04-10829. New Animal Drugs for Use in Animal Feeds; Chlortetracycline and 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 an abbreviated new animal drug application (ANADA) filed by Pennfield Oil Co. The ANADA provides for the use of single-ingredient, chlortetracycline and decoquinate Type A medicated articles to make two-way combination drug Type B and Type C medicated feeds for calves, beef and nonlactating dairy cattle.

DATES:

This rule is effective May 13, 2004.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, filed ANADA 200-359 for use of PENNCHLOR (chlortetracycline) and DECCOX (decoquinate) single-ingredient Type A medicated articles to make two-way combination drug Type B and Type C medicated feeds for calves, beef and nonlactating dairy cattle. Pennfield Oil Co.'s ANADA 200-359 is approved as a generic copy of Alpharma, Inc.'s NADA 141-147. The ANADA is approved as of March 19, 2004, and the regulations are amended in 21 CFR 558.195 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 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 Division of Dockets Management (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.

§ 558.195

[Amended]

2. Section 558.195 is amended in paragraph (e)(2)(iii) in the “Limitations” column by removing “CTC (chlortetracycline) Type A medicated articles under NADA 141-147” and by adding in its place “chlortetracycline Type A medicated articles under NADA 141-147 and ANADA 200-359” and by adding as the last sentence “Chlortetracycline as provided by Nos. 046573 and 053389 in § 510.600(c) of this chapter.”; and in paragraph (e)(2)(iii) in the “Sponsor” column by adding “053389” after “046573”.

Dated: April 23, 2004.

Catherine P. Beck,

Acting Director, Center for Veterinary Medicine.