E6-10444. Oral Dosage Form New Animal Drugs; Ivermectin Liquid

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 a supplemental abbreviated new animal drug application (ANADA) filed by Med-Pharmex, Inc. The supplemental ANADA provides for revisions to labeling for ivermectin liquid, administered by mouth or nasogastric tube to horses for treatment and control of various internal parasites or parasitic conditions.

DATES:

This rule is effective July 5, 2006.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861, filed a supplement to ANADA 200-292 for IVERSOL (ivermectin) Liquid for Horses for the oral treatment and control of various species of internal parasites or parasitic conditions. The supplement provides for revisions to label indications and to the food safety warning. The supplemental ANADA is approved as of May 30, 2006, and 21 CFR 520.1195 is amended to reflect the approval.

Approval of this supplemental ANADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.

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 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.

§ 520.1195

[Amended]

2. In § 520.1195, in paragraph (b)(1) remove “No. 050604” and add in its place “Nos. 050604 and 054925”; and in paragraph (b)(2) remove “054925, 058829,” and add in its place “058829”.

Dated: June 22, 2006.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.