# [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 21 approved new animal drug applications (NADAs) and 43 approved abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Bayer HealthCare LLC.
**DATES:**
This rule is effective March 22, 2013.
**FOR FURTHER INFORMATION CONTACT:**
Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855; 240-276-8300; email: *[email protected].*
**SUPPLEMENTARY INFORMATION:**
Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503 has informed FDA that it has transferred ownership of, and all rights and interest in, the following 21 approved NADAs and 43 approved ANADAs to Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201:
| Application No. | Trade name |
| --- | --- |
| 6-391 | S.Q. (sulfaquinoxaline) 40% Type A Medicated Article. |
| 6-677 | S.Q. (sulfaquinoxaline) 20% Solution. |
| 7-087 | Sulfaquinoxaline Solubilized. |
| 33-157 | SPECTAM (spectinomycin) Scour Halt. |
| 40-040 | SPECTAM (spectinomycin) Injectable Solution. |
| 45-416 | TEVCODYNE (phenylbutazone) Injectable Solution. |
| 48-287 | Oxytetracycline-50 Injectable Solution. |
| 55-002 | TEVCOCIN (chloramphenicol) Injection. |
| 65-110 | PEN-G-MAX (penicillin G procaine) Injectable Suspension. |
| 65-498 | DUAL-CILLIN (penicillin G benzathine and penicillin G procaine). |
| 91-818 | Phenylbutazone Tablets, USP 1 gram. |
| 93-483 | SPECTAM (spectinomycin) Injectable Solution. |
| 94-170 | Phenylbutazone Tablets, USP 100 or 200 mg. |
| 99-169 | Oxytocin Injection. |
| 119-142 | PVL Iron Dextran Injectable (iron hydrogenated dextran injection). |
| 123-815 | Dexamethasone Sodium Phosphate Injection. |
| 124-241 | PVL (oxytocin) Injectable. |
| 128-089 | ZONOMETH (dexamethasone) Solution. |
| 140-270 | SULFASURE (sulfamethazine) SR Cattle Bolus. |
| 141-070 | RAPINOVET (propofol) Injectable Emulsion. |
| 141-245 | TRIBUTAME (embutramide, chloroquine, and lidocaine) Euthanasia Solution. |
| 200-042 | Ketamine Hydrochloride Injection, USP. |
| 200-068 | Oxytetracycline Hydrochloride Injection 100. |
| 200-069 | FERTELIN (gonadorelin diacetate tetrahydrate) Injection. |
| 200-108 | Dexamethasone Solution. |
| 200-118 | Neomycin Oral Solution. |
| 200-123 | MAXIM-200 (oxytetracycline hydrochloride) Injection. |
| 200-124 | Flunixin Meglumine Injection. |
| 200-126 | Phenylbutazone 20% Injection. |
| 200-137 | Gentamicin Sulfate Solution (IU). |
| 200-147 | Gentamicin Sulfate Injection. |
| 200-153 | NEO 200 (neomycin sulfate) Oral Solution. |
| 200-162 | Tripelennamine Hydrochloride Injection. |
| 200-174 | Gentamicin Sulfate Pig Pump Oral Solution. |
| 200-177 | Sulfadimethoxine Injection 40%. |
| 200-178 | Amikacin Sulfate Injection. |
| 200-181 | Amikacin Sulfate Solution. |
| 200-192 | Sulfadimethoxine 12.5% Oral Solution. |
| 200-193 | Clindamycin Hydrochloride Oral Liquid. |
| 200-202 | PHOENECTIN (ivermectin) Oral Solution. |
| 200-219 | Ivermectin Pour-On for Cattle. |
| 200-228 | PHOENECTIN (ivermectin) Injectable Solution. |
| 200-230 | Guaifenesin Injection. |
| 200-246 | Pyrantel Pamoate Oral Suspension (OTC and Rx). |
| 200-248 | Pyrantel Pamoate Oral Suspension. |
| 200-253 | PROSTAMATE (dinoprost tromethamine) Injectable Solution. |
| 200-254 | Iron Dextran Injection—100. |
| 200-256 | Iron Dextran Injection—200. |
| 200-265 | Praziquantel Tablets (OTC and Rx). |
| 200-286 | PHOENECTIN (ivermectin) Paste 1.87%. |
| 200-287 | GBC (gentamicin sulfate, betamethasone valerate, and clotrimazole) Ointment. |
| 200-293 | Furosemide Injection 5%. |
| 200-297 | Ivermectin Chewable Tablets. |
| 200-298 | Clindamycin Hydrochloride Capsules. |
| 200-319 | Acepromazine Maleate Injection. |
| 200-322 | Butorphanol Tartrate Injection. |
| 200-342 | Pyrantel Pamoate Paste. |
| 200-351 | Lincomycin Injectable, USP. |
| 200-360 | TIAGARD (tiamulin) Liquid Concentrate. |
| 200-365 | ROBINUL-V (glycopyrrolate) Injectable. |
| 200-382 | Furosemide Syrup 1%. |
| 200-389 | Amprolium 9.6% Oral Solution. |
| 200-408 | Butorphanol Tartrate Injection. |
| 200-463 | Amprolium-P 9.6% Oral Solution. |
Accordingly, the Agency is amending the regulations in 21 CFR parts 510, 520, 522, 524, 529, and 558 to reflect these transfers of ownership. Following these changes of sponsorship, Teva Animal Health, Inc., is no longer the sponsor of an approved application. As such, 21 CFR 510.600 is being amended to remove the entries for this firm.
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, 529, 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. In § 510.600, in the table in paragraph (c)(1), remove the entry for “Teva Animal Health, Inc.”; and in the table in paragraph (c)(2), remove the entry for “059130”.
**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**
§ 520.100
4. In paragraph (b)(3) of § 520.100, remove “059130” and in its place add “000859”.
§ 520.446
**21 CFR Part 520**
5. In paragraph (b)(1) of § 520.446, remove “059130” and in its place add “000859”.
§ 520.447
**21 CFR Part 520**
6. In paragraph (b) of § 520.447, remove “000009, 051311, 058829, and 059130” and in its place add “000009, 000859, 051311, and 058829”.
§ 520.1010
**21 CFR Part 520**
7. In paragraph (b)(3) of § 520.1010, remove “058829 and 059130” and in its place add “000859 and 058829”.
§ 520.1044b
**21 CFR Part 520**
8. In paragraph (b) of § 520.1044b, remove “059130” and in its place add “000859”.
§ 520.1192
**21 CFR Part 520**
9. In paragraph (b)(2) of § 520.1192, remove “051311, 054925, 059130, and 061623” and in its place add “000859, 051311, 054925, and 061623”.
§ 520.1193
**21 CFR Part 520**
10. In paragraph (b)(2) of § 520.1193, remove “051311 and 059130” and in its place add “000859 and 051311”.
§ 520.1195
**21 CFR Part 520**
11. In paragraph (b)(1) of § 520.1195, remove “050604, 054925, and 059130” and in its place add “000859, 050604, and 054925”.
§ 520.1484
**21 CFR Part 520**
12. In paragraph (b)(3) of § 520.1484, remove “000009, 054925, 058005, and 059130” and in its place add “000009, 000859, 054925, and 058005”.
§ 520.1720a
**21 CFR Part 520**
13. In paragraph (b)(2) of § 520.1720a, remove “059130” and in its place add “000859”.
§ 520.1870
**21 CFR Part 520**
14. In paragraph (b)(2) of § 520.1870, remove “059130” and in its place add “000859”.
§ 520.2043
**21 CFR Part 520**
15. In paragraph (b)(1) of § 520.2043, remove “000069, 058829, and 059130” and in its place add ” 000069, 000859, and 058829”.
§ 520.2044
**21 CFR Part 520**
16. In paragraph (b)(2) of § 520.2044, remove “059130” and in its place add “000859”.
§ 520.2123c
**21 CFR Part 520**
17. In paragraph (b) of § 520.2123c, remove “059130” and in its place add “000859”.
§ 520.2220a
**21 CFR Part 520**
18. In paragraph (a)(1) of § 520.2220a, remove “000010, 000069, 054925, 057561, and 059130” and in its place add “000010, 000069, 000859, 054925, and 057561”.
§ 520.2260b
**21 CFR Part 520**
19. In paragraph (f)(1) of § 520.2260b, remove “059130” and in its place add “000859”.
§ 520.2325a
**21 CFR Part 520**
20. In paragraph (a)(1) of § 520.2325a, remove “059130” and in its place add “000859”.
**21 CFR Part 520**
21. In § 520.2455, revise paragraph (b)(2) and add paragraph (b)(3) to read as follows:
§ 520.2455
(b) * * *
(2) No. 066104 for the product described in paragraph (a)(1) of this section.
(3) No. 000859 for the product described in paragraph (a)(3) of this section.
**21 CFR Part 522**
**PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS**
22. The authority citation for 21 CFR part 522 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
§ 522.23
**21 CFR Part 520**
23. In paragraph (b)(2) of § 522.23, remove “059130” and in its place add “000859”.
§ 522.56
**21 CFR Part 520**
24. In paragraph (b) of § 522.56, remove “059130” and in its place add “000859”.
§ 522.246
**21 CFR Part 520**
25. In § 522.246, in paragraphs (b)(2) and (b)(3), remove “059130” and in its place add “000859”.
§ 522.390
**21 CFR Part 522**
26. In paragraph (b) of § 522.390, remove “059130” and in its place add “000859”.
§ 522.540
**21 CFR Part 522**
27. In § 522.540, in paragraphs (a)(2)(i), (d)(2)(i), and (e)(2), remove “059130” and in its place add “000859”; in paragraphs (b)(3)(i), (b)(3)(ii), (c)(3)(i), and (c)(3)(ii), remove the footnote reference “1”; and remove the text of footnote 1.
§ 522.810
**21 CFR Part 522**
28. In paragraph (b) of § 522.810, remove “059130” and in its place add “000859”.
§ 522.1010
**21 CFR Part 522**
29. In paragraph (b)(3) of § 522.1010, remove “059130” and in its place add “000859”.
§ 522.1044
**21 CFR Part 522**
30. In paragraph (b)(4) of § 522.1044, remove “059130” and in its place add “000859”.
§ 522.1066
**21 CFR Part 522**
31. In paragraph (b) of § 522.1066, remove “059130” and in its place add “000859”.
§ 522.1086
**21 CFR Part 522**
32. In paragraph (b) of § 522.1086, remove “037990 and 059130” and in its place add “000859 and 037990”.
§ 522.1182
**21 CFR Part 522**
33. In § 522.1182, in paragraph (b)(1), remove “042552 and 059130” and in its place add “000859 and 042552”; in paragraph (b)(6), remove “058005 and 059130” and in its place add “000859 and 058005”; and in paragraph (b)(7), remove “042552 and 059130” and in its place add “000859 and 042552”.
§ 522.1192
**21 CFR Part 522**
34. In paragraph (b)(2) of § 522.1192, remove “055529, 058005, 059130, and 061623” and in its place add “000859 055529, 058005, and 061623”.
§ 522.1222a
**21 CFR Part 522**
35. In paragraph (b) of § 522.1222a, remove “059130” and in its place add “000859”.
§ 522.1260
**21 CFR Part 522**
36. In paragraph (b)(2) of § 522.1260, remove “058005 and 059130” and in its place add “000859 and 058005”.
§ 522.1660a
**21 CFR Part 522**
37. In paragraph (b) of § 522.1660a, remove “000010, 000069, 048164, 055529, 057561, 059130, and 061623” and in its place add “000010, 000069, 000859, 048164, 055529, 057561, and 061623”.
§ 522.1662a
**21 CFR Part 522**
38. In paragraph (i)(2) of § 522.1662a, remove “059130” and in its place add “000859”.
§ 522.1680
**21 CFR Part 522**
39. In paragraph (b) of § 522.1680, remove “000010, 000856, 059130, 059130, and 061623” and in its place add “000010, 000856, 000859, and 061623”.
§ 522.1696a
**21 CFR Part 522**
40. In paragraph (b)(2) of § 522.1696a, remove “055529, 059130, and 061623” and in its place add “000859, 055529, and 061623”.
§ 522.1696b
**21 CFR Part 522**
41. In § 520.1696b:
a. In paragraph (b)(1), remove “053501, 055529, and 059130” and in its place add “000859, 053501, and 055529”.
b. In paragraph (d)(2)(i)(A), remove “053501, 055529, 059130, and 061623” and in its place add “000859, 053501, 055529, and 061623”.
c. In paragraph (d)(2)(iii)(B), remove “055529 and 059130” and in its place add “000859 and 055529”.
§ 522.1720
**21 CFR Part 522**
42. In paragraph (b)(1) of § 522.1720, remove “059130” and in its place add “000859”.
§ 522.2005
**21 CFR Part 522**
43. In paragraph (b)(1) of § 522.2005, remove “059130” and in its place add “000859”.
§ 522.2120
**21 CFR Part 522**
44. In paragraph (b) of § 522.2120, remove “059130” and in its place add “000859”.
§ 522.
**21 CFR Part 522**
45. In paragraph (a)(2)(iii) of § 522.2220, remove “059130” and in its place add “000859”.
§ 522.2615
**21 CFR Part 522**
46. In paragraph (b) of § 522.2615, remove “053501 and 059130” and in its place add “000859 and 053501”.
**21 CFR Part 524**
**PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS**
47. The authority citation for 21 CFR part 524 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
§ 524.1044g
**21 CFR Part 524**
48. In paragraph (b)(3) of § 524.1044g, remove “059130” and in its place add “000859”.
§ 524.1193
**21 CFR Part 524**
49. In paragraph (b)(2) of § 524.1193, remove “054925, 059130, and 066916” and in its place add “000859, 054925, and 066916”.
**21 CFR Part 529**
**PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS**
50. The authority citation for 21 CFR part 529 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
§ 529.56
**21 CFR Part 529**
51. In paragraph (b) of § 529.56, remove “059130” and in its place add “000859”.
§ 529.1044a
**21 CFR Part 529**
52. In paragraph (b) of § 529.1044a, remove “000010, 000061, 000856, 057561, 058005, 059130, and 061623” and in its place add “000010, 000061, 000856, 000859, 057561, 058005, and 061623”.
**21 CFR Part 558**
**PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS**
53. The authority citation for 21 CFR part 558 continues to read as follows:
**Authority:**
21 U.S.C. 360b, 371.
§ 558.586
**21 CFR Part 558**
54. In paragraph (b) of § 558.586, remove “059130” and in its place add “000859”.
Dated: March 12, 2013.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.