[Federal Register Volume 76, Number 176 (Monday, September 12, 2011)]
[Notices]
[Pages 56201-56205]
[FR Doc No: 2011-23251]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0128]

Prescription Drug User Fee Act; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to discuss proposed recommendations for the reauthorization of
the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to
collect user fees and use them for the process for the review of human
drug applications for fiscal years (FYs) 2013 through 2017. The
legislative authority for PDUFA expires in September 2012. At that
time, new legislation will be required for FDA to collect prescription
drug user fees for future fiscal years. Following discussions with the
regulated industry and periodic consultations with public stakeholders,
the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to
publish the recommendations for the reauthorized program in the Federal
Register, hold a meeting at which the public may present its views on
such recommendations, and provide for a period of 30 days for the
public to provide written comments on such recommendations. FDA will
then consider such public views and comments and revise such
recommendations as necessary.

DATES: The public meeting will be held on October 24, 2011, from 9 a.m.
to 5 p.m. Registration to attend the meeting must be received by
October 10, 2011. See section IV.B of this document for information on
how to register for the meeting. Submit either electronic or written
comments by October 24, 2011.

ADDRESSES: The meeting will be held at FDA's White Oak Campus, 10903
New Hampshire Ave., Bldg. 31, Rm. 1503, Silver Spring, MD, 20993.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.
    Transcripts of the meeting will be available for review at the
Division of Dockets Management and on the Internet at http://www.regulations.gov approximately 30 days after the public meeting (see
section IV.C of this document).

FOR FURTHER INFORMATION CONTACT: Sunanda Bahl, Food and Drug
Administration, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1168, Silver Spring, MD 20993, 301-796-
3584, fax:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is announcing a public meeting to discuss proposed
recommendations for the reauthorization of the Prescription Drug User
Fee Act (PDUFA), which authorizes FDA to collect user fees and use them
for the process of the review of human drug applications for FYs 2013
through 2017. Without new legislation, FDA will no longer be able to
collect user fees for future fiscal years to fund the human drug review
process. Section 736B(d)(4) (21 U.S.C. 379h-2(d)(4)) of the FD&C Act
requires that after FDA holds negotiations with regulated industry and
periodic consultations with stakeholders, we do the following: (1)
Present recommendations to congressional committees, (2) publish
recommendations in the Federal Register, (3) provide a period of 30
days for the public to provide written comments on the recommendations,
(4) hold a meeting at which the public may present its views, and (5)
after consideration of public views and comments, revise the
recommendations as necessary.
    This notice, the 30-day comment period, and the public meeting will
satisfy some of these requirements. After the public meeting, we will
revise the recommendations as necessary and present our proposed
recommendations to the congressional committees.
    The purpose of the meeting is to hear the public's views on the
proposed recommendations for the reauthorized program (PDUFA V). The
following information is provided to help potential meeting
participants better understand the history and evolution of the PDUFA
program and the current status of the proposed PDUFA V recommendations.

II. The PDUFA Program

A. What is PDUFA? What does it do?

    FDA considers the timely review of the safety and effectiveness of
new drug applications (NDAs) and biologics license applications (BLAs)
to be central to the Agency's mission to protect and promote the public
health. Prior to enactment of PDUFA in 1992, FDA's drug review process
was not very predictable and was relatively slow compared to other
countries. As a result of concerns expressed by both industry and
patients, Congress enacted PDUFA, which provided the added funds
through user fees that enabled FDA to hire additional reviewers and
support staff and upgrade its information technology systems. At the
same time, FDA committed to complete reviews in a predictable
timeframe. These changes revolutionized the drug approval process in
the United States and enabled FDA to speed the application review
process for new drugs and biologics without compromising the Agency's
high standards for demonstration of safety, efficacy, and quality of
new drugs prior to approval.

B. PDUFA Achievements

    PDUFA has produced significant benefits for public health,
providing patients faster access to over 1,500 new drugs and biologics
since enactment in 1992, including treatments for cancer, infectious
diseases, neurological and psychiatric disorders, and cardiovascular
diseases. The United States now leads the world in the first
introduction of new active drug substances.\1\ Since PDUFA was enacted,
the median approval time of original NDAs and BLAs has been reduced by
about 50 percent for standard applications (25.6 months in FY 1992
versus 13 months in FY 2009) and 55 percent for priority applications
(19.9 months in FY 1992 versus 9 months in 2009).
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    \1\ Scrip NCE Review/Scrip Yearbook/Scrip Magazine (1982-2005),
PharmaProjects R&D Annual Review (2006-2009).
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    Increased resources provided by user fees have also enabled FDA to
provide a large body of technical guidance to industry that has
clarified the drug development pathway for many diseases. These
resources have also enhanced FDA's ability to meet with companies
during drug development to

provide critical advice on specific development programs. In the past 5
years alone, FDA has held over 7,000 meetings within a short time after
a sponsor's request. Innovations in drug development are being advanced
by many new companies as well as more established ones, and new
sponsors may need, and often seek, more regulatory guidance during
development. In FY 2009, more than half of the meetings FDA held with
companies at the early investigational stage and midway through the
clinical trial process were with companies that had no approved product
on the U.S. market.
1. Application Review
    PDUFA provides FDA with a source of stable, consistent funding that
has made possible our efforts to focus on promoting innovative
therapies and help bring to market critical products for patients. As
part of the PDUFA agreement, FDA agrees to certain review performance
goals, such as reviewing and acting on standard applications within 10
months and on priority applications within 6 months. Priority
application reviews are for drugs that generally represent advances in
public health, often targeted at severe illnesses where few or no
therapeutic options exist.
    PDUFA funds help support the use of existing mechanisms in place to
expedite the approval of certain promising investigational drugs and
also to make them available to the very ill as early in the development
process as possible, without unduly jeopardizing the patients' safety.
    One such program is the accelerated approval process, instituted by
FDA in 1992. Accelerated approval allows earlier approval of drugs that
treat serious diseases and that fill an unmet medical need. One pathway
for accelerated approval is based on a surrogate endpoint--a marker
used as substitute measurement to represent a clinically meaningful
outcome, such as survival or symptom improvement--that is reasonably
likely to predict clinical benefit; the other pathway bases approval on
a clinical endpoint other than survival or irreversible morbidity. This
program allows drugs to be approved before measures of effectiveness
that would normally be required for approval are available. In these
cases, approval is given on the condition that postmarketing clinical
trials verify the anticipated clinical benefit. Over 100 critical
products, including most HIV therapies and many cancer treatments, have
been approved under accelerated approval since the program was
established.
2. Drug Safety
    In parallel with improvements in the drug review process, PDUFA
funds have enabled FDA to increase its focus on drug safety, including
implementing the Food and Drug Administration Amendments Act of 2007
(FDAAA). In FDAAA, Congress authorized additional user fees totaling
$225 million for the 5 years of PDUFA IV reauthorization to enhance
drug safety activities. FDAAA also provided FDA with important
postmarket safety authorities. Under FDAAA, FDA was given the authority
to require postmarketing studies and clinical trials to address
important drug safety questions. Between the enactment of FDAAA on
September 27, 2007, and June 1, 2011, FDA has required applicants to
conduct approximately 375 postmarketing studies or trials to address
important drug safety questions that could not be addressed before the
drug was approved. FDAAA also gave FDA the authority to require safety
labeling changes based on new safety information identified after a
drug is on the market. FDA has used its new authority to require
applicants to place important new safety information onto their drug
labels quickly, in some cases using this authority to require changes
to the labeling of all members of a class of drugs. FDAAA also provided
FDA with authority to manage risks associated with marketed drug
products through required risk evaluation and mitigation strategies
(REMS). FDA has been using this new authority judiciously to ensure
that drugs that could not otherwise be approved because the risks
without a REMS would outweigh the benefits, are available to patients.
    FDA has implemented other important drug safety initiatives under
FDAAA including, for example, initiating systematic reviews of the
safety of marketed drugs 18 months after approval; conducting regular
screening of the adverse event reporting system database and posting
quarterly reports of new safety information or potential signals of
serious risks identified from that screening; and developing an active
post-market drug safety surveillance capability under the ``Sentinel''
initiative (http://www.fda.gov/Safety/FDAsSentinelInitiative/ucm2007250.htm).

III. Proposed PDUFA V Recommendations

    In preparing the proposed recommendations to Congress for PDUFA
reauthorization, we have conducted discussions with the regulated
industry, and we have consulted with stakeholders as required by the
law. We began the PDUFA reauthorization process with a public meeting
held on April 12, 2010 (75 FR 12555, March 16, 2010). The meeting
included presentations by FDA and a series of panels representing
different stakeholder groups, including patient advocates, consumer
groups, regulated industry, health professionals, and academic
researchers. The stakeholders were asked to respond to the following
questions:
    1. What is your assessment of the overall performance of the PDUFA
IV program thus far?
    2. What aspects of PDUFA should be retained, changed, or
discontinued to further strengthen and improve the program?
    Following the April 2010 public meeting, FDA conducted negotiations
with regulated industry and continued monthly consultations with public
stakeholders from July 2010 through May 2011. As directed by Congress,
FDA posted minutes of these discussions on its Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm117890.htm.
The proposed enhancements for PDUFA V address many of the top
priorities identified by public stakeholders, the top concerns
identified by regulated industry, and the most important challenges
identified within FDA. These include a new review program for new
molecular entity NDAs and original BLAs, proposals to enhance
regulatory science and expedite drug development, enhanced benefit-risk
assessment, modernization of FDA's drug safety system, requirements for
electronic submissions with standardized application data, a technical
correction related to discontinued products, and modifications to the
PDUFA inflation adjuster with continued evaluation of the workload
adjuster. The full descriptions of these proposed enhancements can be
found in the draft PDUFA V commitment letter (draft commitment letter)
posted on FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm149212.htm. Each enhancement is briefly
described below with reference to the section of the draft commitment
letter where more detailed information can be found.

A. A Review Program for New Drug Applications (NDA), New Molecular
Entities (NME), and Original Biologics License Applications (BLA)

    FDA's existing review performance goals for priority and standard

applications, 6 and 10 months respectively, were established in 1997.
Since that time, additional requirements in the drug review process
have made those goals increasingly challenging to meet, particularly
for more complex applications like NME NDAs and original BLAs. FDA also
recognizes that increasing communication between the Agency and
sponsors or applicants during the application review has the potential
to increase efficiency in the review process. To address the desire for
increased communication and efficiency, FDA proposes a new review
program for NME NDAs and original BLAs in PDUFA V that will include
presubmission meetings, mid-cycle communications, and late-cycle
meetings between FDA and sponsors for these applications. FDA's review
clock will begin after the 60-day administrative filing review period
to accommodate this increased interaction during regulatory review. The
impact of these modifications on the efficiency of drug review for this
subset of applications would be assessed during PDUFA V.

B. Enhancing Regulatory Science and Expediting Drug Development

    The following five enhancements focus on enhancing regulatory
science and expediting drug development. Regulatory science is the
science of developing and applying new tools, standards, and approaches
to assess the safety, effectiveness, quality, and performance of FDA-
regulated products. The details of these enhancements can be found in
section IX of the draft commitment letter.
1. Promoting Innovation Through Enhanced Communication Between FDA and
Sponsors During Drug Development
    FDA recognizes that timely interactive communication with sponsors
can help foster efficient and effective drug development. In some
cases, a sponsor's questions may be complex enough to require a formal
meeting with FDA, but in other instances, a question may be relatively
straightforward such that a response can be provided more quickly.
However, our review staff's workload and other competing public health
priorities can make it challenging to develop an Agency response to
matters outside of the formal meeting process.
    This enhancement involves a dedicated drug development
communication and training staff, focused on improving communication
between FDA and sponsors during development. This staff will be
responsible for identifying best practices for communication between
the Agency and sponsors, training review staff, and disseminating best
practices through published guidance.
2. Methods for Meta-Analysis
    A meta-analysis typically attempts to combine the data or findings
from multiple completed studies to explore drug benefits and risks and,
in some cases, uncover what might be a potential safety signal in a
premarket or postmarket context. However, there is no consensus on best
practices in conducting a meta-analysis. With the growing availability
of clinical trial data, an increasing number of meta-analyses are being
conducted based on varying sets of data and assumptions. If such
studies conducted outside FDA find a potential safety signal, FDA will
work to try to confirm--or correct--the information about a potential
harm that will create uncertainty for patients and health
professionals. To do this, FDA must work quickly to conduct its own
meta-analyses of publicly available data and the raw clinical trial
data submitted by drug sponsors that would typically not be available
to outside researchers. This is resource-intensive work that often
exceeds the Agency's current scientific and computational capacity,
causing delays in FDA findings that prolong public uncertainty.
    This proposed recommendation includes the development of a
dedicated staff to evaluate best practices and limitations in meta-
analysis methods. Through a rigorous public comment process, FDA will
develop guidance on best practices and the Agency's approach to meta-
analysis in regulatory review and decision-making.
3. Biomarkers and Pharmacogenomics
    Pharmacogenomics and the application of qualified biomarkers have
the potential to decrease drug development time by helping to
demonstrate benefits, to recognize unmet medical needs, and to identify
patients who are predisposed to adverse events. FDA provides regulatory
advice on the use of biomarkers to facilitate the assessment of human
safety in early phase clinical studies to support claims of efficacy
and to establish the optimal dose selection for pivotal efficacy
studies. This is an area of new science where the Agency has seen a
marked increase in sponsor submissions to FDA. In the 2008 to 2010
period, the Agency experienced nearly a four-fold increase in this type
of review work.
    In PDUFA V, FDA will augment the Agency's clinical, clinical
pharmacology, and statistical capacity to adequately address
submissions that propose to utilize biomarkers or pharmacogenomic
markers. The Agency will also hold a public meeting to discuss
potential strategies to facilitate scientific exchanges on biomarker
issues between FDA and drug manufacturers.
4. Use of Patient-Reported Outcomes (PRO)
    Assessments of study endpoints known as patient-reported outcomes
(PROs) are increasingly an important part of successful drug
development. PROs measure treatment benefit or risk in medical product
clinical trials from the patients' point of view. PROs are critical in
understanding the drug benefits and harm from the patients'
perspective. However, PROs require rigorous evaluation and statistical
design and analysis to ensure reliability to support claims of clinical
benefit. Early consultation between FDA and drug sponsors can ensure
that endpoints are well-defined and reliable. However, the Agency does
not have the capacity to meet the current demand from industry.
    This initiative will improve FDA's clinical and statistical
capacity to address submissions involving PROs and other endpoint
assessment tools, including providing consultation to sponsors during
the early stages of drug development. In addition, FDA will convene a
public meeting to discuss standards for PRO qualification, new theories
in endpoint measurement, and the implications for multinational trials.
5. Development of Drugs for Rare Diseases
    FDA's oversight of rare disease drug development is complex and
resource intensive. Rare diseases are a highly diverse collection of
disorders, their natural histories are often not well-described, only
small population sizes are often available for study, and the diseases
do not usually have well-defined outcome measures. This makes the
design, execution, and interpretation of clinical trials for rare
diseases difficult and time consuming, requiring frequent interaction
between FDA and drug sponsors. If recent trends in orphan designations
are any indication, FDA can expect an increase in investigational
activity and marketing applications for drug products for rare diseases
in the future.
    This PDUFA V enhancement includes FDA facilitation of rare disease
drug development by issuing relevant guidance, increasing the Agency's
outreach efforts to the rare disease patient community, and providing
specialized training in rare disease drug

development for sponsors and FDA staff.

C. Enhancing Benefit-Risk Assessment

    FDA has been exploring how to develop an enhanced structured
approach to benefit-risk assessments that accurately and concisely
describes the benefit and risk considerations in the Agency's drug
regulatory decision-making. Part of FDA's decision-making lies in
thinking about the context of the decision, including gaining a strong
understanding of the condition treated and the nature and extent of the
unmet medical need. Patients who live with a disease have a direct
stake in the outcome of the drug review process. The FDA drug review
process could benefit from a more systematic and expansive approach to
obtaining the patient perspective on disease severity and the potential
gaps or limitations in available treatments in a therapeutic area.
    During PDUFA V, FDA will expand its use of a benefit-risk framework
in the drug review process, including holding public workshops to
discuss the application of frameworks for considering benefits and
risks that are most appropriate for the regulatory setting. FDA will
also conduct a series of public meetings with the relevant patient
advocacy communities to review the medical products available for use
in specific therapeutic areas. The therapeutic areas to be discussed
will be chosen through a public process. This enhancement is discussed
in section X of the draft commitment letter.

D. Enhancement and Modernization of the FDA Drug Safety System

    The drug safety enhancements in PDUFA V focus on FDA's use of REMS
and the Sentinel Initiative. Additional information on these proposals
is found in section XI of the draft commitment letter.
1. Standardizing REMS
    FDAAA gave FDA authority to require a REMS when FDA finds that a
REMS is necessary to ensure that the benefits of a drug outweigh its
risks. Some REMS are more restrictive types of risk management programs
that include elements to assure safe use (ETASU). These programs can
require such tools as prescriber training or certification, pharmacy
training or certification, dispensing only in certain health care
settings, documentation of safe use conditions, patient monitoring, and
patient registries. ETASU REMS can be challenging to implement and
evaluate, involving cooperation of all segments of the health care
system. Our experience with REMS to date suggests that the development
of multiple individual programs has the potential to create burdens on
the health care system and, in some cases, could limit appropriate
patient access to important therapies.
    FDA will initiate a public process in PDUFA V to explore strategies
and initiate projects to standardize REMS programs with the goal of
reducing burden on practitioners, patients, and others in the health
care setting. In addition, FDA will conduct public workshops and
develop guidance on methods for assessing the effectiveness of REMS and
the impact on patient access and burden on the health care system.
2. Using the Sentinel Initiative To Evaluate Drug Safety Issues
    FDA's Sentinel Initiative is a long-term program designed to build
and implement a national electronic system for monitoring the safety of
FDA-approved medical products. FDAAA required FDA to collaborate with
Federal, academic, and private entities to develop methods to obtain
access to disparate data sources and validated means to link and
analyze safety data to monitor the safety of drugs after they reach the
market, an activity also known as ``active postmarket drug safety
surveillance.'' FDA will conduct a series of activities during PDUFA V
to determine the feasibility of using Sentinel to evaluate drug safety
issues that may require regulatory action (e.g., labeling changes,
post-marketing requirements, or postmarketing commitments). This may
shorten the time it takes to better understand new or emerging drug
safety issues. By leveraging public and private health care data
sources to quickly evaluate drug safety issues; this proposal may
reduce the Agency's reliance on required postmarketing studies and
clinical trials.

E. Required Electronic Submissions and Standardization of Electronic
Application Data

    The predictability of the FDA review process relies heavily on the
quality of sponsor and applicant submissions. The Agency currently
receives submissions of original applications and supplements in
formats ranging from paper-only to electronic-only, as well as hybrids
of the two media. The variability and unpredictability of submitted
formats and clinical data layout present major obstacles to conducting
a timely, efficient, and rigorous review within current PDUFA goal time
frames. A lack of standardized data also limits FDA's ability to
transition to more standardized approaches to benefit-risk assessment
and impedes conduct of safety analyses that inform FDA decisions
related to REMS and other postmarketing requirements. The PDUFA V
enhancements in this area include a phased-in requirement for
standardized, fully electronic submissions for all marketing and
investigational applications. Through partnership with open standards
development organizations, the Agency will also conduct a public
process to develop standardized terminology for clinical and
nonclinical data submitted in marketing and investigational
applications. More information on this initiative can be found in
section XII of the draft commitment letter.

F. Technical Change to Section 736(a)(3)(B) of the FD&C Act Related to
Discontinued Products

    FDA proposes to amend section 736(a)(3)(B) of the FD&C Act, which
provides for an exception in assessing a product fee if the same
product is approved as an NDA or ANDA. This amendment will clarify
FDA's long-standing policy to use the active portion of the
Prescription Drug Product List in the ``Approved Drug Products With
Therapeutic Equivalence Evaluations'' (generally know as the ``Orange
Book'') to identify fee-eligible prescription drug products. FDA will
assess a product fee on a prescription drug product when there are no
other products on the Prescription Drug Product List that are the same
as that product.

G. PDUFA V Enhancements for a Modified Inflation Adjuster and
Additional Evaluations of the Workload Adjuster

    In calculating user fees for each new fiscal year, FDA adjusts the
base revenue amount by inflation and workload as specified in the
statute. PDUFA V financial enhancements include a modification to the
inflation adjuster to more accurately account for changes in FDA's
costs related to payroll compensation and benefits as well as changes
in non-payroll costs through use of the Consumer Price Index (CPI).
This new weighted composite inflation adjuster will help ensure that
increases in fees more closely mirror the inflationary pressures that
have an impact on FDA's costs. FDA will also continue evaluating the
workload adjuster that was developed during the PDUFA IV negotiations
to ensure that it continues to adequately capture changes in FDA's
workload during PDUFA V. These evaluations will include options to
discontinue,

modify, or retain any element of the workload adjuster.

H. Impact of PDUFA V Enhancements on User Fee Revenue

    Implementing the proposed enhancements discussed in the previous
sections of this document will add $40.4 million to the PDUFA user fee
revenue amount in FY 2012. The fee revenue amount for FY 2012 is
$652,709,000 as published by notice in the Federal Register of August
1, 2011 (76 FR 45831). This amount includes the additional user fee
revenues for drug safety in FY 2012 totaling $65 million as specified
in the statute. The additional user fee revenue for the PDUFA V
enhancements translates to a 6-percent increase, and a total base of
$693.1 million in FY 2013. The following table summarizes the FY 2013
baseline and added resources to support the new PDUFA V enhancements:

------------------------------------------------------------------------
                   Financial baseline                        Dollars
------------------------------------------------------------------------
FY 2012 Baseline \1\...................................     $499,412,000
Cumulative Inflation Adjustment for FY 2012............      104,277,000
Cumulative Workload Adjustment for FY 2012.............       49,020,000
Fee Revenue Amount for FY 2012 \2\.....................      652,709,000
------------------------------------------------------------------------
                          PDUFA V Enhancements
------------------------------------------------------------------------
Increased Staff Capacity (129 FTE).....................       36,120,000
Other Direct Costs.....................................        4,270,000
Total Statutory Revenue Amount for FY 2013 \3\.........      693,099,000
------------------------------------------------------------------------

    \1\ In determining the fee revenue amount for FY 2012, sections
736(b)(4)(A) and 736(b)(4)(B) of the FD&C Act direct the Secretary
of Health and Human Services (Secretary) to substitute $392,783,000
plus $65,000,000 (for FY 2012) for the amount in paragraph (1)(A).
Furthermore, paragraph (1)(B) directs the Secretary to add the
amount of the modified workload adjustment for FY 2007 to the amount
in paragraph (1)(A) to determine the total revenue amount in FY
2012. This total is $499,412,000.
    \2\ As published in the Federal Register of August 1, 2011 (76
FR 45831).
    \3\ Of this amount, $652,709,000 will be further adjusted
according to the new statutory provisions to account for inflation
and workload adjustments in determining fees for FY 2013. These
adjustments must be captured in calculations of user fee revenue for
FYs 2014-2017.

IV. What information should you know about the meeting?

A. When and where will the meeting occur? What format will FDA use?

    We will convene a public meeting to hear the public's views on the
proposed recommendations for reauthorization of PDUFA. We will conduct
the meeting on October 24, 2011, at FDA's White Oak Campus (see
ADDRESSES). The meeting will include a presentation by FDA and a series
of panels representing different stakeholder groups identified in the
statute (such as patient advocacy groups, consumer advocacy groups,
health professionals, and regulated industry). We will also provide an
opportunity for other organizations and individuals to make
presentations at the meeting or to submit written comments to the
docket before the meeting.

B. How do you register for the meeting or submit comments?

    If you wish to attend this meeting, please register by e-mail at:
<EMAIL_ADDRESS>by October 10, 2011. Your e-mail
should contain complete contact information for each attendee,
including: Name, title, affiliation, address, e-mail address, and phone
number. Registration is free and will be on a first-come, first-served
basis, with the exception below. Early registration is recommended
because seating is limited. FDA may limit the number of participants
from each organization based on space limitations. Registrants will
receive confirmation once they have been accepted. On-site registration
on the day of the meeting will be based on space availability. We will
try to accommodate all persons who wish to make a presentation. If you
need special accommodations because of disability, please contact
Sunanda Bahl (see FOR FURTHER INFORMATION CONTACT) at least 7 days
before the meeting.
    In addition, 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. To ensure consideration, all comments must be received
by October 31, 2011.

C. Will meeting transcripts be available?

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov and http://www.fda.gov. It may be viewed at the Division of Dockets Management
(see ADDRESSES). A transcript will also be made available in either
hard copy or on CD-ROM, after submission of a Freedom of Information
request. Written requests are to be sent to Division of Freedom of
Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD 20857.

    Dated: September 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23251 Filed 9-9-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Pages 26820-26821]
[FR Doc No: 2013-10874]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69499; File No. SR-NASDAQ-2013-070]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of Proposed Rule Change for the Permanent Approval of
a Pilot Program To Permit NOM To Accept Inbound Options Orders From
NASDAQ OMX BX, Inc.

May 2, 2013.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on April 24, 2013, The NASDAQ Stock Market LLC (the
``Exchange'' or ``Nasdaq'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II and III below, which Items have been prepared by the
self-regulatory organization. The Commission is publishing this notice
to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is seeking permanent approval of its pilot program to
permit the NASDAQ Options Market (``NOM'') to accept inbound options
orders routed by Nasdaq Options Services LLC (``NOS'') from NASDAQ OMX
BX, Inc. (``BX'').

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    In conjunction with BX providing outbound routing services to all
options markets using its affiliated routing broker, NOS,\4\ NASDAQ
proposed that NOS be permitted to route orders from BX to NOM on a
pilot basis, subject to certain limitations and conditions, as
described below.\5\ The current pilot program expires June 28, 2013.
NOS is a broker-dealer and member of NASDAQ, NASDAQ OMX PHLX LLC
(``Phlx'') and BX. NOS provides all routing functions for BX Options,
Phlx and NOM. BX, NASDAQ, NOM, Phlx and NOS are affiliates.\6\
Accordingly, the affiliate relationship between NASDAQ and NOS, its
member, raises the issue of an exchange's affiliation with a member of
such exchange. Specifically, in connection with prior filings, the
Commission has expressed concern that the affiliation of an exchange
with one of its members raises the potential for unfair competitive
advantage and potential conflicts of interest between an exchange's
self-regulatory obligations and its commercial interests.\7\
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    \4\ Securities Exchange Act Release No. 67256 (June 26, 2012),
77 FR 39277 (July 2, 2012) (SR-BX-2012-030).
    \5\ See Securities Exchange Act Release No. 67295 (June 28,
2012), 77 FR 39758 (July 5, 2012) (SR-NASDAQ-2012-061).
    \6\ See Securities Exchange Act Release Nos. 58324 (August 7,
2008), 73 FR 46936 (August 12, 2008) (SR-BSE-2008-02; SR-BSE-2008-
23; SR-BSE-2008-25; SR-BSECC-2008-01) (order approving NASDAQ OMX's
acquisition of BX); and 58179 (July 17, 2008), 73 FR 42874 (July 23,
2008) (SR-Phlx-2008-31) (order approving NASDAQ OMX's acquisition of
Phlx).
    \7\ See Securities Exchange Act Release Nos. 59153 (December 23,
2008), 73 FR 80485 (December 31, 2008) (SR-NASDAQ-2008-098); and
62736 (August 17, 2010), 75 FR 51861 (August 23, 2010) (SR-NASDAQ-
2010-100). See also Securities Exchange Act Release No. 58135 (July
10, 2008), 73 FR 40898 (July 16, 2008) (SR-NASDAQ-2008-061)
(permitting NOS to be affiliated with Phlx).
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    Recognizing that the Commission has previously expressed concern
regarding the potential for conflicts of interest in instances where a
member firm is affiliated with an exchange of which it is a member, the
Exchange previously proposed, and the Commission approved, limitations
and conditions on NOS's affiliation with the Exchange.\8\ Also
recognizing that the Commission has expressed concern regarding the
potential for conflicts of interest in instances where a member firm is
affiliated with an exchange to which it is routing orders, the Exchange
previously proposed, and the Commission approved,\9\ NOS's affiliation
with the Exchange to permit the Exchange to accept inbound orders that
NOS routes in its capacity as a facility of BX, subject to the certain
limitations and conditions. The Exchange now proposes to permit NOM to
accept inbound options orders that NOS routes in its capacity as a
facility of BX on a permanent basis, subject to the limitations and
conditions of this pilot:
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 67295 (June 28,
2012), 77 FR 39758 (July 5, 2012) (SR-NASDAQ-2012-061). See also
Securities Exchange Act Release No. 57478 (March 12, 2008), 73 FR
14521 (March 18, 2008) (Order Approving File Nos. SR-NASDAQ-2007-004
and SR-NASDAQ-2007-080).
    \9\ See Securities Exchange Act Release No. 67295 (June 28,
2012), 77 FR 39758 (July 5, 2012) (SR-NASDAQ-2012-061).
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     First, the Exchange and FINRA maintain a Regulatory
Contract, as well as an agreement pursuant to Rule 17d-2 under the Act
(``17d-2 Agreement'').\10\ Pursuant to the Regulatory Contract and the
17d-2 Agreement, FINRA is allocated regulatory responsibilities to
review NOS's compliance with certain Exchange rules.\11\ Pursuant to
the Regulatory Contract, however, NASDAQ retains ultimate
responsibility for enforcing its rules with respect to NOS.
---------------------------------------------------------------------------

    \10\ 17 CFR 240.17d-2.
    \11\ NOS is also subject to independent oversight by FINRA, its
designated examining authority, for compliance with financial
responsibility requirements.
---------------------------------------------------------------------------

     Second, FINRA monitors NOS for compliance with the
Exchange's trading rules, and collects and maintains certain related
information.\12\
---------------------------------------------------------------------------

    \12\ Pursuant to the Regulatory Contract, both FINRA and the
Exchange collect and maintain all alerts, complaints, investigations
and enforcement actions in which NOS (in its capacity as a facility
of BX routing orders to NOM) is identified as a participant that has
potentially violated applicable Commission or Exchange rules. The
Exchange and FINRA retain these records in an easily accessible
manner in order to facilitate any potential review conducted by the
Commission's Office of Compliance Inspections and Examinations.
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     Third, FINRA provides a report to the Exchange's chief
regulatory officer (``CRO''), on a quarterly basis, that: (i)
Quantifies all alerts (of which FINRA is aware) that identify NOS as a
participant that has potentially violated Commission or Exchange rules,
and (ii) lists all investigations that identify NOS as a participant
that has potentially violated Commission or Exchange rules.
     Fourth, the Exchange has in place NASDAQ Rule 2140(c)
[sic], which requires The NASDAQ OMX Group, Inc., as the holding
company owning both the Exchange and NOS, to establish and maintain
procedures and internal controls reasonably designed to ensure that NOS
does not develop or implement changes to its system, based on non-
public information obtained regarding planned changes to the Exchange's
systems as a result of its affiliation with the Exchange, until such
information is available generally to

similarly situated Exchange members, in connection with the provision
of inbound order routing to the Exchange.
    The Exchange has met all the above-listed conditions. By meeting
the above conditions, the Exchange has set up mechanisms that protect
the independence of the Exchange's regulatory responsibility with
respect to NOS, as well as demonstrate that NOS cannot use any
information advantage it may have because of its affiliation with the
Exchange. Because the Exchange has met all the above-listed conditions,
it now seeks permanent approval of this inbound routing relationship.
The Exchange will continue to comply with the conditions 1-4 stated
above.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\13\ in general, and with
Sections 6(b)(5) of the Act,\14\ in particular, in that the proposal is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest, because the
proposed rule change will allow the Exchange to continue to receive
inbound orders from NOS, acting in its capacity as a facility of BX, in
a manner consistent with prior approvals and established protections.
The Exchange believes that these conditions establish mechanisms that
protect the independence of the Exchange's regulatory responsibility
with respect to NOS, as well as ensure that NOS cannot use any
information it may have because of its affiliation with the Exchange to
its advantage.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f.
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended.
Permanent approval of the current pilot program does not raise any
issues of intra-market competition because it involves inbound routing
from an affiliated exchange. Nor does it result in a burden on
competition among exchanges, because there are many competing options
exchanges that provide routing services, including through an
affiliate.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2013-070 on the subject line.

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 SR-NASDAQ-2013-070.
This file number should be included on the subject line if email is
used. To help the Commission 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 (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be 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. Copies of the filing will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2013-070 and should
be submitted on or before May 29, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-10874 Filed 5-7-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 112 (Thursday, June 11, 2015)]
[Notices]
[Pages 33270-33271]
[FR Doc No: 2015-14285]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1414]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Class II Special Controls Guidance
Document: Labeling for Natural Rubber Latex Condoms

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Class II Special Controls Guidance
Document: Labeling for Natural Rubber Latex Condoms'' has been approved
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On January 30, 2015, the Agency submitted a
proposed collection of information

entitled ``Class II Special Controls Guidance Document: Labeling for
Natural Rubber Latex Condoms'' to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0633.
The approval expires on May 31, 2018. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: June 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14285 Filed 6-10-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 222 (Monday, November 18, 2013)]
[Notices]
[Pages 69143-69147]
[FR Doc No: 2013-27478]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 30780; File No. 812-14151-04]

Guggenheim Equal Weight Enhanced Equity Income Fund and
Guggenheim Funds Investment Advisers, LLC; Notice of Application

November 12, 2013.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 19(b) of
the Act and rule 19b-1 under the Act.

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Summary of Application:  Applicants request an order to permit a
registered closed-end investment company to make periodic distributions
of long-term capital gains with respect to its outstanding common
shares as frequently as monthly in any one taxable year, and as
frequently as distributions are specified by or in accordance with the
terms of any outstanding preferred shares that such investment company
may issue.

Applicants:  Guggenheim Equal Weight Enhanced Equity Income Fund (the
``Initial Fund'') and Guggenheim Funds Investment Advisers, LLC (the
``Adviser'').

FILING DATES:  The application was filed on April 22, 2013, and amended
on September 25, 2013.

Hearing or Notification of Hearing:  An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on December 6, 2013, and should be accompanied by proof of service
on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Elizabeth M. Murphy, Secretary, Securities and Exchange
Commission, 100 F Street NE., Washington, DC 20549-1090; Applicants, c/
o Michael K. Hoffman, Skadden, Arps, Slate, Meagher & Flom LLP, Four
Times Square, New York, NY 10036.

FOR FURTHER INFORMATION CONTACT: Bruce R. MacNeil, Senior Counsel, at
(202) 551-6817, or Daniele Marchesani, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Exemptive Applications Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm, or by calling<PHONE_NUMBER>.

Applicants' Representations

    1. The Initial Fund is a closed-end management investment company
registered under the Act and is organized as a Delaware statutory
trust.\1\ The investment objective of the Initial Fund is to provide a
high level of risk adjusted total return with an emphasis on current
income by investing primarily in common stocks and utilizing a call
option writing strategy. The Initial Fund's common shares are currently
listed on the New York Stock Exchange, a national securities exchange
as defined in section 2(a)(26) of the Act. The Initial Fund and any
Future Fund may issue preferred shares. Applicants believe that closed-
end fund investors may prefer an investment vehicle that provides
regular current income through fixed distribution policies.
---------------------------------------------------------------------------

    \1\ Applicants request that any order issued granting the relief
requested in the application also apply to each existing of future
registered closed-end investment company advised by the Adviser
(including any successor in interest) or by an entity controlling,
controlled by or under common control (within the meaning of section
2(a)(9) of the Act) with the Adviser that decides in the future to
rely on the requested relief (``Future Fund'' and together with the
Initial Fund, the ``Funds''). The Initial Fund and the Adviser are
referred to collectively as ``Applicants''. Any Future Fund that may
rely on the order will satisfy each of the representations in the
application. All existing registered closed-end investment companies
currently intending to rely on the order have been named as
Applicants. A successor in interest is limited solely to the entity
that results from a reorganization into another jurisdiction or a
change in the type of business organization.
---------------------------------------------------------------------------

    2. The Adviser is registered under the Investment Advisers Act of
1940 (``Advisers Act'') and serves as the investment adviser to the
Initial Fund. A Fund's portfolio may be managed by one or more
investment sub-advisers (each a ``Sub-Adviser''). Any Sub-Adviser to a
Fund will be registered as an investment adviser under the Advisers Act
or not subject to registration.
    3. Applicants state that, prior to a Fund's implementing a
distribution

policy (``Distribution Policy'') in reliance on the order, the board of
trustees (the ``Board'') of the Fund, including a majority of the
trustees who are not ``interested persons,'' of such Fund as defined in
section 2(a)(19) of the Act (the ``Independent Trustees''), will
request, and the Adviser will provide, such information as is
reasonably necessary to make an informed determination of whether the
Board should adopt a proposed Distribution Policy. In particular, the
Board and the Independent Trustees will review information regarding
the purpose and terms of a proposed Distribution Policy; the likely
effects of such policy on such Fund's long-term total return (in
relation to market price and its net asset value (``NAV'') per common
share); the expected relationship between such Fund's distribution rate
on its common shares under the policy and the Fund's total return (in
relation to NAV per share); whether the rate of distribution would
exceed such Fund's expected total return in relation to its NAV per
share; and any foreseeable material effects of such policy on such
Fund's long-term total return (in relation to market price and NAV per
share). The Independent Trustees will also consider what conflicts of
interest the Adviser and the affiliated persons of the Adviser and each
such Fund might have with respect to the adoption or implementation of
the proposed Distribution Policy. Applicants state that, only after
considering such information will the Board of a Fund, including the
Independent Trustees, approve a Distribution Policy and in connection
with such approval will determine that the Distribution Policy is
consistent with a Fund's investment objectives and in the best
interests of the Fund's common shareholders.
    4. Applicants state that the purpose of a Distribution Policy,
generally, would be to permit a Fund to distribute over the course of
each year, through periodic distributions in relatively equal amounts
(plus any required special distributions), an amount closely
approximating the total taxable income of such Fund during such year
and, if so determined by its Board, all or a portion of returns of
capital paid by portfolio companies to such Fund during the year. Under
the Distribution Policy of a Fund, such Fund would distribute to its
respective common shareholders a fixed monthly percentage of the market
price of such Fund's common shares at a particular point in time or a
fixed monthly percentage of NAV at a particular time or a fixed monthly
amount, any of which may be adjusted from time to time. It is
anticipated that under a Distribution Policy, the minimum annual
distribution rate with respect to such Fund's common shares would be
independent of a Fund's performance during any particular period but
would be expected to correlate with a Fund's performance over time.
Except for extraordinary distributions and potential increases or
decreases in the final dividend periods in light of a Fund's
performance for an entire calendar year and to enable a Fund to comply
with the distribution requirements of Subchapter M of the Internal
Revenue Code (``Code'') for the calendar year, each distribution on the
Fund's common shares would be at the stated rate then in effect.
    5. Applicants state that prior to implementing a Distribution
Policy in reliance on the order, the Board of a Fund will adopt
policies and procedures pursuant to rule 38a-1 under the Act (``Section
19 Compliance Policies'') that: (a) are reasonably designed to ensure
that all notices required to be sent to a Fund's shareholders pursuant
to section 19(a) of the Act, rule 19a-1 thereunder and condition 4
below (each a ``19(a) Notice'') include the disclosure required by rule
19a-1 under the Act and by condition 2(a) below, and that all other
written communications by the Fund or its agents regarding
distributions under the Distribution Policy include the disclosure
required by condition 3(a) below; and (b) require the Fund to keep
records that demonstrate its compliance with all of the conditions of
the order and that are necessary for such Fund to form the basis for,
or demonstrate the calculation of, the amounts disclosed in its 19(a)
Notices.

Applicants' Legal Analysis

    1. Section 19(b) of the Act generally makes it unlawful for any
registered investment company to make long-term capital gains
distributions more than once every twelve months. Rule 19b-1 under the
Act limits the number of capital gains dividends, as defined in section
852(b)(3)(C) of the Code (``distributions''), that a fund may make with
respect to any one taxable year to one, plus a supplemental
distribution made pursuant to section 855 of the Code not exceeding 10%
of the total amount distributed for the year, plus one additional
capital gain dividend made in whole or in part to avoid the excise tax
under section 4982 of the Code.
    2. Section 6(c) of the Act provides, in relevant part, that the
Commission may exempt any person, security, or transaction from any
provision of the Act or any rule under the Act if and to the extent
that such exemption is necessary or appropriate in the public interest
and consistent with the protection of investors and the purposes fairly
intended by the policy and provisions of the Act.
    3. Applicants state that the one of the concerns leading to the
enactment of section 19(b) and adoption of rule 19b-1 was that
shareholders might be unable to distinguish between frequent
distributions of capital gains and dividends from investment income.
Applicants state, however, that rule 19a-1 effectively addresses this
concern by requiring that distributions (or the confirmation of the
reinvestment thereof) estimated to be sourced in part from capital
gains or capital be accompanied by a separate statement showing the
sources of the distribution (e.g., estimated net income, net short-term
capital gains, net long-term capital gains and/or return of capital).
Applicants state that similar information is included in the Funds'
annual reports to shareholders and on the Internal Revenue Service Form
1099-DIV (``Form 1099-DIV''), which is sent to each common and
preferred shareholder who received distributions during a particular
year (including shareholders who have sold shares during the year).
    4. Applicants further state that each of the Funds will make the
additional disclosures required by the conditions set forth below, and
each of them will adopt the Section 19 Compliance Policies to ensure
that all required 19(a) Notices and disclosures are sent to
shareholders. Applicants state that by providing the information
required by section 19(a) and rule 19a-1, the Distribution Policy, the
Section 19 Compliance Policies, and the conditions listed below will
help ensure that each Fund's shareholders are provided sufficient
information to understand that their periodic distributions are not
tied to the Fund's net investment income (which for this purpose is the
Fund's taxable income other than from capital gains) and realized
capital gains to date, and may not represent yield or investment
return. Accordingly, Applicants assert that continuing to subject the
Funds to section 19(b) and rule 19b-1 would afford shareholders no
extra protection.
    5. Applicants note that section 19(b) of the Act and rule 19b-1
were intended to prevent certain improper sales practices, including,
in particular, the practice of urging an investor to purchase shares of
a fund on the basis

of an upcoming capital gains dividend (``selling the dividend''), where
the dividend would result in an immediate corresponding reduction in
NAV and would be in effect a taxable return of the investor's capital.
Applicants submit that the ``selling the dividend'' concern should not
apply to closed-end investment companies, such as the Funds, which do
not continuously distribute shares. According to Applicants, if the
underlying concern extends to secondary market purchases of shares of
closed-end funds that are subject to a large upcoming capital gain
dividend, adoption of a periodic distribution plan may help minimize
the concern by avoiding, through periodic distributions, any buildup of
large end-of-the-year distributions.
    6. Applicants also note that the common shares of closed-end funds
often trade in the marketplace at a discount to their NAV. Applicants
believe that this discount may be reduced if the Funds are permitted to
pay relatively frequent dividends on their common shares at a
consistent rate, whether or not those dividends contain an element of
long-term capital gains.
    7. Applicants assert that the application of rule 19b-1 to a
Distribution Policy actually could have an inappropriate influence on
portfolio management decisions. Applicants state that, in the absence
of an exemption from rule 19b-1, the adoption of a periodic
distribution plan imposes pressure on management (i) not to realize any
net long-term capital gains until the point in the year that the fund
can pay all of its remaining distributions in accordance with rule 19b-
1 and (ii) not to realize any long-term capital gains during any
particular year in excess of the amount of the aggregate pay-out for
the year (since as a practical matter excess gains must be distributed
and, accordingly, would not be available to satisfy pay-out
requirements in following years), notwithstanding that purely
investment considerations might favor realization of long-term gains at
different times or in different amounts. Applicants assert that by
limiting the number of capital gain dividends that a Fund may make with
respect to any one year, rule 19b-1 may prevent the normal and
efficient operation of a periodic distribution plan whenever that
Fund's realized net long-term capital gains in any year exceed the
total of the periodic distributions that may include such capital gains
under the rule.
    8. Applicants also assert that rule 19b-1 may force the fixed
regular periodic distributions under a periodic distribution plan to be
funded with returns of capital \2\ (to the extent net investment income
and realized short term capital gains are insufficient to fund the
distribution), even though realized net long-term capital gains
otherwise would be available. To distribute all of a Fund's long-term
capital gains within the limits in rule 19b-1, a Fund may be required
to make total distributions in excess of the annual amount called for
by its periodic distribution plan or to retain and pay taxes on the
excess amount. Applicants assert that the requested order would
minimize these anomalous effects of rule 19b-1 by enabling the Funds to
realize long-term capital gains as often as investment considerations
dictate without fear of violating rule 19b-1.
---------------------------------------------------------------------------

    \2\ Returns of capital as used in the application means return
of capital for financial accounting purposes and not for tax
accounting purposes.
---------------------------------------------------------------------------

    9. Applicants state that Revenue Ruling 89-81 under the Code
requires that a fund that seeks to qualify as a regulated investment
company under the Code and that has both common shares and preferred
shares outstanding designate the types of income, e.g., investment
income and capital gains, in the same proportion as the total
distributions distributed to each class for the tax year. To satisfy
the proportionate designation requirements of Revenue Ruling 89-81,
whenever a fund has realized a long term capital gain with respect to a
given tax year, the fund must designate the required proportionate
share of such capital gain to be included in common and preferred share
dividends. Applicants state that although rule 19b-1 allows a fund some
flexibility with respect to the frequency of capital gains
distributions, a fund might use all of the exceptions available under
the rule for a tax year and still need to distribute additional capital
gains allocated to the preferred shares to comply with Revenue Ruling
89-81.
    10. Applicants assert that the potential abuses addressed by
section 19(b) and rule 19b-1 do not arise with respect to preferred
shares issued by a closed-end fund. Applicants assert that such
distributions are either fixed or are determined in periodic auctions
by reference to short-term interest rates rather than by reference to
performance of the issuer, and Revenue Ruling 89-81 determines the
proportion of such distributions that are comprised of the long-term
capital gains.
    11. Applicants also submit that the ``selling the dividend''
concern is not applicable to preferred shares, which entitles a holder
to no more than a periodic dividend at a fixed rate or the rate
determined by the market, and, like a debt security, is priced based
upon its liquidation value, dividend rate, credit quality, and
frequency of payment. Applicants state that investors buy preferred
shares for the purpose of receiving payments at the frequency bargained
for and do not expect the liquidation value of their shares to change.
    12. Applicants request an order under section 6(c) of the Act
granting an exemption from the provisions of section 19(b) of the Act
and rule 19b-1 thereunder to permit each Fund to distribute periodic
capital gain dividends (as defined in section 852(b)(3)(C) of the Code)
as often as monthly in any one taxable year in respect of its common
shares and as often as specified by or determined in accordance with
the terms thereof in respect of its preferred shares.

Applicants' Conditions

    Applicants agree that, with respect to each Fund that adopts a
Distribution Policy in reliance upon the order, the order will be
subject to the following conditions:
    1. Compliance Review and Reporting. The Fund's chief compliance
officer will (a) report to the Fund's Board, no less frequently than
once every three months or at the next regularly scheduled quarterly
Board meeting, whether (i) the Fund and its Adviser have complied with
the conditions of the order and (ii) a material compliance matter (as
defined in rule 38a-1(e)(2) under the Act) has occurred with respect to
such conditions; and (b) review the adequacy of the policies and
procedures adopted by the Board no less frequently than annually.
    2. Disclosures to Fund Shareholders.
    (a) Each 19(a) Notice disseminated to the Fund's common
shareholders, in addition to the information required by section 19(a)
and rule 19a-1:
    (i) Will provide, in a tabular or graphical format:
    (1) The amount of the distribution, on a per common share basis,
together with the amounts of such distribution amount, on a per common
share basis and as a percentage of such distribution amount, from
estimated: (A) net investment income; (B) net realized short-term
capital gains; (C) net realized long-term capital gains; and (D) return
of capital or other capital source;
    (2) the fiscal year-to-date cumulative amount of distributions, on
a per common share basis, together with the amounts of such cumulative
amount, on a per common share basis and as a percentage of such
cumulative amount of distributions, from estimated: (A) net investment
income; (B) net realized

short-term capital gains; (C) net realized long-term capital gains; and
(D) return of capital or other capital source;
    (3) the average annual total return in relation to the change in
NAV for the 5-year period (or, if the Fund's history of operations is
less than five years, the time period commencing immediately following
the Fund's first public offering) ending on the last day of the month
ended immediately prior to the most recent distribution record date
compared to the current fiscal period's annualized distribution rate
expressed as a percentage of NAV as of the last day of the month prior
to the most recent distribution record date; and
    (4) the cumulative total return in relation to the change in NAV
from the last completed fiscal year to the last day of the month prior
to the most recent distribution record date compared to the fiscal
year-to-date cumulative distribution rate expressed as a percentage of
NAV as of the last day of the month prior to the most recent
distribution record date. Such disclosure shall be made in a type size
at least as large and as prominent as the estimate of the sources of
the current distribution; and
    (ii) will include the following disclosure:
    (1) ``You should not draw any conclusions about the Fund's
investment performance from the amount of this distribution or from the
terms of the Fund's Distribution Policy,''
    (2) ``The Fund estimates that it has distributed more than its
income and net realized capital gains; therefore, a portion of your
distribution may be a return of capital. A return of capital may occur,
for example, when some or all of the money that you invested in the
Fund is paid back to you. A return of capital distribution does not
necessarily reflect the Fund's investment performance and should not be
confused with `yield' or `income'''; \3\ and
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    \3\ The disclosure in this condition 2(a)(ii)(2) will be
included only if the current distribution or the fiscal year-to-date
cumulative distributions are estimated to include a return of
capital.
---------------------------------------------------------------------------

    (3) ``The amounts and sources of distributions reported in this
19(a) Notice are only estimates and are not being provided for tax
reporting purposes. The actual amounts and sources of the amounts for
tax reporting purposes will depend upon the Fund's investment
experience during the remainder of its fiscal year and may be subject
to changes based on tax regulations. The Fund will send you a Form
1099-DIV for the calendar year that will tell you how to report these
distributions for federal income tax purposes;'' Such disclosure shall
be made in a type size at least as large as and as prominent as any
other information in the 19(a) Notice and placed on the same page in
close proximity to the amount and the sources of the distribution.
    (b) On the inside front cover of each report to shareholders under
rule 30e-1 under the Act, the Fund will:
    (i) describe the terms of the Distribution Policy (including the
fixed amount or fixed percentage of the distributions and the frequency
of the distributions);
    (ii) include the disclosure required by condition 2(a)(ii)(1)
above;
    (iii) state, if applicable, that the Distribution Policy provides
that the Board may amend or terminate the Distribution Policy at any
time without prior notice to Fund shareholders; and
    (iv) describe any reasonably foreseeable circumstances that might
cause the Fund to terminate the Distribution Policy and any reasonably
foreseeable consequences of such termination.
    (c) Each report provided to shareholders under rule 30e-1 under the
Act, and each prospectus filed with the Commission on Form N-2 under
the Act, will provide the Fund's total return in relation to changes in
NAV in the financial highlights table and in any discussion about the
Fund's total return
    3. Disclosure to Shareholders, Prospective Shareholders and Third
Parties.
    (a) The Fund will include the information contained in the relevant
19(a) Notice, including the disclosure required by condition 2(a)(ii)
above, in any written communication (other than a communication on Form
1099) about the Distribution Policy or distributions under the
Distribution Policy by the Fund, or agents that the Fund has authorized
to make such communication on the Fund's behalf, to any Fund
shareholder, prospective shareholder or third-party information
provider;
    (b) The Fund will issue, contemporaneously with the issuance of any
19(a) Notice, a press release containing the information in the 19(a)
Notice and will file with the Commission the information contained in
such 19(a) Notice, including the disclosure required by condition
2(a)(ii) above, as an exhibit to its next filed Form N-CSR; and
    (c) The Fund will post prominently a statement on its (or the
Adviser's) Web site containing the information in each 19(a) Notice,
including the disclosure required by condition 2(a)(ii) above, and
maintain such information on such Web site for at least 24 months.
    4. Delivery of 19(a) Notices to Beneficial Owners. If a broker,
dealer, bank or other person (``financial intermediary'') holds common
shares issued by the Fund in nominee name, or otherwise, on behalf of a
beneficial owner, the Fund:
    (a) will request that the financial intermediary, or its agent,
forward the 19(a) Notice to all beneficial owners of the Fund's shares
held through such financial intermediary;
    (b) will provide, in a timely manner, to the financial
intermediary, or its agent, enough copies of the 19(a) Notice assembled
in the form and at the place that the financial intermediary, or its
agent, reasonably requests to facilitate the financial intermediary's
sending of the 19(a) Notice to each beneficial owner of the Fund's
shares; and
    (c) upon the request of any financial intermediary, or its agent,
that receives copies of the 19(a) Notice, will pay the financial
intermediary, or its agent, the reasonable expenses of sending the
19(a) Notice to such beneficial owners.
    5. Additional Board Determinations for Funds Whose Common Shares
Trade at a Premium.
    If:
    (a) The Fund's common shares have traded on the stock exchange that
they primarily trade on at the time in question at an average premium
to NAV equal to or greater than 10%, as determined on the basis of the
average of the discount or premium to NAV of the Fund's common shares
as of the close of each trading day over a 12-week rolling period (each
such 12-week rolling period ending on the last trading day of each
week); and
    (b) The Fund's annualized distribution rate for such 12-week
rolling period, expressed as a percentage of NAV as of the ending date
of such 12-week rolling period, is greater than the Fund's average
annual total return in relation to the change in NAV over the 2-year
period ending on the last day of such 12-week rolling period; then:
    (i) At the earlier of the next regularly scheduled meeting or
within four months of the last day of such 12-week rolling period, the
Board, including a majority of the Independent Trustees:
    (1) will request and evaluate, and the Adviser will furnish, such
information as may be reasonably necessary to make an informed
determination of whether the Distribution Policy should be continued or
continued after amendment;
    (2) will determine whether continuation, or continuation after
amendment, of the Distribution Policy is

consistent with the Fund's investment objective(s) and policies and is
in the best interests of the Fund and its shareholders, after
considering the information in condition 5(b)(i)(1) above; including,
without limitation:
    (A) whether the Distribution Policy is accomplishing its
purpose(s);
    (B) the reasonably foreseeable material effects of the Distribution
Policy on the Fund's long-term total return in relation to the market
price and NAV of the Fund's common shares; and
    (C) the Fund's current distribution rate, as described in condition
5(b) above, compared with the Fund's average annual taxable income or
total return over the 2-year period, as described in condition 5(b), or
such longer period as the Board deems appropriate; and
    (3) based upon that determination, will approve or disapprove the
continuation, or continuation after amendment, of the Distribution
Policy; and
    (ii) The Board will record the information considered by it
including its consideration of the factors listed in condition
5(b)(i)(2) above and the basis for its approval or disapproval of the
continuation, or continuation after amendment, of the Distribution
Policy in its meeting minutes, which must be made and preserved for a
period of not less than six years from the date of such meeting, the
first two years in an easily accessible place.
    6. Public Offerings. A Fund will not make a public offering of the
Fund's common shares other than:
    (a) a rights offering below NAV to the Fund's common shareholders;
    (b) an offering in connection with a dividend reinvestment plan,
merger, consolidation, acquisition, spin-off or reorganization of the
Fund; or
    (c) an offering other than an offering described in conditions 6(a)
and 6(b) above, provided that, with respect to such other offering:
    (i) the Fund's annualized distribution rate for the six months
ending on the last day of the month ended immediately prior to the most
recent distribution record date,\4\ expressed as a percentage of NAV
per share as of such date, is no more than 1 percentage point greater
than the Fund's average annual total return for the 5-year period
ending on such date; \5\ and
---------------------------------------------------------------------------

    \4\ If the Fund has been in operation fewer than six months, the
measured period will begin immediately following the Fund's first
public offering.
    \5\ If the Fund has been in operation fewer than five years, the
measured period will begin immediately following the Fund's first
public offering.
---------------------------------------------------------------------------

    (ii) the transmittal letter accompanying any registration statement
filed with the Commission in connection with such offering discloses
that the Fund has received an order under section 19(b) to permit it to
make periodic distributions of long-term capital gains with respect to
its common shares as frequently as twelve times each year, and as
frequently as distributions are specified by or determined in
accordance with the terms of any outstanding preferred shares as such
Fund may issue.
    7. Amendments to Rule 19b-1.
    The requested order will expire on the effective date of any
amendment to rule 19b-1 that provide relief permitting certain closed-
end investment companies to make periodic distributions of long-term
capital gains with respect to their outstanding common shares as
frequently as twelve times each year.

     For the Commission, by the Division of Investment Management,
under delegated authority.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-27478 Filed 11-15-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: March 16, 2006 (Volume 71, Number 51)]
[Notices]
[Page 13646-13647]
[DOCID:fr16mr06-91]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53440; File No. SR-NASD-2006-020]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Related to Odd Lot Transactions in the Nasdaq Market Center

March 8, 2006.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 6, 2006, the National Association of Securities Dealers,
Inc. (``NASD''), through its subsidiary, The Nasdaq Stock Market, Inc.
(``Nasdaq''), filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by Nasdaq. On February
27, 2006, NASD filed Amendment No. 1 to the proposed rule change.\3\
The NASD filed the proposal, as amended, pursuant to section
19(b)(3)(A) of the Act \4\ and Rule 19b-4(f)(6) thereunder,\5\ which
renders the proposal effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change, as amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Partial Amendment dated February 27, 2006 (``Amendment
No. 1''). In Amendment No. 1, Nasdaq clarified the rationale behind
the proposed rule change.
    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to amend Rule 4706(d) to permit ITS/CAES Market
Makers to enter orders in increments less than 100 shares. Nasdaq
expects to implement the proposed rule change, as amended, on March 27,
2006.\6\
---------------------------------------------------------------------------

    \6\ Originally, Nasdaq stated that it would implement the
proposed rule change on March 6, 2006. Later, the implementation
date was changed to March 27, 2006. Telephone conversation between
Jeffrey Davis, Associate Vice President, Nasdaq, and Natasha Cowen,
Attorney, Division of Market Regulation, Commission, on March 7,
2006.
---------------------------------------------------------------------------

    The text of the proposed rule change is below. Proposed new
language is in italics; proposed deletions are in brackets.\7\
---------------------------------------------------------------------------

    \7\ Changes are marked to the rule text that appears in the
electronic NASD Manual found at http://www.nasd.com. Prior to the

date when The NASDAQ Stock Market LLC (``NASDAQ LLC'') commences
operations, NASDAQ LLC will file a conforming change to the rules of
NASDAQ LLC approved in Securities Exchange Act Release No. 53128
(January 13, 2006), 71 FR 3550 (January 23, 2006) (File No. 10-131).
---------------------------------------------------------------------------

* * * * *
4706 Order Entry Parameters
    (a)-(c) No Change.
    (d) Order Size--
    (1) [In Nasdaq-listed securities, a] Any order in whole shares up
to 999,999 shares may be entered into the Nasdaq Market Center for
normal execution processing.
    (2) [Orders in ITS Securities must be entered for a minimum of one
round lot,

or in round lot multiples, or in mixed lots.] Orders in ITS Securities
will be delivered to ITS Exchanges in round lots only.
    (e) No Change.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, Nasdaq included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. Nasdaq has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Nasdaq proposes to amend Rule 4706(d) to permit ITS/CAES Market
Makers to enter orders in increments less than 100 shares. This
functionality has been available for several years and is widely
utilized in the trading of Nasdaq-listed securities. Nasdaq has not
previously made this functionality available for the trading of ITS
Securities due to the limitation in the Intermarket Trading System
(``ITS'') that prohibits the sending of commitments in increments
smaller than 100 shares. Nasdaq has identified a method for permitting
Nasdaq participants to enter trading interest into the Nasdaq Market
Center in odd-lot increments and for the Nasdaq Market Center to
execute transactions in odd-lot increments while leaving undisturbed
the ITS limitation requiring participation in round-lot multiples.\8\
In other words, Nasdaq will program its own system to use both round
lots and odd lots, and continue to comply with this ITS restriction by
programming its system not to send ITS commitments in increments
smaller than 100 shares.
---------------------------------------------------------------------------

    \8\ See Amendment No. 1
---------------------------------------------------------------------------

2. Statutory Basis
    Nasdaq believes that the proposed rule change, as amended, is
consistent with the provisions of section 15A of the Act,\9\ in
general, and with section 15A(b)(6) of the Act,\10\ in particular, in
that it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, remove
impediments to a free and open market and a national market system,
and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78o-3.
    \10\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change, as amended,
will result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received from Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change, as amended, does not:
    (1) Significantly affect the protection of investors or the public
interest;
    (2) Impose any significant burden on competition; and
    (3) Become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, if
consistent with the protection of investors and the public interest, it
has become effective pursuant to section 19b(3)(A) of the Act \11\ and
Rule 19b-4(f)(6) thereunder.\12\ As required under Rule 19b-
4(f)(6)(iii) under the Act,\13\ the Nasdaq provided the Commission with
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at least
five business days prior to the date of the filing of the proposed rule
change.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, as amended, the Commission may summarily abrogate the rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.\14\
---------------------------------------------------------------------------

    \14\ For purposes of calculating the 30-day operative delay and
the 60-day abrogation period, the Commission considers the proposed
rule change to have been filed on February 27, 2006, when Amendment
No. 1 was filed.
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, is consistent with the Act. Comments may be
submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASD-2006-020 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASD-2006-020. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comment more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the NASD. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASD-2006-020 and should be submitted on or before April
6, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
[FR Doc. 06-2543 Filed 3-15-06; 8:45 am]

BILLING CODE 8010-01-P