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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; Ractopamine

DATES: This rule is effective May 6, 2004.

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is revising the animal drug regulations for medicated feeds to reflect the approved maximum concentration of ractopamine in Type B medicated feeds. This action is being taken to improve the accuracy of the agency's regulations.

SUMMARY: Ractopamine; technical amendment,

SUPPLEMENTAL INFORMATION

FDA has found that parts 500 to 599 (21 CFR parts 500 to 599) of the Code of Federal Regulations does not reflect the approved maximum concentration of ractopamine in Type B medicated feeds. Higher levels of ractopamine in Type B medicated feeds were approved when this drug was approved for use in cattle on September 18, 2003 (68 FR 54658). At this time, FDA is amending the regulations in 21 CFR 558.4 to reflect the new maximum concentration of ractopamine in Type B medicated feeds.

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. 558.4 [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 ``Ractopamine'' in the ``Type B maximum (200x)'' column by removing ``1.8 g/lb (0.4%)'' and adding in its place ``2.46 g/lb (0.54%)''.

Dated: April 30, 2004.
Catherine P. Beck,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 0410365 Filed 5504; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Eric S. Dubbin, Center for Veterinary Medicine (HFV126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018270232, email: eric.dubbin@fda.gov.