[Federal Register Volume 80, Number 14 (Thursday, January 22, 2015)]
[Notices]
[Pages 3278-3282]
[FR Doc No: 2015-00971]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74062; File No. SR-Phlx-2015-06]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Amendments to Sections II and IV of the Pricing Schedule

January 15, 2015.
    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 January 13, 2015, NASDAQ OMX PHLX LLC (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III, 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 the Monthly Market Maker Cap \3\ and
certain transaction fees applicable to Specialists \4\ and Market
Makers \5\ that have reached the Monthly Market Maker Cap, which are
located in the Exchange's Pricing Schedule at Section II, entitled
``Multiply Listed Options.'' \6\ The Exchange also proposes to make
conforming and clarifying amendments to Section IV, Part A of the
Pricing Schedule entitled ``PIXL Pricing.''
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    \3\ Specialists and Market Makers are subject to a ``Monthly
Market Maker Cap'' of $550,000 for: (i) Electronic and floor Option
Transaction Charges; (ii) QCC Transaction Fees (as defined in
Exchange Rule 1080(o) and Floor QCC Orders, as defined in 1064(e));
and (iii) fees related to an order or quote that is contra to a PIXL
Order or specifically responding to a PIXL auction. The trading
activity of separate Specialist and Market Maker member
organizations is aggregated in calculating the Monthly Market Maker
Cap if there is Common Ownership between the member organizations.
All dividend, merger, short stock interest, reversal and conversion,
jelly roll and box spread strategy executions (as defined in Section
II) are excluded from the Monthly Market Maker Cap.
    \4\ A Specialist is an Exchange member who is registered as an
options specialist pursuant to Rule 1020(a). An options Specialist
includes a Remote Specialist which is defined as an options
specialist in one or more classes that does not have a physical
presence on an Exchange floor and is approved by the Exchange
pursuant to Rule 501.
    \5\ A ``market maker'' includes Registered Options Traders (Rule
1014(b)(i) and (ii)), which includes Streaming Quote Traders (see
Rule 1014(b)(ii)(A)) and Remote Streaming Quote Traders (see Rule
1014(b)(ii)(B)). Directed Participants are also market makers.
    \6\ This includes options overlying equities, ETFs, ETNs and
indexes which are Multiply Listed.
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    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
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
    The purpose of this filing is to amend certain Specialist and
Market Maker pricing located in the Exchange's Pricing Schedule in
Section II, entitled ``Multiply Listed Options'' in order to

continue to incentivize Specialists and Market Makers to transact a
greater amount of volume on Phlx and bring additional liquidity to the
Exchange. The pricing changes are described in further detail below.
    Today, Specialists and Market Makers are subject to a Monthly
Market Maker Cap of $550,000 for: (i) Electronic and floor Option
Transaction Charges; (ii) QCC Transaction Fees (as defined in Exchange
Rule 1080(o) and Floor QCC Orders, as defined in 1064(e)); and (iii)
fees related to an order or quote that is contra to a PIXL \7\ Order or
specifically responding to a PIXL auction.\8\ The trading activity of
separate Specialist and Market Maker member organizations is aggregated
in calculating the Monthly Market Maker Cap if there is Common
Ownership between the member organizations. All dividend, merger, short
stock interest, reversal and conversion, jelly roll and box spread
strategy executions (as defined in Section II) are excluded from the
Monthly Market Maker Cap.
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    \7\ PIXL is the Exchange's price improvement mechanism known as
Price Improvement XL or (PIXL\SM\). See Rule 1080(n).
    \8\ A member may electronically submit for execution an order it
represents as agent on behalf of a public customer, broker-dealer,
or any other entity (``PIXL Order'') against principal interest or
against any other order (except as provided in Rule 1080(n)(i)(E))
it represents as agent (``Initiating Order'') provided it submits
the PIXL order for electronic execution into the PIXL Auction
(``Auction'') pursuant to Rule 1080. See Exchange Rule 1080(n). Non-
Initiating Order interest could be a PIXL Auction Responder or a
resting order or quote that was on the Phlx book prior to the
auction.
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    Specialists or Market Makers that (i) are on the contra-side of an
electronically-delivered \9\ and executed Customer order; and (ii) have
reached the Monthly Market Maker Cap are assessed $0.00 per contract in
the following symbols: AAPL, BAC, EEM, FB, FXI, IWM, QQQ, TWTR, VXX,
and XLF and $0.17 per contract in Penny Pilot Options \10\ and Non-
Penny Pilot Options.
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    \9\ A transaction resulting from an order that was
electronically delivered utilizes Phlx XL. See Exchange Rules 1014
and 1080. Electronically delivered orders do not include orders
transacted on the Exchange floor. A transaction resulting from an
order that is non-electronically-delivered is represented on the
trading floor by a floor broker. See Exchange Rule 1063. All orders
will be either electronically or non-electronically delivered.
    \10\ The Penny Pilot was established in January 2007 and was
last extended in June 30, 2015. See Securities and Exchange Release
No. 73688 (November 25, 2014), 79 FR 71484 (December 2, 2014) (SR-
Phlx-2014-77).
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    The Exchange proposes to decrease the Monthly Market Maker Cap from
$550,000 to $500,000 and amend the types of trades that qualify for the
Monthly Market Maker Cap to exclude fees specifically responding to a
PIXL auction. While the Exchange is excluding fees related to
responding to a PIXL auction as eligible transactions to reach the
Monthly Market Maker Cap, the Exchange believes that lowering the cap
to $500,000 will continue to incentivize Specialists and Market Makers
to transact greater displayed liquidity on the Exchange to be eligible
for the Monthly Market Maker Cap and, in turn, will benefit Phlx
members and the Phlx market.
    The Exchange is also proposing to amend the fees applicable to
Specialists and Market Makers that (i) are on the contra-side of an
electronically-delivered and executed Customer order, and (ii) have
reached the Monthly Market Maker Cap to assess: a $0.00 per contract
Fee for Adding Liquidity in Penny Pilot Options; a $0.17 per contract
Fee for Removing Liquidity in Penny Pilot Options; and a $0.17 per
contract in Non-Penny Pilot Options. The Exchange is proposing to amend
the language to state: ``Specialists or Market Makers that (i) are on
the contra-side of an electronically-delivered and executed Customer
order, excluding responses to a PIXL auction and (ii) have reached the
Monthly Market Maker Cap. . .''
    The Exchange would therefore exclude responses to a PIXL auction
from the Monthly Market Maker Cap and those responses would be subject
to the pricing in Section IV, A of the Pricing Schedule, as is the case
today for all other Specialists and Market Makers that do not qualify
for the Monthly Market Maker Cap, as well as all other market
participants. Today, Specialists or Market Makers that are on the
contra-side of an electronically-delivered and executed Customer PIXL
Order and have reached the Monthly Market Maker Cap are assessed $0.00
per contract in the following symbols: AAPL, BAC, EEM, FB, FXI, IWM,
QQQ, TWTR, VXX, and XLF and $0.17 per contract in Penny Pilot Options
and Non-Penny Pilot Options. With this proposal, an Initiating Order
would be assessed $0.07 per contract or $0.05 per contract if Customer
Rebate Program Threshold Volume defined in Section B is greater than
100,000 contracts per day in a month.\11\ The Initiating Order Fee for
Professional, Firm, Broker-Dealer, Specialist and Market Maker orders
that are contra to a Customer PIXL Order will be reduced to $0.00 if
the Customer PIXL Order is greater than 399 contracts. Also, with
respect to executions in Multiply-Listed Options, when the PIXL Order
is contra to the Initiating Order a Customer PIXL Order will be
assessed $0.00 per contract and non-Customer PIXL Orders will be
assessed $0.30 per contract. When a PIXL Order is contra to a PIXL
Auction Responder, a Customer PIXL Order will be assessed $0.00 per
contract, other market participants will be assessed $0.30 per contract
in Penny Pilot Options or $0.38 per contract in non-Penny Pilot
Options. A Responder will be assessed $0.30 per contract in Penny Pilot
Options or $0.38 per contract in non-Penny Pilot Options, unless the
Responder is a Customer, in which case the fee will be $0.00 per
contract. When a PIXL Order is contra to a resting order or quote a
Customer PIXL Order will be assessed $0.00 per contract, other market
participants will be assessed $0.30 per contract and the resting order
or quote will be assessed the appropriate Options Transaction Charge in
Section II. All other fees discussed in Section II, including Payment
for Order Flow and surcharges, will also apply as appropriate. The
Exchange proposes to amend Section IV, A to indicate that the Monthly
Market Maker Cap will no longer apply to PIXL Orders as noted above.
The Exchange proposes to add the words ``per contract'' to Section IV,
A where appropriate for clarity.
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    \11\ Any member or member organization under Common Ownership
with another member or member organization that qualifies for a
Customer Rebate Tier discount in Section B receives the PIXL
Initiating Order discount.
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    The Exchange also proposes to expand and modify the $0.00 per
contract pricing that today is available to Specialists and Market
Makers that are on the contra-side of an electronically-delivered and
executed Customer order and have reached the Monthly Market Maker Cap
in the following symbols: AAPL, BAC, EEM, FB, FXI, IWM, QQQ, TWTR, VXX,
and XLF to all Penny Pilot Options, provided the Specialist or Market
Maker is adding liquidity. The Exchange will continue to assess a $0.17
per contract fee to Specialists and Market Makers that are on the
contra-side of an electronically-delivered and executed Customer order
and have reached the Monthly Market Maker Cap for Penny Pilot Options,
when removing liquidity and for Non-Penny Pilot Options when either
adding or removing liquidity. Finally, the Exchange would also assess
$0.17 per contract in a non-Complex electronic auction, including the
Quote Exhaust auction and, for purposes of this fee, the opening
process.\12\
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    \12\ A Complex electronic auction includes, but is not limited
to, the Complex Order Live Auction (``COLA'').
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    The Exchange believes that Specialists and Market Makers will

continue to be incentivized to transact a greater amount of liquidity
on Phlx and to add and remove liquidity to the benefit of all other
market participants.
 2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\13\ in general, and with
Section 6(b)(4) and 6(b)(5) of the Act,\14\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility or system which the Exchange operates or controls, and is not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
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    \13\ 15 U.S.C. 78f.
    \14\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange's proposal to decrease the Monthly Market Maker Cap
from $550,000 to $500,000 is reasonable because by lowering the cap,
Specialists and Market Makers will be able to take advantage of lower
fees presumably earlier in the month because the cap is lower.
    The Exchange's proposal to decrease the Monthly Market Maker Cap
from $550,000 to $500,000 is equitable and not unfairly discriminatory
because this benefit would be uniformly applied to all Specialists and
Market Makers that qualified for the Monthly Market Maker Cap.
Specialists and Market Makers have burdensome quoting obligations \15\
to the market that do not apply to Customers, Professionals, Firms and
Broker-Dealers. Specialists and Market Makers serve an important role
on the Exchange with regard to order interaction and they provide
liquidity in the marketplace. Additionally, Specialists and Market
Makers incur costs unlike other market participants including, but not
limited to, Payment for Order Flow (``PFOF'') \16\ and other costs
associated with market making activities, which results in a higher
average cost per execution as compared to Firms, Broker-Dealers and
Professionals. The proposed differentiation as between Specialists and
Market Makers as compared to other market participants recognizes the
differing contributions made to the trading environment on the Exchange
by these market participants. Customer liquidity benefits all market
participants by providing more trading opportunities, which attract
Specialists and Market Makers. An increase in the activity of these
market participants in turn facilitates tighter spreads, which may
cause an additional corresponding increase in order flow from other
market participants.
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    \15\ See Rule 1014 titled ``Obligations and Restrictions
Applicable to Specialists and Registered Options Traders.''
    \16\ Specialists and Market Makers, as compared to other market
participants, are assessed PFOF when transacting Customer electronic
orders.
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    The Exchange's proposal to amend the types of trades that qualify
for the Monthly Market Maker Cap to exclude responses to a PIXL auction
and assess Specialists and Market Makers the PIXL pricing located in
Section IV, A of the Pricing Schedule is reasonable because all other
market participants on Phlx, including Specialists and Market Makers
that are not subject to the Monthly Market Maker Cap, are currently
subject to the PIXL pricing located in Section IV, A of the Pricing
Schedule. Pursuant to this proposal, all market participants will be
uniformly assessed the same fees when responding to a PIXL auction. The
Exchange believes that Specialists and Market Makers will continue to
be incentivized to participate in PIXL, as is the case today with
Specialists and Market Makers that do not qualify for the Monthly
Market Maker Cap and are subject to Section IV, A pricing.
    The Exchange's proposal to amend the types of trades that qualify
for the Monthly Market Maker Cap to exclude fees related to responding
to a PIXL auction and assess Specialists and Market Makers the PIXL
pricing located in Section IV, A of the Pricing Schedule is equitable
and not unfairly discriminatory because the Exchange is proposing to
assess all market participants, including Specialists and Market
Makers, the same PIXL pricing located in Section IV, A of the Pricing
Schedule.
    The Exchange believes that the pricing in Section IV, A of the
Pricing Schedule will continue to encourage market participants to
transact a greater number of PIXL Orders. The proposed PIXL pricing is
competitive with other rates assessed to Specialists and Market Makers
to transact similar orders on other options exchanges with price
improvement mechanisms.\17\ The Exchange will continue to offer
competitive pricing, including Customer rebates in Section B of the
Pricing Schedule. The Exchange's current Pricing Schedule also offers
to reduce the $0.07 per contract PIXL Initiating Order Fee to $0.05 per
contract if the Customer Rebate Program Threshold Volume, defined in
Section B of the Pricing Schedule, for that member is greater than
100,000 contracts per day in a month. Additionally, the Exchange offers
a volume incentive for Specialist and Market Maker orders (as well as
Professional, Firm and Broker-Dealer orders) that are contra to a
Customer PIXL Order. In that situation, the Initiating Order fee is
reduced to $0.00 if the Customer PIXL Order is greater than 399
contracts. The PIXL Initiation Order Fee reduction to $0.00, when
contra to a Customer PIXL Order, is similar to the Exchange's
assessment of fees for Firm Floor Facilitation orders. Today, the
Exchange waives Firm Floor Options Transaction Charges \18\ for members
executing facilitation orders pursuant to Exchange Rule 1064 when such
members are trading in their own proprietary account. The Exchange
waives Firm Facilitation Fees because the waiver of such fees serves to
encourage Firms to facilitate Customer order flow. Likewise, the
Exchange seeks to similarly assess Specialist and Market Maker fees for
PIXL orders, which are electronic orders, as compared to floor orders,
by encouraging Specialists and Market Makers or other Broker-Dealer
members to initiate PIXL Orders within the PIXL auction mechanism in an
effort to lower execution charges by transacting with a Customer PIXL
Order. When a Firm enters an Initiating Order, similar to Firm
Facilitation orders on the Exchange floor, market participants are
afforded an opportunity to respond to the order which should in turn
generate additional responders to a PIXL auction. All market
participants are eligible to respond to an Initiating PIXL Order.
Therefore, offering all market participants an opportunity to deliver
orders into the PIXL auction, for purposes of price improvement,
benefits all market participants by incentivizing order interaction in
PIXL.
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    \17\ See BOX Options Exchange LLC's (``BOX'') Fee Schedule.
Specifically, BOX's auction transaction fees are those transactions
executed through Price Improvement Period (``PIP''), the Complex
Order Price Improvement Period (``COPIP''), the Solicitation Auction
mechanism, and Facilitation Auction mechanism.
    \18\ See Section II of the Pricing Schedule.
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    Further, the Exchange's proposal to assess Specialists and Market
Makers the PIXL pricing in Section IV, A provides market participants
the opportunity to lower fees by transacting a greater number of
Customer orders. When the PIXL Order is contra to the Initiating Order
a Customer PIXL Order will be assessed $0.00 per contract and non-
Customer PIXL Orders will be assessed $0.30 per contract. When a PIXL
Order is contra to a PIXL Auction Responder, a Customer PIXL Order will
be assessed $0.00 per contract, other market participants will be
assessed $0.30 per contract in Penny Pilot Options or $0.38 per
contract in non-

Penny Pilot Options. A Responder will be assessed $0.30 per contract in
Penny Pilot Options or $0.38 per contract in non-Penny Pilot Options,
unless the Responder is a Customer, in which case the fee will be $0.00
per contract. Finally, when a PIXL Order is contra to a resting order
or quote a Customer PIXL Order will be assessed $0.00 per contract,
other market participants will be assessed $0.30 per contract and the
resting order or quote will be assessed the appropriate Options
Transaction Charge in Section II. Customer PIXL Orders will remain free
in all instances and all non-Customer market participant PIXL Orders
will be assessed a fee of $0.30 per contract in Penny Pilot Options and
$0.38 per contract in Non-Penny Pilot Options fee uniformly. All non-
Customers market participants are assessed the same fees with respect
to Section II when a PIXL Order is contra to a resting order or quote.
In this case the resting contra-side orders or quotes will continue to
pay the appropriate Options Transaction Charges in Section II. For the
reasons noted above, the Exchange believes that the PIXL pricing, which
will be uniformly assessed to all market participants, is reasonable,
equitable and not unfairly discriminatory.
    The Exchange's proposal to expand the $0.00 per contract pricing
that today is available to Specialists and Market Makers that are on
the contra-side of an electronically-delivered and executed Customer
order and have reached the Monthly Market Maker Cap in certain symbols
\19\ to all Penny Pilot Options provided the Specialist or Market Maker
is adding liquidity is reasonable because the Exchange desires to
expand this incentive to all Penny Pilot Options to enhance the
displayed liquidity available on the Exchange to the benefit of
investors and other market participants. Specialists and Market Makers
will be able to benefit to a greater extent and be incentivized to add
liquidity in all Penny Pilot Option symbols, provided they qualified
for the Monthly Market Maker Cap. All market participants will benefit
from the increased Customer liquidity brought to the Exchange by this
displayed liquidity incentive.
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    \19\ The symbols are: AAPL, BAC, EEM, FB, FXI, IWM, QQQ, TWTR,
VXX, and XLF.
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    The Exchange's proposal to expand the $0.00 per contract pricing
that today is available to Specialists and Market Makers that are on
the contra-side of an electronically-delivered and executed Customer
order and have reached the Monthly Market Maker Cap in certain symbols
\20\ to all Penny Pilot Options provided the Specialist or Market Maker
is adding liquidity is equitable and not unfairly discriminatory
because Specialists and Market Makers have burdensome quoting
obligations \21\ to the market that do not apply to Customers,
Professionals, Firms and Broker-Dealers. Specialists and Market Makers
serve an important role on the Exchange with regard to order
interaction and they provide liquidity in the marketplace. In addition,
the proposed fees would apply only in certain circumstances where the
Market Maker or Specialist is not otherwise subject to transaction fees
(because the Monthly Market Maker Cap has been reached) and
specifically on the contra-side of an electronically-delivered Customer
order.
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    \20\ Id.
    \21\ See note 15.
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    The Exchange's proposal to continue to assess a $0.17 per contract
fee to Specialists and Market Makers that are on the contra-side of an
electronically-delivered and executed Customer order and have reached
the Monthly Market Maker Cap for Penny Pilot and Non-Penny Pilot
Options provided the Specialist or Market Maker is removing liquidity
is reasonable because the Exchange will be assessing the same fee as
today. The $0.17 per contract fee will continue to be assessed to
remove liquidity. Further, this fee subsidizes Customer rebates offered
by the Exchange.\22\
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    \22\ See Section B of the Pricing Schedule.
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    The Exchange's proposal to continue to assess a $0.17 per contract
fee to Specialists and Market Makers that are on the contra-side of an
electronically-delivered and executed Customer order and have reached
the Monthly Market Maker Cap for Penny Pilot and Non-Penny Pilot
Options provided the Specialist or Market Maker is removing liquidity
is equitable and not unfairly discriminatory because Specialists and
Market Makers have burdensome quoting obligations \23\ to the market
that do not apply to Customers, Professionals, Firms and Broker-
Dealers. Specialists and Market Makers serve an important role on the
Exchange with regard to order interaction and they provide liquidity in
the marketplace. In addition, the proposed fees would apply only in
certain circumstances where the Market Maker or Specialist is not
otherwise subject to transaction fees (because the Monthly Market Maker
Cap has been reached) and specifically on the contra-side of an
electronically-delivered Customer order.
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    \23\ See note 15.
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    The Exchange's proposal to continue to assess a $0.17 per contract
fee to Specialists and Market Makers that are on the contra-side of an
electronically-delivered and executed Customer order and have reached
the Monthly Market Maker Cap in a non-Complex electronic auction,
including the Quote Exhaust auction and, for purposes of this fee, the
opening process is reasonable because the Exchange will be assessing
the same fee as today. The $0.17 per contract fee will continue to be
assessed to these auctions and the opening process. Further, this fee
subsidizes Customer rebates offered by the Exchange.\24\
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    \24\ See Section B of the Pricing Schedule.
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    The Exchange's proposal to add the words ``per contract'' in
Section IV, A of the Pricing Schedule is reasonable, equitable and not
unfairly discriminatory because the Exchange believes the addition of
the words ``per contract'' will add clarity to the Pricing Schedule to
avoid any confusion as to the fee.
    The Exchange's proposal to continue to assess a $0.17 per contract
fee to Specialists and Market Makers that are on the contra-side of an
electronically-delivered and executed Customer order and have reached
the Monthly Market Maker Cap in a non-Complex electronic auction,
including the Quote Exhaust auction and, for purposes of this fee, the
opening process is equitable and not unfairly discriminatory because
Specialists and Market Makers have burdensome quoting obligations \25\
to the market that do not apply to Customers, Professionals, Firms and
Broker-Dealers. Specialists and Market Makers serve an important role
on the Exchange with regard to order interaction and they provide
liquidity in the marketplace. In addition, the proposed fees would
apply only in certain circumstances where the Market Maker or
Specialist is not otherwise subject to transaction fees (because the
Monthly Market Maker Cap has been reached) and specifically on the
contra-side of an electronically-delivered Customer order.
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    \25\ See note 15.
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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 because Specialists and Market
Makers will be offered the opportunity to cap certain transaction fees
and pay lower

transaction fees when they transact $500,000 versus $550,000 of
qualifying transactions. Other market participants will continue to
benefit from the order interaction and liquidity that Specialists and
Market Markers provide to the marketplace.
    The Exchange does not believe that amending the types of trades
that qualify for the Monthly Market Maker Cap by excluding certain
transaction fees related to an order or quote that is contra to a PIXL
Order or assessing Specialists and Market Makers the PIXL pricing
located in Section IV, A of the Pricing Schedule will impose an undue
burden on competition because the Exchange's proposal results in all
market participants on Phlx being assessed the same PIXL pricing.
    The Exchange's proposal for Specialists and Market Makers to pay no
fees after they have satisfied the obligations related to the Monthly
Market Maker Cap, in all Penny Pilot Options, provided they have added
liquidity, and to pay lower fees for all other types of transactions,
including those transacted in auctions and during the opening process,
also does not provide an undue burden on competition. As noted above
Specialists and Market Makers have burdensome quoting obligations to
the market that do not apply to Customers, Professionals, Firms and
Broker-Dealers.\26\ Specialists and Market Makers serve an important
role on the Exchange with regard to order interaction and they provide
liquidity in the marketplace. The proposed differentiation as between
Specialists and Market Makers as compared to other market participants
recognizes the differing contributions made to the trading environment
on the Exchange by these market participants. Customer liquidity
benefits all market participants by providing more trading
opportunities, which attract Specialists and Market Makers. An increase
in the activity of these market participants in turn facilitates
tighter spreads, which may cause an additional corresponding increase
in order flow from other market participants. For these reasons noted
above, the Exchange does not believe that offering Specialists and
Market Makers the opportunity to cap fees in certain symbols imposes an
undue burden on competition.
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    \26\ Id.
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    The Exchange operates in a highly competitive market, comprised of
twelve exchanges, in which market participants can easily and readily
direct order flow to competing venues if they deem fee levels at a
particular venue to be excessive or rebates to be inadequate.
Accordingly, the fees that are assessed and the rebates paid by the
Exchange, as described in the proposal, are influenced by these robust
market forces and therefore must remain competitive with fees charged
and rebates paid by other venues and therefore must continue to be
reasonable and equitably allocated to those members that opt to direct
orders to the Exchange rather than competing venues.

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 foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\27\ 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 should be approved or disapproved.
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    \27\ 15 U.S.C. 78s(b)(3)(A)(ii).
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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-2015-06 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-2015-06. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2015-06 and should be
submitted on or before February 12, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\28\
---------------------------------------------------------------------------

    \28\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-00971 Filed 1-21-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 87 (Monday, May 6, 2019)]
[Notices]
[Page 19796]
[FR Doc No: 2019-09182]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4382-DR; Docket ID FEMA-2019-0001]

California; Amendment No. 5 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of California (FEMA-4382-DR), dated August 4, 2018, and
related determinations.

DATES: This amendment was issued February 15, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, pursuant to the
Consolidated Appropriations Act, 2019, the Federal share of assistance,
including direct Federal assistance, provided under sections 403 and
407 of the Robert T. Stafford Disaster Relief and Emergency Assistance
Act (42 U.S.C. 5170b and 42 U.S.C. 5173), with respect to a major
disaster declared pursuant to such Act for damages resulting from a
wildfire in calendar year 2018, shall be not less than 90 percent of
the eligible costs under such section. The adjustment to the Federal
share applies to assistance provided before, on, or after the date of
enactment of the Act. The major disaster declared on August 4, 2018,
for the State of California is amended as follows:

    Federal funds for debris removal and emergency protective
measures (Categories A and B), including direct federal assistance,
under the Public Assistance program are authorized at 90 percent of
total eligible costs.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-09182 Filed 5-3-19; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: November 1, 2005 (Volume 70, Number 210)]
[Notices]
[Page 65938]
[DOCID:fr01no05-116]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 1-08610]

Issuer Delisting; Notice of Application of SBC Communications
Inc. To Withdraw Its Common Stock, $1.00 Par Value, From Listing and
Registration on the Pacific Exchange, Inc.

October 25, 2005.
    On September 22, 2005, SBC Communications Inc., a Delaware
corporation (``Issuer''), filed an application with the Securities and
Exchange Commission (``Commission''), pursuant to Section 12(d) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 12d2-2(d)
thereunder,\2\ to withdraw its common stock, $1.00 par value
(``Security''), from listing and registration on the Pacific Exchange,
Inc. (``PCX'').
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78l(d).
    \2\ 17 CFR 240.12d2-2(d).
---------------------------------------------------------------------------

    The Board of Directors (``Board'') of the Issuer approved a
resolution on July 23, 2003 to, among other things, authorize certain
officers of the Issuer to list or delist any of the Issuer's securities
on or from any United States or foreign exchange, except to delist the
Security from the New York Stock Exchange, Inc. (``NYSE''). The Issuer
stated that the following reasons factored into its decision to
withdraw the Security from PCX. First, the Issuer stated that the
Security only infrequently trades on Archipelago Exchange (``ArcaEx''),
the trading facility of PCX. Over the past 12 months, shares of the
Security traded on ArcaEx represented 1.2% of the total shares of the
Security traded on all national exchanges. Substantially all of the
Security is traded on NYSE and in the over-the-counter market. Second,
the Issuer intends to continue listing the Security on NYSE. The
Security is registered under Section 12(b) of the Act,\3\ and the
Issuer is subject to the periodic and current reporting requirements
under Section 13 of the Act.\4\ Third, the continued listing of the
Security is costly and unjustified, in the Issuer's opinion, in light
of the limited trading volume of the Security.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78l(b).
    \4\ 15 U.S.C. 78m.
---------------------------------------------------------------------------

    The Issuer stated in its application that it has complied with
applicable rules of PCX by complying with all applicable laws in the
State of Delaware, the state in which the Issuer is incorporated, and
by providing PCX with the required documents governing the withdrawal
of securities from listing and registration on PCX. The Issuer's
application relates solely to the withdrawal of the Security from
listing on PCX and shall not affect its continued listing on NYSE or
the Chicago Stock Exchange, Inc., (``CHX''),\5\ or its obligation to be
registered under Section 12(b) of the Act.\6\
---------------------------------------------------------------------------

    \5\ On September 22, 2005, the Issuer filed an application with
the Commission to withdraw the Security from listing and
registration on CHX. Notice of such application will be published
separately.
    \6\ 15 U.S.C. 781(b).
---------------------------------------------------------------------------

    Any interested person may, on or before November 15, 2005, comment
on the facts bearing upon whether the application has been made in
accordance with the rules of PCX, and what terms, if any, should be
imposed by the Commission for the protection of investors. All comment
letters may be submitted by either of the following methods:

Electronic Comments

     Send an e-mail to<EMAIL_ADDRESS>Please include
the File Number 1-08610 or;

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 100 F Street,
NE.,Washington, DC 20549-9303.

All submissions should refer to File Number 1-08610. This file number
should be included on the subject line if e-mail is used. To help us
process and review your comments more efficiently, please use only one
method. The Commission will post all comments on the Commission's
Internet Web site (http://www.sec.gov/rules/delist.shtml). Comments are

also available for public inspection and copying in the Commission's
Public Reference Room. All comments received will be posted without
change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.
    The Commission, based on the information submitted to it, will
issue an order granting the application after the date mentioned above,
unless the Commission determines to order a hearing on the matter.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(1).
---------------------------------------------------------------------------

Jonathan G. Katz,
Secretary.
 [FR Doc. E5-6019 Filed 10-31-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)]
[Notices]
[Pages 31513-31520]
[FR Doc No: 2020-11238]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1136, FDA-2020-D-1137, FDA-2020-D-1138, FDA-
2020-D-1139]

Guidance Documents Related to Coronavirus Disease 2019 (COVID-
19); 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 FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidances have been implemented without prior comment, but they
remain subject to comment in accordance with the Agency's good guidance
practices.

DATES: The announcement of the guidances is published in the Federal
Register on May 26, 2020. The guidances have been implemented without
prior comment, but they remain subject to comment in accordance with
the Agency's good guidance practices.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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 name of the
guidance(s) that the comments address and the docket number for the
guidance (see table 1). Received comments will be placed in the
docket(s) 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 any of
these guidances to the addresses noted in table 1. Send two self-
addressed adhesive labels to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-
402-7911; Erica Takai, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5456, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; Kimberly
Thomas, Center for Drug Evaluation and Research (CDER), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6220, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; Phil Chao, Center for Food Safety
and Applied Nutrition (CFSAN), CPK1 Rm 1C001, HFS-024, Food and Drug
Administration, College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, Alex
M. Azar II, Secretary of Health and Human Services, pursuant to the
authority under section 319 of the Public Health Service Act (42 U.S.C.
247d) (PHS Act), determined that a PHE exists and has existed since
January 27, 2020, nationwide.\1\ On March 13, 2020, President Donald J.
Trump declared that the COVID-19 outbreak in the United States
constitutes a national emergency, beginning March 1, 2020.\2\
---------------------------------------------------------------------------

    \1\ On April 21, 2020, the PHE Determination was extended,
effective April 26, 2020. These PHE Determinations are available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
---------------------------------------------------------------------------

    In the Federal Register of March 25, 2020 (the March 25, 2020,
notice) (available at: https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making available
FDA guidances related to the COVID-19 PHE. These procedures, which
operate within FDA's established good guidance practices regulations,
are intended to allow FDA to rapidly disseminate Agency recommendations
and policies related to COVID-19 to industry, FDA staff, and other
stakeholders. The March 25, 2020, notice stated that due to the need to
act quickly and efficiently to respond to the COVID-19 PHE, FDA
believes that prior public participation will not be feasible or
appropriate before FDA implements COVID-19-related guidances.
Therefore, FDA will issue COVID-19-related guidances for immediate
implementation without prior public comment (see section 701(h)(1)(C)
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
371(h)(1)(C) and 21 CFR 10.115(g)(2) (Sec.  10.115(g)(2))). The
guidances are available at FDA's web page entitled ``COVID-19-Related
Guidance Documents for Industry, FDA Staff, and Other Stakeholders''
(https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page entitled ``Search for FDA
Guidance Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
    The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance, FDA
intends to publish periodically a consolidated NOA announcing the
availability of certain COVID-19-related guidances FDA issued during
the relevant period, as included in table 1. This notice announces
COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidances

    Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidances:

                       Table 1--Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
                                                                                Contact information to
            Docket No.                   Center/office          Title of guidance        request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1137...................  CBER                    Investigatory COVID-19     Office of Communication,
                                                             Convalescent Plasma        Outreach and
                                                             (April 2020) (Updated      Development, 10903 New
                                                             May 1, 2020).              Hampshire Ave., Bldg.
                                                                                71, Rm. 3128, Silver
                                                                                Spring, MD 20993-0002, 1-
<PHONE_NUMBER> or 240-402-
                                                                                8010, email
<EMAIL_ADDRESS>FDA-2020-D-1138...................  CDRH                    Enforcement Policy for<EMAIL_ADDRESS>                                                             Clinical Electronic       Please include the
                                                             Thermometers During the    document number 20014
                                                             Coronavirus Disease 2019   and complete title of
                                                             (COVID-19) Public Health   the guidance in the
                                                             Emergency (April 4,        request.
                                                             2020).
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for<EMAIL_ADDRESS>                                                             Infusion Pumps and        Please include the
                                                             Accessories During the     document number 20014
                                                             Coronavirus Disease 2019   and complete title of
                                                             (COVID-19) Public Health   the guidance in the
                                                             Emergency (April 5,        request.
                                                             2020).

FDA-2020-D-1138...................  CDRH                    Enforcement Policy for<EMAIL_ADDRESS>                                                             Remote Ophthalmic         Please include the
                                                             Assessment and             document number 20014
                                                             Monitoring Devices         and complete title of
                                                             During the Coronavirus     the guidance in the
                                                             Disease 2019 (COVID-19)    request.
                                                             Public Health Emergency
                                                             (April 6, 2020).
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for<EMAIL_ADDRESS>                                                             Extracorporeal Membrane   Please include the
                                                             Oxygenation and            document number 20014
                                                             Cardiopulmonary Bypass     and complete title of
                                                             Devices During the         the guidance in the
                                                             Coronavirus Disease 2019   request.
                                                             (COVID-19) Public Health
                                                             Emergency (April 6,
                                                             2020).
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for<EMAIL_ADDRESS>                                                             Digital Health Devices    Please include the
                                                             for Treating               document number 20014
                                                             Psychological Disorders    and complete title of
                                                             During the Coronavirus     the guidance in the
                                                             Disease 2019 (COVID-19)    request.
                                                             Public Health Emergency
                                                             (April 14, 2020).
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for<EMAIL_ADDRESS>                                                             Telethermographic         Please include the
                                                             Systems During the         document number 20014
                                                             Coronavirus Disease 2019   and complete title of
                                                             (COVID-19) Public Health   the guidance in the
                                                             Emergency (April 16,       request.
                                                             2020).
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for<EMAIL_ADDRESS>                                                             Non-Invasive Fetal and    Please include the
                                                             Maternal Monitoring        document number 20014
                                                             Devices Used to Support    and complete title of
                                                             Patient Monitoring         the guidance in the
                                                             During the Coronavirus     request.
                                                             Disease 2019 (COVID-19)
                                                             Public Health Emergency
                                                             (April 23, 2020).
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for<EMAIL_ADDRESS>                                                             Imaging Systems During    Please include the
                                                             the Coronavirus Disease    document number 20014
                                                             2019 (COVID-19) Public     and complete title of
                                                             Health Emergency (April    the guidance in the
                                                             23, 2020).                 request.
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for<EMAIL_ADDRESS>                                                             Remote Digital Pathology  Please include the
                                                             Devices During the         document number 20014
                                                             Coronavirus Disease 2019   and complete title of
                                                             (COVID-19) Public Health   the guidance in the
                                                             Emergency (April 24,       request.
                                                             2020).
FDA-2020-D-1136...................  CDER                    Temporary Policy<EMAIL_ADDRESS>                                                             Regarding Non-Standard    Please include the docket
                                                             PPE Practices for          number FDA-2020-D-1136
                                                             Sterile Compounding by     and complete title of
                                                             Pharmacy Compounders not   the guidance in the
                                                             Registered as              request.
                                                             Outsourcing Facilities
                                                             During the COVID-19
                                                             Public Health Emergency
                                                             (April 10, 2020).
FDA-2020-D-1136...................  CDER                    Policy for the Temporary<EMAIL_ADDRESS>                                                             Use of Portable           Please include the docket
                                                             Cryogenic Containers Not   number FDA-2020-D-1136
                                                             in Compliance With 21      and complete title of
                                                             CFR 211.94(e)(1) For       the guidance in the
                                                             Oxygen and Nitrogen        request.
                                                             During the COVID-19
                                                             Public Health Emergency
                                                             (April 2020) (Updated
                                                             April 20, 2020).
FDA-2020-D-1136...................  CDER                    Temporary Policy for<EMAIL_ADDRESS>                                                             Compounding of Certain    Please include the docket
                                                             Drugs for Hospitalized     number FDA-2020-D-1136
                                                             Patients by Outsourcing    and complete title of
                                                             Facilities During the      the guidance in the
                                                             COVID-19 Public Health     request.
                                                             Emergency (April 16,
                                                             2020) (Updated May 8,
                                                             2020).
FDA-2020-D-1136...................  CDER                    Temporary Policy for<EMAIL_ADDRESS>                                                             Compounding of Certain    Please include the docket
                                                             Drugs for Hospitalized     number FDA-2020-D-1136
                                                             Patients by Pharmacy       and complete title of
                                                             Compounders not            the guidance in the
                                                             Registered as              request.
                                                             Outsourcing Facilities
                                                             During the COVID-19
                                                             Public Health Emergency
                                                             Guidance for Industry
                                                             (April 20, 2020)
                                                             (Updated May 8, 2020).
FDA-2020-D-1136...................  CDER                    Temporary Policy on<EMAIL_ADDRESS>                                                             Repackaging or Combining  Please include the docket
                                                             Propofol Drug Products     number FDA-2020-D-1136
                                                             During the COVID-19        and complete title of
                                                             Public Health Emergency    the guidance in the
                                                             (April 22, 2020).          request.
FDA-2020-D-1139...................  CFSAN                   Temporary Policy on        Office of Nutrition and
                                                             Regulatory Enforcement     Food Labeling, Food
                                                             of 21 CFR Part 118 (the    Labeling and Standards
                                                             Egg Safety Rule) During    Staff, Center for Food
                                                             the COVID-19 Public        Safety and Applied
                                                             Health Emergency (April    Nutrition, Food and Drug
                                                             6, 2020).                  Administration, 5001
                                                                                Campus Dr., College
                                                                                Park, MD 20740.
----------------------------------------------------------------------------------------------------------------

    Although these guidances have been implemented immediately without
prior comment, FDA will consider all comments received and revise the
guidances as appropriate (see Sec.  10.115(g)(3)).
    These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec.  10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

A. CBER

    The guidance indicated below refers to previously approved
collections of information. 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. 3501-3521) (PRA). The collections of information
in the following FDA regulations and guidance have been approved by OMB
as listed in the following table:

                                             Table 2--CBER Guidance
----------------------------------------------------------------------------------------------------------------
                                                                        Another guidance title
         COVID-19 guidance title            CFR cite referenced in      referenced in COVID-19      OMB control
                                              COVID-19  guidance               guidance               No(s).
----------------------------------------------------------------------------------------------------------------
Investigatory COVID-19 Convalescent       21 CFR part 312...........  N/A.......................       0910-0014
 Plasma.                                  >21 CFR 606.121...........  ..........................       0910-0116
                                          21 CFR part 630...........  ..........................       0910-0116
                                          Form FDA 3926.............  ..........................       0910-0814
----------------------------------------------------------------------------------------------------------------

B. CDRH

    The guidances listed below refer to previously approved collections
of information. These collections of information are subject to review
by OMB under the PRA. The collections of information in the following
FDA regulations and guidance have been approved by OMB as listed in the
following table:
BILLING CODE 4164-01-P

[GRAPHIC] [TIFF OMITTED] TN26MY20.026

[GRAPHIC] [TIFF OMITTED] TN26MY20.027

BILLING CODE 4164-01-C

C. CDER

    The guidances listed below refer to previously approved collections
of information. These collections of information are subject to review
by OMB under the PRA. The collections of information in the following
FDA regulations and guidances have been approved by OMB as listed in
the following table:

                                       Table 4--Guidances and Regulations
----------------------------------------------------------------------------------------------------------------
                                            CFR or FD&C Act cite
        COVID-19 guidance title            referenced in COVID-19        Another guidance title      OMB control
                                                  guidance               referenced in COVID-19         No(s).
--------------------------------------------------------------------------------guidance------------------------
Policy for Temporary Use of Portable     21 CFR parts 201, 210,      Current Good Manufacturing        0910-0139
 Cryogenic Containers Not in Compliance   211.84, 211.94, and         Practice for Medical Gases
 With 21 CFR 211.94 for Oxygen and        211.100.                    Medical Gas Containers and
 Nitrogen During COVID-19 Public Health                               Closures; Current Good
 Emergency.                                                           Manufacturing Practice
                                                                      Requirements.
Temporary Policy for Compounding of      21 CFR 314.81, 21 CFR       Current Good Manufacturing        0910-0777
 Certain Drugs for Hospitalized           600.82, Section             Practice--Guidance for Human     0910-0338
 Patients by Outsourcing Facilities       503B(b)(1)(A)(i) of the     Drug Compounding Outsourcing     0910-0001
 During the COVID-19 Public Health        FD&C Act (21 U.S.C.         Facilities Under Section 503B    0910-0139
 Emergency.                               353b(b)(1)(A)(i).           of the FD&C Act.

Temporary Policy for Compounding of      ..........................  Compounded Drug Products That     0910-0001
 Certain Drugs for Hospitalized                                       are Essentially Copies of a      0910-0139
 Patients by Pharmacy Compounders not                                 Commercially Available Drug      0910-0338
 Registered as Outsourcing Facilities                                 Product under Section 503A of
 During the COVID-19 Public Health                                    the Federal Food, Drug and
 Emergency.                                                           Cosmetic Act.
                                                                     Temporary Policy for
                                                                      Compounding of Certain Drugs
                                                                      for Hospitalized Patients by
                                                                      Outsourcing Facilities During
                                                                      the COVID-19 Public Health
                                                                      Emergency.
                                                                     Prescription Requirement Under
                                                                      Section 503A of the Federal
                                                                      Food, Drug, and Cosmetic Act.
                                                                     Temporary Policy Regarding Non-
                                                                      Standard PPE Practices for
                                                                      Sterile Compounding by
                                                                      Pharmacy Compounders not
                                                                      Registered as Outsourcing
                                                                      Facilities during the COVID-
                                                                      19 Public Health Emergency.
Temporary Policy on Repackaging or       ..........................  Repackaging of Certain Human      0910-0139
 Combining Propofol Drug Products                                     Drugs by Pharmacies and          0910-0572
 During the COVID-19 Public Health                                    Outsourcing Facilities.          0910-0777
 Emergency.                                                          Temporary Policy for              0910-0800
                                                                      Compounding of Certain Drugs
                                                                      for Hospitalized Patients by
                                                                      Pharmacy Compounders not
                                                                      Registered as Outsourcing
                                                                      Facilities During the COVID-
                                                                      19 Public Health Emergency.
                                                                     Temporary Policy for
                                                                      Compounding of Certain Drugs
                                                                      for Hospitalized Patients by
                                                                      Outsourcing Facilities During
                                                                      the COVID-19 Public Health
                                                                      Emergency.
----------------------------------------------------------------------------------------------------------------

    The guidance indicated below refers to previously approved
collections of information. These collections of information are
subject to review by OMB under the PRA. The collections of information
in the following FDA regulations and guidance have been approved by OMB
as listed in the below table. This guidance also contains a new
collection of information not approved under a current collection. This
new collection of information has been granted a PHE waiver from the
PRA by HHS on March 19, 2020, under section 319(f) of the PHS Act.
Information concerning the PHE PRA waiver can be found on the HHS
website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                     Table 5--New PRA Information Collection
----------------------------------------------------------------------------------------------------------------
                                      CFR cite          Another guidance
    COVID-19 guidance title         referenced in    referenced in COVID-19  OMB control  New collection covered
                                  COVID-19 guidance         guidance             No.         by PHE PRA waiver
----------------------------------------------------------------------------------------------------------------
Temporary Policy Regarding Non-  21 CFR parts 210    Enforcement Policy for    0910-0139  Recordkeeping of
 Standard PPE Practices for       and 211.            Face Masks and                       compounding without
 Sterile Compounding by                               Respirators During                   standard PPE;
 Pharmacy Compounders not                             the Coronavirus                      recordkeeping of any
 Registered as Outsourcing                            Disease (COVID-19)                   change of
 Facilities During the COVID-19                       Public Health                        sterilization/aseptic
 Public Health Emergency.                             Emergency (Revised).                 processing methods;
                                                     Enforcement Policy for                documentation of
                                                      Gowns, Other Apparel,                mitigation strategies
                                                      and Gloves During the                for sterile
                                                      Coronavirus Disease                  compounding without
                                                      (COVID-19) Public                    standard PPE.
                                                      Health Emergency.
                                                     Electronic Drug
                                                      Product Reporting for
                                                      Human Drug
                                                      Compounding
                                                      Outsourcing
                                                      Facilities Under
                                                      Section 503B of the
                                                      Federal Food, Drug,
                                                      and Cosmetic Act.
----------------------------------------------------------------------------------------------------------------

D. CFSAN

    The guidance indicated below refers to previously approved
collections of information. These collections of information are
subject to review by OMB under the PRA. The collections of information
in the following FDA regulations and guidance have been approved by OMB
as listed in the following table:

                                             Table 6--CFSAN Guidance
----------------------------------------------------------------------------------------------------------------
                                                                           Another guidance title
         COVID-19 guidance title              CFR cite referenced in       referenced in COVID-19    OMB control
                                                COVID-19 guidance                 guidance               No.
----------------------------------------------------------------------------------------------------------------
Temporary Policy Regarding Enforcement of  21 CFR part 118............  ...........................    0910-0660
 21 CFR Part 118 (the Egg Safety Rule)
 During the COVID-19 Public Health
 Emergency.
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

    Persons with access to the internet may obtain COVID-19-related
guidances at:
     the FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     the FDA web page entitled ``Search for FDA Guidance
Documents,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.

    Dated: May 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11238 Filed 5-22-20; 8:45 am]
BILLING CODE 4164-01-P