New Animal Drugs for Use in Animal Feeds; Decoquinate and Monensin

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 new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for use of approved, single-ingredient decoquinate and monensin Type A medicated articles to make two-way combination drug Type B and Type C medicated feeds used for prevention of coccidiosis and improved feed efficiency in cattle fed in confinement for slaughter.

DATES:

This rule is effective December 29, 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:

Alpharma Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed NADA 141-148 that provides for use of DECCOX® (27.2 gram per pound (g/lb) decoquinate) and Rumensin® (20, 30, 45, 60, 80, or 90.7 g/lb monensin activity as monensin sodium) Type A medicated articles to make two-way combination Type B and Type C medicated feeds. The Type C medicated feeds contain 13.6 to 27.2 g/ton decoquinate and 5 to 30 g/ton monensin, and are used for prevention of coccidiosis caused by Eimeria bovis and E. zuernii, and improved feed efficiency in cattle fed in confinement for slaughter. The NADA is approved as of November 16, 2000, and the regulations in 21 CFR 558.195 and 558.355 are amended 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)(2) 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 558.195 is amended in the table in paragraph (d) by adding an entry following “13.6 to 27.2 (0.0015 to 0.003 pct)” and before “Chlortetracycline approximately 400” to read as follows:

3. Section 558.355 is amended by adding paragraph (f)(7) to read as follows: