New Animal Drugs For Use in Animal Feeds; Decoquinate

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 Alpharma, Inc. The supplemental NADA provides for the use of decoquinate Type A medicated articles to make Type C medicated feeds for cattle, sheep, and goats at a broader range of concentrations for the prevention of coccidiosis.

DATES:

This rule is effective December 5, 2002.

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, e-mail: jmessenh@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed a supplement to NADA 39-417 that provides for use of DECCOX (decoquinate) Type A medicated articles to make Type C medicated feeds for cattle, sheep, and goats at a broader range of concentrations for the prevention of coccidiosis caused by various Eimeria species. The NADA is approved as of September 4, 2002, and the regulations are amended in 21 CFR 558.195 to reflect the approval. Section 558.195 is also revised to reflect a current format.

In accordance with the freedom of information provisions of 21 CFR part 20 and 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 25.33(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 558.195 is revised to read as follows:

(a) Specifications. Type A medicated article containing 6 percent decoquinate.

(b) Approvals. See No. 046573 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.170 of this chapter.

(d) Special considerations. (1) Bentonite should not be used in decoquinate feeds.

(2) Type A medicated articles may be used to manufacture dry or liquid Type B cattle (including veal calf), sheep, and goat feeds as in paragraphs (e)(2) and (e)(3) of this section.

(3) Type C cattle feeds may be manufactured from decoquinate liquid Type B feeds having a pH between 5.0 to 6.5 and containing a suspending agent to maintain a viscosity of not less than 500 centipoises.

(e) Conditions of use. It is used as follows:

(1) Chickens.

(2) Cattle.

(3) Minor species.