# [Amended]
**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.
**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: [email protected].
**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 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.
**List of Subjects**
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
Animal drugs.
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:
**21 CFR Part 510**
**PART 510—NEW ANIMAL DRUGS**
1. The authority citation for 21 CFR part 510 continues to read as follows:
**Authority:**
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
**21 CFR Part 510**
§ 510.600
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”.
**21 CFR Part 520**
**PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS**
3. The authority citation for 21 CFR part 520 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 520**
§ 520.390a
4. Section 520.390a *Chloramphenicol tablets* is amended in paragraph (b)(2) by removing “061133” and by adding in its place “061623”.
**21 CFR Part 520**
§ 520.540b
5. Section 520.540b *Dexamethasone tablets and boluses* is amended in paragraph (b)(2) by removing “061133” and by adding in its place “061623”.
**21 CFR Part 520**
§ 520.622a
6. Section 520.622a *Diethylcarbamazine citrate tablets* is amended in paragraph (a)(3) by removing “061133” and by adding in its place “061623”.
**21 CFR Part 520**
§ 520.823
7. Section 520.823 *Erythromycin phosphate* is amended in paragraphs (b) by removing “061133” and by adding in its place “061623”.
**21 CFR Part 520**
§ 520.1484
8. Section 520.1484 *Neomycin sulfate soluble powder* is amended in paragraph (b)(2) by removing “061133” and by adding in its place “061623”.
**21 CFR Part 520**
§ 520.1660d
9. Section 520.1660d *Oxytetracycline hydrochloride soluble powder* is amended in paragraph (b)(7) by removing “061133” and by adding in its place “061623”.
**21 CFR Part 520**
§ 520.1696b
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”.
**21 CFR Part 520**
§ 520.1720a
11. Section 520.1720a *Phenylbutazone tablets and boluses* is amended in paragraph (b)(3) by removing “061133” and by adding in its place “061623”.
**21 CFR Part 520**
§ 520.1720d
12. Section 520.1720d *Phenylbutazone gel* is amended in paragraph (b) by removing “061133” and by adding in its place “No. 061623”.
**21 CFR Part 520**
§ 520.2123a
13. Section 520.2123a *Spectinomycin dihydrochloride pentahydrate tablets* is amended in paragraph (b) by removing “061133” and by adding in its place “061623”.
**21 CFR Part 520**
§ 520.2123b
14. Section 520.2123b *Spectinomycin dihydrochloride pentahydrate soluble powder* is amended in paragraph (b) by removing “061133” and by adding in its place “061623”.
**21 CFR Part 520**
§ 520.2260b
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”.
**21 CFR Part 522**
**PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS**
16. The authority citation for 21 CFR part 522 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 522**
§ 522.820
17. Section 522.820 *Erythromycin injection* is amended in paragraph (a) by removing “061133” and by adding in its place “No. 061623”.
**21 CFR Part 522**
§ 522.2444b
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”.
**21 CFR Part 524**
**PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS**
19. The authority citation for 21 CFR part 524 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 524**
§ 524.1580b
20. Section 524.1580b *Nitrofurazone ointment* is amended in paragraph (b) by removing “061133” and by adding in its place “061623”.
**21 CFR Part 526**
**PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS**
21. The authority citation for 21 CFR part 526 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 526**
§ 526.820
22. Section 526.820 *Erythromycin* is amended in paragraph (b) by removing “061133” and by adding in its place “061623”.
**21 CFR Part 558**
**PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS**
23. The authority citation for 21 CFR part 558 continues to read as follows:
**Authority:**
21 U.S.C. 360b, 371.
**21 CFR Part 558**
§ 558.248
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”.
**21 CFR Part 558**
§ 558.625
25. Section 558.625 *Tylosin* is amended in the table in paragraph (b)(39) by removing “061133” and by adding in its place “061623”.
Dated: January 6, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.