[Federal Register Volume 87, Number 71 (Wednesday, April 13, 2022)]
[Notices]
[Pages 21993-22001]
[FR Doc No: 2022-07852]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94629; File No. SR-NYSEArca-2022-17]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To List and Trade
Shares of the FMC Excelsior Focus Equity ETF Under Rule 8.900-E
(Managed Portfolio Shares)

April 7, 2022.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that on April 1, 2022, NYSE Arca, Inc. (``NYSE Arca'' 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 self-regulatory organization. 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\ 15 U.S.C. 78a.
    \3\ 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 list and trade shares of the following
under Rule 8.900-E (Managed Portfolio Shares): FMC Excelsior Focus
Equity ETF. The

proposed rule change is available on the Exchange's website at
www.nyse.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 self-regulatory organization
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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    NYSE Arca Rule 8.900-E permits the listing and trading, or trading
pursuant to unlisted trading privileges, of Managed Portfolio Shares,
which are securities issued by an actively managed open-end investment
management company.\4\ Rule 8.900-E(b)(1) requires the Exchange to file
separate proposals under Section 19(b) of the Act before listing and
trading any series of Managed Portfolio Shares on the Exchange.
Therefore, the Exchange is submitting this proposal in order to list
and trade Managed Portfolio Shares of the FMC Excelsior Focus Equity
ETF (the ``Fund''), a series of the Northern Lights Fund Trust IV (the
``Trust''), under Rule 8.900-E.
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    \4\ Rule 8.900-E(c)(1) provides that the term ``Managed
Portfolio Share'' means a security that (a) represents an interest
in an investment company registered under the Investment Company Act
of 1940 (``Investment Company'') organized as an open-end management
investment company that invests in a portfolio of securities
selected by the Investment Company's investment adviser consistent
with the Investment Company's investment objectives and policies;
(b) is issued in a Creation Unit, or multiples thereof, in return
for a designated portfolio of instruments (and/or an amount of cash)
with a value equal to the next determined net asset value and
delivered to the Authorized Participant (as defined in the
Investment Company's Form N-1A filed with the Commission) through a
Confidential Account; (c) when aggregated into a Redemption Unit, or
multiples thereof, may be redeemed for a designated portfolio of
instruments (and/or an amount of cash) with a value equal to the
next determined net asset value delivered to the Confidential
Account for the benefit of the Authorized Participant; and (d) the
portfolio holdings for which are disclosed within at least 60 days
following the end of every fiscal quarter.
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    The Commission has previously approved or noticed for immediate
effectiveness the listing and trading on the Exchange of Managed
Portfolio Shares under NYSE Arca Rule 8.900-E.\5\
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    \5\ See Securities Exchange Act Release Nos. 89663 (August 25,
2020), 85 FR 53868 (August 31, 2020) (SR-NYSEArca-2020-48) (Order
Approving a Proposed Rule Change, as Modified by Amendment No. 1, To
List and Trade Shares of Gabelli ETFs Under Rule 8.900-E, Managed
Portfolio Shares); 90528 (November 30, 2020), 85 FR 78389 (December
4, 2020) (SR-NYSEArca-2020-80) (Order Approving a Proposed Rule
Change, as Modified by Amendment No. 2, To List and Trade Shares of
Alger Mid Cap 40 ETF and Alger 25 ETF Under Rule 8.900-E); and 90683
(December 16, 2020), 85 FR 83665 (December 22, 2020) (SR-NYSEArca-
2020-94) (Order Approving a Proposed Rule Change, as Modified by
Amendments No. 1 and No. 2, To List and Trade Shares of the
AdvisorShares Q Portfolio Blended Allocation ETF and AdvisorShares Q
Dynamic Growth ETF Under NYSE Arca Rule 8.900-E). See also
Securities Exchange Act Release No. 92349 (July 19, 2021), 86 FR
39084 (July 23, 2021) (SR-NYSEArca-2021-54) (Notice of Filing and
Immediate Effectiveness of Proposed Rule Change to List and Trade
Shares of the Cambiar Large Cap ETF, Cambiar Small Cap ETF and
Cambiar SMID ETF) (the ``Cambiar Notice'').
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Description of the Fund and the Trust
    The shares of the Fund (the ``Shares'') will be issued by the
Trust, a statutory trust organized under the laws of the state of
Delaware and registered with the Commission as an open-end management
investment company.\6\ The investment adviser to the Fund will be First
Manhattan Co. (the ``Adviser''). Vident Investment Advisory, LLC will
be the sub-adviser (the ``Sub-Adviser'') for the Fund. Northern Lights
Distributors, LLC (the ``Distributor'') will serve as the distributor
for each of the Fund's Shares. All statements and representations made
in this filing regarding (a) the description of the portfolio or
reference assets, (b) limitations on portfolio holdings or reference
assets, or (c) the applicability of Exchange rules shall constitute
continued listing requirements for listing the Shares on the Exchange,
as provided under Rule 8.900-E(b)(1).
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    \6\ The Trust is registered under the Investment Company Act of
1940 (the ``1940 Act''). On September 24, 2021, the Trust filed a
registration statement on Form N-1A under the Securities Act of 1933
(the ``1933 Act'') and the 1940 Act for the Fund (File No. 811-
23603) (``Registration Statement''). The Commission issued an order
granting exemptive relief to the Trust (``Exemptive Order'') under
the 1940 Act on March 22, 2022 (Investment Company Act Release No.
34537). The Exemptive Order was granted in response to the Trust's
application for exemptive relief (the ``Exemptive Application'')
(File No. 812-15282). The description of the operation of the Trust
and the Fund herein is based, in part, on the Registration
Statement. The Exchange will not commence trading in Shares of the
Fund until the Registration Statement is effective.
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    Rule 8.900-E(b)(4) provides that, if the investment adviser to the
Investment Company issuing Managed Portfolio Shares is registered as a
broker-dealer or is affiliated with a broker-dealer, such investment
adviser will erect and maintain a ``fire wall'' between the investment
adviser and personnel of the broker-dealer or broker-dealer affiliate,
as applicable, with respect to access to information concerning the
composition of and/or changes to such Investment Company portfolio and/
or the Creation Basket.\7\ Any person related to the investment adviser
or Investment Company who makes decisions pertaining to the Investment
Company's portfolio composition or has access to information regarding
the Investment Company's portfolio composition or changes thereto or
the Creation Basket must be subject to procedures designed to prevent
the use and dissemination of material non-public information regarding
the applicable Investment Company portfolio or changes thereto or the
Creation Basket.
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    \7\ Rule 8.900-E(c)(5) provides that the term ``Creation
Basket'' means, on any given business day, the names and quantities
of the specified instruments (and/or an amount of cash) that are
required for an AP Representative to deposit in-kind on behalf of an
Authorized Participant in exchange for a Creation Unit and the names
and quantities of the specified instruments (and/or an amount of
cash) that will be transferred in-kind to an AP Representative on
behalf of an Authorized Participant in exchange for a Redemption
Unit, which will be identical and will be transmitted to each AP
Representative before the commencement of trading.
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    Rule 8.900-E(b)(4) is similar to Commentary .03(a)(i) and (iii) to
Rule 5.2-E(j)(3); however, Commentary .03(a) in connection with the
establishment of a ``fire wall'' between the investment adviser and the
broker-dealer reflects the applicable open-end fund's portfolio, not an
underlying benchmark index, as is the case with index-based funds.\8\
Rule 8.900-E(b)(4) is also

similar to Commentary .06 to Rule 8.600-E related to Managed Fund
Shares, except that Rule 8.900-E(b)(4) relates to establishment and
maintenance of a ``fire wall'' between the investment adviser and
personnel of the broker-dealer or broker-dealer affiliate, as
applicable, with respect to an Investment Company's portfolio and
Creation Basket, and not just to the underlying portfolio, as is the
case with Managed Fund Shares. The Adviser is not registered as a
broker-dealer but is affiliated with a broker-dealer. The Adviser has
implemented and will maintain a ``fire wall'' with respect to such
broker-dealer affiliate regarding access to information concerning the
composition of and/or changes to the Fund's portfolio and/or Creation
Basket. The Sub-Adviser is not registered as a broker-dealer or
affiliated with a broker-dealer.
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    \8\ An investment adviser to an open-end fund is required to be
registered under the Investment Advisers Act of 1940 (the ``Advisers
Act''). As a result, the Adviser, Sub-Adviser, and their related
personnel will be subject to the provisions of Rule 204A-1 under the
Advisers Act relating to codes of ethics. This Rule requires
investment advisers to adopt a code of ethics that reflects the
fiduciary nature of the relationship to clients as well as
compliance with other applicable securities laws. Accordingly,
procedures designed to prevent the communication and misuse of non-
public information by an investment adviser must be consistent with
Rule 204A-1 under the Advisers Act. In addition, Rule 206(4)-7 under
the Advisers Act makes it unlawful for an investment adviser to
provide investment advice to clients unless such investment adviser
has (i) adopted and implemented written policies and procedures
reasonably designed to prevent violations, by the investment adviser
and its supervised persons, of the Advisers Act and the Commission
rules adopted thereunder; (ii) implemented, at a minimum, an annual
review regarding the adequacy of the policies and procedures
established pursuant to subparagraph (i) above and the effectiveness
of their implementation; and (iii) designated an individual (who is
a supervised person) responsible for administering the policies and
procedures adopted under subparagraph (i) above. The Fund will also
be required to comply with Exchange rules relating to disclosure,
including Rule 5.3-E(i).
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    In the event (a) the Adviser or Sub-Adviser becomes registered as a
broker-dealer or becomes newly affiliated with a broker-dealer, or (b)
any new adviser or sub-adviser is a registered broker-dealer, or
becomes affiliated with a broker-dealer, it will implement and maintain
a fire wall with respect to personnel of the broker-dealer or broker-
dealer affiliate regarding access to information concerning the
composition and/or changes to the portfolio and/or Creation Basket. Any
person related to the Adviser, Sub-Adviser, or the Trust who makes
decisions pertaining to the Fund's portfolio composition or that has
access to information regarding the Fund's portfolio composition or
that has access to information regarding the Fund's portfolio or
changes thereto or the Creation Basket will be subject to procedures
designed to prevent the use and dissemination of material non-public
information regarding such portfolio or changes thereto and the
Creation Basket.
    Further, Rule 8.900-E(b)(5) requires that any person or entity,
including an AP Representative (as defined below), custodian, Reporting
Authority, distributor, or administrator, who has access to non-public
information regarding the Investment Company's portfolio composition or
changes thereto or the Creation Basket, must be subject to procedures
reasonably designed to prevent the use and dissemination of material
non-public information regarding the applicable Investment Company
portfolio or changes thereto or the Creation Basket. Moreover, if any
such person or entity is registered as a broker-dealer or affiliated
with a broker-dealer, such person or entity will erect and maintain a
``fire wall'' between the person or entity and the broker-dealer with
respect to access to information concerning the composition and/or
changes to such Investment Company portfolio or Creation Basket.
Description of the Fund 9
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    \9\ The Exchange represents that, for initial and continued
listing, the Fund will be in compliance with Rule 10A-3 under the
Act. See 17 CFR 240.10A-3.
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    The Fund's holdings will conform to the permissible investments as
set forth in the Exemptive Application and Exemptive Order, and the
holdings will be consistent with all requirements in the Exemptive
Application and Exemptive Order.\10\
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    \10\ Pursuant to the Exemptive Order, the only permissible
investments for the Fund are the following that trade on a U.S.
exchange contemporaneously with Shares of the Fund: exchange-traded
funds (``ETFs''), exchange-traded notes, exchange-listed common
stocks, exchange-traded preferred stocks, exchange-traded American
Depositary Receipts, exchange-traded real estate investment trusts,
exchange-traded commodity pools, exchange-traded metal trusts,
exchange-traded currency trusts, and exchange-traded futures for
which the reference asset is one in which the Fund may invest
directly, in the case of an index future traded on a U.S. exchange,
is based on an index, the components of which are a type of asset in
which the Fund could invest directly, as well as cash and cash
equivalents (which are short-term U.S. Treasury securities,
government money market funds, and repurchase agreements). All of
the equity instruments or futures held by the Fund will be traded on
an exchange that is a member of the Intermarket Surveillance group
(``ISG'') or affiliated with a member of ISG or with which the
Exchange has in place a comprehensive surveillance sharing
agreement.
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    The Fund's primary objective is to seek long-term capital
appreciation. The Fund will primarily invest in U.S. exchange-traded
common stocks of companies that are listed on U.S. national securities
exchanges and trade contemporaneously with the Shares. The Fund does
not have a targeted market capitalization for the common stocks of its
holdings. The Fund will, during normal market conditions, generally own
approximately 25 to 30 holdings but may, from time to time, hold a
greater number of common stocks.
Investment Restrictions
    The Fund's holdings will be consistent with all requirements
described in the Exemptive Application and Exemptive Order.\11\
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    \11\ See id.
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    The Fund's investments, including derivatives, will be consistent
with its investment objective and will not be used to enhance leverage
(although certain derivatives and other investments may result in
leverage). That is, the Fund's investments will not be used to seek
performance that is the multiple or inverse multiple (e.g., 2X or -3X)
of the Fund's primary broad-based securities benchmark index (as
defined in Form N-1A).\12\
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    \12\ The Fund's broad-based securities benchmark index will be
identified in a future amendment to the Registration Statement
following the Fund's first full calendar year of performance.
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Creations and Redemptions of Shares
    Creations and redemptions of Shares will take place as described in
Rule 8.900-E. Specifically, in connection with the creation and
redemption of Creation Units \13\ the delivery or receipt of any
portfolio securities in-kind will be required to be effected through a
separate confidential brokerage account (a ``Confidential
Account'').\14\ An Authorized Participant (``AP''), as defined in the
applicable Form N-1A filed with the Commission, will sign an agreement
with an AP Representative \15\ establishing the Confidential Account
for the benefit of the AP. AP Representatives will be broker-dealers.
An AP must be a participant in the Continuous Net Settlement System of
the National Securities Clearing Corporation (``NSCC'') or a
participant in the Depository Trust Company, and

must have executed an authorized participant agreement (``Participant
Agreement'') with the Distributor with respect to the creation and
redemption of Creation Units and formed a Confidential Account for its
benefit in accordance with the terms of the Participant Agreement. For
purposes of creations or redemptions, all transactions will be effected
through the respective AP's Confidential Account, for the benefit of
the AP, without disclosing the identity of such securities to the AP.
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    \13\ Rule 8.900-E(c)(6) provides that the term ``Creation Unit''
means a specified minimum number of Managed Portfolio Shares issued
by an Investment Company at the request of an Authorized Participant
in return for a designated portfolio of instruments and/or cash.
Rule 8.900-E(c)(7) provides that the term ``Redemption Unit'' means
a specified minimum number of Managed Portfolio Shares that may be
redeemed to an Investment Company at the request of an Authorized
Participant in return for a portfolio of instruments and/or cash.
For purposes of this filing, the terms ``Creation Unit'' means
either a Creation Unit as defined in Rules 8.900-E(c)(6) or a
Redemption Unit as defined in Rule 8.900-E(c)(7).
    \14\ Rule 8.900-E(c)(4) provides that the term ``Confidential
Account'' means an account owned by an Authorized Participant and
held with an AP Representative on behalf of the Authorized
Participant. The account will be established and governed by
contractual agreement between the AP Representative and the
Authorized Participant solely for the purposes of creation and
redemption, while keeping confidential the Creation Basket
constituents of each series of Managed Portfolio Shares, including
from the Authorized Participant. The books and records of the
Confidential Account will be maintained by the AP Representative on
behalf of the Authorized Participant.
    \15\ Rule 8.900-E(c)(3) provides that the term ``AP
Representative'' means an unaffiliated broker-dealer, with which an
Authorized Participant has signed an agreement to establish a
Confidential Account for the benefit of such Authorized Participant,
that will deliver or receive, on behalf of the Authorized
Participant, all consideration to or from the Investment Company in
a creation or redemption. An AP Representative will not be permitted
to disclose the Creation Basket to any person, including the
Authorized Participants.
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    Each day, the Fund's custodian will transmit the underlying
securities of the Fund's Creation Basket (as described below) to each
AP Representative. This information will permit an AP that has
established a Confidential Account with an AP Representative to
transact in the underlying securities of the Creation Basket through
their AP Representatives, enabling them to engage in in-kind creation
or redemption activity without knowing the identity or weighting of
those securities. Fund Shares will be issued and redeemed in Creation
Units of 5,000 Shares or more. The Fund will offer and redeem Creation
Units on a continuous basis at the net asset value (``NAV'') per Share
next determined after receipt of an order in proper form. The Fund's
NAV will be determined as of the scheduled closing time of the regular
trading session on the Exchange (ordinarily, 4:00 p.m. E.T.) on each
day that the Exchange is open.
    In order to keep costs low and permit the Fund to be as fully
invested as possible, Shares will be purchased and redeemed in Creation
Units and generally on an in-kind basis. The Fund will issue and redeem
Creation Units principally in exchange for a basket of securities (the
``Deposit Securities''), together with the deposit of a specified cash
payment (the ``Cash Component''). Together, the Deposit Securities and
Cash Component constitute the ``Portfolio Deposit.'' The Cash Component
serves the function of compensating for any differences between the NAV
per Creation Unit and the market value of the Deposit Securities. On
each business day, prior to the opening of business on the Exchange
(ordinarily, 9:30 a.m. E.T.), the custodian will make available to the
AP Representatives through NSCC the name and amount of each Deposit
Security in the current Portfolio Deposit for the Fund and the
estimated Cash Component. The Deposit Securities and estimated Cash
Component, as applicable, announced are applicable to purchases of
Creation Units until the next announcement of Deposit Securities and
estimated Cash Component, as applicable. The Fund may permit or require
the substitute of an amount of cash to be added to the Cash Component
to replace any Deposit Security. On any given business day, the names
and quantities of the instruments that constitute the Deposit
Securities will correspond pro rata to the positions in the Fund's
portfolio (including cash positions) and, thus, will be identical.
These instruments may be referred to, in the case of either a purchase
or a redemption, as the ``Creation Basket.''
Placement of Purchase Orders
    The Fund will issue Shares through the Distributor on a continuous
basis at NAV. The Exchange represents that the issuance of Shares will
operate in a manner substantially similar to that of other ETFs,
including transparent ETFs. The Fund will issue Shares only at the NAV
per Share next determined after an order in proper form is received.
    The Distributor will furnish acknowledgements to those placing such
orders that the orders have been accepted, but the Distributor may
reject any order which is not submitted in proper form, as described in
the Fund's prospectus or Statement of Additional Information (``SAI'').
The NAV of the Fund is expected to be determined once each business day
as of the close of the regular trading session on the Exchange
(ordinarily, 4:00 p.m. E.T.). An AP must submit an irrevocable purchase
order no later than the earlier of (i) 4:00 p.m. E.T. or (ii) the
closing time of the trading session on the Exchange, on any business
day in order to receive that business day's NAV (``Cut-off Time''). The
business day the order is deemed received by the Distributor is
referred to as the ``Transmittal Date.'' An order to create Creation
Units is deemed received on a business day if (i) such order is
received by the Distributor by the Cut-off Time on such day and (ii)
all other procedures set forth in the Participant Agreement are
properly followed. In purchasing the necessary securities, the AP
Representative will use methods, such as breaking the transaction into
multiple transactions and transacting in multiple marketplaces, to
avoid revealing the composition of the Creation Basket.
    Purchases of Shares will be settled in-kind and/or in cash for an
amount equal to the applicable NAV per Share purchased plus applicable
transaction fees.\16\ Other than the Cash Component, the Fund will
substitute cash only under circumstances that are in the best interests
of the Fund and as set forth under the Fund's policies and procedures
governing the composition of Creation Baskets.
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    \16\ To the extent that the Fund allows creations or redemptions
to be conducted in cash, such transactions will be effected in the
same manner for all APs transacting in cash.
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Authorized Participant Redemption
    The Shares may be redeemed to the Fund in Creation Unit size or
multiples thereof as described below. Redemption orders of Creation
Units must be placed by or through an AP. Creation Units of the Fund
will be redeemable at their NAV per Share next determined after receipt
of a request for redemption by the Trust in the manner specified below
before the Cut-off Time. To initiate a redemption Order, an AP must
submit to the Distributor an irrevocable order to redeem such Creation
Unit no later than the Cut-off Time on the Transmittal Date. A
transaction fee may be imposed to offset costs associated with
redemption orders.
    To redeem a Creation Unit, an AP must submit an irrevocable
redemption request to the Distributor no later than the Cut-off Time.
The Fund would then instruct its custodian to deliver a designated
portfolio of securities (``Redemption Instruments'') to the appropriate
Confidential Account in exchange for the Creation Units being redeemed.
The AP will instruct the AP Representative when to liquidate the
securities in the Confidential Account. As with purchase orders, the
business day the order is deemed received by the Distributor is
referred to as the Transmittal Date. A redemption request is deemed
received if (i) such order is received by the Distributor by the Cut-
off Time on such day and (ii) all other procedures set forth in the
Participant Agreement are properly followed. In response to a
redemption request, the Fund will instruct the custodian to deliver an
in-kind basket of designated securities (the ``Redemption Securities'')
and a Cash Component (together, the ``Redemption Basket'') to the
appropriate Confidential Account. The Cash Component serves the
function of compensating for any differences between the NAV per
Creation Unit and the Redemption Securities. The AP would direct the AP
Representative on that day to liquidate those securities. As with the
purchase of securities, the AP Representative will use methods, such as
breaking the transaction into multiple transactions and transacting in
multiple marketplaces, to avoid revealing the composition of the
Redemption Basket.
    Redemptions will occur primarily in-kind, although redemption
payments may also be made partly or wholly in cash. The Fund may permit
or require

the substitution of cash to be added to the Cash Component to replace
any Redemption Security. The Participant Agreement signed by each AP
will require establishment of a Confidential Account to receive
distributions of securities in-kind upon redemption. Each AP will be
required to open a Confidential Account with an AP Representative in
order to facilitate orderly processing of redemptions.
Net Asset Value
    The NAV will be calculated for the Shares of the Fund on each
business day. The Fund's NAV is determined as of the close of regular
trading on the Exchange, normally 4:00 p.m., E.T. The NAV of the Fund's
Shares is determined by dividing the total value of the Fund's assets,
less any liabilities, by the total number of Shares outstanding of the
Fund at the time the determination is made.
    Generally, the Fund's portfolio securities are valued each day at
the last quoted sales price on each security's primary exchange.
Securities traded or dealt in upon one or more securities exchanges for
which market quotations are readily available and not subject to
restrictions against resale shall be valued at the last quoted sales
price on the primary exchange or, in the absence of a sale on the
primary exchange, at the mean between the current bid and ask prices on
such exchange. Securities primarily traded in the NASDAQ National
Market System for which market quotations are readily available shall
be valued using the NASDAQ Official Closing Price. If market quotations
are not readily available, securities will be valued at their fair
market value as determined in good faith by the Fund's fair value
committee in accordance with procedures approved by the Board.
Securities that are not traded or dealt in any securities exchange
(whether domestic or foreign) and for which over-the-counter market
quotations are readily available generally shall be valued at the last
sale price or, in the absence of a sale, at the mean between the
current bid and ask price on such over-the- counter market.
    More information about the valuation of the Fund's holdings can be
found in the SAI.
    Information regarding the Fund's NAV and how often Shares of the
Fund traded at a price above (i.e., at a premium) or below (i.e., at a
discount) the Fund's NAV will be available on the Fund's website
(www.FMCX.com).
Availability of Information
    The Fund's website, www.FMCX.com, will include the prospectus for
the Fund that may be downloaded. The Fund's website will include
additional quantitative information updated on a daily basis, including
the prior business day's NAV, market closing price or mid-point of the
bid/ask spread at the time of calculation of such NAV (the ``Bid/Ask
Price''),\17\ and a calculation of the premium and discount of the
market closing price or Bid/Ask Price against the NAV. The website and
information will be publicly available at no charge.
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    \17\ The Bid/Ask Price of the Fund's Shares is determined using
the mid-point between the current national best bid and offer at the
time of calculation of the Fund's NAV. The records relating to Bid/
Ask Prices will be retained by the Fund or their service providers.
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    Form N-PORT requires reporting of a Fund's complete portfolio
holdings on a position-by-position basis on a quarterly basis within 60
days after fiscal quarter end. Investors can obtain a Fund's SAI, its
shareholder reports, its Form N-CSR, filed twice a year, and its Form
N-CEN, filed annually. The Fund's SAI and shareholder reports are
available free upon request from the Fund, and those documents and the
Form N-PORT, Form N-CSR, and Form N-CEN may be viewed onscreen or
downloaded from the Commission's website at www.sec.gov.
    Information regarding market price and trading volume of the Shares
will be continually available on a real-time basis throughout the day
on brokers' computer screens and other electronic services. Information
regarding the previous day's closing price and trading volume
information for the Shares will be published daily in the financial
section of newspapers. Quotation and last sale information for the
Shares will be available via the Consolidated Tape Association
(``CTA'') high-speed line. In addition, the Verified Intraday
Indicative Value (``VIIV''), as defined in Rule 8.900-E(c)(2),\18\ will
be widely disseminated by the Reporting Authority \19\ and/or one or
more major market data vendors in one second intervals during the
Exchange's Core Trading Session and will be available to all market
participants at the same time.
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    \18\ Rule 8.900-E(c)(2) provides that the term ``Verified
Intraday Indicative Value'' is the indicative value of a Managed
Portfolio Share based on all of the holdings of a series of Managed
Portfolio Shares as of the close of business on the prior business
day and, for corporate actions, based on the applicable holdings as
of the opening of business on the current business day, priced and
disseminated in one second intervals during the Exchange's Core
Trading Session by the Reporting Authority.
    \19\ Rule 8.900-E(c)(8) provides that the term ``Reporting
Authority'' in respect of a particular series of Managed Portfolio
Shares means the Exchange, an institution, or a reporting service
designated by the Exchange or by the exchange that lists a
particular series of Managed Portfolio Shares (if the Exchange is
trading such series pursuant to unlisted trading privileges), as the
official source for calculating and reporting information relating
to such series, including, but not limited to, the NAV, the VIIV, or
other information relating to the issuance, redemption, or trading
of Managed Portfolio Shares. A series of Managed Portfolio Shares
may have more than one Reporting Authority, each having different
functions.
---------------------------------------------------------------------------

Dissemination of the VIIV
    With respect to trading of the Shares, the ability of market
participants to buy and sell Shares at prices near the VIIV is
dependent upon their assessment that the VIIV is a reliable, indicative
real-time value for the Fund's underlying holdings. Market participants
are expected to accept the VIIV as a reliable, indicative real-time
value because (1) the VIIV will be calculated and disseminated based on
the Fund's actual portfolio holdings, (2) the securities in which the
Fund plans to invest are generally highly liquid and actively traded
and trade at the same time as the Fund and therefore generally have
accurate real time pricing available, and (3) market participants will
have a daily opportunity to evaluate whether the VIIV at or near the
close of trading is indeed predictive of the actual NAV.
    The VIIV will be widely disseminated by the Reporting Authority
and/or by one or more major market data vendors in one second intervals
during the Exchange's Core Trading Session. The VIIV is based on the
current market value of the securities in the Fund's portfolio that
day. The methodology for calculating the Fund's VIIV is available on
the Fund's website. The VIIV is intended to provide investors and other
market participants with a highly correlated per Share value of the
underlying portfolio that can be compared to the current market price.
Therefore, under normal circumstances the VIIV would be effectively a
near real time approximation of the Fund's NAV, available free of
charge from one or more market data vendors, which is computed only
once a day.
Trading Halts
    With respect to trading halts, the Exchange may consider all
relevant factors in exercising its discretion to halt or suspend
trading in the Shares of the Fund.\20\ Trading in Shares of the Fund
will be halted if the circuit breaker parameters in Rule 7.12-E have
been reached. Trading also may be halted because of market conditions
or for reasons that, in the view of the Exchange, make trading in the
Shares inadvisable. Trading in the Shares will be subject to Rule
8.900-E(d)(2)(C), which sets forth circumstances under

which trading in the Shares of the Fund will be halted.
---------------------------------------------------------------------------

    \20\ See Rule 7.12-E.
---------------------------------------------------------------------------

    Specifically, Rule 8.900-E(d)(2)(C)(i) provides that the Exchange
may consider all relevant factors in exercising its discretion to halt
trading in a series of Managed Portfolio Shares. Trading may be halted
because of market conditions or for reasons that, in the view of the
Exchange, make trading in the series of Managed Portfolio Shares
inadvisable. These may include: (a) The extent to which trading is not
occurring in the securities and/or the financial instruments composing
the portfolio; or (b) whether other unusual conditions or circumstances
detrimental to the maintenance of a fair and orderly market are
present.\21\
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    \21\ The Exemptive Application provides that the Investment
Company or their agent will request that the Exchange halt trading
in the applicable series of Managed Portfolio Shares where: (i) The
intraday indicative values calculated by the calculation engines
differ by more than 25 basis points for 60 seconds in connection
with pricing of the VIIV; or (ii) holdings representing 10% or more
of a series of Managed Portfolio Shares' portfolio have become
subject to a trading halt or otherwise do not have readily available
market quotations. Any such requests will be one of many factors
considered in order to determine whether to halt trading in a series
of Managed Portfolio Shares and the Exchange retains sole discretion
in determining whether trading should be halted. As provided in the
Exemptive Application, each series of Managed Portfolio Shares would
employ a pricing verification agent to continuously compare two
intraday indicative values during regular trading hours in order to
ensure the accuracy of the VIIV.
---------------------------------------------------------------------------

    Rule 8.900-E(d)(2)(C)(ii) provides that, if the Exchange becomes
aware that: (i) The VIIV of a series of Managed Portfolio Shares is not
being calculated or disseminated in one second intervals, as required;
(ii) the NAV with respect to a series of Managed Portfolio Shares is
not disseminated to all market participants at the same time; (iii) the
holdings of a series of Managed Portfolio Shares are not made available
on at least a quarterly basis as required under the 1940 Act; or (iv)
such holdings are not made available to all market participants at the
same time (except as otherwise permitted under the currently applicable
exemptive order or no-action relief granted by the Commission or
Commission staff to the Investment Company with respect to the series
of Managed Portfolio Shares), it will halt trading in such series until
such time as the Verified Intraday Indicative Value, the NAV, or the
holdings are available, as required.
Trading Rules
    The Exchange deems the Shares to be equity securities, thus
rendering trading in the Shares subject to the Exchange's existing
rules governing the trading of equity securities. Shares will trade on
the Exchange in all trading sessions in accordance with Rule 7.34-E(a).
As provided in Rule 7.6-E, the minimum price variation (``MPV'') for
quoting and entry of orders in equity securities traded on the NYSE
Arca Marketplace is $0.01, with the exception of securities that are
priced less than $1.00, for which the MPV for order entry is $0.0001. A
minimum of 100,000 Shares of the Fund will be outstanding at the
commencement of trading on the Exchange.
    The Shares will conform to the initial and continued listing
criteria under Rule 8.900-E, as well as all terms in the Exemptive
Order. The Exchange will obtain a representation from the issuer of the
Shares of the Fund that the NAV per Share of the Fund will be
calculated daily and will be made available to all market participants
at the same time.
Surveillance
    The Exchange believes that its surveillance procedures are adequate
to properly monitor the trading of Shares on the Exchange during all
trading sessions and to deter and detect violations of Exchange rules
and the applicable federal securities laws. Trading of Shares through
the Exchange will be subject to the Exchange's surveillance procedures
for derivative products. As part of these surveillance procedures and
consistent with Rule 8.900-E(b)(3) and 8.900-E(d)(2)(B), the Adviser
will upon request make available to the Exchange and/or the Financial
Industry Regulatory Authority (``FINRA''), on behalf of the Exchange,
the daily portfolio holdings of the Fund. The issuer of the Shares of
the Fund will be required to represent to the Exchange that it will
advise the Exchange of any failure by the Fund to comply with the
continued listing requirements, and, pursuant to its obligations under
Section 19(g)(1) of the Exchange Act, the Exchange will surveil for
compliance with the continued listing requirements. If the Fund is not
in compliance with the applicable listing requirements, the Exchange
will commence delisting procedures under Exchange Rule 5.5-E(m).
    FINRA, on behalf of the Exchange, or the regulatory staff of the
Exchange, or both, will communicate as needed regarding trading in the
Shares and certain exchange-traded instruments with other markets and
other entities that are members of the ISG, and FINRA, on behalf of the
Exchange, or the regulatory staff of the Exchange, or both, may obtain
trading information regarding trading such securities from such markets
and other entities. In addition, the Exchange may obtain information
regarding trading in the Shares and certain exchange-traded instruments
from markets and other entities that are members of ISG or with which
the Exchange has in place a comprehensive surveillance sharing
agreement.
    In addition, the Exchange also has a general policy prohibiting the
distribution of material, non-public information by its employees.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\22\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\23\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
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.
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78f(b).
    \23\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that this proposed rule change is designed to
prevent fraudulent and manipulative acts and practices in that the Fund
would meet each of the rules relating to listing and trading of Managed
Portfolio Shares. To the extent that the Fund is not in compliance with
such rules, the Exchange would either prevent the Fund from listing and
trading on the Exchange or commence delisting procedures under Rule
8.900-E(d)(2)(B). Specifically, the Exchange would consider the
suspension of trading, and commence delisting proceedings under Rule
8.900-E(d)(2)(B), of the Fund under any of the following circumstances:
(a) If, following the initial twelve-month period after commencement of
trading on the Exchange, there are fewer than 50 beneficial holders of
the Fund; (b) if the Exchange has halted trading in the Fund because
the VIIV is interrupted pursuant to Rule 8.900-E(d)(2)(C)(ii) and such
interruption persists past the trading day in which it occurred or is
no longer available; (c) if the Exchange has halted trading in the Fund
because the NAV with respect to such Fund is not disseminated to all
market participants at the same time, the holdings of such Fund are not
made available on at least a quarterly basis as required under the 1940
Act, or such holdings are not made available to all market participants
at the same time pursuant to Rule 8.900-E(d)(2)(C)(ii) and such issue
persists past the trading day in which it occurred; (d) if the Exchange
has halted

trading in Shares of the Fund pursuant to Rule 8.900-E(d)(2)(C)(i) and
such issue persists past the trading day in which it occurred; (e) if
the Fund has failed to file any filings required by the Commission or
if the Exchange is aware that the Fund is not in compliance with the
conditions of any currently applicable exemptive order or no-action
relief granted by the Commission or Commission staff with respect to
the Fund; (f) if any of the continued listing requirements set forth in
Rule 8.900-E are not continuously maintained; (g) if any of the
statements of representations regarding (a) the description of the
portfolio, (b) limitations on portfolio holdings, or (c) the
applicability of Exchange listing rules as specified herein to permit
the listing and trading of the Fund, are not continuously maintained;
or (h) if such other event shall occur or condition exists which, in
the opinion of the Exchange, makes further dealings on the Exchange
inadvisable.
    As discussed above, the Adviser is not registered as a broker-
dealer but is affiliated with a broker-dealer and has implemented and
will maintain a ``fire wall'' with respect to such affiliate broker-
dealer regarding access to information concerning the composition and/
or changes to the Fund's portfolio and Creation Basket. The Sub-Adviser
is neither registered as a broker-dealer nor affiliated with a broker-
dealer. In the event that (a) the Adviser or Sub-Adviser becomes
registered as a broker-dealer or becomes newly affiliated with a
broker-dealer, or (b) any new adviser or sub-adviser is a registered
broker-dealer or becomes affiliated with a broker-dealer, the Adviser
or Sub-Adviser, as applicable, will implement and maintain a fire wall
with respect to personnel of the broker-dealer or broker-dealer
affiliate regarding access to information concerning the composition
and/or changes to the portfolio and/or Creation Basket. Any person
related to the Adviser, Sub-Adviser, or the Trust who makes decisions
pertaining to the Fund's portfolio composition or that has access to
information regarding the Fund's portfolio or changes thereto or the
Creation Basket will be subject to procedures designed to prevent the
use and dissemination of material non-public information regarding such
portfolio or changes thereto and the Creation Basket.
    In addition, Rule 8.900-E(b)(5) requires that any person or entity,
including an AP Representative, custodian, Reporting Authority,
distributor, or administrator, who has access to non-public information
regarding the Investment Company's portfolio composition or changes
thereto or the Creation Basket, must be subject to procedures designed
to prevent the use and dissemination of material non-public information
regarding the applicable Investment Company portfolio or changes
thereto or the Creation Basket. Moreover, if any such person or entity
is registered as a broker-dealer or affiliated with a broker-dealer,
such person or entity will erect and maintain a ``fire wall'' between
the person or entity and the broker-dealer with respect to access to
information concerning the composition and/or changes to such
Investment Company portfolio or Creation Basket. Any person or entity
who has access to information regarding the Fund's portfolio
composition or changes thereto or the Creation Basket will be subject
to procedures designed to prevent the use and dissemination of material
nonpublic information regarding the portfolio or changes thereto or the
Creation Basket.
    The Exchange further believes that Rule 8.900-E is designed to
prevent fraudulent and manipulative acts and practices related to the
listing and trading of Shares of the Fund because it provides
meaningful requirements about both the data that will be made publicly
available about the Shares, as well as the information that will only
be available to certain parties and the controls on such information.
Specifically, the Exchange believes that the requirements related to
information protection set forth in Rule 8.900-E(b)(5) will act as a
safeguard against misuse and improper dissemination of information
related to the Fund's portfolio composition, the Creation Basket, or
changes thereto. The requirement that any person or entity implement
procedures to prevent the use and dissemination of material non-public
information regarding the portfolio or Creation Basket will act to
prevent any individual or entity from sharing such information
externally and the internal ``fire wall'' requirements applicable where
an entity is a registered broker-dealer or affiliated with a broker-
dealer will act to make sure that no entity will be able to misuse the
data for their own purposes. Accordingly, the Exchange believes that
this proposal is designed to prevent fraudulent and manipulative acts
and practices.
    The Exchange further believes that the proposal is designed to
prevent fraudulent and manipulative acts and practices related to the
listing and trading of Shares of the Fund and to promote just and
equitable principles of trade and to protect investors and the public
interest because the Exchange would halt trading under certain
circumstances under which trading in the Shares of the Fund may be
inadvisable. Specifically, trading in the Shares will be subject to
Rule 8.900-E(d)(2)(C)(i), which provides that the Exchange may consider
all relevant factors in exercising its discretion to halt trading in
the Fund. Trading may be halted because of market conditions or for
reasons that, in the view of the Exchange, make trading in the series
of Managed Portfolio Shares inadvisable. These may include: (a) The
extent to which trading is not occurring in the securities and/or the
financial instruments composing the portfolio; or (b) whether other
unusual conditions or circumstances detrimental to the maintenance of a
fair and orderly market are present.\24\ Additionally, trading in the
Shares will be subject to Rule 8.900-E(d)(2)(C)(ii), which provides
that the Exchange would halt trading where the Exchange becomes aware
that: (a) The VIIV of a series of Managed Portfolio Shares is not being
calculated or disseminated in one second intervals, as required; (b)
the NAV with respect to a series of Managed Portfolio Shares is not
disseminated to all market participants at the same time; (c) the
holdings of a series of Managed Portfolio Shares are not made available
on at least a quarterly basis as required under the 1940 Act; or (d)
such holdings are not made available to all market participants at the
same time (except as otherwise permitted under the currently applicable
exemptive order or no-action relief granted by the Commission or
Commission staff to the Investment Company with respect to the series
of Managed Portfolio Shares). The Exchange would halt trading in such
Shares until such time as the VIIV, the NAV, or the holdings are
available, as required.
---------------------------------------------------------------------------

    \24\ See note 21, supra.
---------------------------------------------------------------------------

    With respect to the proposed listing and trading of Shares of the
Fund, the Exchange believes that the proposed rule change is designed
to prevent fraudulent and manipulative acts and practices in that the
Shares will be listed and traded on the Exchange pursuant to the
initial and continued listing criteria in Rule 8.900-E.\25\ The Fund's
holdings will conform to the permissible investments as set forth in
the Exemptive Application and Exemptive Order.\26\ As noted above,

FINRA, on behalf of the Exchange, or the regulatory staff of the
Exchange, or both, will communicate as needed regarding trading in the
Shares and the underlying exchange-traded instruments with other
markets and other entities that are members of the ISG, and FINRA, on
behalf of the Exchange, or the regulatory staff of the Exchange, or
both, may obtain trading information regarding trading such securities
from such markets and other entities. In addition, the Exchange may
obtain information regarding trading in the Shares and the underlying
exchange-traded instruments from markets and other entities that are
members of ISG or with which the Exchange has in place a comprehensive
surveillance sharing agreement.
---------------------------------------------------------------------------

    \25\ The Exchange represents that, for initial and continued
listing, the Fund will be in compliance with Rule 10A-3 under the
Act. See 17 CFR 240.10A-3.
    \26\ See note 10, supra.
---------------------------------------------------------------------------

    With respect to trading of Shares of the Fund, the ability of
market participants to buy and sell Shares at prices near the VIIV is
dependent upon their assessment that the VIIV is a reliable, indicative
real-time value for the Fund's underlying holdings. Market participants
are expected to accept the VIIV as a reliable, indicative real-time
value because (1) the VIIV will be calculated and disseminated based on
the Fund's actual portfolio holdings, (2) the securities in which the
Fund plans to invest are generally highly liquid and actively traded
and trade at the same time as the Fund and therefore generally have
accurate real time pricing available, and (3) market participants will
have a daily opportunity to evaluate whether the VIIV at or near the
close of trading is indeed predictive of the actual NAV.
    The proposed rule change is designed to promote just and equitable
principles of trade and to protect investors and the public interest in
that the Exchange will obtain a representation that the NAV per Share
of the Fund will be calculated daily and that the NAV will be made
available to all market participants at the same time. Investors can
also obtain the Fund's SAI, its shareholder reports, its Form N-CSR
(filed twice a year), and its Form N-CEN (filed annually). The Fund's
SAI and shareholder reports will be available free upon request from
the Fund, and those documents and the Form N-PORT, Form N-CSR, and Form
N-CEN may be viewed on-screen or downloaded from the Commission's
website at www.sec.gov. In addition, a large amount of information will
be publicly available regarding the Fund and the Shares, thereby
promoting market transparency. Quotation and last sale information for
the Shares will be available via the CTA high-speed line. Information
regarding the VIIV will be widely disseminated in one second intervals
throughout the Exchange's Core Trading Session by the Reporting
Authority and/or one or more major market data vendors. The website for
the Fund will include a prospectus for the Fund that may be downloaded,
and additional data relating to NAV and other applicable quantitative
information, updated on a daily basis. Moreover, prior to the
commencement of trading, the Exchange will inform its members in an
Information Bulletin of the special characteristics and risks
associated with trading the Shares.
    In addition, as noted above, investors will have ready access to
the VIIV, and quotation and last sale information for the Shares. The
Shares will conform to the initial and continued listing criteria under
Rule 8.900-E. The Fund's investments, including derivatives, will be
consistent with its investment objective and will not be used to
enhance leverage (although certain derivatives and other investments
may result in leverage). That is, the Fund's investments will not be
used to seek performance that is the multiple or inverse multiple
(e.g., 2X or -3X) of the Fund's primary broad-based securities
benchmark index (as defined in Form N-1A).
    The Exchange also believes that the proposed rule change is
designed to perfect the mechanism of a free and open market and, in
general, to protect investors and the public interest in that it will
facilitate the listing and trading of actively-managed exchange-traded
products that will enhance competition among market participants, to
the benefit of investors and the marketplace. As noted above, the
Exchange has in place surveillance procedures relating to trading in
the Shares and may obtain information via ISG from other exchanges that
are members of ISG or with which the Exchange has entered into a
comprehensive surveillance sharing agreement. In addition, as noted
above, investors will have ready access to information regarding the
VIIV and quotation and last sale information for the Shares.
    For the above reasons, the Exchange believes that the proposed rule
change is consistent with the requirements of Section 6(b)(5) of the
Act.

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 that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes the
proposed rule change would permit the listing and trading of an
additional actively-managed exchange-traded product, thereby promoting
competition among exchange-traded products to the benefit of investors
and the marketplace.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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 \27\ and Rule 19b-
4(f)(6) thereunder.\28\
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78s(b)(3)(A).
    \28\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act normally does not become operative for 30 days after the date of
its filing. However, Rule 19b-4(f)(6)(iii) \29\ permits the Commission
to designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange requested
that the Commission waive the 30-day operative delay so that the
proposal may become operative immediately upon filing. The Commission
notes it has approved, and noticed for immediate effectiveness,
proposed rule changes to permit listing and trading on the Exchange of
Managed Portfolio Shares similar to the Funds.\30\ The proposed listing
rule for the Fund raises no novel legal or regulatory issues.
Therefore, the Commission believes that waiver of the 30-day operative
delay is consistent with the protection of investors and the public
interest. Accordingly, the Commission hereby waives the 30-day
operative delay and designates the proposed rule change operative upon
filing.\31\
---------------------------------------------------------------------------

    \29\ 17 CFR 240.19b-4(f)(6)(iii).
    \30\ See supra note 5.
    \31\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).

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

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEArca-2022-17 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-NYSEArca-2022-17. 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-NYSEArca-2022-17 and should be submitted
on or before May 4, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\32\
---------------------------------------------------------------------------

    \32\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-07852 Filed 4-12-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: May 25, 2010 (Volume 75, Number 100)]
[Notices]
[Page 29371-29374]
[DOCID:fr25my10-102]

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

[Release No. 34-62112; File No. SR-NASDAQ-2010-052]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of a Proposed Rule Change and Amendment No. 1 Thereto
To Establish a New Service and Related Fees

May 14, 2010.
    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 April 26, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by Nasdaq. On May 13,
2010, the Exchange filed Amendment No. 1. The Commission is publishing
this notice to solicit comments on the proposed rule change, as
amended, from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq is proposing to establish a new service and related fees.
The Nasdaq Short Sale Volume and Monthly Short Sale Transaction files
(the ``Service'') will establish a product that is comprised of
aggregate reported share volume of executed short sale trades during
regular market hours on a daily basis, as well as every short sale
executed on the Nasdaq execution system and reported to a consolidated
tape for Nasdaq, the New York Stock Exchange (``NYSE'') and regional
exchange-listed securities, including the price of the trade and the
number of shares for every short sale transaction, on a monthly basis,
separated into daily files.
    The text of the proposed rule change is below. Proposed new
language is italicized and proposed deletions are in brackets.
* * * * *
7051. Nasdaq Daily Short Volume and Monthly Short Sale Transaction
Files

    (a) Daily Short Sale Volume files reflect the aggregate number of
shares executed on the Nasdaq market during regular trading hours on a
daily basis. At the security level, Nasdaq will show the volume for
executed short sale trades, as well as the total trading volume for the
Nasdaq market. The file will include short sale data for Nasdaq, NYSE
and regional exchange-listed securities.
    (b) Monthly Short Sale Transaction files provide a trade-by-trade
record of all short sales executed on the Nasdaq execution system and
reported to a consolidated tape in Nasdaq, NYSE and regional exchange-
listed securities. The file will be provided on a monthly basis,
separated into daily files. Historical monthly files are available back
to August 2005.
    (c) Distributor Fees
    (1) The fee for each Distributor of the Short Sale Data Product
described in paragraphs (a) and (b) above is $500 per month, which
allows the distributor access to the downloadable FTP files and to
distribute such files internally and externally.
* * * * *

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

    In its filing with the Commission, Nasdaq 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. Nasdaq 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
    Nasdaq proposes to establish the new Service and related fees that
will provide subscribers with market information and increased market
transparency that will help bolster investor confidence. Nasdaq
believes that in creating these data products it will be addressing the
market demand for: (i) A short sale product that is comprised of
aggregate reported share volume of executed short sale trades during
regular market hours on a daily basis; and (ii) every short sale
executed on the Nasdaq execution system and reported to a consolidated
tape for Nasdaq, NYSE and regional exchange-listed securities,
including the price of the trade and the number of shares for every
short sale transaction, on a monthly basis, separated into daily files.
    Nasdaq proposes to offer the Service at $500 per subscriber, per
month, which allows a distributor access to the downloadable FTP files
and to distribute internally and externally. Use of the Service is
voluntary. The proposed fee will be applied to offset the costs
associated with establishing the Service, responding to customer
requests, configuring Nasdaq's systems, programming to user
specifications, and administering the service, among other things. To
the extent that costs are covered by the proposed fee, the proposed fee
may also provide Nasdaq with a profit.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\3\ in general, and Section
6(b)(4) of the Act,\4\ in particular, in that it provides an equitable
allocation of reasonable fees among users and recipients of Nasdaq
data. In adopting Regulation NMS, the Commission granted self-
regulatory organizations and broker-dealers increased authority and
flexibility to offer new and unique market data to the public. It was
believed that this authority would expand the amount of data available
to consumers, and also spur innovation and competition for the
provision of market data.
---------------------------------------------------------------------------

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

    The Short Sale market data products proposed here appear to be
precisely the sort of market data product that the Commission
envisioned when it adopted Regulation NMS. The Commission concluded
that Regulation NMS--by deregulating the market in proprietary data--
would itself further the Act's goals of facilitating efficiency and
competition:

    [E]fficiency is promoted when broker-dealers who do not need the
data beyond the prices, sizes, market center identifications of the
NBBO and consolidated last sale information are not required to
receive (and pay for) such data. The Commission also believes that
efficiency is promoted when broker-dealers may choose to receive
(and pay for) additional market data based on their own internal
analysis of the need for such data.\5\
---------------------------------------------------------------------------

    \5\ Securities Exchange Act Release No. 51808 (June 9, 2005), 70
FR 37496 (June 29, 2005).

    By removing ``unnecessary regulatory restrictions'' on the ability
of exchanges to sell their own data, Regulation NMS advanced the goals
of the Act and the principles reflected in its legislative history. If
the free market should determine whether, proprietary data is sold to
broker-dealers at all, it follows that the price at which such data is
sold should be set by the market as well.

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

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. As the Commission
has recognized,\6\ the market for transaction execution and routing
services is highly competitive, and the market for proprietary data
products is complementary to it, since

the ultimate goal of such products is to attract further order flow to
an exchange. Thus, exchanges lack the ability to set fees for
executions or data at inappropriately high levels. Order flow is
immediately transportable to other venues in response to differences in
cost or value. Similarly, if data fees are set at inappropriate levels,
customers that control order flow will not make use of the data and
will be more inclined to send order flow to exchanges providing data at
fees they consider more reasonable.
---------------------------------------------------------------------------

    \6\ Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770 (December 9, 2008) (SR-NYSEArca-2006-21).
---------------------------------------------------------------------------

    The market for proprietary data products is currently competitive
and inherently contestable because there is fierce competition for the
inputs necessary to the creation of proprietary data and strict pricing
discipline for the proprietary products themselves. Numerous exchanges
compete with each other for listings, trades, and market data itself,
providing virtually limitless opportunities for entrepreneurs who wish
to produce and distribute their own market data. This proprietary data
is produced by each individual exchange, as well as other entities, in
a vigorously competitive market.
    With regard to the market for executions, broker-dealers currently
have numerous alternative venues for their order flow, including
multiple competing self-regulatory organization (``SRO'') markets, as
well as broker-dealers (``BDs'') and aggregators such as the Direct
Edge and LavaFlow electronic communications network (``ECN''). Each SRO
market competes to produce transaction reports via trade executions,
and FINRA-regulated Trade Reporting Facilities (``TRFs'') compete to
attract internalized transaction reports. It is common for BDs to
further and exploit this competition by sending their order flow and
transaction reports to multiple markets, rather than providing them all
to a single market.
    Competitive markets for order flow, executions, and transaction
reports provide pricing discipline for the inputs of proprietary data
products. The large number of SROs, TRFs, and ECNs that currently
produce proprietary data or are currently capable of producing it
provides further pricing discipline for proprietary data products. Each
SRO, TRF, ECN and BD is currently permitted to produce proprietary data
products, and many currently do or have announced plans to do so,
including Nasdaq, NYSE, Alternext, NYSEArca, and BATS.
    Any ECN or BD can combine with any other ECN, broker-dealer, or
multiple ECNs or BDs to produce jointly proprietary data products.
Additionally, non-BDs such as order routers like LAVA, as well as
market data vendors can facilitate single or multiple broker-dealers'
production of proprietary data products. The potential sources of
proprietary products are virtually limitless.
    The fact that proprietary data from ECNs, BDs, and vendors can by-
pass SROs is significant in two respects. First, non-SROs can compete
directly with SROs for the production and distribution of proprietary
data products, as Archipelago and BATS Trading did prior to registering
as SROs. Second, because a single order or transaction report can
appear in an SRO proprietary product, a non-SRO proprietary product, or
both, the data available in proprietary products is exponentially
greater than the actual number of orders and transaction reports that
exist in the marketplace writ large.
    Market data vendors provide another form of price discipline for
proprietary data products because they control the primary means of
access to end users. Although their business models may differ, vendors
exercise pricing discipline because they can simply refuse to purchase
any proprietary data product that fails to provide sufficient value.
Nasdaq and other producers of proprietary data products must understand
and respond to these varying business models and pricing disciplines in
order to successfully market proprietary data products.
    In addition to the competition and price discipline described
above, the market for proprietary data products is also highly
contestable because market entry is rapid, inexpensive, and profitable.
The history of electronic trading is replete with examples of entrants
that swiftly grew into some of the largest electronic trading platforms
and proprietary data producers: Archipelago, Bloomberg Tradebook,
Island, RediBook, Attain, TracECN, and BATS Trading. Today, BATS
publishes its data at no charge on its Web site in order to attract
order flow, and it uses market data revenue rebates from the resulting
executions to maintain low execution charges for its users.\7\ Several
ECNs have existed profitably for many years with a minimal share of
trading, including Bloomberg Tradebook and LavaFlow.
---------------------------------------------------------------------------

    \7\ However, on April 9, 2010 the Commission approved [sic] BATS
proposed rule change to begin offering and charging for three new
data products, which include BATS Last Sale Feed, BATS Historical
Data Products, and a data product called BATS Market Insight. See
Securities Exchange Act Release No. 61885 (April 9, 2010), 75 FR
20018 (April 16, 2010).
---------------------------------------------------------------------------

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

    Written comments were neither solicited nor received.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    A. By order approve such proposed rule change, or
    B. Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2010-052 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2010-052. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than

those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for 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 such filing also will be available for Web
site viewing and copying at the principal office of Nasdaq. 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 publicly available. All
submissions should refer to File Number SR-NASDAQ-2010-052 and should
be submitted on or before June 15, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-12495 Filed 5-24-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register: August 2, 2010 (Volume 75, Number 147)]
[Notices]
[Page 45144]
[DOCID:fr02au10-87]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1925-DR; Docket ID FEMA-2010-0002]

Kentucky; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the Commonwealth of Kentucky (FEMA-1925-DR), dated July
23, 2010, and related determinations.

DATES: Effective Date: July 23, 2010.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 23, 2010, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the
Commonwealth of Kentucky resulting from severe storms, flooding, and
mudslides beginning on July 17, 2010, and continuing, is of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the Commonwealth of Kentucky.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance and Public
Assistance in the designated areas and Hazard Mitigation throughout
the Commonwealth. Direct Federal assistance is authorized.
Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance, Hazard Mitigation, and Other Needs Assistance
will be limited to 75 percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Douglas G. Mayne, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the Commonwealth of Kentucky have been
designated as adversely affected by this major disaster:

    Pike County for Individual Assistance.
    Pike County for Public Assistance, including direct Federal
assistance.
    All counties within the Commonwealth of Kentucky are eligible to
apply for assistance under the Hazard Mitigation Grant Program.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-18949 Filed 7-30-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 56 (Monday, March 23, 2020)]
[Notices]
[Pages 16370-16372]
[FR Doc No: 2020-05959]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1106]

Policy for Temporary Compounding of Certain Alcohol-Based Hand
Sanitizer Products During the Public Health Emergency; Immediately in
Effect Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Policy for
Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products
During the Public Health Emergency.'' Due to the Coronavirus Disease
2019 (COVID-19) pandemic, FDA has received a number of queries
concerning compounding of alcohol-based hand sanitizers. The Agency is
issuing this guidance to communicate its policy for the temporary
compounding of certain alcohol-based hand sanitizer products by
pharmacists in State-licensed pharmacies or Federal facilities and
registered outsourcing facilities (referred to collectively in this
notice and the guidance as compounders) for the duration of the public
health emergency declared by the Secretary of Health and Human Services
on January 31, 2020. The guidance document is immediately in effect,
but it remains subject to comment in accordance with the Agency's good
guidance practices.

DATES: The announcement of the guidance is published in the Federal
Register on March 23, 2020. The guidance document is immediately in

effect, but it remains 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 Docket No.
FDA-2020-D-1106 for ``Policy for Temporary Compounding of Certain
Alcohol-Based Hand Sanitizer Products During the Public Health
Emergency.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Rosilend Lawson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``Policy
for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer
Products During the Public Health Emergency.'' Due to the COVID-19
pandemic and the resulting public health concerns, FDA has received a
number of queries concerning compounding of alcohol-based hand
sanitizers. We understand that some consumers and healthcare
professionals are currently experiencing difficulties accessing
alcohol-based hand sanitizers containing at least 60 percent alcohol or
70 percent isopropyl alcohol. We are also aware of reports that some
consumers are producing hand sanitizers for personal use; the Agency
lacks information on the methods being used to prepare such products
and whether they are safe for use on human skin. We further recognize
that pharmacists in State-licensed pharmacies or Federal facilities and
registered outsourcing facilities (referred to collectively in this
notice and the guidance as compounders), relative to untrained
consumers, are more familiar with appropriate standards and methods for
producing drug products.
    The Agency is issuing this guidance to communicate a policy for the
temporary compounding of certain alcohol-based hand sanitizer products
by compounders for consumer use and for use as healthcare personnel
hand rubs for the duration of the public health emergency declared by
the Secretary of Health and Human Services on January 31, 2020. In
light of the public health emergency posed by COVID-19, FDA has
determined that prior public participation for this guidance is not
feasible or appropriate and is issuing this guidance without prior
public comment (see section 701(h)(1)(C)(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i)) and 21 CFR 10.115(g)(2)).
Although this guidance is immediately in effect, FDA will consider all
comments received and revise the guidance document as appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Policy for Temporary Compounding of
Certain Alcohol-Based Hand Sanitizer Products During the Public Health
Emergency.'' It does not establish any rights for any

person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA 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). The collection of information for
``Current Good Manufacturing Practices for Finished Pharmaceuticals and
Medical Gases'' has been approved under OMB control number 0910-0139.
The collection of information for ``Postmarketing Adverse Drug
Experience Reporting'' has been approved under OMB control number 0910-
0230. The collection of information for ``MedWatch: Adverse Event and
Product Experience Reporting System (Paper-Based)'' has been approved
under OMB control number 0910-0291. The collection of information for
``Format and Content Requirements for Over-the-Counter Drug Product
Labeling'' has been approved under OMB control number 0910-0340. The
collection of information for ``FDA Adverse Event and Products
Experience Reports; Electronic Submissions'' has been approved under
OMB control number 0910-0645. The collection of information for
``Adverse Event Reporting for Outsourcing Facilities Under Section 503B
of the Federal Food, Drug, and Cosmetic Act'' has been approved under
OMB control number 0910-0800.

IV. Electronic Access

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

    Dated: March 17, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05959 Filed 3-20-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 18, 2008 (Volume 73, Number 139)]
[Notices]
[Page 41362-41363]
[DOCID:fr18jy08-96]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

Rapid Methods for Detecting Mycoplasma Contamination in the
Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and
Other Biological Products; Public Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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

    The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Rapid Methods for Detecting Mycoplasma
Contamination in the Manufacture of Vaccines, Including Pandemic
Influenza Vaccines, and Other Biological Products.'' The purpose of the
public workshop is to provide a forum on recent scientific and
technical achievements in the development of rapid methods for
mycoplasma testing during the manufacture of vaccines and other
biological products. Such discussion may help to assess how these
methods compare with currently used methods. Expedited manufacture may
be of particular importance to public health during an influenza
pandemic.
    Date and Time: The public workshop will be held on September 22,
2008, from 8:30 a.m. to 5 p.m., and September 23, 2008, from 8:30 a.m.
to 12 noon.
    Location: The public workshop will be held at the Hilton Washington
DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.
    Contact Person: Bernadette Kawaley, Center for Biologics Evaluation
and Research (HFM-43), Food and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852-1448,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>(Subject line: Mycoplasma Workshop).

    Registration: Mail, fax, or e-mail your registration information
(including name, title, firm name, address, telephone and fax numbers)
to the contact person by August 22, 2008. There is no registration fee
for the public workshop. Early registration is recommended because
seating is limited. There will be no onsite registration.
    If you need special accommodations due to a disability, please
contact Bernadette Kawaley (see Contact Person) at least 7 days in
advance.
    Submit written abstracts to the contact person by August 15, 2008
(see section II of this document for additional information).

SUPPLEMENTARY INFORMATION:

I. Background

    FDA will explore the use of alternative methods for detecting
mycoplasma contamination in the manufacture of vaccines, including
pandemic influenza vaccines, and other biological products. Alternative
methods that allow detection of mycoplasma in a shorter period, as
compared to the current methods, could expedite the manufacture of
vaccines and other biological products. The workshop is aimed at: (1)
Identifying promising rapid method(s) for further validation to
demonstrate equivalency or superiority to methods currently used for
mycoplasma testing during the manufacture of vaccines and other
biological products and (2) providing information that may lead to
collaborative studies with FDA on testing for mycoplasma. The program
agenda will be available at http://www.fda.gov/cber/scireg.htm, by
September 5, 2008.

II. Submission of the Abstracts

    For purposes of discussion at the workshop, FDA is requesting
submission of abstracts that describe current developments in rapid
methods for detection of mycoplasma contamination during manufacture of
vaccines and other biological products. FDA will select a limited
number of abstracts for formal presentation at the workshop by the
abstract authors. If time permits, FDA may allow additional
presentations from interested persons attending the meeting who did not
submit an abstract. FDA will notify authors of abstracts accepted for
presentation at the workshop by August 25, 2008.
    Abstracts should be a maximum of 350 words, printed (typewritten or
computer) and double-spaced. The title should be brief and capitalized.
The authors name(s), contact information, and agency, institution, or
facility involved should be listed. The author who intends to present
the abstract should submit a current curriculum vitae with the
abstract.

    Dated: July 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16459 Filed 7-17-08; 8:45 am]

BILLING CODE 4160-01-S