrate tablets is amended in paragraph (a)(3) by removing “061133” and by adding in its place “061623”.
End Amendment PartStart Amendment Part[Amended]7. Section 520.823 Erythromycin phosphate is amended in paragraphs (b) by removing “061133” and by adding in its place “061623”.
End Amendment PartStart Amendment Part[Amended]8. Section 520.1484 Neomycin sulfate soluble powder is amended in paragraph (b)(2) by removing “061133” and by adding in its place “061623”.
End Amendment PartStart Amendment Part[Amended]9. Section 520.1660d Oxytetracycline hydrochloride soluble powder is amended in paragraph (b)(7) by removing “061133” and by adding in its place “061623”.
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment PartStart Amendment Part[Amended]12. Section 520.1720d Phenylbutazone gel is amended in paragraph (b) by removing “061133” and by adding in its place “No. 061623”.
End Amendment PartStart Amendment Part[Amended]13. Section 520.2123a Spectinomycin dihydrochloride pentahydrate tablets is amended in paragraph (b) by removing “061133” and by adding in its place “061623”.
End Amendment PartStart Amendment Part[Amended]14. Section 520.2123b Spectinomycin dihydrochloride pentahydrate soluble powder is amended in paragraph (b) by removing “061133” and by adding in its place “061623”.
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment Part Start PartPART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part16. The authority citation for 21 CFR part 522 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]17. Section 522.820 Erythromycin injection is amended in paragraph (a) by removing “061133” and by adding in its place “No. 061623”.
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment Part Start PartPART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part19. The authority citation for 21 CFR part 524 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]20. Section 524.1580b Nitrofurazone ointment is amended in paragraph (b) by removing “061133” and by adding in its place “061623”.
End Amendment Part Start PartPART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part21. The authority citation for 21 CFR part 526 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]22. Section 526.820 Erythromycin is amended in paragraph (b) by removing “061133” and by adding in its place “061623”.
End Amendment Part Start PartPART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
End Part Start Amendment Part23. The authority citation for 21 CFR part 558 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment PartStart Amendment Part[Amended]25. Section 558.625 Tylosin is amended in the table in paragraph (b)(39) by removing “061133” and by adding in its place “061623”.
End Amendment Part Start SignatureEnd Signature End Supplemental InformationDated: January 6, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 03-2295 Filed 1-30-03; 8:45 am]
BILLING CODE 4160-01-S
Document Information
- Effective Date:
- 1/31/2003
- Published:
- 01/31/2003
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- 03-2295
- Dates:
- This rule is effective January 31, 2003.
- Pages:
- 4914-4915 (2 pages)
- PDF File:
- 03-2295.pdf
- CFR: (19)
- 21 CFR 510.600
- 21 CFR 520.823
- 21 CFR 520.1484
- 21 CFR 522.820
- 21 CFR 526.820
- More ...