New Animal Drugs; Change of Sponsor; Follicle Stimulating Hormone, 2807-2808 [2011-909]
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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.
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SUMMARY:
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13:59 Jan 14, 2011
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(c) * * *
(1) * * *
*
*
Drug
labeler
code
Firm name and address
*
*
*
*
OPK Biotech, LLC, 11 and 39
Hurley St., Cambridge, MA
02141 ........................................
PO 00000
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(2) * * *
Frm 00009
Fmt 4700
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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
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2808
Federal Register / Vol. 76, No. 11 / Tuesday, January 18, 2011 / Rules and Regulations
In addition, Therio, Inc., is not
currently listed in the animal drug
regulations as a sponsor of an approved
application. Accordingly, § 510.600 is
being amended to add entries for this
sponsor.
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
Drug labeler
code
Firm name and address
*
052923
*
*
*
*
Therio, Inc., 8801 Anderson Ave.,
Manhattan, KS 66503
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
■
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
I. Background
Authority: 21 U.S.C. 360b.
§ 522.1002
[Amended]
4. In paragraph (a)(2) of § 522.1002,
remove ‘‘059521’’ and add in its place
‘‘No. 052923’’.
■
21 CFR Part 522
Animal drugs.
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 parts 510 and 522 are amended as
follows:
Dated: January 12, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2011–909 Filed 1–14–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF LABOR
PART 510—NEW ANIMAL DRUGS
Occupational Safety and Health
Administration
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.
29 CFR Part 24
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Ausa International, Inc.’’; and
alphabetically add a new entry for
‘‘Therio, Inc.’’; and in the table in
paragraph (c)(2), remove the entry for
‘‘059521’’; and in numerical sequence
add a new entry for ‘‘052923’’ to read as
follows:
RIN 1218–AC25
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
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*
(c) * * *
(1) * * *
*
*
Firm name and address
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*
*
Therio, Inc., 8801 Anderson Ave.,
Manhattan, KS 66503 ...............
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(2) * * *
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[Docket Number: OSHA–2007–0028]
Procedures for the Handling of
Retaliation Complaints Under the
Employee Protection Provisions of Six
Environmental Statutes and Section
211 of the Energy Reorganization Act
of 1974, as Amended
Occupational Safety and Health
Administration, Labor.
ACTION: Final rule.
AGENCY:
This document provides the
final text of regulations governing the
employee protection (or
‘‘whistleblower’’) provisions of Section
211 of the Energy Reorganization Act of
1974, as amended, (‘‘ERA’’),
Drug
implementing the statutory changes
labeler
enacted into law on August 8, 2005, as
code
part of the Energy Policy Act of 2005.
The regulations also finalize changes to
*
the procedures for handling retaliation
complaints under Section 211 of the
052923 ERA and the six environmental
whistleblower statutes that were
*
designed to make them as consistent as
possible with the more recently
promulgated procedures for handling
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retaliation complaints under other
whistleblower provisions administered
by the Occupational Safety and Health
Administration (OSHA).
DATES: This final rule is effective on
January 18, 2011.
FOR FURTHER INFORMATION CONTACT:
Nilgun Tolek, Director, Office of the
Whistleblower Protection Program,
Occupational Safety and Health
Administration, U.S. Department of
Labor, Room N–3610, 200 Constitution
Avenue, NW., Washington, DC 20210;
telephone (202) 693–2199.
SUPPLEMENTARY INFORMATION:
The Energy Policy Act of 2005, Public
Law 109–58, was enacted on August 8,
2005. Among other provisions, this new
law amended the employee protection
provisions for nuclear whistleblowers
under Section 211 of the ERA, 42 U.S.C.
5851; the statutory amendments affect
only ERA whistleblower complaints.
The changes to the regulations also
affect the six environmental
whistleblower statutes because the same
procedures generally apply to each of
the statutes covered in 29 CFR part 24.
Because OSHA recognizes the
importance of consistency in the
procedures governing the whistleblower
statutes that it administers, it has tried
to standardize these regulations with
other whistleblower regulations
promulgated by OSHA to the extent
possible within the bounds of the
statutory language. We have removed
from this background section as
unnecessary and confusing the
statement in the interim final rule that
the 2005 ERA amendments apply to
claims filed on or after August 8, 2005;
OSHA takes no position in these
regulations on the applicability of the
2005 ERA amendments to complaints
filed with the Department before August
8, 2005.
II. Summary of Statutory Changes to
ERA Whistleblower Provisions
Section 629 of Public Law 109–58
(119 Stat. 785) amended Section 211 of
the ERA, 42 U.S.C. 5851, by making the
changes described below.
Revised Definition of ‘‘Employer’’
Section 211 of the ERA defined a
covered ‘‘employer’’ to include:
Licensees of the Nuclear Regulatory
Commission (‘‘Commission’’); applicants
for such licenses, and their contractors
and subcontractors; contractors and
subcontractors of the Department of
Energy, except those involved in naval
nuclear propulsion work under
Executive Order 12344; licensees of an
E:\FR\FM\18JAR1.SGM
18JAR1
]]>Agencies
[Federal Register Volume 76, Number 11 (Tuesday, January 18, 2011)]
[Rules and Regulations]
[Pages 2807-2808]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-909]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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, Sec.
510.600 (21 CFR 510.600) is being amended to remove the entries for
this firm.
[[Page 2808]]
In addition, Therio, Inc., is not currently listed in the animal
drug regulations as a sponsor of an approved application. Accordingly,
Sec. 510.600 is being amended to add entries for this sponsor.
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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 522
Animal drugs.
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 parts 510 and
522 are 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 ``Ausa International, Inc.''; and alphabetically add a new entry
for ``Therio, Inc.''; and in the table in paragraph (c)(2), remove the
entry for ``059521''; and in numerical sequence add a new entry for
``052923'' 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
------------------------------------------------------------------------
* * * * *
Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503........ 052923
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug
labeler Firm name and address
code
------------------------------------------------------------------------
* * * * *
052923 Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503
* * * * *
------------------------------------------------------------------------
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.1002 [Amended]
0
4. In paragraph (a)(2) of Sec. 522.1002, remove ``059521'' and add in
its place ``No. 052923''.
Dated: January 12, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2011-909 Filed 1-14-11; 8:45 am]
BILLING CODE 4160-01-P
