00-26403. Implantation or Injectable Dosage Form New Animal Drugs; Levamisole Phosphate Injection

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 Agri Laboratories, Ltd. The ANADA provides for use of levamisole phosphate solution by subcutaneous injection for the treatment of various species of gastrointestinal parasites in cattle.

DATES:

This rule is effective October 16, 2000.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION:

Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503, filed ANADA 200-271 for LEVAMISOLE PHOSPHATE Injectable Solution, 13.65%. The ANADA provides for use of levamisole phosphate solution by subcutaneous injection for the treatment of various species of gastrointestinal parasites in cattle. The ANADA is approved as a generic copy of Schering-Plough Animal Health's NADA 126-742 for LEVASOLE® Injection. ANADA 200-271 is approved as of September 7, 2000, and the regulations are amended in 21 CFR 522.1244 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 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.

§ 522.1244

[Amended]

2. Section 522.1244 Levamisole phosphate injection is amended in paragraph (b) by removing “No. 000061” and by adding in its place “Nos. 000061 and 057561”.

Dated: October 6, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.