[Federal Register Volume 72, Number 76 (Friday, April 20, 2007)]
[Rules and Regulations]
[Pages 19796-19797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-7594]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Oral Dosage Form New Animal Drugs; Dexmedetomidine; Technical 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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: 
[email protected].

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.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner

[[Page 19797]]

of Food and Drugs, 21 CFR part 522 is amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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


    Authority: 21 U.S.C. 360b.
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2. In Sec.  522.558, paragraph (a) is revised to read as follows:


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