# [Amended]
**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, *[email protected].*
**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.
| File No. | Product name | 21 CFR |
| --- | --- | --- |
| 010-918 | HYGROMIX 8 (hygromycin B) Type A medicated article | 558.274 |
| 011-948 | HYGROMIX 2.4 (hygromycin B) Type A medicated article | 558.274 |
| 012-491 | TYLAN 100 (tylosin) Injection | 522.2640 |
| 012-548 | TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B) | 558.274 |
| 012-965 | TYLAN (tylosin) Injection | 522.2640 |
| 013-076 | TYLAN (tylosin tartrate) Soluble Powder | 520.2640 |
| 013-162 | TYLAN Premix No. 10 (tylosin phosphate) Type A medicated article | 558.625 |
| 013-388 | TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B) | 558.274 |
| 015-166 | TYLAN 100 Premix (tylosin phosphate) Type A medicated article | 558.625 |
| 038-878 | COBAN 45, 60, 90, 110 (monensin) Type A medicated article | 558.355 |
| 041-275 | TYLAN 40 Sulfa-G (tylosin phosphate and sulfamethazine) Type A medicated article | 558.630 |
| 047-933 | COBAN (monensin)/BACIFERM (bacitracin Zn) | 558.355 |
| 049-463 | COBAN (monensin)/BMD (bacitracin methylenedisalicyclate) | 558.355 |
| 095-735 | RUMENSIN 80 and 90 (monensin) Type A medicated article | 558.355 |
| 104-646 | RUMENSIN (monensin)/TYLAN (tylosin phosphate) | 558.355 |
| 106-964 | APRALAN (apramycin sulfate) Soluble Powder | 520.110 |
| 110-315 | COMPONENT E-C or E-S (progesterone and estradiol benzoate) with TYLAN | 522.1940 |
| 115-732 | STRESNIL (azaperone) Injection | 522.150 |
| 118-123 | COMPUDOSE 200 (estradiol); ENCORE (COMPUDOSE 400) | 522.840 |
| 118-980 | MONTEBAN (narasin) Type A medicated article | 558.363 |
| 126-050 | APRALAN 75 (apramycin sulfate) Soluble Powder | 520.110 |
| 127-507 | TYLAN 5, 10, 20, 40 Sulfa-G (tylosin phosphate and sulfamethazine) Type A medicated article | 558.630 |
| 130-736 | COBAN (monensin) Type A medicated article | 558.355 |
| 135-468 | Nicarbazin Type A medicated article | 558.366 |
| 135-906 | COMPONENT E-H (estradiol benzoate and testosterone propionate) with TYLAN | 522.842 |
| 138-952 | MAXIBAN (narasin and nicarbazin) Type A medicated article | 558.366 |
| 140-863 | PAYLEAN 9 and 45 (ractopamine HCl) Type A medicated article | 558.500 |
| 140-872 | POSILAC (sometribove Zn) Injectable Suspension | 522.2112 |
| 140-926 | BMD (bacitracin methylenedisalicyclate)/MAXIBAN (narasin and nicarbazin) | 558.366 |
| 140-929 | MICOTIL 300 (tilmicosin phosphate) Injectable Solution | 522.2471 |
| 140-937 | BMD (bacitracin methylenedisalicyclate)/COBAN (monensin) | 558.355 |
| 140-942 | FLAVOMYCIN (bambermycins)/MAXIBAN (narasin and nicarbazin) | 558.366 |
| 140-947 | LINCOMIX (lincomycin HCl)/MAXIBAN (narasin and nicarbazin) | 558.366 |
| 140-955 | COBAN (monensin)/FLAVOMYCIN (bambermycins) | 558.355 |
| 141-064 | PULMOTIL 90 (tilmicosin phosphate) Type A medicated article | 558.618 |
| 141-277 | COMFORTIS (spinosad) Tablets | 520.2130 |
| 141-298 | SUROLAN (miconazole nitrate, polymyxin B sulfate, prednisolone acetate) Otic Suspension | 524.1445 |
| 141-321 | TRIFEXIS (spinosad and milbemycin oxime) Tablets | 520.2134 |
| 141-110 | COBAN (monensin)/STAFAC (virginiamycin) | 558.355 |
| 141-164 | COBAN (monensin)/TYLAN (tylosin phosphate) | 558.355 |
| 141-170 | MONTEBAN (narasin)/TYLAN (tylosin phosphate) | 558.363 |
| 141-172 | PAYLEAN (ractopamine HCl)/TYLAN (tylosin phosphate) | 558.500 |
| 141-198 | TYLAN (tylosin phosphate)/BIO-COX (salinomycin sodium) | 558.550 |
| 141-221 | OPTAFLEXX 45 (ractopamine HCl) Type A medicated article | 558.500 |
| 141-224 | OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin)/TYLAN (tylosin phosphate) | 558.500 |
| 141-225 | OPTAFLEXX (ractopamine HCl) RUMENSIN (monensin) | 558.500 |
| 141-234 | OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin)/MGA (melengestrol acetate) | 558.500 |
| 141-290 | TOPMAX 9 (ractopamine HCl) Type A medicated article | 558.500 |
| 141-233 | OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin)/TYLAN (tylosin phosphate)/MGA (melengestrol acetate) | 558.500 |
| 141-301 | TOPMAX (ractopamine HCl)/COBAN (monensin) | 558.500 |
| 141-337 | RECUVYA (fentanyl) Topical Solution | 524.916 |
| 141-340 | SKYCIS 100 (narasin) Type A medicated article | 558.363 |
| 141-343 | PULMOTIL 90 (tilmicosin phosphate)/RUMENSIN 90 (monensin) | 558.618 |
| 141-361 | PULMOTIL AC (tilmicosin phosphate) Concentrate Solution | 520.2471 |
| 141-392 | IMPRESTOR (pegbovigrastim) Injection | 522.1684 |
| 141-438 | KAVAULT (avilamycin) Type A medicated article | 558.68 |
| 141-439 | INTEPRITY (avilamycin) Type A medicated article | 558.68 |
| 200-221 | COMPONENT TE-G (trenbolone acetate and estradiol); COMPONENT TE-G with TYLAN; COMPONENT TE-ID with TYLAN; COMPONENT TE-IS; COMPONENT TE-IS with TYLAN; COMPONENT TE-S; COMPONENT TE-S with TYLAN | 522.2477 |
| 200-224 | COMPONENT T-H (trenbolone acetate) with TYLAN; COMPONENT T-S with TYLAN | 522.2476 |
| 200-343 | HEIFERMAX 500 (melengestrol acetate) Type A medicated article | 558.342 |
| 200-346 | COMPONENT TE-200 (trenbolone acetate and estradiol); COMPONENT TE-200 with TYLAN; COMPONENT TE-H; COMPONENT TE-H with TYLAN, COMPONENT TE-H | 522.2477 |
| 200-375 | HEIFERMAX 500 (melengestrol acetate)/RUMENSIN (monensin)/TYLAN (tylosin phosphate) | 558.342 |
| 200-422 | HEIFERMAX 500 (melengestrol acetate) Liquid Premix/RUMENSIN (monensin) | 558.342 |
| 200-424 | HEIFERMAX (melengestrol acetate)/OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin)/TYLAN (tylosin phosphate) | 558.342 |
| 200-427 | HEIFERMAX 500 (melengestrol acetate) Liquid Premix/TYLAN (tylosin phosphate) | 558.342 |
| 200-430 | HEIFERMAX 500 (melengestrol acetate) Liquid Premix/BOVATEC (lasalocid)/TYLAN (tylosin phosphate) | 558.342 |
| 200-448 | HEIFERMAX 500 (melengestrol acetate)/OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin) | 558.500 |
| 200-451 | HEIFERMAX 500 (melengestrol acetate)/BOVATEC (lasalocid) | 558.342 |
| 200-479 | HEIFERMAX 500 (melengestrol acetate)/ZILMAX (zilpaterol)/RUMENSIN (monensin) | 558.665 |
| 200-480 | HEIFERMAX 500 (melengestrol acetate)/ZILMAX (zilpaterol)/RUMENSIN (monensin)/TYLAN (tylosin phosphate) | 558.665 |
| 200-483 | HEIFERMAX 500 (melengestrol acetate)/ZILMAX (zilpaterol) | 558.665 |
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**
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
Animal drugs.
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:
**21 CFR Part 510**
**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.
**21 CFR Part 510**
§ 510.600
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”.
**21 CFR Part 520**
**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.
**21 CFR Part 520**
§ 520.110
4. In § 520.110, in paragraph (b), remove “000986” and in its place add “058198”.
**21 CFR Part 520**
§ 520.2130
5. In § 520.2130, in paragraph (b), remove “000986” and in its place add “058198”.
**21 CFR Part 520**
§ 520.2134
6. In § 520.2134, in paragraph (b), remove “000986” and in its place add “058198”.
**21 CFR Part 520**
§ 520.2471
7. In § 520.2471, in paragraph (b), remove “000986” and in its place add “058198”.
**21 CFR Part 520**
§ 520.2640
8. In § 520.2640, in paragraph (b)(1), remove “000986” and in its place add “058198”.
**21 CFR Part 522**
**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.
**21 CFR Part 522**
§ 522.150
10. In § 522.150, in paragraph (b), remove “000986” and in its place add “058198”.
**21 CFR Part 522**
§ 522.840
11. In § 522.840, in paragraph (b), remove “000986” and in its place add “058198”.
**21 CFR Part 522**
§ 522.842
12. In § 522.842, in paragraph (a)(2), remove “000986” and in its place add “058198”.
**21 CFR Part 522**
§ 522.1684
13. In § 522.1684, in paragraph (b), remove “000986” and in its place add “058198”.
**21 CFR Part 522**
§ 522.1940
14. In § 522.1940, in paragraph (a)(2), remove “000986” and in its place add “058198”.
**21 CFR Part 522**
§ 522.2112
15. In § 522.2112, in paragraph (b), remove “000986” and in its place add “058198”.
**21 CFR Part 522**
§ 522.2471
16. In § 522.2471, in paragraph (b), remove “000986” and in its place add “058198”.
**21 CFR Part 522**
§ 22.2476
17. In § 522.2476, in paragraph (a)(1), remove “021641” and in its place add “058198”.
**21 CFR Part 522**
§ 522.2477
18. In § 522.2477, in paragraph (b)(1), remove “000986” and in its place add “058198”.
**21 CFR Part 522**
§ 522.2640
19. In § 522.2640, in paragraph (b)(1), remove “000986” and in its place add “058198”.
**21 CFR Part 524**
**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 CFR Part 524**
§ 524.916
21. In § 524.916, in paragraph (b), remove “000986” and in its place add “058198”.
**21 CFR Part 524**
§ 524.1445
22. In § 524.1445, in paragraph (b), remove “000986” and in its place add “058198”.
**21 CFR Part 558**
**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.
**21 CFR Part 558**
§ 558.68
24. In § 558.68, in paragraph (b), remove “000986” and in its place add “058198”.
**21 CFR Part 558**
§ 558.274
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”.
**21 CFR Part 558**
§ 558.342
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”.
**21 CFR Part 558**
§ 558.355
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”.
**21 CFR Part 558**
§ 558.363
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”.
**21 CFR Part 558**
§ 558.366
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”.
**21 CFR Part 558**
§ 558.500
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”.
**21 CFR Part 558**
§ 558.550
31. In § 558.550, in paragraph (d)(1)(xxii)(B), remove “000986 and 016592” and in its place add “016592 and 058198”.
**21 CFR Part 558**
§ 558.618
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”.
**21 CFR Part 558**
§ 558.625
33. In § 558.625, in paragraph (b)(1), remove “To 000986” and in its place add “No. 058198”.
**21 CFR Part 558**
§ 558.630
34. In § 558.630, in paragraph (b)(1), remove “000986” and in its place add “058198”.
**21 CFR Part 558**
§ 558.665
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”.
Dated: July 20, 2016.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.