[Federal Register Volume 69, Number 88 (Thursday, May 6, 2004)]
[Rules and Regulations]
[Page 25315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10365]


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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; Ractopamine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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.

DATES: This rule is effective May 6, 2004.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: [email protected].

SUPPLEMENTARY 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. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

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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

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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. 04-10365 Filed 5-5-04; 8:45 am]
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