2011-23865. Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin

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 abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for use of an ivermectin injectable solution for treatment and control of various internal and external parasites in cattle, swine, reindeer, and American bison.

DATES:

This rule is effective September 19, 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 200-447 for the use of BIMECTIN (ivermectin) Injection for Cattle and Swine for treatment and control of various internal and external parasites in cattle, swine, reindeer, and American bison. Cross Vetpharm Group Ltd.'s BIMECTIN Injection for Cattle and Swine is approved as a generic copy of Merial Ltd.'s IVOMEC (ivermectin) Injection for Cattle and Swine, approved under NADA 128-409. The ANADA is approved as of July 5, 2011, and the regulations in 21 CFR 522.1192 are amended to reflect the approval.

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 522

• 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 522 is amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 522 continues to read as follows:

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

2. In § 522.1192, revise paragraph (b)(2) to read as follows:

§ 522.1192

Ivermectin.

* * * * *

(b) * * *

(2) Nos. 055529, 058005, 059130, and 061623 for use of the product described in paragraph (a)(2) of this section as in paragraphs (e)(2), (e)(3), (e)(4), and (e)(5) of this section.

* * * * *

Dated: September 13, 2011.

Bernadette Dunham,

Director, Center for Veterinary Medicine.