E9-19738. New Animal Drugs for Use in Animal Feeds; Semduramicin; Virginiamycin

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 an original new animal drug application (NADA) filed by Phibro Animal Health. The NADA provides for use of single-ingredient Type A medicated articles containing semduramyicin (as semduramicin sodium biomass) and virginiamycin to manufacture 2-way combination drug Type C medicated feeds for use in broiler chickens.

DATES:

This rule is effective August 18, 2009.

FOR FURTHER INFORMATION CONTACT:

Timothy Schell, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8116, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Phibro Animal Health, 65 Challenger Rd., 3d floor, Ridgefield Park, NJ 07660, filed NADA 141-289 that provides for the use of AVIAX II (semduramicin sodium biomass) and STAFAC (virginiamycin) Type A medicated articles to manufacture 2-way combination drug Type C medicated feeds for broiler chickens. The NADA is approved as of July 13, 2009, and the regulations are amended in 21 CFR 558.555 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 § 558.555, add paragraphs (e)(2) through (e)(4) to read as follows:

§ 558.555

Semduramicin.

(e) * * *

Semduramicin in grams per ton	Combination in grams per ton	Indications for use	Limitations	Sponsor
*         *         *         *         *         *         *
(2) 22.7	Virginiamycin 5	Broiler chickens: As in paragraph (e)(1) of this section; for increased rate of weight gain and improved feed efficiency.	Feed continuously as sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin provided by No. 066104 in § 510.600(c) of this chapter.	066104
(3) 22.7	Virginiamycin 5 to 15	Broiler chickens: As in paragraph (e)(1) of this section; for increased rate of weight gain.	Feed continuously as sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin provided by No. 066104 in § 510.600(c) of this chapter.	066104
(4) 22.7	Virginiamycin 20	Broiler chickens: As in paragraph (e)(1) of this section; for prevention of necrotic enteritis caused by C. perfringens susceptible to virginiamycin.	Feed continuously as sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin provided by No. 066104 in § 510.600(c) of this chapter.	066104

Dated: August 12, 2009.

William T. Flynn,

Acting Director, Center for Veterinary Medicine.