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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; Salinomycin, Chlortetracycline, and Roxarsone

DATES: This rule is effective July 10, 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 salinomycin, chlortetracycline, and roxarsone to make threeway combination drug Type C medicated feeds for broiler chickens.

SUMMARY: Salinomycin, chlortetracycline, and roxarsone,

SUPPLEMENTAL INFORMATION

Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, filed ANADA 200355 for use of PENNCHLOR
(chlortetracycline), salinomycin, and roxarsone Type A medicated articles to make threeway combination drug Type C medicated feeds for broiler chickens. Pennfield Oil Co.'s ANADA 200355 is approved as a generic copy of Alpharma, Inc.'s NADA 140867. The ANADA is approved as of March 31, 2003, and the regulations are amended in 21 CFR 558.550 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 Dockets Management Branch (HFA 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9
[[Page 41067]]

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. 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.
2. Section 558.550 is amended by adding paragraph (a)(3); and in paragraph (d)(1)(xv)(c) by removing ``and 046573'' and by adding in its place ``and 053389'' to read as follows:
Sec. 558.550 Salinomycin.
(a) * * *
(3) To 053389 for use as in paragraph (d)(1)(xv) of this section. * * * * *

Dated: June 26, 2003.
Andrew J. Beaulieu,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 0317409 Filed 7903; 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.