[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.
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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]]
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Proprietary name
NADA/ANADA (established name) 21 CFR section
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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).
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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