Revision of Income Tax Regulations Under Sections 367, 884, and 6038B Dealing With Statutory Mergers or Consolidations Under Section 368(a)(1)(A) Involving One or More Foreign Corporations, and Guidance Necessary To Facilitate Business Electronic Filing Under Section 6038B; Correction, 28266-28267 [06-4533]
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28266
Federal Register / Vol. 71, No. 94 / Tuesday, May 16, 2006 / Rules and Regulations
Orphan
Medical, Inc., 13911 Ridgedale Dr., suite
475, Minnetonka, MN 55305, has
informed FDA that it has transferred
ownership of, and all rights and interest
in, NADA 141–075 for ANTIZOL-VET
(fomepizole) to Jazz Pharmaceuticals,
Inc., 3180 Porter Dr., Palo Alto, CA
94304. A supplement was also filed to
NADA 141–075 to remove a vial of
saline diluent from this product. The
supplemental NADA is approved as of
April 18, 2006, and the regulations are
amended in 21 CFR 522.1004 to reflect
the change of sponsorship, the removal
of a vial of saline diluent from the
product, and a current format.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
Following these changes of
sponsorship, Orphan Medical, Inc., is
no longer the sponsor of an approved
application. Accordingly, 21 CFR
510.600(c) is being amended to remove
the entries for Orphan Medical, Inc.
The agency has determined under 21
CFR 25.33(d)(1) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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:
‘‘Orphan Medical, Inc.’’ and
alphabetically add a new entry for ‘‘Jazz
Pharmaceuticals, Inc.’’; and in the table
in paragraph (c)(2) remove the entry for
‘‘062161’’ and numerically add a new
entry for ‘‘068727’’ to read as follows:
DEPARTMENT OF THE TREASURY
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
RIN 1545–BA65
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
Jazz Pharmaceuticals, Inc.,
3180 Porter Dr., Palo
Alto, CA 94304.
*
*
*
Drug labeler
code
*
068727
*
*
*
*
068727
*
*
*
Firm name and address
*
*
*
Jazz Pharmaceuticals, Inc.,
3180 Porter Dr., Palo
Alto, CA 94304
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
List of Subjects
4. In § 522.1004, revise paragraphs (a),
(b), (c)(1), and (c)(3) to read as follows:
21 CFR Part 510
§ 522.1004
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
(a) Specifications. Each vial contains
1.5 grams fomepizole (1.5 milliliter (mL)
of 1.0 gram per mL solution).
(b) Sponsor. See No. 068727 in
§ 510.600(c) of this chapter.
(c) * * *
(1) Amount. 20 milligrams per
kilogram (mg/kg) of body weight
intravenously initially, followed by 15
mg/kg at 12 and 24 hours, and 5 mg/kg
at 36 hours.
*
*
*
*
*
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
21 CFR Part 522
Animal drugs.
I 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:
cprice-sewell on PROD1PC66 with RULES
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
I
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[TD 9243]
Revision of Income Tax Regulations
Under Sections 367, 884, and 6038B
Dealing With Statutory Mergers or
Consolidations Under Section
368(a)(1)(A) Involving One or More
Foreign Corporations, and Guidance
Necessary To Facilitate Business
Electronic Filing Under Section 6038B;
Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendment.
SUMMARY: This document contains a
correction to final regulations (TD
9243), that was published in the Federal
Register on Thursday, January 26, 2006
(71 FR 4276). This final regulation
amends the income tax regulations
under various provisions of the Internal
Revenue Code to account for statutory
mergers and consolidations.
DATES: This correction is effective
January 23, 2006.
FOR FURTHER INFORMATION CONTACT:
Christopher Trump (202) 622–3860 (not
a toll-free number).
SUPPLEMENTARY INFORMATION:
Background
The final regulation (TD 9243) that is
the subject of this correction is under
section 367 of the Internal Revenue
Code.
Need for Correction
Dated: May 3, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 06–4534 Filed 5–15–06; 8:45 am]
BILLING CODE 4160–01–S
26 CFR Part 1
AGENCY:
(2) * * *
Drug labeler
code
Internal Revenue Service
As published, TD 9243 contains an
error that may prove to be misleading
and is in need of clarification.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Correction of Publication
Accordingly, 26 CFR part 1 is
corrected by making the following
correcting amendments:
I
PART 1—INCOME TAXES
Paragraph 1. The authority citation
for part 1 continues to read in part as
follows:
I
Authority: 26 U.S.C. 7805 * * *
§ 1.367(b)–6
[Corrected]
I Par. 2. Section 1.367(b)–6 is amended
by removing the third sentence of
E:\FR\FM\16MYR1.SGM
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Federal Register / Vol. 71, No. 94 / Tuesday, May 16, 2006 / Rules and Regulations
206.2
206.3
206.4
206.5
paragraph (a)(1) and adding the
following sentence in its place to read
as follows:
§ 1.367(b)–6 Effective dates and
coordination rules.
Authority: 20 U.S.C. 1141(a).
(a) * * *
(1) * * * Section 1.367(b)–4(b)(1)(ii)
applies to all triangular reorganizations
and reorganizations described in section
368(a)(1)(G) and (a)(2)(D) occurring on
or after January 23, 2006, although
taxpayers may apply § 1.367(b)–
4(b)(1)(ii) to triangular B reorganizations
occurring on or after February 23, 2000,
that is not closed by the period of
limitations if done consistently with
respect to all such triangular B
reorganizations.* * *
*
*
*
*
*
cprice-sewell on PROD1PC66 with RULES
Eligibility.
Overall program emphasis.
Proposal development and review.
Final proposal process.
§ 206.1 Major characteristics of the NSEP
institutional grants program.
(a) The Institutional Grants Program
provides support in the form of grants
to U.S. institutions of higher education.
During the 1994–95 and 1995–96
academic years, a program of pilot
grants is being initiated with an annual
competition for grants held during the
spring of each year. Grants to
institutions will complement NSEP
scholarship and fellowship programs.
NSEP encourages the development of
programs and curricula which:
(1) Improves the quality and
Guy R. Traynor,
infrastructure of international
Chief, Publications and Regulations Branch,
education;
Legal Processing Division, Associate Chief
(2) Addresses issues of national
Counsel (Procedures and Administration).
capacity; and
[FR Doc. 06–4533 Filed 5–15–06; 8:45 am]
(3) Defines innovative approaches to
BILLING CODE 4830–01–P
issues not addressed by NSEP
scholarship and fellowship programs.
(b) The NSEP Grants Program is
designed to address a number of
DEPARTMENT OF DEFENSE
important objectives critical to the
Office of the Secretary
United States:
(1) To equip Americans with an
32 CFR Part 206
understanding of less commonly taught
languages and cultures and enable them
National Security Education Program
to become integrally involved in global
(NSEP) Grants to Institutions of Higher issues.
Education
(2) To build a critical base of future
leaders in the marketplace and in
AGENCY: Department of Defense.
government service who have cultivated
ACTION: Final rule.
international relationships and worked
SUMMARY: This document republishes 32 and studied along-side foreign experts.
(3) To develop a cadre of
CFR part 206, ‘‘National Security
professionals with more than the
Education Program’’ which was
traditional knowledge of language and
removed from the CFR in error. No
culture who can use this ability to help
changes have been made.
the U.S. make sound decisions and deal
DATES: This rule is effective May 16,
effectively with global issues; and
2006.
(4) To enhance institutional capacity
FOR FURTHER INFORMATION CONTACT: L.
and increase the number of faculty who
Bynum 703–696–4970.
can educate U.S. citizens toward
SUPPLEMENTARY INFORMATION: The
achieving these goals.
removal was published in the Federal
(c) Grants will be awarded for initial
Register on Tuesday, May 9, 2006 (71
1- or 2-year periods. Potential follow-on
FR 26831).
commitments will be based on a
rigorous evaluation and assessment
List of Subjects in 32 CFR Part 206
process. Between 15 and 25 awards are
Colleges and universities, Grant
expected to be made in the first year
programs—education.
ranging from approximately $25,000 to
I Accordingly, 32 CFR part 206 is
$250,000. These are only estimates and
added to read as follows:
do not bind the NSEP to a specific
number of grants or to the amount of the
PART 206—NATIONAL SECURITY
grant.
EDUCATION PROGRAM (NSEP)
(d) The following key characteristics
GRANTS TO INSTITUTIONS OF
will be emphasized in the NSEP
HIGHER EDUCATION
Institutional Grants Program:
(1) Programmatic in emphasis. The
Sec.
purpose of the grants is to address
206.1 Major characteristics of the NSEP
weaknesses and gaps in programs and
institutional grants program.
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28267
curricula. The grants should be used to
strengthen the national capacity in
international education. While
‘‘operational’’ support for already
existing centers and projects may be a
component of a grant, NSEP emphasizes
commitment of its limited resources to
projects that establish and improve
educational programs available to
students and teachers.
(2) Demand and requirements
oriented. Grants are designed to address
national needs. These needs must be
clearly articulated and defended in a
grant proposal. It must be clear that the
following questions are addressed:
(i) Who will benefit from the program
funded by the grant?
(ii) What need does the program
address?
(iii) How will this program augment
the capacity of the Federal Government
or of the field of education in areas
consistent with the objectives of the
NSEP? How does it fit the national
requirement?
(3) Cooperation and collaboration
among institutions is mandated in order
to ensure that a wider cross-section of
colleges and universities benefit from a
program funded under NSEP. NSEP is
committed to providing opportunities to
the widest cross-section of the higher
education population as is feasible.
Cooperation can be in the form of formal
consortia arrangements or less formal
but equally effective agreements among
institutions. Both vertical (among
different types of institutions) and
horizontal (among similar institutions
across functional areas) integration are
encouraged. Outreach to institutions
that do not normally benefit from such
programs is also strongly favored.
(4) Complementary to other Federal
programs such as Title VI of the Higher
Education Act. NSEP is designed to
address gaps and shortfalls in Higher
Education and to build and expand
national capacity. NSEP recognizes that
base capacity currently exists in some
foreign languages and area studies. It
also recognizes that funding shortfalls
and other factors have contributed to
tremendous gaps and weaknesses.
Funding for expansion of the
international education infrastructure
remains limited. Duplication of effort is
not affordable. NSEP encourages new
initiatives as well as expansion of
existing programs to increase supply in
cases where the demand cannot be met
and encourages efforts that increase
demand.
(5) NSEP encourages proposals that
address two categories of issues relating
to the mission of NSEP:
(i) Programs in specific foreign
languages, countries or areas; and/or
E:\FR\FM\16MYR1.SGM
16MYR1
Agencies
[Federal Register Volume 71, Number 94 (Tuesday, May 16, 2006)]
[Rules and Regulations]
[Pages 28266-28267]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-4533]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9243]
RIN 1545-BA65
Revision of Income Tax Regulations Under Sections 367, 884, and
6038B Dealing With Statutory Mergers or Consolidations Under Section
368(a)(1)(A) Involving One or More Foreign Corporations, and Guidance
Necessary To Facilitate Business Electronic Filing Under Section 6038B;
Correction
AGENCY: Internal Revenue Service (IRS), Treasury.
ACTION: Correcting amendment.
-----------------------------------------------------------------------
SUMMARY: This document contains a correction to final regulations (TD
9243), that was published in the Federal Register on Thursday, January
26, 2006 (71 FR 4276). This final regulation amends the income tax
regulations under various provisions of the Internal Revenue Code to
account for statutory mergers and consolidations.
DATES: This correction is effective January 23, 2006.
FOR FURTHER INFORMATION CONTACT: Christopher Trump (202) 622-3860 (not
a toll-free number).
SUPPLEMENTARY INFORMATION:
Background
The final regulation (TD 9243) that is the subject of this
correction is under section 367 of the Internal Revenue Code.
Need for Correction
As published, TD 9243 contains an error that may prove to be
misleading and is in need of clarification.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and recordkeeping requirements.
Correction of Publication
0
Accordingly, 26 CFR part 1 is corrected by making the following
correcting amendments:
PART 1--INCOME TAXES
0
Paragraph 1. The authority citation for part 1 continues to read in
part as follows:
Authority: 26 U.S.C. 7805 * * *
Sec. 1.367(b)-6 [Corrected]
0
Par. 2. Section 1.367(b)-6 is amended by removing the third sentence of
[[Page 28267]]
paragraph (a)(1) and adding the following sentence in its place to read
as follows:
Sec. 1.367(b)-6 Effective dates and coordination rules.
(a) * * *
(1) * * * Section 1.367(b)-4(b)(1)(ii) applies to all triangular
reorganizations and reorganizations described in section 368(a)(1)(G)
and (a)(2)(D) occurring on or after January 23, 2006, although
taxpayers may apply Sec. 1.367(b)-4(b)(1)(ii) to triangular B
reorganizations occurring on or after February 23, 2000, that is not
closed by the period of limitations if done consistently with respect
to all such triangular B reorganizations.* * *
* * * * *
Guy R. Traynor,
Chief, Publications and Regulations Branch, Legal Processing Division,
Associate Chief Counsel (Procedures and Administration).
[FR Doc. 06-4533 Filed 5-15-06; 8:45 am]
BILLING CODE 4830-01-P