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
Federal Register, Volume 77 Issue 104 (Wednesday, May 30, 2012)
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
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
-
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
-
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
-
The authority citation for 21 CFR part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.840 Amended
0
-
In paragraph (b) of Sec. 522.840, remove ``021641'' and in its place add ``000986''.
Sec. 522.842 Amended
0
-
In paragraph (a)(2) of Sec. 522.842, remove ``021641'' and in its place add ``000986''.
Sec. 522.1940 Amended
0
-
In paragraph (a)(2) of Sec. 522.1940, remove ``021641'' and in its place add ``000986''.
Sec. 522.2476 Amended
0
-
In paragraph (b)(l) of Sec. 522.2476, remove ``021641'' and in its place add ``000986''.
Sec. 522.2477 Amended
0
-
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
-
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
-
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
-
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
-
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
