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Rule

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

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.

 

Table of Contents Back to Top

DATES: Back to Top

This rule is effective May 30, 2012.

FOR FURTHER INFORMATION CONTACT: Back to Top

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: Back to Top

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.

NADA/ANADA Proprietary name (established name) 21 CFR section
110-315 COMPONENT E-C (progesterone and estradiol benzoate) with TYLAN (tylosin tartrate) 522.1940
COMPONENT E-S (progesterone and estradiol benzoate) with TYLAN (tylosin tartrate).  
118-123 COMPONENT 200 (estradiol benzoate)  
ENCORE (COMPUDOSE 400) (estradiol benzoate). 522.840
135-906 COMPONENT E-H (estradiol benzoate and testosterone propionate) with TYLAN (tylosin tartrate) 522.842
200-221 COMPONENT TE-IS (trenbolone acetate and estradiol) 522.2477
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 (trenbolone acetate) with TYLAN (tylosin tartrate) 522.2476
COMPONENT T-S (trenbolone acetate) with TYLAN (tylosin tartrate).  
200-343 HEIFERMAX 500 (melengestrol acetate) Liquid Premix 558.342
200-346 COMPONENT TE-H (trenbolone acetate and estradiol) 522.2477
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 (melengestrol acetate) Liquid Premix/RUMENSIN (monensin)/TYLAN (tylosin phosphate) 558.342
200-422 HEIFERMAX 500 (melengestrol acetate) Liquid Premix plus RUMENSIN (monensin) 558.342
200-424 HEIFERMAX 500 (melengestrol acetate) Liquid Premix/OPTAFLEXX (ractopamine HCI)/RUMENSIN (monensin)/TYLAN (tylosin phosphate) 558.500
200-427 HEIFERMAX 500 (melengestrol acetate) Liquid Premix plus TYLAN (tylosin phosphate) 558.342
200-430 HEIFERMAX 500 (melengestrol acetate) Liquid Premix/BOVATEC (lasalocid)/TYLAN (tylosin phosphate) 558.342
200-448 HEIFERMAX 500 (melengestrol acetate) Liquid Premix/OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin) 558.500
200-451 HEIFERMAX 500 (melengestrol acetate) Liquid Premix plus BOVATEC (lasalocid) 558.342
200-479 HEIFERMAX 500 (melengestrol acetate) Liquid Premix/ZILMAX (zilpaterol)/RUMENSIN (monensin) 558.665
200-480 HEIFERMAX 500 (melengestrol acetate) Liquid Premix/ZILMAX (zilpaterol)/RUMENSIN (monensin)/TYLAN (tylosin phosphate) 558.665
200-483 HEIFERMAX 500 (melengestrol acetate) Liquid Premix plus ZILMAX (zilpaterol) 558.665

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, § 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 Back to Top

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:

begin regulatory text

PART 510—NEW ANIMAL DRUGS Back to Top

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.

§ 510.600 [Amended]

2. In § 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 Back to Top

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

Authority:

21 U.S.C. 360b.

§ 522.840 [Amended]

4.In paragraph (b) of § 522.840, remove “021641” and in its place add “000986”.

§ 522.842 [Amended]

5.In paragraph (a)(2) of § 522.842, remove “021641” and in its place add “000986”.

§ 522.1940 [Amended]

6.In paragraph (a)(2) of § 522.1940, remove “021641” and in its place add “000986”.

§ 522.2476 [Amended]

7.In paragraph (b)(l) of § 522.2476, remove “021641” and in its place add “000986”.

§ 522.2477 [Amended]

8.In paragraph (b)(l) of § 522.2477, remove “021641” and in its place add “000986”.

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS Back to Top

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

Authority:

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

§ 558.342 [Amended]

10.In § 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” 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”.

§ 558.500 [Amended]

11.In § 558.500, in the “Sponsor” column of the table, in paragraphs (e)(2)(viii) and (e)(2)(x), remove “021641”.

§ 558.665 [Amended]

12.In § 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”.

end regulatory text

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

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