Excise Taxes on Prohibited Tax Shelter Transactions and Related Disclosure Requirements; Disclosure Requirements With Respect to Prohibited Tax Shelter Transactions; Requirement of Return and Time for Filing; Correction, 45997-45998 [E7-16080]
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Federal Register / Vol. 72, No. 158 / Thursday, August 16, 2007 / Proposed Rules
component in the directions for use for
the blood collecting, processing, and
storage system approved for such use by
the Director, CBER.
9. Section 640.20 is amended by
revising paragraph (b) to read as follows:
§ 640.20
Platelets.
*
*
*
*
*
(b) Source. The source material for
Platelets is plasma which may be
obtained by whole blood collection or
by plateletpheresis.
10. Section 640.21 is amended by
removing and reserving paragraph (b)
and revising paragraph (c) to read as
follows:
§ 640.21
Suitability of donors.
*
*
*
*
*
(b) [Reserved]
(c) Plateletpheresis donors must meet
the criteria for suitability as prescribed
in §§ 640.3 and 640.63(c)(6), or as
described in an approved biologics
license application (BLA) or an
approved supplement to a BLA.
Informed consent must be obtained as
prescribed in § 640.61.
11. Section 640.22 is amended by
removing and reserving paragraph (b)
and revising paragraph (c) to read as
follows:
§ 640.22
Collection of source material.
*
*
*
*
*
(b) [Reserved]
(c) If plateletpheresis is used, the
procedure for collection must be as
prescribed in §§ 640.62, 640.64 (except
paragraph (c)), and 640.65, or as
described in an approved biologics
license application (BLA) or an
approved supplement to a BLA.
*
*
*
*
*
12. Section 640.24 is amended by
revising paragraph (a) to read as follows:
§ 640.24
Processing.
rwilkins on PROD1PC63 with PROPOSALS
(a) Separation of plasma and platelets
and resuspension of the platelets must
be in a closed system. Platelets must not
be pooled during processing unless the
platelets are pooled as specified in the
directions for use for the blood
collecting, processing, and storage
system approved for such use by the
Director, Center for Biologics Evaluation
and Research.
*
*
*
*
*
§ 640.25
[Amended]
13. Section 640.25 is amended in
paragraph (b)(2) by removing ‘‘6.0’’ and
adding in its place ‘‘6.2’’.
14. Section 640.30 is amended by
revising paragraph (a) to read as follows:
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17:19 Aug 15, 2007
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§ 640.30
Plasma.
(a) Proper name and definition. The
proper name of this component is
Plasma. The component is defined as:
(1) The fluid portion of one unit of
human blood intended for intravenous
use which is collected in a closed
system, stabilized against clotting, and
separated from the red cells; or
(2) The fluid portion of human blood
intended for intravenous use which is
prepared by apheresis methods as
specified in the directions for use for the
blood collecting, processing, and storage
system including closed and open
systems.
*
*
*
*
*
15. Section 640.32 is amended by
revising paragraph (a) to read as follows:
§ 640.32
Collection of source material.
(a) Whole Blood must be collected,
transported, and stored as prescribed in
§ 640.4. When whole blood is intended
for Plasma, Fresh Frozen Plasma, and
Liquid Plasma, until the plasma is
removed, the whole blood must be
maintained at a temperature between 1
and 6° C or as specified in the directions
for use for the blood collecting,
processing, and storage system
approved for such use by the Director,
Center for Biologics Evaluations and
Research. Whole blood intended for
Platelet Rich Plasma must be
maintained as prescribed in § 640.24
until the plasma is removed. The red
blood cells must be placed in storage at
a temperature between 1 and 6° C
immediately after the plasma is
separated.
*
*
*
*
*
16. Section 640.34 is amended by
revising the second sentence in
paragraph (b) to read as follows:
§ 640.34
Processing.
*
*
*
*
*
(b) Fresh Frozen Plasma. * * * The
plasma must be separated from the red
blood cells or collected by an apheresis
procedure, and placed in a freezer
within 8 hours or within the timeframe
specified in the directions for use for the
blood collecting, processing, and storage
system, and stored at 18° C or colder.
*
*
*
*
*
17. Section 640.64 is amended by
revising paragraphs (b) and (c) to read
as follows:
§ 640.64
plasma.
Collection of blood for source
*
*
*
*
*
(b) Blood containers. Blood containers
and donor sets must be pyrogen-free,
sterile, and identified by lot number.
(c) The anticoagulant solution. The
anticoagulant solution must be sterile
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Sfmt 4702
45997
and pyrogen-free. Anticoagulant
solutions must be compounded and
used according to a formula that has
been approved for the applicant by the
Director, Center for Biologics Evaluation
and Research.
*
*
*
*
*
Dated: July 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–15942 Filed 8–15–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Parts 53 and 301
[REG–142039–06; REG–139268–06]
RIN 1545–BG18; 1545–BG20
Excise Taxes on Prohibited Tax Shelter
Transactions and Related Disclosure
Requirements; Disclosure
Requirements With Respect to
Prohibited Tax Shelter Transactions;
Requirement of Return and Time for
Filing; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Corrections to notice of
proposed rulemaking by cross-reference
to temporary regulations and notice of
proposed rulemaking.
AGENCY:
SUMMARY: This document contains
corrections to notice of proposed
rulemaking by cross-reference to
temporary regulations (REG–142039–06)
and notice of proposed rulemaking
(REG–139268–06) that were published
in the Federal Register on Friday, July
6, 2007 (72 FR 36927) providing
guidance under 4965 of the Internal
Revenue Code and relating to entitylevel and manager-level excise taxes
with respect to prohibited tax shelter
transactions to which tax-exempt
entities are parties; §§ 6033(a)(2) and
6011(g), relating to certain disclosure
obligations with respect to such
transactions; and §§ 6011 and 6071,
relating to the requirement of a return
and time for filing with respect to
section 4965 taxes.
FOR FURTHER INFORMATION CONTACT:
Concerning the regulations, Galina
Kolomietz, (202) 622–6070, or Michael
Blumenfeld, (202) 622–1124 (not tollfree numbers). For questions specifically
relating to qualified pension plans,
individual retirement accounts, and
similar tax-favored savings
arrangements, contact Dana Barry, (202)
622–6060 (not a toll-free number).
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45998
Federal Register / Vol. 72, No. 158 / Thursday, August 16, 2007 / Proposed Rules
text of the proposed amendment to
§ 301.6033–5 is the same’’.
SUPPLEMENTARY INFORMATION:
Background
The notice of proposed rulemaking by
cross-reference to temporary regulations
and notice of proposed rulemaking that
are the subjects of this correction are
under sections 6011, 6033, 6071, and
4965 of the Internal Revenue Code.
LaNita Van Dyke,
Chief, Publications and Regulations Branch,
Legal Processing Division, Associate Chief
Counsel (Procedure and Administration).
[FR Doc. E7–16080 Filed 8–15–07; 8:45 am]
BILLING CODE 4830–01–P
Need for Correction
As published, proposed regulations
(REG–142039–06 and REG–139268–06)
contain errors that may prove to be
misleading and are in need of
clarification.
Correction of Publication
Accordingly, the publication of the
proposed regulations (REG–142039–06
and REG–139268–06) which were the
subjects of FR Doc.E7–12902), is
corrected as follows:
§ 53.4965–4
[Corrected]
1. On page 36933, column 1,
§ 53.4365–4(c) Example 2., line 12 of the
paragraph, the language ‘‘by Notice
2006–16 (2006–9 IRB 538). The’’ is
corrected to read ‘‘by Notice 2006–16
(2006–9 IRB 538)). The’’.
§ 53.4965–8
[Corrected]
2. On page 36936, column 3,
§ 53.4965–8(e), line 2 of the paragraph,
the language ‘‘periods. If a transaction
(other than a’’ is corrected to read
‘‘periods. If a transaction other than a’’.
PART 301—PROCEDURE AND
ADMINISTRATION
3. On page 36938, column 1,
paragraph 8, line 2, the language ‘‘301
continues to read, part, as follows:’’ is
corrected to read ‘‘301 continues to
read, in part, as follows:’’.
rwilkins on PROD1PC63 with PROPOSALS
§ 301.6011(g)–1
[Corrected]
4. On page 36938, column 1,
§ 301.6011(g)–1(a)(2)(i), line 4 of the
paragraph, the language ‘‘of its taxexempt, tax-indifferent or tax-’’ is
corrected to read ‘‘of its tax-exempt, tax
indifferent or tax-’’.
5. On page 36938, column 1,
§ 301.6011(g)–1(a)(2)(ii), line 3 of the
paragraph, the language ‘‘exempt, taxindifferent or tax-favored’’ is corrected
to read ‘‘exempt, tax indifferent or taxfavored’’.
§ 301.6033–5
[Corrected]
6. On page 36939, column 1,
§ 301.6033–5, line 1 of the paragraph,
the language ‘‘[The text of this section
is the same’’ is corrected to read ‘‘[The
VerDate Aug<31>2005
17:19 Aug 15, 2007
Jkt 211001
DEPARTMENT OF AGRICULTURE
Forest Service
36 CFR Part 220
RIN 0596–AC49
National Environmental Policy Act
Procedures
Forest Service, USDA.
Notice of proposed rule; request
for comment.
AGENCY:
ACTION:
SUMMARY: The Forest Service is
proposing to move its National
Environmental Policy Act (NEPA)
implementing procedures from Forest
Service Manual (FSM) 1950 and Forest
Service Handbook (FSH) 1909.15 to 36
Code of Federal Regulations, part 220
(36 CFR 220). The Agency also proposes
to clarify existing NEPA procedures and
add new procedures to incorporate
Council on Environmental Quality
(CEQ) guidance and to better align
Agency NEPA procedures with Agency
decision processes.
Agency explanatory guidance
interpreting CEQ and Agency
procedures in regulation will remain in
FSH 1909.15. Agency NEPA authority,
objectives, policy, and responsibilities
will remain in FSM 1950.
This rule would meet 40 CFR 1507.3
by placing Agency-implementing
procedures in their proper regulatory
position. Maintaining Agency
explanatory guidance in directives
would facilitate timely Agency
responses to new ideas, new
information, procedural interpretations,
training needs, and editorial changes to
assist field units when implementing
the NEPA process. Finally, the proposed
changes to the Forest Service NEPA
procedures are intended to provide an
environmental analysis process that fits
better with modern thinking on
decisionmaking, collaboration, and
adaptive management to meet the intent
of NEPA through establishing
incremental alternative development,
and adaptive management principles.
DATES: Comments must be received in
writing by October 15, 2007.
ADDRESSES: Comments concerning this
notice should be sent by e-mail to
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fsnepa@contentanalysisgroup.com, or
by facsimile to 801–397–2601, or via the
U.S. Postal Service to: NEPA
Implementation Procedures, C/O
Content Analysis Group, 1584 South
500 West, Suite 201, Woods Cross, UT
84010. Electronic or facsimile comments
are preferred. If comments are sent via
U.S. Postal Service, please do not
submit duplicate electronic or facsimile
comments. Please confine comments to
the proposed move of existing NEPA
procedures from FSH to regulation,
proposed changes to existing NEPA
procedures, and proposed new NEPA
procedures and explain the reasons for
any recommended changes.
All comments, including names and
addresses when provided, are placed in
the record and are available for public
inspection and copying.
FOR FURTHER INFORMATION CONTACT: Joe
Carbone, Ecosystem Management Staff,
(202) 205–0884, Forest Service, USDA.
Individuals who use telecommunication
devices for the deaf (TDD) may call the
Federal Information Relay Service
(FIRS) at 1–800–877–8339 between 8
a.m. and 8 p.m. Eastern Standard Time,
Monday through Friday.
SUPPLEMENTARY INFORMATION:
Background and Need for the Proposed
Rule
Council on Environmental Quality
(CEQ) regulations at 40 CFR 1507.3
require Federal agencies to adopt
procedures as necessary to supplement
CEQ’s regulations implementing the
National Environmental Policy Act
(NEPA) and to consult with CEQ during
their development and prior to
publication in the Federal Register. The
regulation further encourages agencies
to publish agency explanatory guidance
for CEQ’s regulations and agency
procedures.
In 1979, the Forest Service chose to
combine its implementing procedures
and explanatory guidance in Agency
directives (Forest Service Manual 1950
and Forest Service Handbook 1909.15).
The blending of NEPA implementing
procedures with explanatory guidance
requires the Forest Service to provide
for public notice and comment and to
consult with CEQ, as required by 40
CFR1507.3, when amending any
guidance for explaining CEQ or Agency
procedures, resulting in an increased
administrative burden for the Agency
and CEQ.
This proposal would meet the intent
of 40 CFR 1507.3 by placing Agencyimplementing procedures in their
proper regulatory position. Placing
Agency explanatory guidance in
directives would facilitate quicker
E:\FR\FM\16AUP1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 158 (Thursday, August 16, 2007)]
[Proposed Rules]
[Pages 45997-45998]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16080]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Parts 53 and 301
[REG-142039-06; REG-139268-06]
RIN 1545-BG18; 1545-BG20
Excise Taxes on Prohibited Tax Shelter Transactions and Related
Disclosure Requirements; Disclosure Requirements With Respect to
Prohibited Tax Shelter Transactions; Requirement of Return and Time for
Filing; Correction
AGENCY: Internal Revenue Service (IRS), Treasury.
ACTION: Corrections to notice of proposed rulemaking by cross-reference
to temporary regulations and notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: This document contains corrections to notice of proposed
rulemaking by cross-reference to temporary regulations (REG-142039-06)
and notice of proposed rulemaking (REG-139268-06) that were published
in the Federal Register on Friday, July 6, 2007 (72 FR 36927) providing
guidance under 4965 of the Internal Revenue Code and relating to
entity-level and manager-level excise taxes with respect to prohibited
tax shelter transactions to which tax-exempt entities are parties;
Sec. Sec. 6033(a)(2) and 6011(g), relating to certain disclosure
obligations with respect to such transactions; and Sec. Sec. 6011 and
6071, relating to the requirement of a return and time for filing with
respect to section 4965 taxes.
FOR FURTHER INFORMATION CONTACT: Concerning the regulations, Galina
Kolomietz, (202) 622-6070, or Michael Blumenfeld, (202) 622-1124 (not
toll-free numbers). For questions specifically relating to qualified
pension plans, individual retirement accounts, and similar tax-favored
savings arrangements, contact Dana Barry, (202) 622-6060 (not a toll-
free number).
[[Page 45998]]
SUPPLEMENTARY INFORMATION:
Background
The notice of proposed rulemaking by cross-reference to temporary
regulations and notice of proposed rulemaking that are the subjects of
this correction are under sections 6011, 6033, 6071, and 4965 of the
Internal Revenue Code.
Need for Correction
As published, proposed regulations (REG-142039-06 and REG-139268-
06) contain errors that may prove to be misleading and are in need of
clarification.
Correction of Publication
Accordingly, the publication of the proposed regulations (REG-
142039-06 and REG-139268-06) which were the subjects of FR Doc.E7-
12902), is corrected as follows:
Sec. 53.4965-4 [Corrected]
1. On page 36933, column 1, Sec. 53.4365-4(c) Example 2., line 12
of the paragraph, the language ``by Notice 2006-16 (2006-9 IRB 538).
The'' is corrected to read ``by Notice 2006-16 (2006-9 IRB 538)).
The''.
Sec. 53.4965-8 [Corrected]
2. On page 36936, column 3, Sec. 53.4965-8(e), line 2 of the
paragraph, the language ``periods. If a transaction (other than a'' is
corrected to read ``periods. If a transaction other than a''.
PART 301--PROCEDURE AND ADMINISTRATION
3. On page 36938, column 1, paragraph 8, line 2, the language ``301
continues to read, part, as follows:'' is corrected to read ``301
continues to read, in part, as follows:''.
Sec. 301.6011(g)-1 [Corrected]
4. On page 36938, column 1, Sec. 301.6011(g)-1(a)(2)(i), line 4 of
the paragraph, the language ``of its tax-exempt, tax-indifferent or
tax-'' is corrected to read ``of its tax-exempt, tax indifferent or
tax-''.
5. On page 36938, column 1, Sec. 301.6011(g)-1(a)(2)(ii), line 3
of the paragraph, the language ``exempt, tax-indifferent or tax-
favored'' is corrected to read ``exempt, tax indifferent or tax-
favored''.
Sec. 301.6033-5 [Corrected]
6. On page 36939, column 1, Sec. 301.6033-5, line 1 of the
paragraph, the language ``[The text of this section is the same'' is
corrected to read ``[The text of the proposed amendment to Sec.
301.6033-5 is the same''.
LaNita Van Dyke,
Chief, Publications and Regulations Branch, Legal Processing Division,
Associate Chief Counsel (Procedure and Administration).
[FR Doc. E7-16080 Filed 8-15-07; 8:45 am]
BILLING CODE 4830-01-P
