E7-25605. New Animal Drugs For Use in Animal Feed; Semduramicin

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 new animal drug application (NADA) filed by Phibro Animal Health. The NADA provides for use of a Type A medicated article containing semduramicin (as semduramicin sodium biomass) to manufacture Type C medicated broiler chicken feed for the prevention of coccidiosis.

DATES:

This rule is effective January 4, 2008.

FOR FURTHER INFORMATION CONTACT:

Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Phibro Animal Health, 65 Challenger Rd., 3d floor, Ridgefield Park, NJ 07660, filed NADA 141-281 that provides for the use of AVIAX II (semduramicin) Type A medicated article containing semduramicin (as semduramicin sodium biomass) to manufacture Type C medicated broiler chicken feed for the prevention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and E. mitis. The NADA is approved as of December 3, 2007, and the regulations are amended in 21 CFR 558.4 and 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.

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning on the date of approval.

FDA has determined under 21 CFR 25.33(a)(3) 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 paragraph (d) of § 558.4, in the “Category I” table, revise the entry for “Semduramicin” and alphabetically add an entry for “Semduramicin (as semduramicin sodium biomass)” to read as follows:

§ 558.4

Requirement of a medicated feed mill license.

* * * * *

(d) * * *

Category I

Drug	Assay limits percent1 Type A	Type B maximum (200x)	Assay limits percent1 Type B/C2
*         *         *         *         *         *         *
Semduramicin (as semduramicin sodium)	90-110	2.27 g/lb (0.50%)	80-110
Semduramicin (as semduramicin sodium biomass)	90-110	2.27 g/lb (0.50%)	80-120
*         *         *         *         *         *         *
1 Percent of labeled amount.
2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed.

* * * * *

3. In § 558.555, revise paragraphs (a) and (b); and add paragraph (e) to read as follows:

§ 558.555

Semduramicin.

(a) Specifications. Type A medicated article containing:

(1) 22.7 grams (g) per pound (lb) (50 g/kilogram (kg)) semduramicin (as semduramicin sodium).

(2) 22.7 g/lb (50 g/kg) semduramicin (as semduramicin sodium biomass).

(b) Approvals. See No. 066104 in § 510.600(c) of this chapter for use of product described in paragraph (a)(1) as in paragraph (d) of this section; for use of product described in paragraph (a)(2) as in paragraph (e) of this section.

* * * * *

(e) Conditions of use in chickens. It is used in chicken feed as follows:

Semduramicin in grams per ton	Combination in grams per ton	Indications for use	Limitations	Sponsor
(1) 22.7 (25 ppm)		Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and E. mitis.	Do not feed to laying hens.	066104
(2) [Reserved]

Dated: December 20, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.