E7-7594. Oral Dosage Form New Animal Drugs; Dexmedetomidine; Technical Amendment

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.

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: [e-mail].

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.

List of Subjects in 21 CFR Part 522

• Animal drugs

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 522 is amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 522 continues to read as follows:

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

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

§ 522.558

Dexmedetomidine.

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

* * * * *

Dated: April 13, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.