Document ID: FDA-2010-N-0002-0098
Agency: fda
Document Type: Rule
Title: Certain Other Dosage Form New Animal Drugs: Detomidine; Correction
Posted Date: 2011-03-24T04:00Z

[Federal Register Volume 76, Number 57 (Thursday, March 24, 2011)]
[Rules and Regulations]
[Page 16533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6791]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529

[Docket No. FDA-2010-N-0002]

Certain Other Dosage Form New Animal Drugs; Detomidine; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Correcting amendment.

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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: 
George.Haibel@fda.hhs.gov.

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

0
1. The authority citation for part 529 continues to read as follows:

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

0
2. In Sec.  529.536, amend paragraph (c)(3) by adding a sentence after 
the first sentence to read as follows:

Sec.  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.
[FR Doc. 2011-6791 Filed 3-23-11; 8:45 am]
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