2011-6791. Certain Other Dosage Form New Animal Drugs; Detomidine; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Correcting amendment.

SUMMARY:

The Food and Drug Administration (FDA) published a document in the Federal Register of April 23, 2010 (75 FR 21162), that amended the animal drug regulations to reflect approval of an original new animal drug application (NADA). FDA is correcting a paragraph describing limitations to the approved conditions of use for detomidine hydrochloride oromucosal gel in horses. This correction is being made to improve the accuracy of the animal drug regulations.

DATES:

This rule is effective March 24, 2011.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

FDA published a document in the Federal Register of April 23, 2010 (75 FR 21162), that amended the animal drug regulations to reflect approval of an original NADA. FDA is correcting a paragraph describing limitations to the approved conditions of use for detomidine hydrochloride oromucosal gel in horses. This correction is being made to improve the accuracy of the animal drug regulations.

List of Subjects in 21 CFR Part 529

• Animal drugs

Accordingly, 21 CFR part 529 is corrected by making the following correcting amendment:

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for part 529 continues to read as follows:

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

2. In § 529.536, amend paragraph (c)(3) by adding a sentence after the first sentence to read as follows:

§ 529.536

Detomidine.

* * * * *

(c) * * *

(3) * * * Do not use in horses intended for human consumption.

Dated: March 17, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.