New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in November and December 2015.

DATES:

This rule is effective March 30, 2016.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Approval Actions

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during November and December 2015, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

II. Changes of Sponsorship

Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201 (Bayer) has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816:

Bayer has also informed FDA that it has transferred ownership of, and all rights and interest in, approved ANADA 200-342 for Pyrantel Pamoate Paste to Farnam Companies, Inc., 301 West Osborn Rd., Phoenix, AZ 85013-3928.

Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Hwy., St. Joseph, MO 64506-2002 has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:

In addition, Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408 (Novartis) has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140.

As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship. Elanco US, Inc., is retaining Novartis' drug labeler code (058198). Accordingly, the animal drug regulations need only be amended in § 510.600(c) to add Elanco US, Inc., who previously was not the sponsor of an approved application. Cronus Pharma LLC will also be added as a new listing. Following these changes of sponsorship, Novartis is no longer the sponsor of an approved application and will be removed from § 510.600(c).

III. Technical Amendments

FDA has noticed the animal drug regulations in 21 CFR part 556 contain tolerances for residues in edible tissues for sulfathiazole, which is no longer the subject of an approved application (79 FR 15540, March 20, 2014). Accordingly, § 556.690 is being removed. FDA has also noticed that the animal drug regulations in 21 CFR 558.4 (§ 558.4) contain assay limits for ronnel and sulfaethoxypyridazine in medicated feed. As there is no longer an approved application for use of either of these drugs in medicated feed, the table for Category II drugs in § 558.4 is being amended to remove assay limits in medicated feed for both drugs. These actions are being taken to improve the accuracy of the regulations.

In addition, FDA is taking this opportunity to revise the spelling of a bacitracin salt to a preferred form, bacitracin methylenedisalicylate, and to correct the spelling of a genus of pathogenic bacteria, Haemophilus. These actions are being taken to improve the accuracy of the regulations.

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, 528, and 529

• Animal drugs

21 CFR Part 556

• Animal drugs
• Foods

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, 528, 529, 556, 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.

2. In § 510.600, in the table in paragraph (c)(1), remove the entry for “Novartis Animal Health US, Inc.” and add entries for “Cronus Pharma LLC” and “Elanco US, Inc.” in alphabetical order; and in the table in paragraph (c)(2), revise the entry for “058198” and add an entry for “069043” in numerical order to read as follows:

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.

4. In § 520.88b, in paragraph (b)(1)(ii)(B), remove “ Hemophilus” and in its place add “Haemophilus”.

5. In § 520.154b:

a. Revise the section heading.

b. In paragraph (a), remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

The revision reads as follows:

6. In § 520.441, in paragraphs (b)(2) and (d)(4)(iii)(C), remove “000010” and in its place add “016592”; and in in paragraphs (d)(1)(i)(A)( 1), (d)(2)(i)(A)(1), (d)(4)(iii)(B), and (d)(4)(iv)(B), remove “Hemophilus” and in its place add “Haemophilus”.

7. In § 520.443, in paragraph (b), remove “No. 054628” and in its place add “Nos. 016592 and 054628”; and in paragraphs (d)(1)(i), (d)(2)(i), and (d)(3)(i), remove “ Hemophilus” and in its place add “Haemophilus”.

8. In § 520.445, in paragraph (b), remove “000010” and in its place add “016592”.

9. In § 520.446, in paragraph (b)(1), remove “No. 054771” and in its place add “Nos. 054771 and 069043”.

10. In § 520.447, in paragraph (b), remove “Nos. 000859, 051311, 054771, 058829, and 061623” and in its place add “Nos. 051311, 054771, 058829, 061623, and 069043”.

11. In § 520.823, in paragraph (d)(2)(ii), remove “ Hemophilus” and in its place add “Haemophilus”.

12. In § 520.1010, in paragraph (b)(3), remove “Nos. 000859 and 058829” and in its place add “Nos. 058829 and 069043”.

13. In § 520.1193, in paragraph (b)(2), remove “Nos. 000859 and 051311” and in its place add “Nos. 051311 and 069043”.

14. In § 520.1720a, in paragraph (b)(2), remove “Nos. 000859 and 054628” and in its place add “Nos. 054628 and 069043”.

15. In § 520.1870, revise paragraph (b) to read as follows:

16. In § 520.2043, in paragraph (b)(1), remove “Nos. 000859, 054771, and 058829” and in its place add “Nos. 054771, 058829, and 069043”.

17. In § 520.2044, in paragraph (b)(2), remove “000859” and in its place add “017135”.

18. In § 520.2200, in paragraph (b), remove “000010” and in its place add “016592”.

19. In § 520.2260a, in paragraph (a)(1), remove “000010” and in its place add “016592”.

20. In § 520.2261a, in paragraph (b), remove “000010” and in its place add “016592”.

21. In § 520.2261b, in paragraph (b), remove “000010” and in its place add “016592”.

22. In § 520.2345d, in paragraphs (b)(5), (d)(1)(iii), and (d)(2)(iii), remove “000010” and in its place add “016592”; and in paragraphs (d)(1)(ii) and (d)(2)(ii), remove “ Hemophilus” and in its place add “Haemophilus”.

23. In § 520.2471, revise paragraph (d)(2) to read as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

24. The authority citation for 21 CFR part 522 continues to read as follows:

Authority: 21 U.S.C. 360b.

25. In § 522.56, in paragraph (b), remove “000859” and in its place add “069043”.

26. In § 522.390, in paragraph (b), remove “Nos. 000859 and 054771” and in its place add “Nos. 054771 and 069043”.

27. In § 522.540, in paragraph (e)(2), remove “000859” and in its place add “069043”.

28. In § 522.810, in paragraph (b), remove “000859” and in its place add “069043”.

29. In § 522.1066, in paragraph (b), remove “Nos. 000859 and 054771” and in its place add “Nos. 054771 and 069043”.

30. In § 520.1662a, in paragraphs (b)(3)(i)( b), (c)(3)(i), (d)(3)(i)(a), (e)(3)(i)(b), (g)(3)(i)(b), and (k)(3)(ii), remove “Hemophilus” and in its place add “Haemophilus”.

31. In § 522.2260, in paragraph (b), remove “000010” and in its place add “016592”.

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

32. The authority citation for 21 CFR part 524 continues to read as follows:

Authority: 21 U.S.C. 360b.

33. In § 522.1044g, in paragraph (b)(3), remove “000859” and in its place add “069043”.

PART 528—NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS

34. The authority citation for 21 CFR part 528 continues to read as follows:

Authority: 21 U.S.C. 360b.

35. Add § 528.2010 to read as follows:

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

36. The authority citation for 21 CFR part 529 continues to read as follows:

Authority: 21 U.S.C. 360b.

37. Add § 529.539 to read as follows:

PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

38. The authority citation for 21 CFR part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

39. In § 556.70, in paragraph (b), remove “methylene disalicylate” and in its place add “methylenedisalicylate”; and add paragraph (c) to read as follows:

40. In § 556.283, revise paragraphs (b)(3) and (4) to read as follows:

41. Remove § 556.690.

42. In § 556.765, revise paragraph (b)(1)(i) and add paragraphs (b)(1)(ii) and (c) to read as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

43. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

44. In § 558.4, in paragraph (d), in the “Category I” table, in the “Drug” column, remove “Bacitracin methylene disalicylate” and in its place add ” Bacitracin methylenedisalicylate”; and in the “Category II” table, remove the entries for “Ronnel” and “Sulfaethoxypyridazine”.

45. In § 558.55, in paragraph (d)(2)(ii), in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

46. In § 558.58, in paragraph (e)(4), in the “Limitations” column, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

47. In § 558.68, remove paragraph (e)(3).

48. In § 558.76, remove paragraph (e)(2), redesignate paragraph (e)(3) as paragraph (e)(2), and revise redesignated paragraph (e)(2) to read as follows:

49. In § 558.128, in paragraph (e)(7)(ii), remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

50. In § 558.175, in paragraph (d)(2), in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

51. In § 558.195, in paragraph (e)(1)(ii), in the “Combination in grams/ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

52. In § 558.198, in paragraphs (d)(1)(ii) and (d)(2)(ii), in the “Combination grams/ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

53. In § 588.258, in paragraphs (e)(2)(vi) and (vii), in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

54. In § 558.261, redesignate paragraphs (c)(2)(i) and (ii) as paragraphs (c)(2)(ii) and (i), respectively, revise redesignated paragraph (c)(2)(ii), and add paragraph (c)(4) to read as follows:

55. In § 558.265, in paragraphs (d)(1)(vi) and (d)(2)(ii), remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

56. In § 558.300, in paragraphs (e)(2) and (3), in the “Combination in g/ton of feed” column, remove “methylene disalicylate” and in its place add “methylenedisalicylate”; and in paragraph (e)(9), in the “Combination in g/ton of feed ” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

57. In § 558.311, in paragraphs (e)(1)(iv) and (x), in the “Limitations” column, remove “methylene disalicylate” and in its place add “methylenedisalicylate”; and in paragraph (e)(1)(xv), in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

58. In § 558.355, in paragraphs (f)(1)(iii)( b), (f)(1)(xxiv), (f)(1)(xxix) introductory text, (f)(1)(xxix)(b), (f)(1)(xxx) introductory text, (f)(1)(xxx)(b), (f)(2)(ii) introductory text, (f)(2)(ii)(b), (f)(2)(iii) introductory text, (f)(2)(iii)(a), (f)(2)(iii)(b), (f)(4)(ii) introductory text, (f)(4)(ii)(b), (f)(4)(iii) introductory text, (f)(4)(iii)(b), (f)(4)(v) introductory text, and (f)(4)(v)(b), remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

59. In § 558.363, in paragraphs (d)(1)(iv) introductory text, (d)(1)(iv)(B), and (d)(3)(ii), remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

60. In § 558.366, in paragraph (d), in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” wherever it occurs and in its place add “methylenedisalicylate”.

61. In § 558.450, in paragraph (d)(5)(v), in the “Indications for Use” column, remove “ Hemophilus” and in its place add “Haemophilus”.

62. In § 558.515, in paragraph (d), in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” wherever it occurs and in its place add “methylenedisalicylate”.

63. In § 558.550, in paragraphs (d)(1)(iii)( a), (d)(1)(iii)(c), (d)(1)(vi)(a), (d)(1)(xx)(A), (d)(1)(xx)(C), (d)(1)(xxi)(A), (d)(1)(xxi)(C), (d)(3)(ii) introductory text, (d)(3)(ii)(B), (d)(3)(iii) introductory text, (d)(3)(iii)(B), (d)(3)(v) introductory text, and (d)(3)(v)(B), remove “methylene disalicylate” and in its place add “methylenedisalicylate”; and in paragraph (d)(1)(vi)(c), remove “Bacitracin MD” and in its place add “Bacitracin methylenedisalicylate”.

64. In § 558.555, in paragraph (d)(2), in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

65. In § 558.680, in paragraphs (d)(1)(ii), (iii), (iv), (vi), (vii), and (viii) in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”; and in paragraph (d)(2)(ii), in the “Combination in grams per ton” column, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.