[Federal Register: October 15, 2010 (Volume 75, Number 199)]
[Notices]
[Page 63468]
[DOCID:fr15oc10-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

October 5, 2010.
    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using
the eLibrary link. Enter the docket number, excluding the last three
digits, in the docket number field to access the document. For
assistance, please contact FERC, Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

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                                         File
              Docket No.                 date    Presenter or  requester
------------------------------------------------------------------------
Prohibited:
1. ER08-386-000......................    9-8-10  Peter C. Luchsinger.
Exempt:
1. CP09-35-000.......................   9-14-10  Elizabeth Kendziora.
2. CP10-477-000......................   9-22-10  Hon. John Barrow.
3. CP10-494-000......................   9-30-10  Ashley and Stuart
                                                  Moberley.
4. CP10-494-000......................   10-4-10  Lisa Reddick.
5. CP10-494-000......................   9-30-10  Jackie and Victoria
                                                  Truelove.
6. Project No. 606-000...............   9-16-10  Hon. Wally Herger.
7. Project No. 2621-000..............   9-29-10  Jim Seay.\1\
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    \1\ E-mail exchange with FERC staff.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-26039 Filed 10-14-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56122-56126]
[FR Doc No: 2022-19684]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95695; File No. SR-BX-2022-015]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Equity 4,
Rules 4120, 4702 and 4703

September 7, 2022.
    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 August 25, 2022, Nasdaq BX, Inc. (``BX'' or the ``Exchange'')
filed with the Securities and Exchange Commission (the ``Commission'')
the proposed rule change as described in Items I and II below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice 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.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Equity 4, Rules 4120, 4702 and 4703
in light of planned changes to the System as well as to address
existing issues, as described further below.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/bx/rules, 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
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
    The Exchange is preparing to introduce a new upgraded version of
the OUCH Order entry protocol \3\ that will enable the Exchange to make
functional enhancements and improvements to specific Order Types \4\
and Order Attributes.\5\ Specifically, enhancements to OUCH will enable
the Exchange to upgrade the logic and implementation of these Order
Types and Order Attributes so that the features are more robust,
streamlined, and harmonized across the Exchange's Systems and Order
entry protocols. The Exchange developed OUCH with simplicity in mind,
and therefore, it presently lacks certain complex order handling
capabilities. By contrast, the Exchange specifically designed its RASH
Order Entry Protocol \6\ to support advanced functionality, including
discretion, random reserve, pegging and routing. The introduction of
OUCH upgrades will enable participants to utilize OUCH, in addition to
RASH, to enter Order Types that require advanced functionality. Thus,
the proposal does not seek to introduce new functionality, but rather,
it offers to OUCH users advanced functionality that already exists for
RASH users.
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    \3\ The OUCH Order entry protocol is a proprietary protocol that
allows subscribers to quickly enter orders into the System and
receive executions. OUCH accepts limit Orders from members, and if
there are matching Orders, they will execute. Non-matching Orders
are added to the Limit Order Book, a database of available limit
Orders, where they are matched in price-time priority. OUCH only
provides a method for members to send Orders and receive status
updates on those Orders. See https://www.nasdaqtrader.com/Trader.aspx?id=OUCH.
    \4\ An ``Order Type'' is a standardized set of instructions
associated with an Order that define how it will behave with respect
to pricing, execution, and/or posting to the Exchange Book when
submitted to the Exchange. See Equity 1, Section 1(a)(11).
    \5\ An ``Order Attribute'' is a further set of variable
instructions that may be associated with an Order to further define
how it will behave with respect to pricing, execution, and/or
posting to the Exchange Book when submitted to the Exchange. See id.
    \6\ The RASH (Routing and Special Handling) Order entry protocol
is a proprietary protocol that allows members to enter Orders,
cancel existing Orders and receive executions. RASH allows
participants to use advanced functionality, including discretion,
random reserve, pegging and routing. See http://nasdaqtrader.com/content/technicalsupport/specifications/TradingProducts/rash_sb.pdf.
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    The Exchange plans to implement its enhancement of the OUCH
protocol sequentially, by Order Type and Order Attribute.\7\
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    \7\ The Exchange notes that its sister exchanges, The Nasdaq
Stock Market and Nasdaq PSX, plan to file similar proposed rule
changes with the Commission shortly.
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    To support and prepare for the introduction of OUCH upgrades, the
Exchange proposes to amend Rule 4702 pertaining to Order Types to
specify that, going forward, OUCH may be used to enter certain Order
Types together with certain Order Attributes, whereas now, Rule 4702
specifies that RASH and FIX, but not OUCH, may be used to enter such
combinations of Order Types and Attributes. The Exchange also proposes
to adjust the current functionality of the Pegging,\8\ Reserve,\9\ and
Trade Now Order Attributes,\10\ as described below, so that they align
with how OUCH, once upgraded, will handle these Order Attributes going
forward.
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    \8\ See Rule 4703(d).
    \9\ See Rule 4703(h).
    \10\ See Rule 4703(l).
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Changes to Use of Certain Order Types With Certain Order Attributes
    Pursuant to Rule 4702(b), the availability of certain Order
Attributes for use with certain Order Types presently depends upon the
particular Order entry protocol a participant uses to enter its Order.
For Price to Comply and Price to Display Orders entered though OUCH,
the Reserve Size, Primary Pegging and Market Pegging, and Discretion
Attributes are not available to participants presently. For Non-
Displayed Orders entered through OUCH, the Primary Pegging, Market
Pegging, and Discretion Attributes are not available presently. The
Exchange proposes to amend Rule 4702(b) so that for each of the Order
Types listed above, participants may utilize the corresponding Order
Attributes when participants enter their Orders using the upgraded
version of OUCH.
    Meanwhile, for Non-Displayed Orders with the Midpoint Pegging
Attribute, the behavior of such Orders presently varies, as set forth
in Rule 4703(d), based upon whether a participant uses OUCH/FLITE or
RASH/FIX to enter them into the System. Going forward, the Exchange
proposes to amend the Rule to reference the amended version Rule
4703(d) (discussed below), which will describe variances in behavior
involving Non-Displayed Orders with Midpoint Pegging which will no
longer depend strictly upon the Order entry protocol associated with
the Orders.
Changes to Market Maker Peg Orders
    Rule 4702(b)(7)(A) presently provides that Market Maker Peg Orders
may be entered through RASH or FIX only. The Exchange proposes to amend
this provision to state that the upgraded

version of OUCH may be used to enter such Orders going forward.
Changes to Pegging Order Attribute
    In addition to the above, the Exchange proposes to amend Rule
4703(d), which governs the Pegging Order Attribute, to account for the
new capabilities of the upgraded version of OUCH.
    As described in Rule 4703(d), Pegging is an Order Attribute that
allows an Order to have its price automatically set with reference to
the NBBO. The Exchange offers three types of Pegging: Primary Pegging,
Market Pegging, and Midpoint Pegging.\11\ The behavior of each of these
types of Pegged Orders currently varies based upon the particular Order
entry protocol associated with their use. With the introduction of the
upgraded version of OUCH, these variances will narrow, as OUCH will be
capable of handling Pegged Orders similar to how RASH and FIX handle
them. However, variances will not disappear entirely, as the upgraded
version of OUCH will continue to handle Orders with Midpoint Pegging
that the System cancels in response to changes to the Midpoint (``Fixed
Midpoint Orders'') the same way that the current iteration of OUCH and
FLITE handles them.
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    \11\ See Rule 4703(d) (defining ``Primary Pegging'' as pegging
with reference to the inside quotation on the same side of the
market, ``Market Pegging'' as pegging with reference to the inside
quotation on the opposite side of the market, and ``Midpoint
Pegging'' as pegging with reference to the midpoint between the
inside bid and the inside offer).
---------------------------------------------------------------------------

    Indeed, pursuant to the proposed rule filing, the behavior of
Pegged Orders will no longer vary strictly by the Order entry protocol
that a participant uses; instead, variance will occur based upon
whether the Pegged Orders are subject to management during their
lifetimes, i.e., the Exchange may adjust the prices of those Orders
during their lifetimes. Managed Pegged Orders (``Peg Managed Orders'')
will include Primary Pegged and Market Pegged Orders entered using
OUCH, RASH, and FIX, as well as Midpoint Pegged Orders, entered using
the same protocols, which the System may update in response to changes
to the Midpoint (``Managed Midpoint Orders''). The Exchange will handle
Managed Midpoint Orders differently from non-managed Orders, i.e.,
Fixed Midpoint Orders, in like circumstances.
    The specific proposed amendments that effectuate the above are as
follows.
    Existing Rule 4703(d) states that if, at the time of entry, there
is no price to which a Pegged Order, that has not been assigned a
Routing Order Attribute, can be pegged, or pegging would lead to a
price at which the Order cannot be posted, then the Order will not be
immediately available on the Exchange Book and will be entered once
there is a permissible price, provided, however, that the System will
cancel the Pegged Order if no permissible pegging price becomes
available within one second after Order entry.\12\ This existing
language applies to Primary, Market, and Midpoint Pegging Orders
entered through RASH/FIX, but not Orders entered through OUCH/FLITE.
The Exchange proposes to amend this provision of the Rule so that it
applies to ``Peg Managed Orders,'' rather than ``Pegged Orders,'' which
in practice will mean that the behavior it currently describes for
Primary Pegged and Market Pegged Orders entered through RASH/FIX will
also now apply to such Orders entered through the upgraded version of
OUCH, as well as to Managed Midpoint Orders entered through RASH/FIX/
upgraded OUCH.\13\ Moreover, the proposed amended provision would
provide for Managed Midpoint Orders that are not assigned a Routing
Order Attribute (or a Time in Force of IOC) to behave similarly if the
Inside Bid and Inside Offer are crossed (i.e., the Managed Midpoint
Order will not be immediately available on the Exchange Book unless and
until a permissible price emerges within one second of entry (or other
such time that the Exchange designates, at its discretion)).
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    \12\ The Exchange may, in the exercise of its discretion, modify
the length of this one second time period by posting advance notice
of the applicable time period on its website.
    \13\ The Exchange also proposes to clarify that this provision
applies to a Peg Managed Order that has not been assigned a Routing
Order Attribute or a Time-in-Force of Immediate-Or-Cancel (``IOC'').
This additional amendment makes it clear that IOC orders in this
scenario will cancel immediately if no permissible pegging price is
available upon Order entry, rather than waiting up to one second
after Order entry to do so.
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    Existing Rule 4703(d) also states that if a Pegged Order has been
assigned a Routing Order Attribute, but there is no permissible price
to which the Order can be pegged at the time of entry, then the
Exchange will reject it, except that the Exchange will accept a
Displayed Order with Market Pegging and a Market or a Primary Pegged
Order with a Non-Display Attribute at their respective limit prices in
this circumstance. The Exchange again proposes to amend this provision
so that it applies to Peg Managed Orders, rather than Pegged Orders. It
also proposes to apply this provision to Managed Midpoint Orders that
are assigned a Routing Order Attribute, if the Inside Bid and Inside
Offer are crossed. Finally, as is explained further below, the Exchange
proposes to delete the last two sentences of this paragraph, which
describe the behavior of Orders with Midpoint Pegging, and move them to
the end of the next paragraph, which also pertains to Orders with
Midpoint Pegging. The Exchange proposes this organizational change for
ease of readability.
    As to the next paragraph of Rule 4703(d), the Exchange proposes
several changes. First, the Exchange proposes to delete the first
sentence of this paragraph, which lists the Order entry protocols for
which Primary Pegging and Market Pegging are presently available (RASH
and FIX). This sentence is no longer needed because, as discussed
above, the Exchange proposes to add a new sentence that specifies that
all Peg Managed Orders will be available, not only through RASH and
FIX, but also through OUCH, going forward. Second, the Exchange
proposes to modify the second sentence of the paragraph, which
presently states that for an Order entered through OUCH or FLITE with
Midpoint Pegging, the Order will have its price set upon initial entry
to the Midpoint, unless the Order has a limit price, and that limit
price is lower than the Midpoint for an Order to buy (higher than the
Midpoint for an Order to sell), in which case the Order will be ranked
on the Exchange Book at its limit price. The Exchange proposes to apply
this language to Midpoint Pegging Orders generally, rather than only
Midpoint Pegging Orders entered through OUCH or FLITE, as it will apply
to both Fixed Midpoint Orders and Managed Midpoint Orders. Third, the
Exchange proposes to add and partially restate the following language
from the preceding paragraph:

    In the case of an Order with Midpoint Pegging, if the Inside Bid
and Inside Offer are locked, the Order will be priced at the locking
price; and for Orders with Midpoint Pegging entered through OUCH or
FLITE, if the Inside Bid and Inside Offer are crossed or if there is
no Inside Bid and/or Inside Offer, the Order will not be accepted.
However, even if the Inside Bid and Inside Offer are locked, an
Order with Midpoint Pegging that locked an Order on the Exchange
Book would execute.

    Specifically, the Exchange proposes to replace the phrase ``and for
Orders with Midpoint Pegging entered through OUCH or FLITE'' with ``and
for Fixed Midpoint Orders,'' because going forward, some Midpoint
Pegging Orders entered through the upgraded version of OUCH will not
behave in this manner; only Fixed Midpoint Orders will do so.\14\
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    \14\ The Exchange also proposes to make a stylistic, non-
substantive change to this text by deleting the phrase ``In the case
of an Order with Midpoint Pegging.'' The Exchange believes this
phrase is no longer needed due to the fact that the new paragraph to
which it proposes to move the text clearly applies to Orders with
Midpoint Pegging.

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    The Exchange proposes to amend the next paragraph, which describes
how the Exchange handles Orders with Midpoint Pegging entered through
OUCH or FLITE where the Exchange does not adjust the prices of the
Orders based on changes to the Inside Bid or Offer that occur after the
Orders post to the Exchange Book. The Exchange proposes to amend this
paragraph to state that it applies to Fixed Midpoint Orders (rather
than Orders with Midpoint Pegging entered through OUCH or FLITE) and to
state expressly that it applies to such Orders after they post to the
Exchange Book.
    The subsequent paragraph of Rule 4703(d) describes how the Exchange
handles Pegged Orders entered through RASH or FIX where the Exchange
does adjust the prices of the Orders based on changes to the relevant
Inside Quotation that occur after the Orders Post to the Exchange Book.
Like the preceding paragraph, the Exchange proposes to amend this
paragraph to state that it applies to Peg Managed Orders (rather than
Orders entered through RASH or FIX with Pegging). The Exchange also
proposes to amend text in this paragraph, which states that the
Exchange will reject such an Order, if it assigned a Routing Order
Attribute, and if the price to which it is pegged becomes unavailable
or pegging would lead to a price at which it cannot be posted. The
proposed amended language states that the Exchange will cancel such an
Order back to the participant in these circumstances, rather than
``reject'' it; the use of the term ``cancel'' is more appropriate than
``reject'' in this provision insofar as the Exchange only rejects
Orders upon entry, but thereafter, it cancels them. Consistent with
amendments elsewhere in the proposal, the Exchange also proposes to
state that Managed Midpoint Orders assigned a Routing Order Attribute
will cancel back to the participant if the Inside Bid and Inside Offer
become crossed. The Exchange also proposes to qualify the foregoing by
noting that an Order with Market Pegging, or an Order with Primary
Pegging and a Non-Display Attribute, will be re-entered at its limit
price. Finally, the Exchange proposes to amend the subsequent text,
which presently reads as follows:

    ``. . . if the Order is not assigned a Routing Order Attribute,
the Order will be removed from the Exchange Book and will be re-
entered once there is a permissible price, provided however, that
the System will cancel the Pegged Order if no permissible pegging
price becomes available within one second after the Order was
removed and no longer available on the Exchange Book (the Exchange
may, in the exercise of its discretion modify the length of this one
second time period by posting advance notice of the applicable time
period on its website).''

    The Exchange proposes to amend this text to specify that it applies
to a ``Peg Managed Order,'' rather than simply an ``Order.''
Additionally in this clause, the Exchange proposes to add, after the
phrase, ``if [a Peg Managed Order] is not assigned a Routing Order
Attribute,'' the following text, for clarity: ``and the price to which
it is pegged becomes unavailable, pegging would lead to a price at
which the Order cannot be posted, or, in the case of a Managed Midpoint
Order, if the Inside Bid and Inside Offer become crossed, . . . .'' The
Exchange believes that these conditions are implicit in the existing
Rule text and should be made explicit to avoid confusion. Insofar as
this proposed amended text will now account for Managed Midpoint
Orders, then the Exchange proposes to delete the following existing
text, which will otherwise be duplicative:

    ``For an Order with Midpoint Pegging, if the Inside Bid and
Inside Offer become crossed or if there is no Inside Bid and/or
Inside Offer, the Order will be removed from the Exchange Book and
will be re-entered at the new midpoint once there is a valid Inside
Bid and Inside Offer that is not crossed; provided, however, that
the System will cancel the Order with Midpoint Pegging if no
permissible price becomes available within one second after the
Order was removed and no longer available on the Exchange Book (the
Exchange may, in the exercise of its discretion modify the length of
this one second time period by posting advance notice of the
applicable time period on its website).''

    Finally, the Exchange proposes to restate the paragraph of Rule
4703(d) that describes Pegging Order collars. In pertinent part, this
paragraph presently states that ``any portion of a Pegging Order that
could execute, either on the Exchange or when routed to another market
center, at a price of more than $0.25 or 5 percent worse than the NBBO
at the time when the order reaches the System, whichever is greater,
will be cancelled.'' The Exchange proposes to restate this text to
account for the fact that under certain conditions, the System will
cancel Pegging Orders before clearing liquidity inside the collar. For
non-routable Pegged Orders, the System cancels these Orders prior to
polling the Exchange Book for liquidity (even inside of the collar)
when the combination of limit price, pegging, offset, discretionary
price, discretionary pegging, and discretionary offset attributes would
result in the Order attempting to post to the book or clear resting
Orders beyond the collar price (even if such liquidity does not
exist).\15\ For routable Primary or Market Peg Orders, by contrast, the
System will clear any liquidity inside of the collar before
cancelling.\16\ The Exchange proposes to more precisely describe this
behavior with the following restated text:
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    \15\ For example, if NYSE is quoting $10.00 x $11.00 and a
Displayed Sell Order of 100 shares is setting the NBO by resting on
the Book at $10.05, then an incoming Primary Peg Buy order with a
Limit Price of $10.75 and an Offset Value of $0.56 will be cancelled
back without executing against the resting order at $10.05. The
Primary Peg attribute initially sets the price of the Order at
$10.00, then the offset amends the price to $10.56; the collar price
is set to $10.05 + ($10.05 x 5%) = $10.5525, which is less than the
price the incoming Order would attempt to book at.
    \16\ For example, if NYSE is quoting $10.00 x $11.00 and a
Displayed Sell Order of 100 shares is setting the NBO by resting on
the Book at $10.05, then an incoming Primary Peg Buy order of 200
shares with a Limit Price of $10.75, an Offset Value of $0.56, and
the SCAN routing strategy will execute against the resting order
before the remainder is cancelled before booking outside the collar
price.

    Any portion of a Pegging Order with a Routing attribute to buy
(sell) that could execute, either on the Exchange or when routed to
another market center, at a price of more than the greater of $0.25
or 5 percent higher (lower) than the NBO (NBB) at the time when the
order reaches the System (the ``Collar Price''), will be cancelled.
An Order entered without a Routing attribute will be cancelled if it
would, as a result of the price determined by a Pegging or
Discretionary Pegging attribute, execute or post to the Exchange
Book at a price through the Collar Price.
Change To Reserve Attribute
    The Exchange proposes to amend its rules governing the Reserve
Order Attribute, at Rule 4703(h) to state that when a Reserve Order is
entered using OUCH with a displayed size of an odd lot, the System will
reject the Order, whereas if such an order is entered using RASH or
FIX, then as is the case now under the existing Rule, the System will
accept the Order but with the full size of the Order Displayed. The
Exchange believes that this new proposed behavior will benefit
participants insofar as Reserve Orders entered with odd lot displayed
sizes are often the product of errors. Rather than expose erroneous
displayed sizes, OUCH will cancel the Orders and thus provide
participants with an opportunity to correct their errors, or to

validate their original choices, by re-entering the Reserve Order.
Change To Trade Now Attribute
    The Exchange proposes to amend its rules governing the Trade Now
Order Attribute, at Rule 4703(l) to state that when the Trade Now
Attribute is entered through RASH or FIX, and going forward, also
through OUCH, the Trade Now Order Attribute may be enabled on an order-
by-order or a port-level basis. In the next sentence in the paragraph,
the existing text will continue to apply, but as to FLITE only, and not
to OUCH. Thus, when entered through FLITE (but not OUCH), the Trade Now
Order Attribute may be enabled on a port-level basis for all Order
Types that support it, and for the Non-Displayed Order Type, also on an
order-by-order basis.
Change To Limit Up-Limit Down Mechanism
    The Exchange proposed to amend its rules governing Limit Up-Limit
Down (``LULD'') functionality, at Rule 4120(a)(13)(E)(2)(a) to state
that limit priced orders entered via the OUCH protocol, which are not
assigned a Managed Pegging, Discretionary, or Reserve Attribute, shall
be repriced upon entry only if the Price Bands are such that the price
of the limit-priced interest to buy (sell) would be above (below) the
upper (lower) Price Band. Additionally, the Exchange is proposing to
amend Rule 4120(a)(13)(E)(2)(b) to state that limit-priced orders
entered via RASH or FIX protocols, or via the OUCH protocol if assigned
a Managed Pegging, Discretionary, or Reserve Attribute, the order shall
be eligible to be repriced by the system multiple times if the Price
Bands move such that the price of resting limit-priced interest to buy
(sell) would be above (below) the upper (lower) Price Band.
    The Exchange intends to implement the foregoing changes at the end
of the Third Quarter or early in the Fourth Quarter of 2022. The
Exchange will issue an Equity Trader Alert at least 7 days in advance
of implementing the changes.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\17\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\18\ in particular, in that it is 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, and, in general to protect investors and the public
interest.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78f(b).
    \18\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Generally speaking, it is consistent with the Act to amend the
Rulebook to reflect upgrades to the Exchange's OUCH Order entry
protocols. The planned upgrades will enable members to utilize OUCH in
additional circumstances, including for the entry of: (1) Price to
Comply and Price to Display Orders with the Reserve Size, Primary and
Market Pegging, and Discretion Order Attributes; (2) Non-Displayed
Orders with the Primary and Market Pegging, Midpoint Pegging (in
scenarios described in amended Rule 4703(d)), and Discretion Order
Attributes; and (3) Market Maker Peg Orders.
    Likewise, the Exchange believes that its proposed amendments to the
Pegging Order Attribute, at Rule 4703(d), are consistent with the Act.
The proposed amendments account for the fact that OUCH will become
capable of use for the entry of Peg Managed Orders, including Managed
Midpoint Orders, in addition to Fixed Midpoint Orders. The Exchange
believes that it will be clearer and more coherent to describe the
behavior of Pegged Orders and Orders with Midpoint Pegging in the Rule
with regard to whether these Orders are ``Managed'' or ``Fixed,''
rather than with regard to the protocol used to enter them, especially
as OUCH will be available for use in entering both Managed and Fixed
Pegging Orders going forward. Additionally, proposed amendments to Rule
4703(d) would reorganize the description of the behavior of various
types of Pegged Orders so that it flows more logically and is more
readily comprehensible. Finally, proposed changes would describe the
behavior of Pegged Orders more comprehensively, by adding language that
was mistakenly omitted from the Rule.
    Meanwhile, the Exchange's proposal to restate the Rule's
description of the price collar applicable to Pegged Orders is
consistent with the Act because it accounts for the fact that under
certain conditions, the System will cancel Pegging Orders before
clearing liquidity inside the collar.
    The Exchange's proposal is consistent with the Act to amend its
Rule governing the Reserve Order Attribute, at Rule 4703(h) to state
that when a Reserve Order is entered using OUCH with a displayed size
of an odd lot, the System will reject the Order. The Exchange believes
that this new proposed behavior will benefit participants insofar as
Reserve Orders entered with odd lot displayed sizes are often the
product of errors. Rather than expose erroneous displayed sizes, OUCH
will cancel the Orders and thus provide participants with an
opportunity to correct their errors, or to validate their original
choices, by re-entering the Reserve Order.
    Additionally, the Exchange's proposal to amend its Rule governing
the Trade Now Order Attribute, at Rule 4703(l), is consistent with the
Act, because it accounts for the fact that when entered through the
upgraded version of OUCH, the Trade Now Order Attribute may be enabled
on an order-by-order or a port-level basis.
    Finally, the Exchange's proposal to amend its Rule governing the
Limit Up-Limit Down Mechanism, at Rules 4120(a)(13)(E)(2)(a) and
4120(a)(13)(E)(2)(b) are consistent with the Act because the proposed
amendments align with OUCH's capability going forward, once upgraded,
to handle certain Order Types and Order Attributes similar to how RASH
and FIX handle them. Additionally, as discussed above, variance will
occur in certain Order Types based upon whether the orders are subject
to management during their lifetimes.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. As a general principle, the
proposed changes are reflective of the significant competition among
exchanges and non-exchange venues for order flow. In this regard,
proposed changes that facilitate enhancements to the Exchange's System
and Order entry protocols as well as those that amend and clarify the
Exchange's Rules regarding its Order Attributes, are pro-competitive
because they bolster the efficiency, functionality, and overall
attractiveness of the Exchange in an absolute sense and relative to its
peers.
    Moreover, none of the proposed changes will unduly burden intra-
market competition among various Exchange participants. Participants
will experience no competitive impact from its proposals, as these
proposals will restate and reorganize portions of the Rule to reflect
the upgraded capabilities of OUCH, as well as to render the
descriptions of OUCH's new capabilities easier to read and understand.

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

    No written comments were either solicited or received.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \19\ and Rule 19b-4(f)(6) thereunder.\20\
Because the foregoing proposed rule change does not: (i) significantly
affect the protection of investors or the public interest; (ii) impose
any significant burden on competition; and (iii) become operative prior
to 30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \21\ and Rule
19b-4(f)(6) thereunder.\22\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \20\ 17 CFR 240.19b-4(f)(6).
    \21\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \22\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \23\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\24\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
---------------------------------------------------------------------------

    \23\ 17 CFR 240.19b-4(f)(6).
    \24\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Exchange has represented that the proposal does not seek to
introduce new functionality, but rather, it offers to OUCH users
advanced functionality that already exists for RASH users. The
Commission believes that waiver of the 30-day operative delay for this
proposal is consistent with the protection of investors and the public
interest as it will allow the Exchange to provide existing advanced
functionality to OUCH users without delay. Accordingly, the Commission
hereby waives the 30-day operative delay and designates the proposal
operative upon filing.\25\
---------------------------------------------------------------------------

    \25\ For purposes only of accelerating the operative date of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \26\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-BX-2022-015 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2022-015. 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 website (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 website 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BX-2022-015 and should be submitted on
or before October 4, 2022.

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

    \27\ 17 CFR 200.30-3(a)(12), (59).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-19684 Filed 9-12-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Notices]
[Pages 53492-53493]
[FR Doc No: 2017-24797]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-11-000]

East Cheyenne Gas Storage, LLC; Notice of Application

    Take notice that on October 27, 2017, East Cheyenne Gas Storage,
LLC (East Cheyenne), 10370 Richmond Avenue, Suite 510, Houston, Texas
77042, filed in the above referenced docket an application pursuant to
section 7(c) of the Natural Gas Act (NGA), and Part 157 of the
Commission's regulations requesting authorization to amend its
certificate of public convenience and necessity issued by the
Commission in Docket No. CP10-34-000, as amended in Docket Nos. CP11-
40-000, CP12-35-000, CP12-124-000, CP14-486-000, and CP16-25-000, to:
(i) Consolidate the working gas capacity and cushion gas capacity of
the West Peetz and Lewis Creek portions of the East Cheyenne Gas
Storage Project (Project) into one working gas capacity and one cushion
gas capacity, (ii) allow a unified maximum bottom-hole pressure for the
Project reservoir, (iii) reallocate the storage gas capacity in the
Project by increasing the working gas capacity and decreasing the
cushion gas capacity of the Project by 3.6 billion cubic feet (Bcf)
each, (iv) reconfigure certain facilities in the Lewis Creek portion of
the Project, and (v) expand the buffer zone of the Project. Also, East
Cheyenne requests the Commission to issue an order reaffirming its
market-based rate authorization in light of the increase in working gas
capacity of the Project, all as more fully set forth in the application
which is on file with the Commission and open to public inspection. The

filing is available for review at the Commission in the Public
Reference Room or may be viewed on the Commission's Web site web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions concerning this application may be directed to James
Hoff, Vice President, Reservoir Engineering, East Cheyenne Gas Storage,
LLC, 10370 Richmond Avenue, Suite 510, Houston, Texas 77042, at (713)
403-6467.
    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9),
within 90 days of this Notice, the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit seven copies of filings made in the proceeding with the
Commission and must mail a copy to the applicant and to every other
party. Only parties to the proceeding can ask for court review of
Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 7 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on November 29, 2017.

    Dated: November 8, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-24797 Filed 11-15-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: November 22, 2005 (Volume 70, Number 224)]
[Notices]
[Page 70603-70604]
[DOCID:fr22no05-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ES06-6-000]

NorthWestern Corporation; Notice of Filing

November 10, 2005.
    Take notice that on November 3, 2005, NorthWestern Corporation
(NorthWestern) submitted an application pursuant to section 204 of the
Federal Power Act seeking authorization to: (1) Borrow proceeds from
the sale by the city of Forsyth, Montana (City) of not to exceed
$170,205,000 principal amount of City's Pollution Control Revenue
Refunding Bonds Series 2005 ( the Series 2005 PCRRBs); (2) provide for
repayment thereof; and (3) issue and deliver to the Trustee for the
Series 2005 PCRRBs a like principal amount of a new series of its First
Mortgage Bonds to secure payment of the Series 2005 PCRRBs.
    NorthWestern also requests a waiver from the Commission's
competitive bidding and negotiated placement requirements at 18 CFR
34.2.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant. On or before the comment date, it is
not necessary to serve motions to intervene or protests on persons
other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission,

888 First Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on November 18, 2005.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6423 Filed 11-21-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 167 (Thursday, August 27, 2020)]
[Notices]
[Pages 53007-53008]
[FR Doc No: 2020-18894]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0938]

Evaluating Cancer Drugs in Patients With Central Nervous System
Metastases; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Evaluating
Cancer Drugs in Patients with Central Nervous System Metastases.'' This
draft guidance document provides recommendations regarding the design
of clinical trials of drugs and biological products regulated by the
Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER) that are intended to support
product labeling describing the antitumor activity in patients with
central nervous system (CNS) metastases from solid tumors originating
outside the CNS. The draft guidance includes study design
recommendations regarding the patient population, available therapy,
prior therapies, assessment of CNS disease, study endpoints, and
leptomeningeal disease.

DATES: Submit either electronic or written comments on the draft
guidance by October 26, 2020, to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-0938 for ``Evaluating Cancer Drugs in Patients with Central
Nervous System Metastases.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting

of comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002 or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The draft guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Shanthi Marur, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2369, Silver Spring, MD 20993-0002, 240-
402-6373; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Evaluating Cancer Drugs in Patients with Central Nervous
System Metastases.'' This draft guidance provides recommendations for
sponsors designing clinical trials of drugs and biological products
regulated by CDER and CBER that are intended to support product
labeling describing the antitumor activity in patients with central
nervous system (CNS) metastases from solid tumors originating outside
the CNS. Specifically, the draft guidance includes recommendations
regarding the patient population, available therapy, prior therapies,
assessment of CNS disease, study endpoints, and leptomeningeal disease.
The draft guidance describes that CNS metastases should be evaluated in
the context of the entire disease burden and discusses how treatment
effects may be described in drug labeling. The recommendations pertain
to clinical trials for systemic anticancer drugs where patients with
CNS metastases are included in the study population. These
recommendations are also applicable to trials conducted exclusively in
patients with CNS metastases.
    CNS metastases are associated with significant morbidity and
mortality and development of therapeutic products for patients with CNS
metastases is needed. FDA has participated in efforts to facilitate
drug development for patients with CNS metastases including a March
2019 ``Workshop on Product Development for CNS Metastases''.
Stakeholders at this meeting stated there is a need for further FDA
guidance on specific topics including identifying optimal study
endpoints. Study design challenges for CNS metastases include
uncertainty regarding optimal endpoints, lack of standardized response
assessments, understanding how CNS metastases are evaluated in the
context of the entire burden of metastatic disease to characterize a
drug's potential benefit (e.g., timing of CNS radiographic assessments
relative to other sites of metastases), and interpreting radiographic
response in the setting of recent radiation therapy or surgery. This
draft guidance is intended to provide recommendations on these study
design challenges.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Evaluating
Cancer Drugs in Patients with Central Nervous System Metastases.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014; the collections of information in 21 CFR
part 314 have been approved under OMB control number 0910-0001; the
collections of information in 21 CFR part 601 have been approved under
0910-0338; and the collections of information in 21 CFR 201.56 and
201.57 have been approved under OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: August 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18894 Filed 8-26-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 57 (Thursday, March 24, 2022)]
[Proposed Rules]
[Pages 16674-16676]
[FR Doc No: 2022-06058]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0266; Airspace Docket No. 19-AAL-56]
RIN 2120-AA66

Proposed Establishment of United States Area Navigation (RNAV)
Route T-388; Port Heiden, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish United States Area
Navigation (RNAV) route T-388 in the vicinity of Port Heiden, AK in
support of a large and comprehensive T-route modernization project for
the state of Alaska.

DATES: Comments must be received on or before May 9, 2022.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2022-0266; Airspace Docket No. 19-AAL-56 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order JO 7400.11F, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Christopher McMullin, Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would expand the availability of RNAV in Alaska and
improve the efficient flow of air traffic within the National Airspace
System (NAS) by lessoning the dependency on ground based navigation.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2022-0266; Airspace Docket No. 19-AAL-56) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2022-0266; Airspace Docket No. 19-AAL-56.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The

proposal contained in this action may be changed in light of comments
received. All comments submitted will be available for examination in
the public docket both before and after the comment closing date. A
report summarizing each substantive public contact with FAA personnel
concerned with this rulemaking will be filed in the docket.

Availability of NPRM

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Western Service Center, Operations
Support Group, Federal Aviation Administration, 2200 South 216th St.,
Des Moines, WA 98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11F, Airspace
Designations and Reporting Points, dated August 10, 2021, and effective
September 15, 2021. FAA Order JO 7400.11F is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11F
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

Background

    In 2003, Congress enacted the Vision 100--Century of Aviation
Reauthorization Act (Pub. L. 108-176), which established a joint
planning and development office in the FAA to manage the work related
to the Next Generation Air Transportation System (NextGen). Today,
NextGen is an ongoing FAA-led modernization of the nation's air
transportation system to make flying safer, more efficient, and more
predictable.
    In support of NextGen, this proposal is part of a larger and
comprehensive T-route modernization project in the state of Alaska. The
project mission statement states: ``To modernize Alaska's Air Traffic
Service route structure using satellite based navigation Development of
new T-routes and optimization of existing T-routes will enhance safety,
increase efficiency and access, and will provide enroute continuity
that is not subject to the restrictions associated with ground based
airway navigation.'' As part of this project, the FAA evaluated the
existing Colored airway structure for: (a) Direct replacement (i.e.,
overlay) with a T-route that offers a similar or lower Minimum Enroute
Altitude (MEA) or Global Navigation Satellite System Minimum Enroute
Altitude (GNSS MEA); (b) the replacement of the Colored airway with a
T-route in an optimized but similar geographic area, while retaining
similar or lower MEA; or (c) removal with no route structure (T-route)
restored in that area because the value was determined to be
insignificant.
    The aviation industry/users have indicated a desire for the FAA to
transition the Alaskan en route navigation structure away from
dependency on Non-Directional Beacons (NDB), and move to develop and
improve the RNAV route structure. Port Heiden, AK, (PDN) and Woody
Island, AK, (RWO) NDBs are on the list of to be decommissioned in the
near future. Colored Federal airway Green 10 (G-10) is dependent upon
both of these NAVAIDs and would be rendered unusable upon
decommissioning. In order to mitigate the loss of G-10, this proposal
would create a new RNAV route, T-388, to replace the portion between
these two NDBs. The segment of G-10 that navigates from PDN to Cold
Bay, AK is not included in this proposal since there are already
mitigating factors in place.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to establish
RNAV route T-388 in the vicinity of Port Heiden, AK in support of a
large and comprehensive T-route modernization project for the state of
Alaska. The proposed route is described below.
    T-388: The FAA proposes to establish RNAV route T-388 from a newly
established waypoint (WP) WIXER, AK, WP over PDN to the BAILY, AK, WP
to the northwest of Kodiak Airport, Alaska. Full details of the
proposed route are included in ``The Proposed Amendment'' section.
    United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11F dated August 10, 2021 and effective
September 15, 2021, which is incorporated by reference in 14 CFR 71.1.
The RNAV route listed in this document would be published subsequently
in FAA Order JO 7400.11.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6011 United States Area Navigation Routes

* * * * *

T-388 WIXER, AK to BAILY, AK [New]

WIXER, AK                     WP                  (Lat. 56[deg]54'29.00'' N, long. 158[deg]36'10.00'' W)
ZOPAB, AK                     WP                  (Lat. 57[deg]09'28.12'' N, long. 157[deg]48'14.87'' W)
HEBMI, AK                     WP                  (Lat. 57[deg]24'13.13'' N, long. 156[deg]51'24.77'' W)
ZEMIR, AK                     WP                  (Lat. 57[deg]51'13.88'' N, long. 154[deg]02'28.16'' W)
BAILY, AK                     WP                  (Lat. 57[deg]54'33.79'' N, long. 152[deg]54'36.97'' W)

* * * * *

    Issued in Washington, DC, on March 17, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-06058 Filed 3-23-22; 8:45 am]
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[Federal Register Volume 79, Number 239 (Friday, December 12, 2014)]
[Notices]
[Pages 73948-73949]
[FR Doc No: 2014-29127]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2014-0115]

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System

    In accordance with Part 235 of Title 49 Code of Federal Regulations
(CFR) and 49 U.S.C. 20502(a), this document provides the public notice
that by a document dated October 22, 2014, Norfolk Southern Corporation
(NS) has petitioned the Federal Railroad Administration (FRA) seeking
approval for the discontinuance or modification of a signal system. FRA
assigned the petition Docket Number FRA-2014-0115.

Applicant: Norfolk Southern Corporation, Mr. Brian L. Sykes, Chief
Engineer C&S Engineering, 1200 Peachtree Street NE., Atlanta, GA 30309.

    NS seeks approval of the proposed discontinuance of a traffic
control system (TCS) on the Winding Gulf Branch between Horsepen,
Milepost (MP) WG 6.5 and Tams, MP WG 12.1, near Amigo, WV.
    The reason given for the proposed changes is that the TCS is no
longer desirable or needed to handle current train operations. The TCS
will be discontinued and replaced with NS Rule 171 for track authority
operation. CP Horsepen will be renewed, and fixed approach signals will
be installed, in approach to the start of TCS territory.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.

Communications received by January 26, 2015 will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to

better inform its processes. DOT posts these comments, without edit,
including any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy. See also
http://www.regulations.gov/#!privacyNotice for the privacy notice of
regulations.gov.

    Issued in Washington, DC, on December 8, 2014.
Ron Hynes,
Director, Office of Technical Oversight.
[FR Doc. 2014-29127 Filed 12-11-14; 8:45 am]
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[Federal Register Volume 87, Number 156 (Monday, August 15, 2022)]
[Notices]
[Pages 50162-50163]
[FR Doc No: 2022-17459]

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DEPARTMENT OF TRANSPORTATION

[Docket No. PHMSA-2021-0085]

Pipeline Safety: Information Collection Activities--Revision to
the National Pipeline Mapping System Information Collection

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice and request for comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 this
notice announces that the information collection request abstracted
below is being forwarded to the Office of Management and Budget (OMB)
for review and comment. A Federal Register notice with a 60-day comment
period soliciting comments on the information collection was published
on March 11, 2022.

DATES: Interested persons are invited to submit comments on or before
September 14, 2022.

ADDRESSES: The public is invited to submit comments regarding this
information collection request, including suggestions for reducing the
burden, to the Office of Management and Budget, Attention: Desk Officer
for the Office of the Secretary of Transportation, 725 17th Street NW,
Washington, DC 20503. Comments can also be submitted electronically at
www.reginfo.gov/public/do/PRAMain.

FOR FURTHER INFORMATION CONTACT: Angela Hill by telephone at 202-680-
2034, by email at [email protected], or by mail at DOT, PHMSA, 1200
New Jersey Avenue SE, PHP-30, Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

I. Background

    Title 5, Code of Regulations (CFR) section 1320.8(d), requires
PHMSA to provide interested members of the public and affected agencies
the opportunity to comment on information collection and recordkeeping
requests before they are submitted to OMB for approval. In accordance
with this regulation, on March 11, 2022, (87 FR 14097) PHMSA published
a Federal Register notice with a 60-day comment period soliciting
comments on its plan to request a revision to the National Pipeline
Mapping System information collection that is currently approved under
OMB Control Number 2137-0596. PHMSA received no comments in response to
the proposed revision to this information collection request. This
notice announces that PHMSA will submit the information collection
revision request abstracted below to OMB for approval.
    The following information is provided for this information
collection: (1) Title of the information collection; (2) OMB control
number; (3) Current expiration date; (4) Type of request; (5) Abstract
of the information collection activity; (6) Description of affected
public; (7) Estimate of total annual reporting and recordkeeping
burden; and (8) Frequency of collection.
    PHMSA will request a three-year term of approval for this
information collection. PHMSA requests comments on the following
information:
    1. Title: National Pipeline Mapping System Program.
    OMB Control Number: 2137-0596.
    Expiration Date: 1/31/2023.
    Type of Request: Revision of a previously approved information
collection.
    Abstract: The Pipeline Safety Improvement Act of 2002 (Pub. L. 107-
355), 49 U.S.C. 60132, ``National Pipeline Mapping System,'' requires
the operator of a pipeline facility (except distribution lines and
gathering lines) to provide information to PHMSA. Each operator is
required to submit geospatial data appropriate for use in the National
Pipeline Mapping System or data in a format that can be readily
converted to geospatial data; the name and address of the person with
primary operational control (to be known as its operator); and a means
for a member of the public to contact the operator for additional
information about the pipeline facilities it operates. Operators will
submit the requested data elements once and make annual updates to the
data if necessary. These data elements strengthen the effectiveness of
PHMSA's risk rankings and evaluations, which are used as a factor in
determining pipeline inspection priority and frequency; allow for more
effective assistance to emergency responders by providing them with a
more reliable, complete

data set of pipelines and facilities; and provide better support to
PHMSA's inspectors by providing more accurate pipeline locations and
additional pipeline-related geospatial data that can be linked to
tabular data in PHMSA's inspection database.
    This revision will require operators to submit geospatial data for
moderate consequence areas (MCAs), as defined in 49 CFR part 192, and
data based on the applicability of 49 CFR 192.710 assessments outside
of high consequence areas. This revision would also require operators
to submit the data element ``specified minimum yield strength'' in
pounds per square inch gauge in place of submitting data on pipe grade.
PHMSA does not expect operators to incur additional burden due to the
inclusion of these two new elements. PHMSA believes that the annual
burden allotted for this information collection is sufficient for
operators to include the newly requested data elements. A detailed
breakdown of the estimated burden for this information collection can
be found at www.regulations.gov.
    Respondents: Operators of gas transmission, hazardous liquid, or
liquefied natural gas pipeline facilities.
    Annual Reporting and Recordkeeping Burden:
    Estimated Number of Responses: 1,346 responses.
    Estimated Total Annual Burden: 162,208 hours.
    Frequency of Collection: Annually.
    Comments are invited on:
    (a) The need for the renewal and revision of this collection of
information for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (b) The accuracy of the Agency's estimate of the burden of the
proposed collection of information,
    (c) Ways to enhance the quality, utility, and clarity of the
information to be collected; and
    (d) Ways to minimize the burden of the collection of information on
those who are required to respond, including the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended; and 49 CFR 1.48.

    Issued in Washington, DC, on August 8, 2022, under authority
delegated in 49 CFR 1.97.
Alan K. Mayberry,
Associate Administrator for Pipeline Safety.
[FR Doc. 2022-17459 Filed 8-12-22; 8:45 am]
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