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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; technical amendment.

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

DATES: This rule is effective May 2, 2001.

DOCUMENT 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.

SUMMARY: Monensin, sulfadimethoxine, and ormetoprim,

SUPPLEMENTAL 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.

[[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. 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. 558.4 [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 ``90110'' and adding in its place ``85115''; and in the ``Category II'' table in both paired entries for ``Sulfadimethoxine'' and ``Ormetoprim'' in the ``Assay limits percent type A'' column by removing ``95115'' and in its place adding ``90110''.

Dated: April 20, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 0110874 Filed 5101; 8:45 am] BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Mary G. Leadbetter, Center for Veterinary Medicine (HFV143), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018276964.