New Animal Drugs; Change 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 57 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco US, Inc.

DATES:

This rule is effective July 26, 2016.

FOR FURTHER INFORMATION CONTACT:

Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-0571, steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 has informed FDA that it has transferred ownership of, and all rights and interest in, the 71 approved NADAs and ANADAs in table 1 to Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140.

Accordingly, the Agency is amending the regulations in 21 CFR parts 520, 522, 524, and 558 to reflect these changes of sponsorship.

Following these changes of sponsorship, Elanco Animal Health, A Division of Eli Lilly & Co. is no longer the sponsor of any approved application. Accordingly, the regulations are being amended to remove this firm from the lists of sponsors of approved applications in 21 CFR 510.600(c).

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, 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 and redelegated to the Center for Veterinary Medicine, 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, in the table in paragraph (c)(1), remove the entry for “Elanco Animal Health, A Division of Eli Lilly & Co.”; and in the table in paragraph (c)(2), remove the entry for “000986”.

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 § 520.110, in paragraph (b), remove “000986” and in its place add “058198”.

5. In § 520.2130, in paragraph (b), remove “000986” and in its place add “058198”.

6. In § 520.2134, in paragraph (b), remove “000986” and in its place add “058198”.

7. In § 520.2471, in paragraph (b), remove “000986” and in its place add “058198”.

8. In § 520.2640, in paragraph (b)(1), remove “000986” and in its place add “058198”.

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

10. In § 522.150, in paragraph (b), remove “000986” and in its place add “058198”.

11. In § 522.840, in paragraph (b), remove “000986” and in its place add “058198”.

12. In § 522.842, in paragraph (a)(2), remove “000986” and in its place add “058198”.

13. In § 522.1684, in paragraph (b), remove “000986” and in its place add “058198”.

14. In § 522.1940, in paragraph (a)(2), remove “000986” and in its place add “058198”.

15. In § 522.2112, in paragraph (b), remove “000986” and in its place add “058198”.

16. In § 522.2471, in paragraph (b), remove “000986” and in its place add “058198”.

17. In § 522.2476, in paragraph (a)(1), remove “021641” and in its place add “058198”.

18. In § 522.2477, in paragraph (b)(1), remove “000986” and in its place add “058198”.

19. In § 522.2640, in paragraph (b)(1), remove “000986” and in its place add “058198”.

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

21. In § 524.916, in paragraph (b), remove “000986” and in its place add “058198”.

22. In § 524.1445, in paragraph (b), remove “000986” and in its place add “058198”.

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

24. In § 558.68, in paragraph (b), remove “000986” and in its place add “058198”.

25. In § 558.274, in paragraph (a)(1), remove “000986” and in its place add “058198”; and in paragraphs (c)(1)(i) and (ii) and (c)(2)(i) and (ii), in the “Sponsor” column, remove “000986” and in its place add “058198”.

26. In § 558.342, in paragraph (b)(2), remove “000986” and in its place add “058198”; and in paragraphs (e)(1)(i) through (iv) and (e)(1)(ix) and (x), in the “Sponsor” column, remove “000986” and in its place add “058198”.

27. In § 558.355, in paragraphs (b)(1) and (2), (b)(4) through (9), (b)(11) and (12), and (b)(14), in paragraphs (f)(1)(xiii)( b), (f)(1)(xxi)(b), (f)(1)(xxii)(b), (f)(1)(xxviii)(b), (f)(1)(xxix)(b), (f)(1)(xxxi)(b), paragraphs (f)(3)(i)(b)(2)(iii), (f)(3)(ii)(b), (f)(3)(xii)(b), in paragraphs (f)(4)(ii)(b) and (f)(4)(iii)(b), and in paragraph (f)(6)(i)(b)(2)(iii), remove “000986” and in its place add “058198”.

28. In § 558.363, in paragraphs (a)(1), (3), and (8), and in paragraphs (d)(1)(ii)(B), (d)(1)(iii)(B), (d)(1)(iv)(B), (d)(1)(v)(B), and (d)(1)(vi)(B), remove “000986” and in its place add “058198”.

29. In § 558.366, in paragraph (b), remove “000986” and in its place add “058198”; and in paragraph (d), in the six row entries beginning in the “Nicarbazin in grams per ton” column with “27 to 45”, in the “Limitations” and “Sponsor” columns, remove “000986” wherever it occurs and in its place add “058198”.

30. In § 558.500, in paragraph (b), remove “000986 and 054771” and in its place add “054771 and 058198”; and in paragraphs (e)(1)(i) through (iv) and (e)(2)(i) through (xiii), in the “Limitations” and “Sponsor” columns, remove “000986” wherever it occurs and in its place add “058198”; and in paragraphs (e)(3)(i) through (iv), in the “Sponsor” column, remove “000986” wherever it occurs and in its place add “058198”.

31. In § 558.550, in paragraph (d)(1)(xxii)(B), remove “000986 and 016592” and in its place add “016592 and 058198”.

32. In § 558.618, in paragraph (b), remove “000986 and 016592” and in its place add “016592 and 058198”; and in paragraphs (e)(1)(i) and (e)(2)(i) through (iii), in the “Sponsor” column, remove “000986” and in its place add “058198”.

33. In § 558.625, in paragraph (b)(1), remove “To 000986” and in its place add “No. 058198”.

34. In § 558.630, in paragraph (b)(1), remove “000986” and in its place add “058198”.

35. In § 558.665, in paragraphs (e)(2), (3), (4), (5), (6), (8), (10), (11), and (12), in the “Limitations” column, remove “000986” wherever it occurs and in its place add “058198”; and in paragraphs (e)(2), (3), (4), and (6), in the “Sponsor” column, remove “000986” and in its place add “058198”.