[Federal Register: January 28, 2009 (Volume 74, Number 17)]
[Notices]
[Page 5009-5014]
[DOCID:fr28ja09-92]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59282; File No. SR-NYSE-2008-119]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Amendment No. 1 and Order Granting Accelerated
Approval to a Proposed Rule Change, as Modified by Amendment No. 1, To
Establish Trading Rules for the New York Block Exchange

January 22, 2009.

I. Introduction

    On November 13, 2008, the New York Stock Exchange LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Exchange Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to adopt Exchange Rule 1600
governing the New York Block Exchange (``NYBX''), an electronic
facility for the posting and trading of undisplayed orders. The
proposed rule change was published for comment in the Federal Register
on November 24, 2008.\3\ The Exchange filed Amendment No. 1 on January
22, 2009. The Commission received no comments on the proposal. This
notice and order provides notice of filing of Amendment No. 1 and
grants accelerated approval to the proposed rule change, as modified by
Amendment No. 1.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 58969 (November 24,
2008), 73 FR 71050 (``Notice'').
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II. Background

A. General

    The NYBX facility will offer NYSE members and member organizations
a means for posting and executing undisplayed orders. It is designed to
facilitate trading in block-sized orders, although orders submitted to
NYBX can be as small as one round lot. These orders would not be
displayed to the public or NYSE members. Only NYSE-listed securities
will trade in NYBX. All NYSE members and member organizations are
automatically eligible to access NYBX, although they must complete a
connectivity authorization process. A non-member who wishes to access
the NYBX facility may do so as a ``Sponsored Participant'' pursuant to
NYSE Rule 123B.
    Trading in the facility will occur only when trading is occurring
on the Exchange.\4\ However, orders submitted to the facility will not
participate in any openings, re-openings, or closings on the Exchange,
or in any trades resulting from a liquidity refreshment point or a gap
quote situation.\5\ Trading on the facility will be halted or suspended
whenever the NYSE halts or suspends trading in a particular
security.\6\
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    \4\ NYSE's regular trading hours are 9:30 a.m. Eastern Time
(``ET'') to 4 p.m. ET. If the Exchange closes for business at a time
other than 4:00 p.m., NYBX will close at the same time. See proposed
NYSE Rule 1600(a)(2).
    \5\ See e-mail from Bob Hill, Senior Vice President, NYSE
Euronext, to Michael Gaw, Assistant Director, Division of Trading
and Markets, Commission (January 21, 2009).
    \6\ See proposed NYSE Rule 1600(g)(1).
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    In a separate action today, the Commission is also approving a
proposed rule change by NYSE relating to the corporate governance of
the NYBX facility.\7\
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    \7\ See Securities Exchange Act Release No. 59281 (January 22,
2009) (SR-NYSE-2008-120).
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B. Order Entry and Order Parameters

    Users may transmit orders to NYBX by means of an electronic
interface. The facility can be accessed through an electronic FIX
application or an Internet-based, password-protected order-entry
application. Orders can be entered, canceled, and replaced from 3:30
a.m. ET until the close of the regular hours of the Exchange on any day
that the Exchange is open for business. The facility will support a
variety of order types--including limit, midpoint, and pegging orders--
but not market orders.\8\ An order may be pegged, for example, to the
national best bid or best offer (``NBBO'') or to the NBBO plus or minus
the Exchange's minimum price variation.\9\ The facility will accept day
orders, which expire at the end of the regular trading session on the
day of entry, and ``Good til a Specified Time'' orders, which are
available for execution until a specified time. Unless otherwise
specified, the facility will treat all incoming orders as day orders.
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    \8\ See proposed NYSE Rules 1600(c)(2) and 1600(c)(3)(A).
    \9\ See NYSE Rule 62 (describing the minimum price variation).
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    For an order priced equal to or greater than $1.00, the minimum
quoting increment in the facility is one penny ($0.01).\10\ For an
order priced less than $1.00, the minimum quoting increment is one-
tenth of a penny ($0.001).\11\ When there is an odd-increment spread, a
midpoint execution on the facility will occur in a smaller increment
($x.xx5 if above $1.00, $0.xxx5 if below $1.00).\12\ The facility will
reject any pegging order priced below $1.00.\13\
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    \10\ See proposed NYSE Rule 1600(d)(2)(A).
    \11\ See proposed NYSE Rule 1600(d)(2)(B).
    \12\ See proposed NYSE Rule 1600(d)(3)-(4).
    \13\ See proposed NYSE Rule 1600(d)(2)(C).
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    The facility will accept orders with round lots and partial round
lots.\14\ Orders that are initially submitted with an odd-lot size
would be rejected. However, if the execution of an NYBX order results
in an odd-lot remainder, that remainder would not be canceled and would
continue to be processed by the facility.
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    \14\ See proposed NYSE Rule 1600(c)(4).
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    Orders submitted to the NYBX facility may include a ``Minimum
Trading Volume'' (``MTV'') parameter, which is designed to prevent an
execution unless the resulting fill would be of at least the designated
size.\15\ The facility would not initiate the execution of an order
unless the MTV is met at the time the order is evaluated for execution.
If no MTV is designated, an order would be treated as if the MTV is
zero. The facility would act upon market information available to it at
the time an order is entered into the facility, taking a ``snapshot''
of the market. Contraside orders resting in the Display Book (whether
displayed or non-displayed) and contraside orders in the facility would
automatically be considered for MTV purposes. In addition, the system
default would be to include protected quotations of automated trading
centers for MTV purposes, although an MTV could not be met solely by
protected bids or offers. A user could elect to have protected bids and
offers of automated trading centers excluded for MTV purposes.
Therefore, if an NYBX order is marketable against a protected bid or
offer displayed by an away market but not against any order in the
facility or on the Display Book, the facility would not route the order
to the away market to seek an execution (even if the NYBX order's MTV
were met by the size of the protected bid or offer). Regardless of an
order's MTV designation, the facility would always route to away
markets as necessary to comply with Rule 611 of Regulation NMS.\16\ The
facility would not consider for MTV purposes any marketable interest on
an away market that is priced inferior to that market's protected
quotation.
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    \15\ See proposed NYSE Rules 1600(b)(2)(E) and
1600(c)(3)(B)(ii).
    \16\ 17 CFR 242.611.
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    The MTV designation does not guarantee that a user would receive
the full size of the MTV from any resulting execution(s). For example,
when the MTV of an NYBX order is met, the facility might route parts of
that order to the Display Book or to one or more away markets for
execution. Those contraside

orders might be executed or canceled before the NYBX order can access
them.

C. Priority, Execution, and Relationship to the Display Book

    All orders entered into the NYBX facility are prioritized in order
of price, then time.\17\ In addition, execution is conditioned on all
applicable MTVs being met.
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    \17\ See proposed NYSE Rule 1600(d)(1)(A).
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    The NYBX facility and the Display Book, the Exchange's principal
facility for the trading of equity securities, are separate electronic
systems. When it receives an order, the NYBX facility will check for
contraside interest on the facility, the Display Book (both displayed
and undisplayed orders), and away markets to ascertain whether to
attempt to execute the order.\18\ Where an NYBX order is marketable
against eligible contraside liquidity and its MTV is met, the facility
will attempt to execute that order against the eligible contraside
liquidity at the order's limit price or better. If there is eligible
contraside liquidity in the facility at a better price than any
liquidity on the Display Book, the order will attempt to execute in the
facility until it is exhausted, expired, or canceled back to the user
pursuant to its time-in-force conditions, or until that contraside
liquidity in the facility is exhausted.\19\ If eligible contraside
liquidity is available on the Display Book, an order would be sent to
the Display Book to attempt to execute against that liquidity. NYBX
orders that are routed to the Display Book will be prioritized and
executed pursuant to NYSE Rule 72.
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    \18\ The facility would route orders to the Display Book or to
away markets as necessary via the NYSE Routing Broker. See NYSE Rule
17(b) (describing operation of the Routing Broker).
    \19\ If the prices of two NYBX orders are crossed, the execution
will occur at the price of the order that is nearest to or at the
midpoint of the NBBO. See proposed NYSE Rule 1600(d)(1)(C)(vi).
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    In all cases, the facility would not effect an execution except as
permitted by Rule 611 of Regulation NMS. Thus, if the execution of an
NYBX order would trade through a protected bid or offer of an automated
trading center, the facility would route the applicable size of the
order to the automated trading center to attempt to execute against
that protected bid or offer.
    If an order submitted to the facility cannot immediately be
executed, it would remain on the NYBX book pursuant to its time-in-
force conditions. As new orders are submitted to the facility or the
Display Book, or the NBBO changes, the NYBX facility will re-evaluate
whether the booked order is marketable and whether any applicable MTV
is met. If so, the facility would attempt to execute the order, routing
parts of the order to the Display Book or to away markets as necessary.
    Orders in the Display Book, whether displayed or undisplayed, have
priority over orders in the facility at the same price. Therefore, no
trade could take place in the facility until all equal- or better-
priced orders in the Display Book had been executed (or canceled),
subject to any applicable MTV being met. Although, as noted above, the
NYBX facility will monitor orders resting in the Display Book and route
orders to the Display Book as appropriate, the Display Book will not
monitor the undisplayed orders resting in the NYBX facility. Thus,
marketable orders entered into the Display Book would execute without
regard to any undisplayed orders that may be resting in the NYBX
facility. In effect, submitting an order to the NYBX facility is
equivalent to submitting an undisplayed order to the Exchange with the
conditions that it not execute against any market or marketable limit
orders submitted to the Display Book, and that it not execute unless
any applicable MTV is met.\20\
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    \20\ In addition, as noted above, NYBX orders will not
participate in any openings, closings, or re-openings, or in any
trades resulting from a liquidity refreshment point or a gap quote
situation. NYSE has represented that it will disclose to users of
the NYBX facility the implied conditions of NYBX orders. See
Amendment No. 1.
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    Where an NYBX order executes in part but is not exhausted, the
unfilled portion of the order (the ``residual order'') would be held in
the facility where it would attempt to execute against later-submitted
eligible contraside liquidity until the residual order is exhausted,
expired, or canceled.\21\ If the residual order is larger than the
original MTV of the order, the original MTV would remain on the order.
If the residual order is smaller than the original MTV, the facility
would modify the MTV to equal the size of the residual order. A
residual order maintains its original time stamp unless it is modified.
If a user modifies the price, size, side, MTV, or time-in-force
condition of a residual order, it would be considered a newly submitted
order and receive a new time stamp.\22\
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    \21\ See proposed NYSE Rules 1600(d)(1)(C) and 1600(d)(1)(D).
    \22\ Similarly, a pegging order that is repriced with a change
in the NBBO also would lose its original priority and go behind
previously submitted orders in the NYBX queue at the new price. See
proposed NYSE Rule 1600(d)(1)(A)(ii).
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D. Clearance and Settlement

    Details of each trade occurring in the facility will be
automatically compared and matched by the Exchange, and locked-in
trades will be submitted to the National Securities Clearing
Corporation (``NSCC'') for clearance and settlement.\23\ NYBX
transaction reports will not reveal contraparty and clearing firm
identities, except under the following circumstances: (1) for
regulatory purposes or to comply with an order of a court or
arbitrator; and (2) if NSCC will not act on behalf of a member or its
clearing firm.\24\ The trade reports that NSCC will receive from the
facility will contain the identities of the parties to the trade--thus
enabling NSCC to conduct its risk management functions and settle
trades between the appropriate parties--but will contain an indicator
noting that the trade is anonymous. On the contract sheets that NSCC
issues to its participants, NSCC will substitute ``ANON'' for the
acronym of each counterparty.
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    \23\ See proposed NYSE Rule 1600(e)(1). NYBX executions will be
compared through the Regional Interface Organization Online process
(``RIO Online''). RIO Online is NYSE Arca's internal processing
interface that sends order execution information to DTCC. RIO Online
gathers the trades that are executed on any given day, places the
trades into the appropriate message format and sends them to DTCC.
RIO Online provides a record of all trades that were sent to DTCC.
RIO Online is also used to manage any approved trade corrections.
    \24\ See proposed NYSE Rule 1600(e)(2)-(3).
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E. Recordkeeping

    Users of the facility will be required to comply with all relevant
rules of the Exchange and Commission in relation to reports and records
of transactions.\25\ Such rules include, but are not limited to, NYSE
Rules 132B (Order Tracking Requirements), 342 (Supervision), and 440
(Books and Records), and Section 17 of the Exchange Act \26\ and Rules
17a-3, 17a-4, and 17a-6 thereunder.\27\ The Exchange will retain the
identity of each user that executes an anonymous transaction on the
facility, thus enabling the user to satisfy its recordkeeping
obligations under Exchange Act Rules 17a-3(a)(1) and 17a-4(a).\28\
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    \25\ See proposed NYSE Rule 1600(i).
    \26\ See 15 U.S.C. 78q.
    \27\ 17 CFR 240.17a-3, 240.17a-4, and 240.17a-6.
    \28\ 17 CFR 240.17a-3(a)(1) and 240.17a-4(a).
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F. Limitations on the Use of the Facility

    Designated Market Maker (``DMMs'') and Registered Competitive
Market Makers (``RCMMs'') on the floor of the Exchange may not submit
orders to the NYBX facility.\29\ The off-floor unit of a DMM or RMM may
submit orders to the facility if it has policies and procedures that
are designed to prohibit inappropriate sharing of information

between the floor personnel and the off-floor personnel.\30\
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    \29\ See proposed NYSE Rule 1600(h).
    \30\ See proposed NYSE Rule 1600(h)(A).
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    In addition, NYSE has proposed certain restrictions on entering
orders into the facility designed to promote compliance with Section
11(a) of the Exchange Act.\31\ A member may not enter an order into the
facility from the floor of the Exchange when such order is for its own
account, the account of an associated person, or an account over which
it or an associated person exercises investment discretion.\32\ Also, a
member on the floor may not have an order entered into the facility by
sending it to an off-floor facility for entry. However, a member may
submit a proprietary or customer order to the facility from off the
floor of the Exchange.
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    \31\ 15 U.S.C. 78k(a). Section 11(a) provides that a member of
an exchange may not trade for its own account on that exchange
unless an exemption applies.
    \32\ See proposed NYSE Rule 1600(h)(B).
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G. NYBX-Only Trades

    A trade that results from the execution of two NYBX orders (an
``NYBX-Only Trade'') will print with a special modifier (``N.X'') to
identify it as occurring outside the Display Book.\33\ The same ``N.X''
modifier is also used to identify executions in MatchPoint, which is a
separate trading facility of the Exchange that matches non-displayed
orders.\34\ A trade that results from an NYBX order that is routed to
the Display Book and executes against one or more Display Book orders
will print as a regular-way NYSE trade (``N'').
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    \33\ See proposed NYSE Rule 1600(f).
    \34\ See NYSE Rule 1500. NYBX orders will not interact with
MatchPoint orders, and vice versa.
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    The Exchange proposes to amend certain of its rules that apply to
or take account of executions on the Display Book by carving out NYBX-
Only Trades from their scope. Thus, for example, a trade effected in
the NYBX facility would not be deemed the ``last different round lot
price'' for purposes of NYSE Rule 100, which relates to executions of
odd-lot orders. NYSE believes that a DMM, who takes the contraside for
all executions of odd-lot orders in its securities, could be
inappropriately disadvantaged if it were required to execute at last
different round lot prices that included the prices of NYBX-Only
Trades. In this situation, the DMM would be bound as the contraside of
odd-lot orders up to the size of the print in the NYBX facility even
though it would have no knowledge of the size of the orders that made
up the print. NYSE also has argued that, because a DMM has market re-
entry obligations for stabilization purposes, such obligations should
not apply to NYBX-Only Trades, as the DMM will have no information
about orders within NYBX.

H. Amendment No. 1

    In Amendment No. 1, the Exchange deleted the proposed carve-out
relating to NYSE Rule 15A (Order Protection Rule). The Exchange
believes that this carve-out is ``not necessary to ensure the effective
operation of the NYBX Facility.'' In addition, the Exchange represented
that it would publish an informational memorandum for its members
describing the NYBX facility and how orders entered into NYBX will
interact with orders entered into the Display Book. The memorandum will
describe, among other things, the implied trading conditions of the
NYBX trading platform. Finally, the Exchange in Amendment No. 1 made
certain technical, non-substantive changes to the proposed rule text.
The text of Amendment No. 1 is available from the Exchange's Web site
(http://www.nyx.com), the Exchange's principal office, and the
Commission's Public Reference Room.

III. Discussion

A. Generally

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Exchange Act and the
rules and regulations thereunder applicable to a national securities
exchange.\35\ In particular, the Commission believes that the proposed
rule change is consistent with Section 6(b)(1) of the Exchange Act,\36\
which requires a national securities exchange, among other things, to
be so organized to carry out the purposes of the Exchange Act. The
Commission further believes that the proposed rule change is consistent
with Section 6(b)(5) of the Exchange Act,\37\ which requires, among
other things, that an exchange have rules designed 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. Moreover, the Commission
believes that the proposed rule change is consistent with Section
11A(a)(1)(C) of the Exchange Act,\38\ in which Congress found that it
is in the public interest and appropriate for the protection of
investors and the maintenance of fair and orderly markets to assure,
among other things, economically efficient execution of securities
transactions and the practicability of brokers executing investors'
orders in the best market. The ability to post undisplayed interest to
the NYBX facility will provide additional opportunities for block-sized
orders, in particular, to interact with both displayed interest (on the
Display Book and away markets) and undisplayed interest (in the
facility and the Display Book). The MTV designation permits order
senders to limit information leakage and the resulting market impact. A
user selecting a large MTV could choose to execute only when
significant contraside interest can be identified by the NYBX facility.
A user selecting a smaller MTV could choose to obtain a series of more
rapid partial executions while accepting a greater risk that market
participants could infer the existence of the user's order before
achieving a meaningful amount of executed volume. This functionality
appears reasonably designed to give brokers additional opportunities to
execute investors' orders in the best market and to promote the
efficient execution of securities transactions, particularly
transactions of block size.
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    \35\ In approving the proposed rule change, the Commission has
considered its impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
    \36\ 15 U.S.C. 78f(b)(1)
    \37\ 15 U.S.C. 78f(b)(5).
    \38\ 15 U.S.C. 78k-1(a)(1)(C).
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B. Relationship of NYBX Facility to the Exchange

    The Commission believes that the Exchange's rules of execution
priority as they relate to the interaction of orders between the NYBX
facility and the Display Book, the Exchange's main trading facility,
are consistent with the Exchange Act. The Commission notes, however,
that the two facilities do not constitute a completely integrated
liquidity pool. For example, orders submitted to the NYBX facility
would not participate in any openings, closings, or re-openings on the
Exchange, or in any trades resulting from a liquidity refreshment point
or gap quote. Furthermore, by submitting an order to the NYBX facility
rather than to the Display Book, the order sender is electing not to
interact with certain marketable order flow that may be submitted to
the Display Book. For example, while an order resting in the NYBX
facility could interact with

resting orders in the Display Book, it could not interact with
marketable orders entered into the Display Book or participate in
openings, closings, re-openings, and certain other discrete events.
Orders that are marketable against interest in the Display Book when
they are submitted would interact only with contraside interest in the
Display Book (or be routed to access one or more protected quotations).
    The Commission believes that the Exchange's manner of operating the
NYBX facility in relation to the Display Book is consistent with the
Exchange Act. The NYBX facility appears reasonably designed to permit
members' orders, particularly large ones, to interact with each other
and with certain orders in the Display Book, while preserving members'
ability to limit information leakage and consequent market impact with
respect to such orders. The Exchange would route these orders to away
markets as necessary to avoid trade-throughs of protected quotations.
The Exchange also would route these orders to interact with any
displayed or undisplayed interest resting in the Display Book so long
as any applicable MTV is met. Although orders entered into the NYBX
facility would not interact with marketable orders entered into the
Display Book, participate in certain discrete NYSE trading events, or
execute unless any applicable MTV is met, the Commission has previously
approved the use of discretionary orders that are undisplayed and that
elect to interact only with certain kinds of order flow or if certain
conditions are met. The Commission concludes, therefore, that it is
consistent with the Exchange Act for the Exchange to offer its members
this discretion over the display and execution of orders submitted to
the NYBX facility.
    The Exchange also proposes to amend certain NYSE rules to exclude
transactions that occur solely within the NYBX facility from the
operation of the traditional NYSE market. For example, certain
responsibilities of the Exchange's DMMs and RCMMs are keyed off the
last sale on the Exchange. Under this proposal, an NYBX-Only Trade
would not be deemed a last sale for purposes of those rules. In
addition, stop orders and stop-stock provisions of the Exchange rules
would not be triggered by NYSE-Only Trades. The Commission does not
believe that the Exchange Act requires NYSE's rules to treat Display
Book trades and NYBX-Only Trades the same for all purposes, and that
excluding NYBX-Only Trades as triggering events for certain Exchange
rules is broadly within the Exchange's discretion. The Commission
concludes, therefore, that these exclusions for NYBX-Only Trades are
consistent with the Exchange Act.

C. Trading Ahead of Customer Orders

    Because orders in the NYBX facility could be executed at the
midpoint of the NBBO, it is possible that an NYSE member would trade
ahead of a held customer order by less than $0.01 (i.e., $ 0.005). If
an NYBX order executes at the midpoint of the NBBO and results in a
member or member organization's trading ahead of a held customer order
at the same price, NYSE Rule 92 (Limitations on Member's Trading
Because of Customers' Orders) may be implicated. Rule 92(a) generally
restricts a member or member organization from entering a proprietary
order while in possession of a customer order. Rule 92(b) through (d)
provides several exceptions to the general restrictions of Rule
92(a).\39\ The Exchange has stated that all users will be expected to
comply with Rule 92(a) when trading on the NYBX facility unless such
trading falls within an applicable exception in NYSE Rule 92(b) through
(d).
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    \39\ See NYSE Information Memo 2001-33 (October 8, 2001);
Securities Exchange Act Release No. 44139 (March 30, 2001), 66 FR
18339 (April 6, 2001) (SR-NYSE-94-34).
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D. Section 11(a) of the Exchange Act

    Section 11(a) of the Exchange Act prohibits a member of a national
securities exchange from effecting a transaction on that exchange for
its own account, the account of an associated person, or an account
over which it or its associated persons exercises discretion (each a
``Covered Account'') unless an exemption applies.\40\ Rule 11a2-2(T)
under the Exchange Act,\41\ known as the ``effect versus execute''
rule, provides exchange members with one exemption from the Section
11(a) prohibition. To comply with Rule 11a2-2(T)'s conditions, a
member: (1) Must transmit the order from off the exchange floor; (2)
may not participate in the execution of the transaction once it has
been transmitted to the member performing the execution; (3) may not be
affiliated with the executing member; and (4) with respect to an
account over which the member has investment discretion, neither the
member not its associated person may retain any compensation in
connection with effecting the transaction without express written
consent from the person authorized to transact business for the account
in accordance with the rule. The Exchange believes that orders entered
into the NYBX facility from off the floor will comply with these
provisions of Rule 11a2-2(T).
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    \40\ 15 U.S.C. 78k(a).
    \41\ 17 CFR 240.11a2-2(T).
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    Off-Floor Transmission. The requirement in Rule 11a2-2(T) for
orders to be transmitted from off the exchange floor reflects Congress'
intent that Section 11(a) should operate to put member money managers
and non-member money managers on the same footing for purposes of their
transactions for Covered Accounts. In considering other automated
systems, the Commission and the staff have stated that the off-floor
transmission requirement would be met if a Covered Account order is
transmitted from off the floor directly to the exchange floor by
electronic means.\42\ Orders will be electronically entered into the
NYBX facility from on and off the floor of the Exchange; however, a
member is not permitted to enter an order into the NYBX facility from
the floor of the Exchange when such order is for a Covered Account.\43\
Similarly, a

member on the floor may not enter into the facility an order sent to it
by an affiliated member from off the floor, if the order is for such
affiliated member's own account, an account of an associated person, or
an account over which it or an associated person exercises investment
discretion. Consequently, the Commission believes orders transmitted
for execution on the NYBX facility satisfy the off-floor transmission
requirement.
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    \42\ See Securities Exchange Act Release No. 57058 (December 28,
2007), 73 FR 903 (January 4, 2008) (approving MatchPoint)
(``MatchPoint Order'') at 908, note 54. See Securities Exchange Act
Release Nos. 54552 (September 29, 2006), 71 FR 59546 (October 10,
2006) (order approving proposed rule change of the American Stock
Exchange (``Amex'') to establish new hybrid market); 29237 (May 31,
1991) (regarding NYSE's Off-Hours Trading Facility); and 15533
(January 29, 1979) (``1979 Release''), 44 FR 6084 (January 31, 1979)
(regarding the Amex Post Execution Reporting System, the Amex
Switching System, the Intermarket Trading System, the Multiple
Dealer Trading Facility of the Cincinnati Stock Exchange, the PCX's
Communications and Execution System, and the Phlx's Automated
Communications and Execution System). See also letter from Paula R.
Jensen, Deputy Chief Counsel, Division of Market Regulation,
Commission, to Angelo Evangelou, Senior Attorney, Chicago Board
Options Exchange, (``CBOE''), (March 31, 2003) (regarding CBOEdirect
system); letter from Paula R. Jenson, Deputy Chief Counsel, Division
of Market Regulation, Commission, to Jeffrey P. Burns, Assistant
General Counsel, Amex (July 9, 2002) (regarding Amex's auto-ex
system for options); letter from Paula R. Jenson, Deputy Chief
Counsel, Division of Market Regulation, Commission, to Richard S.
Rudolph, Counsel, Philadelphia Stock Exchange (``Phlx'') (April 15,
2002) (regarding Phlx's AUTOM System and its automatic execution
feature AUTO-X); letter from Paula R. Jenson, Deputy Chief Counsel,
Division of Market Regulation, Commission, to Kathryn L. Beck,
Senior Vice President, Special Counsel and Antitrust Compliance
Officer, Pacific Exchange (October 25, 2001) (regarding Archipelago
Exchange); letter from Brandon Becker, Director, Division of Market
Regulation, Commission, to George T. Simon, Foley & Lardner
(November 30, 1994) (regarding Chicago Match).
    \43\ See Notice, supra note 3, 73 FR at 71061. The Commission
notes that proposed NYSE Rule 1600(h) (Limitations on the Use of the
New York Block Exchange) will prohibit a member from entering an
order into the NYBX facility from the floor of the Exchange when
such order is for a Covered Account. Further, the rule also
prohibits a member from having such order entered into the facility
by sending it to an off-floor facility for entry. A member with
authorized access to the facility may enter only customer orders
into the NYBX facility from the floor of the Exchange.
---------------------------------------------------------------------------

    Non-Participation in Order Execution. Rule 11a2-2(T) further
provides that a member and its associated persons may not participate
in the execution of an order once it has been transmitted to the
exchange floor.\44\ This requirement was included to prevent members
with their own brokers on the exchange floor from using those persons
to influence or guide their orders' execution. This requirement does
not preclude a member from canceling or modifying an order, or from
modifying the instructions for executing the order after it has been
transmitted to the floor. However, such cancellations or modifications
must be transmitted from off the exchange floor.\45\
---------------------------------------------------------------------------

    \44\ See Securities Exchange Act Release No. 44983 (October 25,
2001), 66 FR 55225 (November 1, 2001) (approving ArcaEx as the
equities trading facility of PCX Equities). See also MatchPoint
Order, supra note 42, 73 FR at 908 note 56 and accompanying text.
    \45\ See MatchPoint Order, supra note 42, 73 FR at 908. See also
Securities Exchange Act Release No. 14563 (March 14, 1978), 43 FR
11542 (March 17, 1978); see also Securities Exchange Act Release No.
53128 (January 13, 2006), 71 FR 3550 (January 23, 2006) (order
approving Nasdaq Stock Market LLC's registration as a national
securities exchange) (``Nasdaq Exchange Order'').
---------------------------------------------------------------------------

    The Commission has stated that the non-participation requirement is
satisfied by an automated system when the member's use of such a system
entails relinquishing the ability to influence or guide the execution
of a Covered Account order once transmitted into the system.\46\ Once
an order is entered into the NYBX facility, a member may not
participate in, guide, or influence the execution of such order. NYBX
orders are sent by electronic means directly into the NYBX facility. A
user may enter and cancel an NYBX order any time during the regular
trading day of the Exchange. NYSE has represented that matching,
trading, and routing of orders are effectuated through an algorithm,
which does not permit a user to affect the order or its execution in
any way; thus, the member relinquishes all control of an NYBX order
when trading commences. The Commission believes that, because a member
relinquishes control of an order upon transmission to the facility and
will not be able to influence or guide the execution of that order, the
non-participation requirement is met with respect to orders that are
executed automatically in the facility.
---------------------------------------------------------------------------

    \46\ See 1979 Release, supra note 42; see also, e.g., Securities
Exchange Act Release Nos. 54422 (September 11, 2006), 71 FR 54537
(September 15, 2006) (order approving proposed rule change of CBOE
to establish a screen based trading system for non-option
securities); 51666 (May 9, 2005), 70 FR 25631, 25633 (May 13, 2005)
(order approving proposed rule change by International Securities
Exchange to establish facilitation, block order, and solicited order
mechanisms).
---------------------------------------------------------------------------

    Execution through Unaffiliated Member. Although Rule 11a2-2(T)
contemplates having an order executed by an exchange member who is
unaffiliated with the member initiating the order, the Commission has
recognized that the requirement is not applicable when an automated
exchange system is used, if the execution of the order is automatic
once it has been transmitted into the system, and if the design of the
system ensures that members do not possess any special or unique
trading advantages in handling their orders after transmitting them to
the system.\47\ The Commission has stated that, in such instances,
executions obtained through these systems satisfy the independent
execution requirement of Rule 11a2-2(T).\48\ NYBX orders are sent by
electronic means to the NYBX facility. The Exchange has represented
that the design of the NYBX facility ensures that members do not posses
any special or unique trading advantages in the handling of the orders.
---------------------------------------------------------------------------

    \47\ In considering the operation of an automated execution
system operated by an exchange, the Commission has noted that, while
there is no independent executing exchange member, the execution of
an order is automatic once it has been transmitted into the system.
The Commission has stated that, because the design of these systems
ensures that members do not possess any special or unique trading
advantages in handling their orders after transmitting them to the
exchange, executions obtained through these systems satisfy the
independent execution requirement of Rule 11a2-2(T). See 1979
Release, supra note 42; see also MatchPoint Order supra note 42, 73
FR at 908, note 59 and accompanying text; Securities Exchange Act
Release No. 49068 (January 13, 2004), 69 FR 2775 (January 20, 2004)
(order approving the Boston Options Exchange as an options trading
facility of the Boston Stock Exchange).
    \48\ See 1979 Release, supra note 42; see also e.g., MatchPoint
Order, supra note 42; Securities Exchange Act Release No. 54238
(July 28, 2005), 71 FR 44758 (August 7, 2006) (order approving
proposed rule change of NYSE Arca to establish the OX trading
platform); Nasdaq Exchange Order, supra note 45.
---------------------------------------------------------------------------

    Non-Retention of Compensation. The Commission notes that members
that intend to rely on Rule 11a2-2(T) in connection with orders
submitted to the NYBX facility must comply with the requirements of
paragraph (a)(2)(iv) of that rule.
    In reliance on NYSE's representations and for the reasons set forth
above, the Commission believes that members entering orders into the
NYBX facility would satisfy the requirements of Rule 11a2-2(T) under
the Exchange Act.

E. Accelerated Approval

    The Commission finds good cause, pursuant to Section 19(b)(2) of
the Exchange Act,\49\ for approving the proposed rule change, as
modified by Amendment No. 1, prior to the thirtieth day after
publication of notice of filing of Amendment No. 1 in the Federal
Register. In Amendment No. 1, the Exchange proposes to delete the
carve-out relating to NYSE Rule 15A (Order Protection Rule). The
Exchange has stated that this carve-out is ``not necessary to ensure
the effective operation of the NYBX Facility,'' and elimination of the
proposed change to Rule 15A clarifies that the operation of the NYBX
facility would not affect the Exchange's obligation to comply with Rule
611 of the Exchange Act. The Exchange also represented that it would
disclose to NYBX users the implied conditions on NYBX orders. The other
changes made by Amendment No. 1 are technical corrections to the
proposed rule text. The rest of the proposed rule text, which has been
subject to a full comment period, is unaffected. The Commission
believes, therefore, that good cause exists to approve the proposed
rule change, as amended, on an accelerated basis.
---------------------------------------------------------------------------

    \49\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

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-NYSE-2008-119 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-NYSE-2008-119. 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 NYSE. 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-NYSE-2008-119 and should be submitted on or before February 18,
2009.

VI. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Exchange Act,\50\ that the proposed rule change (SR-NYSE-2008-119), as
modified by Amendment No. 1, be, and it hereby is, approved on an
accelerated basis.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\51\
---------------------------------------------------------------------------

    \51\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E9-1805 Filed 1-27-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 177 (Tuesday, September 13, 2011)]
[Rules and Regulations]
[Pages 56290-56294]
[FR Doc No: 2011-22468]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0151; Directorate Identifier 2009-NM-205-AD;
Amendment 39-16781; AD 2011-17-17]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Model DHC-8-400 Series
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are superseding an existing airworthiness directive (AD)
that applies to the products listed above. This AD results from
mandatory continuing airworthiness information (MCAI) originated by an
aviation authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Two cases of main landing gear collapse had been reported. Main
landing gear collapse may result in unsafe landing of the aircraft.
* * * * *
We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective October 18, 2011.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of October 18,
2011.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Craig Yates, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
New York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on March 8, 2011 (76 FR
12629), and proposed to supersede AD 2007-22-09, Amendment 39-15245 (72
FR 61288, October 30, 2007). That NPRM proposed to correct an unsafe
condition for the specified products. The MCAI states:

    Two cases of main landing gear collapse had been reported. Main
landing gear collapse may result in unsafe landing of the aircraft.
    Revision 1 of this directive amended the time compliance in
paragraph C.2 (3 months in addition to 500 hours air time), to add
new paragraph C.3 to cater for retract actuator which has
accumulated less than 4,000 landings or 2 years since new and to add
new paragraphs B.2 and C.4 to require that the respective
inspections be repetitively performed until terminating action
becomes available.
    Revision 2 of this directive amends the detailed visual
inspection requirement in paragraph C.3 to include the main landing
gear retract actuator, part number 46550-11, and to add new
paragraph F to mandate the incorporation of main landing gear
retract actuator part number, 46550-13 as the terminating action and
to add new paragraph G for the maintenance requirement.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (76 FR 12629, March 8,
2011) or on the determination of the cost to the public.

Change Made to This AD

    We have removed paragraph (v)(3)(i)(D) of the NPRM (76 FR 12629,
March 8, 2011) from this AD, and reidentified subsequent paragraphs
accordingly.

Conclusion

    We reviewed the available data, and determined that air safety and
the public interest require adopting the AD with the change described
previously. We determined that this change will not increase the
economic burden on any operator or increase the scope of the AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA

policies. Any such differences are highlighted in a Note within the AD.

Costs of Compliance

    We estimate that this AD will affect about 55 products of U.S.
registry.
    The actions that are required by AD 2007-22-09, Amendment 39-15245
(72 FR 61288, October 30, 2007), and retained in this AD take about 5
work-hours per product, at an average labor rate of $85 per work-hour.
Based on these figures, the estimated cost of the currently required
actions is $425 per product.
    We estimate that it will take about 8 work-hours per product to
comply with the new basic requirements of this AD. The average labor
rate is $85 per work-hour. Required parts will cost about $27,511 per
product. Where the service information lists required parts costs that
are covered under warranty, we have assumed that there will be no
charge for these parts. As we do not control warranty coverage for
affected parties, some parties may incur costs higher than estimated
here. Based on these figures, we estimate the cost of this AD to the
U.S. operators to be $1,550,505, or $28,191 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (76 FR 12629, March 8, 2011),
the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Amendment 39-15245 (72 FR
61288, October 30, 2007) and adding the following new AD:

2011-17-17 Bombardier, Inc.: Amendment 39-16781. Docket No. FAA-
2011-0151; Directorate Identifier 2009-NM-205-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective October
18, 2011.

Affected ADs

    (b) This AD supersedes AD 2007-22-09, Amendment 39-15245 (72 FR
61288, October 30, 2007).

Applicability

    (c) This AD applies to Bombardier, Inc. Model DHC-8-400, -401,
and -402 airplanes, certificated in any category, having serial
numbers (S/Ns) 4001, 4003, 4004, 4006, and 4008 through 4208
inclusive.

Subject

    (d) Air Transport Association (ATA) of America Code 32: Landing
Gear.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    Two cases of main landing gear collapse had been reported. Main
landing gear collapse may result in unsafe landing of the aircraft.
* * * * *

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Restatement of Requirements of AD 2007-22-09, Amendment 39-15245 (72 FR
61288, October 30, 2007), With Updated Service Information, Limited
Affected Airplanes, and Revised Compliance Times

General Visual Inspection of Main Landing Gear (MLG) System, and
Corrective Actions

    (g) For airplanes having S/Ns 003, 004, 006, and 008 through 182
inclusive (now referred to as S/Ns 4003, 4004, 4006, and 4008
through 4182 inclusive), before further flight, do a general visual
inspection to detect discrepancies of the left- and right-hand MLG
system and do all applicable corrective actions, in accordance with
a method approved by the Manager, New York Aircraft Certification
Office (ACO), FAA; or Transport Canada Civil Aviation (TCCA) (or its
delegated agent).

    Note 1: For the purposes of this AD, a general visual inspection
is: ``A visual examination of an interior or exterior area,
installation, or assembly to detect obvious damage, failure, or
irregularity. This level of inspection is made from within touching
distance unless otherwise specified. A mirror may be necessary to
ensure visual access to all surfaces in the inspection area. This
level of inspection is made under normally available lighting
conditions such as daylight, hangar lighting, flashlight, or
droplight and may require removal or opening of access panels or
doors. Stands, ladders, or platforms may be required to gain
proximity to the area being checked.''

    Note 2: Guidance on doing a general visual inspection to detect
discrepancies of the left- and right-hand MLG system can be found in
Tasks Z700-03E and Z700-04E of Part 1 (Maintenance Review Board
Report) of the Bombardier DHC-8 Series 400 Maintenance Requirements
Manual (PSM 1-84-7).

General Visual Inspection of the Jam Nut of the Retract Actuator of
the MLG and Corrective Actions

    (h) For all airplanes except for the airplane having serial
number 4001: Before further flight, do a general visual inspection
of the jam nut of the retract actuator of the left- and right-hand
MLG to ensure the wire lock is in place and the nut is secured. If
the wire lock is not in place or if the jam nut is not

secured, before further flight, adjust the retracted length of the
rod end, torque the jam nut, install a wire lock, and lubricate the
piston, as applicable, in accordance with Bombardier Repair Drawing
(RD) 8/4-32-059, Issue 4, dated September 14, 2007; or Issue 7,
dated June 26, 2008. As of the effective date of this AD, use only
Bombardier RD 8/4-32-059, Issue 7, dated June 26, 2008. Doing the
revision required by paragraph (r) of this AD terminates the
inspection required by this paragraph.

    Note 3: Bombardier RD 8/4-32-059, Issue 4, dated September 14,
2007, refers to Goodrich Service Concession Request SCR 086-07,
Revision C, dated September 14, 2007 (specifically item 14); and
Bombardier RD 8/4-32-059, Issue 7, dated June 26, 2008, refers to
Goodrich Service Concession Request SCR 086-07, Revision F, dated
June 13, 2008 (specifically item 14); as an additional source of
service information for adjusting the retracted length of the rod
end, torquing the jam nut, installing a wire lock, and lubricating
the piston if necessary, as required by paragraph (h) of this AD.

Detailed Inspection of the Retract Actuator of the MLG, With
Extended Compliance Time for Paragraph (j) of This AD

    (i) For airplanes having S/Ns 003, 004, 006, and 008 through 182
inclusive (now referred to as S/Ns 4003, 4004, 4006, and 4008
through 4182 inclusive) on which the retract actuator of the MLG,
part number (P/N) 46550-7 or 46550-9, has accumulated 8,000 or more
total landings or has been in-service 4 or more years since new, as
of November 14, 2007 (the effective date of AD 2007-22-09, Amendment
39-15245 (72 FR 61288, October 30, 2007)): Before further flight, do
a detailed inspection of affected parts for any signs of corrosion
or wear, and applicable related investigative and corrective
actions, in accordance with Bombardier RD 8/4-32-059, Issue 4, dated
September 14, 2007; or Issue 7, dated June 26, 2008. As of the
effective date of this AD, use only Bombardier RD 8/4-32-059, Issue
7, dated June 26, 2008.

    Note 4: For the purposes of this AD, a detailed inspection is:
``An intensive examination of a specific item, installation, or
assembly to detect damage, failure, or irregularity. Available
lighting is normally supplemented with a direct source of good
lighting at an intensity deemed appropriate. Inspection aids such as
mirror, magnifying lenses, etc., may be necessary. Surface cleaning
and elaborate procedures may be required.''

    (j) For airplanes having S/Ns 003, 004, 006, and 008 through 182
inclusive (now referred to as S/Ns 4003, 4004, 4006, and 4008
through 4182 inclusive) with a retract actuator of the MLG, P/N
46550-7 or 46550-9, other than those identified in paragraph (i) of
this AD: Do a detailed inspection of affected parts for any signs of
corrosion or wear, and applicable related investigative and
corrective actions, in accordance with Bombardier RD 8/4-32-059,
Issue 4, dated September 14, 2007; or Issue 7, dated June 26, 2008;
at the later of the times specified in paragraphs (j)(1) and (j)(2)
of this AD. As of the effective date of this AD, use only Bombardier
RD 8/4-32-059, Issue 7, dated June 26, 2008.
    (1) Before the accumulation of 4,500 total landings or 27 months
since new, whichever occurs first.
    (2) Within 500 flight hours after November 14, 2007, or within 3
months after the effective date of this AD, whichever occurs first.

    Note 5: Bombardier RD 8/4-32-059, Issue 7, dated June 26, 2008,
refers to Goodrich Service Concession Request SCR 086-07, Revision
F, dated June 13, 2008, as an additional source of service
information for accomplishing the applicable related investigative
and corrective actions required by paragraphs (i) and (j) of this
AD.

Actions Done in Accordance With Previous Issues of Service
Information

    (k) Actions done before November 14, 2007, in accordance with
repair drawings specified in Table 1 of this AD, are acceptable for
compliance with the corresponding actions specified in paragraphs
(h) through (j) of this AD.

                    Table 1--Previous Repair Drawings
------------------------------------------------------------------------
            Document               Issue                Date
------------------------------------------------------------------------
Bombardier Repair Drawing 8/4-          1  September 12, 2007.
 32-059.
Bombardier Repair Drawing 8/4-          2  September 13, 2007.
 32-059.
Bombardier Repair Drawing 8/4-          3  September 13, 2007.
 32-059.
------------------------------------------------------------------------

New Requirements of This AD

General Visual Inspection of the Jam Nut of the Retract Actuator of
the MLG, and Corrective Actions

    (l) For all airplanes: At the later of the times specified in
paragraphs (l)(1) and (l)(2) of this AD, do a general visual
inspection of the left- and right-hand MLG retract actuator jam nut
to ensure that the wire lock is in place and that the nut is secure,
in accordance with a method approved by the Manager, New York ACO,
FAA; or TCCA (or its delegated agent). If the wire lock is not in
place or the jam nut is not secured, before further flight, re-
torque the jam nut and safety lockwire, in accordance with
Bombardier RD 8/4-32-059, Issue 7, dated June 26, 2008. Repeat the
inspection thereafter at intervals not to exceed 250 flight cycles
or 30 days, whichever occurs first. Doing the revision required by
paragraph (r) of this AD terminates the inspections required by this
paragraph.
    (1) Within 250 flight cycles or 30 days after accomplishing the
inspection required by paragraph (h) of this AD, whichever occurs
first.
    (2) Within 7 days after the effective date of this AD.

    Note 6: Guidance for doing a general visual inspection to detect
discrepancies of the left- and right-hand MLG system can be found in
Tasks Z700-03E and Z700-04E of Part 1 (Maintenance Review Board
Report) of the Bombardier DHC-8 Series 400 Maintenance Requirements
Manual (PSM 1-84-7).

Detailed Inspection of the Retract Actuator of the MLG, and Related
Investigative and Corrective Actions

    (m) For airplanes equipped with a MLG retract actuator having P/
N 46550-7 or 46550-9: At the later of the times specified in
paragraphs (m)(1) and (m)(2) of this AD, do a detailed inspection of
affected parts for any signs of corrosion or wear, and do applicable
related investigative and corrective actions, in accordance with
Bombardier RD 8/4-32-059, Issue 7, dated June 26, 2008. Do all
applicable related investigative and corrective actions before
further flight. Repeat the inspection thereafter at intervals not to
exceed 2,000 flight cycles or 12 months, whichever occurs first.
    (1) Within 2,000 flight cycles or within 12 months after
accomplishing the inspection required by paragraph (i) or (j) of
this AD, whichever occurs first.
    (2) Within 30 days after the effective date of this AD.
    (n) For airplanes having serial numbers 4001, 4003, 4004, 4006,
and 4008 through 4182 inclusive equipped with a MLG retract actuator
having P/N 46550-11: At the later of the times specified in
paragraphs (n)(1) and (n)(2) of this AD, do a detailed inspection of
affected parts for any signs of corrosion or wear, and applicable
related investigative and corrective actions, in accordance with
Bombardier RD 8/4-32-059, Issue 7, dated June 26, 2008. Do all
applicable related investigative and corrective actions before
further flight. Repeat the inspection thereafter at intervals not to
exceed 2,000 flight cycles or 12 months, whichever occurs first.
    (1) Before the accumulation of 4,500 total landings or 27 months
since new, whichever occurs first.
    (2) Within 500 flight hours or 3 months after the effective date
of this AD, whichever occurs first.
    (o) For airplanes having serial numbers 4001, 4003, 4004, 4006,
and 4008 through 4182 inclusive equipped with a MLG retract actuator
having P/N 46550-7, P/N 46550-9, or P/N 46550-11, and that have
accumulated 7,500 total flight cycles or more as of the effective
date of this AD, or that have more

than 48 months since new: Within 500 flight cycles or 3 months after
the effective date of this AD, whichever occurs first, replace the
affected retract actuator with a new design retract actuator having
P/N 46550-13, in accordance with Bombardier Service Bulletin 84-32-
55, Revision A, dated March 10, 2008 (Bombardier Modsum 4-901603).
Doing the replacement specified in this paragraph terminates the
requirements of paragraphs (i), (j), (m), and (n) of this AD.
    (p) For airplanes having serial numbers 4001, 4003, 4004, 4006,
and 4008 through 4182 inclusive equipped with MLG retract actuators
having P/N 46550-7, P/N 46550-9, or P/N 46550-11, that have
accumulated less than 7,500 total flight cycles as of the effective
date of this AD and that have 48 months or less since new: Prior to
the accumulation of 8,000 total flight cycles, or within 51 months
since new, whichever occurs first, replace the affected retract
actuator with a new design retract actuator having P/N 46550-13, in
accordance with Bombardier Service Bulletin 84-32-55, Revision A,
dated March 10, 2008 (Bombardier Modsum 4-901603). Doing the
replacement specified in this paragraph terminates the requirements
of paragraphs (i), (j), (m), and (n) of this AD.
    (q) Replacing the affected retract actuator with a new design
retract actuator having P/N 46550-15, in accordance with the
Accomplishment Instructions of Bombardier Service Bulletin 84-32-60,
Revision A, dated September 29, 2008 (Bombardier Modsum 4-901610),
is also acceptable for compliance with the requirements of
paragraphs (o) and (p) of this AD.

Revision of the Maintenance Program

    (r) For all airplanes: Within 30 days after the effective date
of this AD, revise the maintenance program by incorporating Task
320100-211 (repetitive detailed inspections of the retraction
actuator rod end jam nut, gland nut, and actuator attachment pins
for condition, the security of installation, and corrosion) and Task
320100-212 (repetitive restorations of the retraction actuator for
complete overhaul), as specified in Bombardier Temporary Revision
(TR) MRB-35, dated November 18, 2008, to the Bombardier Q400 Dash 8
Maintenance Requirements Manual (PSM 1-84-7). Doing this revision
terminates the requirements of paragraphs (h) and (l) of this AD.
The initial compliance times for doing Task 320100-211 and Task
320100-212 are specified in paragraphs (r)(1) and (r)(2) of this AD.
After doing this revision, no alternative inspections, restorations,
or intervals may be used, unless the inspections, restorations, or
intervals are approved as an alternative method of compliance (AMOC)
in accordance with the procedures specified in paragraph (v)(1) of
this AD.
    (1) For Task 320100-211 in Bombardier TR MRB-35, dated November
18, 2008, to the Bombardier Q400 Dash 8 Maintenance Requirements
Manual (PSM 1-84-7): The compliance time for the initial inspection
is within 600 flight hours after the effective date of this AD.
    (2) For Task 320100-212 in Bombardier TR MRB-35, dated November
18, 2008, to the Bombardier Q400 Dash 8 Maintenance Requirements
Manual (PSM 1-84-7): The compliance time for the initial restoration
is the later of the times of paragraphs (r)(2)(i) and (r)(2)(ii) of
this AD.
    (i) Prior to the accumulation of 25,000 total flight cycles, or
within 12 years since the date of issuance of the original
airworthiness certificate or the date of issuance of the original
export certificate of airworthiness, whichever occurs first.
    (ii) Within 500 flight cycles after the effective date of this
AD.

    Note 7: The actions required by paragraph (r) of this AD may be
done by inserting copies of Bombardier TR MRB-35, dated November 18,
2008, into the Bombardier Q400 Dash 8 Maintenance Requirements
Manual (PSM 1-84-7). When this TR has been included in general
revisions of the PSM, the general revisions may be inserted in the
PSM, provided the relevant information in the general revision is
identical to that in Bombardier TR MRB-35, dated November 18, 2008.

Credit for Actions Accomplished in Accordance With Previous Service
Information

    (s) Doing a general visual inspection of the jam nut of the
retract actuator of the left- and right-hand MLG; and doing a
detailed inspection of affected parts for any signs of corrosion or
wear, and applicable related investigative and corrective actions;
is also acceptable for compliance with the corresponding
requirements of paragraphs (h), (i), (j), (l), (m), and (n) of this
AD, if done before the effective date of this AD in accordance with
Bombardier Repair Drawing 8/4-32-059, Issue 5, dated September 20,
2007; or Bombardier Repair Drawing 8/4-32-059, Issue 6, dated
January 31, 2008.
    (t) Replacing the affected retract actuator with a new design
retract actuator having P/N 46550-13 is also acceptable for
compliance with the requirements of paragraphs (o) and (p) of this
AD, if done before the effective date of this AD in accordance with
Bombardier Service Bulletin 84-32-55, dated January 14, 2008 (Modsum
4-901603).

No Reporting

    (u) While Canadian Airworthiness Directive CF-2007-20R2, dated
February 6, 2009, has a reporting action, this AD does not require
reporting.

FAA AD Differences

    Note 8: This AD differs from the MCAI and/or service information
as follows: Although the MCAI or service information tells you to
submit information to the manufacturer, paragraph (u) of this AD
specifies that such submittal is not required.

Other FAA AD Provisions

    (v) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the ACO, send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, New York 11590; telephone<PHONE_NUMBER>; fax 516-794-
5531. Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office. The AMOC approval letter must specifically
reference this AD. AMOCs approved previously in accordance with AD
2007-22-09, Amendment 39-15245 (72 FR 61288, October 30, 2007), are
approved as AMOCs for the corresponding provisions of paragraph (i)
and (j) of this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Special Flight Permits: Special flight permits may be issued
in accordance with sections 21.197 and 21.199 of the Federal
Aviation Regulations (14 CFR 21.197 and 21.199) to operate the
airplane to a location where the airplane can be inspected (if the
operator elects to do so), provided that the procedures and
limitations in paragraphs (v)(3)(i) and (v)(3)(ii) of this AD are
adhered to.
    (i) Flight Crew Limitations and Procedures:
    (A) Ferry flight with gear extended and pinned;
    (B) Landing to be conducted at a minimum descent rate;
    (C) Minimize braking on landing;
    (D) Only essential crew on board; and
    (E) Flight in known or forecast icing condition is prohibited.
    (ii) Maintenance Procedures:
    (A) Do the general visual inspection required by paragraph (h)
of this AD;
    (B) Do the general visual inspections of the stabilizer stay and
the hinge points of the MLG for general condition and security, in
accordance with Bombardier Q400 All Operator Message 236A, dated
September 11, 2007;
    (C) If no discrepancy is detected during the inspections
required by paragraph (v)(3)(ii)(A) and (v)(3)(ii)(B) of this AD,
before further flight, insert the ground lock pins and a wire lock
of the MLG in place.
    (D) Ensure the nose landing gear ground lock is engaged.

Related Information

    (w) Refer to MCAI Canadian Airworthiness Directive CF-2007-20R2,
dated February 6, 2009; Bombardier Service Bulletin 84-32-55,
Revision A, dated March 10, 2008; Bombardier Service Bulletin 84-32-
60, Revision A, dated September 29, 2008; Bombardier Repair Drawing
8/4-32-059, Issue 7, dated June 26, 2008; Bombardier TR MRB-35,
dated November 18, 2008, to the Bombardier Q400 Dash 8 Maintenance
Requirements Manual (PSM 1-84-7); and

Bombardier Q400 All Operator Message 236A, dated September 11, 2007;
for related information.

Material Incorporated by Reference

    (x) You must use the service information contained in Table 2 of
this AD to do the actions required by this AD, as applicable, unless
the AD specifies otherwise. If accomplished, you must use Bombardier
Q400 All Operator Message 236A, dated September 11, 2007, to do the
actions specified in paragraph (v)(3)(ii)(B) of this AD. The
document number and date of the Bombardier Q400 all operator message
are identified only on the first page of that document.

                        Table 2--Material Incorporated by Reference for Required Actions
----------------------------------------------------------------------------------------------------------------
               Document                            Revision/Issue                            Date
----------------------------------------------------------------------------------------------------------------
Bombardier Service Bulletin 84-32-55..  A..................................  March 10, 2008.
Bombardier Service Bulletin 84-32-60..  A..................................  September 29, 2008.
Bombardier Repair Drawing 8/4-32-059..  Issue 7............................  June 26, 2008.
Bombardier Temporary Revision MRB-35    ...................................  November 18, 2008.
 to the Bombardier Q400 Dash 8
 Maintenance Requirements Manual (PSM
 1-84-7).
----------------------------------------------------------------------------------------------------------------

     (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>Internet
http://www.bombardier.com. (The document number of Bombardier Repair
Drawing 8/4-32-059 is identified as 8/4-32-0059 in the technical
publications database on http://www.bombardier.com.)
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on August 11, 2011.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-22468 Filed 9-12-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 154 (Thursday, August 9, 2012)]
[Notices]
[Page 47619]
[FR Doc No: 2012-19514]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2169-104]

Alcoa Power Generating Inc.; Brookfield Smoky Mountain Hydropower
LLC; Notice of Application for Transfer of License, and Soliciting
Comments and Motions To Intervene

    On July 31, 2012, Alcoa Power Generating Inc. (transferor) and
Brookfield Smoky Mountain Hydropower LLC (transferee) filed an
application for the transfer of license for the Tapoco Hydroelectric
Project (FERC No. 2169), located on the Little Tennessee and Cheoah
Rivers in Graham and Swain counties in North Carolina, and Blount and
Monroe counties in Tennessee.
    Applicants seek Commission approval to transfer the license for the
Tapoco Hydroelectric Project from the transferor to the transferee.
    Applicants' Contact: Transferor: Alcoa Inc., 390 Park Avenue, New
York, New York 10022, Attn: Mr. Marc A. Pereira, Director, Corporate
Development and Mr. David R. Poe, Bracewell & Giuliani LLP, 2000 K
Street NW., Suite 500, Washington, DC 20006,<PHONE_NUMBER>, email
<EMAIL_ADDRESS>    Transferee: BAIF U.S. Renewable Power Holdings LLC, 200 Donald
Lynch Blvd., Suite 300, Marlboro, MA 01752, Attn: Mr. David Bono, Vice
President, Law and General Counsel and Mr. Patrick E. Groomes,
Fulbright & Jaworski, L.L.P., 801 Pennsylvania Ave. NW., Washington,
DC,<PHONE_NUMBER>, email<EMAIL_ADDRESS>    FERC Contact: Patricia W. Gillis<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments and motions to intervene: 30 days from
the issuance date of this notice. Comments and motions to intervene may
be filed electronically via the Internet. See 18 CFR 385.2001(a)(1) and
the instructions on the Commission's Web site under 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. If unable to be filed electronically, documents may be paper-
filed. To paper-file, an original plus seven copies should be mailed
to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
888 First Street NE., Washington, DC 20426. More information about this
project can be viewed or printed on the eLibrary link of Commission's
Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the
docket number (P-2169) in the docket number field to access the
document. For assistance, call toll-free 1-866-208-3372.

    Dated: August 3, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-19514 Filed 8-8-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 157 (Wednesday, August 14, 2013)]
[Notices]
[Pages 49505-49506]
[FR Doc No: 2013-19579]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP13-1223-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: ACA Filing--Order No. 776 (2013) to be effective 10/1/
2013.
    Filed Date: 8/2/13.
    Accession Number: 20130802-5101.
    Comments Due: 5 p.m. ET 8/14/13.

    Docket Numbers: RP13-1224-000.
    Applicants: WBI Energy Transmission, Inc.
    Description: ACA Compliance Filing to be effective 10/1/2013.
    Filed Date: 8/2/13.
    Accession Number: 20130802-5111.
    Comments Due: 5 p.m. ET 8/14/13.

    Docket Numbers: RP13-1225-000.
    Applicants: Tallgrass Interstate Gas Transmission, L.
    Description: ACA by Reference Filing TIGT to be effective 10/1/
2013.
    Filed Date: 8/2/13.
    Accession Number: 20130802-5205.
    Comments Due: 5 p.m. ET 8/14/13.

    Docket Numbers: RP13-1226-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: ACA by Reference Filing--REX to be effective 10/1/
2013.
    Filed Date: 8/2/13.
    Accession Number: 20130802-5207.
    Comments Due: 5 p.m. ET 8/14/13.

    Docket Numbers: RP13-1227-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: ACA by Reference Filing TB to be effective 10/1/2013.
    Filed Date: 8/2/13.

    Accession Number: 20130802-5208.
    Comments Due: 5 p.m. ET 8/14/13.
    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 Sec.  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.

Filings in Existing Proceedings

    Docket Numbers: RP13-1223-001.
    Applicants: National Fuel Gas Supply Corporation.
    Description: Errata Filing--ACA Filing--Order No. 776 (2013) to be
effective 10/1/2013.
    Filed Date: 8/2/13.
    Accession Number: 20130802-5178.
    Comments Due: 5 p.m. ET 8/14/13.
    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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: August 5, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-19579 Filed 8-13-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: November 6, 2008 (Volume 73, Number 216)]
[Notices]
[Page 66050-66051]
[DOCID:fr06no08-50]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0567]

Designating Additions to the Current List of Tropical Diseases in
the Food and Drug Administration Amendments Act; Public Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing to obtain input on adding additional diseases to the list of
tropical diseases recognized under the Food and Drug Administration
Amendments Act (FDAAA), which adds a new section to the Federal Food,
Drug, and Cosmetic Act (the act). The new section authorizes FDA to
award priority review vouchers to sponsors of certain tropical disease
product applications that meet the criteria specified by the act. The
new section lists diseases considered to be ``tropical diseases'' for
the purposes of this legislation, and provides for expansion of the
list to include diseases meeting certain criteria. This public meeting
is being held to obtain comments from the public on the criteria that
should be used to determine whether an infectious disease should be
added to the list, and to elicit suggestions for adding specific
diseases.

DATES: The public hearing will be held on December 12, 2008, from 9
a.m. to 5 p.m. However, depending on the level of public participation,
the meeting may be extended or may end early. Submit written or
electronic requests for oral presentations and comments by November 17,
2008. Written or electronic comments will be accepted after the hearing
until February 6, 2009.

ADDRESSES: The public hearing will be held at the National
Transportation Safety Board Boardroom and Conference Center at 429
L'Enfant Plaza, SW, Washington, DC 20594. Submit written comments to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. All comments
should be identified with the docket number found in brackets in the
heading of this document. Transcripts of the hearing will be available
for review at the Division of Dockets Management and on the Internet at
http://www.regulations.gov approximately 30 days after the hearing.

FOR FURTHER INFORMATION CONTACT: Jeff O'Neill, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20903,<PHONE_NUMBER>, FAX: 301-847-
8753, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The new section, section 524 of the act (21 U.S.C. 360n), is
designed to encourage development of new drug or biological products
for prevention and treatment of certain tropical diseases affecting
millions of people throughout the world. Section 524 provides a means
by which the holder of an application for a tropical disease product
may be eligible to receive a priority review voucher upon approval of
that application. This voucher entitles the sponsor to be granted a
priority review for a subsequent application of a drug or biologic,
submitted under section 505(b)(1) of the act (21 U.S.C. 355(b)(1)) or
section 351 of the Public Health Service Act (42 U.S.C. 262), of the
sponsor's choosing that would not otherwise be eligible for a priority
review. FDA is committed to a goal of reviewing and taking an action
within 6 months of receipt on 90% of applications that have been
granted a priority review (see http://www.fda.gov/oc/pdufa4/
pdufa4goals.html).
    To be granted a priority review voucher, the tropical disease
application must meet all of the following criteria:
     The application must be a human drug application as
defined in section 735(1) of the act (21 U.S.C. 379g(1)).
     The application must be for the prevention or treatment of
a tropical disease.
     The tropical disease application must be eligible for
priority review.
     The tropical disease application must be for ``a human
drug, no active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other application under
section 505(b)(1) or section 351 of the Public Health service Act.''
    After being granted a priority review voucher, the owner of the
voucher may transfer it to another sponsor. The sponsor intending to
redeem a priority review voucher must notify the agency at least 365
days prior to submission of the application for which the voucher is to
be redeemed. This notification constitutes a legally binding agreement
to pay a supplemental user fee that is mandated by the act to be
applied to an application using a priority review voucher.

    The act identifies the following list of specific diseases that
qualify as ``tropical diseases'' (section 524(a)(3)):
     Tuberculosis
     Malaria
     Blinding trachoma
     Buruli Ulcer
     Cholera
     Dengue/Dengue haemorrhagic fever
     Dracunculiasis (guinea-worm disease)
     Fascioliasis
     Human African trypanosomiasis
     Leishmaniasis
     Leprosy
     Lymphatic filariasis
     Onchocerciasis
     Schistosomiasis
     Soil transmitted helminthiasis
     Yaws
    The legislation allows for the addition to this list of ``any other
infectious disease for which there is no significant market in
developed nations and that disproportionately affects poor and
marginalized populations, designated by regulation by the Secretary.''
    This hearing is being convened to encourage feedback from the
public regarding criteria that should by used to determine the
eligibility of an infectious disease for inclusion in this list and the
process that should be used to make additions to the list. FDA staff
will provide an overview of section 524 at the beginning of the
meeting.

II. Scope of the Hearing

    FDA is interested in obtaining public comment on the following
issues related to the tropical diseases listed in section 524 of the
act:
    1. Should other infectious diseases be added at this time to the
list of tropical diseases that are eligible for receiving a priority
review voucher? If so, are there specific infectious diseases that you
believe should be added? Provide justification for your
recommendations, consistent with the act's requirements for inclusion
of additional tropical diseases.
    2. To be added to the list of tropical diseases, the act requires
that the disease meet the following criteria:
     There must be no significant market in developed nations
     It must disproportionately affect poor and marginalized
populations.
How should this language be interpreted?
    3. What procedures, prior to the rulemaking required by section
524(a)(3), would facilitate the process for adding infectious diseases
to the list of tropical diseases?

III. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Office of the
Commissioner, the Center for Drug Evaluation and Research, and the
Center for Biologics Evaluation and Research.
    Under Sec.  15.30(f), the hearing is informal and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
    Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10 (21 CFR part 10, subpart C)). Under Sec.  10.205,
representatives of the electronic media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public administrative proceedings, including presentations by
participants.
    If you wish to make an oral presentation during the hearing, you
must submit a written or electronic request by close of business on
Monday, November 17, 2008. You must provide your name, title, business
affiliation (if applicable), address, and type of organization you
represent (e.g., industry, consumer organization), and a brief summary
of the presentation (including the discussion topic(s) that will be
addressed to Jeff O'Neill at<EMAIL_ADDRESS>(see FOR FURTHER
INFORMATION CONTACT). Persons registered to make an oral presentation
should check in before the hearing.
    Participants should submit a copy of each presentation to the
contact person (see FOR FURTHER INFORMATION CONTACT). We will file the
hearing schedule with the Division of Dockets Management (see
ADDRESSES), indicating the order of presentation and time allotted to
each person. We will also mail or fax the schedule to each participant
before the hearing. Participants are encouraged to arrive early to
ensure the designated order of presentation.
    Attendees who do not wish to make an oral presentation do not need
to register. The meeting is free and seating will be on a first-come,
first-served basis.
    The hearing will be transcribed as stipulated in Sec.  15.30(b).
Transcripts will be available 45 days after the hearing on the Internet
at http://www.regulations.gov. It may be viewed at the Division of
Dockets Management (see ADDRESSES). A transcript will also be available
in either hard copy or on CD-ROM after submission of a Freedom of
Information request. Written requests are to be sent to the Division of
Freedom of Information (HFI-35), Office of Management Programs, Food
and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD
20857.
    Any handicapped persons requiring special accommodations to attend
the hearing should direct those needs to the contact person (see FOR
FURTHER INFORMATION CONTACT).
    To the extent that the conditions for the hearing, as described in
this notice, conflict with any provisions set out in part 15, this
notice acts as a waiver of those provisions as specified in Sec.
15.30(h).

IV. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments for consideration.
Persons who wish to provide additional materials for consideration
should file these materials with the Division of Dockets Management.
You should annotate and organize your comments to identify the specific
questions identified by topic to which they refer. Submit a single copy
of electronic comments or two paper copies of any mailed comments,
except that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: October 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26528 Filed 11-5-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: June 30, 2008 (Volume 73, Number 126)]
[Notices]
[Page 36882-36883]
[DOCID:fr30jn08-87]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1766-DR]

Indiana; Amendment No. 8 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Indiana (FEMA-1766-DR), dated June 8, 2008, and
related determinations.

EFFECTIVE DATE: June 19, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Indiana is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the catastrophe declared a major disaster by the President in his
declaration of June 8, 2008.

    Grant, Huntington, Pike and Washington Counties for Individual
Assistance.
    Jefferson, Lawrence, and Ripley Counties for Individual
Assistance (already designated for emergency protective measures
[Category B], limited to direct Federal assistance, under the Public
Assistance program.)

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidential Declared Disaster Areas; 97.049, Presidential Declared
Disaster Assistance--Disaster Housing Operations for Individuals and
Households; 97.050, Presidential Declared Disaster Assistance to
Individuals and Households--Other Needs; 97.036, Disaster

Grants--Public Assistance (Presidentially Declared Disasters);
97.039, Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-14742 Filed 6-27-08; 8:45 am]

BILLING CODE 9110-10-P