[Federal Register Volume 76, Number 90 (Tuesday, May 10, 2011)]
[Notices]
[Pages 27062-27067]
[FR Doc No: 2011-11348]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0326]

Biologics Price Competition and Innovation Act of 2009; Options
for a User Fee Program for Biosimilar and Interchangeable Biological
Product Applications for Fiscal Years 2013 Through 2017; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing this document to request comments relating to the development
of a user fee program for biosimilar and interchangeable biological
product (351(k)) applications submitted under the Public Health Service
Act (PHS Act). FDA is requesting input on the identified principles for
development of a 351(k) user fee program, FDA's proposed structure for
a 351(k) user fee program that would adhere to these principles, and
performance goals for this program. FDA plans to review the comments
submitted to the docket, hold meetings with public stakeholders, and
hold industry stakeholder meetings to develop proposed recommendations
for a user fee program for 351(k) applications for fiscal years (FYs)
2013 through 2017.

DATES: Submit either electronic or written comments by June 9, 2011.
Submit notification of interest in participating in public stakeholder
meetings or industry stakeholder meetings on or before June 3, 2011.

ADDRESSES: 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. Public and industry stakeholders who have not yet
notified FDA of their interest in participating in these meetings
should e-mail complete contact information to
<EMAIL_ADDRESS>(See sections VI.B and VI.C of
this document for additional information.)

FOR FURTHER INFORMATION CONTACT: Sunanda Bahl, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1168, Silver Spring, MD 20993-0002, 301-
796-3584, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On March 23, 2010, President Obama signed into law the Affordable
Care Act (Pub. L. 111-148). The Affordable Care Act contains a subtitle
called the Biologics Price Competition and Innovation Act of 2009 (BPCI
Act) that amends the PHS Act and other statutes to create an
abbreviated approval pathway for biological products shown to be highly
similar (biosimilar) to, or interchangeable with, an FDA-licensed
reference biological product. (See sections 7001 through 7003 of the
Affordable Care Act.) Section 351(k) of the PHS Act (42 U.S.C. 262(k)),
added by the BPCI Act, allows a company to submit an application for
licensure of a biosimilar or interchangeable biological product.
    The BPCI Act amends section 735 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 379g) to include 351(k)
applications in the definition of ``human drug application'' for the
purposes of the prescription drug user fee provisions. (See section
7002(f)(3)(A) of the Affordable Care Act.) Accordingly, under section
736 of the FD&C Act (21 U.S.C. 379h), the fee for a biologics license
application (BLA) is currently the same regardless of whether the
application is submitted

under the new 351(k) approval pathway or the preexisting 351(a)
approval pathway.
    The authority conferred by the FD&C Act's prescription drug user
fee provisions expires in September 2012. The BPCI Act directs FDA to
develop recommendations for a user fee program for 351(k) applications
for FYs 2013 through 2017. (See section 7002(f)(1) of the Affordable
Care Act.) In developing recommendations for a biosimilar and
interchangeable biological products user fee program, FDA is required
to consult with a range of groups, including scientific and academic
experts, health care professionals, representatives of patient and
consumer advocacy groups, and regulated industry. The recommendations
must be presented to Congress by January 15, 2012. (See section
7002(f)(1) of the Affordable Care Act.)
    Developing a user fee program for 351(k) applications presents
unique challenges as compared to other medical product user fee
programs. One key consideration in developing a user fee program is the
state of the regulated industry. For example, when the Prescription
Drug User Fee Act (PDUFA) program was first implemented in FY 1993, the
biopharmaceutical industry was relatively mature. FDA had a record of
more than 2,000 drug and biological products already on the market,
more than 200 establishments were involved in the manufacturing of
these products, and approximately 120 new drug marketing applications
were submitted each year for FDA review. The number of participants in
the industry and the volume of anticipated annual applications allowed
FDA to generate significant revenue from user fees tied to marketing
application submissions and currently marketed products (product and
establishment fees). In contrast, given that the biosimilar and
interchangeable biological product approval pathway did not exist prior
to March 2010, the biosimilar and interchangeable biological product
market is just forming. Although FDA has met with sponsors who are
interested in developing biosimilar and interchangeable biological
products, no products have been approved for marketing under section
351(k) of the PHS Act. As such, although the PDUFA program is a useful
model, FDA believes that a user fee program for 351(k) applications
will need to include different elements to ensure an equitable program
that generates adequate revenue.
    In this document, FDA describes the principles it proposes to use
to develop a biosimilars user fee program, a proposed structure for the
program based on these principles, and proposed performance goals. FDA
is requesting public comment on each of these proposals, and is also
posing several questions for public input on some unresolved issues
associated with developing performance goals for this new user fee
program.

II. Principles for Development of a Biosimilars User Fee Program

    FDA proposes to develop recommendations for the 351(k) user fee
program that are guided by a set of key principles to support the
development of a fair and adequate initial user fee program.\1\ These
proposed principles are based on FDA's prior experience with elements
that foster strong and successful user fee programs, as well as
comments submitted to the docket by external stakeholders. FDA solicits
comment on these proposed principles. The proposed principles are:
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    \1\ As we expect the program to be reevaluated and reauthorized
periodically as are all of FDA's other medical product user fee
programs, our focus here is on the initial program.
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    (1) Biosimilar and interchangeable biologics represent a critical
public health benefit to patients, with the potential to offer life-
saving or life-altering benefits at reduced costs to the patient. FDA
needs sufficient review capacity to prevent unnecessary delays in the
development and approval of these products.
    (2) At least for the initial 5-year authorization of the 351(k)
user fee program, 351(k) user fees should remain comparable to 351(a)
user fees. This aligns with the PDUFA standard for assessing human drug
application fees for applications for which clinical data (other than
bioavailability or bioequivalence studies) with respect to safety or
effectiveness are required for approval. That is, under PDUFA, the fee
for a new drug application (NDA) that is submitted under section
505(b)(2) of the FD&C Act (21 U.S.C. 355(b)(2)) and that requires
clinical data is the same as the fee for an NDA submitted under section
505(b) that requires clinical data for approval, even though the
505(b)(2) approval pathway allows an applicant to rely on studies not
conducted by or for the applicant and for which the applicant has not
obtained a right of reference or use. FDA believes a similar approach
is appropriate for applications for biosimilar products because, at
least initially, review to determine biosimilarity or
interchangeability of a proposed product in a 351(k) application is
expected to be comparably complex, technically demanding, and resource-
intensive as review of a proposed 351(a) application. For example,
characterizing biological products for the purpose of determining
biosimilarity or interchangeability is challenging because the
molecules of biological products tend to be much larger and have a far
more complex spatial structure than small-molecule drugs. However, FDA
does not expect that review of the 351(k) applications will require
more resources than review of 351(a) applications. Therefore, the level
of user fees for biosimilars should not exceed the level of 351(a) user
fees.
    (3) The 351(k) user fee program should provide funding to support
activities that occur early in the biosimilar and interchangeable
product development cycle. Given that the approval pathway for
biosimilar and interchangeable biological products is new, FDA services
are most critical for continued and successful development of
biosimilar and interchangeable biological products during the
investigational stage prior to submission of a marketing application.
To date, most of FDA's work on biosimilars has been focused on
development of regulatory standards, policy, and consultations with
351(k) sponsors to support product development leading to a marketing
application. As a result, in developing an effective 351(k) user fee
program, FDA should consider fee structures that fund critical
activities that support submission of a marketing application.
    (4) Innovator biologics represent a critical public health benefit
to patients, often offering life-saving or life-altering therapies to
treat previously unmet medical needs. The same expert scientific teams
that conduct FDA's review of 351(a) applications will typically be
involved in the review of 351(k) applications. The 351(k) user fee
program should ensure adequate resources for the review of 351(k)
applications, so that critical resources for 351(a) review are not
redirected from innovator drug review to biosimilar products.
Applications submitted under both section 351(a) and section 351(k)
need adequate resourcing to ensure the best health outcomes for U.S.
patients and fairness to all industry sponsors.

III. Proposal for 351(k) User Fee Program for FYs 2013 Through 2017

    FDA believes the proposed structure for a user fee program
described in this section adheres to the proposed principles identified
in section II of this document. The proposed structure would ensure
sound funding for development of the scientific,

regulatory, and policy infrastructure necessary for review of 351(k)
applications, including resources for critical development-phase FDA
consultation and review work, while charging no more for review of a
351(k) application than would be paid by applicants seeking review of a
351(a) marketing application. The level and timing of the proposed fee
funding is also expected to minimize the risk of redirection of 351(a)
review resources to biosimilars review work.
    FDA's proposed structure for a 351(k) user fee program has some
features that would be similar to the current PDUFA structure. First,
because FDA expects that marketing application review, preapproval
facility inspections, and safety issues will be comparably complex for
351(k) and 351(a) applications, for the initial 5-year authorization,
the Agency proposes to maintain the PDUFA fee levels for 351(k)
marketing applications, manufacturing establishments, and products.
However, the Agency proposes to modify this structure to provide
resources in the near-term because, as noted in section I of this
document, there is no existing inventory of marketed products that
would generate fees.
    Sponsors are currently submitting requests for FDA meetings and
consultations during the biosimilar product development phase. Given
that sponsors have limited experience utilizing the novel 351(k)
pathway, FDA expects that sponsors will continue to require significant
advice and support throughout this phase. As a result, the Agency is
proposing a 351(k) user fee structure that would shift payment for FDA
review to the earlier stage of development where FDA activities
currently are in greatest demand and increased review capacity is
needed.
    The proposed 351(k) user fee program would consist of the
following:
For an Application in the Premarket Phases
     Biosimilar Product Development fee, paid upon submission
of an investigational new drug application (IND) and annually
thereafter for a biosimilar or interchangeable product (molecule) under
active development that is intended for submission in a single 351(k)
marketing application.
     351(k) Marketing Application fee, paid for each submitted
351(k) marketing application. This fee would be set equal to a 351(a)
marketing application fee, less the sum of all of the previously paid
annual Biosimilar Product Development fees associated with the
biosimilar product that is the subject of the 351(k) application.
For Marketed 351(k) Products, the Annual Fees Would Include
     Establishment fee, paid annually for each biosimilar and
interchangeable biological product establishment listed in an approved
351(k) application. The establishment fee is assessed for each
biosimilar and interchangeable biological product that is assessed a
product fee--unless the establishment listed in the application does
not manufacture the product during the FY.
     Product fee, paid annually for each eligible approved
biosimilar and interchangeable biological product.

    These fees are described in more detail. (See sections III.A and
B.)

A. Description of Proposed Fees

1. Biosimilar Product Development Fee
    FDA proposes an annual 351(k) Biosimilar Product Development fee
for each distinct biosimilar or interchangeable product (molecule)
under active development. The sponsor would pay this fee at IND
submission and annually thereafter for the duration of the active
development phase. The sponsor would be required to declare that the
development program is intended to support a 351(k) marketing
application upon IND submission. During the development phase, if the
sponsor changes the approval pathway from 351(k) to another, such as
the 351(a) approval pathway, then the sponsor would stop paying the
Biosimilar Product Development fee. Similarly, if a sponsor changes the
development program for an existing IND from the 351(a) pathway to the
351(k) pathway, the sponsor would be required to begin paying the
Biosimilar Product Development fee. Failure to pay the Biosimilar
Product Development fee on initial IND submission or annually as
required would result in the IND being placed on Full Clinical Hold.
When the applicant submits the associated 351(k) marketing application,
the sum of the previously paid annual Biosimilar Product Development
fees would be deducted from the 351(k) marketing application fee.
    This annual Biosimilar Product Development fee would support the
ongoing scientific, technical, and other regulatory activities
associated with 351(k) biosimilar development, including milestone
meetings and the application data reviews required to provide advice
for the next steps in development. These fees are essential to enable
the staffing capacity to handle the workload associated with activities
that support 351(k) product development programs. FDA estimates that
the annual activities in this phase may be comparable to, or greater
than, 351(a) IND application activities. These activities can include
FDA review of study protocols; review of clinical, safety and other
data; and providing sponsors with timely feedback and advice for their
351(k) development program. FDA anticipates that the FY 2013 annual
Biosimilar Product Development fee amount would be on the order of
$150,000.
2. 351(k) Marketing Application Fee
    FDA estimates that the cost of reviewing a 351(k) marketing
application will be comparable to the cost of reviewing a 351(a)
marketing application. FDA therefore proposes to set the marketing
application fee for a 351(k) submission equal to that of a 351(a)
submission. The feedback and consultation that FDA expects to provide
for active 351(k) INDs is expected to improve the efficiency of the
351(k) product development process and the quality of submitted 351(k)
marketing applications. Therefore, FDA considers the deduction of the
Biosimilar Product Development fee payments from the associated
marketing application fee payment is a reasonable approach to shift
resources forward to the point in development where FDA review is
currently being sought by sponsors. When a 351(k) marketing application
is submitted, the applicant would pay the 351(k) application fee less
the sum of any associated paid annual Biosimilar Product Development
fees. For example, if the IND sponsor paid a total of $450,000 in
Biosimilar Product Development annual fees, upon submission of the
351(k) marketing application, the applicant would pay the prevailing
351(k) marketing application fee (set equal to the 351(a) marketing
application fee) less $450,000.
3. Annual Establishment and Product Fees for Marketed 351(k) Products
    Because the complexity and level of effort required for FDA
oversight of manufacturing and postmarket safety issues for products
licensed under 351(k) is expected to be comparable to that required for
products licensed under 351(a), FDA also proposes setting the
establishment and product fee rates equal to the comparable PDUFA rates
for any FY. FDA anticipates a modest level of funding from these
sources because only biosimilar biological products already approved
for marketing would be subject to these fees.

B. Summary of Proposed 351(k) User Fee Program

    The intent of the proposed 351(k) user fee program is to provide
FDA with adequate funding throughout each stage in the development of a
biosimilar or interchangeable biological product, ensuring efficiency
in FDA's review and approval of these important therapies without
compromising review quality or approval standards. Table 1 of this
document contains a summary of the proposed recommendations for the
351(k) user fee program.

                Table 1--Proposed 351(k) User Fee Program
------------------------------------------------------------------------
                                                         Estimated fee
          Fee category            Fee administration   rates for FY 2013
------------------------------------------------------------------------
                    Pre 351(k) Market Approval Phase
------------------------------------------------------------------------
Biosimilar Product Development    Annual for each     Based on the
 Fee.                              351(k) IND, for     annual estimated
                                   duration of IND     cost of IND
                                   phase.              activities per
                                                       year per IND.
                                                       Estimated to be
                                                       $150,000.
Application Fee.................  For each 351(k)     Set equal to PDUFA
                                   marketing           original NDA/BLA
                                   application at      fee, less sum of
                                   time of             payments of
                                   application         Biosimilar
                                   submission.         Product
                                                       Development fees.
------------------------------------------------------------------------
                      Marketed 351(k) Applications
------------------------------------------------------------------------
Establishment Fee...............  Annual............  Set equal to PDUFA
                                                       establishment
                                                       fee.
Product Fee.....................  Annual............  Set equal to PDUFA
                                                       product fee.
------------------------------------------------------------------------

IV. Proposed Performance Goals for 351(k) Applications for FYs 2013
Through 2017

    Under section 351(k)(7) of the PHS Act, a 351(k) application may
not be submitted to the Secretary of Health and Human Services (the
Secretary) until 4 years after the reference product was first licensed
under section 351(a); however, the Secretary may not make approval of a
351(k) application effective until 12 years after the reference product
was first licensed. Accordingly, in proposing performance goals for
351(k) applications for FYs 2013 through 2017, FDA must take into
account the fact that two different categories of 351(k) applications
may be submitted. In the first category are applications that are
submitted 10 or more years after the date of first licensure of the
reference product. Such applications would be eligible for approval in
2 years or less, depending on the relevant filing dates. For these
applications, performance goals similar to those for 351(a)
applications may be appropriate. Like the initial PDUFA review
performance goals, FDA is proposing that the goals be phased in over
the first 5 years of the program so that an increasing percentage of
applications would be expected to be reviewed within the goal each
year.
    In the second category are applications submitted between 4 and 10
years after the date of first licensure of the reference product. Under
section 351(k)(7) of the PHS Act, such applications would not be
eligible for approval for more than 2 years and perhaps for as long as
8 years. For this second category of applications, FDA is concerned
about committing resources to meet performance goals that might ready
an application for approval years before it could be approved,
necessitating updating of the application, new reviews, and new
inspections of facilities shortly before the application becomes
eligible for approval under the section 351(k)(7). Accordingly, FDA is
proposing performance goals for applications in the first category and
soliciting public input on several questions relating to establishing
performance goals for applications in the second category.
    For 351(k) applications that are submitted 10 or more years after
the date of first licensure of the reference product, FDA recommends
the following proposed review performance goals for FYs 2013 through
2017:

FY 2013

     For applications requesting a biosimilarity determination,
FDA proposes to review and act on 50 percent of original 351(k)
submissions within 10 months of the 60-day filing date.
     For applications requesting an interchangeability
determination, FDA proposes to review and act on 50 percent of original
351(k) submissions for interchangeability determination within 10
months of the 60-day filing date.
     For applications requesting a biosimilarity determination,
FDA proposes to review and act on 50 percent of 351(k) resubmissions in
response to a complete response action within 6 months of receipt.
     For applications requesting an interchangeability
determination, FDA proposes to review and act on 50 percent of 351(k)
resubmissions in response to a complete response action within 6 months
of receipt.

FY 2014

     For applications requesting a biosimilarity determination,
FDA proposes to review and act on 60 percent of original 351(k)
submissions within 10 months of the 60-day filing date.
     For applications requesting an interchangeability
determination, FDA proposes to review and act on 60 percent of original
351(k) submissions for interchangeability determination within 10
months of the 60-day filing date.
     For applications requesting a biosimilarity determination,
FDA proposes to review and act on 60 percent of 351(k) resubmissions in
response to a complete response action within 6 months of receipt.
     For applications requesting an interchangeability
determination, FDA proposes to review and act on 60 percent of 351(k)
resubmissions in response to a complete response action within 6 months
of receipt.

FY 2015

     For applications requesting a biosimilarity determination,
FDA proposes to review and act on 70 percent of original 351(k)
submissions within 10 months of the 60-day filing date.
     For applications requesting an interchangeability
determination, FDA proposes to review and act on 70 percent of original
351(k) submissions for interchangeability determination within 10
months of the 60-day filing date.
     For applications requesting a biosimilarity determination,
FDA proposes to review and act on 70 percent of 351(k) resubmissions in
response to a complete response action within 6 months of receipt.

     For applications requesting an interchangeability
determination, FDA proposes to review and act on 70 percent of 351(k)
resubmissions in response to a complete response action within 6 months
of receipt.

FY 2016

     For applications requesting a biosimilarity determination,
FDA proposes to review and act on 80 percent of original 351(k)
submissions within 10 months of the 60-day filing date.
     For applications requesting an interchangeability
determination, FDA proposes to review and act on 80 percent of original
351(k) submissions for interchangeability determination within 10
months of the 60-day filing date.
     For applications requesting a biosimilarity determination,
FDA proposes to review and act on 80 percent of 351(k) resubmissions in
response to a complete response action within 6 months of receipt.
     For applications requesting an interchangeability
determination, FDA proposes to review and act on 80 percent of 351(k)
resubmissions in response to a complete response action within 6 months
of receipt.

FY 2017

     For applications requesting a biosimilarity determination,
FDA proposes to review and act on 90 percent of original 351(k)
submissions within 10 months of the 60-day filing date.
     For applications requesting an interchangeability
determination, FDA proposes to review and act on 90 percent of original
351(k) submissions for interchangeability determination within 10
months of the 60-day filing date.
     For applications requesting a biosimilarity determination,
FDA proposes to review and act on 90 percent of 351(k) resubmissions in
response to a complete response action within 6 months of receipt.
     For applications requesting an interchangeability
determination, FDA proposes to review and act on 90 percent of 351(k)
resubmissions in response to a complete response action within 6 months
of receipt.

    To help the Agency develop performance goals for 351(k)
applications that are submitted earlier than 10 years after first
licensure of the reference product (i.e., between year four and year
ten), FDA requests comment on the following questions:
    Question IV.1: What factors should the Agency consider in
determining appropriate performance goals for 351(k) applications that
are filed earlier than 2 years prior to the date on which a 351(k)
application would be eligible for approval (i.e., 12 years after the
date of first licensure of the reference product)? For example, how
should the Agency address issues relating to review of critical quality
attributes of the 351(k) product, technological developments, facility
changes, and other issues that arise during the period of time between
the filing of a 351(k) application (as early as 4 years after the date
of first licensure of the reference product) and the date on which a
351(k) application would be eligible for approval (12 years after the
date of first licensure of the reference product)?
    Question IV.2: How should the performance goals take into account
readiness for inspection? For example, should the performance goal (or
user fee) structure take into account such factors as whether the
product that is the subject of a 351(k) is already in commercial
production for sale in another country? In such a case, if the sponsor
proposes to use the same manufacturing facility for the 351(k) product,
FDA could conduct an inspection at the facility and actually observe
the production process. If the product is not being produced in another
country, there may not be a facility ready for preapproval inspection,
or even built yet. How should the performance goals take this into
account?
    Question IV.3: What other factors relating to the unique
characteristics of the 351(k) approval pathway should the Agency
consider when setting performance goals for 351(k) applications?

V. Stakeholder Meetings

A. Public Stakeholder Meetings

    In the Federal Register of December 8, 2010 (75 FR 76472) (December
2010 notice), FDA issued a notice to request that public stakeholders,
including patient and consumer advocacy groups, health care
professionals, and scientific and academic experts, notify FDA of their
intent to participate in consultation meetings related to the
development of recommendations for a user fee program for biosimilar
and interchangeable biological product applications. Public
stakeholders who identified themselves in response to the December 2010
notice will be notified and invited to participate in future public
stakeholder meetings that will be held over the same period when FDA is
holding industry stakeholder meetings. (See section V.B of this
document.) FDA regulatory policy issues are beyond the scope of the
proposed stakeholder discussions. Accordingly, stakeholder
presentations and discussions will focus on the structure of the 351(k)
user fee program, and not policy issues.

B. Industry Stakeholder Meetings

    The BPCI Act requires FDA to consult with ``regulated industry'' in
developing recommendations for the 351(k) user fee program.
Acknowledging the nascent state of the biosimilar biologics industry,
FDA proposes to hold a series of industry stakeholder meetings to
comply with this requirement.
    Given that no approval pathway for biosimilar biological products
existed prior to the BPCI Act, it is not clear which companies comprise
``regulated industry'' for biosimilar and interchangeable biological
products. Accordingly, in the Federal Register document that announced
the November 2 and 3, 2010, public hearing (November 2010 public
hearing document) on the implementation of the BPCI Act, FDA sought
comments relating to user fees and requested that those who submitted
comments identify companies that would be affected by a 351(k) user fee
program, as well as industry associations representing such companies.
(See 75 FR 61497, October 5, 2010.) Based on comments submitted to the
docket, FDA anticipates that companies that principally manufacture
innovator drugs and companies that principally manufacture generic
drugs will pursue biosimilar and interchangeable product development
programs. Given the potential competing interests of the affected
stakeholders, and given that no industry association exists to
expressly represent the interests of 351(k) sponsors, FDA concludes
that it will need to follow a different process for the 351(k) user fee
program than for its other medical product user fee programs.
    Specifically, FDA proposes to conduct a series of industry-
stakeholder meetings over a period of 2 to 3 months in 2011, with the
hope that this process will lead to a package of proposed
recommendations with which all parties can align. All industry
associations who have expressed interest, and individual industry
sponsors who have identified their interest and intention to develop
biosimilar biological products, will be invited to participate in the
industry-stakeholder meetings. The industry stakeholder meetings will
address the following:
     Review and discussion of key principles and criteria for
design of a fair and adequate 351(k) user fee program.

     Review and discussion of FDA's proposed 351(k) user fee
program structure and any alternative structures submitted to the
public docket in response to this document that would also meet the key
design principles and criteria.
     Review and discussion of FDA's proposed performance goals
for 351(k) applications. FDA will review and analyze the industry
stakeholder input obtained through this process. FDA will take this
information into account, as well as information obtained from public
stakeholder consultation meetings, in developing the proposed set of
recommendations that will be presented to Congressional Committee
staff, published in the Federal Register for public review and comment,
and presented at a public meeting to obtain public input. After the
public meeting, the proposed recommendations would be revised as
necessary before transmittal to Congress by January 15, 2012.

VI. Next Steps

A. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
    FDA encourages members of the public to submit comments to the
docket on the following topics:
    Question VI.1: FDA-proposed principles for a fair and adequate
351(k) user fee program (section II of this document),
    Question VI.2: FDA-proposed structure for a 351(k) user fee program
that aligns with these principles (section III of this document), and
    Question VI.3: FDA-proposed performance goals for a 351(k) user fee
program for FYs 2013 through 2017 (section IV of this document).

    FDA also encourages the public to submit comments to the docket
concerning any potential alternative 351(k) user fee structures that
would align with the proposed principles. When you submit comments to
the docket, identify the section of this document and the number of
each question you address. FDA plans to review the comments submitted
to the docket, hold consultation meetings with public stakeholder
groups, and hold industry stakeholder meetings, to refine the proposed
recommendations for a 351(k) user fee program for FYs 2013 through
2017.

B. Public Stakeholder Identification

    Public stakeholders who have not yet notified FDA that they wish to
participate in these consultation meetings should notify FDA by e-mail
to<EMAIL_ADDRESS>on or before June 3, 2011.
Your e-mail should contain complete contact information, including
name, title, organization affiliation, address, e-mail address,
telephone number, and notice of any special accommodations required
because of disability. Stakeholders will receive confirmation and
additional information about the first meeting once FDA receives their
notification.

C. Industry Stakeholder Identification

    FDA is requesting that industry stakeholders, including industry
associations with relevant interests and individual companies with
ongoing efforts or interest in developing biosimilar and
interchangeable biological products, identify their interest in
participating in industry stakeholder meetings. The purpose of these
industry stakeholder meetings is to hold a series of discussions to
develop proposed recommendations for a user fee program for biosimilar
and interchangeable biological product applications for FYs 2013
through 2017.
    If you have not yet notified FDA that you are a company or trade
association that would be affected by a 351(k) user fee program, please
provide notification by e-mail to<EMAIL_ADDRESS>on or before June 3, 2011. Your e-mail should contain
complete contact information, including name, title, organization
affiliation, address, e-mail address, telephone number, and notice of
any special accommodations required because of disability.

VII. Additional Information on the BPCI Act

    There are several sources of information on FDA's Web site that may
serve as useful resources for stakeholders intending to participate in
consultation meetings:
     The Federal Register document that announced the November
2010, public hearing and requested public comments is available at
http://edocket.access.gpo.gov/2010/pdf/2010-24853.pdf. (FDA has
verified the Web site address, but FDA is not responsible for any
subsequent changes to the Web site after this document publishes in the
Federal Register.)
     Comments submitted in response to the November 2010 public
hearing document can be found at http://www.regulations.gov using
Docket No. FDA-2010-N-0477.
     The Federal Register notice that requested notification of
stakeholder intention to participate in consultation meetings is
available at http://edocket.access.gpo.gov/2010/pdf/2010-30713.pdf.
     Additional information regarding implementation of the
BPCI Act is available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/UCM215031.

    Dated: May 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11348 Filed 5-9-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)]
[Notices]
[Page 36583]
[FR Doc No: 2018-16219]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic review at the Commission in the Public
Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the eLibrary link. Enter the docket number,
excluding the last three digits, in the docket number field to access
the document. For assistance, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

------------------------------------------------------------------------
           Docket No.               File date     Presenter or requester
------------------------------------------------------------------------
Prohibited:
    1. CP15-558-000............       7-16-2018  \1\ Mass Mailing
Exempt:
    1. P-2809-034..............       7-10-2018  State of Maine
                                                  Department of Marine
                                                  Resources
------------------------------------------------------------------------
\1\ Twenty Seven letters have been sent to FERC Commissioners under this
  docket number.

    Dated: July 24, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-16219 Filed 7-27-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: December 27, 2007 (Volume 72, Number 247)]
[Notices]
[Page 73394-73397]
[DOCID:fr27de07-108]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56983; File No. SR-NYSEArca-2007-128]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Order Granting Accelerated Approval of a Proposed Rule Change, as
Modified by Amendment No. 1 Thereto, To List and Trade Shares of the
iShares MSCI Japan Small Cap Index Fund

December 18, 2007.
    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 December 13, 2007, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange''),
through its wholly owned subsidiary, NYSE Arca Equities, Inc. (``NYSE
Arca Equities''), filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by the Exchange.
On December 18, 2007, the Exchange filed Amendment No. 1 to the
proposed rule change. This order provides notice of the proposed rule
change, as amended, and approves the proposed rule change, as modified
by Amendment No. 1 thereto, on an accelerated basis.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to list and trade shares (``Shares'') of the
iShares MSCI Japan Small Cap Index Fund (``Fund'').\3\ The text of the
proposed rule change is available at the Exchange's principal office,
the Commission's Public Reference Room, and http://www.nyse.com.

---------------------------------------------------------------------------

    \3\ The Shares will be issued by iShares, Inc., an open-ended
management investment company registered under the Investment
Company Act of 1940 (15 U.S.C. 80a).
---------------------------------------------------------------------------

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 III 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to list and trade the Shares of the Fund
under NYSE Arca Equities Rule 5.2(j)(3), the Exchange's listing
standards for Investment Company Units (``ICUs'').\4\ The Fund seeks to
provide investment results that correspond generally to the price and
yield performance, before fees and expenses, of publicly traded
securities in the aggregate in the Japanese market, as represented by
the MSCI Japan Small Cap Index (the ``Index''). The Index, which is
designed to measure the small capitalization equity market performance
in the Japanese market, consists of small capitalization stocks traded
primarily on the Tokyo Stock Exchange.
---------------------------------------------------------------------------

    \4\ An Investment Company Unit is a security that represents an
interest in a registered investment company that holds securities
comprising, or otherwise based on or representing an interest in, an
index or portfolio of securities (or holds securities in another
registered investment company that holds securities comprising, or
otherwise based on or representing an interest in, an index or
portfolio of securities). See NYSE Arca Equities Rule 5.2(j)(3)(A).
---------------------------------------------------------------------------

    NYSE Arca represents that the Shares meet each of the ``generic''
listing requirements of Commentary .01(a)(B) to NYSE Arca Equities Rule
5.2(j)(3) applicable to the listing of ICUs based on equity securities
comprising international or global indexes, except for the requirement
set forth in Commentary .01(a)(B)(2) to NYSE Arca Equities Rule
5.2(j)(3), which states that component stocks that, in the aggregate,
account for at least 90% of the weight of the index each must have a
minimum worldwide monthly trading volume during each of the last six
months of at least 250,000 shares. The Exchange represents that, as of
December 10, 2007, the component stocks comprising 88% of the weight of
the Index traded at least 250,000 shares in each of the previous six
months. Because the component stocks of the Index fall below the
required minimum percentage in Commentary .01(a)(B)(2) to NYSE Arca
Equities Rule 5.2(j)(3), the Exchange has filed the proposed rule
change to obtain Commission approval to list and trade the Shares. The
Exchange represents that, except for Commentary .01(a)(B)(2) to NYSE
Arca Equities Rule 5.2(j)(3), the Shares currently satisfy all of the
generic listing standards under NYSE Arca Equities Rule 5.2(j)(3) and
further represents that the continued listing standards under NYSE Arca
Equities Rule 5.5(g)(2) applicable to Investment Company Units shall
apply to the Shares.
    Detailed descriptions of the Fund, the Index (including the
methodology used to determine the composition of the Index), investment
objective of the Fund, management and structure of the Fund, procedures
and payment requirements for creating and redeeming Shares, transaction
fees and expenses, dividends, distributions, taxes, reports to be
distributed to beneficial owners of the Shares, availability of
information regarding the Shares, and calculation and dissemination of
key values can be found in the Registration Statement \5\ or on the Web
site for the Fund (http://www.ishares.com).

---------------------------------------------------------------------------

    \5\ See iShares, Inc.'s Registration Statement on Form N-1A, as
amended through July 19, 2007 (File Nos. 33-97598 and 811-09102)
(``Registration Statement'').
---------------------------------------------------------------------------

    Availability of Information. The Exchange states that quotations
and last-sale information regarding the Shares will be disseminated
through the facilities of the Consolidated Tape Association (``CTA'').
The Index value is calculated by Morgan Stanley Capital International,
Inc. (``MSCI''), the Index provider, for each trading day in the
applicable foreign exchange markets based on official closing prices in
such exchange markets and publicly disseminates the Index values for
the previous day's close.\6\ MSCI or third-party major market data
vendors will make available at least every 60 seconds

an updated Index value when foreign trading market hours overlap with
the Core Trading Session (9:30 a.m. to 4:15 p.m. Eastern Time or
``ET'').\7\ When the foreign markets are closed during Exchange trading
hours, the Fund will provide closing Index values on http://www.ishares.com.
 iShares, Inc. will cause to be made available daily

the names and required number of shares of each of the securities to be
deposited in connection with the issuance of the Fund's Shares, as well
as information relating to the required cash payment representing, in
part, the amount of accrued dividends for the Fund.
---------------------------------------------------------------------------

    \6\ The Exchange notes that, when a broker-dealer or a broker-
dealer's affiliate, such as MSCI, is involved in the development and
maintenance of a stock index upon which a product such as iShares is
based, the broker-dealer or its affiliate should have procedures
designed specifically to address the improper sharing of
information. See Securities Exchange Act Release No. 52178 (July 29,
2005), 70 FR 46244 n.18 (August 9, 2005) (SR-NYSE-2005-41)
(describing the procedures which must be in place to prevent the
improper sharing of information). The Exchange represents that MSCI
has implemented procedures to prevent the misuse of material, non-
public information regarding changes to component stocks in the
MSCI, in accordance with the requirements of Commentary .01(b)(1) to
NYSE Arca Equities Rule 5.2(j)(3).
    \7\ See NYSE Arca Equities Rule 7.34.
---------------------------------------------------------------------------

    In addition, the Indicative Optimized Portfolio Value or ``IOPV''
on a per-Share basis will be calculated by an independent third party
and disseminated through the facilities of the CTA at least every 15
seconds during the Core Trading Session.\8\ The Exchange states that,
because the Fund utilizes a representative sampling strategy, the IOPV
likely will not reflect the value of all securities included in the
Index or necessarily reflect the precise composition of the current
portfolio of securities held by the Fund at a particular moment. The
Exchange notes that the IOPV disseminated during the Core Trading
Session should not be viewed as a real-time update of the NAV of the
Fund, which is calculated only once a day.
---------------------------------------------------------------------------

    \8\ The Exchange states that there is an overlap in trading
hours between the foreign and U.S. markets for the Fund and the
foreign market that trades securities in the underlying Index.
Therefore, the IOPV calculator will update the IOPV at least every
15 seconds to reflect price changes in the applicable foreign market
and convert such prices into U.S. dollars based on the currency
exchange rate. When the foreign market is closed and the U.S.
markets are open, the IOPV will be updated at least every 15 seconds
to reflect changes in currency exchange rates after the foreign
market closes.
---------------------------------------------------------------------------

    The Fund administrator, State Street Bank and Trust Company, will
calculate the net asset value or ``NAV'' for the Fund once a day on
each day that the New York Stock Exchange LLC is open for trading,
generally at 4 p.m. ET. The NAV will also be available to the public on
http://www.ishares.com, from the Fund distributor by means of a toll-

free phone number, and to participants of the National Securities
Clearing Corporation.
    Information with respect to recent NAV, number of Shares
outstanding, estimated cash amount and total cash amount per Creation
Unit Aggregation,\9\ and other data with respect to the Fund will also
be disseminated prior to the opening of the Core Trading Session on a
daily basis by means of CTA and Consolidated Quote High Speed Lines. In
addition, the Web site for the Fund will contain the following
information, on a per-Share basis: (1) The prior business day's NAV,
the mid-point of the bid-ask price at the time of calculation of such
NAV (``Bid/Ask Price''),\10\ and a calculation of the premium or
discount of such price against such NAV; and (2) data in chart format
displaying the frequency distribution of discounts and premiums of the
Bid/Ask Price against the NAV, within appropriate ranges, for each of
the four previous calendar quarters. Finally, the Exchange states that
MSCI's Web site at http://www.mscibarra.com will make available the

components of the Index, and the holdings of the Fund will be available
at http://www.ishares.com. The Exchange represents that the information

on the Fund Web site will be available to all market participants at
the same time.
---------------------------------------------------------------------------

    \9\ See Registration Statement, supra note 5 (providing the
definition of Creation Unit Aggregation and the procedures for
purchasing and redeeming Shares).
    \10\ The Bid-Ask Price of the Fund is determined using the
highest bid and lowest offer on the Exchange as of the time of
calculation of the Fund's NAV.
---------------------------------------------------------------------------

    Trading Rules and Halts. The Exchange deems the Shares to be equity
securities, thus rendering trading in the Shares subject to the
Exchange's existing rules governing the trading of equity securities.
The Shares will trade on the Exchange from 4 a.m. to 8 p.m. ET in
accordance with NYSE Arca Equities Rule 7.34. The Exchange represents
that it has appropriate rules to facilitate transactions in the Shares
during all trading sessions, including rules governing trading halts,
as provided in NYSE Arca Equities Rule 5.5(g)(2)(b).
    Surveillance. The Exchange intends to utilize its existing
surveillance procedures applicable to ICUs to monitor trading in the
Shares. The Exchange represents that these procedures, which focus on
detecting when securities trade outside their normal patterns, are
adequate to properly monitor Exchange trading of the Shares in all
trading sessions and to deter and detect violations of Exchange rules.
The Exchange further represents that it may obtain information via the
Intermarket Surveillance Group (``ISG'') from other exchanges that are
members or affiliate members of ISG.\11\ The Exchange states that it
has a general policy prohibiting the distribution of material, non-
public information by its employees.
---------------------------------------------------------------------------

    \11\ The Exchange notes that the Tokyo Stock Exchange, which is
the exchange on which the stocks comprising the Index are primarily
traded, is an affiliate member of ISG. The Exchange further notes
that one or more of the securities comprising the Index may trade on
exchanges that are not members or affiliate members of ISG, and the
Exchange may not have in place comprehensive surveillance sharing
agreements with such exchanges.
---------------------------------------------------------------------------

    Information Bulletin. Prior to the commencement of trading, the
Exchange will inform its ETP Holders \12\ in an Information Bulletin
(``Bulletin'') of the special characteristics and risks associated with
trading the Shares. Specifically, the Bulletin will discuss: (1) The
procedures for purchases and redemptions of Shares in Creation Unit
Aggregations (and that Shares are not individually redeemable); (2)
NYSE Arca Equities Rule 9.2(a), which imposes a duty of due diligence
on its ETP Holders to learn the essential facts relating to every
customer prior to trading the Shares; (3) how information regarding the
IOPV is disseminated; (4) the risks involved in trading the shares
during the Opening and Late Trading Sessions when an updated IOPV will
not be calculated or publicly available; (5) the requirement that ETP
Holders deliver a prospectus to investors purchasing newly issued
Shares prior to or concurrently with the confirmation of a transaction;
and (6) trading information. In addition, the Bulletin will reference
that the Fund is subject to various fees and expenses described in the
Registration Statement and will also discuss any exemptive, no-action,
or interpretive relief granted by the Commission from provisions of the
Act and the rules thereunder. The Bulletin will also disclose that the
NAV for the Shares will be calculated after 4 p.m. ET each trading day.
---------------------------------------------------------------------------

    \12\ See NYSE Arca Equities Rule 1.1 (defining ETP Holder as a
registered broker or dealer that is a sole proprietorship,
partnership, corporation, limited liability company, or other
organization in good standing that has been issued an Equity Trading
Permit or ``ETP'').
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with section 6(b) of the Act,\13\ in general, and furthers the
objectives of section 6(b)(5) of the Act,\14\ in particular, in that it
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 facilitating
transactions in securities, and to remove impediments to and perfect
the mechanism of a free and open market and a national market system.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \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
impose 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

    The Exchange states that written comments on the proposed rule
change were neither solicited nor recieved.

III. 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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NYSEArca-2007-128 on the subject line.

Paper Comments

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

    All submissions should refer to File Number SR-NYSEArca-2007-128.
This file number should be included on the subject line if e-mail 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 inspection
and copying 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 such filing also will 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-NYSEArca-2007-128 and should
be submitted on or before January 17, 2008.

IV. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\15\ In particular, the Commission finds that the proposed
rule change is consistent with section 6(b)(5) of the Act,\16\ which
requires that the rules of a national securities exchange be designed,
among other things, to promote just and equitable principles of trade,
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.
---------------------------------------------------------------------------

    \15\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Although NYSE Arca Equities Rule 5.2(j)(3) permits the Exchange to
list and trade ICUs, the Shares do not meet all of the generic listing
requirements \17\ under such rule because the components of the Index
do not meet the requirements of Commentary .01(a)(B)(2) to NYSE Arca
Equities Rule 5.2(j)(3). Commentary .01(a)(B)(2) to NYSE Arca Equities
Rule 5.2(j)(3) requires that, upon the initial listing of any series of
ICUs pursuant to Rule 19b-4(e) under the Act, component stocks that, in
the aggregate, account for at least 90% of the weight of the Index or
portfolio, must each have a minimum worldwide trading volume during
each of the last six months of at least 250,000 shares. According to
the Exchange, as of December 10, 2007, those component stocks
comprising the Index that individually exceed the minimum worldwide
monthly trading volume of 250,000 shares during each of the previous
six months, in the aggregate, accounted for only 88% of the weight of
the Index. Such percentage misses the minimum required threshold by 2%,
and therefore the Shares cannot be listed and traded pursuant to the
generic listing standards of NYSE Arca Equities Rule 5.2(j)(3).
---------------------------------------------------------------------------

    \17\ The generic listing requirements under NYSE Arca Equities
Rule 5.2(j)(3) permit the listing and trading of ICUs pursuant to
Rule 19b-4(e) under the Act (17 CFR 240.19b-4(e)). Rule 19b-4(e)
provides that the listing and trading of a new derivative securities
product by a self-regulatory organization (``SRO'') shall not be
deemed a proposed rule change, pursuant to Rule 19b-4(c)(1), if the
Commission has approved, pursuant to Section 19(b) of the Act, the
SRO's trading rules, procedures, and listing standards for the
product class that would include the new derivatives securities
product, and the SRO has a surveillance program for the product
class.
---------------------------------------------------------------------------

    The Commission believes, however, that the listing and trading of
the Shares is consistent with the Act. The Commission notes that, based
on the Exchange's representations, the Shares otherwise meet all of the
other applicable generic listing standards under NYSE Arca Equities
Rule 5.2(j)(3). The Commission further notes that it has previously
approved the listing and trading of derivative securities products
based on indices that were composed of stocks that did not meet certain
quantitative generic listing criteria by only a slight margin.\18\
---------------------------------------------------------------------------

    \18\ See, e.g., Securities Exchange Act Release Nos. 55953 (June
25, 2007), 72 FR 36084 (July 2, 2007) (SR-NYSE-2007-46) (approving
the listing and trading of shares of the HealthShares\TM\ Orthopedic
Repair exchange-traded fund where the component stocks comprising
the index that individually exceeded the minimum worldwide monthly
trading volume of 250,000 shares during each of the last six months
accounted, in the aggregate, for 86.2% of the weight of the index)
and 56695 (October 24, 2007), 72 FR 61413 (October 30, 2007) (SR-
NYSEArca-2007-111) (approving the listing and trading of shares
Shares of the HealthShares\TM\ Ophthalmology exchange-traded fund
where the component stocks comprising the index that individually
exceeded the minimum worldwide monthly trading volume of 250,000
shares during each of the last six months accounted, in the
aggregate, for only 88.2% of the weight of the index).
---------------------------------------------------------------------------

    The Commission also finds that the proposal is consistent with
section 11A(a)(1)(C)(iii) of the Act,\19\ which sets forth Congress'
finding that it is in the public interest and appropriate for the
protection of investors and the maintenance of fair and orderly markets
to assure the availability to brokers, dealers, and investors of
information with respect to quotations for and transactions in
securities. Quotations and last-sale information for the Shares will be
disseminated through the facilities of the CTA. MSCI or third-party
major market data vendors will make available at least every 60 seconds
an updated Index value during the Exchange's Core Trading Session. In
addition, an independent third-party calculator will calculate and
disseminate the IOPV through the facilities of the CTA at least every
15 seconds during the Exchange's Core

Trading Session. Further, the Fund's Web site will disseminate
information relating to the NAV and the Bid/Ask Price for the Shares,
as well as the specific holdings of the Fund.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
---------------------------------------------------------------------------

    The Commission believes that the proposed rule change is reasonably
designed to promote fair disclosure of information that may be
necessary to appropriately price the Shares. Under Rule 5.2(j)(3)(v),
the Exchange is required to obtain a representation from iShares, Inc.
that the NAV per Share will be calculated daily and made available to
all market participants at the same time. In addition, the Exchange
represents that the Web site disclosure of the information regarding
the Shares and the portfolio composition of the Fund will be made to
all market participants at the same time. The Exchange further
represents that MSCI has procedures in place that comply with the
requirements of Commentary .01(b)(1) to NYSE Arca Equities Rule
5.2(j)(3), which relates to restricted access of information concerning
changes and adjustments to the Index.
    The Commission further believes that the trading rules and
procedures to which the Shares would be subject pursuant to this
proposal are consistent with the Act. The Shares would trade as equity
securities and be subject to NYSE Arca's rules governing the trading of
equity securities. The Commission also believes that the Exchange's
trading halt rules under NYSE Arca Equities Rule 5.5(g)(2)(b) are
reasonably designed to prevent trading in the Shares when transparency
is impaired.
    In support of this proposal, the Exchange has made the following
representations:
    1. The Exchange would utilize its existing surveillance procedures
applicable to ICUs to monitor trading of the Shares. The Exchange
represents that such surveillance procedures are adequate to properly
monitor the trading of the Shares. The Exchange may obtain trading
information via the ISG from other exchanges that are members or
affiliate members of ISG.\20\
---------------------------------------------------------------------------

    \20\ See supra note 11.
---------------------------------------------------------------------------

    2. Prior to the commencement of trading, the Exchange will inform
its ETP Holders in the Bulletin of the special characteristics and
risks (including the risks involved in trading the shares during the
Opening and Late Trading Sessions when an updated IOPV will not be
calculated or publicly available) associated with trading the Shares.
The Bulletin will discuss the procedures for purchases and redemptions
of Shares, the Exchange's suitability requirements, information
regarding the IOPV, and prospectus delivery requirements.
    3. The Exchange represents that iShares, Inc. is required to comply
with Rule 10A-3 under the Act \21\ for the initial and continued
listing of the Shares.

    \21\ 17 CFR 240.10A-3.

This approval order is based on the Exchange's representations.
    The Commission finds good cause, pursuant to section 19(b)(2) of
the Act,\22\ for approving the proposed rule change prior to the 30th
day after the date of publication of notice in the Federal Register.
The Commission notes that the Shares are substantially similar in
structure, operation, and function to the shares of other exchange-
traded funds, the shares of which are currently listed and trading in
the marketplace.\23\ As mentioned above, the Commission has previously
approved the listing and trading of other derivative securities
products based on indices that narrowly missed a quantitative generic
listing criterion but satisfied all the others.\24\ Given that the
Shares comply with all of NYSE Arca's initial generic listing standards
for ICUs (except for the one requirement of Commentary .01(a)(B)(2) to
NYSE Arca Equities Rule 5.2(j)(3)) and would be subject to NYSE Arca's
continued listing requirements for ICUs under NYSE Arca Equities Rule
5.5(g)(2), the listing and trading of the Shares does not appear to
present any novel or significant regulatory issues. Therefore, the
Commission believes that accelerating approval of this proposal should
benefit investors by creating, without undue delay, additional
competition in the market for such products. Accordingly, the
Commission finds that there is good cause, consistent with section
6(b)(5) of the Act,\25\ to approve the proposed rule change, as
modified by Amendment No. 1 thereto, on an accelerated basis.
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78s(b)(2).
    \23\ See, e.g., Securities Exchange Release Nos. 52178 (July 29,
2005), 70 FR 46244 (August 9, 2005) (SR-NYSE-2005-41) (approving the
listing and trading of shares of the iShares MSCI EAFE Growth Index
Fund and the iShares MSCI EAFE Value Index Fund, the underlying
indices of which are composed of non-U.S. component stocks) and
52761 (November 10, 2005), 70 FR 70010 (November 18, 2005) (SR-NYSE-
2005-76) (approving the listing and trading of shares of a number of
iShares foreign equity index funds).
    \24\ See supra note 18.
    \25\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

V. Conclusion

    IT IS THEREFORE ORDERED, pursuant to section 19(b)(2) under the
Act,\26\ that the proposed rule change (SR-NYSEArca-2007-128), as
modified by Amendment No. 1 thereto, be, and it hereby is, approved on
an accelerated basis.
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-24988 Filed 12-26-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Notices]
[Pages 54559-54560]
[FR Doc No: 2015-22737]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC15-199-000.
    Applicants: Grand Ridge Energy LLC, Grand Ridge Energy II LLC,
Grand Ridge Energy III LLC, Grand Ridge Energy IV LLC, Grand Ridge
Energy Storage LLC.
    Description: Application for Authorization under Section 203 of the
Federal Power Act and Request for Waivers and Expedited Action of Grand
Ridge Energy LLC, et al.
    Filed Date: 9/2/15.
    Accession Number: 20150902-5078.
    Comments Due: 5 p.m. ET 9/23/15.

    Docket Numbers: EC15-200-000.
    Applicants: ITC Midwest LLC.
    Description: Application Pursuant to Section 203 of the Federal
Power Act to Acquire New Assets of ITC Midwest LLC.
    Filed Date: 9/2/15.
    Accession Number: 20150902-5079.
    Comments Due: 5 p.m. ET 9/23/15.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-1819-012; ER10-1820-015; ER10-1818-010; ER10-
1817-011.

    Applicants: Northern States Power Company, a Minnesota corporation,
Northern States Power Company, a Wisconsin corporation, Public Service
Company of Colorado, Southwestern Public Service Company.
    Description: Notice of Change in Status of Northern States Power
Company, a Minnesota corporation, et al.
    Filed Date: 9/2/15.
    Accession Number: 20150902-5072.
    Comments Due: 5 p.m. ET 9/23/15.

    Docket Numbers: ER15-243-001.
    Applicants: PJM Interconnection, L.L.C., The Dayton Power and Light
Company.
    Description: Compliance filing: Dayton submits a compliance filing
revising Attachment H-15 per 8/14/15 Order to be effective 1/1/2015.
    Filed Date: 9/1/15.
    Accession Number: 20150901-5238.
    Comments Due: 5 p.m. ET 9/22/15.

    Docket Numbers: ER15-2592-000.
    Applicants: Sierra Pacific Power Company.
    Description: Sec.  205(d) Rate Filing: Rate Schedule No. 55 SPPC
Liberty 1st Amended Service Agreement 073115 to be effective 1/1/2016.

    Filed Date: 9/1/15.
    Accession Number: 20150901-5263.
    Comments Due: 5 p.m. ET 9/22/15.

    Docket Numbers: ER15-2593-000.
    Applicants: Desert Stateline LLC.
    Description: Baseline eTariff Filing: Application and Initial
Baseline Tariff Filing to be effective 11/1/2015.
    Filed Date: 9/1/15.
    Accession Number: 20150901-5269.
    Comments Due: 5 p.m. ET 9/22/15.

    Docket Numbers: ER15-2594-000.
    Applicants: South Central MCN, LLC.
    Description: Application for Acceptance of Transmission Rate
Formula and Approval of Transmission Rate Incentives of South Central
MCN LLC.
    Filed Date: 9/1/15.
    Accession Number: 20150901-5274.
    Comments Due: 5 p.m. ET 9/22/15.

    Docket Numbers: ER15-2595-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp Termination of SA 565 Klamath Geothermal
No. 1 KL-01 LLC SGIA Facilities Maintenance Agreement.
    Filed Date: 9/1/15.
    Accession Number: 20150901-5276.
    Comments Due: 5 p.m. ET 9/22/15.

    Docket Numbers: ER15-2596-000.
    Applicants: Golden Spread Electric Cooperative, Inc.
    Description: Sec.  205(d) Rate Filing: Exhibit C Amendment Filing
to be effective 11/6/2014.
    Filed Date: 9/2/15.
    Accession Number: 20150902-5131.
    Comments Due: 5 p.m. ET 9/23/15.

    Docket Numbers: ER15-2597-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Service Agreement No. 4241;
Queue AA1-067 (ICSA) to be effective 8/4/2015.
    Filed Date: 9/2/15.
    Accession Number: 20150902-5135.
    Comments Due: 5 p.m. ET 9/23/15.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES15-66-000.
    Applicants: El Paso Electric Company.
    Description: Application of El Paso Electric Company for FPA
Section 204 authorization.
    Filed Date: 9/2/15.
    Accession Number: 20150902-5113.
    Comments Due: 5 p.m. ET 9/23/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 2, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-22737 Filed 9-9-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 249 (Friday, December 29, 2023)]
[Notices]
[Page 90222]
[FR Doc No: 2023-28785]

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

[SEC File No. 270-420, OMB Control No. 3235-0479]

Submission for OMB Review; Comment Request; Extension: Rule 15c2-
7

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in Rule
15c2-7 (17 CFR 240.15c2-7) under the Securities Exchange Act of 1934
(15 U.S.C. 78a et seq.).
    Rule 15c2-7 places disclosure requirements on broker-dealers who
have correspondent relationships, or agreements identified in the Rule,
with other broker-dealers. Whenever any such broker-dealer enters a
quotation for a security through an inter-dealer quotation system, Rule
15c2-7 requires the broker-dealer to disclose these relationships and
agreements in the manner required by the Rule. The inter-dealer
quotation system must also be able to make these disclosures public in
association with the quotation the broker-dealer is making.
    When Rule 15c2-7 was adopted in 1964, the information it requires
was necessary for execution of the Commission's mandate under the
Securities Exchange Act of 1934 to prevent fraudulent, manipulative,
and deceptive acts by broker-dealers. In the absence of the information
collection required under Rule 15c2-7, investors and broker-dealers
would have been unable to accurately determine the market depth of, and
demand for, securities in an inter-dealer quotation system.
    There are approximately 3,493 broker-dealers registered with the
Commission. Any of these broker-dealers could be potential respondents
for Rule 15c2-7, so the Commission is using that number as the number
of respondents. Rule 15c2-7 applies only to quotations entered into an
inter-dealer quotation system, such as OTC Link, operated by OTC
Markets Group Inc. (``OTC Link''). According to a representative of OTC
Link, it has not received any Rule 15c2-7 notices since the previous
PRA extension for Rule 15c2-7 in 2020; nor does OTC Link anticipate
receiving any Rule 15c2-7 notices. However, because such notices could
be made, the Commission estimates that one filing is made annually
pursuant to Rule 15c2-7.
    Based on prior industry reports, the Commission estimates that the
average time required to enter a disclosure pursuant to the Rule is .75
minutes, or 45 seconds. The Commission sees no reason to change this
estimate. We estimate that impacted respondents spend a total of .0125
hours per year to comply with the requirements of Rule 15c2-7 (1 notice
(x) 45 seconds/notice).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent by January 29, 2024 to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom, Director/Chief Information
Officer, Securities and Exchange Commission, c/o John Pezzullo, 100 F
Street NE, Washington, DC 20549, or by sending an email to:
[email protected].

    Dated: December 26, 2023.
Christina Z. Milnor,
Assistant Secretary.
[FR Doc. 2023-28785 Filed 12-28-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: April 1, 2010 (Volume 75, Number 62)]
[Notices]
[Page 16534-16535]
[DOCID:fr01ap10-130]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61782; File No. SR-BX-2010-021]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Extending
the Pilot Period To Receive Inbound Routes of Orders From Nasdaq
Execution Services

March 25, 2010.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on March 23, 2010, NASDAQ OMX BX, Inc. (the ``Exchange'' or
``BX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II, below, which Items have been prepared by BX. BX has designated the
proposed rule change as constituting a non-controversial rule change
under Rule 19b-4(f)(6) under the Act,\3\ which renders the proposal
effective upon filing with the Commission. 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\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    BX submits this proposed rule change to extend the pilot period of
BX's prior approval to receive inbound routes of equities orders from
Nasdaq Execution Services, LLC (``NES'') through June 23, 2010.

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

    In its filing with the Commission, BX 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. BX 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
    Currently, NES is the approved outbound routing facility of the
NASDAQ Stock Market LLC (``NASDAQ'') for cash equities, providing
outbound routing from NASDAQ to other market centers.\4\ BX also has
been previously approved to receive inbound routes of equities orders
by NES in its capacity as an order routing facility of NASDAQ.\5\ The
Exchange's authority to receive inbound routes of equities orders by
NES is subject to a pilot period ending March 23, 2010.\6\ The Exchange
hereby seeks to extend the previously approved pilot period (with the
attendant obligations and conditions) for an additional 3 months,
through June 23, 2010.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release Nos. 50311 (September 3,
2004), 69 FR 54818 (September 10, 2004) (Order Granting Application
for a Temporary Conditional Exemption Pursuant To Section 36(a) of
the Exchange Act by the National Association of Securities Dealers,
Inc. Relating to the Acquisition of an ECN by The Nasdaq Stock
Market, Inc.) and 52902 (December 7, 2005), 70 FR 73810 (December
13, 2005) (SRNASD-2005-128) (Order Approving a Proposed Rule Change
To Establish Rules Governing the Operation of the INET System). See
also Securities Exchange Act Release Nos. 58752 (October 8, 2008),
73 FR 61181 (October 15, 2008) (SR-NASDAQ-2008-079); 58135 (July 10,
2008), 73 FR 40898 (July 16, 2008) (SR-NASDAQ-2008-061); 58069 (June
30, 2008), 73 FR 39360 (July 9, 2008) (SR-NASDAQ-2008-054); 56708
(October 26, 2007), 72 FR 61925 (November 1, 2007) (SR-NASDAQ-2007-
078); 56867 (November 29, 2007), 72 FR 69263 (December 7, 2007) (SR-
NASDAQ-2007-065); 55335 (February 23, 2007), 72 FR 9369 (March 1,
2007) (SR-NASDAQ-2007-005); 54613 (October 17, 2006), 71 FR 62325
(October 24, 2006) (SR-NASDAQ 2006-043); 54271 (August 3, 2006), 71
FR 45876 (August 10, 2006) (SR-NASDAQ-2006-027); and 54155 (July 14,
2006), 71 FR 41291 (July 20, 2006) (SR-NASDAQ-2006-001).
    \5\ See Securities Exchange Act Release No. 59154 (December 23,
2008), 73 FR 80468 (December 31, 2008).
    \6\ See Securities Exchange Act Release No. 61271 (December 31,
2009), 75 FR 1102 (January 8, 2010).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\7\ in general, and with
Section 6(b)(5) of the Act,\8\ 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. Specifically, the proposed rule change will allow the
Exchange to continue receiving inbound routes of equities orders from
NES acting in its capacity as a facility of NASDAQ, in a manner
consistent with prior approvals and established protections. The
Exchange believes that extending the previously approved pilot period
for 3 months is of sufficient length to permit both the Exchange and
the Commission to assess the impact of the Exchange's authority to
receive direct inbound routes of equities orders via NES (including the
attendant obligations and conditions).
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    BX does not believe that the proposed rule change will impose any
burden on competition 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

    No written comments were either solicited or received.

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

    Because the foregoing rule change 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 after the date of this filing, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \9\ and Rule 19b-4(f)(6) thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\11\
However, Rule 19b-4(f)(6)(iii) \12\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. BX has requested that the Commission
waive the 30-day operative delay.\13\ BX notes that the proposal will
allow the Exchange to continue receiving inbound routes of equities
orders from NES, in a manner consistent with prior approvals and
established protections, while also permitting the Exchange and the
Commission to assess the impact of the pilot.\14\ The Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because such waiver
would allow the pilot period to be extended without interruption
through June 23, 2010. For this reason, the Commission designates the
proposed rule change to be operative upon filing with the
Commission.\15\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule
19b[ndash x ]4(f)(6)(iii) requires that a self-
regulatory organization submit to the Commission 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 filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
    \12\ Id.
    \13\ E-mail from Thomas Moran, Associate General Counsel, Office
of General Counsel, NASDAQ OMX BX, to Theodore S. Venuti, Special
Counsel, Division of Trading and Markets, Commission, dated March
24, 2010.
    \14\ See supra Section II.A.2.
    \15\ For the purposes only of waiving the 30-day operative
delay, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change the Commission may summarily abrogate such 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.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BX-2010-021 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-BX-2010-021. This file
number should be included on the subject line if e-mail 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 inspection and
copying in the Commission's Public Reference Room on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such filing also
will 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-BX-
2010-021 and should be submitted on or before April 22, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-7361 Filed 3-31-10; 8:45 am]
BILLING CODE 8011-01-P