[Federal Register Volume 68, Number 61 (Monday, March 31, 2003)]
[Rules and Regulations]
[Page 15371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7598]


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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; 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 amending the animal 
drug regulations to reflect the approved caution statements that must 
appear on animal feeds containing monensin. This action is being taken 
to improve the accuracy of the regulations.

DATES: This rule is effective March 31, 2003.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-2), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0159, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA has found that the animal drug 
regulations do not reflect the approved caution statements that must 
appear on animal feeds containing monensin. The regulation in 21 CFR 
558.355 is being amended to correct inaccurate references to mature 
turkeys and guinea fowl that were incorporated into the regulations in 
the Federal Register published on July 26, 2000 (65 FR 45879). This 
action is being taken to improve the accuracy of the regulations.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). Notice 
and public procedure are unnecessary because FDA is merely correcting 
nonsubstantive errors.
    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.  558.355  [Amended]

    2. Section 558.355 Monensin is amended in paragraph (d)(6), in the 
first sentence, by removing the phrase ``, other equines, mature 
turkeys, or guinea fowl'' and by adding in its place the phrase ``or 
other equines'' and in the second sentence by removing ``and guinea 
fowl''.

    Dated: March 25, 2003.
Clifford Johnson,
Director, Office of Surveillance and Compliance, Center for Veterinary 
Medicine.
[FR Doc. 03-7598 Filed 3-28-03; 8:45 am]
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