Document ID: FDA-2009-N-0665-0071
Agency: fda
Document Type: Notice
Title: New Animal Drugs; Change of Sponsor; Ketamine - Final Rule
Posted Date: 2009-12-16T05:00Z

[Federal Register: December 16, 2009 (Volume 74, Number 240)]
[Rules and Regulations]               
[Page 66573]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de09-8]                         

[[Page 66573]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

[Docket No. FDA-2009-N-0665]

 
New Animal Drugs; Change of Sponsor; Ketamine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for an abbreviated new 
animal drug application (ANADA) for ketamine hydrochloride injectable 
solution from Bioniche Animal Health USA, Inc., to Bioniche Teoranta.

DATES: This rule is effective December 16, 2009.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Bioniche Animal Health USA, Inc., 119 Rowe 
Rd., Athens, GA 30601, has informed FDA that it has transferred 
ownership of, and all rights and interest in, ANADA 200-257 for 
Ketamine HCl (ketamine hydrochloride injection, USP) to Bioniche 
Teoranta, Inverin, County Galway, Ireland. Accordingly, the agency is 
amending the regulations in 21 CFR 522.1222a to reflect the transfer of 
ownership.
    In addition, Bioniche Teoranta is not currently listed in the 
animal drug regulations as a sponsor of an approved application. 
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this 
sponsor.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 522

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and 
522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1) alphabetically 
add a new entry for ``Bioniche Teoranta''; and in the table in 
paragraph (c)(2) numerically add a new entry for ``063286'' to read as 
follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
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                                * * * * *
------------------------------------------------------------------------
Bioniche Teoranta, Inverin, County Galway,    063286
 Ireland
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------
063286                       Bioniche Teoranta, Inverin, County Galway,
                              Ireland
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

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

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

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

Sec.  522.1222a  [Amended]

0
4. In paragraph (b) of Sec.  522.1222a, remove ``064847'' and add in 
its place ``063286''.

    Dated: December 10, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-29888 Filed 12-15-09; 8:45 am]

BILLING CODE 4160-01-S