Document ID: FDA-2010-N-0002-0091
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor
Posted Date: 2011-01-18T05:00Z

[Federal Register: January 18, 2011 (Volume 76, Number 11)]
[Rules and Regulations]               
[Page 2807]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ja11-8]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

[Docket No. FDA-2010-N-0002]

 
New Animal Drugs; Change of Sponsor

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 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: 
steven.vaughn@fda.hhs.gov.

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, Sec.  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

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), 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:

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

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

------------------------------------------------------------------------
                                                                  Drug
                    Firm name and address                       labeler
                                                                  code
------------------------------------------------------------------------

                                * * * * *
OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA 02141..     063075

                                * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
   Drug
 labeler                       Firm name and address
   code
------------------------------------------------------------------------

                                * * * * *
   063075  OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA 02141

                                * * * * *
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    Dated: January 11, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2011-904 Filed 1-14-11; 8:45 am]
BILLING CODE 4160-01-P