Document ID: FDA-2014-N-0002-0085
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor
Posted Date: 2016-07-26T04:00Z

[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Rules and Regulations]
[Pages 48700-48703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17501]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 558

[Docket No. FDA-2014-N-0002]

New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 48701]]

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.

   Table 1--NADAs and ANADAs Transferred From Elanco Animal Health, a
             Division of Eli Lilly & Co. to Elanco US, Inc.
------------------------------------------------------------------------
                                                              21 CFR
            File No.                   Product name           Section
------------------------------------------------------------------------
010-918........................  HYGROMIX 8 (hygromycin          558.274
                                  B) Type A medicated
                                  article.
011-948........................  HYGROMIX 2.4                    558.274
                                  (hygromycin B) Type A
                                  medicated article.
012-491........................  TYLAN 100 (tylosin)            522.2640
                                  Injection.
012-548........................  TYLAN (tylosin                  558.274
                                  phosphate)/HYGROMIX
                                  (hygromycin B).
012-965........................  TYLAN (tylosin)                522.2640
                                  Injection.
013-076........................  TYLAN (tylosin                 520.2640
                                  tartrate) Soluble
                                  Powder.
013-162........................  TYLAN Premix No. 10             558.625
                                  (tylosin phosphate)
                                  Type A medicated
                                  article.
013-388........................  TYLAN (tylosin                  558.274
                                  phosphate)/HYGROMIX
                                  (hygromycin B).
015-166........................  TYLAN 100 Premix                558.625
                                  (tylosin phosphate)
                                  Type A medicated
                                  article.
038-878........................  COBAN 45, 60, 90, 110           558.355
                                  (monensin) Type A
                                  medicated article.
041-275........................  TYLAN 40 Sulfa-G                558.630
                                  (tylosin phosphate and
                                  sulfamethazine) Type A
                                  medicated article.
047-933........................  COBAN (monensin)/               558.355
                                  BACIFERM (bacitracin
                                  Zn).
049-463........................  COBAN (monensin)/BMD            558.355
                                  (bacitracin
                                  methylenedisalicyclate
                                  ).
095-735........................  RUMENSIN 80 and 90              558.355
                                  (monensin) Type A
                                  medicated article.
104-646........................  RUMENSIN (monensin)/            558.355
                                  TYLAN (tylosin
                                  phosphate).
106-964........................  APRALAN (apramycin              520.110
                                  sulfate) Soluble
                                  Powder.
110-315........................  COMPONENT E-C or E-S           522.1940
                                  (progesterone and
                                  estradiol benzoate)
                                  with TYLAN.
115-732........................  STRESNIL (azaperone)            522.150
                                  Injection.
118-123........................  COMPUDOSE 200                   522.840
                                  (estradiol); ENCORE
                                  (COMPUDOSE 400).
118-980........................  MONTEBAN (narasin) Type         558.363
                                  A medicated article.
126-050........................  APRALAN 75 (apramycin           520.110
                                  sulfate) Soluble
                                  Powder.
127-507........................  TYLAN 5, 10, 20, 40             558.630
                                  Sulfa-G (tylosin
                                  phosphate and
                                  sulfamethazine) Type A
                                  medicated article.
130-736........................  COBAN (monensin) Type A         558.355
                                  medicated article.
135-468........................  Nicarbazin Type A               558.366
                                  medicated article.
135-906........................  COMPONENT E-H                   522.842
                                  (estradiol benzoate
                                  and testosterone
                                  propionate) with TYLAN.
138-952........................  MAXIBAN (narasin and            558.366
                                  nicarbazin) Type A
                                  medicated article.
140-863........................  PAYLEAN 9 and 45                558.500
                                  (ractopamine HCl) Type
                                  A medicated article.
140-872........................  POSILAC (sometribove           522.2112
                                  Zn) Injectable
                                  Suspension.
140-926........................  BMD (bacitracin                 558.366
                                  methylenedisalicyclate
                                  )/MAXIBAN (narasin and
                                  nicarbazin).
140-929........................  MICOTIL 300 (tilmicosin        522.2471
                                  phosphate) Injectable
                                  Solution.
140-937........................  BMD (bacitracin                 558.355
                                  methylenedisalicyclate
                                  )/COBAN (monensin).
140-942........................  FLAVOMYCIN                      558.366
                                  (bambermycins)/MAXIBAN
                                  (narasin and
                                  nicarbazin).
140-947........................  LINCOMIX (lincomycin            558.366
                                  HCl)/MAXIBAN (narasin
                                  and nicarbazin).
140-955........................  COBAN (monensin)/               558.355
                                  FLAVOMYCIN
                                  (bambermycins).
141-064........................  PULMOTIL 90 (tilmicosin         558.618
                                  phosphate) Type A
                                  medicated article.
141-277........................  COMFORTIS (spinosad)           520.2130
                                  Tablets.
141-298........................  SUROLAN (miconazole            524.1445
                                  nitrate, polymyxin B
                                  sulfate, prednisolone
                                  acetate) Otic
                                  Suspension.
141-321........................  TRIFEXIS (spinosad and         520.2134
                                  milbemycin oxime)
                                  Tablets.
141-110........................  COBAN (monensin)/STAFAC         558.355
                                  (virginiamycin).
141-164........................  COBAN (monensin)/TYLAN          558.355
                                  (tylosin phosphate).
141-170........................  MONTEBAN (narasin)/             558.363
                                  TYLAN (tylosin
                                  phosphate).
141-172........................  PAYLEAN (ractopamine            558.500
                                  HCl)/TYLAN (tylosin
                                  phosphate).
141-198........................  TYLAN (tylosin                  558.550
                                  phosphate)/BIO-COX
                                  (salinomycin sodium).
141-221........................  OPTAFLEXX 45                    558.500
                                  (ractopamine HCl) Type
                                  A medicated article.
141-224........................  OPTAFLEXX (ractopamine          558.500
                                  HCl)/RUMENSIN
                                  (monensin)/TYLAN
                                  (tylosin phosphate).
141-225........................  OPTAFLEXX (ractopamine          558.500
                                  HCl) RUMENSIN
                                  (monensin).
141-234........................  OPTAFLEXX (ractopamine          558.500
                                  HCl)/RUMENSIN
                                  (monensin)/MGA
                                  (melengestrol acetate).
141-290........................  TOPMAX 9 (ractopamine           558.500
                                  HCl) Type A medicated
                                  article.
141-233........................  OPTAFLEXX (ractopamine          558.500
                                  HCl)/RUMENSIN
                                  (monensin)/TYLAN
                                  (tylosin phosphate)/
                                  MGA (melengestrol
                                  acetate).
141-301........................  TOPMAX (ractopamine             558.500
                                  HCl)/COBAN (monensin).
141-337........................  RECUVYA (fentanyl)              524.916
                                  Topical Solution.
141-340........................  SKYCIS 100 (narasin)            558.363
                                  Type A medicated
                                  article.
141-343........................  PULMOTIL 90 (tilmicosin         558.618
                                  phosphate)/RUMENSIN 90
                                  (monensin).
141-361........................  PULMOTIL AC (tilmicosin        520.2471
                                  phosphate) Concentrate
                                  Solution.
141-392........................  IMPRESTOR                      522.1684
                                  (pegbovigrastim)
                                  Injection.
141-438........................  KAVAULT (avilamycin)             558.68
                                  Type A medicated
                                  article.
141-439........................  INTEPRITY (avilamycin)           558.68
                                  Type A medicated
                                  article.

[[Page 48702]]

 
200-221........................  COMPONENT TE-G                 522.2477
                                  (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.
200-224........................  COMPONENT T-H                  522.2476
                                  (trenbolone acetate)
                                  with TYLAN; COMPONENT
                                  T-S with TYLAN.
200-343........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)
                                  Type A medicated
                                  article.
200-346........................  COMPONENT TE-200               522.2477
                                  (trenbolone acetate
                                  and estradiol);
                                  COMPONENT TE-200 with
                                  TYLAN; COMPONENT TE-H;
                                  COMPONENT TE-H with
                                  TYLAN, COMPONENT TE-H.
200-375........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)/
                                  RUMENSIN (monensin)/
                                  TYLAN (tylosin
                                  phosphate).
200-422........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)
                                  Liquid Premix/RUMENSIN
                                  (monensin).
200-424........................  HEIFERMAX (melengestrol         558.342
                                  acetate)/OPTAFLEXX
                                  (ractopamine HCl)/
                                  RUMENSIN (monensin)/
                                  TYLAN (tylosin
                                  phosphate).
200-427........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)
                                  Liquid Premix/TYLAN
                                  (tylosin phosphate).
200-430........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)
                                  Liquid Premix/BOVATEC
                                  (lasalocid)/TYLAN
                                  (tylosin phosphate).
200-448........................  HEIFERMAX 500                   558.500
                                  (melengestrol acetate)/
                                  OPTAFLEXX (ractopamine
                                  HCl)/RUMENSIN
                                  (monensin).
200-451........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)/
                                  BOVATEC (lasalocid).
200-479........................  HEIFERMAX 500                   558.665
                                  (melengestrol acetate)/
                                  ZILMAX (zilpaterol)/
                                  RUMENSIN (monensin).
200-480........................  HEIFERMAX 500                   558.665
                                  (melengestrol acetate)/
                                  ZILMAX (zilpaterol)/
                                  RUMENSIN (monensin)/
                                  TYLAN (tylosin
                                  phosphate).
200-483........................  HEIFERMAX 500                   558.665
                                  (melengestrol acetate)/
                                  ZILMAX (zilpaterol).
------------------------------------------------------------------------

    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

0
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.

Sec.  510.600  [Amended]

0
2. In Sec.  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

0
3. The authority citation for part 520 continues to read as follows:

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

Sec.  520.110  [Amended]

0
4. In Sec.  520.110, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.

Sec.  520.2130  [Amended]

0
5. In Sec.  520.2130, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.

Sec.  520.2134  [Amended]

0
6. In Sec.  520.2134, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.

Sec.  520.2471  [Amended]

0
7. In Sec.  520.2471, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.

Sec.  520.2640  [Amended]

0
8. In Sec.  520.2640, in paragraph (b)(1), remove ``000986'' and in its 
place add ``058198''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for part 522 continues to read as follows:

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

Sec.  522.150  [Amended]

0
10. In Sec.  522.150, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.

Sec.  522.840  [Amended]

0
11. In Sec.  522.840, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.

Sec.  522.842  [Amended]

0
12. In Sec.  522.842, in paragraph (a)(2), remove ``000986'' and in its 
place add ``058198''.

Sec.  522.1684  [Amended]

0
13. In Sec.  522.1684, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.

Sec.  522.1940  [Amended]

0
14. In Sec.  522.1940, in paragraph (a)(2), remove ``000986'' and in 
its place add ``058198''.

Sec.  522.2112  [Amended]

0
15. In Sec.  522.2112, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.

[[Page 48703]]

Sec.  522.2471  [Amended]

0
16. In Sec.  522.2471, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.

Sec.  22.2476  [Amended]

0
17. In Sec.  522.2476, in paragraph (a)(1), remove ``021641'' and in 
its place add ``058198''.

Sec.  522.2477  [Amended]

0
18. In Sec.  522.2477, in paragraph (b)(1), remove ``000986'' and in 
its place add ``058198''.

Sec.  522.2640  [Amended]

0
19. In Sec.  522.2640, in paragraph (b)(1), remove ``000986'' and in 
its place add ``058198''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
20. The authority citation for part 524 continues to read as follows:

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

Sec.  524.916  [Amended]

0
21. In Sec.  524.916, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.

Sec.  524.1445  [Amended]

0
22. In Sec.  524.1445, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
23. The authority citation for part 558 continues to read as follows:

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

Sec.  558.68  [Amended]

0
24. In Sec.  558.68, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.

Sec.  558.274  [Amended]

0
25. In Sec.  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''.

Sec.  558.342  [Amended]

0
26. In Sec.  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''.

Sec.  558.355  [Amended]

0
27. In Sec.  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''.

Sec.  558.363  [Amended]

0
28. In Sec.  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''.

Sec.  558.366  [Amended]

0
29. In Sec.  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''.

Sec.  558.500  [Amended]

0
30. In Sec.  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''.

Sec.  558.550  [Amended]

0
31. In Sec.  558.550, in paragraph (d)(1)(xxii)(B), remove ``000986 and 
016592'' and in its place add ``016592 and 058198''.

Sec.  558.618  [Amended]

0
32. In Sec.  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''.

Sec.  558.625  [Amended]

0
33. In Sec.  558.625, in paragraph (b)(1), remove ``To 000986'' and in 
its place add ``No. 058198''.

Sec.  558.630  [Amended]

0
34. In Sec.  558.630, in paragraph (b)(1), remove ``000986'' and in its 
place add ``058198''.

Sec.  558.665  [Amended]

0
35. In Sec.  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.
[FR Doc. 2016-17501 Filed 7-25-16; 8:45 am]
 BILLING CODE 4164-01-P