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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendments.

SUMMARY:

The Food and Drug Administration (FDA or we) 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 July, August, and September 2018. FDA is 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 make technical amendments to improve the readability of the regulations.

DATES:

This rule is effective March 13, 2019, except for amendatory instruction 25 to 21 CFR 520.2041, which is effective March 25, 2019.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 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 July, August, and September 2018, 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 office of the Dockets Management Staff (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: https://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: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm .

II. Change of Sponsorship

Piedmont Animal Health, 204 Muirs Chapel Rd., Suite 200, Greensboro, NC 27410 has informed FDA that it has transferred ownership of, and all rights and interest in, newly approved ANADA 200-608 for BAYTRIL (enrofloxacin) Soft Chewable Tablets to Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. Following this change of sponsorship, Piedmont Animal Health is no longer the sponsor of an approved application. Accordingly, it will not be added to the list of sponsors of approved applications in § 510.600(c) (21 CFR 510.600(c)).

Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Cronus Pharma Specialities India Private Ltd., Sy No: 99/1, M/s GMR Hyderabad Aviation SEZ L, Mamidipalli Village, Shamshabad Mandal, Ranga, Hyderabad, Telangana 501218, India:

Following this change of sponsorship, Cronus Pharma LLC is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in § 510.600(c). As a new sponsor of approved applications, Cronus Pharma Specialities India Private Ltd. will be added to § 510.600(c); however, as the drug labeler code was not changed, no further amendments are necessary.

Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland:

Following this change of sponsorship, Cross Vetpharm Group Ltd. is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in § 510.600(c) (21 CFR 510.600(c)). As a new sponsor of approved applications, Bimeda Animal Health Ltd. will be added to § 510.600(c) and the regulations amended to reflect this action. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship.

III. Withdrawals of Approval

Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 140-939 for use of RUMENSIN (monensin) and TYLAN (tylosin phosphate) Type A medicated articles in the manufacture of combination drug Type C medicated cattle feeds because the product is no longer manufactured or marketed.

Also, Sergeant's Pet Care Products, Inc., 10077 S 134th St., Omaha, NE 68138 has requested that FDA withdraw approval of ANADA 200-600 for WORMX (pyrantel pamoate) Flavored Tablets because the product is no longer manufactured or marketed.

Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 140-939 and ANADA 200-600, and all supplements and amendments thereto, is withdrawn, effective March 25, 2019. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.

IV. Technical Amendments

In addition, we are reformatting the regulations to present the approved conditions of use of halofuginone, monensin, and salinomycin in tabular format in the respective named sections of 21 CFR part 558. This action is being taken to improve the readability of the regulations.

V. Legal Authority

This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires Federal Register publication of “notice[s] . . . effective as a regulation,” of the conditions of use of approved new animal drugs. This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities.

Although denominated a rule pursuant to the FD&C Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3) because it is a “rule of particular applicability” under 5 U.S.C. 804(3)(A). Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as “an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

List of Subjects

21 CFR Part 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• Reporting and recordkeeping requirements

21 CFR Parts 520, 522, 524, 526, 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, 21 CFR parts 510, 520, 522, 524, 526, 529, 556, and 558 are amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 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 entries for “Cronus Pharma LLC” and “Cross Vetpharm Group Ltd.” and alphabetically add entries for “Bimeda Animal Health Ltd.” and “Cronus Pharma Specialities India Private Ltd.”; and in the table in paragraph (c)(2), numerically add an entry for “061133”, remove the entry for “061623”, and revise the entry for “069043”.

The additions and revisions read as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for part 520 continues to read as follows:

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

4. In § 520.43, revise paragraph (c)(2) to read as follows:

5. In § 520.48, in paragraph (b), remove “061623” and in its place add “061133”.

6. In § 520.100, in paragraph (b)(1), remove “No. 016592” and in its place add “Nos. 016592 and 061133”; and in paragraph (b)(2), remove “No. 066104” and in its place add “Nos. 051072 and 066104”.

7. In § 520.390a, in paragraph (b)(2)(i), remove “061623” and in its place add “061133”.

8. In § 520.447, in paragraph (b), remove “061623” and in its place add “061133”.

9. In § 520.540b, in paragraph (b)(2), remove “061623” and in its place add “061133”.

10. In § 520.622a, in paragraph (a)(3), remove “061623” and in its place add “061133”.

11. In § 520.812, revise paragraphs (a) and (b)(1) and (2) and add paragraph (b)(3) to read as follows:

12. In § 520.823, in paragraph (b), remove “061623” and in its place add “061133”.

13. In § 520.970, in paragraph (b)(2), remove “061623” and in its place add “061133”.

14. In § 520.1044c, in paragraph (b)(2), remove “061623” and in its place add “061133”.

15. In § 520.1100, in paragraph (b)(2), remove “061623” and in its place add “061133”.

16. In § 520.1192, in paragraph (b)(2), remove “061623” and in its place add “061133”.

17. In § 520.1242a, in paragraph (b)(4), remove “059130” and in its place add “061133”.

18. In § 520.1263c, in paragraph (b)(2), remove “061623” and in its place add “061133”.

19. In § 520.1265, in paragraph (b)(2), remove “061623” and in its place add “061133”.

20. In § 520.1484, in paragraph (b)(2), remove “061623” and in its place add “061133”.

21. In § 520.1660d, in paragraphs (b)(5), (b)(7), (d)(1)(ii)(A)( 3), (d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and (d)(1)(iii)(C), remove “061623” and in its place add “061133”.

22. In § 520.1696b, in paragraph (b), remove “061623” and in its place add “061133”.

23. In § 520.1720a, in paragraph (b)(3), remove “061623” and in its place add “061133”.

24. In § 520.1720d, in paragraph (b), remove “061623” and in its place add “061133”.

25. Effective March 25, 2019, in § 520.2041, in paragraph (b), remove “066916, 017135,” and add in its place “017135”.

26. In § 520.2044, in paragraph (b)(3), remove “061623” and in its place add “061133”.

27. In § 520.2046, in paragraph (b)(2), remove “061623” and in its place add “061133”.

28. In § 520.2123a, in paragraph (b), remove “061623” and in its place add “061133”.

29. In § 520.2123b, in paragraph (b), remove “061623” and in its place add “061133”.

30. In § 520.2123c, in paragraph (b), remove “061623” and in its place add “061133”.

31. In § 520.2220a, in paragraph (b)(2), remove “061623” and in its place add “061133”.

32. In § 520.2260b, in paragraphs (c)(1) and (e)(1), remove “061623” and in its place add “061133”.

33. In § 520.2261b, in paragraph (b), remove “061623” and in its place add “061133”.

34. In § 520.2345d, in paragraph (b)(4), remove “061623” and in its place add “061133”; and in paragraphs (d)(1)(iii) and (d)(2)(iii), remove “059130, and 061623” and in its place add “and 061133”.

35. In § 520.2640, in paragraph (b)(2), remove “061623” and in its place add “061133”.

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

36. The authority citation for part 522 continues to read as follows:

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

37. In § 522.147, in paragraph (b), remove “No. 052483” and in its place add “Nos. 015914 and 052483”.

38. In § 522.224, revise paragraph (c) to read as follows:

39. In § 522.480, in paragraph (b)(1), remove “061623” and in its place add “061133”.

40. In § 522.540, in paragraphs (a)(2)(i), (b)(2), and (c)(2), remove “061623” and in its place add “061133”.

41. In § 522.690, in paragraph (b)(3), remove “061623” and in its place add “061133”.

42. In § 522.812, revise paragraph (b)(1); remove paragraph (b)(2) and redesignate paragraph (b)(3) as paragraph (b)(2); remove paragraph (e)(3)(i)(B) and redesignate paragraph (e)(3)(i)(C) as (e)(3)(i)(B); and revise paragraphs (e)(3)(i)(A) and newly designated (e)(3)(i)(B).

The revisions read as follows:

43. In § 522.820, in paragraph (b), remove “061623” and in its place add “061133”.

44. In § 522.970, in paragraph (b)(1), remove “061623” and in its place add “061133”.

45. In § 522.1010, in paragraph (b)(2), remove “061623” and in its place add “061133”.

46. In § 522.1044, in paragraph (b)(4), remove “061623” and in its place add “061133”.

47. In § 522.1077, in paragraph (b)(3), remove “061623” and in its place add “061133”.

48. In § 522.1192, in paragraph (b)(2), remove “061623” and in its place add “061133”.

49. In § 522.1260, in paragraph (b)(4), remove “061623” and in its place add “061133”.

50. In § 522.1660a, in paragraph (b), remove “061623” and in its place add “061133”.

51. In § 522.1662a, in paragraph (k)(2), remove “061623” and in its place add “061133”.

52. In § 522.1680, in paragraph (b), remove “061623” and in its place add “061133”.

53. In § 522.1696a, in paragraphs (b)(1), (b)(2), and (d)(2)(iii), remove “061623” and in its place add “061133”; and in paragraphs (d)(1)(ii) and (d)(2)(ii), remove “ Conditions of use” and in its place add “Indications for use”.

54. In § 522.1696b, in paragraphs (b)(2), (d)(2)(i)(A), and (d)(2)(iii)(A), remove “061623” and in its place add “061133”.

55. In § 522.1720, in paragraph (b)(2), remove “061623” and in its place add “061133”.

56. In § 522.1870, in paragraph (b), remove “061623” and in its place add “061133”.

57. In § 522.1883, in paragraph (b), remove “061623” and in its place add “061133”.

58. In § 522.1962, in paragraph (b)(2), remove “061623” and in its place add “061133”.

59. In § 522.2063, in paragraph (b)(2), remove “061623” and in its place add “061133”.

60. In § 522.2220, in paragraph (b)(3), remove “061623” and in its place add “061133”.

61. In § 522.2444b, in paragraph (b), remove “061623” and in its place add “061133”.

62. In § 522.2473, in paragraph (b), remove “061623” and in its place add “061133”.

63. In § 522.2640, in paragraph (b)(2), remove “061623” and in its place add “061133”.

64. In § 522.2662, in paragraph (b)(2), remove “061623” and in its place add “061133”.

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

65. The authority citation for part 524 continues to read as follows:

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

66. In § 524.1193, in paragraph (b)(1), remove “061623” and in its place add “061133”.

67. In § 524.1580a, in paragraph (b)(1), remove “061623” and in its place add “061133”.

PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

68. The authority citation for part 526 continues to read as follows:

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

69. In § 526.820, in paragraph (b), remove “061623” and in its place add “061133”.

70. In § 526.1696a, in paragraph (c), remove “061623” and in its place add “061133”.

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

71. The authority citation for part 529 continues to read as follows:

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

72. In § 529.1044a, in paragraph (b), remove “061623” and in its place add “061133”.

73. In § 529.1660, in paragraphs (b)(1) and (2), remove “061623” and in its place add “061133”.

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

74. The authority citation for part 556 continues to read as follows:

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

75. In § 556.445, add paragraph (a) and revise paragraph (b) to read as follows:

(a) Acceptable daily intake (ADI). The ADI for total residues of nicarbazin (4,4′-dinitrocarbanilide and 2-hydroxy-4,6-dimethylpyrimidine) is 200 micrograms per kilogram of body weight per day.

(b) Tolerance. The tolerance for 4,4′-dinitrocarbanilide (marker residue) is:

(1) Chickens—Liver (target tissue): 52 ppm.

(2) [Reserved]

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

76. The authority citation for part 558 continues to read as follows:

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

77. In § 558.4, in paragraph (d), in the “Category I” table, revise the entry for “Narasin”, alphabetically add an entry for “Nicarbazin (granular)” followed immediately by an indented entry for “Narasin”; and in the “Category II” table, remove the entry for “Narasin” and revise the entry for “Nicarbazin (powder)”.

The revisions and addition read as follows:

78. In § 558.68, in paragraph (e)(1)(i), in the “Limitations” column, remove “10 days of age” and in its place add “18 days of age”.

79. In § 558.128, in paragraph (e)(4)(iv), in the row for “1.”, in the “Limitations” column, remove “sponsor No. 069254” and in its place add “sponsor Nos. 054771 and 069254”.

80. In § 558.248, in paragraph (b), remove “061623” and in its place add “061133”.

81. In § 558.265, revise paragraphs (b) and (d) to read as follows:

82. In § 558.311, redesignate paragraphs (e)(5)(ii) through (v) as paragraphs (e)(5)(iii) and (vi), and add new paragraph (e)(5)(ii) to read as follows:

83. In § 558.325, add paragraph (e)(1)(vi) to read as follows:

84. In § 558.355, revise paragraph (b), add paragraph (c), and revise paragraph (f) to read as follows:

85. In § 558.364, revise paragraph (d)(1)(i) to read as follows:

86. In § 558.550, revise paragraph (b), add paragraph (c), revise paragraph (d), and add paragraph (e) to read as follows:

87. In § 558.625, revise paragraphs (b)(1) through (4) to read as follows: