02-32848. Implantation or Injectable Dosage Form New Animal Drugs; Praziquantel Injectable 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 abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The ANADA provides for the veterinary prescription use of an injectable praziquantel solution in dogs and cats for the removal of various species of cestodes (tapeworms).

DATES:

This rule is effective December 31, 2002.

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:

Phoenix Scientific, Inc., 3915 South 48th St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-176 that provides for the veterinary prescription use of PRAZITECH (praziquantel) Injection in dogs and cats for the removal of various species of cestodes (tapeworms). Phoenix Scientific's PRAZITECH Injection is approved as a generic copy of Bayer Corp.'s DRONCIT 5.68% Injectable Solution, approved under NADA 111-607. The ANADA is approved as of October 16, 2002, and the regulations are amended in 21 CFR 522.1870 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 Dockets Management Branch (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.

§ 522.1870

[Amended]

2. Section 522.1870 Praziquantel injectable solution is amended in paragraph (b) by removing “Sponsor. See 000859” and by adding in its place “Sponsors. See Nos. 000859 and 059130”.

Dated: December 18, 2002.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.