2011-16501. Oral Dosage Form New Animal Drugs; Amprolium

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 abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for the use of amprolium soluble powder as an aid in the treatment and prevention of coccidiosis in calves.

DATES:

This rule is effective July 1, 2011.

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: [e-mail].

SUPPLEMENTARY INFORMATION:

Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, filed ANADA 200-464 for the use of AMPROMED (amprolium) for Calves, a water-soluble powder used as an aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zuernii. Cross Vetpharm Group Ltd.'s AMPROMED for Calves is approved as a generic copy of Huvepharma AD's CORID (amprolium) 20% Soluble Powder, approved under NADA 33-165. The ANADA is approved as of May 23, 2011, and the regulations in 21 CFR 520.100 are amended 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.

FDA 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 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. In § 520.100, add paragraph (b)(4) to read as follows:

§ 520.100

Amprolium.

* * * * *

(b) * * *

(4) No. 061623 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.

* * * * *

Dated: June 24, 2011.

Bernadette Dunham,

Director, Center for Veterinary Medicine.