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Rule

New Animal Drugs; Change of Sponsor; Ketamine

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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.

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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.

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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.

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List of Subjects

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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,

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PART 510—NEW ANIMAL DRUGS

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1. The authority citation for

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

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2. In § 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:

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

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*    *    *    *    *
Bioniche Teoranta, Inverin, County Galway, Ireland063286
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
063286Bioniche Teoranta, Inverin, County Galway, Ireland
*    *    *    *    *
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PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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3. The authority citation for

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

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[Amended]
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4. In paragraph (b) of § 522.1222a, remove “064847” and add in its place “063286”.

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Dated: December 10, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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[FR Doc. E9-29888 Filed 12-15-09; 8:45 am]

BILLING CODE 4160-01-S