Deemed IRAs in Governmental Plans/Qualified Nonbank Trustee Rules, 33387-33388 [E7-11636]
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Federal Register / Vol. 72, No. 116 / Monday, June 18, 2007 / Rules and Regulations
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by
Pharmacia & Upjohn Co., a Div. of
Pfizer, Inc. The supplemental NADA
provides for the use of lincomycin in
feed of swine weighing greater than 250
pounds and for the addition of a
reproductive cautionary statement to
labeling.
DATES:
FOR FURTHER INFORMATION CONTACT:
Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov.
Pharmacia
& Upjohn Co., a Div. of Pfizer, Inc., 235
E. 42d St., New York, NY 10017, filed
a supplement to NADA 97–505 that
provides for use of LINCOMIX 20
(lincomycin hydrochloride) and
LINCOMIX 50 Feed Medications in
single-ingredient Type B and Type C
medicated feeds for swine weighing
greater than 250 pounds and for the
addition of a reproductive caution
statement to labeling. The supplemental
application is approved as of May 23,
2007, and the regulations are amended
in 21 CFR 558.325 to reflect the
approval.
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.
The agency has determined under 21
CFR 25.33(a)(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:
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
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 558 is amended as follows:
I
2. In § 558.325, add paragraph (c) and
in the table in paragraphs (d)(2)(i)
through (d)(2)(iv), in the ‘‘Limitations’’
column, remove ‘‘Not to be fed to swine
that weigh more than 250 lb.’’ wherever
it occurs to read as follows:
I
Lincomycin.
17:03 Jun 15, 2007
Jkt 211001
*
*
*
*
(c) Special considerations—(1)
Labeling of Type A medicated articles
and Type B and Type C medicated feeds
containing lincomycin shall bear the
following directions: ‘‘CAUTION: Do
not allow rabbits, hamsters, guinea pigs,
horses, or ruminants access to feeds
containing lincomycin. Ingestion by
these species may result in severe
gastrointestinal effects.’’
(2) Labeling of Type A medicated
articles and Type B and Type C
medicated feeds containing lincomycin
intended for use in swine shall bear the
following directions: ‘‘CAUTION:
Occasionally, swine fed lincomycin may
within the first 2 days after the onset of
treatment develop diarrhea and/or
swelling of the anus. On rare occasions,
some pigs may show reddening of the
skin and irritable behavior. These
conditions have been self-correcting
within 5 to 8 days without
discontinuing the lincomycin
treatment.’’
(3) Labeling of Type A medicated
articles and single-ingredient Type B
and Type C medicated feeds containing
lincomycin intended for use in swine
shall bear the following directions:
(i) No. 000009: ‘‘CAUTION: The
effects of lincomycin on swine
reproductive performance, pregnancy,
and lactation have not been determined.
Not for use in swine intended for
breeding when lincomycin is fed at 20
grams per ton of complete feed.’’
(ii) Nos. 043733 and 051311:
‘‘CAUTION: Not to be fed to swine that
weigh more than 250 lb.’’
*
*
*
*
*
Dated: June 8, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E7–11611 Filed 6–15–07; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9331]
Authority: 21 U.S.C. 360b, 371.
*
2007.
pwalker on PROD1PC71 with RULES
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
§ 558.325
This rule is effective June 18,
VerDate Aug<31>2005
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
33387
RIN 1545–BG46
Deemed IRAs in Governmental Plans/
Qualified Nonbank Trustee Rules
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations and removal of
temporary regulations.
AGENCY:
SUMMARY: This document contains final
regulations under section 408 of the
Internal Revenue Code. The final
regulations provide special rules for a
governmental unit which seeks to
qualify as a nonbank trustee of a
deemed IRA that is part of its qualified
employer plan. These final regulations
affect only such governmental units.
DATES: Effective Date: June 18, 2007.
Applicability Date: For dates of
applicability, see § 1.408–2(e)(8)(iv).
FOR FURTHER INFORMATION CONTACT:
Linda L. Conway, 202–622–6090, or
Cathy A. Vohs, 202–622–6090 (not tollfree numbers).
SUPPLEMENTARY INFORMATION:
Background
This document contains final
amendments to the Income Tax
Regulations (26 CFR Part 1) under
section 408 of the Internal Revenue
Code of 1986 (Code). On July 22, 2004,
temporary and proposed regulations
under section 408 were issued. A notice
of proposed rulemaking (REG–101447–
04) was published in the Federal
Register (69 FR 43786). The text of the
temporary regulations also served as the
text of the proposed regulations. The
text of temporary § 1.408–2(e)(8) was
published in the same issue of the
Federal Register (69 FR 43735). The RIN
published in connection with that
notice of proposed rulemaking was
1545–BD07. However, due to technical
difficulties that RIN is no longer valid
and the RIN number of these final
regulations is 1545–BG46. No comments
were received regarding the proposed
regulations.
Explanation of Provisions and
Summary of Comments
These final regulations amend
§ 1.408–2(e) of the regulations to
provide that a governmental unit may
serve as the trustee of any deemed IRA
established by that governmental unit as
part of its qualified employer plan if
that governmental unit establishes to the
E:\FR\FM\18JNR1.SGM
18JNR1
33388
Federal Register / Vol. 72, No. 116 / Monday, June 18, 2007 / Rules and Regulations
satisfaction of the Commissioner that
the manner in which it will administer
the deemed IRA will be consistent with
the requirements of section 408. These
final regulations also provide special
rules regarding the application of
§ 1.408–2(e) to governmental units.
These final regulations are adopted
without substantive change from the
proposed and temporary regulations.
These final regulations are applicable
for written applications made on or after
June 18, 2007. The rules in this section
also may be relied on for applications
submitted on or after August 1, 2003 (or
such earlier application as the
Commissioner deems appropriate) and
before June 18, 2007.
Special Analyses
It has been determined that this
Treasury Decision is not a significant
regulatory action as defined in
Executive Order 12866. Therefore, a
regulatory assessment is not required. It
also has been determined that section
553(b) of the Administrative Procedure
Act (5 U.S.C. chapter 5) does not apply
to these regulations, and, because the
regulation does not impose a collection
of information on small entities, the
Regulatory Flexibility Act (5 U.S.C.
chapter 6) does not apply. Pursuant to
section 7805(f) of the Code, the notice
of proposed rulemaking preceding these
final regulations was submitted to the
Chief Counsel for Advocacy of the Small
Business Administration for comment
on its impact on small business.
Drafting Information
The principal author of these
regulations is Linda L. Conway of the
Office of the Division Counsel/Associate
Chief Counsel (Tax Exempt and
Government Entities). However, other
personnel from the IRS and Treasury
Department participated in the
development of these regulations.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Adoption of Amendments to the
Regulations
Accordingly, 26 CFR part 1 is
amended as follows:
I
PART 1—INCOME TAXES
Paragraph 1.The authority citation for
part 1 continues to read in part as
follows:
pwalker on PROD1PC71 with RULES
I
Authority: 26 U.S.C. 7805 * * *
I Par. 2. Section 1.408–2(e)(8) is revised
to read as follows:
VerDate Aug<31>2005
17:03 Jun 15, 2007
Jkt 211001
§ 1.408–2
Individual retirement accounts.
*
*
*
*
*
(e) * * *
(8) Special rules for governmental
units—(i) In general. A governmental
unit that seeks to qualify as a nonbank
trustee of a deemed IRA that is part of
its qualified employer plan must
demonstrate to the satisfaction of the
Commissioner that it is able to
administer the trust in a manner that is
consistent with the requirements of
section 408. The demonstration must be
made by written application to the
Commissioner. Notwithstanding the
requirement of paragraph (e)(1) of this
section that a person must demonstrate
by written application that the
requirements of paragraphs (e)(2)
through (e)(6) of this section will be met
in order to qualify as a nonbank trustee,
a governmental unit that maintains a
plan qualified under section 401(a),
403(a), 403(b) or 457 need not
demonstrate that all of these
requirements will be met with respect to
any individual retirement accounts
maintained by that governmental unit
pursuant to section 408(q). For example,
a governmental unit need not
demonstrate that it satisfies the net
worth requirements of paragraph
(e)(3)(ii) of this section if it
demonstrates instead that it possesses
taxing authority under applicable law.
The Commissioner, in his discretion,
may exempt a governmental unit from
certain other requirements upon a
showing that the governmental unit is
able to administer the deemed IRAs in
the best interest of the participants.
Moreover, in determining whether a
governmental unit satisfies the other
requirements of paragraphs (e)(2)
through (e)(6) of this section, the
Commissioner may apply the
requirements in a manner that is
consistent with the applicant’s status as
a governmental unit.
(ii) Governmental unit. For purposes
of this special rule, the term
governmental unit means a state,
political subdivision of a state, and any
agency or instrumentality of a state or
political subdivision of a state.
(iii) Additional rules. The
Commissioner may in revenue rulings,
notices, or other guidance of general
applicability provide additional rules
for governmental units seeking approval
as nonbank trustees.
(iv) Effective/applicability date. This
section is applicable for written
applications made on or after June 18,
2007. The rules in this section also may
be relied on for applications submitted
on or after August 1, 2003 (or such
earlier application as the Commissioner
PO 00000
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deems appropriate) and before June 18,
2007.
§ 1.408–2T
I
[Removed]
Par. 3. Section 1.408–2T is removed.
Kevin M. Brown,
Deputy Commissioner for Services and
Enforcement.
Approved:
Eric Solomon,
Assistant Secretary of the Treasury (Tax
Policy).
[FR Doc. E7–11636 Filed 6–15–07; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[COTP San Francisco Bay 07–025]
RIN 1625–AA00
Safety Zone; BART Transbay Tube
Seismic Upgrade; San Francisco, CA
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
SUMMARY: The Coast Guard is
establishing a moving temporary safety
zone in the navigable waters of San
Francisco Bay, California, during
geotechnical borings for a seismic
upgrade of the Bay Area Rapid Transit
(BART) Transbay tube. The borings will
require placement of a drilling vessel at
test sites along the BART Transbay tube.
The safety zone will surround the vessel
and move with the vessel as it conducts
the tests at eighteen sites along the
BART Transbay tube. This safety zone is
necessary to protect persons and vessels
from hazards, injury, and damage
associated with the geotechnical
borings. Unauthorized persons or
vessels are prohibited from entering
into, transiting through, or remaining in
the safety zone without permission of
the Captain of the Port or his designated
representative.
DATES: This rule is effective from May
30, 2007 through June 25, 2007.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket COTP San
Francisco Bay 07–025 and are available
for inspection or copying at the
Waterways Safety Branch of Sector San
Francisco, Yerba Buena Island, Bldg.
278, San Francisco, California 94130,
between 9 a.m. and 4 p.m., Monday
through Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT:
Ensign Erin Bastick, U.S. Coast Guard
E:\FR\FM\18JNR1.SGM
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Agencies
[Federal Register Volume 72, Number 116 (Monday, June 18, 2007)]
[Rules and Regulations]
[Pages 33387-33388]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11636]
=======================================================================
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9331]
RIN 1545-BG46
Deemed IRAs in Governmental Plans/Qualified Nonbank Trustee Rules
AGENCY: Internal Revenue Service (IRS), Treasury.
ACTION: Final regulations and removal of temporary regulations.
-----------------------------------------------------------------------
SUMMARY: This document contains final regulations under section 408 of
the Internal Revenue Code. The final regulations provide special rules
for a governmental unit which seeks to qualify as a nonbank trustee of
a deemed IRA that is part of its qualified employer plan. These final
regulations affect only such governmental units.
DATES: Effective Date: June 18, 2007.
Applicability Date: For dates of applicability, see Sec. 1.408-
2(e)(8)(iv).
FOR FURTHER INFORMATION CONTACT: Linda L. Conway, 202-622-6090, or
Cathy A. Vohs, 202-622-6090 (not toll-free numbers).
SUPPLEMENTARY INFORMATION:
Background
This document contains final amendments to the Income Tax
Regulations (26 CFR Part 1) under section 408 of the Internal Revenue
Code of 1986 (Code). On July 22, 2004, temporary and proposed
regulations under section 408 were issued. A notice of proposed
rulemaking (REG-101447-04) was published in the Federal Register (69 FR
43786). The text of the temporary regulations also served as the text
of the proposed regulations. The text of temporary Sec. 1.408-2(e)(8)
was published in the same issue of the Federal Register (69 FR 43735).
The RIN published in connection with that notice of proposed rulemaking
was 1545-BD07. However, due to technical difficulties that RIN is no
longer valid and the RIN number of these final regulations is 1545-
BG46. No comments were received regarding the proposed regulations.
Explanation of Provisions and Summary of Comments
These final regulations amend Sec. 1.408-2(e) of the regulations
to provide that a governmental unit may serve as the trustee of any
deemed IRA established by that governmental unit as part of its
qualified employer plan if that governmental unit establishes to the
[[Page 33388]]
satisfaction of the Commissioner that the manner in which it will
administer the deemed IRA will be consistent with the requirements of
section 408. These final regulations also provide special rules
regarding the application of Sec. 1.408-2(e) to governmental units.
These final regulations are adopted without substantive change from the
proposed and temporary regulations. These final regulations are
applicable for written applications made on or after June 18, 2007. The
rules in this section also may be relied on for applications submitted
on or after August 1, 2003 (or such earlier application as the
Commissioner deems appropriate) and before June 18, 2007.
Special Analyses
It has been determined that this Treasury Decision is not a
significant regulatory action as defined in Executive Order 12866.
Therefore, a regulatory assessment is not required. It also has been
determined that section 553(b) of the Administrative Procedure Act (5
U.S.C. chapter 5) does not apply to these regulations, and, because the
regulation does not impose a collection of information on small
entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not
apply. Pursuant to section 7805(f) of the Code, the notice of proposed
rulemaking preceding these final regulations was submitted to the Chief
Counsel for Advocacy of the Small Business Administration for comment
on its impact on small business.
Drafting Information
The principal author of these regulations is Linda L. Conway of the
Office of the Division Counsel/Associate Chief Counsel (Tax Exempt and
Government Entities). However, other personnel from the IRS and
Treasury Department participated in the development of these
regulations.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and recordkeeping requirements.
Adoption of Amendments to the Regulations
0
Accordingly, 26 CFR part 1 is amended as follows:
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 * * *
0
Par. 2. Section 1.408-2(e)(8) is revised to read as follows:
Sec. 1.408-2 Individual retirement accounts.
* * * * *
(e) * * *
(8) Special rules for governmental units--(i) In general. A
governmental unit that seeks to qualify as a nonbank trustee of a
deemed IRA that is part of its qualified employer plan must demonstrate
to the satisfaction of the Commissioner that it is able to administer
the trust in a manner that is consistent with the requirements of
section 408. The demonstration must be made by written application to
the Commissioner. Notwithstanding the requirement of paragraph (e)(1)
of this section that a person must demonstrate by written application
that the requirements of paragraphs (e)(2) through (e)(6) of this
section will be met in order to qualify as a nonbank trustee, a
governmental unit that maintains a plan qualified under section 401(a),
403(a), 403(b) or 457 need not demonstrate that all of these
requirements will be met with respect to any individual retirement
accounts maintained by that governmental unit pursuant to section
408(q). For example, a governmental unit need not demonstrate that it
satisfies the net worth requirements of paragraph (e)(3)(ii) of this
section if it demonstrates instead that it possesses taxing authority
under applicable law. The Commissioner, in his discretion, may exempt a
governmental unit from certain other requirements upon a showing that
the governmental unit is able to administer the deemed IRAs in the best
interest of the participants. Moreover, in determining whether a
governmental unit satisfies the other requirements of paragraphs (e)(2)
through (e)(6) of this section, the Commissioner may apply the
requirements in a manner that is consistent with the applicant's status
as a governmental unit.
(ii) Governmental unit. For purposes of this special rule, the term
governmental unit means a state, political subdivision of a state, and
any agency or instrumentality of a state or political subdivision of a
state.
(iii) Additional rules. The Commissioner may in revenue rulings,
notices, or other guidance of general applicability provide additional
rules for governmental units seeking approval as nonbank trustees.
(iv) Effective/applicability date. This section is applicable for
written applications made on or after June 18, 2007. The rules in this
section also may be relied on for applications submitted on or after
August 1, 2003 (or such earlier application as the Commissioner deems
appropriate) and before June 18, 2007.
Sec. 1.408-2T [Removed]
0
Par. 3. Section 1.408-2T is removed.
Kevin M. Brown,
Deputy Commissioner for Services and Enforcement.
Approved:
Eric Solomon,
Assistant Secretary of the Treasury (Tax Policy).
[FR Doc. E7-11636 Filed 6-15-07; 8:45 am]
BILLING CODE 4830-01-P