[Federal Register Volume 66, Number 85 (Wednesday, May 2, 2001)]
[Rules and Regulations]
[Pages 21861-21862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10874]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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.

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.

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.

[[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.

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.


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 
``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''.

    Dated: April 20, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-10874 Filed 5-1-01; 8:45 am]
BILLING CODE 4160-01-S