[Federal Register Volume 80, Number 46 (Tuesday, March 10, 2015)]
[Notices]
[Pages 12666-12671]
[FR Doc No: 2015-05485]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74439; File No. SR-EDGX-2015-08]

Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of
Filing of a Proposed Rule Change, as Modified by Amendment No. 1, To
Amend Rules 11.6, 11.8, 11.9, 11.10 and 11.11 of EDGX Exchange, Inc.

March 4, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 20, 2015, EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which items have been prepared by the self-regulatory
organization. On February 27, 2015, the Exchange filed Amendment No. 1
to the proposal.\3\ The Commission is publishing this notice, as
modified by Amendment No. 1, to solicit comments on the proposed rule
change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 replaces SR-EDGX-2015-08 and supersedes such
filing in its entirety.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange filed a proposal to amend Rules 11.6, 11.8, 11.9,
11.10 and 11.11 to clarify and to include additional specificity
regarding the current functionality of the Exchange's System,\4\
including the operation of its order types and order instructions, as
further described below.
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    \4\ The term ``System'' is defined as ``the electronic
communications and trading facility designated by the Board through
which securities orders of Users are consolidated for ranking,
execution and, when applicable, routing away.'' See Exchange Rule
1.5(cc).
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    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    On June 5, 2014, Chair Mary Jo White asked all national securities
exchanges to conduct a comprehensive review of each order type offered
to members and how it operates.\5\ The Exchange notes that a
comprehensive rule filing clarifying and updating Exchange rules was
recently approved.\6\ However, based on the request from Chair White,
the Exchange did indeed conduct further review of each order types and
its operation. The proposals set forth below are based on this
comprehensive review and are intended to clarify and to include
additional specificity regarding the current functionality of the
Exchange's System, including the operation of its order types and order
instructions. The proposals set forth below are intended to supplement
the recently approved filing based on further review conducted by the
Exchange and are intended to clarify and enhance the understandability
of the Exchange's rules related to the ranking and execution of orders.
The proposal is also intended to add additional detail with respect to
the handling of orders with a Discretionary

Range \7\ instruction and orders with a Non-Displayed \8\ instruction.
The Exchange is not proposing any substantive modifications to the
System.
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    \5\ See Mary Jo White, Chair, Commission, Speech at the Sandler
O'Neill & Partners, L.P. Global Exchange and Brokerage Conference,
(June 5, 2014) (available at http://www.sec.gov/News/Speech/Detail/Speech/1370542004312#.VD2HW610w6Y).
    \6\ Securities Exchange Act Release No. 73468 (October 29,
2014), 79 FR 65450 (November 4, 2014) (SR-EDGX-2014-18).
    \7\ See Exchange Rule 11.6(d).
    \8\ See Exchange Rule 11.6(e)(2).
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Orders With a Discretionary Range and Non-Displayed Orders
    Pursuant to current Rule 11.6(d), the Exchange defines a
Discretionary Range as an instruction the User \9\ may attach to an
order to buy (sell) a stated amount of a security at a specified,
displayed price with discretion to execute up (down) to a specified,
non-displayed price. For purposes of this proposal, the Exchange will
use the term ``Discretionary Range'' to describe the amount between the
displayed price to and including the highest price at which a buyer is
willing to buy or lowest price at which a seller is willing to sell.
The Exchange proposes to make clear that although an order with a
Discretionary Range instruction may be accompanied by a Displayed \10\
instruction, an order with a Discretionary Range instruction may also
be accompanied by a Non-Displayed instruction, and if so, will have a
non-displayed ranked price as well as a discretionary price. The
Exchange further proposes to specifically state that resting orders
with a Discretionary Range instruction will be executed at a price that
uses the minimum amount of discretion necessary to execute the order
against an incoming order. In addition, the Exchange proposes to make
clear certain circumstances where the Discretionary Range of an order
is temporarily reduced due to contra-side interest resting on the EDGX
Book.\11\
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    \9\ The term ``User'' is defined as ``any Member or Sponsored
Participant who is authorized to obtain access to the System
pursuant to Rule 11.3.'' See Exchange Rule 1.5(ee).
    \10\ See Exchange Rule 11.6(e)(1).
    \11\ The term ``EDGX Book'' is defined as ``the System's
electronic file of orders.'' See Exchange Rule 1.5(d).
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    The Exchange also proposes to specify certain situations where the
Discretionary Range of an order is temporarily reduced based on contra-
side interest resting on the Exchange. The Exchange notes that it is
possible for an order with a Discretionary Range instruction have its
Discretionary Range temporarily reduced based on contra-side interest
resting on the Exchange because an incoming order with a Post Only
instruction \12\ will be posted to the EDGX Book rather than executing
against the Discretionary Range of a resting order.
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    \12\ See Exchange Rule 11.6(n)(4).
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    With respect to displayed contra-side liquidity, the Exchange
proposes to make clear that if an order posted to the EDGX Book has a
Discretionary Range and there is a contra-side order that is displayed
by the System on the EDGX Book within such Discretionary Range, the
order with a Discretionary Range will not be permitted to execute at
the price of or at a price more aggressive than such contra-side
displayed order unless and until there is no contra-side displayed
order on the EDGX Book within the Discretionary Range. In such case,
the order with a Discretionary Range will have discretion to one
Minimum Price Variation \13\ below (above) the contra-side offer (bid)
that is displayed by the System on the EDGX Book.
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    \13\ See Exchange Rule 11.6(i).
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    With respect to non-displayed contra-side liquidity, the Exchange
proposes to make clear that if an order posted to the EDGX Book has a
Discretionary Range and there is a contra-side order with a Non-
Displayed instruction,\14\ the order with a Discretionary Range will
not be permitted to execute at a price more aggressive than the ranked
price of such contra-side order unless and until there is no contra-
side order on the EDGX Book within the Discretionary Range. In such
case, the order with a Discretionary Range will have discretion to the
ranked price of the contra-side offer (bid) with a Non-Displayed
instruction that is maintained by the System on the EDGX Book.
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    \14\ The Exchange notes that the reference to orders with a Non-
Displayed instruction is intended to apply to all orders that are
not displayed on the Exchange, such as MidPoint Match Orders as
defined in Rule 11.8(d). The Exchange notes, however, that because
neither MidPoint Match Orders nor orders with a Discretionary Range
instruction (as described below) can be entered with a Post Only
instruction, that the Rule is not currently applicable to any orders
other than Limit Orders with a Non-Displayed instruction.
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    Similarly, the Exchange proposes to amend Rule 11.6(l)(3), which
addresses re-pricing of orders with a Non-Displayed instruction. As set
forth in Rule 11.6(l)(3), an order with a Non-Displayed instruction
that is priced better than the midpoint of the NBBO will be ranked at
the midpoint of the NBBO with discretion to execute to its limit price.
The Exchange proposes to add language stating that if a contra-side
order is resting on the EDGX Book at the limit price within the
Discretionary Range, the order will be ranked at the mid-point of the
NBBO but its discretion to execute to its limit price will be
temporarily reduced consistent with the Discretionary Range definition
described above.
    The Exchange notes that the language proposed with respect to the
temporary reduction of the Discretionary Range of an order is
consistent with the Exchange's recently amended rules.\15\
Specifically, the Exchange suspends the discretion of an order subject
to the Hide Not Slide \16\ instruction for so long as a contra-side
order that equals the Locking Price \17\ is displayed by the System on
the EDGX Book. The Exchange suspends this discretion to avoid an
apparent priority issue. In particular, in such a situation the
Exchange believes a User representing an order that is displayed on the
Exchange might believe that an incoming order was received by the
Exchange and then bypassed such displayed order, removing some other
non-displayed liquidity on the same side of the market as such
displayed order. For the same reason, the Exchange believes it is
appropriate to prevent an order with a Discretionary Range instruction
to execute at the same price or at a price more aggressive than a
contra-side order that is displayed on the EDGX Book. Similarly,
although the Exchange believes it is appropriate to permit an order
with a Discretionary Range instruction to execute at the same price as
a contra-side order with a Non-Displayed instruction, the Exchange
suspends such discretion at any more aggressive prices in order to
avoid trading through orders that have been ranked on and are resting
on the EDGX Book. Below are examples of the operation of orders with a
Discretionary Range.
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    \15\ See supra note 6.
    \16\ See Exchange Rule 11.6(l)(1)(B).
    \17\ See Exchange Rule 11.6(f).
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Example No. 1: Modification and Reinstatement of Discretionary Range
With a Displayed Contra-Side Order
    Assume the NBBO is $10.00 by $10.10, that the best-priced order to
buy in the System is a displayed bid at $9.99, and that the best-priced
order to sell in the System is a displayed offer at $10.11. A Limit
Order \18\ to buy 100 shares at $10.00 with a Discretionary Range of
$0.05 is entered into the System. The order will be displayed on the
EDGX Book at $10.00 with discretion to execute up to $10.05. If a Limit
Order to sell 100 shares at $10.05 with a Displayed instruction and a
Post Only instruction is entered into the System such order will be
posted and displayed by the System on the EDGX Book as an order to sell
100 shares at $10.05. The buy order with the Discretionary Range
instruction will

have its discretion to execute at $10.05 temporarily suspended but such
order will continue to have discretion to execute up to $10.04. The
following examples demonstrate various potential outcomes following the
temporary suspension of the buy order's discretion to execute at
$10.05.
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    \18\ See Exchange Rule 11.8(b).
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     If a non-routable Limit Order to sell 100 shares at $10.05
is entered into the System, depending on applicable User instructions,
such order will either be posted and displayed by the System on the
EDGX Book as an order to sell 100 shares (i.e., with priority behind
the order to sell that is already displayed on the EDGX Book at $10.05)
or will be cancelled back to the entering User.
     If, instead, a Limit Order to sell 100 shares at $10.04 is
entered into the System, such order will execute at $10.04 against the
resting buy order with a Discretionary Range instruction.
     If, instead, a Limit Order to sell 100 shares at $10.02 is
entered into the System, such order will execute at $10.02 against the
resting buy order with a Discretionary Range instruction.
     If, instead, a Limit Order to sell 100 shares at $10.00 or
lower or a Market Order to sell 100 shares is entered into the System,
such order will execute at $10.00 against the resting buy order with a
Discretionary Range instruction.
     If, instead, the sell order at $10.05 with a Post Only
instruction is then canceled, the buy order with a Discretionary Range
instruction will have its discretion to execute up to $10.05
reinstated.
     If, instead, a Limit Order to buy 100 shares at $10.05 or
higher or a Market Order to buy 100 shares is then entered into the
System, such order will execute at $10.05 against the displayed order
to sell with a Post Only instruction and the buy order with a
Discretionary Range instruction will have its discretion to execute up
to $10.05 reinstated.
Example No. 2: Modification and Reinstatement of Discretionary Range
With a Non-Displayed Contra-Side Order Priced Less Aggressive Than the
Midpoint of the NBBO
    Assume the NBBO is $10.00 by $10.10, that the best-priced order to
buy in the System is a displayed bid at $9.99, and that the best-priced
order to sell in the System is a displayed offer at $10.11. A Limit
Order with to buy 100 shares at $10.00 with a Discretionary Range of
$0.07 is entered into the System. The order will be ranked and
displayed on the EDGX Book at $10.00 with discretion to execute up to
$10.07. If a Limit Order to sell 100 shares at $10.06 with a Non-
Displayed instruction and a Post Only instruction is entered into the
System such order will be posted by the System on the EDGX Book as an
order to sell 100 shares at $10.06. The buy order's discretion to
execute at $10.07 will be temporarily suspended but such order will
continue to have discretion to execute up to $10.06. The following
examples demonstrate various potential outcomes following the temporary
suspension of the buy order's discretion to execute at $10.07.
     If a non-routable Limit Order to sell 100 shares at $10.07
with a Displayed instruction is entered into the System, depending on
applicable User instructions, such order will be posted and displayed
by the System on the EDGX Book as an order to sell 100 shares at $10.07
or will be cancelled back to the entering User.
     If, instead, a Limit Order to sell 100 shares at $10.06 is
entered into the System, such order will execute at $10.06 against the
resting buy order with a Discretionary Range instruction.
     If, instead, a Limit Order to sell 100 shares at $10.02 is
entered into the System, such order will execute at $10.02 against the
resting buy order with a Discretionary Range instruction.
     If, instead, a Limit Order to sell 100 shares at $10.00 or
lower or a Market Order to sell 100 shares is entered into the System,
such order will execute at $10.00 against the resting buy order with a
Discretionary Range instruction.
     If, instead, the sell order with a Non-Displayed
instruction of 100 shares that is ranked at $10.06 is then canceled,
the buy order with a Discretionary Range instruction will have its
discretion to execute up to $10.07 reinstated.
Example No. 3: Modification and Reinstatement of Discretionary Range
With a Non-Displayed Contra-Side Order Priced More Aggressive Than the
Midpoint of the NBBO
    Assume the NBBO is $10.00 by $10.10, that the best-priced order to
buy in the System is a displayed bid at $9.99, and that the best-priced
order to sell in the System is a displayed offer at $10.11. A Limit
Order with to buy 100 shares at $10.00 with a Discretionary Range of
$0.07 is entered into the System. The order will be displayed on the
EDGX Book at $10.00 with discretion to execute up to $10.07. If a Limit
Order to sell 100 shares at $10.04 with a Non-Displayed instruction and
a Post Only instruction is entered into the System such order will be
posted by the System on the EDGX Book as an order to sell 100 shares at
$10.05 (i.e., ranked at the midpoint of the NBBO, as described above)
with discretion to $10.04. The buy order's discretion to execute at
$10.07 will be temporarily suspended but such order will continue to
have discretion to execute up to $10.05. The following examples
demonstrate various potential outcomes following the temporary
suspension of the buy order's discretion to execute at $10.07.
     If a non-routable Limit Order to sell 100 shares at $10.07
with a Displayed instruction is entered into the System, depending on
applicable User instructions, such order will be posted and displayed
by the System on the EDGX Book as an order to sell 100 shares at $10.07
or will be cancelled back to the entering User.
     If, instead, a Limit Order to sell 100 shares at $10.05 is
entered into the System, such order will execute at $10.05 against the
resting buy order with a Discretionary Range instruction.
     If, instead, a Limit Order to buy 100 shares at $10.05 is
entered into the System, such order will execute at $10.05 against the
resting sell order with a Non-Displayed instruction and a Post Only
instruction (i.e., at the ranked price of such order).
     If, instead, a Limit Order to sell 100 shares at $10.04 is
entered into the System, such order will execute at $10.04 against the
resting buy order with a Discretionary Range instruction.
     If, instead, a Limit Order to buy 100 shares at $10.04 is
entered into the System, such order will execute at $10.04 against the
resting sell order with a Non-Displayed instruction and a Post Only
instruction (i.e., using the discretion of the resting sell order with
a Non-Displayed instruction to sell at the order's limit price).
     If, instead, a Limit Order to sell 100 shares at $10.00 or
lower or a Market Order to sell 100 shares is entered into the System,
such order will execute at $10.00 against the resting buy order with a
Discretionary Range instruction.
     If, instead, the sell order with a Non-Displayed
instruction of 100 shares that is ranked at $10.05 is then canceled,
the buy order with a Discretionary Range instruction will have its
discretion to execute up to $10.07 reinstated.
    As the above examples demonstrate, the Exchange prevents executions
against the Discretionary Range of an order at or through the price of
a resting contra-side order with a Displayed instruction and through
the price of a resting contra-side order with a Non-Displayed
instruction (i.e., an execution can occur at the ranked price of an
order with a Non-Displayed instruction but not at a price that would be
better than such order's ranked price). The

Exchange does not, however, prevent executions against the
Discretionary Range of an order when there is a contra-side order with
a Discretionary Range at or through that price same price.
    The Exchange's handling of orders with a Discretionary Range
instruction, including the discretion of an order with a Non-Displayed
instruction more aggressive than the midpoint of the NBBO to its limit
price, is intended to reflect the relatively passive nature of orders
with a Discretionary Range. In all cases, although the Users submitting
such orders have indicated a willingness to execute at a more
aggressive price, such orders are ranked at a lower price to buy or a
higher price to sell. In turn, if an order is executed at its ranked
price, rather than at a price within the Discretionary Range, then the
User that submitted the order receives a better result in each case
(i.e., buys for less or sells for more). With this background, the
Exchange believes it is reasonable that an order with a Discretionary
Range instruction or a Non-Displayed instruction might temporarily
become not executable at certain prices because such prices are more
aggressive than their ranked price (i.e., higher prices for orders to
buy or lower prices for orders to sell). Further, to the extent a User
would prefer an execution at more aggressive price levels, such User
could simply choose other order type instructions that would increase
the likelihood of execution at these prices (e.g., a routable order
rather than a non-routable order, an order that is ranked at its full
price rather than an order ranked at a less aggressive price with a
Discretionary Range, or an order with a Displayed instruction rather
than an order with a Non-Displayed instruction).
    In addition to the changes described above, the Exchange proposes
to re-locate within Rule 11.8(b) and re-word the statement regarding
the inclusion of a Discretionary Range on a Limit Order. Current Rule
11.8(b)(8) currently states that a ``User may include a Discretionary
Range instruction.'' This ability to include a Discretionary Range
instruction on a Limit Order is currently grouped with other
functionality that can be elected for Limit Orders that also include a
Post Only or Book Only instruction as well as specified time-in-force
instructions for orders that can be entered into the System and post to
the EDGX Book. However, the System does not allow the combination of a
Discretionary Range and a Post Only instruction. Accordingly, the
Exchange proposes to re-locate the reference to the Discretionary Range
instruction within Rule 11.8(b) so that it is no longer grouped with
other orders that can be combined with a Post Only instruction. The
Exchange also proposes to state in Rule 11.8(b) that: (i) A Limit Order
with a Discretionary Range instruction may also include a Book Only
instruction; and (ii) a Limit Order with a Discretionary Range
instruction and a Post Only instruction will be rejected. Further, the
Exchange proposes to refer to the ability of a Limit Order to include a
Discretionary Range instruction, rather than a ``User'' that may
include a Discretionary Range instruction.
Priority and Execution Algorithm
    With respect to the Exchange's priority and execution algorithm,
the Exchange is proposing various minor and structural to changes that
are intended to emphasize the processes by which orders are accepted,
priced, ranked, displayed and executed, as well as a new provision
related to the ability of orders to rest at locking prices that is
consistent with the changes to provisions related to the operation of
orders with a Discretionary Range instruction described above. First,
the Exchange has proposed modifications to Rule 11.9, Priority of
Orders, to make clear that the ranking of orders described in such rule
is in turn dependent on Exchange rules related to the execution of
orders, primarily Rule 11.10. The Exchange believes that this has
always been the case under Exchange rules but there was not previously
a description of the cross-reference to Rule 11.10 within such rules.
Accordingly, the Exchange proposes to add reference to the execution
process in addition to the numeric cross-reference to Rule 11.10.\19\
The Exchange also proposes to change certain references within Rule
11.9 to refer to ranking rather than executing equally priced trading
interest, as the Rule as a whole is intended to describe the manner in
which resting orders are ranked and maintained, specifically in price
and time priority, while awaiting execution against incoming orders.
The Exchange does not believe that the proposed modifications
substantively modify the operation of the rules but the Exchange
believes that it is important to make clear that the ranking of orders
is a separate process from the execution of orders. The Exchange also
proposes changes to Rule 11.9(a)(4) and (a)(5) to specify that orders
retain and lose ``time'' priority under certain circumstances as
opposed to priority generally because retaining or losing price
priority does not require the same descriptions, as price priority will
always be retained unless the price of an order changes.
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    \19\ The Exchange notes that it recently filed an immediately
effective proposal containing marking errors with respect to the
rule text proposed for sub-paragraphs (a)(2), (a)(2)(A) and
(a)(2)(B). See Securities Exchange Act Release No. 74023 (January 9,
2015), 80 FR 2163 (January 15, 2015) (SR-EDGX-2015-03). Accordingly,
the Exchange has correctly marked the change in connection with this
proposal.
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    Next, the Exchange proposes to move language contained within sub-
paragraph (a)(2) of Rule 11.10 to the main paragraph, paragraph (a),
such that the language is more generally applicable to the rules.
Although sub-paragraph (a)(2) contains information relevant to
executability, in that it describes orders that are executable in
compliance with Regulation NMS or otherwise do not trade through
quotations of other markets, there are other provisions set forth in
paragraph (a) that relate to executability. Accordingly, the Exchange
proposes to relocate language stating that any order falling within the
parameters of this paragraph shall be referred to as ``executable'' and
that an order will be cancelled back to the User, if based on market
conditions, User instructions, applicable Exchange Rules and/or the Act
and the rules and regulations thereunder, such order is not executable,
cannot be routed to another Trading Center pursuant to Rule 11.11 or
cannot be posted to the EDGX Book.
    The Exchange proposes to adopt paragraph (C) of Rule 11.10(a)(4) to
provide further clarity regarding the situations where orders are not
executable, which although covered in other existing rules, would focus
on the incoming order on the same side of an order displayed on the
EDGX Book rather than the resting order that is rendered not executable
because it is opposite such order displayed on the EDGX Book. Proposed
paragraph (C) would further state that if an incoming order is on the
same side of the market as an order displayed on the EDGX Book and upon
entry would execute against contra-side interest at the same price as
such displayed order, such incoming order will be cancelled or posted
to the EDGX Book and ranked in accordance with Rule 11.9. As described
above, the Exchange suspends the discretion of an order subject to the
Hide Not Slide instruction for so long as a contra-side order that
equals the Locking Price is displayed by the System on the EDGX Book.
Similarly, as proposed to be added to EDGX Rules, the Exchange
temporarily suspends the ability of an order to execute at the same
price as a contra-side displayed order for any order with a
Discretionary Range

instruction or any order with a Non-Displayed instruction that has been
re-priced to the midpoint of the NBBO pursuant to Exchange rules. The
Exchange temporarily suspends this discretion to avoid an apparent
priority issue where a User representing an order that is displayed on
the Exchange either believes such order has time priority among
displayed orders at that price or that the displayed order is the only
order at such price level and then sees an execution published by the
Exchange at that price.
    To demonstrate the functionality in place on the Exchange described
above, assume the NBBO is $10.00 by $10.01. A non-routable Limit Order
to buy 100 shares at $10.01 with a Hide Not Slide instruction is
entered into the System. The order will be displayed on the EDGX Book
at $10.00 and ranked at $10.005 with discretion to $10.01. If a Limit
Order to sell 100 shares at $10.01 with a Displayed instruction and a
Post Only instruction is entered into the System such order will be
posted and displayed by the System on the EDGX Book as an order to sell
100 shares at $10.01. The buy order with the Hide Not Slide instruction
will have its discretion to execute at $10.01 temporarily suspended but
such order will continue to be ranked at $10.005. The following
examples demonstrate various potential outcomes following the temporary
suspension of the buy order's discretion to execute at $10.01.
     If a non-routable Limit Order to sell 100 shares at $10.01
is entered into the System, depending on applicable User instructions,
such order will either be posted and displayed by the System on the
EDGX Book as an order to sell 100 shares (i.e., with priority behind
the order to sell that is already displayed on the EDGX Book at $10.01)
or will be cancelled back to the entering User.
     If, instead, a Limit Order to sell 100 shares at $10.00 is
entered into the System, such order will execute at $10.005 against the
resting buy order with a Hide Not Slide instruction.
     If, instead, a Limit Order to buy 100 shares at $10.01 or
higher or a Market Order to buy 100 shares is entered into the
System,\20\ such order will execute at $10.01 against the resting sell
order displayed on the EDGX Book, as such resting order is fully
executable and displayed as an offer on the EDGX Book.
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    \20\ The Exchange notes that an incoming order for purposes of
comparison to a resting order can be any incoming order unless the
terms of that incoming order itself preclude execution. In this
example, a Limit Order to buy 100 shares at $10.01 that executes
against the order to sell displayed at $10.01 on the EDGX Book could
be a Limit Order with a Displayed instruction, a Limit Order with a
Non-Displayed instruction, a Limit Order with a Hide Not Slide
instruction, a Limit Order with a Price Adjust instruction, a
routable Limit Order, a non-routable Limit Order, an order with a
Limit Price of $10.00 and a Discretionary Range of $0.01, or any
other type of incoming Limit Order to buy that is executable at
$10.01. Thus, this example demonstrates that on entry the incoming
order is compared to contra-side orders on the EDGX Book regardless
of the modifiers that will determine how it will be displayed,
ranked or otherwise handled by the System and that unless the
ability of an order to execute has been suspended based on the
Exchange's rules, the resting contra-side order with priority at
that price will be executed against the incoming order.
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    The Exchange notes that it is proposing to add descriptive titles
to paragraphs (A) and (B) of Rule 11.10(a)(4), which describe the
process by which executable orders are matched within the System.
Specifically, so long as it is otherwise executable, an incoming order
to buy will be automatically executed to the extent that it is priced
at an amount that equals or exceeds any order to sell in the EDGX Book
and an incoming order to sell will be automatically executed to the
extent that it is priced at an amount that equals or is less than any
other order to buy in the EDGX Book. These rules further state that an
order to buy shall be executed at the price(s) of the lowest order(s)
to sell having priority in the EDGX Book and an order to sell shall be
executed at the price(s) of the highest order(s) to buy having priority
in the EDGX Book. The Exchange emphasizes these current rules only
insofar as to highlight the interconnected nature of the priority rule.
    The Exchange also proposes to modify paragraph (h) of Rule 11.11 to
clarify the Exchange's rule regarding the priority of routed orders.
Paragraph (h) currently sets forth the proposition that a routed order
does not retain priority on the Exchange while it is being routed to
other markets. The Exchange believes that its proposed clarification to
paragraph (h) is appropriate because it more clearly states that a
routed order is not ranked and maintained in the EDGX Book pursuant to
Rule 11.9(a), and therefore is not available to execute against
incoming orders pursuant to Rule 11.10.
2. Statutory Basis
    The Exchange believes that the proposed rule changes are consistent
with Section 6(b) of the Securities Exchange Act of 1934 (the ``Act'')
\21\ and further the objectives of Section 6(b)(5) of the Act \22\
because they are designed to promote just and equitable principles of
trade, to remove impediments to and perfect the mechanism of a free and
open market and a national market system, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, and, in general, to protect investors and the public
interest. The proposed rule changes are also designed to support the
principles of Section 11A(a)(1) \23\ of the Act in that they seek to
assure fair competition among brokers and dealers and among exchange
markets.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78f(b).
    \22\ 15 U.S.C. 78f(b)(5).
    \23\ 15 U.S. C. 78k-1(a)(1).
---------------------------------------------------------------------------

    Specifically, the Exchange also believes that the changes to
provide additional clarity and specificity regarding the functionality
of the System with respect to an order with a Discretionary Range
instruction and an order with a Non-Displayed instruction that has
discretion pursuant to the Exchange's re-pricing process would promote
just and equitable principles of trade and remove impediments to a free
and open market by providing greater transparency concerning the
operation of the System. The Exchange also believes that the proposed
amendments to clarify and re-structure the Exchange's priority,
execution and routing rules will contribute to the protection of
investors and the public interest by making the Exchange's rules easier
to understand. Further, the Exchange believes that it is consistent
with the Act to temporarily reduce the Discretionary Range of an order
that has been posted to the EDGX Book for so long as there is contra-
side liquidity on the EDGX Book because this functionality prevents an
apparent priority issue on the EDGX Book as described above as well as
the ability of an order to execute at a price that trades through the
ranked price of an order resting on the EDGX Book. The Exchange
reiterates that such behavior, as described above, is temporary in
nature; an order's full Discretionary Range will be returned as soon as
the contra-side liquidity that caused the reduction in the first place
is no longer maintained on the EDGX Book. The Exchange believes that
its overall handling of orders, including the temporary suspension of
the ability of an order with a Discretionary Range to execute at one or
more prices is consistent with the Act because it removes impediments
to and perfects the mechanism of a free and open market and a national
market system by reflecting the relatively passive nature of an order
with a Discretionary Range instruction while honoring the instructions
of a User submitting a contra-side order that does not remove liquidity
on entry. As explained above, the Exchange's handling of orders with

a Discretionary Range instruction, including the discretion of an order
with a Non-Displayed instruction more aggressive than the midpoint of
the NBBO to its limit price, is intended to reflect the relatively
passive nature of orders with a Discretionary Range. The Exchange
believes it is reasonable that an order with a Discretionary Range
instruction or a Non-Displayed instruction might temporarily become not
executable at certain prices because such prices are more aggressive
than their ranked price (i.e., higher prices for orders to buy or lower
prices for orders to sell). Further, to the extent a User would prefer
an execution at more aggressive price levels, such User could simply
choose other order type instructions that would increase the likelihood
of execution at these prices. Finally, the Exchange believes that its
proposal to re-locate and re-word the Discretionary Range instruction
reference within Rule 11.8(b), related to Limit Orders, is consistent
with the Act because the change will correct an error within the
Exchange's rules and prevent potential confusion regarding the ability
to combine a Discretionary Range instruction with a Post Only
instruction.

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

    The Exchange does not believe that the proposed rule changes will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The proposed
rule changes are not designed to address any competitive issue but
rather to add specificity and clarity to Exchange rules, thus providing
greater transparency regarding the operation of the System.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule changes.

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

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

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as modified by Amendment No. 1, is consistent with the Act.
Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please
include File Number SR-EDGX-2015-08 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-EDGX-2015-08. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-EDGX-2015-08 and should be
submitted on or before March 31, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-05485 Filed 3-9-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: October 7, 2010 (Volume 75, Number 194)]
[Notices]
[Page 62154-62156]
[DOCID:fr07oc10-87]

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

[Investment Company Act Release No. 29455; 812-13624]

Van Eck Associates Corporation, et al.; Notice of Application

October 1, 2010.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application to amend a prior order under section
6(c) of the Investment Company Act of 1940 (``Act'') for an exemption
from sections 2(a)(32), 5(a)(1), 22(d), 22(e) and 24(d) of the Act and
rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for
an exemption from sections 17(a)(1) and (a)(2) of the Act, and under
section 12(d)(1)(J) of the Act granting an exemption from sections
12(d)(1)(A) and 12(d)(1)(B) of the Act.

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    Summary of Application: Applicants request an order to amend a
prior order that permits: (a) Series of an open-end management
investment company (each a ``Fund,'' collectively, the ``Funds'') to
issue shares that can be redeemed only in large aggregations
(``Creation Units''); (b) secondary market transactions in shares to
occur at negotiated prices; (c) dealers to sell such shares to
secondary market purchasers unaccompanied by a statutory prospectus
when prospectus delivery is not required by the Securities Act of 1933
(``Securities Act''); (d) under specified limited circumstances,
certain Funds to pay redemption proceeds more than seven days after the
tender of shares; (e) certain registered management investment
companies and unit investment trusts outside of the same group of
investment companies as the Funds to acquire shares; and (f) certain
affiliated persons of the Funds to deposit securities into, and receive
securities from, the Funds in connection with the purchase and
redemption of Creation Units of such Funds (``Prior Order'').\1\
Applicants seek to amend the Prior Order to: (a) Permit certain Funds
based on equity and/or fixed income securities indexes for which Van
Eck Associates Corporation (``Adviser'') or an ``affiliated person'' of
the Adviser as defined in section 2(a)(3) of the Act, is an index
provider (each a ``Self Indexing Fund''); (b) delete the relief granted
from section 24(d) of the Act and revise various disclosure
requirements in the applications for the Prior Order (``Prior
Applications''); (c) modify the 80% investment requirement in the Prior
Applications; (d) revise the discussion of depositary receipts in the
Prior Applications; and (e) revise the discussion in the Prior
Applications of the composition of securities deposited with the Fund
to purchase Creation Units (``Deposit Securities'') and securities
received in connection with redemption of Creation Units (``Fund
Securities'').
---------------------------------------------------------------------------

    \1\ Van Eck Associates Corporation, et al., Investment Company
Act Release Nos. 27283 (Apr. 7, 2006) (notice) and 27311 (May 2,
2006) (order), as subsequently amended by Van Eck Associates
Corporation, et al., Investment Company Act Release Nos. 27694 (Jan.
31, 2007) (notice) and 27742 (Feb. 27, 2007) (order), Van Eck
Associates Corporation, et al., Investment Company Act Release Nos.
28007 (Sept. 28, 2007) (notice) and 28021 (Oct. 24, 2007) (order),
Van Eck Associates Corporation, et al., Investment Company Act
Release Nos. 28349 (July 31, 2008) (notice) and 28365 (August 25,
2008) (order).
---------------------------------------------------------------------------

    Applicants: Adviser, Market Vectors ETF Trust (``Trust''), and Van
Eck Securities Corporation (``Distributor'').
    Filing Dates: The application was filed on January 23, 2009, and
amended

on June 3, 2009, March 12, 2010, June 23, 2010, August 13, 2010, and
August 25, 2010.
    Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on October 25, 2010, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons may request notification of a hearing by writing to
the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549-1090. Applicants, 335 Madison Avenue,
New York, NY 10017.

FOR FURTHER INFORMATION CONTACT: Deepak T. Pai, Senior Counsel, at
(202) 551-6876, or Michael W. Mundt, Assistant Director, at (202) 551-
6821 (Division of Investment Management, Office of Investment Company
Regulation).

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

Applicants' Representations

    1. The Trust is an open-end management investment company
registered under the Act and organized as a Delaware statutory trust.
The Trust is organized as a series fund with multiple series. The
Adviser, an investment adviser registered under the Investment Advisers
Act of 1940 (``Advisers Act''), will serve as investment adviser to the
Trust. The Adviser may retain sub-advisers (``Sub-Advisers'') to manage
the assets of one or more Funds. Any Sub-Adviser will be registered
under the Advisers Act. The Distributor, a broker-dealer registered
under the Securities Exchange Act of 1934 (``Exchange Act''), will
serve as the principal underwriter and distributor of the Trust's
shares.
    2. The applicants are currently permitted to offer Funds that track
the performance of equity and fixed income indexes developed by either
(i) third parties that are not ``affiliated persons'' (as such term is
defined in section 2(a)(3) of the Act), or affiliated persons of
affiliated persons, of the Trust, the Adviser, any Sub-Adviser, the
Distributor or a promoter of a Fund or (ii) by the Adviser to the
extent the Adviser may be deemed a sponsor of an underlying index due
to licensing arrangements between the Adviser and S-Network Global
Indexes, LLC or other similar arrangements. Applicants seek to amend
the Prior Order to permit Self Indexing Funds. Applicants request that
the order apply to any Self Indexing Funds offered in the future that
are advised by the Adviser or an entity controlling, controlled by or
under common control with the Adviser and operate pursuant to the terms
and conditions of the Prior Order, as amended. Applicants also seek to
amend the Prior Order to (a) Delete the relief granted from section
24(d) of the Act and revise the Prior Applications accordingly; (b)
modify the Fund's 80% investment requirement; (c) revise the discussion
of depositary receipts; and (d) revise the discussion of the
composition of Deposit Securities and Fund Securities.

Self-Indexing Funds

    3. Each underlying index (``Underlying Index'') for a Self Indexing
Fund is or will be a rules based index comprised of equity and/or fixed
income securities (including depositary receipts). A wholly owned
subsidiary of the Adviser currently domiciled in Germany (the ``Index
Provider'') will create and/or own a proprietary, rules based
methodology (``Rules-Based Process'') to create indexes for use by the
Self Indexing Funds and other equity or fixed income investors.\2\ The
Index Provider intends to license the use of the Underlying Indexes,
their names and other related intellectual property to the Adviser for
use in connection with the Trust and the Self Indexing Funds. The
licenses for the Self Indexing Funds will specifically state that the
Adviser must provide the use of the Underlying Indexes and related
intellectual property at no cost to the Trust and the Self Indexing
Funds.
---------------------------------------------------------------------------

    \2\ The Underlying Indexes may be made available to registered
investment companies, as well as separately managed accounts of
institutional investors and privately offered funds that are not
deemed to be ``investment companies'' in reliance on section 3(c)(1)
or 3(c)(7) of the Act for which the Adviser acts as adviser or
subadviser (``Affiliated Accounts'') as well as other such
registered investment companies, separately managed accounts and
privately offered funds for which it does not act either as adviser
or subadviser (``Unaffiliated Accounts''). The Affiliated Accounts
and the Unaffiliated Accounts (collectively referred to herein as
``Accounts''), like the Funds, would seek to track the performance
of one or more Underlying Index(es) by investing in the constituents
of such Underlying Index(es) or a representative sample of such
constituents of the Underlying Index. Consistent with the relief
requested from section 17(a), the Affiliated Accounts will not
engage in Creation Unit transactions with a Fund.
---------------------------------------------------------------------------

    4. Applicants contend that any potential conflicts of interest
arising from the fact that the Index Provider will be an ``affiliated
person'' of the Adviser will not have any impact on the operation of
the Self Indexing Funds because the Underlying Indexes will maintain
transparency, the Self Indexing Funds' portfolios will be transparent,
and the Index Provider, the Adviser, any Sub-Adviser and the Self
Indexing Funds each will adopt policies and procedures to address any
potential conflicts of interest (``Policies and Procedures''). The
Index Provider will publish in the public domain, including on its Web
site and/or the Self Indexing Funds' Web site (``Web site''), the rules
that govern the construction and maintenance of each of its Underlying
Indexes. Applicants believe that this will prevent the Adviser from
possessing any advantage over other market participants by virtue of
its affiliation with the Index Provider. Applicants note that the
identity and weightings of the component securities of an Underlying
Index (``Component Securities'') for a Self Indexing Fund will be
readily ascertainable by anyone, since the Rules-Based Process will be
publicly available.
    5. While the Index Provider does not presently contemplate specific
changes to the Rules-Based Process, it could be modified, for example,
to reflect changes in the underlying market tracked by an Underlying
Index, the way in which the Rules-Based Process takes into account
market events or to change the way a corporate action, such as a stock
split, is handled. Such changes would not take effect until the
employees of the Index Provider (``Index Group'') have given (a) the
Calculation Agent (defined below) reasonable prior written notice of
such rule changes, and (b) the investing public at least sixty (60)
days published notice that such changes will be implemented. Each
Underlying Index for a Self Indexing Fund will be reconstituted or
rebalanced on at least an annual basis, but no more frequently than
monthly.
    6. As owner of the Underlying Indexes, the Index Provider will
enter into an agreement (``Calculation Agent Agreement'') with a third
party to act as ``Calculation Agent.'' The Calculation Agent will be
solely responsible for the calculation and maintenance of each
Underlying Index, as well as the dissemination of the values of each

Underlying Index. The Calculation Agent is not, and will not be, an
affiliated person, as such term is defined in the Act, or an affiliated
person of an affiliated person, of the Self Indexing Funds, the
Adviser, any Sub-Adviser, any promoter or the Distributor.
    7. The Adviser and the Index Provider will adopt and implement
Policies and Procedures to minimize or eliminate any potential
conflicts of interest. Among other things, the Policies and Procedures
will be designed to limit or prohibit communication with respect to
issues/information related to the maintenance, calculation and
reconstitution of the Underlying Indexes between the ``Index
Administrator,'' the Index Group and the employees of the Adviser. As
employees of the Index Provider, the Index Administrator and members of
the Index Group (i) Will not have any responsibility for the management
of the Self Indexing Funds or the Affiliated Accounts, (ii) will be
expressly prohibited from sharing this information with any employees
of the Adviser or those of any Sub-Adviser, including those persons
that have responsibility for the management of the Self Indexing Funds
or the Affiliated Accounts until such information is publicly
announced, and (iii) will be expressly prohibited from sharing or using
this non-public information in any way except in connection with the
performance of their respective duties. In addition, the Adviser and
any Sub-Adviser have adopted or will adopt, pursuant to Rule 206(4)-7
under the Advisers Act, written policies and procedures designed to
prevent violations of the Advisers Act and the rules under the Advisers
Act. Also, the Adviser has adopted a Code of Ethics pursuant to rule
17j-1 under the Act and rule 204A-1 under the Advisers Act.

Additional Changes to Prior Order

    8. Applicants also seek to amend the Prior Order to delete the
relief granted from the requirements of section 24(d) of the Act.
Applicants believe that the deletion of the exemption from section
24(d) that was granted in the Prior Order is warranted because the
adoption of the summary prospectus under Investment Company Act Release
No. 28584 (Jan. 13, 2009) (the ``Summary Prospectus Rule'') should make
unnecessary any need by a Fund to use a product description (``Product
Description''). Applicants also note that, to date, no Fund has
utilized a Product Description. The deletion of the relief granted with
respect to section 24(d) of the Act from the Prior Order will also
result in the deletion of related discussions in the Prior Application,
revision of the Prior Application to delete references to the Product
Descriptions including in the conditions, and the deletion of condition
7 to the Prior Order.\3\
---------------------------------------------------------------------------

    \3\ Condition 7 states ``Before an Index Fund may rely on this
order, the Commission will have approved, pursuant to rule 19b-4
under the Exchange Act, an Exchange rule requiring Exchange members
and member organizations effecting transactions in Shares to deliver
a Product Description to purchasers of Shares.''
---------------------------------------------------------------------------

    9. The application for the Prior Order states that a Fund will
hold, in the aggregate, at least 80% of its total assets in Component
Securities of its Underlying Index and investments that have economic
characteristics that are substantially identical to the economic
characteristics of the Component Securities of its Underlying Index.
Applicants seek to amend the Prior Order to require a Fund to hold at
least 80% of its total assets in Component Securities of its Underlying
Index or in Depositary Receipts (defined below) or to-be-announced
transactions (``TBAs'') representing Component Securities.
    10. The application for the Prior Order states, among other things,
that the Fund will invest only in Depositary Receipts listed on a
national securities exchange, as defined in section 2(a)(26) of the Act
(``Exchange''), and that all Depositary Receipts in which the Funds
invest will be sponsored by the issuers of the underlying security,
except for certain specified exceptions. Applicants seek to amend the
application for the Prior Order by revising the discussion of
Depositary Receipts to note that ``Depositary Receipts'' include
American Depositary Receipts (``ADRs'') and Global Depositary Receipts
(``GDRs''). With respect to ADRs, the depositary is typically a U.S.
financial institution and the underlying securities are issued by a
foreign issuer. The ADR is registered under the Securities Act on Form
F-6. ADR trades occur either on an Exchange or off-exchange. FINRA Rule
6620 requires all off-exchange transactions in ADRs to be reported
within 90 seconds and ADR trade reports to be disseminated on a real-
time basis. With respect to GDRs, the depositary may be foreign or a
U.S. entity, and the underlying securities may have a foreign or a U.S.
issuer. All GDRs are sponsored and trade on a foreign exchange. No
affiliated persons of applicants will serve as the depositary for any
Depositary Receipts held by a Fund. A Fund will not invest in any
Depositary Receipts that the Adviser deems to be illiquid or for which
pricing information is not readily available.
    11. The Prior Order provides that Deposit Securities and Fund
Securities generally will correspond pro rata, to the extent
practicable, to the portfolio securities of a Fund (``Portfolio
Securities''). Applicants seek to amend this discussion of the
composition of Deposit Securities and Fund Securities to state that
Deposit Securities and Fund Securities either (a) will correspond pro
rata to the Portfolio Securities of a Fund, or (b) will not correspond
pro rata to the Portfolio Securities, provided that the Deposit
Securities and Fund Securities (1) consist of the same representative
sample of Portfolio Securities designed to generate performance that is
highly correlated to the performance of the Portfolio Securities, (2)
consist only of securities that are already included among the existing
Portfolio Securities, and (3) are the same for all Authorized
Participants on a given Business Day. In either case, the Deposit
Securities and Fund Securities may differ from each other (and from the
Portfolio Securities) (a) to reflect minor differences when it is not
possible to break up bonds beyond certain minimum sizes needed for
transfer and settlement, or (b) for temporary periods to effect changes
in the Portfolio Securities as a result of the rebalancing of an
Underlying Index.
    12. The Self Indexing Funds, except as otherwise noted herein, will
operate in a manner identical to the operation of the other Funds.
Applicants agree that any order of the Commission granting the
requested relief will be subject to all of the conditions in the Prior
Order, except that condition 7 will be deleted.\4\ Applicants believe
that the requested relief continues to meet the necessary exemptive
standards.
---------------------------------------------------------------------------

    \4\ All representations and conditions contained in the
Application that require a Fund to disclose particular information
in its Prospectus and/or annual report shall be effective with
respect to the Fund until the time that the Fund complies with the
disclosure requirements adopted by the Commission in Investment
Company Act Release No. 28584 (Jan. 13, 2009).

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-25294 Filed 10-6-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register: February 19, 2010 (Volume 75, Number 33)]
[Rules and Regulations]
[Page 7358-7361]
[DOCID:fr19fe10-4]

=======================================================================
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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 744

[Docket No. 100115025-0032-01]
RIN 0694-AE84

Addition of Certain Persons to the Entity List: Addition of
Persons Acting Contrary to the National Security or Foreign Policy
Interests of the United States

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: This rule amends the Export Administration Regulations (EAR)
by adding ten additional persons located in Hong Kong and Taiwan to the
Entity List (Supplement No. 4 to Part 744) on the basis of Section
744.11 of the EAR. These persons that are added to the Entity List have
been determined by the U.S. Government to be acting contrary to the
national security or foreign policy interests of the United States.
    The Entity List provides notice to the public that certain exports,
reexports, and transfers (in-country) to parties identified on the
Entity List require a license from the Bureau of Industry and Security
(BIS) and that availability of license exceptions in such transactions
is limited.

DATES: Effective Date: This rule is effective February 19, 2010.
Although there is no formal comment period, public comments on this
regulation are welcome on a continuing basis.

ADDRESSES: You may submit comments, identified by RIN 0694-AE84, by any
of the following methods:
    E-mail<EMAIL_ADDRESS>Include ``RIN 0694-AE84'' in
the subject line of the message.
    Fax:<PHONE_NUMBER>. Please alert the Regulatory Policy Division,
by calling<PHONE_NUMBER>, if you are faxing comments.
    Mail or Hand Delivery/Courier: Timothy Mooney, U.S. Department of
Commerce, Bureau of Industry and Security, Regulatory Policy Division,
14th St. & Pennsylvania Avenue, NW., Room 2705, Washington, DC 20230,
Attn: RIN 0694-AE84. Send comments regarding the collection of
information associated with this rule, including suggestions for
reducing the burden, to Jasmeet K. Seehra, Office of Management and
Budget (OMB), by e-mail to<EMAIL_ADDRESS>or by fax
to<PHONE_NUMBER>; and to the Regulatory Policy Division, Bureau of
Industry and Security, Department of Commerce, 14th St. & Pennsylvania
Avenue, NW., Room 2705, Washington, DC 20230. Comments on this
collection of information should be submitted separately from comments
on the final rule (i.e. RIN 0694-AE84)--all comments on the latter
should be submitted by one of the three methods outlined above.

FOR FURTHER INFORMATION CONTACT: Elizabeth Scott Sangine, Acting
Chairman, End-User Review Committee, Office of the Assistant Secretary,
Export Administration, Bureau of Industry and Security, Department of
Commerce, Phone:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The Entity List provides notice to the public that certain exports,
reexports, and transfers (in-country) to parties identified on the
Entity List require a license from the Bureau of Industry and Security
(BIS) and that availability of license exceptions in such transactions
is limited. Persons are placed on the Entity List on the basis of
criteria set forth in certain sections of part 744 (Control Policy:
End-User and End-Use Based) of the EAR.
    The End-User Review Committee (ERC), composed of representatives of
the Departments of Commerce (Chair), State, Defense, Energy and, where
appropriate, the Treasury, makes all decisions regarding additions to,
removals from or changes to the Entity List. The ERC makes all
decisions to add an entry to the Entity List by majority vote and all
decisions to remove or modify an entry by unanimous vote.

ERC Entity List Decisions

    The ERC made a determination to add ten persons to the Entity List
on the basis of Sec.  744.11 (License Requirements That Apply to
Entities Acting Contrary to the National Security or Foreign Policy
Interests of the United States) of the EAR. The ten entries added to
the Entity List consist of six persons in Hong Kong and four persons in
Taiwan.
    The ERC reviewed Sec.  744.11(b) (Criteria for revising the Entity
List) in making the determination to add these persons to the Entity
List. Under that paragraph, entities for which there is reasonable
cause to believe, based on specific and articulable facts, that have
been involved, are involved, or pose a significant risk of being or
becoming involved in activities that are contrary to the national
security or foreign policy interests of the United States and those
acting on behalf of such entities may be added to the Entity List
pursuant to Sec.  744.11. Paragraphs (b)(1)-(b)(5) include an
illustrative list of activities that could be contrary to the national
security or foreign policy interests of the United States. The persons
being added to the Entity List under this rule have been determined by
the ERC to be involved in activities that could be contrary to the
national security or foreign policy interests of the United States.

Additions to the Entity List

    This rule implements the decision of the ERC to add ten persons to
the Entity List on the basis of Sec.  744.11 of the EAR. For all of the
ten persons added to the Entity List, the ERC specifies a license
requirement for all items subject to the EAR and establishes a license
application review policy of a presumption of denial. The license
requirement applies to any transaction in which items are to be
exported, reexported or transferred (in-country) to such persons or in
which such persons act as purchaser, intermediate consignee, ultimate
consignee, or end-user. In addition, no license exceptions are
available for shipments to those persons being added to the Entity
List.
    Specifically, this rule adds the following ten persons to the
Entity List:

Hong Kong

    (1) ACTeam Logistics Ltd., Unit B1-B3, 21/F, Block B, Kong Nam
Industrial Building, 603-609 Castle Peak Road, Tsuen Wan, N.T., Hong
Kong;
    (2) Dick Kuo, Room 9-11, 5/F, Block B, Hoplite Industrial Centre,
3-5 Wang Tai Road, Kowloon, Hong Kong;
    (3) Dick Leung, GF Seapower Industrial Building 177, Hoi Bun Road,
Kowloon, Hong Kong;
    (4) Joe Shih, Room 9-11, 5/F, Block B, Hoplite Industrial Centre,
3-5 Wang Tai Road, Kowloon, Hong Kong;
    (5) Signet Express Co., Ltd., Room 9-11, 5/F, Block B, Hoplite
Industrial Centre, 3-5 Wang Tai Road, Kowloon, Hong Kong; and
    (6) Tex-Co Logistics Ltd., GF Seapower Industrial Building 177, Hoi
Bun Road, Kowloon, Hong Kong, and Room 2202, 22F, Causeway Bay Plaza 1,
489 Hennessey Road, Causeway Bay, Hong Kong, and Room B03, 6/F, Cheong
Wah Factory Building, 39-41 Sheung Heung Road, Tokwawan, Kowloon, Hong
Kong.

Taiwan

    (1) Christine Sun, 7th Floor, Number 17, Zhonghua Rd., Sec 2,
Xinzhuang City, Taipei, Taiwan;
    (2) In-Tech Company, a.k.a., In-Tech Telecom, Number 15, Lane 347,

Jhongjheng Road, Sinjihuang City, Taipei, Taiwan, and 7th Floor, Number
17, Zhonghua Rd., Sec 2, Xinzhuang City, Taipei, Taiwan;
    (3) Landstar Tech Company Ltd., 13/F, Number 181, Sec 1, Datong
Rd., Sijhih City, Taipei, Taiwan; and
    (4) Yi-Lan Chen, a.k.a., Kevin Chen, 13/F, Number 181, Sec 1,
Datong Rd., Sijhih City, Taipei, Taiwan, and 7th Floor, Number 17,
Zhonghua Rd., Sec 2, Xinzhuang City, Taipei, Taiwan.
    A BIS license is required for the export, reexport or transfer (in-
country) of any item subject to the EAR to any of the persons listed
above, including any transaction in which any of the listed persons
will act as purchaser, intermediate consignee, ultimate consignee, or
end-user of the items. This listing of these persons also prohibits the
use of license exceptions (see part 740 of the EAR) for exports,
reexports and transfers (in-country) of items subject to the EAR
involving such persons.

Savings Clause

    Shipments of items removed from eligibility for a License Exception
or export or reexport without a license (NLR) as a result of this
regulatory action that were on dock for loading, on lighter, laden
aboard an exporting or reexporting carrier, or en route aboard a
carrier to a port of export or reexport, on February 19, 2010, pursuant
to actual orders for export or reexport to a foreign destination, may
proceed to that destination under the previous eligibility for a
License Exception or export or reexport without a license (NLR) so long
as they are exported or reexported before March 22, 2010. Any such
items not actually exported or reexported before midnight, on March 22,
2010, require a license in accordance with this rule.
    Although the Export Administration Act expired on August 20, 2001,
the President, through Executive Order 13222 of August 17, 2001, 3 CFR,
2001 Comp., p. 783 (2002), as extended by the Notice of August 13,
2009, 74 FR 41325 (August 14, 2009), has continued the Export
Administration Regulations in effect under the International Emergency
Economic Powers Act.

Rulemaking Requirements

    1. This rule has been determined to be not significant for purposes
of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to nor be subject to a penalty for failure to
comply with a collection of information, subject to the requirements of
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA),
unless that collection of information displays a currently valid Office
of Management and Budget (OMB) Control Number. This regulation involves
collections previously approved by the OMB under control numbers 0694-
0088, ``Multi-Purpose Application,'' which carries a burden hour
estimate of 58 minutes to prepare and submit form BIS-748.
Miscellaneous and recordkeeping activities account for 12 minutes per
submission. Total burden hours associated with the Paperwork Reduction
Act and Office and Management and Budget control number 0694-0088 are
expected to increase slightly as a result of this rule.
    3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
    4. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed rulemaking, the opportunity for
public participation, and a delay in effective date, are inapplicable
because this regulation involves a military or foreign affairs function
of the United States. (See 5 U.S.C. 553(a)(1)). Further, no other law
requires that a notice of proposed rulemaking and an opportunity for
public comment be given for this rule. Because a notice of proposed
rulemaking and an opportunity for public comment are not required to be
given for this rule by 5 U.S.C. 553, or by any other law, the
analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601
et seq., are not applicable.

List of Subjects in 15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

0
Accordingly, part 744 of the Export Administration Regulations (15 CFR
parts 730-774) is amended as follows:

PART 744--[AMENDED]

0
1. The authority citation for 15 CFR part 744 continues to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179;
E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR,
1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222,
66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3
CFR, 2001 Comp., p. 786; Notice of August 13, 2009, 74 FR 41325
(August 14, 2009); Notice of November 6, 2009, 74 FR 58187 (November
10, 2009).

0
2. Supplement No. 4 to part 744 is amended:
0
a. By adding under Hong Kong, in alphabetical order, six Hong Kong
entities; and
0
b. By adding, in alphabetical order, the destination of Taiwan under
the Country column and four Taiwanese entities;
    The additions read as follows:

Supplement No. 4 to Part 744--Entity List

----------------------------------------------------------------------------------------------------------------
                                                                         License review       Federal Register
        Country                 Entity          License requirement          policy               citation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
HONG KONG

                                                  * * * * * * *
                        ACTeam Logistics       For all items subject  Presumption of        75 FR [INSERT FR
                         Ltd., Unit B1-B3, 21/  to the EAR. (See       denial.               PAGE NUMBER], 2/19/
                         F, Block B, Kong Nam   Sec.   744.11 of the                         10.
                         Industrial Building,   EAR).
                         603-609 Castle Peak
                         Road, Tsuen Wan,
                         N.T., Hong Kong.

                                                  * * * * * * *
                        Dick Kuo, Room 9-11,   For all items subject  Presumption of        75 [INSERT FR PAGE
                         5/F, Block B,          to the EAR. (See       denial.               NUMBER], 2/19/10.
                         Hoplite Industrial     Sec.   744.11 of the
                         Centre, 3-5 Wang Tai   EAR).
                         Road, Kowloon, Hong
                         Kong.
                        Dick Leung, GF         For all items subject  Presumption of        75 FR [INSERT FR
                         Seapower Industrial    to the EAR. (See       denial.               PAGE NUMBER], 2/19/
                         Building 177, Hoi      Sec.   744.11 of the                         10.
                         Bun Road, Kowloon,     EAR).
                         Hong Kong.

                                                  * * * * * * *
                        Joe Shih, Room 9-11,   For all items subject  Presumption of        75 FR [INSERT FR
                         5/F, Block B,          to the EAR. (See       denial.               PAGE NUMBER], 2/19/
                         Hoplite Industrial     Sec.   744.11 of the                         10.
                         Centre, 3-5 Wang Tai   EAR).
                         Road, Kowloon, Hong
                         Kong.

                                                  * * * * * * *
                        Signet Express Co.,    For all items subject  Presumption of        75 FR [INSERT FR
                         Ltd., Room 9-11, 5/    to the EAR. (See       denial.               PAGE NUMBER], 2/19/
                         F, Block B, Hoplite    Sec.   744.11 of the                         10.
                         Industrial Centre, 3-  EAR).
                         5 Wang Tai Road,
                         Kowloon, Hong Kong.

                                                  * * * * * * *
                        Tex-Co Logistics       For all items subject  Presumption of        75 FR [INSERT FR
                         Ltd., GF Seapower      to the EAR. (See       denial.               PAGE NUMBER], 2/19/
                         Industrial Building    Sec.   744.11 of the                         10.
                         177, Hoi Bun Road,     EAR).
                         Kowloon, Hong Kong,
                         and Room 2202, 22F,
                         Causeway Bay Plaza
                         1, 489 Hennessey
                         Road, Causeway Bay,
                         Hong Kong, and Room
                         B03, 6/F, Cheong Wah
                         Factory Building, 39-
                         41 Sheung Heung
                         Road, Tokwawan,
                         Kowloon, Hong Kong.

                                                  * * * * * * *
TAIWAN................  Christine Sun, 7th     For all items subject  Presumption of        75 FR [INSERT FR
                         Floor, Number 17,      to the EAR. (See       denial.               PAGE NUMBER], 2/19/
                         Zhonghua Rd., Sec 2,   Sec.   744.11 of the                         10.
                         Xinzhuang City,        EAR).
                         Taipei, Taiwan.
                        In-Tech Company,       For all items subject  Presumption of        75 FR [INSERT FR
                         a.k.a., In-Tech        to the EAR. (See       denial.               PAGE NUMBER], 2/19/
                         Telecom, Number 15,    Sec.   744.11 of the                         10.
                         Lane 347, Jhongjheng   EAR).
                         Road, Sinjihuang
                         City, Taipei,
                         Taiwan, and 7th
                         Floor, Number 17,
                         Zhonghua Rd., Sec 2,
                         Xinzhuang City,
                         Taipei, Taiwan.
                        Landstar Tech Company  For all items subject  Presumption of        75 FR [INSERT FR
                         Ltd., 13/F, Number     to the EAR. (See       denial.               PAGE NUMBER], 2/19/
                         181, Sec 1, Datong     Sec.   744.11 of the                         10.
                         Rd., Sijhih City,      EAR).
                         Taipei, Taiwan.
                        Yi-Lan Chen, a.k.a.,   For all items subject  Presumption of        75 FR [INSERT FR
                         Kevin Chen, 13/F,      to the EAR. (See       denial.               PAGE NUMBER], 2/19/
                         Number 181, Sec 1,     Sec.   744.11 of the                         10.
                         Datong Rd., Sijhih     EAR).
                         City, Taipei,
                         Taiwan, and 7th
                         Floor, Number 17,
                         Zhonghua Rd., Sec 2,
                         Xinzhuang City,
                         Taipei, Taiwan.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    Dated: February 3, 2010.
Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2010-3278 Filed 2-18-10; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)]
[Notices]
[Pages 10240-10241]
[FR Doc No: 2016-04087]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9942-41-ORD]

Regional Monitoring Networks (RMNs) To Detect Changing Baselines
in Freshwater Wadeable Streams

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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

SUMMARY: Environmental Protection Agency (EPA) is announcing the
availability of a document titled, ``Regional Monitoring Networks
(RMNs) to Detect Changing Baselines in Freshwater Wadeable Streams''
(EPA/600/R-15/280). The document was prepared by the National Center
for Environmental Assessment (NCEA) within EPA's Office of Research and
Development. The document describes the development of the current
regional monitoring networks (RMNs) for riffle-dominated, freshwater
wadeable streams.
    The final document is available via the Internet on the NCEA home
page under the Recent Additions and the Data and Publications menus at
http://www.epa.gov/risk/ecological-risk-assessment-products-and-publications.

DATES: The document will be available on or around February 29, 2016.

ADDRESSES: The final report, ``Regional Monitoring Networks (RMNs) to
Detect Changing Baselines,'' is available primarily via the Internet on
the Ecological Risk Assessment Products and Publications Web page at
http://www.epa.gov/risk/ecological-risk-assessment-products-and-publications. A limited number of paper copies are available from the
Information Management Team, NCEA; telephone:<PHONE_NUMBER>; facsimile:
703-347-8691. If you are requesting a paper copy, please provide your
name, mailing address, and the document title.

FOR FURTHER INFORMATION CONTACT: For technical information, contact
Britta Bierwagen, NCEA; telephone:<PHONE_NUMBER>; facsimile: 703-347-
8694; or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About the Project/Document

    The United States Environmental Protection Agency is working with
its regional offices, states, tribes, river basin commissions, and
other entities to establish Regional Monitoring Networks (RMNs) for
freshwater wadeable streams. RMNs have been established in the
Northeast, Mid Atlantic, and Southeast, and efforts are expanding into
other regions. Long term biological, thermal, hydrologic, physical
habitat, and water chemistry data are being collected at RMN sites to
document current conditions and detect long term changes. Consistent
methods are being used to increase the comparability of data, minimize
biases and variability, and ensure that the data meet data quality
objectives. RMN surveys build

on existing state and tribal bioassessment efforts, with the goal of
collecting comparable data at a limited number of sites that can be
pooled at a regional level. Pooling data enables more robust regional
analyses and improves the ability to detect trends over shorter time
periods. This document describes the development and implementation of
the RMNs. It includes information on selection of sites, expectations
for data collection, the rationale for collecting these data, data
infrastructure, and provides examples of how the RMN data will be used
and analyzed. The report concludes with a discussion on the status of
monitoring activities and next steps.

    Dated: February 19, 2016.
Mary A. Ross,
Deputy Director, National Center for Environmental Assessment.
[FR Doc. 2016-04087 Filed 2-26-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: April 8, 2009 (Volume 74, Number 66)]
[Notices]
[Page 15992-15993]
[DOCID:fr08ap09-76]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0400]

International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 4C on
Microbiological Examination of Nonsterile Products: Acceptance Criteria
for Pharmaceutical Preparations and Substances for Pharmaceutical Use
General Chapter; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4C:
Microbiological Examination of Nonsterile Products: Acceptance Criteria
for Pharmaceutical Preparations and Substances for Pharmaceutical Use
General Chapter.'' The guidance was prepared under the auspices of the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH). The guidance
provides the results of the ICH Q4B evaluation of the Microbiological
Examination of Nonsterile Products: Acceptance Criteria for
Pharmaceutical Preparations and Substances for Pharmaceutical Use
General Chapter harmonized text from each of the three pharmacopoeias
(United States, European, and Japanese) represented by the
Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition
of the three pharmacopoeial methods by the three ICH regulatory regions
and provides specific information regarding the recognition. The
guidance is intended to recognize the interchangeability between the
local regional pharmacopoeias, thus avoiding redundant testing in favor
of a common testing strategy in each regulatory region. In the Federal
Register of February 21, 2008 (73 FR 9575), FDA made available a
guidance on the Q4B process entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.''

DATES:  Submit written or electronic comments on agency guidances at
any time.

ADDRESSES:  Submit written requests for single copies of the guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. The guidance may also be obtained by mail by calling CBER at 1-
800-835-4709 or<PHONE_NUMBER>. Send two self-addressed adhesive labels
to assist the office in processing your requests. Requests and comments
should be identified with the docket number found in brackets in the
heading of this document. Submit written comments on the guidance 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. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Robert H. King, Sr., Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993-0002,
301-796-1242; or Christopher Joneckis, Center for Biologics Evaluation
and Research (HFM-25), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of August 5, 2008 (73 FR 45467), FDA
published a notice announcing the availability of a draft tripartite
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 4C: Microbiological Examination
of Non-Sterile Products: Acceptance Criteria for Pharmaceutical
Preparations and Substances for Pharmaceutical Use General Chapter.''
The notice gave interested persons an opportunity to submit comments by
October 6, 2008.
    After consideration of the comments received and revisions to the
guidance, a final draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 4C: Microbiological Examination of Nonsterile Products:
Acceptance Criteria for Pharmaceutical Preparations and Substances for
Pharmaceutical Use General Chapter'' was submitted to the ICH Steering
Committee and endorsed by the three participating regulatory agencies
in November 2008.
    The guidance provides the specific evaluation outcome from the ICH
Q4B process for the Microbiological Examination of Nonsterile Products:
Acceptance Criteria for Pharmaceutical Preparations and Substances for
Pharmaceutical Use General Chapter harmonization proposal originating
from the three-party PDG. This guidance is in the form of an annex to
the core ICH Q4B guidance. When implemented, the annex will provide
guidance for industry and regulators on the use of the specific
pharmacopoeial texts evaluated by the ICH Q4B process. Following
receipt of comments on the draft, no substantive changes were made to
the annex.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the guidance.
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 the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/cder/guidance/index.htm,
or http://www.fda.gov/cber/guidelines.htm.

    Dated: March 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7905 Filed 4-7-09; 8:45 am]

BILLING CODE 4160-01-S