Extension of Withholding to Certain Payments Made by Government Entities; Correction, 32864-32865 [2011-13932]
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Federal Register / Vol. 76, No. 109 / Tuesday, June 7, 2011 / Rules and Regulations
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Stephanie Shapley, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6323,
Silver Spring, MD 20993–0002, 301–
796–4836; or Laura Rich, Center for
Biologics Evaluation and Research
(HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6210.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a guidance for industry and
investigators entitled ‘‘Enforcement of
Safety Reporting Requirements for INDs
and BA/BE Studies.’’ This guidance is
being issued consistent with FDA’s good
guidance practices (GGPs) regulation
(§ 10.115 (21 CFR 10.115)). The
guidance provides that the Agency
intends to grant a 6-month period of
enforcement discretion relating to the
new reporting requirements (described
in this document) that became effective
on March 28, 2011. Accordingly, this
guidance is being implemented without
prior public comment because the
Agency has determined that prior public
participation is not feasible or
appropriate (§ 10.115(g)(2)). The Agency
made this determination because the
guidance deals with a short-term and
highly time-sensitive issue. Although
this guidance document is immediately
in effect, it remains subject to comment
in accordance with the Agency’s GGPs
regulation.
On September 29, 2010, FDA
published a final rule ‘‘Investigational
New Drug Safety Reporting
Requirements for Human Drug and
Biological Products and Safety
Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans’’ (75 FR 59935) and
issued related draft guidance ‘‘Safety
Reporting Requirements for INDs and
BA/BE Studies’’ (75 FR 60129, Docket
No. FDA–2010–D–0482). The final rule
amended the investigational new drug
safety reporting requirements under part
312 (21 CFR part 312) and added safety
reporting requirements for persons
conducting bioavailability and
bioequivalence studies under part 320
(21 CFR part 320). The effective date for
the final rule was March 28, 2011. In
comments to the docket, and in other
communications to the Agency placed
in the docket, stakeholders have
requested an extension to the effective
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15:11 Jun 06, 2011
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date of the final rule because of the need
for significant internal process changes
in order to meet the new requirements.
Specifically, the comments indicated
that sponsors needed additional time to
implement changes to their internal
procedures to comply with the new
reporting requirements. The Agency
acknowledges these concerns and
intends to exercise enforcement
discretion regarding the reporting
requirements in the final rule until
September 28, 2011. During this period
of time, FDA does not intend to take
enforcement action if sponsors and
investigators report in compliance with
the reporting requirements under
§§ 312.32, 312.64, and 320.31 that were
in effect prior to March 28, 2011.
The guidance represents the Agency’s
current thinking on enforcement of
safety reporting requirements for
investigational new drug applications
and bioavailability/bioequivalence
studies. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/default.htm, or
https://www.regulations.gov. Always
access an FDA guidance document by
using FDA’s Web site listed previously
to find the most current version of the
guidance.
Dated: June 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13950 Filed 6–6–11; 8:45 am]
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 31
[TD 9524]
RIN 1545–BG45
Extension of Withholding to Certain
Payments Made by Government
Entities; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correction to final regulations.
AGENCY:
This document describes
corrections to final regulations (TD
9524) that were published in the
Federal Register on Monday, May 9,
2011 (76 FR 26583) relating to
withholding by government entities.
These regulations reflect changes in the
law made by the Tax Increase
Prevention and Reconciliation act of
2005 that require Federal, State, and
local government entities to withhold
income tax when making payments to
persons providing property or services.
These regulations affect Federal, State,
and local government entities that will
be required to withhold and report tax
from payments to persons providing
property or services and also affect the
person receiving payments for property
or services from the government
entities.
SUMMARY:
This correction is effective on
June 7, 2011, and is applicable on May
9, 2011.
FOR FURTHER INFORMATION CONTACT: A.
G. Kelley, (202) 622–6040 (not a toll-free
number).
SUPPLEMENTARY INFORMATION:
DATES:
Background
The final regulations that are the
subject of this correction are under
sections 3402(t), 3406(g), 6011(a), 6051,
6071(a), and 6302 of the Internal
Revenue Code.
Need for Correction
As published, final regulations (TD
9524) contain errors that may prove to
be misleading and are in need of
clarification.
Correction of Publication
Accordingly, the publication of the
final regulations (TD 9524) which were
the subject of FR Doc. 2011–10760 is
corrected as follows:
1. On page 26584, column 1, in the
preamble, under the paragraph heading
‘‘Summary of Comments and
Explanation of Provisions’’, the second
paragraph of the column, line 1, the
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07JNR1
Federal Register / Vol. 76, No. 109 / Tuesday, June 7, 2011 / Rules and Regulations
erowe on DSK5CLS3C1PROD with RULES
language ‘‘As discussed in section IX of
the’’ is corrected to read ‘‘As discussed
in section VIII of the’’.
2. On page 26854, column 1, in the
preamble, under the paragraph heading
‘‘Summary of Comments and
Explanation of Provisions’’, the second
paragraph of the column, line 13, the
language ‘‘materially modified (but see
section IX’’ is corrected to read
‘‘materially modified (but see section
VIII’’.
3. On page 26586, column 2, in the
preamble, under the paragraph heading
‘‘D. Advance and Interim Payments’’,
first paragraph, last line, the language
‘‘IV.E.1 of this preamble).’’ is corrected
to read ‘‘III.E.1 of this preamble).’’.
4. On page 26587, column 2, in the
preamble, the language of the paragraph
heading ‘‘IV. Payments Excepted From
the Section 3402(t) Withholding
Requirements’’ is corrected to read ‘‘III.
Payments Excepted From the Section
3402(t) Withholding Requirements’’.
5. On page 26591, column 1, in the
preamble, the language of the paragraph
heading ‘‘V. Application of Section
3402(t) to Passthrough Entities’’ is
corrected to read ‘‘IV. Application of
Section 3402(t) to Passthrough Entities’’.
6. On page 26591, column 2, in the
preamble, the language of the paragraph
heading ‘‘VI. Deposits and Reporting of
Amounts Withheld Under Section
3402(t)’’ is corrected to read ‘‘V. Deposits
and Reporting of Amounts Withheld
Under Section 3402(t)’’.
7. On page 26591, column 3, in the
preamble, the language of the paragraph
heading ‘‘VII. Crediting of Amounts
Withheld’’ is corrected to read ‘‘VI.
Crediting of Amounts Withheld’’.
8. On page 26592, column 2, in the
preamble, the language of the paragraph
heading ‘‘VIII. Correction of Errors and
Liability of Government Entity’’ is
corrected to read ‘‘VII. Correction of
Errors and Liability of Government
Entity’’.
9. On page 26593, column 2, in the
preamble, the language of the paragraph
heading ‘‘IX. Extension of Applicability
Date and Transition Relief for Existing
Contracts’’ is corrected to read ‘‘VIII.
Extension of Applicability Date and
Transition Relief for Existing Contracts’’.
10. On page 26594, column 1, in the
preamble, the language of the paragraph
heading ‘‘X. Transition Rule for Interest
and Penalties on Underpayments’’ is
corrected to read ’’ IX. Transition Rule
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for Interest and Penalties on
Underpayments’’.
LaNita Van Dyke,
Chief, Publications and Regulations Branch,
Legal Processing Division, Associate Chief
Counsel (Procedure and Administration).
[FR Doc. 2011–13932 Filed 6–6–11; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF DEFENSE
Department of the Navy
32 CFR Part 706
Certifications and Exemptions Under
the International Regulations for
Preventing Collisions at Sea, 1972
Department of the Navy, DoD.
Final rule.
AGENCY:
ACTION:
The Department of the Navy
(DoN) is amending its certifications and
exemptions under the International
Regulations for Preventing Collisions at
Sea, 1972 (72 COLREGS), to reflect that
the Deputy Assistant Judge Advocate
General (DAJAG) (Admiralty and
Maritime Law) has determined that USS
SAN DIEGO (LPD 22) is a vessel of the
Navy which, due to its special
construction and purpose, cannot fully
comply with certain provisions of the 72
COLREGS without interfering with its
special function as a naval ship. The
intended effect of this rule is to warn
mariners in waters where 72 COLREGS
apply.
DATES: This rule is effective June 7, 2011
and is applicable beginning May 18,
2011.
SUMMARY:
comply with the following specific
provisions of 72 COLREGS without
interfering with its special function as a
naval ship: Rule 27 (a)(i) and (b)(i),
pertaining to the placement of all-round
task lights in a vertical line; Annex I,
paragraph 3(a), pertaining to the
horizontal distance between the forward
and after masthead lights; and Annex I,
paragraph 2(k), pertaining to the vertical
separation between anchor lights. The
DAJAG (Admiralty and Maritime Law)
has also certified that the lights
involved are located in closest possible
compliance with the applicable 72
COLREGS requirements.
Moreover, it has been determined, in
accordance with 32 CFR Parts 296 and
701, that publication of this amendment
for public comment prior to adoption is
impracticable, unnecessary, and
contrary to public interest since it is
based on technical findings that the
placement of lights on this vessel in a
manner differently from that prescribed
herein will adversely affect the vessel’s
ability to perform its military functions.
List of Subjects in 32 CFR Part 706
Marine safety, Navigation (water), and
Vessels.
For the reasons set forth in the
preamble, amend part 706 of title 32 of
the CFR as follows:
PART 706—CERTIFICATIONS AND
EXEMPTIONS UNDER THE
INTERNATIONAL REGULATIONS FOR
PREVENTING COLLISIONS AT SEA,
1972
1. The authority citation for part 706
continues to read:
■
Authority: 33 U.S.C. 1605.
FOR FURTHER INFORMATION CONTACT:
Lieutenant Jaewon Choi, JAGC, U.S.
Navy, Admiralty Attorney, (Admiralty
and Maritime Law), Office of the Judge
Advocate General, Department of the
Navy, 1322 Patterson Ave., SE., Suite
3000, Washington Navy Yard, DC
20374–5066, telephone 202–685–5040.
SUPPLEMENTARY INFORMATION: Pursuant
to the authority granted in 33 U.S.C.
1605, the DoN amends 32 CFR part 706.
This amendment provides notice that
the DAJAG (Admiralty and Maritime
Law), under authority delegated by the
Secretary of the Navy, has certified that
USS SAN DIEGO (LPD 22) is a vessel of
the Navy which, due to its special
construction and purpose, cannot fully
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32865
2. Section 706.2 is amended as
follows:
■ A. In Table Three by adding, in alpha
numerical order, by vessel number, an
entry for USS SAN DIEGO (LPD 22); and
■ B. In Table Four, under paragraph 20,
add, in alpha numerical order, by vessel
number, and entry for USS SAN DIEGO
(LPD 22); and
■ C. In Table Five by adding, in alpha
numerical order, by vessel number, and
entry for USS SAN DIEGO (LPD 22).
■
§ 706.2 Certifications of the Secretary of
the Navy under Executive Order 11964 and
33 U.S.C. 1605.
*
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Agencies
[Federal Register Volume 76, Number 109 (Tuesday, June 7, 2011)]
[Rules and Regulations]
[Pages 32864-32865]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13932]
=======================================================================
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 31
[TD 9524]
RIN 1545-BG45
Extension of Withholding to Certain Payments Made by Government
Entities; Correction
AGENCY: Internal Revenue Service (IRS), Treasury.
ACTION: Correction to final regulations.
-----------------------------------------------------------------------
SUMMARY: This document describes corrections to final regulations (TD
9524) that were published in the Federal Register on Monday, May 9,
2011 (76 FR 26583) relating to withholding by government entities.
These regulations reflect changes in the law made by the Tax Increase
Prevention and Reconciliation act of 2005 that require Federal, State,
and local government entities to withhold income tax when making
payments to persons providing property or services. These regulations
affect Federal, State, and local government entities that will be
required to withhold and report tax from payments to persons providing
property or services and also affect the person receiving payments for
property or services from the government entities.
DATES: This correction is effective on June 7, 2011, and is applicable
on May 9, 2011.
FOR FURTHER INFORMATION CONTACT: A. G. Kelley, (202) 622-6040 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
Background
The final regulations that are the subject of this correction are
under sections 3402(t), 3406(g), 6011(a), 6051, 6071(a), and 6302 of
the Internal Revenue Code.
Need for Correction
As published, final regulations (TD 9524) contain errors that may
prove to be misleading and are in need of clarification.
Correction of Publication
Accordingly, the publication of the final regulations (TD 9524)
which were the subject of FR Doc. 2011-10760 is corrected as follows:
1. On page 26584, column 1, in the preamble, under the paragraph
heading ``Summary of Comments and Explanation of Provisions'', the
second paragraph of the column, line 1, the
[[Page 32865]]
language ``As discussed in section IX of the'' is corrected to read
``As discussed in section VIII of the''.
2. On page 26854, column 1, in the preamble, under the paragraph
heading ``Summary of Comments and Explanation of Provisions'', the
second paragraph of the column, line 13, the language ``materially
modified (but see section IX'' is corrected to read ``materially
modified (but see section VIII''.
3. On page 26586, column 2, in the preamble, under the paragraph
heading ``D. Advance and Interim Payments'', first paragraph, last
line, the language ``IV.E.1 of this preamble).'' is corrected to read
``III.E.1 of this preamble).''.
4. On page 26587, column 2, in the preamble, the language of the
paragraph heading ``IV. Payments Excepted From the Section 3402(t)
Withholding Requirements'' is corrected to read ``III. Payments
Excepted From the Section 3402(t) Withholding Requirements''.
5. On page 26591, column 1, in the preamble, the language of the
paragraph heading ``V. Application of Section 3402(t) to Passthrough
Entities'' is corrected to read ``IV. Application of Section 3402(t) to
Passthrough Entities''.
6. On page 26591, column 2, in the preamble, the language of the
paragraph heading ``VI. Deposits and Reporting of Amounts Withheld
Under Section 3402(t)'' is corrected to read ``V. Deposits and
Reporting of Amounts Withheld Under Section 3402(t)''.
7. On page 26591, column 3, in the preamble, the language of the
paragraph heading ``VII. Crediting of Amounts Withheld'' is corrected
to read ``VI. Crediting of Amounts Withheld''.
8. On page 26592, column 2, in the preamble, the language of the
paragraph heading ``VIII. Correction of Errors and Liability of
Government Entity'' is corrected to read ``VII. Correction of Errors
and Liability of Government Entity''.
9. On page 26593, column 2, in the preamble, the language of the
paragraph heading ``IX. Extension of Applicability Date and Transition
Relief for Existing Contracts'' is corrected to read ``VIII. Extension
of Applicability Date and Transition Relief for Existing Contracts''.
10. On page 26594, column 1, in the preamble, the language of the
paragraph heading ``X. Transition Rule for Interest and Penalties on
Underpayments'' is corrected to read '' IX. Transition Rule for
Interest and Penalties on Underpayments''.
LaNita Van Dyke,
Chief, Publications and Regulations Branch, Legal Processing Division,
Associate Chief Counsel (Procedure and Administration).
[FR Doc. 2011-13932 Filed 6-6-11; 8:45 am]
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