# [Amended]
**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: *[email protected].*
**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.
| 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**
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
Animal drugs.
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:
**21 CFR Part 510**
**PART 510—NEW ANIMAL DRUGS**
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.
**21 CFR Part 510**
§ 510.600
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”.
**21 CFR Part 522**
**PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS**
3. The authority citation for 21 CFR part 522 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 522**
§ 522.840
4. In paragraph (b) of § 522.840, remove “021641” and in its place add “000986”.
**21 CFR Part 522**
§ 522.842
5. In paragraph (a)(2) of § 522.842, remove “021641” and in its place add “000986”.
**21 CFR Part 522**
§ 522.1940
6. In paragraph (a)(2) of § 522.1940, remove “021641” and in its place add “000986”.
**21 CFR Part 522**
§ 522.2476
7. In paragraph (b)(l) of § 522.2476, remove “021641” and in its place add “000986”.
**21 CFR Part 522**
§ 522.2477
8. In paragraph (b)(l) of § 522.2477, remove “021641” and in its place add “000986”.
**21 CFR Part 558**
**PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS**
9. The authority citation for 21 CFR part 558 continues to read as follows:
**Authority:**
21 U.S.C. 360b, 371.
**21 CFR Part 558**
§ 558.342
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”.
**21 CFR Part 558**
§ 558.500
11. In § 558.500, in the “Sponsor” column of the table, in paragraphs (e)(2)(viii) and (e)(2)(x), remove “021641”.
**21 CFR Part 558**
§ 558.665
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”.
Dated: May 23, 2012.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.