2011-904. New Animal Drugs; Change of Sponsor

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 hemoglobin glutamer-200 from Biopure Corp. to OPK Biotech, LLC.

DATES:

This rule is effective January 18, 2011.

FOR FURTHER INFORMATION CONTACT:

Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240-276-8300, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Biopure Corp., 11 Hurley St., Cambridge, MA 02141 has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141-067 for OXYGLOBIN (hemoglobin glutamer-200) to OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA 02141. There is no change in drug labeler code.

Following this change of sponsorship, Biopure Corp. is no longer the sponsor of an approved application. In addition, OPK Biotech, LLC, is not currently listed in the animal drug regulations as a sponsor of an approved application. Accordingly, § 510.600 is being amended to reflect these changes.

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 “Biopure Corp.”; and alphabetically add a new entry for “OPK Biotech, LLC”; and in the table in paragraph (c)(2), revise the entry for “063075” 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
*    *    *    *    *
OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA 02141	063075
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
063075	OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA 02141
*    *    *    *    *

Dated: January 11, 2011.

Steven D. Vaughn,

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