New Animal Drugs for Use in Animal Feeds; Zilpaterol

Summary:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of three abbreviated new animal drug applications (ANADAs) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The ANADAs provides for use of single-ingredient Type A medicated articles containing zilpaterol, melengestrol, monensin, and tylosin to make two-way, three-way, and four-way combination drug Type B and Type C medicated feeds for heifers fed in confinement for slaughter.

For further information contact:

John K. Harshman, Center for Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:john.harshman@fda.hhs.gov.

Supplementary information:

Ivy Laboratories, Div. of Ivy Animal Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200-483 for use of ZILMAX (zilpaterol hydrochloride) and HEIFERMAX 500 (melengestrol acetate) Liquid Premix single-ingredient Type A medicated articles to make dry and liquid, two way combination drug Type B and Type C medicated feeds for heifers fed in confinement for slaughter. Ivy Laboratories' ANADA 200-483 is approved as a generic copy of Intervet, Inc.'s combination medicated feed use of ZILMAX and MGA 500 (melengestrol acetate), approved under NADA 141-284.

Ivy Laboratories also filed ANADA 200-479 for use of ZILMAX, HEIFERMAX 500 Liquid Premix, and RUMENSIN (monensin USP) single-ingredient Type A medicated articles to make dry and liquid, three-way combination drug Type B and Type C medicated feeds for heifers fed in confinement for slaughter. Ivy Laboratories' ANADA 200-479 is approved as a generic copy of Intervet, Inc.'s combination medicated feed use of ZILMAX, MGA 500, and RUMENSIN, approved under NADA 141-282.

Ivy Laboratories also filed ANADA 200-480 for use of ZILMAX, HEIFERMAX 500 Liquid Premix, RUMENSIN, and TYLAN (tylosin phosphate) single-ingredient Type A medicated articles to make dry and liquid, four-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter. Ivy Laboratories' ANADA 200-480 is approved as a generic copy of Intervet, Inc.'s combination medicated feed use of ZILMAX, MGA 500, RUMENSIN, and TYLAN, approved under NADA 141-280.

The abbreviated applications are approved as of December 30, 2009, and the regulations are amended in 21 CFR 558.665 to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of each application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33 that these actions are of a type that do not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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 subject in 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 part 558 is amended as follows:

Part 558—new animal drugs for use in animal feeds

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

Authority:

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

§ 558.665 2. In § 558.665, in the table in paragraphs (e)(2), (e)(4), and (e)(6), in the “Limitations” column remove “No. 000009” and add in its place “Nos. 000009 or 021641” and in the “Sponsor”column add in numerical sequence “021641”. Dated: March 8, 2010. William T. Flynn,

Acting Director, Center for Veterinary Medicine.

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