-
Start Preamble
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
Start Printed Page 48701SUMMARY:
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.
Start Further InfoFOR 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.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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.
Table 1—NADAs and ANADAs Transferred From Elanco Animal Health, a Division of Eli Lilly & Co. to Elanco US, Inc.
File No. Product name 21 CFR Section 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 Start Printed Page 48702 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.
Start List of SubjectsList 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:
Start PartPART 510—NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for part 510 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment Part Start PartPART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part3. The authority citation for part 520 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]4. In § 520.110, in paragraph (b), remove “000986” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]5. In § 520.2130, in paragraph (b), remove “000986” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]6. In § 520.2134, in paragraph (b), remove “000986” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]7. In § 520.2471, in paragraph (b), remove “000986” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]8. In § 520.2640, in paragraph (b)(1), remove “000986” and in its place add “058198”.
End Amendment Part Start PartPART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part9. The authority citation for part 522 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]10. In § 522.150, in paragraph (b), remove “000986” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]11. In § 522.840, in paragraph (b), remove “000986” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]12. In § 522.842, in paragraph (a)(2), remove “000986” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]13. In § 522.1684, in paragraph (b), remove “000986” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]14. In § 522.1940, in paragraph (a)(2), remove “000986” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]15. In § 522.2112, in paragraph (b), remove “000986” and in its place add “058198”.
End Amendment Part Start Amendment Part16. In § 522.2471, in paragraph (b), remove “000986” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]17. In § 522.2476, in paragraph (a)(1), remove “021641” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]18. In § 522.2477, in paragraph (b)(1), remove “000986” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]19. In § 522.2640, in paragraph (b)(1), remove “000986” and in its place add “058198”.
End Amendment Part Start PartPART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part20. The authority citation for part 524 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]21. In § 524.916, in paragraph (b), remove “000986” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]22. In § 524.1445, in paragraph (b), remove “000986” and in its place add “058198”.
End Amendment Part Start PartPART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
End Part Start Amendment Part23. The authority citation for part 558 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]24. In § 558.68, in paragraph (b), remove “000986” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment PartStart Amendment Part[Amended]31. In § 558.550, in paragraph (d)(1)(xxii)(B), remove “000986 and 016592” and in its place add “016592 and 058198”.
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment PartStart Amendment Part[Amended]33. In § 558.625, in paragraph (b)(1), remove “To 000986” and in its place add “No. 058198”.
End Amendment PartStart Amendment Part[Amended]34. In § 558.630, in paragraph (b)(1), remove “000986” and in its place add “058198”.
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment Part Start SignatureEnd Signature End Supplemental InformationDated: July 20, 2016.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-17501 Filed 7-25-16; 8:45 am]
BILLING CODE 4164-01-P
Document Information
- Effective Date:
- 7/26/2016
- Published:
- 07/26/2016
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- 2016-17501
- Dates:
- This rule is effective July 26, 2016.
- Pages:
- 48700-48703 (4 pages)
- Docket Numbers:
- Docket No. FDA-2014-N-0002
- Topics:
- Administrative practice and procedure, Animal drugs, Animal feeds, Labeling, Reporting and recordkeeping requirements
- PDF File:
- 2016-17501.pdf
- Supporting Documents:
- » FREEDOM OF INFORMATION SUMMARY ANADA 200-512 TRIAMULOX tiamulin hydrogen fumarate, 12.3% Liquid Concentrate Swine re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
- » FREEDOM OF INFORMATION SUMMARY NADA 034-267 GENTOCIN DURAFILM (Gentamicin Sulfate and Betamethasone) Sterile Ophthalmic Solution re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
- » FREEDOM OF INFORMATION SUMMARY NADA 141-349 DRAXXIN 25 Injectable Solution Tulathromycin Injection Cattle (suckling calves, dairy calves, and veal calves) re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
- » FREEDOM OF INFORMATION SUMMARY NADA 141-276 ZILMAX plus RUMENSIN plus TYLAN (zilpaterol hydrochloride 4.8%; monensin, USP; and tylosin phosphate) Type A Medicated Articles For Use in the Manufacture of Type B and C Medicated Feeds Cattle Fed in Confinemen
- » FREEDOM OF INFORMATION SUMMARY NADA 141-258 ZILMAX Zilpaterol Hydrochloride 4.8% Type A medicated article to be used in the manufacture of Type B and C medicated feeds Cattle fed in confinement for slaughter re New Animal Drugs; Approval of New Animal Dru
- » FREEDOM OF INFORMATION SUMMARY NADA 141-232 SIMPLICEF Cefpodoxime proxetil Chewable tablets Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
- » FREEDOM OF INFORMATION SUMMARY NADA 141-068 BAYTRIL 100 Injectable Solution Enrofloxacin Swine re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
- » FREEDOM OF INFORMATION SUMMARY NADA 141-034 GAINPRO bambermycins Type A Medicated Article to be used in the manufacture of Type C Medicated Feeds Pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers) re New Animal
- » FREEDOM OF INFORMATION SUMMARY NADA 141-437 OSURNIA florfenicol, terbinafine, betamethasone acetate Otic gel Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
- » FREEDOM OF INFORMATION SUMMARY ANADA 200-575 Carprofen Chewable Tablets Carprofen Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
- CFR: (30)
- 21 CFR 22.2476
- 21 CFR 510.600
- 21 CFR 520.110
- 21 CFR 520.2130
- 21 CFR 520.2134
- More ...