Certain Other Dosage Form New Animal Drugs; Detomidine; Correction

---
identifier: "/us/fr/2011-6791"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Certain Other Dosage Form New Animal Drugs; Detomidine; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2011-6791"
section_name: "Certain Other Dosage Form New Animal Drugs; Detomidine; Correction"
positive_law: false
currency: "2011-03-24"
last_updated: "2011-03-24"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2011-6791"
document_type: "rule"
publication_date: "2011-03-24"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 529"
fr_citation: "76 FR 16533"
fr_volume: 76
docket_ids:
  - "Docket No. FDA-2010-N-0002"
effective_date: "2011-03-24"
fr_action: "Correcting amendment."
---


#  Detomidine.

**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: *[email protected].*

**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:

**21 CFR Part 529**

**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.

**21 CFR Part 529**

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

§ 529.536

(c) * * *

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

Dated: March 17, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.