00-18827. Oral Dosage Form New Animal Drugs; Ivermectin Sustained-Release Bolus

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 new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA provides for changes to labeling of ivermectin sustained-release bolus for cattle.

DATES:

This rule is effective July 26, 2000.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION:

Merial Ltd., 2100 Ronson Rd., Iselin, NJ 08830-3077, filed a supplement to NADA 140-988 that provides for use of Ivomec® (ivermectin) SR bolus for cattle. The supplement provides for reducing the predicted duration of effectiveness in labeling from approximately 135 days to approximately 130 days, based on bolus stability data. The supplement is approved as of June 21, 2000, and the regulations in 21 CFR 520.1197 are amended 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 part 20 (21 CFR part 20) and § 514.11(e)(2)(ii) (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 25.24(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.

§ 520.1197

[Amended]

2. Section 520.1197 Ivermectin sustained-release bolus is amended in paragraph (d)(2) by removing the parenthetical phrase “(approximately 135 days)” and by adding in its place “ (approximately 130 days)”.

Dated: July 18, 2000.

Claire M. Lathers,

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