05-3595. Implantation or Injectable Dosage Form New Animal Drugs; Euthanasia 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 an original abbreviated new animal drug application (ANADA) filed by Med-Pharmex, Inc. The ANADA provides for use of an injectable solution of pentobarbital sodium and phenytoin sodium for humane, painless, and rapid euthanasia of dogs.

DATES:

This rule is effective February 24, 2005.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861, filed ANADA 200-280 that provides for use of EUTHANASIA III (pentobarbital sodium and phenytoin sodium) Solution for humane, painless, and rapid euthanasia of dogs. Med-Pharmex, Inc.'s EUTHANASIA-III Solution is approved as a generic copy of Schering-Plough Animal Health Corp.'s BEUTHANASIA-D Special, approved under NADA 119-807. The ANADA is approved as of February 3, 2005, and the regulations are amended in 21 CFR 522.900 to reflect the approval. 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.

The agency 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 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. Section 522.900 is amended by revising paragraph (b)(1) to read as follows:

§ 522.900

Euthanasia solution.

* * * * *

(b) * * *

(1) Nos. 000061, 051259, and 051311 for use of product described in paragraph (a)(1) of this section.

* * * * *

Dated: February 15, 2005.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.