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