New Animal Drugs; Change of Sponsor; Isoflurane, 68529-68530 [E9-30590]
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Federal Register / Vol. 74, No. 247 / Monday, December 28, 2009 / Rules and Regulations
document via the Internet through the
Commission’s Home Page (https://
www.ferc.gov) and in the Commission’s
Public Reference Room during normal
business hours (8:30 a.m. to 5 p.m.
Eastern time) at 888 First Street, NE.,
Room 2A, Washington, DC 20426.
27. From the Commission’s Home
Page on the Internet, this information is
available in eLibrary. The full text of
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both in PDF and Microsoft Word format
for viewing, printing, and/or
downloading. To access this document
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excluding the last three digits of this
document in the docket number field.
28. User assistance is available for
eLibrary and the Commission’s Web site
during the Commission’s normal
business hours. For assistance, contact
FERC Online Support by e-mail at
FERCOnlineSupport@ferc.gov, or by
telephone at 202–502–6652 (toll-free at
(866) 208–3676) or for TTY, contact
(202) 502–8659.
§ 366.1
List of Subjects
(a) General. (1) FERC Form No. 60.
Unless otherwise exempted or granted a
waiver by Commission rule or order
pursuant to §§ 366.3 and 366.4, every
centralized service company (see § 367.2
of this chapter) in a holding company
system, regardless of whether that
service company is providing services to
a public utility, a natural gas company,
or both, must file an annual report,
FERC Form No. 60, as provided in
§ 369.1 of this chapter. Every report
must be submitted on the FERC Form
No. 60 then in effect and must be
prepared in accordance with the
instructions incorporated in that form.
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■ 8. The heading of part 367 is revised
to read as follows:
18 CFR Part 366
Electric power, Natural gas, Reporting
and recordkeeping requirements.
18 CFR Part 367
Electric power, Natural gas, Uniform
System of Accounts, Reporting and
recordkeeping requirements.
By the Commission.
Kimberly D. Bose,
Secretary.
In consideration of the foregoing, the
Commission amends parts 366 and 367,
subchapter U, Chapter I, Title 18, Code
of Federal Regulations, as follows:
■ 1. The title of Subchapter U is revised
to read as follows:
SUBCHAPTER U—REGULATIONS UNDER
THE PUBLIC UTILITY HOLDING COMPANY
ACT OF 2005, FEDERAL POWER ACT AND
NATURAL GAS ACT
2. The title of part 366 is revised to
read as follows:
■
PART 366—BOOKS AND RECORDS
Definitions.
*
*
*
*
*
Service company. The term ‘‘service
company’’ means any associate
company within a holding company
system organized specifically for the
purpose of providing non-power goods
or services or the sale of goods or
construction work to any public utility
or any natural gas company, or both, in
the same holding company system.
*
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■ 6. The heading of Subpart B is revised
to read as follows:
Subpart B—Accounting and
Recordkeeping Under PUHCA 2005,
the Federal Power Act and the Natural
Gas Act
7. In § 366.23, paragraph (a)(1) is
revised to read as follows:
■
§ 366.23 FERC Form No. 60, Annual
reports of centralized service companies,
and FERC–61, Narrative description of
service company functions.
PART 367—UNIFORM SYSTEM OF
ACCOUNTS FOR CENTRALIZED
SERVICE COMPANIES SUBJECT TO
THE PROVISIONS OF THE PUBLIC
UTILITY HOLDING COMPANY ACT OF
2005, FEDERAL POWER ACT AND
NATURAL GAS ACT
9. The authority citation for part 367
is revised to read as follows:
3. The authority citation for part 366
is revised to read as follows:
■
Authority: 15 U.S.C. 717 et seq., 16 U.S.C.
791a et seq., and 42 U.S.C. 16451–16463.
Authority: 15 U.S.C. 717 et seq., 16 U.S.C.
791a et seq., and 42 U.S.C. 16451–16463.
■
4. The heading of Subpart A is revised
to read as follows:
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■
■
Subpart A—Definitions and Provisions
Under PUHCA 2005, the Federal Power
Act and the Natural Gas Act
§ 367.1
5. In § 366.1, the definition of ‘‘service
company’’ is revised to read as follows:
■
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10:44 Dec 24, 2009
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10. In § 367.1, paragraph (a)(45) is
revised to read as follows:
Definitions.
(a) * * *
(45) Service company means any
associate company within a holding
company system organized specifically
for the purpose of providing non-power
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68529
goods or services or the sale of goods or
construction work to any public utility
or any natural gas company, or both, in
the same holding company system.
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■ 11. In § 367.2, paragraph (a) is revised
to read as follows:
§ 367.2 Companies for which this system
of accounts is prescribed.
(a) Unless otherwise exempted or
granted a waiver by Commission rule or
order pursuant to §§ 366.3 and 366.4 of
this chapter, this Uniform System of
Accounts applies to any centralized
service company operating, or organized
specifically to operate, within a holding
company system for the purpose of
providing non-power services to any
public utility or any natural gas
company, or both, in the same holding
company system.
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[FR Doc. E9–30449 Filed 12–24–09; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 529
[Docket No. FDA–2009–N–0665]
New Animal Drugs; Change of
Sponsor; Isoflurane
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 an abbreviated
new animal drug application (ANADA)
for isoflurane, USP, from Nicholas
Piramal India Ltd. UK, to Piramal
Healthcare Ltd.
DATES: This rule is effective December
28, 2009.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Nicholas
Piramal India Ltd. UK has informed
FDA that it has transferred ownership
of, and all rights and interest in,
ANADA 200–237 for Isoflurane, USP, to
Piramal Healthcare Ltd., Piramal Tower,
Ganpatrao Kadam Marg, Lower Parel,
Mumbai - 400 013, India. Accordingly,
the regulations are amended in 21 CFR
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Federal Register / Vol. 74, No. 247 / Monday, December 28, 2009 / Rules and Regulations
529.1186 to reflect this change of
sponsorship.
Following this change of sponsorship,
Nicholas Piramal India Ltd. UK is no
longer the sponsor of an approved
application. In addition, Piramal
Healthcare Ltd. is not currently listed in
the animal drug regulations as a sponsor
of an approved application.
Accordingly, 21 CFR 510.600(c) is being
amended to remove the entries for
Nicholas Piramal India Ltd. UK to add
entries for Piramal Healthcare Ltd.
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.
Firm name and address
Drug labeler
code
Piramal Healthcare Ltd.,
Piramal Tower,
Ganpatrao Kadam Marg,
Lower Parel, Mumbai 400 013, India
065085
*
*
*
*
*
(2) * * *
Drug labeler
code
*
Firm name and address
*
*
065085
*
*
Piramal Healthcare Ltd.,
Piramal Tower,
Ganpatrao Kadam Marg,
Lower Parel, Mumbai 400 013, India
List of Subjects
*
21 CFR Part 510
*
*
*
*
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
3. The authority citation for 21 CFR
part 529 continues to read as follows:
■
21 CFR Part 529
Authority: 21 U.S.C. 360b.
Animal drugs.
§ 529.1186
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 529 are amended as
follows:
■
PART 510—NEW ANIMAL DRUGS
[Amended]
4. In § 529.1186, in paragraph (b),
remove ‘‘066112’’ and in its place add
‘‘065085’’.
■
Dated: December 17, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E9–30590 Filed 12–24–09; 8:45 am]
BILLING CODE 4160–01–S
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
DEPARTMENT OF THE TREASURY
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
Internal Revenue Service
2. In § 510.600, in the table in
paragraph (c)(1) alphabetically add an
entry for ‘‘Piramal Healthcare Ltd.’’ and
remove the entry for ‘‘Nicholas Piramal
India Ltd. UK’’; and in the table in
paragraph (c)(2) remove the entry for
‘‘066112’’ and numerically add an entry
for ‘‘065085’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
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(c) * * *
(1) * * *
*
*
Drug labeler
code
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10:44 Dec 24, 2009
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[TD 9476]
RIN 1545–BI62; RIN 1545–BG39
Apportionment of Tax Items Among
the Members of a Controlled Group of
Corporations
AGENCY: Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations and removal of
temporary regulations.
Firm name and address
*
26 CFR Part 1
SUMMARY: This document contains final
regulations that provide guidance to
corporations that are component
members of a controlled group of
corporations and to consolidated groups
filing life-nonlife Federal income tax
returns. They provide guidance to
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component members regarding the
apportionment of tax benefit items and
the amount and type of information they
are required to submit with their
returns.
DATES: Effective Date: These regulations
are effective on December 28, 2009.
Applicability Date: For dates of
applicability, see §§ 1.1502–43(e),
1.1502–47(t), 1.1561–1(d), 1.1561–2(f)
and 1.1561–3(d). In accordance with
section 7805(b)(1), respective portions
of this Treasury decision are applicable
to consolidated Federal income tax
returns due on or after December 21,
2009 or to taxable years beginning on or
after December 21, 2009, as the case
may be.
FOR FURTHER INFORMATION CONTACT: Grid
Glyer, (202) 622–7930 (not a toll-free
number).
SUPPLEMENTARY INFORMATON:
Background
On December 22, 2006, the IRS and
the Treasury Department published
several temporary regulations, including
temporary regulations under sections
1502 and 1561. See TD 9304 (71 FR
76904), 2007–1 CB 423. Also on
December 22, 2006, the IRS and the
Treasury Department issued a notice of
proposed rulemaking cross-referencing
those temporary regulations. See REG–
161919–05 (71 FR 76955), 2007–1 CB
463. For administrative reasons, these
regulations were relocated in REG–
113688–09. See TD 9451 (74 FR 25147),
2009–23 IRB 1060.
On December 26, 2007, the IRS and
the Treasury Department published
several temporary regulations, including
an additional temporary regulation
under section 1561. See TD 9369 (72 FR
72929), 2008–6 IRB 394. Also on
December 26, 2007, the IRS and the
Treasury Department issued a notice of
proposed rulemaking cross-referencing
those temporary regulations. See REG–
104713–07 (72 FR 72970), 2008–6 IRB
409.
Explanation of Provisions
This Treasury decision adopts the
proposed regulations (§§ 1.1502–43,
1.1502–47, 1.1561–0, 1.1561–1, 1.1561–
2 and 1.1561–3) with no substantive
changes. However, this Treasury
decision makes clarifying changes to
§§ 1.1561–2 and 1.1561–3. These
changes are discussed in the following
portion of this preamble.
1. Only the Positive Taxable Income
or Positive Alternative Minimum
Taxable Income of the Component
Members of a Controlled Group of
Corporations Shall Be Combined for
Purposes of Determining the Amount of
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28DER1
]]>Agencies
[Federal Register Volume 74, Number 247 (Monday, December 28, 2009)]
[Rules and Regulations]
[Pages 68529-68530]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-30590]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 529
[Docket No. FDA-2009-N-0665]
New Animal Drugs; Change of Sponsor; Isoflurane
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 an abbreviated new
animal drug application (ANADA) for isoflurane, USP, from Nicholas
Piramal India Ltd. UK, to Piramal Healthcare Ltd.
DATES: This rule is effective December 28, 2009.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Nicholas Piramal India Ltd. UK has informed
FDA that it has transferred ownership of, and all rights and interest
in, ANADA 200-237 for Isoflurane, USP, to Piramal Healthcare Ltd.,
Piramal Tower, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013,
India. Accordingly, the regulations are amended in 21 CFR
[[Page 68530]]
529.1186 to reflect this change of sponsorship.
Following this change of sponsorship, Nicholas Piramal India Ltd.
UK is no longer the sponsor of an approved application. In addition,
Piramal Healthcare Ltd. is not currently listed in the animal drug
regulations as a sponsor of an approved application. Accordingly, 21
CFR 510.600(c) is being amended to remove the entries for Nicholas
Piramal India Ltd. UK to add entries for Piramal Healthcare Ltd.
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 529
Animal drugs.
0
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
529 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) alphabetically
add an entry for ``Piramal Healthcare Ltd.'' and remove the entry for
``Nicholas Piramal India Ltd. UK''; and in the table in paragraph
(c)(2) remove the entry for ``066112'' and numerically add an entry for
``065085'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Piramal Healthcare Ltd., Piramal Tower, 065085
Ganpatrao Kadam Marg, Lower Parel, Mumbai -
400 013, India
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
065085 Piramal Healthcare Ltd., Piramal Tower,
Ganpatrao Kadam Marg, Lower Parel, Mumbai
400 013, India
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1186 [Amended]
0
4. In Sec. 529.1186, in paragraph (b), remove ``066112'' and in its
place add ``065085''.
Dated: December 17, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-30590 Filed 12-24-09; 8:45 am]
BILLING CODE 4160-01-S
