New Animal Drugs; Change of Sponsor

Federal Register, Volume 81 Issue 143 (Tuesday, July 26, 2016)

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.

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21 CFR

File No. Product name Section

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010-918........................ HYGROMIX 8 (hygromycin 558.274

2. 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).

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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