New Animal Drugs; Change of Sponsor, 2807 [2011-904]
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Federal Register / Vol. 76, No. 11 / Tuesday, January 18, 2011 / Rules and Regulations
7217, section 19(b)(2) of the Act, 15
U.S.C. 78s(b)(2), and section 19(b)(3) of
the Act, 15 U.S.C. 78s(b)(3), to institute
proceedings to determine whether a
proposed rule change of the Public
Company Accounting Oversight Board
should be disapproved and to provide to
the Public Company Accounting
Oversight Board notice of the grounds
for disapproval under consideration. In
addition, pursuant to section 107 of the
Sarbanes-Oxley Act of 2002, 15 U.S.C.
7217, and section 19(b)(2)(B) of the Act,
15 U.S.C. 78s(b)(2)(B), to extend for a
period not exceeding 240 days from the
date of publication of notice of the filing
of a proposed rule change pursuant to
section 19(b)(1) of the Act, 15 U.S.C.
78s(b)(1), the period during which the
Commission must issue an order
approving or disapproving the proposed
rule change and to determine whether
such longer period is appropriate and
publish the reasons for such
determination.
(5) Pursuant to section 107 of the
Sarbanes-Oxley Act of 2002, 15 U.S.C.
7217, and section 19(b)(3)(C) of the Act,
15 U.S.C. 78s(b)(3)(C), to temporarily
suspend a rule of the Public Company
Accounting Oversight Board.
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Dated: January 11, 2011.
By the Commission.
Elizabeth M. Murphy,
Secretary.
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 glutamer200) 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.
SUPPLEMENTARY INFORMATION:
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:
[FR Doc. 2011–835 Filed 1–14–11; 8:45 am]
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Part 510
[Docket No. FDA–2010–N–0002]
New Animal Drugs; Change of Sponsor
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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:
■
Food and Drug Administration
Final rule.
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
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.
WReier-Aviles on DSKDVH8Z91PROD with RULES
SUMMARY:
VerDate Mar<15>2010
13:59 Jan 14, 2011
Jkt 223001
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(c) * * *
(1) * * *
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Drug
labeler
code
Firm name and address
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OPK Biotech, LLC, 11 and 39
Hurley St., Cambridge, MA
02141 ........................................
PO 00000
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(2) * * *
Frm 00009
Fmt 4700
Sfmt 4700
Firm name and address
*
063075
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OPK Biotech, LLC, 11 and 39
Hurley St., Cambridge, MA
02141
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063075
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA–2010–N–0002]
New Animal Drugs; Change of
Sponsor; Follicle Stimulating Hormone
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for a new animal drug
application (NADA) for follicle
stimulating hormone from Ausa
International, Inc., to Therio, Inc.
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: Ausa
International, Inc., Rt. 8, P.O. Box 324–
12, Tyler, TX 75703 has informed FDA
that it has transferred ownership of, and
all rights and interest in, NADA 141–
014 for SUPER–OV (follicle stimulating
hormone) to Therio, Inc., 8801
Anderson Ave., Manhattan, KS 66503.
Accordingly, the Agency is amending
the regulations in 21 CFR 522.1002 to
reflect the transfer of ownership.
Following this change of sponsorship,
Ausa International, Inc., is no longer the
sponsor of an approved application.
Accordingly, § 510.600 (21 CFR
510.600) is being amended to remove
the entries for this firm.
SUMMARY:
PART 510—NEW ANIMAL DRUGS
BILLING CODE 8011–01–P
Drug labeler
code
E:\FR\FM\18JAR1.SGM
18JAR1
]]>Agencies
[Federal Register Volume 76, Number 11 (Tuesday, January 18, 2011)]
[Rules and Regulations]
[Page 2807]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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
* * * * *
------------------------------------------------------------------------
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
