Document ID: FDA-2012-N-0002-0011
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Changes of Sponsors: Estradiol; Estradiol Benzoate and Testosterone Propionate; Progesterone and Estradiol Benzoate; etc.
Posted Date: 2012-05-30T04:00Z

[Federal Register Volume 77, Number 104 (Wednesday, May 30, 2012)]
[Rules and Regulations]
[Pages 31722-31724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13010]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, and 558

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Change of Sponsor; Estradiol; Estradiol 
Benzoate and Testosterone Propionate; Progesterone and Estradiol 
Benzoate; Trenbolone Acetate; Trenbolone Acetate and Estradiol; 
Melengestrol; Ractopamine; Zilpaterol

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for 17 new animal drug 
applications (NADAs) and abbreviated new animal drug applications 
(ANADAs) for various steroid ear implants for cattle and for 
melengestrol acetate liquid Type A medicated article and use in 
combination medicated feeds for heifers fed in confinement for 
slaughter from Ivy Laboratories, Division of Ivy Animal Health, Inc., 
to Elanco Animal Health, Division of Eli Lilly & Co.

DATES: This rule is effective May 30, 2012.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8300, email: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal 
Health, Inc., 8857 Bond St., Overland Park, KS 66214, has informed FDA 
that it has transferred ownership of, and all rights and interest in, 
the NADAs and ANADAs in this table to Elanco Animal Health, Division of 
Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285.

[[Page 31723]]

------------------------------------------------------------------------
                                 Proprietary name
         NADA/ANADA             (established name)      21 CFR section
------------------------------------------------------------------------
110-315.....................  COMPONENT E-C                     522.1940
                               (progesterone and
                               estradiol benzoate)
                               with TYLAN (tylosin
                               tartrate).
                              COMPONENT E-S
                               (progesterone and
                               estradiol benzoate)
                               with TYLAN (tylosin
                               tartrate).
118-123.....................  COMPONENT 200
                               (estradiol benzoate).
                              ENCORE (COMPUDOSE 400)             522.840
                               (estradiol benzoate).
135-906.....................  COMPONENT E-H                      522.842
                               (estradiol benzoate
                               and testosterone
                               propionate) with
                               TYLAN (tylosin
                               tartrate).
200-221.....................  COMPONENT TE-IS                   522.2477
                               (trenbolone acetate
                               and estradiol).
                              COMPONENT TE-S
                               (trenbolone acetate
                               and estradiol).
                              COMPONENT TE-G
                               (trenbolone acetate
                               and estradiol).
                              COMPONENT TE-IS
                               (trenbolone acetate
                               and estradiol) with
                               TYLAN (tylosin
                               tartrate).
                              COMPONENT TE-S
                               (trenbolone acetate
                               and estradiol) with
                               TYLAN (tylosin
                               tartrate).
                              COMPONENT TE-G
                               (trenbolone acetate
                               and estradiol) with
                               TYLAN (tylosin
                               tartrate).
                              COMPONENT TE-ID
                               (trenbolone acetate
                               and estradiol) with
                               TYLAN (tylosin
                               tartrate).
200-224.....................  COMPONENT T-H                     522.2476
                               (trenbolone acetate)
                               with TYLAN (tylosin
                               tartrate).
                              COMPONENT T-S
                               (trenbolone acetate)
                               with TYLAN (tylosin
                               tartrate).
200-343.....................  HEIFERMAX 500                      558.342
                               (melengestrol
                               acetate) Liquid
                               Premix.
200-346.....................  COMPONENT TE-H                    522.2477
                               (trenbolone acetate
                               and estradiol).
                              COMPONENT TE-H
                               (trenbolone acetate
                               and estradiol) with
                               TYLAN (tylosin
                               tartrate).
                              COMPONENT TE-IH
                               (trenbolone acetate
                               and estradiol).
                              COMPONENT TE-200
                               (trenbolone acetate
                               and estradiol).
                              COMPONENT TE-200
                               (trenbolone acetate
                               and estradiol) with
                               TYLAN (tylosin
                               tartrate).
200-375.....................  HEIFERMAX 500                      558.342
                               (melengestrol
                               acetate) Liquid
                               Premix/RUMENSIN
                               (monensin)/TYLAN
                               (tylosin phosphate).
200-422.....................  HEIFERMAX 500                      558.342
                               (melengestrol
                               acetate) Liquid
                               Premix plus RUMENSIN
                               (monensin).
200-424.....................  HEIFERMAX 500                      558.500
                               (melengestrol
                               acetate) Liquid
                               Premix/OPTAFLEXX
                               (ractopamine HCI)/
                               RUMENSIN (monensin)/
                               TYLAN (tylosin
                               phosphate).
200-427.....................  HEIFERMAX 500                      558.342
                               (melengestrol
                               acetate) Liquid
                               Premix plus 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) Liquid
                               Premix/OPTAFLEXX
                               (ractopamine HCl)/
                               RUMENSIN (monensin).
200-451.....................  HEIFERMAX 500                      558.342
                               (melengestrol
                               acetate) Liquid
                               Premix plus BOVATEC
                               (lasalocid).
200-479.....................  HEIFERMAX 500                      558.665
                               (melengestrol
                               acetate) Liquid
                               Premix/ZILMAX
                               (zilpaterol)/RUMENSIN
                               (monensin).
200-480.....................  HEIFERMAX 500                      558.665
                               (melengestrol
                               acetate) Liquid
                               Premix/ZILMAX
                               (zilpaterol)/RUMENSIN
                               (monensin)/TYLAN
                               (tylosin phosphate).
200-483.....................  HEIFERMAX 500                      558.665
                               (melengestrol
                               acetate) Liquid
                               Premix plus ZILMAX
                               (zilpaterol).
------------------------------------------------------------------------

    Accordingly, the Agency is amending the regulations in parts 522 
and 558 (21 CFR parts 522, and 558) to reflect the transfer of 
ownership.
    Following these changes of sponsorship, Ivy Laboratories, Division 
of Ivy Animal Health, Inc., is no longer the sponsor of an approved 
application. Accordingly, Sec.  510.600 (21 CFR 510.600) is being 
amended to remove the entries for this firm.
    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 Part 522

    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, 
522, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

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

Sec.  510.600  [Amended]

    2. In Sec.  510.600, in the table in paragraph (c)(l), remove the 
entry for ``Ivy Laboratories, Div. of Ivy Animal Health, Inc.''; and in 
the table in paragraph (c)(2), remove the entry for ``021641''.

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

0
3. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

Sec.  522.840  [Amended]

0
4. In paragraph (b) of Sec.  522.840, remove ``021641'' and in its 
place add ``000986''.

Sec.  522.842  [Amended]

0
5. In paragraph (a)(2) of Sec.  522.842, remove ``021641'' and in its 
place add ``000986''.

Sec.  522.1940  [Amended]

0
6. In paragraph (a)(2) of Sec.  522.1940, remove ``021641'' and in its 
place add ``000986''.

Sec.  522.2476  [Amended]

0
7. In paragraph (b)(l) of Sec.  522.2476, remove ``021641'' and in its 
place add ``000986''.

Sec.  522.2477  [Amended]

0
8. In paragraph (b)(l) of Sec.  522.2477, remove ``021641'' and in its 
place add ``000986''.

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

0
9. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.342  [Amended]

0
10. In Sec.  558.342, in paragraph (b)(2) and in the ``Sponsor'' column 
of the table, in paragraphs (e)(l)(i), (e)(1)(ii), (e)(l)(iii), and 
(e)(l)(ix) remove ``021641''

[[Page 31724]]

and in its place add ``000986''; in paragraphs (e)(1)(iv) and (e)(1)(x) 
add ``000986''; and in paragraph (e)(1)(xi), remove ``02164'' and in 
its place add ``000986''.

Sec.  558.500  [Amended]

0
11. In Sec.  558.500, in the ``Sponsor'' column of the table, in 
paragraphs (e)(2)(viii) and (e)(2)(x), remove ``021641''.

Sec.  558.665  [Amended]

0
12. In Sec.  558.665, in the ``Sponsor'' column of the table, in 
paragraphs (e)(2), (e)(4), and (e)(6), remove ``021641'' and in its 
place add ``000986''.

    Dated: May 23, 2012.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2012-13010 Filed 5-29-12; 8:45 am]
BILLING CODE 4160-01-P