[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,
[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.
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]
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