06-8275. Oral Dosage Form New Animal Drugs; Amprolium Solution

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 (ANADA) filed by IVX Animal Health, Inc. The ANADA provides for use of amprolium solution to make medicated drinking water or as a drench for the prevention or treatment of coccidiosis in calves.

DATES:

This rule is effective September 27, 2006.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

IVX Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed ANADA 200-389 that provides for the use of Amprolium 9.6% Oral Solution to make medicated drinking water or as a drench for the prevention or treatment of coccidiosis in calves. IVX Animal Health's Amprolium 9.6% Oral Solution is approved as a generic copy of Merial Ltd.'s CORID (amprolium) 9.6% Solution approved under NADA 13-149. The ANADA is approved as of September 6, 2006, and the regulations are amended in 21 CFR 520.100 to reflect the approval and a current format. The basis of approval is discussed in the freedom of information summary.

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.

FDA has determined under 21 CFR 25.33(a)(1) 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 Subject in 21 CFR Part 520

• Animal drugs

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 520 is amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 520 continues to read as follows:

Authority: 21 U.S.C. 360b.

2. Revise § 520.100 to read as follows:

§ 520.100

Amprolium.

(a) Specifications—(1) Each milliliter of solution contains 96 milligrams (mg) amprolium (9.6 percent solution).

(2) Each gram of powder contains 200 mg amprolium (20 percent).

(3) Each ounce (28.4 grams) of crumbles contains 355 mg amprolium (1.25 percent).

(b) Sponsors. See sponsors in § 510.600(c) of this chapter.

(1) No. 050604 for use of products described in paragraph (a) of this section as in paragraph (e) of this section.

(2) No. 051311 for use of product described in paragraph (a)(1) of this section as in paragraph (e)(1) of this section.

(3) No. 059130 for use of product described in paragraph (a)(1) of this section as in paragraph (e)(2) of this section.

(c) Related tolerances. See § 556.50 of this chapter.

(d) Special considerations. See § 500.25 of this chapter.

(e) Conditions of use—(1) Chickens and turkeys. It is used in drinking water as follows:

(i) Amount. Administer at the 0.012 percent level in drinking water as soon as coccidiosis is diagnosed and continue for 3 to 5 days (in severe outbreaks, give amprolium at the 0.024 percent level); continue with 0.006 percent amprolium-medicated water for an additional 1 to 2 weeks.

(ii) Indications for use. For the treatment of coccidiosis.

(iii) Limitations. Use as the sole source of amprolium.

(2) Calves. Administer crumbles top-dressed on or thoroughly mixed in the daily feed ration; administer concentrate solution or soluble powder as a drench or in drinking water as follows:

(i) Indications for use and amounts—(A) As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zuernii, administer 5 mg per kilogram (mg/kg) body weight in drinking water for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard.

(B) As an aid in the treatment of coccidiosis caused by E. bovis and E. zuernii, administer 10 mg/kg body weight in drinking water for 5 days.

(ii) Limitations. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Use as the sole source of amprolium.

§ 520.100a

[Removed]

3. Remove § 520.100a.

§ 520.100b

[Removed]

4. Remove § 520.100b.

§ 520.100c

[Removed]

5. Remove § 520.100c.

Dated: September 18, 2006.

Bernadette A. Dunham,

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