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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Monensin and Chlortetracycline

DATES: This rule is effective September 29, 2003.

DOCUMENT 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 singleingredient Type A medicated articles containing monensin and chlortetracycline to make twoway combination drug Type C medicated feeds for broiler chickens.

SUMMARY: Monensin and chlortetracycline,

SUPPLEMENTAL INFORMATION

Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, filed ANADA 200354 for use of PENNCHLOR
(chlortetracycline) and COBAN (monensin) Type A medicated articles to make twoway combination drug Type C medicated feeds for broiler chickens. Pennfield Oil Co.'s ANADA 200354 is approved as a generic copy of Alpharma, Inc.'s NADA 121553 for combination use of AUREOMYCIN (chlortetracycline) and COBAN. The ANADA is approved as of August 15, 2003, and the regulations are amended in 21 CFR 558.355 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 (HFA305), 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
[[Page 55826]]

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. 801808.
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 558NEW 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.
Sec. 558.355 [Amended]
2. Section 558.355 Monensin is amended in paragraph (f)(1)(xiv)(b) after ``046573'' by adding ``and 053389''.

Dated: September 11, 2003.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 0324436 Filed 92603; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Lonnie W. Luther, Center for Veterinary Medicine (HFV104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 3018278549, email: lluther@cvm.fda.gov.