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Rule

New Animal Drugs; Change of Sponsor

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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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.

Start Further Info

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.

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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.

Table 1—NADAs and ANADAs Transferred From Elanco Animal Health, a Division of Eli Lilly & Co. to Elanco US, Inc.

File No.Product name21 CFR Section
010-918HYGROMIX 8 (hygromycin B) Type A medicated article558.274
011-948HYGROMIX 2.4 (hygromycin B) Type A medicated article558.274
012-491TYLAN 100 (tylosin) Injection522.2640
012-548TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B)558.274
012-965TYLAN (tylosin) Injection522.2640
013-076TYLAN (tylosin tartrate) Soluble Powder520.2640
013-162TYLAN Premix No. 10 (tylosin phosphate) Type A medicated article558.625
013-388TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B)558.274
015-166TYLAN 100 Premix (tylosin phosphate) Type A medicated article558.625
038-878COBAN 45, 60, 90, 110 (monensin) Type A medicated article558.355
041-275TYLAN 40 Sulfa-G (tylosin phosphate and sulfamethazine) Type A medicated article558.630
047-933COBAN (monensin)/BACIFERM (bacitracin Zn)558.355
049-463COBAN (monensin)/BMD (bacitracin methylenedisalicyclate)558.355
095-735RUMENSIN 80 and 90 (monensin) Type A medicated article558.355
104-646RUMENSIN (monensin)/TYLAN (tylosin phosphate)558.355
106-964APRALAN (apramycin sulfate) Soluble Powder520.110
110-315COMPONENT E-C or E-S (progesterone and estradiol benzoate) with TYLAN522.1940
115-732STRESNIL (azaperone) Injection522.150
118-123COMPUDOSE 200 (estradiol); ENCORE (COMPUDOSE 400)522.840
118-980MONTEBAN (narasin) Type A medicated article558.363
126-050APRALAN 75 (apramycin sulfate) Soluble Powder520.110
127-507TYLAN 5, 10, 20, 40 Sulfa-G (tylosin phosphate and sulfamethazine) Type A medicated article558.630
130-736COBAN (monensin) Type A medicated article558.355
135-468Nicarbazin Type A medicated article558.366
135-906COMPONENT E-H (estradiol benzoate and testosterone propionate) with TYLAN522.842
138-952MAXIBAN (narasin and nicarbazin) Type A medicated article558.366
140-863PAYLEAN 9 and 45 (ractopamine HCl) Type A medicated article558.500
140-872POSILAC (sometribove Zn) Injectable Suspension522.2112
140-926BMD (bacitracin methylenedisalicyclate)/MAXIBAN (narasin and nicarbazin)558.366
140-929MICOTIL 300 (tilmicosin phosphate) Injectable Solution522.2471
140-937BMD (bacitracin methylenedisalicyclate)/COBAN (monensin)558.355
140-942FLAVOMYCIN (bambermycins)/MAXIBAN (narasin and nicarbazin)558.366
140-947LINCOMIX (lincomycin HCl)/MAXIBAN (narasin and nicarbazin)558.366
140-955COBAN (monensin)/FLAVOMYCIN (bambermycins)558.355
141-064PULMOTIL 90 (tilmicosin phosphate) Type A medicated article558.618
141-277COMFORTIS (spinosad) Tablets520.2130
141-298SUROLAN (miconazole nitrate, polymyxin B sulfate, prednisolone acetate) Otic Suspension524.1445
141-321TRIFEXIS (spinosad and milbemycin oxime) Tablets520.2134
141-110COBAN (monensin)/STAFAC (virginiamycin)558.355
141-164COBAN (monensin)/TYLAN (tylosin phosphate)558.355
141-170MONTEBAN (narasin)/TYLAN (tylosin phosphate)558.363
141-172PAYLEAN (ractopamine HCl)/TYLAN (tylosin phosphate)558.500
141-198TYLAN (tylosin phosphate)/BIO-COX (salinomycin sodium)558.550
141-221OPTAFLEXX 45 (ractopamine HCl) Type A medicated article558.500
141-224OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin)/TYLAN (tylosin phosphate)558.500
141-225OPTAFLEXX (ractopamine HCl) RUMENSIN (monensin)558.500
141-234OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin)/MGA (melengestrol acetate)558.500
141-290TOPMAX 9 (ractopamine HCl) Type A medicated article558.500
141-233OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin)/TYLAN (tylosin phosphate)/MGA (melengestrol acetate)558.500
141-301TOPMAX (ractopamine HCl)/COBAN (monensin)558.500
141-337RECUVYA (fentanyl) Topical Solution524.916
141-340SKYCIS 100 (narasin) Type A medicated article558.363
141-343PULMOTIL 90 (tilmicosin phosphate)/RUMENSIN 90 (monensin)558.618
141-361PULMOTIL AC (tilmicosin phosphate) Concentrate Solution520.2471
141-392IMPRESTOR (pegbovigrastim) Injection522.1684
141-438KAVAULT (avilamycin) Type A medicated article558.68
141-439INTEPRITY (avilamycin) Type A medicated article558.68
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200-221COMPONENT 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 TYLAN522.2477
200-224COMPONENT T-H (trenbolone acetate) with TYLAN; COMPONENT T-S with TYLAN522.2476
200-343HEIFERMAX 500 (melengestrol acetate) Type A medicated article558.342
200-346COMPONENT TE-200 (trenbolone acetate and estradiol); COMPONENT TE-200 with TYLAN; COMPONENT TE-H; COMPONENT TE-H with TYLAN, COMPONENT TE-H522.2477
200-375HEIFERMAX 500 (melengestrol acetate)/RUMENSIN (monensin)/TYLAN (tylosin phosphate)558.342
200-422HEIFERMAX 500 (melengestrol acetate) Liquid Premix/RUMENSIN (monensin)558.342
200-424HEIFERMAX (melengestrol acetate)/OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin)/TYLAN (tylosin phosphate)558.342
200-427HEIFERMAX 500 (melengestrol acetate) Liquid Premix/TYLAN (tylosin phosphate)558.342
200-430HEIFERMAX 500 (melengestrol acetate) Liquid Premix/BOVATEC (lasalocid)/TYLAN (tylosin phosphate)558.342
200-448HEIFERMAX 500 (melengestrol acetate)/OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin)558.500
200-451HEIFERMAX 500 (melengestrol acetate)/BOVATEC (lasalocid)558.342
200-479HEIFERMAX 500 (melengestrol acetate)/ZILMAX (zilpaterol)/RUMENSIN (monensin)558.665
200-480HEIFERMAX 500 (melengestrol acetate)/ZILMAX (zilpaterol)/RUMENSIN (monensin)/TYLAN (tylosin phosphate)558.665
200-483HEIFERMAX 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.

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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
End List of Subjects

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:

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PART 510—NEW ANIMAL DRUGS

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1. The authority citation for part 510 continues to read as follows:

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Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

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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”.

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PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

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

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

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

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

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

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PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

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

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

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

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

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

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

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

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

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

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

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PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

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

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

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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

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

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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”.

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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”.

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[Amended]
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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”.

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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”.

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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”.

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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”.

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

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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”.

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

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

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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”.

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Dated: July 20, 2016.

William T. Flynn,

Acting Director, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. 2016-17501 Filed 7-25-16; 8:45 am]

BILLING CODE 4164-01-P