[Federal Register Volume 76, Number 11 (Tuesday, January 18, 2011)]
[Rules and Regulations]
[Page 2807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-904]
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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:
[email protected].
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) * * *
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Drug
Firm name and address labeler
code
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* * * * *
OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA 02141.. 063075
* * * * *
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(2) * * *
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Drug
labeler Firm name and address
code
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* * * * *
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