E9-28019. New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for use of the same dose levels approved for single-ingredient Type C medicated feeds containing melengestrol acetate, monensin, or tylosin phosphate for heifers fed in confinement for slaughter in three-way, combination drug Type C medicated feeds containing melengestrol acetate, monensin, and tylosin phosphate.

DATES:

This rule is effective November 23, 2009.

FOR FURTHER INFORMATION CONTACT:

Suzanne J. Sechen, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8105, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement to NADA 138-870 for use of MGA (melengestrol acetate), RUMENSIN (monensin, USP), and TYLAN (tylosin phosphate) single-ingredient Type A medicated articles to make three-way, combination drug Type C medicated feeds for heifers fed in confinement for slaughter. The supplemental NADA provides for use of the same dose levels approved for single ingredient Type C medicated feeds containing melengestrol acetate, monensin, or tylosin phosphate in the three-way, combination drug Type C medicated feeds. The supplemental application is approved as of October 19, 2009, and the regulations are amended in 21 CFR 558.342 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 this 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 this action is of a type that does 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 Subjects 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.

2. In § 558.342, add paragraph (e)(1)(xi) to read as follows:

§ 558.342

Melengestrol.

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(e) * * *

(1) * * *

Melengestrol acetate in mg/head/day	Combination in mg/head/day	Indications for use	Limitations	Sponsor
*         *         *         *         *         *         *
(xi) 0.25 to 0.5	Monensin 50 to 480, plus tylosin 60 to 90	Heifers fed in confinement for slaughter: As in paragraph (e)(1)(i) of this section; for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes.	Feed continuously as sole ration (liquid or dry) at a rate of 0.5 to 2.0 lb/head/day to provide 0.25 to 0.5 mg/head/day melengestrol acetate; 0.14 to 0.42 mg monensin/lb body weight/day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day; and 60 to 90 mg/head/day tylosin. The melengestrol acetate portion of this Type C medicated feed must be mixed into a complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin in the amount of complete feed consumed by an animal per day.   Monensin and tylosin phosphate provided by No. 000986 in § 510.600(c) of this chapter.	000009

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Dated: November 17, 2009.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.