[Federal Register Volume 86, Number 135 (Monday, July 19, 2021)]
[Notices]
[Pages 38147-38151]
[FR Doc No: 2021-15186]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92377; File No. SR-Phlx-2021-40]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Equity 4,
Rules 3301A and 3301B

July 13, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 2, 2021, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
prepared by 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, Rule 3301B, as described
further below.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/phlx/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 aspects of such
statements.

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

1. Purpose
    Presently, the Exchange is making functional enhancements and
improvements to specific Order Attributes \3\ that are currently only
available via the RASH Order entry protocol.\4\ Specifically, the
Exchange will be upgrading the logic and implementation of these Order
Types and Order Attributes so that the features are more streamlined
across the Exchange Systems and order entry protocols, and will enable
the Exchange to process these Orders more quickly and efficiently.
Additionally, this System upgrade will pave the way for the Exchange to
enhance the OUCH Order entry protocol \5\ so that Participants may
enter such Order Types and Order Attributes via OUCH, in addition to
the RASH Order entry protocols.\6\ The Exchange plans to implement its
enhancement of the OUCH protocol sequentially, by Order Type and Order
Attribute.\7\
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    \3\ An ``Order Attribute'' is a 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 System. See Equity 1, Section
1(b)(7).
    \4\ 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.
    \5\ 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.
    \6\ The Exchange designed the OUCH protocol to enable members to
enter Orders quickly into the System. As such, the Exchange
developed OUCH with simplicity in mind, and it therefore lacks more
complex order handling capabilities. By contrast, the Exchange
specifically designed RASH to support advanced functionality,
including discretion, random reserve, pegging and routing. Once the
System upgrades occur, then the Exchange intends to propose further
changes to its Rules to permit participants to utilize OUCH, in
addition to RASH, to enter order types that require advanced
functionality.
    \7\ The Exchange notes that its sister exchange, The Nasdaq
Stock Market, LLC (``Nasdaq''), has already filed similar proposed
rule changes with the Commission. See Securities Exchange Act
Release No. 34-92180 (June 15, 2021), 86 FR 33420 (June 24, 2021)
(SR-NASDAQ-2021-044).
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    To support and prepare for these upgrades and enhancements, the
Exchange recently submitted two rule filings to the Commission that
amended its rules pertaining to, among other things, Market Maker Peg
Orders and Orders with Reserve Size.\8\ The Exchange now proposes to
further amend its Rules governing Order Attributes, at Rule 3301B. In
particular, the Exchange proposes to adjust the current functionality
of the Pegging \9\ and Trade Now Attributes,\10\ as described below, so
that they align with how the System, once upgraded, will handle these
Order Attributes going forward. The Exchange also proposes to amend the
Midpoint Peg Post-Only Order Type, at Rule 3301A, to accommodate
changes to the Trade Now Attribute.
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    \8\ See Securities Exchange Act Release No. 34-91263 (March 5,
2021), 86 FR 13950 (March 11, 2021) (SR-Phlx-2021-11); Securities
Exchange Act Release No. 34-90558 (December 3, 2020), 85 FR 79231
(December 9, 2020) (SR-Phlx-2020-51).
    \9\ See Rule 3301B(d).
    \10\ See Rule 3301B(l).

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Changes to Pegging Order Attribute
    First, the Exchange proposes to amend Rule 3301B(d), which governs
the Pegging Order Attribute. The Exchange offers three types of
Pegging: Primary Pegging, Market Pegging, and Midpoint Pegging.\11\ The
Rule presently provides that if, at the time of entry, there is no
price to which a Pegged Order can be pegged, the Order will be
rejected, provided, however, that a Displayed Order that has Market
Pegging, or an Order with a Non-Display Attribute that has Primary
Pegging or Market Pegging, will be accepted at its limit price. The
Exchange proposes to replace this text by stating 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.\12\ The Exchange proposes this change so
as to enhance the manner in which the Exchange presently handles Pegged
Orders in this scenario. Rather than reject such Orders outright, and
require customers to continuously reenter the Orders thereafter until a
pegging price emerges, which may cost them queue priority, the Exchange
believes that it would be more efficient and customer-friendly to
simply hold a Pegged Order until a permissible pegging price
emerges.\13\
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    \11\ See Rule 3301B(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).
    \12\ This change is applicable to Primary, Market and Midpoint
Pegging Orders entered via RASH/FIX; OUCH/FLITE Midpoint Pegging
behavior is not affected by this change. The Exchange also proposes
to amend existing language in this provision which states that ``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.'' The
proposed amendment would specify that this language applies only to
Orders with Midpoint Pegging entered through OUCH or FLITE. The
proposed changes to pegged orders entered through RASH or FIX will
allow the Exchange to handle the Order more consistent with the
customer intended instruction, and are necessary to facilitate
forthcoming System enhancements.
    \13\ Meanwhile, the Exchange proposes to amend the Rule to state
that if a Pegged Order is assigned a Routing Order Attribute, and a
permissible pegging price is not available upon entry, then the
Order will continue to be rejected. The Exchange proposes to retain
existing practice for Pegged Orders with Routing Order Attributes
because the Exchange is not yet prepared to make similar changes to
such Orders, although it contemplates doing so in the near future.
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    A similar rationale applies to the Exchange's proposal to cease
accepting certain Market or Primary Pegged Orders at their limit prices
if no pegging price is available. Because participants presumably
prefer for their orders to post at the pegging price, the Exchange
believes that participants would prefer for the Exchange to hold such
orders until a permissible pegging price emerges, rather than post the
orders at their limit prices.14 15
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    \14\ When a Pegged Order lacks a pegging price or a permissible
pegging price, the System will not wait indefinitely for a pegging
price or a permissible pegging price to become available. Instead,
the System will cancel the Order if no permissible pegging price
becomes available within one second after Order entry or after the
Order was removed due to the lack of a permissible pegging price and
no longer available on the Book. The Exchange may, in the exercise
of its discretion, modify the length of this maximum time period by
posting advance notice of the applicable new time period on its
website.
    \15\ In this paragraph of Rule 3301B(d), the Exchange again
proposes to state that it will continue to reject a Pegged Order
entered through RASH or FIX when a permissible pegging price is
unavailable, if the Pegged Order is assigned a Routing Order
Attribute. The Exchange will continue to accept certain Market and
Primary Pegged Orders at their limit price where they have Routing
Order Attributes. The Exchange proposes to retain existing practice
for Pegged Orders with Routing Order Attributes because the Exchange
is not yet prepared to make similar changes to such Orders, although
it contemplates doing so in the near future.
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    The Exchange proposes similar changes to the paragraph of Rule
3301B(d) that applies to Pegged Orders entered through RASH or FIX that
posted to the Exchange Book. The text presently provides that if the
price to which an Order is pegged is not available, the Order will be
rejected. The Exchange proposes instead to state that if the price to
which an Order is pegged becomes unavailable or pegging would lead to a
price at which the Order cannot be posted,\16\ then the Exchange will
remove the Order from the Exchange Book and re-enter it once there is a
permissible price. Again, the Exchange proposes this change to enhance
and make the System more efficient by providing for the Exchange to re-
post the Pegged Orders rather than rejecting them when there is no
permissible pegging price and requiring participants to re-enter them
once a valid price becomes available.\17\ The Exchange notes that the
proposed change will not apply to Pegged Orders with Routing Attributes
assigned to them; the existing Rule functionality will continue to
apply to those Orders.
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    \16\ An example of a scenario where pegging would lead to a
price at which an Order cannot be posted is as follows. Assume that
the NBBO is $0.0002 x $0.0003. A Primary Pegged Order to buy is
entered with a passive offset amount of $0.0003. This would result
in the Order being made unavailable by the Exchange as -$0.0001 is
not a permissible price. Currently, the Exchange accepts such Orders
at its limit price, and will post the Orders to the Exchange Book in
accordance with the parameters that apply to the underlying Order
Type.
    \17\ The Exchange proposes to apply a similar time limitation to
the holding period prescribed above. Similarly, for an Order with
Midpoint Pegging, if the Inside Bid and Inside Offer become crossed,
or there is no Inside Bid or Inside Offer, the System will cancel
the Order 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). For an Order
with Midpoint Pegging with a Routing Attribute, the new one second
time period will be applicable.
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    Rule 3301B(d) also subjects Pegging Orders to collars, meaning that
any portion of a Pegging Order that would \18\ 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. Although
the Rule states that it applies this collar to Orders with Primary and
Market Pegging, the Exchange has always intended for the collar to also
apply to Orders with Midpoint Pegging, and in practice, it does so. The
failure of the Rule to reflect the application of the collar to
Midpoint Pegged Orders was an unintended omission. The Exchange now
proposes to revise Rule 3301B(d) to correct this omission.
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    \18\ Additionally, the Exchange proposes to replace the word
``would'' with ``could'' in this provision, so as to clarify that
collars apply in circumstances in which Pegged Orders might execute,
but do not necessarily do so. An example of a circumstance in which
such Orders do not execute is as follows. Assume that the NBBO is
$10.00 x $10.01. A Market Pegged Order to buy posts at $10.01. The
NBBO then updates to $10.00 x $11.00. Because re-pricing and posting
the Market Pegged Order would result in the Order being available on
the Book and executable at $11.00 (outside of the collars), the
Order will be canceled.
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Changes to the Trade Now Order Attribute
    Additionally, the Exchange proposes to amend its rules governing
the Trade Now Attribute, at Rule 3301B(l). Pursuant to Rule 3301B(l),
Trade Now is an Order Attribute that allows a resting Order that
becomes locked by an incoming Displayed Order to execute against a
locking or crossing Order as a liquidity taker. The Exchange proposes
to amend Trade Now in several respects.
    First, the Exchange proposes to incorporate so-called ``Midpoint
Trade Now'' functionality into the Trade Now Attribute, similar what
Nasdaq did in a recent corresponding rule filing.\19\ This

functionality would allow a resting Order that becomes locked at its
non-displayed price by an incoming Midpoint Peg Post-Only Order to
execute against a locking or crossing Order as a liquidity taker. This
functionality will allow market participants to have their Orders
executed as a taker of liquidity should that Order become locked at its
non-displayed price by a contra-side incoming Midpoint Peg Post-Only
Order. This functionality will therefore promote an efficient and
orderly market by allowing Orders in this scenario to execute and
resolve a locked market. Similarly, allowing a subsequent Order to
execute against a locking Midpoint Peg Post-Only Order if the resting
Order that is locked by the Midpoint Peg Post-Only Order has not
enabled the Trade Now functionality will also promote an efficient and
orderly market by allowing the incoming Order in that scenario to
execute and resolve an instance where Orders with a non-displayed price
on both the buy and sell side of the market are priced equally but not
executing against each other.
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    \19\ See Securities Exchange Act Release No. 34-92180 (June 15,
2021), 86 FR 33420 (June 24, 2021) (SR-NASDAQ-2021-044). The
Exchange notes that prior to SR-NASDAQ-2021-044, Midpoint Trade Now
was a distinct Order Attribute in the Nasdaq rulebook, first
introduced in 2018. See Securities Exchange Act Release No. 34-84621
(November 19, 2018), 83 FR 60514 (November 26, 2018) (SR-NASDAQ-
2018-090). SR-NASDAQ-2021-044 incorporated Midpoint Trade Now into
Trade Now.
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    Next, the Exchange proposes to amend Rule 3301B(l) by streamlining
and simplifying the instructions that participants must enter to
address the handling of their orders in various locking or crossing
scenarios.\20\ Specifically, rather than require a participant to
manually send a Trade Now instruction whenever an Order entered through
OUCH or FLITE becomes locked, the proposed amended Rule will allow for
a participant to enable Trade Now functionality on a port-level basis
for all Order entry protocols and for all Order Types that support
Trade Now, as well as on an order-by-order basis, for the Non-Displayed
Order Type, when entered through OUCH or FLITE.\21\ For Orders entered
through RASH or FIX, Trade Now will be available on an order-by-order
basis for all Order Types that support Trade Now. The proposal will not
extend Trade Now functionality to new Order Types.\22\ However, the
Exchange notes that it proposes conforming changes to the Midpoint Peg
Post-Only Order Type, at Rule 3301A, which already includes Trade Now,
to accommodate the adoption of Midpoint Trade Now functionality.
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    \20\ An example of a crossing scenario is as follows. A non-
displayed Order to buy rests on the Book at $0.9995. Thereafter, a
Post Only Order to sell is entered at $0.9994, which would post on
the Book and display at $0.9994, thereby crossing the non-displayed
Order as the price improvement requirements were not met.
    \21\ This proposed change in functionality for OUCH and FLITE is
enabled by the migration of Trade Now to the Exchange's matching
System.
    \22\ The Exchange proposes to add language to Rule 3301B(l) to
state that Trade Now allows a resting Order that becomes locked ``or
crossed, as applicable at its non-displayed price'' by the ``posted
price'' of an incoming Displayed Order to execute against a locking
or crossing Order(s) automatically. The Exchange proposes to add the
phrase ``or crossed, as applicable,'' for completeness. It also
proposes to add the phrases ``at its non-displayed price'' and
``posted price'' for purposes of clarity. They merely communicate
that the incoming Displayed Order or Midpoint Peg Post-Only Order
first posts to the Exchange Book, thereby locking or crossing the
resting Order at its non-displayed price.
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    The Exchange intends to implement the foregoing changes during the
Third Quarter of 2021. 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,\23\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\24\ 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.
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    \23\ 15 U.S.C. 78f(b).
    \24\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that its proposed amendments to the Pegging
Order Attribute, at Rule 3301B(d), are consistent with the Act. The
proposals to eliminate the functionality that provides for the System
to reject certain Pegged Orders that lack a permissible pegging price,
or to post the Orders at their limit price, are consistent with the Act
because they eliminate unwarranted inefficiencies that arise when
participants must repeatedly re-enter rejected Pegged Orders until a
permissible price becomes available.25 26 It is also
consistent with the Act to maintain the existing practice in the Rule
of rejecting a Pegged Order without a permissible pegging price where
the Order has been assigned a Routing Attribute. The Exchange is not
yet prepared to hold such Orders in the same way that it proposes to do
so for Pegged Orders without Routing Attributes, although it
contemplates doing so in the near future.
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    \25\ The Exchange notes that as part of this proposed change, if
there is no Pegging Price upon entry for a Displayed Order that has
Market Pegging, or an Order with a Non-Display Attribute that has
Primary Pegging or Market Pegging, then it will no longer accept
such Orders at their limit price. The Exchange believes that this
proposed change is consistent with the Act because it better aligns
with customer intentions for Pegged Orders to post at a Pegging
Price. That is, the Exchange believes that participants prefer for
Pegged Orders to be entered at a Pegging Price, rather than its
entered limit price, even if that means that the Order must wait for
a Pegging Price to become available. As discussed above, the
Exchange does not propose this change for Pegged Orders with Routing
Attributes.
    \26\ It is also consistent with the Act to limit the time period
for which the Exchange will hold, without canceling, Pegged Orders
for which there is no pegging price or permissible pegging price
because the Exchange does not believe that customers would want the
Exchange to hold their orders indefinitely. Moreover, holding such
orders indefinitely would encumber the Exchange's System. The
Exchange believes that a one second holding period for such orders
is long enough to provide the above-stated efficiencies for
participants, but not too long as to encumber them. However, the
Exchange believes that it is reasonable to reserve discretion to
alter the holding period, from time to time, should it determine
that doing so better meets the needs of customers or its System
resources.
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    Moreover, the proposal to amend Rule 3301B(d) to state expressly
that Midpoint Pegging Orders are subject to price collars, like Orders
with Primary and Market Pegging, will correct an unintended omission
and ensure that the Rule is consistent with existing Exchange practice
and with customer expectations. The application of these collars will
prevent Pegged Orders from having prices that deviate too far away from
where the security was trading when the Order was first entered.\27\
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    \27\ Additionally, the Exchange believes that it is consistent
with the Act to replace the word ``would'' with ``could'' in this
provision, because doing so would clarify that collars apply in
circumstances in which Pegged Orders might execute, but do not
necessarily do so. See supra, n.19.
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    The Exchange's proposals to amend its rules governing the Trade Now
Attribute, at Rule 3301B(l), is consistent with the Act. First, it is
consistent with the Act to add to Trade Now so-called ``Midpoint Trade
Now'' functionality, which presently exists on Nasdaq. This
functionality will allow market participants to have their Orders
executed as a taker of liquidity should that Order become locked at its
non-displayed price by a contra-side Midpoint Peg Post-Only Order. This
functionality will therefore promote an efficient and orderly market by
allowing Orders in this scenario to execute and resolve a locked
market. Similarly, allowing a subsequent Order to execute against a
locking Midpoint Peg Post-Only Order if the resting Order that is
locked by the Midpoint Peg Post-Only Order has not enabled the Trade
Now functionality will also promote an efficient and orderly market by
allowing the incoming Order in that scenario to execute and resolve an
instance where Orders with a non-displayed price on both the buy and
sell side of the market

are priced equally but not executing against each other.
    The proposed amendments to Trade Now will also streamline and
simplify the instructions that participants must enter to address the
handling of their orders in various locking or crossing scenarios.
Rather than require a participant to manually send a Trade Now
instruction whenever an Order entered through OUCH or FLITE becomes
locked, the proposed amended Rule will allow for a participant to
enable Trade Now functionality on a port-level basis for all Order
entry protocols and for all Order Types that support Trade Now, as well
as on an order-by-order basis, for the Non-Displayed Order Type, when
entered through OUCH and FLITE.\28\ Furthermore, it is consistent with
the Act to add language to Rule 3301B(l) to state that Trade Now allows
a resting Order that becomes locked ``or crossed, as applicable, at its
non-displayed price'' by the ``posted price'' of an incoming Displayed
Order to execute against a locking or crossing Order(s) automatically.
The Exchange proposes to add the phrase ``or crossed, as applicable,''
for completeness. The Exchange also proposes to add the phrases ``at
its non-displayed price'' and [sic] for purposes of clarity. They
merely communicate that the incoming Displayed Order or Midpoint Peg
Post-Only Order first posts to the Exchange Book, thereby locking or
crossing the resting Order at its non-displayed price.
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    \28\ As noted above, for Orders entered through RASH or FIX,
Trade Now will be available on an order-by-order basis for all Order
Types that support Trade Now.
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    Finally, the Exchange believes that it is consistent with the Act
to make conforming changes to the Midpoint Peg Post-Only Order Type, at
Rule 3301A, which already includes Trade Now, to accommodate the
adoption of Midpoint Trade Now functionality.

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, integrity, 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 to hold (up to
one second), rather than reject (or accept at their limit price),
Pegging Orders (other than those with Routing Attributes) in
circumstances in which no permissible pegging price is available, as
these proposals will merely eliminate unwarranted inefficiencies that
ensue from the System requiring participants to repeatedly re-enter
Pegged Orders until a price becomes available, or the System posting
Pegged Orders at their limit prices, if there is no pegging price.
Moreover, the proposal to amend Rule 3301B(d) to state expressly that
Midpoint Pegging Orders are subject to price collars, like Orders with
Primary and Market Pegging, will have no competitive impact as the
proposal is consistent with existing Exchange practice and with
customer expectations.
    The Exchange's proposals to amend its rules governing Trade Now
will have no adverse competitive impact on participants. The proposed
addition of Midpoint Trade Now functionality will expand the Exchange's
capabilities relative to competitors, thereby rendering it a more
attractive trading venue. Moreover, this new functionality is optional
for participants to employ. Meanwhile, the other proposed changes to
Rule 3301B(l) will render the Trade Now Order Attribute more efficient
and easier for participants to utilize. The proposed conforming changes
to the Midpoint Peg Post-Only Order Type, at Rule 3301A, will merely
accommodate the adoption of Midpoint Trade Now functionality.

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

    No written comments were either solicited or received.

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

    Because the foregoing 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 for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \29\ and Rule 19b-
4(f)(6) thereunder.\30\
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    \29\ 15 U.S.C. 78s(b)(3)(A).
    \30\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
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.
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    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 to
determine whether the proposed rule change should be approved or
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 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-Phlx-2021-40 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-Phlx-2021-40. 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-Phlx-2021-40, and should be
submitted on or before August 9, 2021.
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    \31\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\31\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-15186 Filed 7-16-21; 8:45 am]
BILLING CODE 8011-01-P


MEMORANDUM

DATE:		July 24, 2014

TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Ray Saracino, EPA

SUBJECT:	July 18, 2014, Meeting Regarding Proposed Clean Power Plan for Existing Power Plants
--------------------------------------------------------------------------------

SUMMARY

      A meeting was held between EPA and the attendees listed below on July 18, 2014 to discuss the proposed Clean Power Plan for Existing Power Plants. The Clean Power Plan for Existing Power Plants was proposed on June 2, 2014.

ATTENDEES

Cory Hunt, Nevada Governor's Office
Colleen Cripps, Nevada Department of Environmental Protection
Dave Emme, Nevada Department of Environmental Protection
Deborah Jordan, EPA
Amy Zimpfer, EPA
Reid Harvey, EPA
James Critchfield, EPA
Beth Conlin, EPA
Joe Bryson, EPA
Brian Fisher, EPA
Erika Wilson, EPA
Brent Maier, EPA
Niloufar Glosson, EPA
Ray Saracino, EPA


[Federal Register: November 1, 2007 (Volume 72, Number 211)]
[Proposed Rules]
[Page 61850-61854]
[DOCID:fr01no07-20]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[ Docket No. FEMA-B-7742 & FEMA-D-7828]

Proposed Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule.

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

SUMMARY: Comments are requested on the proposed Base (1 percent annual-
chance) Flood Elevations (BFEs) and proposed BFE modifications for the
communities listed in the table below. The purpose of this notice is to
seek general information and comment regarding the proposed regulatory
flood elevations for the reach described by the downstream and upstream
locations in the table below. The BFEs and modified BFEs are a part of
the floodplain management measures that the community is required
either to adopt or show evidence of having in effect in order to
qualify or remain qualified for participation in the National Flood
Insurance Program (NFIP). In addition, these elevations, once
finalized, will be used by insurance agents, and others to calculate
appropriate flood insurance premium rates for new buildings and the
contents in those buildings.

DATES: Comments are to be submitted on or before January 30, 2008.

ADDRESSES: The corresponding preliminary Flood Insurance Rate Map
(FIRM) for the proposed BFEs for each community are available for
inspection at the community's map repository. The respective addresses
are listed in the table below.
    You may submit comments, identified by Docket No. FEMA-B-7742, to
William R. Blanton, Jr., Chief, Engineering Management Branch,
Mitigation Directorate, Federal Emergency Management Agency, 500 C
Street, SW., Washington, DC 20472,<PHONE_NUMBER>, or (e-mail)
<EMAIL_ADDRESS>

FOR FURTHER INFORMATION CONTACT: William R. Blanton, Jr., Chief,
Engineering Management Branch, Mitigation Directorate, Federal
Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202) 646-3151 or (e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) proposes to make determinations of BFEs and modified BFEs for
each community listed below, in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR
67.4(a).
    These proposed BFEs and modified BFEs, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own, or pursuant to policies established
by other Federal, State, or regional entities. These proposed
elevations are used to meet the floodplain management requirements of
the NFIP and are also used to calculate the appropriate flood insurance
premium rates for new buildings built after these elevations are made
final, and for the contents in these buildings.
    Comments on any aspect of the Flood Insurance Study and FIRM, other
than the proposed BFEs, will be considered. A letter acknowledging
receipt of any comments will not be sent.
    Administrative Procedure Act Statement. This matter is not a
rulemaking governed by the Administrative Procedure Act (APA), 5 U.S.C.
553. FEMA publishes flood elevation determinations for notice and
comment; however, they are governed by the Flood Disaster Protection
Act of 1973, 42 U.S.C. 4105, and the National Flood Insurance Act of
1968, 42 U.S.C. 4001, et seq., and do not fall under the APA.
    National Environmental Policy Act. This proposed rule is
categorically excluded from the requirements of 44 CFR part 10,
Environmental Consideration. An environmental impact assessment has not
been prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Executive Order 12866, Regulatory Planning and Review. This
proposed rule is not a significant regulatory action under the criteria
of section 3(f) of Executive Order 12866, as amended.
    Executive Order 13132, Federalism. This proposed rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This proposed rule
meets the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.

    Accordingly, 44 CFR part 67 is proposed to be amended as follows:

PART 67--[AMENDED]

    1. The authority citation for part 67 continues to read as follows:

    Authority: 42 U.S.C. 4001, et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.4  [Amended]

    2. The tables published under the authority of Sec.  67.4 are
proposed to be amended as follows:

----------------------------------------------------------------------------------------------------------------
                                                                  * Elevation in feet
                                                                 (NGVD) + Elevation in
                                                                 feet (NAVD)
         Flooding source(s)            Location of referenced     Depth in feet above      Communities affected
                                            elevation**                 ground
                                                              --------------------------
                                                                Effective     Modified
----------------------------------------------------------------------------------------------------------------
                               Riverside County, California and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Colorado River......................  At the downstream               None        + 244  Colorado River Indian
                                       corporate limits of                                Tribe, Unincorporated
                                       Riverside County.                                  Areas of Riverside
                                                                                County.
                                      At the upstream                 None        + 338
                                       corporate limits of
                                       Riverside County.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street SW., Washington, DC 20472.

Colorado River Indian Tribe
Maps are available for inspection at the Colorado River Indian Tribal Offices, 26600 Mohave Road, Parker,
 Arizona.

                                    Unincorporated Areas of Riverside County

Maps are available for inspection at the Riverside County Flood Control District Office, 1995 Market Street,
 Riverside, California.
----------------------------------------------------------------------------------------------------------------
                            San Bernardino County, California and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Colorado River......................  At the downstream               None        + 338  City of Needles,
                                       corporate limits of                                Colorado River Indian
                                       San Bernardino County.                             Tribe, Fort Mojave
                                                                                Indian Tribe,
                                                                                Unincorporated Areas
                                                                                of San Bernardino.
                                      At the upstream                 None        + 485
                                       corporate limits of
                                       San Bernardino County.
Hooke Creek.........................  At confluence with Fern         None      + 4,877  Unincorporated Areas of
                                       Canyon.                                            San Bernardino County.
                                      Approximately 500 feet          None      + 5,238
                                       upstream of Hooke Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street SW., Washington, DC 20472.

City of Needles
Maps are available for inspection at the Needles City Hall, 817 Third Street, Needles, California.

Colorado River Indian Tribe
Maps are available for inspection at the Colorado River Indian Tribal Offices, 26600 Mohave Road, Parker,
 Arizona.

Fort Mojave Indian Tribe
Maps are available for inspection at the Mohave Indian Tribal Offices, 500 Merriman Avenue, Needles, California.

Unincorporated Areas of San Bernardino County
Maps are available for inspection at the San Bernardino County Public Works Department, 825 East Third Street,
 San Bernardino, California.
----------------------------------------------------------------------------------------------------------------
                                 Monroe County, New York, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
East Branch.........................  At Northbridge Road....        + 379        + 380  Town of Greece.
Larkin Creek........................  Approximately 1,440             None         +456
                                       feet upstream of St.
                                       Andrews Dam.
East Branch Red Creek...............  At confluence with              +525         +523  Town of Henrietta.
                                       Middle Branch Red
                                       Creek.
                                      Approximately 2,400             +570         +572
                                       feet upstream of Erie
                                       Station Road.
East Branch Round Pond Creek........  At Ridgeway Road.......         +474         +472  Town of Greece.

                                      Approximately 2,900             +511         +515
                                       feet upstream of Long
                                       Pond Road.
East Branch Shipbuilders Creek......  At Railroad............         +321         +328  Town of Webster.
                                      Approximately 1,800             +426         +430
                                       feet upstream of Dirt
                                       Track.
East Branch Tributary Red Creek.....  At confluence with East         +529         +530  Town of Henrietta.
                                       Branch Red Creek.
                                      Approximately 150 feet          +575         +574
                                       upstream of East
                                       Henrietta Road.
East Stem Middle Branch Red Creek...  At confluence with              +525         +524  Town of Henrietta.
                                       Middle Branch Red
                                       Creek and West Stem
                                       Middle Branch Red
                                       Creek.
                                      Approximately 150 feet          +579         +578
                                       upstream of Erie
                                       Station Road.
Irondequoit Creek Reach 1...........  Approximately 387 feet          None         +357  Village of East
                                       downstream of Linden                               Rochester, Town of
                                       Avenue.                                            Perinton.
                                      Approximately 1,600             None         +380
                                       feet upstream of
                                       Ontario Street.
Larkin Creek........................  At approximately 20             +253         +255  Town of Greece, Town of
                                       feet upstream of Lake                              Ogden.
                                       Ontario State Parkway.
                                      Approximately 430 feet          None         +464
                                       upstream of Black
                                       Forest Drive in Town
                                       of Ogden.
Middle Branch Red Creek.............  At confluence with Red          +525         +523  Town of Henrietta.
                                       Creek and East Branch
                                       Red Creek.
                                      At confluence with East         +525         +524
                                       and West Stem Middle
                                       Branch Red Creek.
Northrup Creek......................  At Flynn Road..........         +250         +249  Town of Greece, Town of
                                                                                Ogden, Town of Parma,
                                                                                Village of
                                                                                Spencerport.
                                      Approximately 612 feet          None         +593
                                       upstream of Wood Duck
                                       Run.
Red Creek...........................  At confluence with Erie         +517         +514  Town of Henrietta, City
                                       Canal.                                             of Rochester, Town of
                                                                                Brighton.
                                      At confluence with              +525         +523
                                       Middle and East Branch
                                       Red Creek.
Round Pond Creek Reach 1............  At Island Cottage Road.         +256         +257  Town of Greece.
                                      Approximately 4,400             +459         +461
                                       feet downstream of
                                       Flood Control Dam.
South Stem East Branch Tributary Red  At confluence with East         +554         +553  Town of Henrietta.
 Creek.                                Branch Tributary Red
                                       Creek.
                                      Approximately 42 feet           +575         +582
                                       upstream of East
                                       Henrietta Road.
West Branch Red Creek...............  At confluence with Red          +520         +518  City of Rochester, Town
                                       Creek.                                             of Brighton.
                                      At Bridge to Park Dump.         +520         +519
West Stem Middle Branch Red Creek...  At confluence with              +525         +524  Town of Henrietta.
                                       Middle Branch Red
                                       Creek and East Stem
                                       Middle Branch Red
                                       Creek.
                                      Approximately 270 feet          +560         +563
                                       upstream of Erie
                                       Station Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street SW., Washington, DC 20472.

                                                    ADDRESSES

City of Rochester
Maps are available for inspection at Rochester City Hall, 30 Church Street, Rochester, NY.

Town of Brighton
Maps are available for inspection at Brighton Town Hall, 2300 Elmwood Avenue, Rochester, NY.
Town of Greece

Maps are available for inspection at Greece Town Hall, 1 Vince Tofany Boulevard, Greece, NY.
Town of Henrietta...............................................................................................

Maps are available for inspection at Henrietta Town Hall, 475 Calkins Road, Henrietta, NY.

Town of Ogden

Maps are available for inspection at Ogden Town Hall, 269 Ogden Center Road, Spencerport, NY.

Town of Parma

Maps are available for inspection at Parma Town Hall, 1300 Hilton-Parma Corners Road, Hilton, NY.

Town of Perinton

Maps are available for inspection at Perinton Town Hall, 1350 Turk Hill Road, Fairport, NY.

Town of Webster

Maps are available for inspection at Webster Town Hall, 1000 Ridge Road, Webster, NY.

Village of East Rochester

Maps are available for inspection at East Rochester Village Hall, 120 West Commercial Street, East Rochester,
 NY.
Village of Spencerport

Maps are available for inspection at Spencerport Village Building Department, 269 Ogden Center Road,
 Spencerport, NY.
----------------------------------------------------------------------------------------------------------------
                                Carroll County, Virginia, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------

Chestnut Creek......................  Approximately 2450 feet         None        +2298  Unincorporated Areas of
                                       downstream of                                      Carroll County.
                                       Cliffview Road.
                                      Approximately 7500 feet         None        +2332
                                       upstream of Cliffview
                                       Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street SW., Washington, DC 20472.

                                                    ADDRESSES

                                     Unincorporated Areas of Carroll County
Maps are available for inspection at Building Officials Office, 605-1 Pine Street, Hillsville, VA 24343.
----------------------------------------------------------------------------------------------------------------

                                Grayson County, Virginia, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Chestnut Creek......................  Near Sewage Treatment           None        +2332  Unincorporated Areas of
                                       Plant, just upstream                               Grayson County.
                                       of County Boundary.
                                      Near Sewage Treatment           None        +2335
                                       Plant, approximately
                                       375 feet downstream of
                                       old Railroad Bridge.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street SW., Washington, DC 20472.

                                                    ADDRESSES
                                     Unincorporated Areas of Grayson County
Maps are available for inspection at County Administrators Office, 129 Davis Street, Independence, VA 24348.
----------------------------------------------------------------------------------------------------------------
                                  None County, Virginia, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Chestnut Creek......................  Just upstream of                None        +2308  City of Galax.
                                       Cliffview Road.
                                      Approximately 7500 feet         None        +2332  .......................
                                       upstream of Cliffview
                                       Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street SW., Washington, DC 20472.

                                                    ADDRESSES
City of Galax

Maps are available for inspection at Galax Municipal Building, 111 East Grayson Street, Galax, VA 24333.
----------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: October 24, 2007.
David I. Maurstad,
Federal Insurance Administrator of the National Flood Insurance
Program, Department of Homeland Security, Federal Emergency Management
Agency.
 [FR Doc. E7-21540 Filed 10-31-07; 8:45 am]

BILLING CODE 9110-12-P


[Federal Register Volume 85, Number 249 (Tuesday, December 29, 2020)]
[Notices]
[Pages 85645-85646]
[FR Doc No: 2020-28608]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2012-N-0197; FDA-2017-N-1095; FDA-2011-N-0424; FDA-
2017-N-2021 and FDA-2010-N-0493]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                           OMB  control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Shortages Data Collection...............       0910-0491      05/31/2021
Electronic Submission of Allegations of        0910-0769      11/30/2023
 Regulatory Misconduct Associated with
 Medical Devices........................

Temporary Marketing Permit Applications.       0910-0133      12/31/2023
Channels of Trade Policy for Commodities       0910-0562      12/31/2023
 with Residues of Pesticide Chemicals
 for Which Tolerances Have Been Revoked,
 Suspended, or Modified by the EPA......
Additional Criteria and Procedures for         0910-0688      12/31/2023
 Classifying Over-the-Counter Drugs as
 Generally Recognized as Safe and
 Effective and Not Misbranded...........
------------------------------------------------------------------------

    Dated: December 21, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28608 Filed 12-28-20; 8:45 am]
BILLING CODE 4164-01-P


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Monday, April 4, 2016 5:06 PM
To:
<EMAIL_ADDRESS><EMAIL_ADDRESS>Cc:
David Ailor<EMAIL_ADDRESS><EMAIL_ADDRESS>Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
Your coke ICR letter and attachments - Arcelor Mittal - Monessen

Hello  -  Attached you will find a pdf of your signed cover letter for the Coke ICR. Also attached are Enclosures 1&2 as pdf files. Enclosures #3 through #8 are attached in a combined pdf file; these are standard enclosures we include with all ICRs. Please visit the Coke ICR website at: https://icr2010.rti.org/  for the latest versions of the data tables (Excel files) to use for your answers to Enclosures 1 and 2 as well as Word versions of both Enclosures 1&2. Your packages which include hard copies of all of the attached enclosures as well as a disc with Word versions of Enclosures 1&2 and the Excel data tables. Feel free to use this disc for your first submission, but you can also send a USB/flash drive with the files, or alternatively upload the files to a password protected area of the ICR website. Note that discs and flash drives will not be returned until the end of the ICR process.
_____________________________________________________________
Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D 243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

<< Coke114_cover_letter_04-04-16_AMM_signed.PDF >>
<< Coke ICR-Enclosure 1-04-01-16P.pdf >>
<< Coke ICR-Enclosure 2-04-04B-16.pdf >>
<< Enclosure 3 - 8-2016-RTI.pdf >>


[Federal Register: February 21, 2008 (Volume 73, Number 35)]
[Notices]
[Page 9575-9576]
[DOCID:fr21fe08-69]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0081 (formerly Docket No. 2006D-0297)]

International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; 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.'' 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 describes a process
for the evaluation and recommendation by the ICH Q4B Expert Working
Group (EWG) of selected pharmacopeial texts to facilitate their
recognition by regulatory authorities for use as interchangeable in the
ICH regions. Following favorable evaluations, ICH will issue topic-
specific annexes with information about these texts and their
implementation (the Q4B Outcomes). Implementation of the Q4B annexes is
intended to avoid redundant testing by industry in favor of a common
testing strategy in each ICH regulatory region.

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

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, or the Office of Communication, Training and
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
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.
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. 21, rm. 3542, Silver Spring, MD 20993-0002,
301-796-1242;or
    Christopher Joneckis, Center for Biologics Evaluation and Research
(HFM-20), Food and Drug Administration, 1401 Rockville Pike, 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

    FDA is announcing the availability of a guidance entitled ``Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
ICH Regions.'' 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 8, 2006 (71 FR 45059), FDA
published a notice announcing the availability of a draft guidance
entitled ``Q4B Regulatory Acceptance of Analytical Procedures and/or
Acceptance Criteria.'' The notice gave interested persons an
opportunity to submit comments by October 10, 2006.
    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'' was
submitted to the ICH Steering Committee and endorsed by the three
participating regulatory agencies in November 2007.
    The guidance provides information on a Q4B process for evaluating
harmonization proposals for specific pharmacopeial topics originating
from the three-party Pharmacopoeial Discussion Group (PDG) or from
individual PDG pharmacopeias. The PDG consists of representatives from
the European Directorate for the Quality of Medicines in the Council of
Europe; the Japanese Ministry of Health, Labour and Welfare, and the
United States Pharmacopeial Convention, Inc. The results of the
individual Q4B evaluations will move forward as topic-specific annexes
to the core Q4B guidance. Each annex will be issued separately
following the ICH step process, providing guidance to assist industry
and regulators in the implementation of the specific topic evaluated by
the ICH Q4B process. Following the receipt of comments on the draft
guidance, the Q4B EWG made no substantive changes to the Q4B process or
the use of annexes to convey the results of Q4B evaluations. The title
of the guidance, as well as some of the text, was revised to more
closely reflect the actual workings and process of the Q4B EWG.
    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 Q4B evaluation and recommendation of
pharmacopoeial texts for use in the ICH regions. 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 this document.
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.
    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.

III. Electronic Access

    Persons with access to the Internet may obtain the document
athttp://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.
gov/cber/publications.htm.

    Dated: February 12, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3186 Filed 2-20-08; 8:45 am]

BILLING CODE 4160-01-S