00-28523. New Animal Drugs for Use in Animal Feeds; Pyrantel Tartrate

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 Farnam Companies, Inc. The ANADA provides for use of pyrantel tartrate in horse feed for the prevention and control of various species of internal parasites.

DATES:

This rule is effective November 7, 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:

Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-3928, is sponsor of ANADA 200-282 that provides for use of CONTINUEX^TM (pyrantel tartrate) Daily Dewormer. The ANADA provides for use of pyrantel tartrate in horse feed for the prevention and control of various species of internal parasites. The ANADA is approved as a generic copy of Pfizer Inc.'s NADA 140-819 for STRONGID® 48. ANADA 200-282 is approved as of September 26, 2000, and the regulations are amended in 21 CFR 558.485 to reflect the approval. The basis for 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 558

• Animal drugs
• Animal feeds

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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

2. Section 558.485 is amended by adding paragraph (a)(29) to read as follows:

§ 558.485

Pyrantel tartrate.

(a) * * *

(29) To 017135: 48 grams per pound, paragraph (e)(2) of this section.

* * * * *

Dated: October 26, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.