Prohibition Against Conflicts of Interest in Certain Securitizations, 24-25 [2011-33614]
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24
Federal Register / Vol. 77, No. 1 / Tuesday, January 3, 2012 / Proposed Rules
rulemaking among the responsible
agencies as provided in section 619 of
the Dodd-Frank Act. Therefore, the
Agencies are extending the comment
period for the proposed rule from
January 13, 2012 to February 13, 2012.
Dated: December 22, 2011.
John Walsh,
Acting Comptroller of the Currency.
Electronic Comments
By order of the Board of Governors of the
Federal Reserve System, acting through the
Secretary under delegated authority,
December 23, 2011.
Jennifer J. Johnson,
Secretary of the Board.
By delegated authority from the Board of
Directors of the Federal Deposit Insurance
Corporation.
Federal Deposit Insurance Corporation.
Robert E. Feldman,
Executive Secretary.
By the Securities and Exchange
Commission.
Dated: December 23, 2011.
Kevin M. O’Neill,
Deputy Secretary.
[FR Doc. 2011–33623 Filed 12–30–11; 8:45 am]
BILLING CODE 4810–33–P; 6714–10–P; 6210–01–P
SECURITIES AND EXCHANGE
COMMISSION
17 CFR Part 230
[Release No. 34–66058; File No. S7–38–11]
RIN 3235–AL04
Prohibition Against Conflicts of
Interest in Certain Securitizations
Securities and Exchange
Commission.
ACTION: Proposed rule; extension of
comment period.
AGENCY:
The Securities and Exchange
Commission is extending the comment
period for a release proposing a new
rule to implement Section 621 of the
Dodd-Frank Wall Street Reform and
Consumer Protection Act of 2010 (the
‘‘Dodd-Frank Act’’) on material conflicts
of interest in connection with certain
securitizations (the ‘‘ABS Conflicts
Proposal’’). The original comment
period for the ABS Conflicts Proposal
was scheduled to end on December 19,
2011. On December 13, 2011, the
comment period was extended until
January 13, 2012. Today, the
Commission is again extending the time
period in which to provide the
Commission with comments on the ABS
Conflicts Proposal until February 13,
2012. This action will allow interested
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persons additional time to analyze the
issues and prepare their comments.
DATES: Comments should be received on
or before February 13, 2012.
ADDRESSES: Comments may be
submitted by any of the following
methods:
Use the Commission’s Internet
comment form (https://www.sec.gov/
rules/proposed.shtml);
• Send an email to rulecomments@sec.gov. Please include File
Number S7–38–11 on the subject line;
or
• Use the Federal Rulemaking Portal
(https://www.regulations.gov). Follow the
instructions for submitting comments.
Paper Comments
• Send paper comments in triplicate
to Elizabeth M. Murphy, Secretary,
Securities and Exchange Commission,
100 F Street NE., Washington, DC
20549–1090.
All submissions should refer to File
Number S7–38–11. This file number
should be included on the subject line
if email is used. To help us process and
review your comments more efficiently,
please use only one method. The
Commission will post all comments on
the Commission’s Internet Web site
(https://www.sec.gov/rules/
proposed.shtml). Comments are also
available for Web site viewing and
printing in the Commission’s Public
Reference Room, 100 F Street NE.,
Washington, DC 20549, on official
business days between the hours of
10 a.m. and 3 p.m. All comments
received will be posted without change;
we do not edit personal identifying
information from submissions. You
should submit only information that
you wish to make available publicly.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Sandoe, Senior Special
Counsel, Anthony Kelly, Special
Counsel, or Barry O’Connell, Attorney
Advisor, Office of Trading Practices,
Division of Trading and Markets, at
(202) 551–5720, and David Beaning,
Special Counsel and Katherine Hsu,
Chief, Office of Structured Finance,
Division of Corporation Finance, at
(202) 551–3850.
SUPPLEMENTARY INFORMATION: The
Commission has requested comment on
Proposed Rule 127B under the
Securities Act of 1933 (‘‘Securities Act’’)
in the ABS Conflicts Proposal to
implement Section 621 of the DoddFrank Act.1 Proposed Rule 127B under
the Securities Act would prohibit
certain persons who create and
distribute an asset-backed security,
including a synthetic asset-backed
security, from engaging in transactions,
within one year after the date of the first
closing of the sale of the asset-backed
security, that would involve or result in
a material conflict of interest with
respect to any investor in the assetbacked security. The proposed rule also
would provide exceptions from this
prohibition for certain risk-mitigating
hedging activities, liquidity
commitments, and bona fide marketmaking. The ABS Conflicts Proposal
was published in the Federal Register
on September 28, 2011.
The Commission originally requested
that comments on the ABS Conflicts
Proposal be received by December 19,
2011, including comment about any
potential interplay 2 between Proposed
Rule 127B and the ‘‘Volcker Rule
Proposal.’’ 3 The Volcker Rule Proposal
would implement Section 619 of the
Dodd-Frank Act concerning
prohibitions and restrictions on
proprietary trading and certain interests
in, and relationships with, hedge funds
and private equity funds. The original
comment period for the Volcker Rule
Proposal was scheduled to end on
January 13, 2012.
On December 13, 2011, the
Commission extended the ABS Conflicts
Proposal comment period from
December 19, 2011 to January 13, 2012
to coincide with the end of the comment
period for the Volcker Rule Proposal.
The Commission extended the Volcker
Rule Proposal comment period until
February 13, 2012.4 In an effort to
provide the public with a better
opportunity to consider any potential
interplay between the ABS Conflicts
and Volcker Rule Proposals, the
Commission is also extending the ABS
Conflicts Proposal comment period
until February 13, 2012.
The Commission has determined to
provide the public additional time to
consider simultaneously the ABS
Conflicts and the Volcker Rule
Proposals. This extended opportunity to
submit comprehensive comments
regarding the ABS Conflicts Proposal
and any potential interplay with the
Volcker Rule Proposal would benefit the
Commission in its consideration of any
final rules. Therefore, the Commission
is again extending the comment period
for the ABS Conflicts Proposal until
February 13, 2012 to coincide with the
2 See,
e.g., 76 FR 60320, 60341.
Act Release No. 34–65545 (October
12, 2011), 76 FR 68846 (November 7, 2011).
4 Exchange Act Release No. 34–66057.
3 Exchange
1 Exchange Act Release No. 34–65355 (September
19, 2011), 76 FR 60320 (September 28, 2011).
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Federal Register / Vol. 77, No. 1 / Tuesday, January 3, 2012 / Proposed Rules
end of the Volcker Rule Proposal
comment period.
Reduction Act of 1995’’ section of this
document).
By the Commission.
Dated: December 23, 2011.
Kevin M. O’Neill,
Deputy Secretary.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
[FR Doc. 2011–33614 Filed 12–30–11; 8:45 am]
BILLING CODE 8011–01–P
Written Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 10
[Docket No. FDA–2011–N–0697]
Amendments to Regulations on Citizen
Petitions, Petitions for Stay of Action,
and Submission of Documents to
Dockets
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA) is proposing to
amend certain regulations relating to
citizen petitions, petitions for stay of
action, and the submission of
documents to the Agency. In particular,
the proposed rule would establish new
regulations to implement certain
provisions of the Federal Food, Drug,
and Cosmetic Act (FD&C Act), which
concern certain citizen petitions and
petitions for stay of action (PSAs) that
involve a request for FDA to take any
form of action relating to a pending
abbreviated new drug application
(ANDA) or 505(b)(2) application. We are
making these changes to implement
provisions of the Food and Drug
Administration Amendments Act of
2007 (FDAAA).
DATES: Submit either electronic or
written comments by April 2, 2012.
Submit comments on information
collection issues under the Paperwork
Reduction Act of 1995 by February 2,
2012, (see section ‘‘VI. Paperwork
Reduction Act of 1995’’ of this
document). See section II.E of this
document for the proposed effective
date of a final rule based on this
proposed rule.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2011–N–
0697, by any of the following methods;
except that comments on information
collection issues under the Paperwork
Reduction Act of 1995 must be
submitted to the Office of Regulatory
Affairs, Office of Management and
Budget (OMB) (see the ‘‘Paperwork
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Submit written submissions in the
following ways:
• FAX: (301) 827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2011–N–0697 for this
rulemaking. All comments received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number(s), found in brackets in
the heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Nicole Mueller, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6312,
Silver Spring, MD 20993–0002, (301)
796–3601.
SUPPLEMENTARY INFORMATION:
I. Background
A. Enactment of Section 505(q)
On September 27, 2007, Congress
enacted FDAAA (Pub. L. 110–85).
Section 914 of title IX of FDAAA added
new section 505(q) to the FD&C Act (21
U.S.C. 355(q)). Section 505(q) applies to
certain citizen petitions and PSAs
(collectively referred to as petitions) that
request FDA to take any form of action
related to a pending application
submitted under section 505(b)(2) or (j)
of the FD&C Act (21 U.S.C. 355(b)(2) or
(j)). An application submitted under
section 505(b)(2) of the FD&C Act is a
type of new drug application (NDA)
described in that subsection and is
referred to in this document as a
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25
‘‘505(b)(2) application.’’ An application
submitted under section 505(j) is an
ANDA for a generic drug product.
Section 505(q) governs the manner in
which FDA handles certain citizen
petitions and PSAs that ask the Agency
to take any form of action related to
pending 505(b)(2) applications or
ANDAs. Over the years, FDA has
received numerous petitions asking the
Agency not to approve a particular
ANDA or 505(b)(2) application (or
classes of these applications concerning
a particular drug product or active
ingredient) unless certain criteria set
forth in the petition are met. In many
cases, the petitions have raised
scientific and/or legal issues relating to
the standards for approval of an
application. Examples include: Petitions
suggesting a particular method for
determining the bioequivalence of a
proposed generic product to the
reference listed drug (RLD) and
petitions maintaining that a proposed
generic product does not contain the
same active ingredient as the RLD.
When submitted early, such as when we
are making decisions about the
bioequivalence requirements for a
generic drug product or before we have
received the first ANDA or 505(b)(2)
application for a drug product, a
petition containing material information
can assist us in establishing standards
for these applications. However, when
petitions are submitted late in the
review process for challenged
applications and do not raise valid
scientific and/or legal issues, they may
have the effect of improperly delaying
the approval of an application. By
enacting section 505(q), Congress
indicated a desire to ensure that
petitions not be used to improperly
delay approval of ANDAs and 505(b)(2)
applications.
B. Provisions of Section 505(q) of the
FD&C Act
Section 505(q)(1)(A) of the FD&C Act
specifies that FDA must not delay
approval of a pending ANDA or
505(b)(2) application because of any
request to take any form of action
relating to the application, unless the
request is in writing and in a citizen
petition submitted under § 10.30 (21
CFR 10.30) or a PSA submitted under
§ 10.35 (21 CFR 10.35), and the Agency
determines, upon reviewing the
petition, that a delay is necessary to
protect the public health.
Section 505(q)(1)(F) of the FD&C Act
governs the timeframe for final Agency
action on a petition. Under this
provision, FDA must take final Agency
action on a petition not later than 180
days after the date on which the petition
E:\FR\FM\03JAP1.SGM
03JAP1
Agencies
[Federal Register Volume 77, Number 1 (Tuesday, January 3, 2012)]
[Proposed Rules]
[Pages 24-25]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33614]
=======================================================================
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SECURITIES AND EXCHANGE COMMISSION
17 CFR Part 230
[Release No. 34-66058; File No. S7-38-11]
RIN 3235-AL04
Prohibition Against Conflicts of Interest in Certain
Securitizations
AGENCY: Securities and Exchange Commission.
ACTION: Proposed rule; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Securities and Exchange Commission is extending the
comment period for a release proposing a new rule to implement Section
621 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of
2010 (the ``Dodd-Frank Act'') on material conflicts of interest in
connection with certain securitizations (the ``ABS Conflicts
Proposal''). The original comment period for the ABS Conflicts Proposal
was scheduled to end on December 19, 2011. On December 13, 2011, the
comment period was extended until January 13, 2012. Today, the
Commission is again extending the time period in which to provide the
Commission with comments on the ABS Conflicts Proposal until February
13, 2012. This action will allow interested persons additional time to
analyze the issues and prepare their comments.
DATES: Comments should be received on or before February 13, 2012.
ADDRESSES: Comments may be submitted by any of the following methods:
Electronic Comments
Use the Commission's Internet comment form (https://www.sec.gov/rules/proposed.shtml);
Send an email to rule-comments@sec.gov. Please include
File Number S7-38-11 on the subject line; or
Use the Federal Rulemaking Portal (https://www.regulations.gov). Follow the instructions for submitting comments.
Paper Comments
Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.
All submissions should refer to File Number S7-38-11. This file number
should be included on the subject line if email is used. To help us
process and review your comments more efficiently, please use only one
method. The Commission will post all comments on the Commission's
Internet Web site (https://www.sec.gov/rules/proposed.shtml). Comments
are also available for Web site viewing and printing in the
Commission's Public Reference Room, 100 F Street NE., Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. All comments received will be posted without change; we do not
edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly.
FOR FURTHER INFORMATION CONTACT: Elizabeth Sandoe, Senior Special
Counsel, Anthony Kelly, Special Counsel, or Barry O'Connell, Attorney
Advisor, Office of Trading Practices, Division of Trading and Markets,
at (202) 551-5720, and David Beaning, Special Counsel and Katherine
Hsu, Chief, Office of Structured Finance, Division of Corporation
Finance, at (202) 551-3850.
SUPPLEMENTARY INFORMATION: The Commission has requested comment on
Proposed Rule 127B under the Securities Act of 1933 (``Securities
Act'') in the ABS Conflicts Proposal to implement Section 621 of the
Dodd-Frank Act.\1\ Proposed Rule 127B under the Securities Act would
prohibit certain persons who create and distribute an asset-backed
security, including a synthetic asset-backed security, from engaging in
transactions, within one year after the date of the first closing of
the sale of the asset-backed security, that would involve or result in
a material conflict of interest with respect to any investor in the
asset-backed security. The proposed rule also would provide exceptions
from this prohibition for certain risk-mitigating hedging activities,
liquidity commitments, and bona fide market-making. The ABS Conflicts
Proposal was published in the Federal Register on September 28, 2011.
---------------------------------------------------------------------------
\1\ Exchange Act Release No. 34-65355 (September 19, 2011), 76
FR 60320 (September 28, 2011).
---------------------------------------------------------------------------
The Commission originally requested that comments on the ABS
Conflicts Proposal be received by December 19, 2011, including comment
about any potential interplay \2\ between Proposed Rule 127B and the
``Volcker Rule Proposal.'' \3\ The Volcker Rule Proposal would
implement Section 619 of the Dodd-Frank Act concerning prohibitions and
restrictions on proprietary trading and certain interests in, and
relationships with, hedge funds and private equity funds. The original
comment period for the Volcker Rule Proposal was scheduled to end on
January 13, 2012.
---------------------------------------------------------------------------
\2\ See, e.g., 76 FR 60320, 60341.
\3\ Exchange Act Release No. 34-65545 (October 12, 2011), 76 FR
68846 (November 7, 2011).
---------------------------------------------------------------------------
On December 13, 2011, the Commission extended the ABS Conflicts
Proposal comment period from December 19, 2011 to January 13, 2012 to
coincide with the end of the comment period for the Volcker Rule
Proposal. The Commission extended the Volcker Rule Proposal comment
period until February 13, 2012.\4\ In an effort to provide the public
with a better opportunity to consider any potential interplay between
the ABS Conflicts and Volcker Rule Proposals, the Commission is also
extending the ABS Conflicts Proposal comment period until February 13,
2012.
---------------------------------------------------------------------------
\4\ Exchange Act Release No. 34-66057.
---------------------------------------------------------------------------
The Commission has determined to provide the public additional time
to consider simultaneously the ABS Conflicts and the Volcker Rule
Proposals. This extended opportunity to submit comprehensive comments
regarding the ABS Conflicts Proposal and any potential interplay with
the Volcker Rule Proposal would benefit the Commission in its
consideration of any final rules. Therefore, the Commission is again
extending the comment period for the ABS Conflicts Proposal until
February 13, 2012 to coincide with the
[[Page 25]]
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end of the Volcker Rule Proposal comment period.
By the Commission.
Dated: December 23, 2011.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-33614 Filed 12-30-11; 8:45 am]
BILLING CODE 8011-01-P