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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; Technical Amendment

DATES: This rule is effective March 31, 2003.

DOCUMENT 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.

SUMMARY: Monensin,

SUPPLEMENTAL 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. 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. 558.355 [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. 037598 Filed 32803; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Mohammad I. Sharar, Center for Veterinary Medicine (HFV2), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018270159, email:
msharar@cvm.fda.gov.