[Federal Register Volume 78, Number 71 (Friday, April 12, 2013)]
[Notices]
[Pages 21921-21923]
[FR Doc No: 2013-08584]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12790-002]

Andrew Peklo III; Notice of Application Accepted for Filing,
Intent To Waive Scoping, Soliciting Motions To Intervene and Protests,
Ready for Environmental Analysis, and Soliciting Comments, Terms and
Conditions, Recommendations, and Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection. An
application for exemption from licensing was filed on February 16,
2011; however, on January 17, 2013, the applicant converted its
application for exemption from licensing to an application for license.
This notice refers to the docket for the application for license (P-
12790-002). All stakeholder comments, motions to intervene, and
protests filed on the proceeding for the application for exemption from
licensing (P-12790-001) are incorporated into the docket for the
application for license.
    a. Type of Application: Minor License.
    b. Project No.: 12790-002.
    c. Date filed: January 17, 2013.
    d. Applicant: Andrew Peklo III.
    e. Name of Project: Pomperaug Hydro Project.

    f. Location: On the Pomperaug River, in the Town of Woodbury,
Litchfield County, Connecticut. The project would not occupy lands of
the United States.
    g. Filed Pursuant to: Federal Power Act (FPA) 16 U.S.C. 791 (a)-
825(r).
    h. Applicant Contact: Andrew Peklo III, 29 Pomperaug Road,
Woodbury, CT 06798,<PHONE_NUMBER><EMAIL_ADDRESS>    i. FERC Contact: Steve Kartalia,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item k below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See, 94 FERC ]
61,076 (2001).
    k. Deadline for filing motions to intervene and protests, comments,
terms and conditions, recommendations, prescriptions, and requests for
cooperating agency status: Due to the previous opportunities to file
motions to intervene and protests, comments, terms and conditions,
recommendations, and prescriptions under P-12970-001, the 60-day
timeframe specified in 18 CFR 4.34(b) for filing comments (including
mandatory and recommended terms and conditions or prescriptions) on the
application for license is shortened. Motions to intervene and
protests, comments, terms and conditions, recommendations,
prescriptions, and requests for cooperating agency status on the
license application are due 30 days from the issuance date of this
notice. All reply comments must be filed with the Commission within 45
days from the date of this notice. Comments, interventions, and
protests filed on the exemption from licensing proceeding (P-12790-001)
do not need to be refiled under P-12970-002. However, conditions filed
under section 30(c) of the FPA will be considered under section 10(a)
of the FPA unless they are withdrawn or superseded by conditions
appropriate for an application for license.
    All new documents may be filed electronically via the Internet. See
18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and five copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    l. The application for license has been accepted for filing and is
now ready for environmental analysis.
    m. The Pomperaug Hydro Project would consist of: (1) The existing
90-foot-long, 15-foot-high Pomperaug River dam equipped with three
existing gates; (2) an existing 3-acre impoundment with a normal water
surface elevation of 226.43 feet above mean sea level; (3) an existing
40-foot-long, 42- to 50-inch-diameter penstock; and (4) an existing
powerhouse integral to the dam, containing one new 76-kilowatt turbine
generating unit. Project power would be transmitted through a new 35-
foot-long, 208-volt underground transmission line. The proposed project
is estimated to generate an average of 300,000 kilowatt-hours annually.
    The applicant proposes to: (1) Rehabilitate the existing gates and
construct a new intake structure; (2) install the new turbine
generating unit; (3) construct new fish and eel passage facilities; and
(4) bury the new transmission line. The application for license does
not include any proposed modifications to the crest elevation of the
dam or the water surface elevation of the impoundment.
    n. Due to the applicant's close coordination with federal and state
agencies during the preparation of the application, completed studies,
and prior opportunities for public and agency comment, we intend to
waive scoping. The issues that need to be addressed in Commission
staff's environmental assessment (EA) have been adequately identified
through comments filed on P-12970-001 and comments made during a
January 18, 2012, public meeting and site visit and no new issues are
likely to be identified through additional scoping. The EA will
consider assessing the potential effects of project construction and
operation on geology and soils, aquatic resources, terrestrial
resources, recreation, land use, aesthetic resources, and cultural
resources.
    o. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site 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, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    Anyone may submit comments, a protest, or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, 385.211, and 385.214. In determining the appropriate
action to take, the Commission will consider all protests or other
comments filed, but only those who file a motion to intervene in
accordance with the Commission's Rules may become a party to the
proceeding. Any comments, protests, or motions to intervene must be
received on or before the deadline specified in item k above. Comments,
interventions, and protests filed on the exemption from licensing
proceeding (P-12790-001) do not need to be refiled under P-12970-002.
    All filings must: (1) Bear in all capital letters the title
``PROTEST,'' ``MOTION TO INTERVENE,'' ``REQUEST FOR COOPERATING AGENCY
STATUS,'' ``COMMENTS,'' ``REPLY COMMENTS,'' ``RECOMMENDATIONS,''
``TERMS AND CONDITIONS,'' or ``PRESCRIPTIONS;'' (2) set forth in the
heading the name of the applicant and the project number of the
application to which the filing responds; (3) furnish the name,
address, and telephone number of the person submitting the filing; and
(4) otherwise comply with the requirements of 18 CFR 385.2001 through
385.2005. All comments, recommendations, terms and conditions or
prescriptions must set forth their evidentiary basis and otherwise
comply with the requirements of 18 CFR 4.34(b). Agencies may obtain
copies of the application directly from the applicant.

Each filing must be accompanied by proof of service on all persons
listed on the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b), and 385.2010.
    p. Public notice of the filing of the initial development
application was made under P-12970-001 and established the due date for
filing competing applications or notices of intent. Under the
Commission's regulations, any competing development application must be
filed in response to and in compliance with public notice of the
initial development application. No competing applications or notices
of intent may be filed in response to this notice.
    q. The license applicant must file no later than 60 days following
the date of issuance of this notice: (1) A copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification.
    r. Procedural schedule: The application will be processed according
to the following procedural schedule. Revisions to the schedule may be
made as appropriate.

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                Milestone                           Target date
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Notice of the availability of the EA.....  August 2013.
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    Dated: April 8, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-08584 Filed 4-11-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 4, 2006 (Volume 71, Number 192)]
[Notices]
[Page 58650-58656]
[DOCID:fr04oc06-102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54528; File No. SR-ISE-2006-48]

Self-Regulatory Organizations; International Securities Exchange,
Inc. (n/k/a International Securities Exchange, LLC); Order Approving
Proposed Rule Change and Notice of Filing and Order Granting
Accelerated Approval of Amendment No. 1 Thereto Relating to the
Adoption of Rules To Govern Its Electronic Trading System for Equities

 September 28, 2006.

I. Introduction

    On August 4, 2006, the International Securities Exchange, Inc. (n/
k/a International Securities Exchange, LLC) (``ISE'' or ``Exchange'')
\1\ filed with the

Securities and Exchange Commission (``Commission'') a proposed rule
change pursuant to Section 19(b)(1) of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ to adopt rules to
govern its electronic trading system for equity securities. The
proposed rule change was published for comment in the Federal Register
on August 15, 2006.\4\ The Commission received no comments on the
proposal. On September 27, 2006, the Exchange filed Amendment No. 1 to
the proposal.\5\ This order approves the proposed rule change, grants
accelerated approval to Amendment No. 1, and solicits comments from
interested persons on Amendment No. 1.
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    \1\ On September 1, 2006, the Exchange adopted a holding company
structure by forming a new parent company, International Securities
Exchange Holdings, Inc. (``Holdings''). As part of the
restructuring, International Securities Exchange, Inc. (``ISE
Inc.''), the registered national securities exchange, merged into a
newly formed entity, International Securities Exchange, LLC (``ISE
LLC''), a wholly-owned subsidiary of Holdings. ISE LLC continues to
conduct the business operations of the exchange and is the successor
to the registration of ISE Inc. as a national securities exchange.
See Securities Exchange Act Release No. 53705 (April 21, 2006), 71
FR 25260 (April 28, 2006) (File No. SR-ISE-2006-04). Holdings is
also the parent company of ISE Stock Exchange, LLC, the facility to
which the proposed rule change relates. All references herein to
``ISE'' or the ``Exchange'' refer to ISE Inc. or ISE LLC, as
appropriate.
    \2\ 15 U.S.C. 78s(b)(1).
    \3\ 17 CFR 240.19b-4.
    \4\ See Securities Exchange Act Release No. 54287 (August 8,
2006), 71 FR 46947.
    \5\ In Amendment No. 1, the Exchange: (i) Amended proposed ISE
Rule 2110 (Minimum Price Variation) to conform with the language of
Rule 612 of Regulation NMS; (ii) amended proposed ISE Rule 2106
(Opening Process) to reflect all order types that cannot participate
in the opening process and to add a provision addressing closing
procedures; (iii) changed the term ``partial round lot'' to ``mixed
lots'' to correspond to the current industry term and clarified
corresponding proposed ISE Rule 2105 (Order Entry); (iv) amended
proposed ISE Rule 2107 (Priority and Execution of Orders) to address
how orders entered into the ISE Stock Exchange will interact with
MidPoint Match orders; (v) amended proposed ISE Rule 2118 (Trade
Modifiers) to incorporate applicable requirements of Rule 611 of
Regulation NMS; (vi) made clarifying changes to the clearing
requirements; (vii) made conforming changes to the proposed rules to
match, where applicable, the rules filed under the Form PILOT
relating to MidPoint Match; (viii) added proposed ISE Rule 2120
(Taking or Supplying Securities); (ix) clarified routing procedures
before and after February 5, 2007, the Regulation NMS ``Trading
Phase Date''; and (x) made other minor clarifying changes to various
proposed rules. The complete text of Amendment No. 1 is available on
the Commission's Web site (http://www.sec.gov/rules/sro.shtml), at

the Commission's Public Reference Room, and at the Exchange.
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II. Summary Description of the Proposal

    The Exchange proposes to adopt new rules and amend existing ISE
rules to govern the operation of the ISE Stock Exchange, LLC (``ISE
Stock Exchange''), a new electronic trading system for equity
securities (``System'').\6\ In addition, the Exchange proposes to apply
certain of its options rules to the trading of equity securities on the
ISE Stock Exchange. The ISE Stock Exchange will trade equity securities
only pursuant to unlisted trading privileges (``UTP'').\7\
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    \6\ On September 1, 2006, the Commission approved a proposed
rule change establishing the ISE Stock Exchange as a ``facility,''
as defined in Section 3(a)(2) of the Act, of the Exchange. See
Securities Exchange Act Release No. 54399, 71 FR 53728 (September
12, 2006) (SR-ISE-2006-45).
    \7\ While the proposed rules would allow the ISE Stock Exchange
to trade common stock, Commodity-Based Trust Shares, Currency Trust
Shares, Partnership Units, Trust Issued Receipts including those
based on Investment Shares, and Investment Company Units by either
listing and/or trading pursuant to UTP, the Commission notes that,
to list equity securities, the Exchange would need to amend its
rules to comply with Rule 10A-3 under the Act, 17 CFR 240.10A-3, and
to incorporate qualitative listing criteria by filing a proposed
rule change under Section 19(b)(1) of the Act.
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    The System will provide for the electronic execution and display of
orders, as well as a midpoint matching feature (``MidPoint Match'').
The class of members who will be eligible to trade on the ISE Stock
Exchange are electronic access members (``EAMs'') of the Exchange whom
ISE specifically authorizes to trade on the ISE Stock Exchange
(``Equity EAMs''). Orders will be ranked in the System based on price-
time priority, regardless of the identity of the entering Equity EAM.
Executions will take place automatically and immediately upon order
entry if trading interest is available. The System will provide a
routing service for orders when trading interest is not present on the
ISE Stock Exchange. The ISE Stock Exchange will not have any market
makers, only Equity EAMs who will provide liquidity to the ISE Stock
Exchange. The ISE Stock Exchange will be an order-driven marketplace.
    The proposed rules incorporate the ISE Stock Exchange's compliance
with Rule 611 of Regulation NMS \8\ by requiring that, for any
execution to occur on the ISE Stock Exchange during regular trading
hours, the price must be equal to, or better than, any ``protected
quotation'' within the meaning of Regulation NMS (``Protected
Quotation''),\9\ unless an exception to Rule 611 of Regulation NMS is
available.\10\ The Exchange proposes to direct to away markets for
execution all or a portion of the orders that cannot be executed at the
Protected Quotation on the ISE Stock Exchange, and are not
cancelled.\11\ The proposed rules also incorporate the prohibition in
Regulation NMS on locking or crossing Protected Quotations,\12\ except
in certain circumstances.\13\
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    \8\ 17 CFR 242.611.
    \9\ See proposed ISE Rule 2100(c)(16).
    \10\ See proposed ISE Rule 2107(c).
    \11\ See proposed ISE Rule 2107(d).
    \12\ 17 CFR 242.610(d).
    \13\ See proposed ISE Rule 2112.
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    The MidPoint Match feature of the System will be a mechanism for
trading equity securities in a continuous matching system.\14\ Users
will enter unpriced orders into MidPoint Match, and MidPoint Match will
continuously monitor buy and sell orders in MidPoint Match and, subject
to certain limitations discussed more fully below, will execute orders
at the midpoint of the NBBO when interest is resident in MidPoint Match
on both sides of the market.\15\
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    \14\ See proposed ISE Rule 2129.
    \15\ The Exchange previously filed with the Commission pursuant
to Rule 19b-5 under the Act, 17 CFR 240.19b-5, a Form PILOT setting
forth rules governing MidPoint Match. See PILOT-ISE-2006-01 (July
28, 2006). ISE commenced operation of MidPoint Match on September 8,
2006. The rules filed under the Form PILOT, with minor
modifications, were incorporated into the Exchange's proposed rule
change, as amended. Upon the Commission's approval of the proposed
rule change, the rules relating to the fully displayed market will
be effective, but will not be operative until ISE launches its fully
displayed market, and the rules pertaining to MidPoint Match that
are incorporated into the proposed rule change will be operative
immediately. Prior to launch of the fully displayed market, the
Exchange intends to file a proposed rule change with the Commission
to indicate that the rules relating to the fully displayed market
have become operative. The Exchange represents that it intends to
commence trading in the displayed market prior to February 5, 2007,
the Regulation NMS ``Trading Phase Date.''
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    A more complete discussion of the features of the ISE Stock
Exchange is contained below.

III. Discussion

    After careful review, the Commission finds that the proposed rule
change, as amended, is consistent with the Act and the rules and
regulations promulgated thereunder applicable to a national securities
exchange \16\ and, in particular, with the requirements of Section 6(b)
of the Act.\17\ Specifically, the Commission finds that approval of the
proposed rule change is consistent with Section 6(b)(5) of the Act \18\
in that it is designed to facilitate transactions in securities; 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.
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    \16\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition, and capital
formation. 15 U.S.C. 78c(f).
    \17\ 15 U.S.C. 78f(b).
    \18\ 15 U.S.C. 78f(b)(5).
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A. Access to ISE Stock Exchange

    The class of members who will be eligible to trade on the ISE Stock
Exchange are Equity EAMs. All current EAMs of the Exchange are eligible
to become Equity EAMs. Any broker-dealer that is not currently an EAM
can become an Equity EAM first by applying for EAM status through the
existing membership process and then by connecting to the ISE Stock
Exchange through the FIX or CMS protocols and paying any applicable
fees. Such fees will be the same for current and new EAMs seeking to
become Equity EAMs. The Commission believes that the proposed
definition of, and the procedures relating to authorization of an EAM
to act as, an Equity EAM are consistent with the Act.

B. Order Types

    The following order types will be eligible for execution on the ISE
Stock Exchange, including MidPoint Match orders, which are described
below.
    Market Orders: A Market Order is an order to buy or sell a stated
amount of a security that is to be executed immediately and
automatically at the best available price(s) \19\ when the order
reaches the ISE Stock Exchange, to the greatest extent possible without
causing an execution during regular trading hours at a price that is
inferior to a Protected Quotation (``Trade-Through''). Any unexecuted
shares of a Market Order may be routed in whole or in part to other
Trading Centers \20\ with Protected Quotations.
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    \19\ The ``best available price'' means the highest bid price
and the lowest offer price, including orders with executable
undisplayed interest to buy or sell and interest to buy or sell that
may exist in MidPoint Match. See proposed ISE Rule 2100(c)(3).
    \20\ A ``Trading Center'' is a national securities exchange or
national securities association that operates an SRO trading
facility, an alternative trading system, an exchange market maker,
an OTC market maker, or any other broker or dealer that executes
orders internally by trading as principal or crossing orders as
agent. See proposed ISE Rule 2100(c)(20).
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    Limit Orders: A Limit Order is a one-sided order to buy or sell a
stated quantity of a security at a specified price or better. The types
of Limit Orders that the ISE Stock Exchange will accept include Reserve
Orders, Immediate-or-Cancel (``IOC'') Orders, Intermarket Sweep Orders
(``ISOs''), Fill-or-Kill (``FOK'') Orders, Not Routable Orders, and
Post Only Orders.
    Reserve Orders will have a portion of their size displayed, while a
reserve portion of their size at the same price will not be displayed.
The reserve size will be used to refresh the displayed size when the
displayed size is executed in full. When the displayed size of a
Reserve Order is replenished from the reserve size, the displayed order
is considered newly entered for purposes of time priority.
    IOC Orders will be executed immediately and automatically against
existing orders on the System at the best available price(s) to the
greatest extent possible without causing a Trade-Through, and any
unexecuted balance will be cancelled. Any Equity EAM may use an IOC
Order to immediately and automatically execute against the full size of
the displayed quotation on the System (including any undisplayed or
reserve size available at the price of the displayed quotation).
    With respect to orders received by the ISE Stock Exchange, ISOs are
orders to be executed in whole or in part upon receipt against existing
orders on the System at their executable price, in order of their
ranking and without regard to better-priced quotations displayed at
other Trading Centers, and if not so executed are to be cancelled. With
respect to orders sent by the ISE Stock Exchange to other Trading
Centers, ISOs are orders to be executed in whole or in part at such
Trading Centers without regard to better-priced quotations displayed at
other Trading Centers, and if not so executed are to be cancelled.\21\
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    \21\ The Exchange intends the ISO order type to be equivalent to
the ``intermarket sweep order'' defined in Rule 600(b)(30) of
Regulation NMS under the Act, 17 CFR 242.600(b)(30).
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    FOK Orders are to be executed in their entirety or cancelled upon
receipt. Not Routable Orders are to be executed in whole or in part
upon receipt, and if not fully executed, displayed on the ISE Stock
Exchange, as long as the order would not be executable against a
Protected Quotation. Post Only Orders are to be displayed on the ISE
Stock Exchange upon receipt or cancelled if they are executable upon
entry, either on the ISE Stock Exchange or at another Trading Center.
    Pegged Orders: Pegged Orders are Limit Orders to buy or sell a
stated amount of a security at a displayed price set to track the
current NBBO. The tracking of the relevant NBBO for Pegged Orders will
occur on a real-time basis. If the calculated price for the Pegged
Order would exceed its limit price, it will no longer track the NBBO
and will remain displayed at its limit price.
    The Commission believes that these order types are appropriate in
the context of the trading services proposed to be offered by the ISE
Stock Exchange. In addition, these order types should help provide
market participants with flexibility in executing transactions that
meet the specific requirements of the order type.

C. Operating Hours and Opening Process

    The ISE Stock Exchange will operate during regular trading
hours.\22\ The System will accept orders each day prior to the
opening.\23\ The ISE Stock Exchange will open based upon the opening of
the primary market for a security.\24\ When the primary market is
either the NYSE or the Amex, the opening trade will be executed at the
midpoint of the first reported NBBO subsequent to a reported trade on
the primary market. When the primary market is Nasdaq, the opening
trade will be executed at the midpoint of the first reported NBBO. All
orders eligible to trade at the midpoint will be processed in time
sequence, beginning with the oldest order. Matches will occur until
there is no remaining volume or there is an imbalance of orders.
Following the opening execution process in an individual security, all
orders remaining will be executed in accordance with the proposed ISE
rules, as more fully discussed in the following section. All unexecuted
orders will be displayed on the order book, cancelled, or routed to
other Trading Centers in accordance with the proposed rules.
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    \22\ For common stock, the hours of business for the ISE Stock
Exchange will be 9:30 a.m. until 4 p.m. (ET). For securities other
than common stock, the hours of business are set forth in proposed
ISE Rules 2123 through 2127. See proposed ISE Rule 2102.
    \23\ All order types other than Stop, Stop Limit, No MPM, Post
Only, FOK, and IOC may participate in the opening transaction.
    \24\ Proposed ISE Rule 2106(c) defines the primary market as the
listing market for a security. If a security is traded on both the
NYSE and the Amex, the primary market would be considered the NYSE.
If a security is listed on both the NYSE and Nasdaq, the NYSE would
be considered the primary market.
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    The Commission believes that the proposed rules relating to the
System's operating hours and opening procedures are consistent with the
Act.

D. Order Execution and Priority

    Once the opening occurs for individual securities, the ISE Stock
Exchange will operate during regular trading hours. All orders will be
ranked automatically by the ISE Stock Exchange following price-time
priority as soon they are entered in the order book. Orders are ranked
beginning with the highest priced orders to buy and the lowest priced
orders to sell.\25\ For the

purposes of ranking, the System will use the price at which the order
is displayed. Within each price, orders will be ranked in time priority
based on the time that an order is displayed or ``updated'' at that
price, except that the undisplayed portions of Reserve Orders will be
ranked after all other orders and displayed portions of Reserve Orders
at the same price. When the displayed size of a Reserve Order is
replenished from the reserve size, the displayed order is considered
newly entered for the purposes of time priority.
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    \25\ See proposed ISE Rule 2107.
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    In addition, all orders will be available for price improvement at
the midpoint of the NBBO if contra-side interest exists in MidPoint
Match, unless the order is marked ``No MPM.'' \26\ Except as indicated
below, incoming orders will be executed at or within the NBBO. The
Commission believes that the proposed rules relating to order priority
and order execution are consistent with the Act.\27\
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    \26\ Equity EAMs can choose to place orders into MidPoint Match
or into the displayed market. Orders placed into the displayed
market will be eligible, by default, to interact with MidPoint Match
orders for purposes of gaining price improvement. Optionally, orders
in the displayed market can bypass MidPoint Match by being marked as
No MPM.
    \27\ Section 11(a) of the Act, 15 U.S.C. 78k(a)(1), prohibits a
member of a national securities exchange from effecting transactions
on that exchange for its own account, the account of an associated
person, or an account over which it or an associated person
exercises discretion, unless an exception applies. Rule 11a2-2(T)
under the Act, 17 CFR 240.11a2-2(T), commonly known as the ``effect
versus execute'' rule, provides exchange members with an exemption
from this prohibition. The Exchange represents that, consistent with
this rule, the System's time-priority execution parameters will
place all participants on the ``same footing,'' and no participant
will enjoy any special control over the timing of execution or any
special order handling advantages. According to the Exchange, all
orders will be transmitted directly to the System by electronic
means, and, once submitted, all orders will be executed, displayed,
cancelled, or routed automatically by the System, based on
established trading rules. The Commission notes that the Exchange
would enforce this requirement pursuant to its obligation under
Section 6(b)(1) of the Act, 15 U.S.C. 78f(b)(1), to enforce
compliance by its members and persons associated with its members
with the Federal securities laws and rules thereunder.
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E. Compliance With Regulation NMS Under the Act

    The System is designed to automatically prevent Trade-Throughs of
Protected Quotations. The System will accomplish this in two principal
ways: (i) By providing outbound routing for those orders that will be
available to route; and (ii) by displaying orders at prices that would
not cause a Trade-Through when executed. Additionally, the System will
take advantage of various exceptions to Rule 611 of Regulation NMS
under the Act.\28\ The Exchange has proposed to adopt an exception
(``self-help'') to allow for the System to Trade-Through a Protected
Quotation displayed by a Trading Center that is experiencing a failure,
material delay, or malfunction of its systems or equipment. If another
Trading Center repeatedly fails to respond within one second to
incoming orders attempting to access its Protected Quotations, the
System may bypass those Protected Quotations by: (i) Notifying the non-
responding Trading Center immediately after (or at the same time as)
electing self-help; and (ii) assessing whether the cause of the problem
lies with its own systems and, if so, taking immediate steps to resolve
the problem. ISOs may, by definition, trade at a price inferior to a
Protected Quotation. In addition, transactions may be executed at a
time when the Protected Quotations are crossed.
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    \28\ See proposed ISE Rule 2107(c).
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    The ISE Stock Exchange will not intentionally lock or cross any
Protected Quotations on another Trading Center,\29\ except in certain
circumstances. For instance, the System may lock or cross a Protected
Quotation: (i) When a Protected Bid is higher than a Protected
Offer;\30\ or (ii) if the locking or crossing quotation is an automated
quotation and an ISO has simultaneously been routed to execute against
the full displayed size of the locked or crossed Protected Quotation.
---------------------------------------------------------------------------

    \29\ See proposed ISE Rule 2112.
    \30\ See proposed ISE Rule 2100(c)(15).
---------------------------------------------------------------------------

    The Commission believes that the proposed rule change is consistent
with the requirements of Rule 610(d) and Rule 611 of Regulation NMS.

F. Order Routing

    The ISE Stock Exchange will offer a routing service for Equity
EAMs, when it does not have interest equal to or better than the
Protected Bid or Protected Offer.\31\ Certain order types, including
Market Orders and Limit Orders, are eligible to be routed.\32\ To be
eligible to enter routable orders into the ISE Stock Exchange, Equity
EAMs must, among other things, enter into a Routing Agreement with the
outbound routing facility of the Exchange.\33\
---------------------------------------------------------------------------

    \31\ Prior to February 5, 2007, the Regulation NMS ``Trading
Phase Date,'' the ISE Stock Exchange will not execute orders at a
price that is inferior to the best bid or offer of other Trading
Centers.
    \32\ See proposed ISE Rule 2107(d).
    \33\ See proposed ISE Rule 2105(d). A ``Routing Agreement'' is
an agreement between an Equity EAM and the outbound routing facility
of the ISE Stock Exchange, under which the outbound routing facility
agrees to act as agent for routing orders of the Equity EAM entered
into the ISE Stock Exchange to other market centers or broker-
dealers for execution, other than orders excluded by the terms of
the Routing Agreement, whenever such routing is required. See
proposed ISE Rule 2100(c)(18).
---------------------------------------------------------------------------

    The System will accept the following orders to be handled on the
ISE Stock Exchange, without routing to another Trading Center: IOC
Orders, FOK Orders, Not Routable Orders, and Post Only Orders.\34\ No
Equity EAM may enter any other type of order unless it has entered into
a Routing Agreement with the outbound routing facility of the
Exchange.\35\
---------------------------------------------------------------------------

    \34\ See proposed ISE Rules 2107(b)(2)(i), (ii), (iii), and
(iv), respectively. In addition, MidPoint Match orders would not be
routed, because MidPoint Match will execute all trades at the
midpoint of the NBBO.
    \35\ See proposed ISE Rule 2105(d).
---------------------------------------------------------------------------

    Market Orders and Routable Limit Orders Executable on the ISE Stock
Exchange. For orders that are routable, an IOC or ISO will
automatically be sent to one or more Trading Centers with a Protected
Quotation that is better than the ISE Stock Exchange quote for the
lesser of the full displayed size of the Protected Quotation or the
balance of the order. Any additional balance of the order will be
executed on the ISE Stock Exchange simultaneously. If the market is
crossed, the order will be handled as described below.
    Routable Limit Orders Unexecutable on the ISE Stock Exchange. If
display of a Limit Order (or any balance thereof) on the ISE Stock
Exchange would lock or cross a Protected Quotation, an ISO will
automatically be sent to one or more Trading Centers with a Protected
Quotation that would be locked or crossed by the display of the order
for up to the full displayed size of the Protected Quotation. Any
additional balance of the order will be displayed on the ISE Stock
Exchange immediately.
    Market Orders Unexecutable on the ISE Stock Exchange. An IOC will
automatically be sent to one or more Trading Centers with a Protected
Quotation for the full size of the Market Order that is not executable
on the ISE Stock Exchange.
    The Commission finds that the proposed rules governing the routing
of orders to other Trading Centers are consistent with the Act.

G. Outbound Routing Facility

    In connection with the proposed trading rules described above, the
Exchange intends to enter into a contractual relationship with a
broker-dealer that will function solely as the outbound routing
facility (``ORF'') of the Exchange. The ORF will be a member of both
the National Association of Securities Dealers, Inc. (``NASD'') and

ISE. The ORF will provide an optional routing service for the Exchange,
in which the ORF will route orders from the ISE Stock Exchange to
Trading Centers with Protected Quotations through other brokers
(``Access Brokers'') that are members or participants of those Trading
Centers. As an outbound router, the ORF will receive routing
instructions from the System, route orders to another Trading Center
through an Access Broker, and be responsible for reporting resulting
executions back to the System, which in turn will report resulting
executions back to the Equity EAM. All orders routed through the ORF
will be subject to the Exchange's rules. The ORF would not be able to
change the terms of an order or the routing instructions, nor would it
have any discretion about where to route an order. The ORF includes the
clearing functions that the ORF may perform for trades with respect to
orders routed to other Trading Centers. Use of the ORF is optional for
Equity EAMs.
    The outbound router function of the ORF will operate as a facility
(as defined in Section 3(a)(2) of the Act) of the Exchange.\36\ As
such, the outbound router function of the ORF is subject to the
Commission's continuing oversight. In particular, and without
limitation, under the Act, the Exchange is responsible for filing with
the Commission proposed rule changes and fees relating to the ORF
outbound router function, and the ORF is subject to exchange non-
discrimination requirements.\37\
---------------------------------------------------------------------------

    \36\ 15 U.S.C. 78c(a)(2).
    \37\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Pursuant to Rule 17d-1 under the Act,\38\ where a member of the
Securities Investor Protection Corporation is a member of more than one
self-regulatory organization (``SRO''), the Commission will designate
to one of such organizations the responsibility for examining such
member for compliance with the applicable financial responsibility
rules.\39\ The SRO designation by the Commission is referred to as a
``Designated Examining Authority'' (``DEA''). As noted above, the ORF
will apply to become a member organization of the Exchange and a member
of the NASD. The NASD is an SRO not affiliated with the Exchange or its
affiliates and is a DEA pursuant to Rule 17d-1 under the Act.\40\
Furthermore, the Exchange represents that it will enter into a 17d-2
Agreement with the NASD to delegate to the NASD all regulatory
oversight and enforcement responsibilities with respect to the ORF
pursuant to applicable laws. The Exchange represents that it will
submit the 17d-2 Agreement to the Commission under Rule 17d-2 within 90
days of the date of this order.
---------------------------------------------------------------------------

    \38\ 17 CFR 240.17d-1.
    \39\ Pursuant to Rule 17d-1 under the Act, in making such
designation the Commission will take into consideration the
regulatory capabilities and procedures of the SROs, availability of
staff, convenience of location, unnecessary regulatory duplication,
and such other factors as the Commission may consider germane to the
protection of investors, the cooperation and coordination among
SROs, and the development of a national market system for the
clearance and settlement of securities transactions.
    \40\ 17 CFR 240.17d-1.
---------------------------------------------------------------------------

    The Exchange will establish and maintain procedures and internal
controls to restrict the flow of confidential and proprietary
information between the Exchange and the ORF and any other entity or
affiliate of the ORF.\41\ The books, records, premises, officers,
directors, agents, and employees of the ORF, as a facility of the
Exchange, shall be deemed to be the books, records, premises, officers,
directors, agents, and employees of the Exchange for purposes of and
subject to oversight pursuant to the Act. The books and records of the
ORF, as a facility of the Exchange, shall be subject at all times to
inspection and copying by the Exchange and the Commission.
---------------------------------------------------------------------------

    \41\ See proposed ISE Rule 2108.
---------------------------------------------------------------------------

    The Commission agrees with the Exchange that the ORF's services
would qualify it as a ``facility'' of the Exchange, and, consequently,
the operation of the ORF will be subject to Exchange oversight, as well
as Commission oversight. The Commission notes that the outbound routing
functionality is not the exclusive means for accessing better-priced
orders in other market centers should an order not be executable on the
ISE Stock Exchange. Accordingly, the ORF's routing services are
optional, and an Equity EAM is free to route its orders to other market
centers through alternative means. In light of the protections afforded
by the conditions discussed above, the Commission believes that the
Exchange's outbound routing function, and the rules and procedures
governing the ORF, are appropriate and consistent with the Act.

H. MidPoint Match

    MidPoint Match is a mechanism of the ISE Stock Exchange for trading
common stocks and similar securities in a continuous midpoint matching
system.\42\ Equity EAMs will be able to enter MidPoint Match orders to
buy or sell at the midpoint of the NBBO. Although orders in MidPoint
Match will be unpriced, members may specify a boundary price above
which they will not buy (or below which they will not sell). The System
will continuously monitor buy and sell orders in MidPoint Match and
will execute orders at the midpoint of the NBBO as long as the
execution does not violate the boundary price on an order.
---------------------------------------------------------------------------

    \42\ See proposed ISE Rule 2129.
---------------------------------------------------------------------------

    When entering an order, a member can specify what, if any,
information the System should disseminate:
    (i) The member can specify that the System not disseminate any
information regarding the order (``Standard Order''); or
    (ii) The member can specify that the System disseminate that there
is a pending order in a particular security, but not identify the side
or the size of the order (``Solicitation of Interest'' or ``SOI'').\43\
---------------------------------------------------------------------------

    \43\ However, an SOI must be for a minimum of 2000 shares, so
users would be aware that the SOI represented interest of at least
that size.
---------------------------------------------------------------------------

    MidPoint Match will reject an SOI (but not a Standard Order) with a
boundary price that is not then currently executable. Upon arrival of
an SOI, MidPoint Match will immediately generate a single broadcast
internally to all Equity EAMs that have programmed their systems to
accept this message announcing the arrival of the order. An Equity EAM
entering an SOI may not cancel that SOI for five seconds. In addition,
if an SOI is not executed within ten seconds, the SOI will convert into
a Standard Order.
    Because MidPoint Match will execute all trades at the midpoint of
the NBBO, MidPoint Match will never execute a trade outside of the
NBBO. In addition, MidPoint Match will not execute a trade if the
quotation for a security is ``crossed,'' with the national best bid
being greater than the national best offer. In that situation, MidPoint
Match will suspend executions, since both buyers and sellers may be
able to receive executions in other markets at prices better than the
NBBO midpoint. If the quotation is ``locked,'' with the national best
bid equaling the national best offer, MidPoint Match will execute all
trades at the locked price.
    Unless marked otherwise, all incoming orders to the ISE Stock
Exchange will be eligible for price improvement at the midpoint of the
NBBO if contra-side interest exists in MidPoint Match. As set forth in
the proposed rules, incoming orders will be executed at the best
available price on the ISE Stock Exchange, which means the highest bid
price and the lowest offer price, including undisplayed

orders to buy or sell that may exist in MidPoint Match. Orders marked
``No MPM'' will not be executed against orders residing in MidPoint
Match.
    The Commission believes that the order types and execution
parameters established in MidPoint Match are consistent with the Act.

I. Anonymity

    Except as described below, transactions executed on the ISE Stock
Exchange will be processed anonymously.\44\ This means that the ISE
Stock Exchange transaction reports will indicate the details of the
transaction but will not reveal contra-party identities.\45\ The
Commission notes that post-trade anonymity should not compromise an
Equity EAM's ability to settle an erroneous trade, because under
proposed ISE Rule 2128, the clearly erroneous execution resolution
process is coordinated by the Exchange, without the need for contra
parties to know each other's identities.
---------------------------------------------------------------------------

    \44\ See proposed ISE Rule 2117.
    \45\ ISE intends to submit a request for a limited exemption
from paragraph (a)(2)(i)(A) of Rule 10b-10 under the Act, 17 CFR
240.10b-10, on behalf of Equity EAMs that execute trades on the ISE
Stock Exchange for their customers and a request for no-action
relief with respect to the corresponding books and records
requirements of Rules 17a-3 and 17a-4 under the Act, 17 CFR 240.17a-
3 and 17a-4, respectively. Rule 10b-10, among other things, requires
a broker-dealer to disclose to its customers the identity of the
party the broker-dealer sold to, or bought from, to fill the
customer's order. The ISE Stock Exchange will not routinely reveal
the identity of the actual contra-party when the order is executed
against another Equity EAM. Therefore, the Equity EAMs will not be
able to comply with the contra-party identification requirement of
Rule 10b-10. To permit Equity EAMs to utilize the ISE Stock Exchange
without violating Rule 10b-10, the Exchange is seeking an exemption,
on behalf of such Equity EAMs, from the contra-party identification
requirement. Additionally, the Exchange has asked the Commission not
to recommend enforcement action for violations of the corresponding
books and records requirements of Rules 17a-3 and 17a-4 if, in lieu
of making and preserving a separate record, a broker-dealer relies
on the Exchange's retention of the identities of Equity EAMs that
execute anonymous trades on the ISE Stock Exchange. The Exchange
represents that it will not commence operation of the displayed
market unless the Exchange receives an exemption from Rule 10b-10
with respect to that market.
---------------------------------------------------------------------------

    The Exchange will only reveal the identity of the Equity EAM or the
Equity EAM's clearing firm in the following circumstances: (i) For
regulatory purposes or to comply with an order of a court or
arbitrator; (ii) when the National Securities Clearing Corporation
(``NSCC'') ceases to act for the Equity EAM or the Equity EAM's
clearing firm, and NSCC determines not to guarantee the settlement of
the Equity EAM's trades; or (iii) on risk management reports provided
to the contra-party of the Equity EAM or Equity EAM's clearing firm
each day after 4:00 p.m. that discloses trading activity on an
aggregate dollar value basis. Also, the Exchange will reveal to an
Equity EAM, no later than the end of the day on the date an anonymous
trade was executed, when that Equity EAM submits an order that has
executed against an order submitted by that same Equity EAM.
    The Commission finds that the Exchange's proposed anonymity
provisions are appropriate and consistent with the Act.

J. Clearly Erroneous Executions

    Pursuant to proposed ISE Rule 2128, an Equity EAM that receives an
execution on an order that was submitted erroneously to the ISE Stock
Exchange for its own or a customer account may request that Market
Control, along with a member of the regulatory staff, review the
transaction under proposed ISE Rule 2128(b) within the time limits
described therein. Market Control will review the transaction with a
view toward maintaining a fair and orderly market and the protection of
investors and the public interest. A member of the regulatory staff
will advise and participate in all steps of Market Control's review of
the transaction. Based upon this review, Market Control will decline to
``break'' a disputed transaction if Market Control believes that the
transaction under dispute is not clearly erroneous. However, if Market
Control determines that the transaction in dispute is clearly
erroneous, Market Control will declare that the transaction is null and
void or modify one or more terms of the transaction. When adjusting the
terms of a transaction, Market Control will seek to adjust the price
and/or size of the transaction to achieve an equitable rectification of
the error that would place the parties to a transaction in the same
position, or as close as possible to the same position, as they would
have been in had the error not occurred. For purposes of the clearly
erroneous rule, the terms of a transaction are ``clearly erroneous''
when there is an obvious error in any term, such as price, number of
shares or other unit of trading, or identification of the security.
    Market Control may, on its own motion, review transactions on the
ISE Stock Exchange that arose during any disruption or malfunction in
the use or operation of any electronic communications or trading
facilities of the ISE Stock Exchange, or extraordinary market
conditions or other circumstances in which the nullification or
modification of transactions may be necessary for the maintenance of a
fair and orderly market or the protection of investors and the public
interest. Each affected Equity EAM will be notified as soon as
practicable, and the Equity EAM aggrieved by the action may appeal such
action to the Trade Panel.
    The Commission believes that proposed ISE Rule 2128 is consistent
with the Act because it is reasonably designed to promote fair and
orderly markets by setting forth procedures for reviewing and, if
necessary, nullifying or adjusting a clearly erroneous trade. The
Commission previously has determined that it is consistent with the Act
for an exchange to be able to nullify or adjust trades that are clearly
erroneous.\46\
---------------------------------------------------------------------------

    \46\ See, e.g., NYSE Arca Equities Rule 7.10 (Clearly Erroneous
Executions) and Nasdaq Rule 11890 (Clearly Erroneous Transactions).
---------------------------------------------------------------------------

K. Miscellaneous Rules

    Proposed ISE Rules 2123 (Investment Company Unit), 2124 (Trust
Issued Receipts), 2125 (Commodity-Based Trust Shares), 2126 (Currency
Trust Shares), and 2127 (Partnership Units) would permit the trading of
derivative products on the ISE Stock Exchange. While these proposed ISE
rules would allow the ISE Stock Exchange to trade such products by
either listing and/or trading pursuant to UTP, the ISE Stock Exchange
will only trade these products pursuant to UTP. In order to list such
products, the Exchange would first need to seek Commission approval and
amend its applicable rules.
    Proposed ISE Rule 2117 (Settlement Through Clearing Corporations)
adds provisions governing the settlement and clearing of equity
securities.
    Proposed ISE Rule 2101 (Equity Securities Traded) provides that, if
the Exchange trades its own securities, or the securities of an
affiliate or any entity that operates and/or owns a trading system or
facility of the Exchange, on the ISE Stock Exchange, the Exchange will
file a report each quarter with the SEC describing: (i) The Exchange's
monitoring of the issuer's compliance with the Exchange's listing
standards (in the event the Exchange adopts such listing standards);
and (ii) the Exchange's monitoring of the trading of the security. If
the Exchange adopts listing standards, an independent accounting firm
must annually review the listing standards for the subject security to
ensure that the issuer is in compliance with the applicable listing
requirements. If the Exchange determines that the subject issuer is
non-compliant with any listing standard, the Exchange must file a

report with the Commission at the same time that the Exchange notifies
the issuer of its non-compliance.
    The following Rules have been incorporated from the Exchange's
options rules: ISE Rule 100 (Definitions) is being expanded to include
equities in the following definitions: Bid, clearing corporation, offer
and order; ISE Rule 500 (Designation of Securities) is being amended to
accommodate for the newly adopted rules in Chapter 21; and ISE Rules
702 and 703 (Trading Halts and Trading Halts Due to Extraordinary
Market Volatility, respectively) are being amended to account for
halting trading in equity securities.\47\
---------------------------------------------------------------------------

    \47\ In addition, the Exchange proposes to apply certain of its
options rules to the trading of equity securities on the ISE Stock
Exchange, as set forth in Appendix A to proposed Chapter 21 of the
ISE rules.
---------------------------------------------------------------------------

    The Commission finds that these various proposed ISE rules are
consistent with the Act.

L. Accelerated Approval of Amendment No. 1

    The Commission finds good cause for approving Amendment No. 1 to
the proposed rule change prior to the thirtieth day after publishing
notice of Amendment No. 1 in the Federal Register pursuant to Section
19(b)(2) of the Act.\48 \
---------------------------------------------------------------------------

    \48\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    In Amendment No. 1, the Exchange amended proposed ISE Rule 2110
(Minimum Price Variation) to conform with the language of Rule 612 of
Regulation NMS and amended proposed ISE Rule 2118 (Trade Modifiers) to
incorporate applicable requirements of Rule 611 of Regulation NMS. The
Exchange also amended proposed Rule 2106 (Opening Process) to reflect
that Stop Orders, Stop Limit Orders, No MPM Orders, Post Only Orders,
FOK Orders and IOC Orders cannot participate in the opening process and
to add a provision that the System would cease matching orders in a
security upon the close of the primary market for that security. In
addition, the Exchange changed the term ``partial round lot'' to
``mixed lots'' to correspond to the current industry term and clarified
corresponding proposed ISE Rule 2105 (Order Entry). The Exchange also
added proposed ISE Rule 2120 (Taking or Supplying Securities), which
governs situations in which an Equity EAM can, upon receipt of a
customer order, take or supply securities named in the order on behalf
of itself or related parties.
    In Amendment No. 1, the Exchange made certain revisions to the
proposed rules to provide for the interaction of MidPoint Match orders
with other orders entered into the ISE Stock Exchange, as described
more fully above. The Exchange also revised the text of proposed ISE
Rule 2107(d) to clarify that, prior to February 5, 2007, the ISE Stock
Exchange will not trade through the best bid or offer of other Trading
Centers, while on and after February 5, 2007, the ISE Stock Exchange
will not trade through a Protected Quotation. Finally, the Exchange
made clarifying changes to the clearing requirements and other proposed
rules and made changes to the proposed rules to conform them to the
rules filed with the Commission on the Form PILOT relating to MidPoint
Match.\49\
---------------------------------------------------------------------------

    \49\ See supra note 15.
---------------------------------------------------------------------------

    The Commission notes that Amendment No. 1 is intended to clarify
various provisions of the Exchange's proposed rules. The Commission
believes that Amendment No. 1 proposes revisions that are non-
substantive in nature and do not raise novel issues, and that Amendment
No. 1 is consistent with the Act. Therefore, the Commission finds good
cause to accelerate approval of Amendment No. 1, pursuant to Section
19(b)(2) of the Act.\50\
---------------------------------------------------------------------------

    \50\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning Amendment No. 1, including whether Amendment No. 1
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 No. SR-ISE-2006-48 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 Amendment No. 1 to File No. SR-ISE-
2006-48. 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. Copies of such
filing will also be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
Amendment No. 1 to File No. SR-SE-2006-48 and should be submitted on or
before October 25, 2006.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\51\ that the proposed rule change (SR-ISE-2006-48) be, and it
hereby is, approved, and Amendment No. 1 is approved on an accelerated
basis.
---------------------------------------------------------------------------

    \51\ 15 U.S.C. 78s(b)(2).
    \52\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\52\
Nancy M. Morris,
Secretary.
 [FR Doc. E6-16366 Filed 10-3-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4280-4281]
[FR Doc No: 2015-01410]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0198]

Current Good Manufacturing Practice Requirements for Combination
Products; Draft Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry and FDA staff entitled
``Current Good Manufacturing Practice Requirements for Combination
Products.'' The guidance describes and explains the final rule on
current good manufacturing practice (CGMP) requirements for combination
products, including presenting general considerations for CGMP
compliance as well as analysis of hypothetical scenarios.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 30, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Current Good Manufacturing Practice
Requirements for Combination Products'' to the Office of Combination
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 5129, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
    Submit electronic comments on the draft guidance 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. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Current Good Manufacturing Practice
Requirements for Combination Products.'' The guidance provides
background on combination products, including an overview of the final
rule on CGMP requirements for combination products (78 FR 4307, January
22, 2013) (21 CFR part 4) and the role of the lead center and other
Agency components with respect to combination product CGMP issues. The
guidance addresses general considerations for CGMP requirements for
combination products and the purpose and content of specific CGMP
provisions addressed in part 4. The guidance also contains hypothetical
scenarios intended to clarify how to

comply with certain CGMP requirements addressed in part 4 by presenting
compliance considerations for specific types of combination products.
Throughout the guidance, reference is made to other existing guidance
and additional sources of information addressing CGMP requirements for
drugs, devices, biological products, and human cells, tissues, and
cellular and tissue-based products (HCT/Ps). Concurrent with
publication of this draft guidance, FDA is withdrawing the draft
guidance for industry and FDA staff entitled ``Current Good
Manufacturing Practice for Combination Products,'' which was issued in
September 2004.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on CGMP
requirements for combination products. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.

III. Paperwork Reduction Act

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). We
note that the information collected under the underlying CGMP
regulations for drugs, devices, and biological products, including
current good tissue practices for HCT/Ps, found at 21 CFR parts 211,
820, 600 through 680, and 1271, have already been approved and are in
effect. The provisions of part 211 are approved under the Office of
Management and Budget (OMB) control number 0910-0139. The provisions of
part 820 are approved under OMB control number 0910-0073. The
provisions of parts 606, 640, and 660 are approved under OMB control
number 0910-0116. The provisions of part 610 are approved under OMB
control number 0910-0116 and OMB control number 0910-0338 (also for
part 680). The provisions of part 1271, subparts C and D, are approved
under OMB control number 0910-0543.

IV. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Regulatory Information/Guidances/
ucm126198.htm or http://www.regulations.gov.

    Dated: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01410 Filed 1-26-15; 8:45 am]
BILLING CODE 4164-01-P