2010-9045. New Animal Drugs; Change of Sponsor's Name and Address

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.

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: [e-mail].

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 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 in 21 CFR Part 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• Reporting and recordkeeping requirements

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 part 510 is amended as follows:

PART 510—NEW ANIMAL DRUGS

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.

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:

§ 510.600

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

(c) * * *

(1) * * *

Firm name and address	Drug labeler code
*    *    *    *    *
Piramal Critical Care, Inc., 3950 Schelden Circle, Bethlehem, PA 18017	060307
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
060307	Piramal Critical Care, Inc., 3950 Schelden Circle, Bethlehem, PA 18017
*    *    *    *    *

Dated: April 15, 2010.

Elizabeth Rettie,

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