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Oral Dosage Form New Animal Drugs; Dexmedetomidine; Technical Amendment

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending a final rule that appeared in the Federal Register of January 4, 2007 (72 FR 263), revising the animal drug regulations to reflect approval of an original new animal drug application (NADA). The document incorrectly listed the amount of drug per milliliter of dexmedetomidine hydrochloride injectable solution. This action is being taken to improve the accuracy of the regulations.

DATES:

This rule is effective April 20, 2007.

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FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-267-9019, e-mail: george.haibel@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

FDA has discovered that an error has been incorporated into the agency's regulations for 21 CFR part 522. This document corrects that error. Publication of this document constitutes final action under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment is nonsubstantive.

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List of Subjects in 21 CFR Part 522

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner

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PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for

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Authority: 21 U.S.C. 360b.

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2. In § 522.558, paragraph (a) is revised to read as follows:

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Dexmedetomidine.

(a) Specifications. Each milliliter of solution contains 0.5 milligram (mg) of dexmedetomidine hydrochloride.

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Dated: April 13, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.

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[FR Doc. E7-7594 Filed 4-19-07; 8:45 am]

BILLING CODE 4160-01-S