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 January, February, and March 2019. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. Technical amendments are also being made to improve the accuracy, consistency, and readability of the regulations.

DATES:

This rule is effective August 9, 2019, except for amendatory instructions 51 to 21 CFR 524.916 and 63 to 21 CFR 558.325, which are effective August 19, 2019, and instruction 60 to 21 CFR 558.235, which is effective September 9, 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 January, February, and March 2019, 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. Changes of Sponsors' Names and Addresses

Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057-3009 has informed FDA that it has changed its name to Aurora Pharmaceutical, Inc.

Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002 has informed FDA that it has changed its name and address to Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096.

Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 11967 has informed FDA that it has changed its name to American Regent, Inc.

Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405 has informed FDA that it has changed its name to Pharmgate, Inc.

Accordingly, we are amending § 510.600(c) to reflect these changes.

III. Changes of Sponsorship

Provetica AH LLC, 455 Sovereign Ct., Baldwin, MO 63011 has informed FDA that it has transferred ownership of, and all rights and interest in, newly approved ANADA 200-637 for DOXIDYL (deracoxib) Chewable Tablets to Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France. Following this change of sponsorship, Provetica AH LLC 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)).

Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096:

Following this change of sponsorship, Merial, Inc., 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 provided in the regulatory text, the animal drug regulations are amended to reflect these changes of sponsorship.

IV. Withdrawals of Approval

Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096, has requested that FDA withdraw approval of newly transferred NADA 141-054 for use of LINCOMIX (lincomycin hydrochloride) plus IVOMEC (ivermectin) Type A medicated articles to manufacture 2-way, combination drug Type C medicated feed for swine because the product is no longer manufactured or marketed.

Also, Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 141-337 for use of RECOVYRA (fentanyl) Transdermal Solution for Dogs because the product is no longer manufactured or marketed.

Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 141-054 and 141-337, and all supplements and amendments thereto, is withdrawn effective August 19, 2019. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.

V. Technical Amendments

FDA is removing “IDEXX Pharmaceuticals, Inc.” from the list of sponsors of approved applications in § 510.600(c). This action is being taken to improve the accuracy of the regulations.

In addition, we are reformatting the regulations to present the approved conditions of use of famphur, morantel, and thiabendazole in tabular format in the respective named sections of subpart B of part 558. This action is being taken to improve the readability and consistency of the regulations.

VI. 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)(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. 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, and 524

• 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, 21 CFR parts 510, 520, 522, 524, 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:

a. In the table in paragraph (c)(1):

i. Add an entry in alphabetical order for “American Regent, Inc.”;

ii. Revise the entries for “Aurora Pharmaceutical, LLC”, “Boehringer Ingelheim Vetmedica, Inc.”;

iii. Remove the entries for “IDEXX Pharmaceuticals, Inc.”, “Luitpold Pharmaceuticals, Inc.”, and “Merial, Inc.”; and

iv. Revise the entry for “Pharmgate, LLC”; and

b. In the table in paragraph (c)(2):

i. Revise the entries for “000010” and “010797”;

ii. Remove the entry for “050604”;

iii. Revise the entry for “051072”;

iv. Remove the entry for “065274”; and

v. Revise the entry for “069254”.

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, in paragraph (b), remove “050604” and in its place add “000010”.

5. In § 520.284a, in paragraph (b), remove “050604” and in its place add “000010”.

6. In § 520.284b, in paragraph (b), remove “050604” and in its place add “000010”.

7. In § 520.284c, in paragraph (b), remove “050604” and in its place add “000010”.

8. Revise § 520.420 to read as follows:

9. In § 520.462, in paragraph (b), remove “050604” and in its place add “000010”.

10. In § 520.538, in paragraph (b), remove “No. 058198” and in its place add “Nos. 013744 and 058198”.

11. In § 520.804, in paragraph (b), remove “050604” and in its place add “000010”.

12. In § 520.928, in paragraph (b), remove “050604” and in its place add “000010”.

13. In § 520.930, in paragraph (b), remove “050604” and in its place add “000010”.

14. In § 520.1192, in paragraph (b)(1), remove “050604” and in its place add “000010”.

15. In § 520.1193, in paragraph (b)(1), remove “050604” and in its place add “000010”.

16. In § 520.1195, in paragraph (b)(1), remove “000859, 050604,” and in its place add “000010, 000859,”; and in paragraph (b)(3), remove “050604” and in its place add “000010”.

17. In § 520.1196, in paragraph (b), remove “050604” and in its place add “000010”.

18. In § 520.1197, in paragraph (b), remove “050604” and in its place add “000010”.

19. In § 520.1198, in paragraphs (b)(1) and (3), remove “050604” and in its place add “000010”.

20. In § 520.1615, in paragraph (b), remove “050604” and in its place add “000010”.

21. In § 520.1696c, in paragraph (b), remove “050604” and in its place add “000010”.

22. In § 520.1696d, in paragraph (b), remove “050604” and in its place add “000010”.

23. In § 520.1760, revise paragraphs (a) and (c)(1) to read as follows:

24. In § 520.1855, in paragraph (b), remove “050604” and in its place add “000010”.

25. In § 520.2170, in paragraph (b), remove “050604” and in its place add “000010”.

26. In § 520.2380a, in paragraph (b)(2), remove “050604” and in its place add “000010”.

27. In § 520.2380b, in paragraph (b), remove “050604” and in its place add “000010”.

28. In § 520.2380c, in paragraph (b), remove “050604” and in its place add “000010”.

29. In § 520.2380d, in paragraph (b), remove “050604” and in its place add “000010”.

30. Redesignate §§ 520.2380e and 520.2380f as §§ 520.2380f and 520.2380e, respectively.

31. In newly redesignated § 520.2380e, in paragraph (b), remove “050604” and in its place add “000010”.

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

33. In § 522.144, in paragraph (b), remove “050604” and in its place add “000010”.

34. In § 522.313b, revise paragraphs (a), (b), and (e)(2)(iii) to read as follows:

35. In § 522.814, in paragraph (b), remove “050604” and in its place add “000010”.

36. In § 522.850, in paragraph (b), remove “050604” and in its place add “000010”.

37. In § 522.930, in paragraph (b), remove “050604” and in its place add “000010”.

38. In § 522.1014, in paragraph (b), remove “050604” and in its place add “000010”.

39. In § 522.1077, in paragraph (b)(4), remove “050604” and in its place add “000010”.

40. In § 522.1145, in paragraph (e)(2)(i), remove “050604” and in its place add “000010”.

41. In § 522.1150, in paragraph (b), remove “050604” and in its place add “000010”.

42. In § 522.1160, revise paragraphs (b)(1) and (2); redesignate the text of paragraph (c)(1)(i) as paragraph (c)(1)(i)(A); add a paragraph heading to newly redesignated paragraph (c)(1)(i)(A); and add paragraph (c)(1)(i)(B).

The revision and addition read as follows:

43. In § 522.1192, in paragraph (b)(1), remove “050604” and in its place add “000010”.

44. In § 522.1193, revise paragraphs (b) and (e)(3) to read as follows:

45. In § 522.1362, in paragraph (b), remove “050604” and in its place add “000010”.

46. In § 522.1452, in paragraph (b), remove “050604” and in its place add “000010”.

47. In § 522.1885, in paragraph (b), remove “050604” and in its place add “000010”.

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

49. In § 524.814, in paragraph (b), remove “050604” and in its place add “000010”.

50. In § 524.815, in paragraph (b), remove “050604” and in its place add “000010”.

51. Effective August 19, 2019, remove § 524.916.

52. In § 524.1193, in paragraph (b)(1), remove “050604” and in its place add “000010”.

53. In § 524.1484g, in paragraph (b), remove “026637 and 050604” and in its place add “000010 and 026637”.

54. In § 524.1484j, in paragraph (b), remove “050604” and in its place add “000010”.

55. In § 524.2101, in paragraph (b), remove “000061, 017135, and 050604” and in its place add “000010, 000061, and 017135”.

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

57. In § 558.58, redesignate paragraphs (e)(3) through (6) as paragraphs (e)(2) through (5), and redesignate paragraph (e)(9) as new paragraph (e)(6).

58. In § 558.76, redesignate paragraphs (e)(1)(ix) through (xvi) as paragraphs (e)(1)(vii) through (xiv).

59. In § 558.128, revise paragraphs (b)(1) and (e)(4)(xv), redesignate paragraphs (e)(4)(xvi) through (xxvi) as paragraphs (e)(4)(xvii) through (xxvii), and add new paragraph (e)(4)(xvi).

The revisions and addition read as follows:

60. Effective September 9, 2019, in § 558.235, in paragraph (b), remove “050604” and in its place add “000010”.

61. Revise § 558.254 to read as follows:

62. In § 558.300, in paragraph (b), remove “050604” and in its place add “No. 000010”; in paragraphs (e)(1) through (6), in the “Sponsor” column, remove “050604” and in its place add “000010”; and remove paragraph (f).

63. Effective August 19, 2019, in § 558.325, remove paragraphs (e)(2)(iii), (x), and (xvi); and redesignate paragraphs (e)(2)(iv) through (ix) as paragraphs (e)(2)(iii) through (viii), paragraphs (e)(2)(xi) through (xv) as paragraphs (e)(2)(ix) through (xiii), and paragraph (e)(2)(xvii) as paragraph (e)(2)(xiv).

64. Revise § 558.360 to read as follows:

65. Revise § 558.600 to read as follows: