78 FR 56 pgs. 17595-17598 - New Animal Drugs; Changes of Sponsor
Type: RULEVolume: 78Number: 56Pages: 17595 - 17598
Docket number: [Docket No. FDA-2013-N-0002]
FR document: [FR Doc. 2013-06126 Filed 3-21-13; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529, and 558
[Docket No. FDA-2013-N-0002]
New Animal Drugs; Changes of Sponsor
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: steven.vaughn@fda.hhs.gov.
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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
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, 529, and 558 are amended as follows:
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.
§ 510.600 [Amended]
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".
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.
§ 520.100 [Amended]
4. In paragraph (b)(3) of § 520.100, remove "059130" and in its place add "000859".
§ 520.446 [Amended]
5. In paragraph (b)(1) of § 520.446, remove "059130" and in its place add "000859".
§ 520.447 [Amended]
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 [Amended]
7. In paragraph (b)(3) of § 520.1010, remove "058829 and 059130" and in its place add "000859 and 058829".
§ 520.1044b [Amended]
8. In paragraph (b) of § 520.1044b, remove "059130" and in its place add "000859".
§ 520.1192 [Amended]
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 [Amended]
10. In paragraph (b)(2) of § 520.1193, remove "051311 and 059130" and in its place add "000859 and 051311".
§ 520.1195 [Amended]
11. In paragraph (b)(1) of § 520.1195, remove "050604, 054925, and 059130" and in its place add "000859, 050604, and 054925".
§ 520.1484 [Amended]
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 [Amended]
13. In paragraph (b)(2) of § 520.1720a, remove "059130" and in its place add "000859".
§ 520.1870 [Amended]
14. In paragraph (b)(2) of § 520.1870, remove "059130" and in its place add "000859".
§ 520.2043 [Amended]
15. In paragraph (b)(1) of § 520.2043, remove "000069, 058829, and 059130" and in its place add " 000069, 000859, and 058829".
§ 520.2044 [Amended]
16. In paragraph (b)(2) of § 520.2044, remove "059130" and in its place add "000859".
§ 520.2123c [Amended]
17. In paragraph (b) of § 520.2123c, remove "059130" and in its place add "000859".
§ 520.2220a [Amended]
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 [Amended]
19. In paragraph (f)(1) of § 520.2260b, remove "059130" and in its place add "000859".
§ 520.2325a [Amended]
20. In paragraph (a)(1) of § 520.2325a, remove "059130" and in its place add "000859".
21. In § 520.2455, revise paragraph (b)(2) and add paragraph (b)(3) to read as follows:
§ 520.2455 Tiamulin.
(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.
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 [Amended]
23. In paragraph (b)(2) of § 522.23, remove "059130" and in its place add "000859".
§ 522.56 [Amended]
24. In paragraph (b) of § 522.56, remove "059130" and in its place add "000859".
§ 522.246 [Amended]
25. In § 522.246, in paragraphs (b)(2) and (b)(3), remove "059130" and in its place add "000859".
§ 522.390 [Amended]
26. In paragraph (b) of § 522.390, remove "059130" and in its place add "000859".
§ 522.540 [Amended]
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 [Amended]
28. In paragraph (b) of § 522.810, remove "059130" and in its place add "000859".
§ 522.1010 [Amended]
29. In paragraph (b)(3) of § 522.1010, remove "059130" and in its place add "000859".
§ 522.1044 [Amended]
30. In paragraph (b)(4) of § 522.1044, remove "059130" and in its place add "000859".
§ 522.1066 [Amended]
31. In paragraph (b) of § 522.1066, remove "059130" and in its place add "000859".
§ 522.1086 [Amended]
32. In paragraph (b) of § 522.1086, remove "037990 and 059130" and in its place add "000859 and 037990".
§ 522.1182 [Amended]
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 [Amended]
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 [Amended]
35. In paragraph (b) of § 522.1222a, remove "059130" and in its place add "000859".
§ 522.1260 [Amended]
36. In paragraph (b)(2) of § 522.1260, remove "058005 and 059130" and in its place add "000859 and 058005".
§ 522.1660a [Amended]
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 [Amended]
38. In paragraph (i)(2) of § 522.1662a, remove "059130" and in its place add "000859".
§ 522.1680 [Amended]
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 [Amended]
40. In paragraph (b)(2) of § 522.1696a, remove "055529, 059130, and 061623" and in its place add "000859, 055529, and 061623".
§ 522.1696b [Amended]
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 [Amended]
42. In paragraph (b)(1) of § 522.1720, remove "059130" and in its place add "000859".
§ 522.2005 [Amended]
43. In paragraph (b)(1) of § 522.2005, remove "059130" and in its place add "000859".
§ 522.2120 [Amended]
44. In paragraph (b) of § 522.2120, remove "059130" and in its place add "000859".
§ 522. 2220 [Amended]
45. In paragraph (a)(2)(iii) of § 522.2220, remove "059130" and in its place add "000859".
§ 522.2615 [Amended]
46. In paragraph (b) of § 522.2615, remove "053501 and 059130" and in its place add "000859 and 053501".
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 [Amended]
48. In paragraph (b)(3) of § 524.1044g, remove "059130" and in its place add "000859".
§ 524.1193 [Amended]
49. In paragraph (b)(2) of § 524.1193, remove "054925, 059130, and 066916" and in its place add "000859, 054925, and 066916".
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 [Amended]
51. In paragraph (b) of § 529.56, remove "059130" and in its place add "000859".
§ 529.1044a [Amended]
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".
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 [Amended]
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.
[FR Doc. 2013-06126 Filed 3-21-13; 8:45 am]
BILLING CODE 4160-01-P