Document ID: FDA-2013-N-0002-0017
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin; Correction
Posted Date: 2013-06-05T04:00Z

[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Rules and Regulations]
[Pages 33698-33699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13331]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2013-N-0002]

New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; 
Monensin; and Tylosin; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Correcting amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a 
document amending the animal drug regulations to reflect approval 
actions for new animal drug applications and abbreviated new animal 
drug applications during March 2013 that appeared in the Federal 
Register of April 30, 2013. FDA is correcting the approved strengths of 
dexmedetomidine hydrochloride injectable solution. This correction is 
being made to improve the accuracy of the animal drug regulations.

DATES: This rule is effective June 5, 2013.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug

[[Page 33699]]

Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, 
ghaibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) is 
correcting a document amending the animal drug regulations to reflect 
approval actions for new animal drug applications and abbreviated new 
animal drug applications during March 2013 that appeared in the Federal 
Register of April 30, 2013 (78 FR 25182). FDA is correcting the 
approved strengths of dexmedetomidine hydrochloride injectable 
solution. This correction is being made to improve the accuracy of the 
animal drug regulations.

List of Subjects in 21 CFR Part 522

    Animal drugs.

    Therefore, 21 CFR part 522 is corrected by making the following 
correcting amendment.

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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. In Sec.  522.558, revise paragraph (a) to read as follows:

Sec.  522.558  Dexmedetomidine.

    (a) Specifications. Each milliliter of solution contains 0.1 or 0.5 
milligrams dexmedetomidine hydrochloride.
* * * * *

    Dated: May 31, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-13331 Filed 6-4-13; 8:45 am]
BILLING CODE 4160-01-P