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New Animal Drugs; Change of Sponsor's Name and Address

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Information about this document as published in the Federal Register.

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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's name from Minrad, Inc. to Piramal Critical Care, Inc. The sponsor's mailing address will also be changed.

DATES:

This rule is effective April 20, 2010.

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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:

Minrad, Inc., 836 Main St., 2d floor, Buffalo, NY 14202 has informed FDA that it has changed its name and address to Piramal Critical Care, Inc., 3950 Schelden Circle, Bethlehem, PA 18017. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect this change.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because Start Printed Page 20523it 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 in 21 CFR Part 510

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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), remove the entry for “Minrad, Inc.” and alphabetically add a new entry for “Piramal Critical Care, Inc.”; and in the table in paragraph (c)(2), revise the entry for “060307” 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
*    *    *    *    *
Piramal Critical Care, Inc., 3950 Schelden Circle, Bethlehem, PA 18017060307
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
060307Piramal Critical Care, Inc., 3950 Schelden Circle, Bethlehem, PA 18017
*    *    *    *    *
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Dated: April 15, 2010.

Elizabeth Rettie,

Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

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[FR Doc. 2010-9045 Filed 4-19-10; 8:45 am]

BILLING CODE 4160-01-S