Skip to Content

Rule

New Animal Drugs for Use in Animal Feeds; Monensin, Sulfadimethoxine, and Ormetoprim; Technical Amendment

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is updating the animal drug regulations for medicated feeds to correctly reflect previously approved assay limits for Type A medicated articles containing monensin, or sulfadimethoxine and ormetoprim in combination. This action is being taken to improve the accuracy of the agency’s regulations.

DATES:

This rule is effective May 2, 2001.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Mary G. Leadbetter, Center for Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6964.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

FDA has found that the April 1, 2000, edition of Title 21, Parts 500 to 599 of the Code of Federal Regulations (CFR) does not reflect revised assay limits for Type A medicated articles containing monensin, or sulfadimethoxine and ormetoprim in combination, that were approved in the new animal drug applications for these drugs. At this time, FDA is amending the regulations to correct these errors in 21 CFR 558.4.

Start Printed Page 21862

This is 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.

Start List of Subjects

List of Subjects in 21 CFR Part 558

End List of Subjects Start Amendment Part

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,

End Amendment Part Start Part

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

End Part Start Amendment Part

1. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 360b, 371.

End Authority
[Amended]

2. Section 558.4 Requirement of a medicated feed mill license is amended in paragraph (d) in the “Category I” table in the entry for “Monensin” in the “Assay limits percent type A” column by removing “90-110” and adding in its place “85-115”; and in the “Category II” table in both paired entries for “Sulfadimethoxine” and “Ormetoprim” in the “Assay limits percent type A” column by removing “95-115” and in its place adding “90-110”.

Start Signature

Dated: April 20, 2001.

Claire M. Lathers,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. 01-10874 Filed 5-1-01; 8:45 am]

BILLING CODE 4160-01-S