[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38110-38115]
[FR Doc No: 2023-12414]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97653; File No. SR-NYSEARCA-2023-37]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of Proposed Rule Change To List and Trade Shares of the COtwo Advisors
Physical European Carbon Allowance Trust Under NYSE Arca Rule 8.201-E
(Commodity-Based Trust Shares)

June 6, 2023.
    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 May 23, 2023, NYSE Arca, Inc. (``NYSE Arca'' or ``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 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 COtwo
Advisors Physical European Carbon Allowance Trust under NYSE Arca Rule
8.201-E (Commodity-Based Trust Shares). 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
    The Exchange proposes to list and trade shares (``Shares'') of the
COtwo Advisors Physical European Carbon Allowance Trust (the
``Trust''), under NYSE Arca Rule 8.201-E, which governs the listing and
trading of Commodity-Based Trust Shares.\4\ Under NYSE Arca Rule 8.201-
E, the Exchange may propose to list and/or trade Commodity-Based Trust
Shares pursuant to unlisted trading privileges.
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    \4\ Commodity-Based Trust Shares are securities issued by a
trust that represent investors' discrete identifiable and undivided
beneficial ownership interest in the commodities deposited into the
trust.
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    The Trust was formed as a Delaware statutory trust on January 12,
2023.\5\ The Trust has no fixed termination date. The Trust will not be
registered as an investment company under the Investment Company Act of
1940, as amended,\6\ and is not required to register under such act.
The Trust is not a commodity pool for purposes of the Commodity
Exchange Act, as amended.\7\
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    \5\ On May 12, 2023, the Trust filed with the Commission a
registration statement on Form S-1 (File No. 333-271910) (the
``Registration Statement'') under the Securities Act of 1933 (15
U.S.C. 77a) (the ``Securities Act''). The description of the
operation of the Trust herein is based, in part, on the Registration
Statement. The Registration Statement in not yet effective and the
Shares will not trade on the Exchange until such time that the
Registration Statement is effective.
    \6\ 15 U.S.C. 80a-1.
    \7\ 17 U.S.C. 1.
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    The sponsor of the Trust is COtwo Advisors LLC, a Delaware limited
liability company (``Sponsor''). State Street Bank and Trust Company
serves as the Trust's administrator (the ``Administrator'') to perform
various administrative, accounting and recordkeeping functions on
behalf of the Trust. Wilmington Trust serves as trustee of the Trust
(the ``Trustee''). State Street Bank and Trust Company serves as the
Trust's transfer agent (the ``Transfer Agent'') and as custodian of the
Trust's cash, if any (``Cash Custodian'').\8\
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    \8\ The Cash Custodian is responsible for holding the Trust's
cash as well as receiving and dispensing cash on behalf of the Trust
in connection with the payment of Trust expenses.
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    The Exchange represents that the Shares will satisfy the
requirements of NYSE Arca Rule 8.201-E and thereby will qualify for
listing on the Exchange.
Operation of the Trust \9\
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    \9\ The description of the operation of the Trust, the Shares,
and the carbon credit industry contained herein are based, in part,
on the Registration Statement. See note 5, supra.
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    The investment objective of the Trust will be for the Shares to
reflect the performance of the price of EU Carbon Emission Allowances
for stationary installations (``EUAs''), less the Trust's expenses. The
Trust intends to achieve its objective by investing all of its assets
in EUAs on a non-discretionary basis (i.e., without regard to whether
the value of EUAs is rising or falling over any particular period).
Shares of the Trust will represent units of fractional undivided
beneficial interest in and ownership of the Trust. The Trust's only
ordinary recurring expense will be the Sponsor's annual fee. The Trust
will not hold any assets other than EUAs or, possibly, cash. The Trust
may hold a very limited amount of cash to pay Trust expenses. The Trust
may also cause the Sponsor to receive EUAs from the Trust in such a
quantity as may be necessary to pay the Sponsor's annual fee.
    The Trust will not invest in futures, options, or swap contracts on
any futures exchange or in the over-the-counter market. The Trust will
not hold or trade in commodity futures contracts, ``commodity
interests,'' or any other instruments regulated by the Commodity
Exchange Act. As stated above, the Trust's Cash Custodian may hold cash
proceeds from EUA sales to pay Trust expenses. All EUAs will be held in
the Union Registry (defined below).
    The Trust is not a proxy for investing in physical carbon credits.
Rather, the Shares are intended to provide a cost-effective means of
obtaining investment exposure to the price of EUAs through the
securities markets that is similar to an investment in futures
contracts or other derivatives.
EUAs and the EUA Industry
Description of EU Emissions Trading Scheme
    According to the Registration Statement, the European Union
Emissions Trading System (``EU ETS'') is a ``cap and trade'' system
that caps the total volume of greenhouse gas (``GHG'') emissions from
installations and aircraft operators responsible for around 40% of
European Union (``EU'') GHG emissions.\10\ The EU ETS is the largest
cap and trade system in the world and covers more than 11,000 power
stations and industrial plants in 31 countries, and flights between
airports of participating countries. The EU ETS is administered by the
EU

Commission, which issues a predefined amount of EUAs through auctions
or free allocation. An EUA represents the right to emit one metric ton
of carbon dioxide equivalent into the atmosphere by operators of
stationary installations (``Covered Entities''). By the end of April
each year, all Covered Entities are required to surrender EUAs equal to
the total volume of actual emissions from their installation for the
last calendar year. EU ETS operators can buy or sell EUAs to achieve EU
ETS compliance.
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    \10\ There are two types of EU emissions allowance: (i) general
allowances for stationary installations, or EUA; and (ii) allowances
for the aviation sector (``EUAA''). The Trust will hold EUAs only.
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    In 2012, EU ETS operations were centralized into a single EU
registry operated by the EU Commission (the ``Union Registry''), which
covers all countries participating in the EU ETS. The Union Registry is
an online database that holds accounts for all entities covered by the
EU ETS as well as for participants (such as the Trust) not covered
under the EU ETS. An account must be opened in the Union Registry in
order to transact in EUAs and the Union Registry is at all times
responsible for holding the EUAs. All EUAs are held in the Union
Registry.
Major Holders and Allowance Use Cases
    According to the Registration Statement, while there is limited
publicly available data on individuals or individual organizations'
holdings in physical carbon allowances, carbon allowances are primarily
held for three different use cases:
    (a) Complying with the EU ETS: Companies that need to surrender
allowances under the EU ETS hold allowances to surrender them annually.
These positions are typically built over time and ultimately
surrendered at time of compliance. Therefore, the largest emitters in
the EU ETS hold a significant amount of allowances, which include
entities such as large utilities with a substantial share of fossil
fuel fired power plants, cement companies, steel producers, chemical
producers, oil and gas majors and airlines.
    (b) Providing financial services for hedging purposes or
speculation, such as clearing houses for the European Energy Exchange
or the Intercontinental Exchange, or banks holding allowances for their
clients.
    (c) Trading on and speculating around price moves, using physical
emission allowances. This can take many forms, including ``yield
trades'', which includes holding a physical allowance and selling an
EUA future at a premium to gain the yield in the forward curve; or
outright positions for short term or long term speculation.
    In addition to holding physical allowances, there is a liquid
secondary futures and options market that is primarily used for hedging
future emissions or speculating.
Trading Location
    According to the Registration Statement, the EU ETS is linked to
small emissions trading systems in Europe (Norway, Switzerland, Iceland
and Liechtenstein), but not to any other major cap and trade markets.
Therefore, allowances handed out in the EU ETS are not transferable to
any registry outside of the EU ETS and cannot be used for compliance in
any other cap and trade market.
    There are a number of other trading systems globally, and like the
EU ETS, no allowances of any of these systems can be used in any other
system:
    (a) Western Climate Initiative (WCI): The State of California and
the Canadian province Quebec created a linked cap and trade market,
that covers >80% of emissions.
    (b) Regional Greenhouse Gas Initiative (RGGI): a group of US east
coast states created a linked market that covers power generators only.
    (c) The China National ETS: Technically not a cap and trade scheme
(as the amount of allowances is not fixed but calculated according to
historic production of units).
    (d) South Korea ETS: A comprehensive market covering the majority
of Korean emissions.
Pricing of Allowances and Trading Volume
    According to the Registration Statement, there are two primary
avenues for trading EUAs: a primary market and a secondary market. The
primary market involves participation in a regularly scheduled auction.
The secondary market involves transactions between buyers and sellers
on regulated markets via trading in spot, options, and futures
contracts. There are also over-the-counter transactions, but they
comprise a negligible percentage of transactions.
    The EUA markets are generally liquid. EUA auctions are held on a
near-daily basis throughout the year, other than between mid-December
to mid-January, when auctions are paused. Prices achieved in these
auctions are published on various publicly-accessible websites,
including the European Commission's primary website.
    The secondary market trading takes place predominantly on the
European Energy Exchange AG (``EEX'') and ICE Endex. As of January
2023, the secondary market had average daily trading volume of [euro]2
billion, with the majority of the liquidity in the futures market.
Prices for secondary market transactions are published on various
publicly-accessible websites, including those of EEX and ICE Endex.
Both EEX and ICE Endex are affiliates of Exchange groups that are
members of the Intermarket Surveillance Group (``ISG'').
    Most liquidity in the secondary market is achieved by trading
futures contracts. These contracts have expiration going out as far as
2030. The most liquid contract is the single day futures contract on
EUAs (the ``Daily EUA Future''), which settles each day at the close of
trading. Generally, Daily EUA Futures trade from approximately 2:00
a.m. Eastern Time (``E.T.'') to approximately 12:00 p.m. E.T. The
settlement price is fixed each business day and is published by the
exchange at approximately 12:15 E.T. Final cash settlement occurs the
first business day following the expiry day.
    In 2021, the secondary spot market for EUAs (including the Daily
EUA Future) averaged around 2.4 million EUAs daily and the primary
auctions accounted for almost 2.5 million EUAs being auctioned several
times per week. The current value (spot price) for a EUA is greatly
influenced by a number of factors, including regulatory changes, world
events and general level of economic activity.
Creation and Redemption of Shares
    According to the Registration Statement, the Trust will create and
redeem Shares on a continuous basis in one or more Creation Units. A
Creation Unit equals a block of 50,000 Shares, which amount may be
revised from time-to-time. The Trust will issue Shares in Creation
Units to certain authorized participants (``Authorized Participants'')
on an ongoing basis. Each Authorized Participant must be a registered
broker-dealer or other securities market participant such as a bank or
other financial institution which is not required to register as a
broker-dealer to engage in securities transactions, a participant in
The Depository Trust Company (``DTC'') and have entered into an
agreement with the Sponsor and the Transfer Agent (the ``Participant
Agreement'').
    Creation Units may be created or redeemed only by Authorized
Participants. The creation and redemption of Creation Units is only
made in exchange for the delivery to the Trust or the distribution by
the Trust of the amount of EUAs represented by the Creation Units being
created or redeemed. The amount of EUAs required to be delivered to the
Trust in connection with any creation, or paid out upon redemption, is
based on the

combined net asset value of the number of Shares included in the
Creation Units being created or redeemed as determined on the day the
order to create or redeem Creation Units is properly received and
accepted. Orders must be placed by 11:00 a.m. New York time. The day on
which the Administrator receives a valid purchase or redemption order
is the order date. Creation Units may only be issued or redeemed on a
day that the Exchange is open for regular trading.
    An Authorized Participant who places a purchase order is
responsible for crediting the Trust's Union Registry account with the
required EUA deposit by 2:00 p.m. New York time on the second business
day following the order date. Upon receipt of the EUA deposit amount in
the Trust's Union Registry account, the Union Registry will notify the
Sponsor that the EUAs have been deposited. Upon receipt of confirmation
from the Union Registry that the EUA deposit amount has been received,
the Administrator will direct DTC to credit the number of Shares
created to the Authorized Participant's DTC account.
    According to the Registration Statement, the redemption
distribution due from the Trust will be delivered once the
Administrator notifies the Sponsor that the Authorized Participant has
delivered the Shares to be redeemed to the Trust's DTC account. The
redemption distribution will be delivered to the Authorized Participant
on the second business day following the order date. Once the
Administrator notifies the Sponsor that the Shares have been received
in the Trust's DTC account, the Sponsor instructs the Union Registry to
transfer the redemption EUA amount from the Trust's Union Registry
account to the Authorized Participant's Union Registry account.
    The Sponsor is the only entity that may initiate a withdrawal of
EUAs from the Trust's Union Registry account, and the only accounts
that may receive EUAs from the Trust's Union Registry account are
Authorized Participants' or the Sponsor's Union Registry accounts.
Net Asset Value (``NAV'')
    The Trust's NAV is calculated by taking the current market value of
its total assets, less any liabilities of the Trust, and dividing that
total by the total number of outstanding Shares.
    The Administrator will calculate the NAV of the Trust once each
Exchange trading day. The NAV for a normal trading day will be released
after the end of the Core Trading Session, which is typically 4 p.m.
New York time. The NAV for the Trust's Shares will be disseminated
daily to all market participants at the same time. The Administrator
will use the settlement price for the Daily EUA Futures established by
ICE Endex to calculate the NAV. The Administrator also converts the
value of Euro denominated assets into US Dollar equivalent using
published foreign currency exchange prices by an independent pricing
vendor. Third parties supplying quotations or market data may include,
without limitation, dealers in the relevant markets, end-users of the
relevant product, information vendors, brokers and other sources of
market information.
Indicative Fund Value (``IFV'')
    In order to provide updated information relating to the Trust for
use by investors and market professionals, an updated IFV will be made
available through on-line information services throughout the Exchange
Core Trading Session (normally 9:30 a.m. to 4:00 p.m. E.T.) on each
trading day. The IFV will be calculated by using the prior day's
closing NAV per Share of the Trust as a base and updating that value
throughout the trading day to reflect changes in the most recently
reported mid-point of the bid-ask spread of the Daily EUA Future. The
IFV disseminated during NYSE Arca Core Trading Session hours should not
be viewed as an actual real time update of the NAV, because the NAV
will be calculated only once at the end of each trading day based upon
the relevant end of day values of the Trust's investments. Although the
IFV will be disseminated throughout the Core Trading Session, the
customary trading hours for EUAs are 2 a.m. to 12 p.m. Eastern Time.
During the gap in time at the end of each trading day during which the
Shares are traded on the Exchange, but real-time trading prices for
EUAs are not available, the IFV will be calculated based on the end of
day price of EUAs immediately preceding the trading session.
    The IFV will be disseminated on a per Share basis every 15 seconds
during regular NYSE Arca Core Trading Session.
Availability of Information
    The NAV for the Trust's Shares will be disseminated daily to all
market participants at the same time. The intraday, closing prices, and
settlement prices for EUAs will be readily available from the
applicable futures exchange websites, automated quotation systems,
published or other public sources, or major market data vendors. The
IFV per Share for the Shares will be disseminated by one or more major
market data vendors on at least a 15 second delayed basis as required
by NYSE Arca Rule 8.201-E(e)(2)(v).
    Complete real-time data for EUAs and Daily EUA Futures is available
by subscription through on-line information services. Quotation and
last-sale information regarding the Shares will be disseminated through
the facilities of the Consolidated Tape Association. The IFV will be
available through on-line information services. The trading prices for
EUAs and Daily EUA Futures will be disseminated by on-line subscription
services or by one or more major market data vendors during the NYSE
Arca Core Trading Session of 9:30 a.m. to 4:00 p.m. E.T. Additionally,
the NAV may be influenced by non-concurrent trading hours between the
Exchange and the EUA markets. While the Trust's Shares trade on the
Exchange from 9:30 a.m. to 4:00 p.m. E.T., the trading hours for EUA
markets do not coincide during all of this time. EEX provides on its
website, on a daily basis, transaction volumes and transaction prices
for the EUA spot market. ICE Endex provides on its website, on a daily
basis, transaction volumes, transaction prices, daily settlement prices
and historical settlement prices for Daily EUA Futures that were traded
outside of block trades by EUA futures brokers. In addition,
transaction volumes, transaction prices, daily settlement prices and
historical settlement prices for Daily EUA Futures traded in block
trades by futures brokers are available on a daily basis through a
subscription service to ICE Endex. However, ICE Endex provides the
daily settlement price change of the Daily EUA Future on its website.
    In addition, the Trust's website (www.cotwoadvisors.com) will
contain the following information, on a per Share basis, for the Trust:
(a) the prior business day's end of day closing NAV; (b) the Official
Closing Price \11\ or the midpoint of the national best bid and the
national best offer (``NBBO'') as of the time the NAV is calculated
(``Bid-Ask Price''); (c) calculation of the premium or discount of the
Official Closing Price against the NAV expressed as a percentage of
such NAV; (d) the prospectus; and (e) other applicable quantitative
information. The Trust will also provide website disclosure of its

EUA holdings before 9:30 a.m. E.T. on each trading day.
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    \11\ The term ``Official Closing Price'' is defined in NYSE Arca
Rule 1.1(ll) as the reference price to determine the closing price
in a security for purposes of Rule 7-E Equities Trading, and the
procedures for determining the Official Closing Price are set forth
in that rule.
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    The Trust's website will be publicly available prior to the public
offering of Shares and accessible at no charge. The website disclosure
of the Trust's daily holdings will occur at the same time as the
disclosure by the Trust of the daily holdings to Authorized
Participants so that all market participants are provided daily
holdings information at the same time. Therefore, the same holdings
information will be provided on the public website as well as in
electronic files provided to Authorized Participants. Accordingly, each
investor will have access to the current daily holdings of the Trust
through the Trust's website. In addition, 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.
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. Trading in the Shares
on the Exchange will occur in accordance with NYSE Arca Rule 7.34-E
(Early, Core, and Late Trading Sessions). The Exchange has appropriate
rules to facilitate transactions in the Shares during all trading
sessions. As provided in NYSE Arca 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.
    The Shares will conform to the initial and continued listing
criteria under NYSE Arca Rule 8.201-E. The trading of the Shares will
be subject to NYSE Arca Rule 8.201-E(g), which sets forth certain
restrictions on Equity Trading Permit (``ETP'') Holders acting as
registered Market Makers in Commodity-Based Trust Shares to facilitate
surveillance. The Exchange represents that, for initial and continued
listing, the Trust will be in compliance with Rule 10A-3 \12\ under the
Act, as provided by NYSE Arca Rule 5.3-E. A minimum of 100,000 Shares
will be outstanding at the commencement of trading on the Exchange.
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    \12\ With respect to the application of Rule 10A-3 (17 CFR
240.10A-3) under the Act, the Trust relies on the exemption
contained in Rule 10A-3(c)(7).
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    As a general matter, the Exchange has regulatory jurisdiction over
its ETP Holders and their associated persons, which include any person
or entity controlling an ETP Holder. To the extent the Exchange may be
found to lack jurisdiction over a subsidiary or affiliate of an ETP
Holder that does business only in commodities or futures contracts, the
Exchange could obtain information regarding the activities of such
subsidiary or affiliate through surveillance sharing agreements with
regulatory organizations of which such subsidiary or affiliate is a
member.
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. Trading on the Exchange in the Shares may be
halted because of market conditions or for reasons that, in the view of
the Exchange, make trading in the Shares inadvisable. These may
include: (1) the extent to which conditions in the underlying carbon
credit market have caused disruptions and/or lack of trading, or (2)
whether other unusual conditions or circumstances detrimental to the
maintenance of a fair and orderly market are present. In addition,
trading in Shares will be subject to trading halts caused by
extraordinary market volatility pursuant to the Exchange's ``circuit
breaker'' rule.\13\
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    \13\ See NYSE Arca Rule 7.12-E.
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    The Exchange may halt trading during the day in which an
interruption occurs to the dissemination of the IFV, as described
above. If the interruption to the dissemination of the IFV persists
past the trading day in which it occurs, the Exchange will halt trading
no later than the beginning of the trading day following the
interruption. In addition, if the Exchange becomes aware that the NAV
with respect to the Shares is not disseminated to all market
participants at the same time, it will halt trading in the Shares until
such time as the NAV is available to all market participants.
Surveillance
    The Exchange represents that trading in the Shares will be subject
to the existing trading surveillances administered by the Exchange, as
well as cross-market surveillances administered by the Financial
Industry Regulatory Authority Inc. (``FINRA''), on behalf of the
Exchange, which are designed to detect violations of Exchange rules and
applicable federal securities laws.\14\ The Exchange represents that
these procedures are adequate to properly monitor Exchange trading of
the Shares in all trading sessions and to deter and detect violations
of Exchange rules and federal securities laws applicable to trading on
the Exchange.
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    \14\ FINRA conducts cross-market surveillances on behalf of the
Exchange pursuant to a regulatory services agreement. The Exchange
is responsible for FINRA's performance under this regulatory
services agreement.
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    The surveillances referred to above generally focus on detecting
securities trading outside their normal patterns, which could be
indicative of manipulative or other violative activity. When such
situations are detected, surveillance analysis follows and
investigations are opened, where appropriate, to review the behavior of
all relevant parties for all relevant trading violations.
    The Exchange or FINRA, on behalf of the Exchange, or both, will
communicate as needed regarding trading in the Shares with other
markets and other entities that are members of the ISG, and the
Exchange or FINRA, on behalf of the Exchange, or both, may obtain
trading information regarding trading in the Shares from such markets
and other entities. In addition, the Exchange may obtain information
regarding trading in the Shares from markets and other entities that
are members of ISG or with which the Exchange has in place a
comprehensive surveillance sharing agreement.\15\
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    \15\ For a list of the current members of ISG, see
www.isgportal.org.
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    Also, pursuant to NYSE Arca Rule 8.201-E(g), the Exchange is able
to obtain information regarding trading in the Shares in connection
with ETP Holders' proprietary or customer trades which they effect
through ETP Holders on any relevant market.
    In addition, the Exchange also has a general policy prohibiting the
distribution of material, non-public information by its employees.
    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 listing rules specified in this rule filing
shall constitute continued listing requirements for listing the Shares
on the Exchange.
    The Trust has represented to the Exchange that it will advise the
Exchange of any failure by the Trust to comply with the continued
listing requirements, and, pursuant to its

obligations under section 19(g)(1) of the Act, the Exchange will
monitor for compliance with the continued listing requirements. If the
Trust is not in compliance with the applicable listing requirements,
the Exchange will commence delisting procedures under NYSE Arca Rule
5.5-E(m).
Information Bulletin
    Prior to the commencement of trading, the Exchange will inform its
ETP Holders in an Information Bulletin of the special characteristics
and risks associated with trading the Shares. Specifically, the
Information Bulletin will discuss the following: (1) the procedures for
purchases and redemptions of Shares in Creation Units (including noting
that Shares are not individually redeemable); (2) NYSE Arca Rule 9.2-
E(a), which imposes a duty of due diligence on its ETP Holders to learn
the essential facts relating to every customer prior to trading the
Shares; (3) how information regarding the IFV is disseminated; (4) the
requirement that ETP Holders deliver a prospectus to investors
purchasing newly issued Shares prior to or concurrently with the
confirmation of a transaction; (5) the possibility that trading spreads
and the premium or discount on the Shares may widen as a result of
reduced liquidity of EUAs during the Core and Late Trading Sessions;
and (6) trading information. For example, the Information Bulletin will
advise ETP Holders, prior to the commencement of trading, of the
prospectus delivery requirements applicable to the Trust. The Exchange
notes that investors purchasing Shares directly from the Trust will
receive a prospectus. ETP Holders purchasing Shares from the Trust for
resale to investors will deliver a prospectus to such investors.
    In addition, the Information Bulletin will reference that the Trust
is subject to various fees and expenses as will be described in the
Registration Statement. The Information Bulletin will also reference
the fact that while last sale information regarding EUAs would be
subject to regulation by EEX and ICE Endex, the Commission and the CFTC
do not have jurisdiction over the trading of EUAs as a commodity. The
Information Bulletin will also discuss any relief, if granted, by the
Commission or the staff from any rules under the Act.
    The Information Bulletin will also disclose the trading hours of
the Shares and that the NAV for the Shares will be calculated after
4:00 p.m. E.T. each trading day. The Information Bulletin will disclose
that information about the Shares will be publicly available on the
Trust's website.
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under section 6(b)(5) \16\ that an exchange have rules that
are 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, in general, to protect investors and the public interest.
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    \16\ 15 U.S.C. 78f(b)(5).
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    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 NYSE Arca Rule 8.201-E. The
Exchange has in place surveillance procedures that are adequate to
properly monitor trading in the Shares in all trading sessions and to
deter and detect violations of Exchange rules and applicable federal
securities laws. The Exchange 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.
    The proposed rule change is designed to promote just and equitable
principles of trade and to protect investors and the public interest in
that there is a considerable amount of information on EUAs available on
public websites and through professional and subscription services. In
addition, the Trust's website will provide pricing information for EUAs
and the Shares. Market prices for the Shares will be available from a
variety of sources including brokerage firms, information websites and
other information service providers. The NAV of the Trust will be
published on each day that the NYSE Arca is open for regular trading
and will be posted on the Trust's website. The IFV relating to the
Shares will be widely disseminated by one or more major market data
vendors at least once every 15 seconds as required by NYSE Arca Rule
8.201-E(e)(2)(v). The Trust's website will also provide its prospectus
and other relevant quantitative information regarding the Shares. In
addition, 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.
    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
an additional type of exchange-traded product 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.

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 will enhance competition by accommodating Exchange
trading of an additional exchange-traded product relating to physical
carbon credits.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate 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 or disapprove the 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 email to [email protected]. Please include
File Number SR-NYSEARCA-2023-37 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-2023-37. 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. Do not include
personal identifiable information in submissions; you should submit
only information that you wish to make available publicly. We may
redact in part or withhold entirely from publication submitted material
that is obscene or subject to copyright protection. All submissions
should refer to File Number SR-NYSEARCA-2023-37, and should be
submitted on or before July 3, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-12414 Filed 6-9-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 160 (Tuesday, August 19, 2014)]
[Proposed Rules]
[Pages 49025-49027]
[FR Doc No: 2014-19632]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 /
Proposed Rules

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2014-N-1168]

Generic Drug User Fee Amendments of 2012; Public Hearing on
Policy Development; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing to solicit public comment on certain topics related to
implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA),
and the GDUFA Commitment Letter that accompanies the legislation. The
public hearing also will provide an opportunity for public input on
future policy priorities. FDA is seeking participation in the public
hearing and written comments from all interested parties, including,
but not limited to, regulated industry, consumers, patients,
caregivers, health care professionals, and patient groups.

DATES: The public hearing will be held on September 17, 2014, from 9
a.m. to 5 p.m. The public hearing may be extended or may end early
depending on the level of public participation. Submit electronic or
written requests to make oral presentations at the hearing by September
3, 2014. Electronic or written comments will be accepted after the
hearing until October 13, 2014.

ADDRESSES: The public hearing will be held at the College Park Marriott
Hotel and Conference Center, 3501 University Blvd., East, Hyattsville,
MD 20783.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. Identify all comments with the docket number found in brackets
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Shaniece Bowens, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1611,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>or Connie Wisner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1674,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Public Law 98-417) (the Hatch-Waxman Amendments) amended the Federal
Food, Drug, and Cosmetic Act (the FD&C Act). The Hatch-Waxman
Amendments created section 505(j) of the FD&C Act (21 U.S.C. 355(j)).
Section 505(j) of the FD&C Act established the abbreviated new drug
application (ANDA) approval pathway, which allows lower-priced generic
versions of previously approved innovator drugs to be approved and
marketed.
    On July 9, 2012, GDUFA was signed into law by the President to help
speed the delivery of safe and effective generic drugs to the public
and to reduce costs to industry. Under GDUFA, FDA agreed to certain
obligations as laid out in the GDUFA Commitment Letter that accompanies
the legislation.\1\ To support these obligations, FDA is developing
numerous guidance documents. Thus far, FDA has developed the following
draft guidances for industry: \2\
---------------------------------------------------------------------------

    \1\ See Generic Drug User Fee Act Program Performance Goals and
Procedures (GDUFA Commitment Letter) for fiscal years 2013 through
2017, available at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf).
    \2\ The draft guidance documents referenced in this document are
available on the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

 ANDA Submissions--Content and Format of ANDAs
 ANDA Submissions--Refuse to Receive for Lack of Proper
Justification of Impurity Limits
 ANDA Submissions--Amendments and Easily Correctable
Deficiencies Under GDUFA
 ANDA Submissions--Prior Approval Supplements Under GDUFA
 Controlled Correspondence Related to Generic Drug Development

II. Purpose and Scope of the Public Hearing

A. GDUFA Implementation: Draft Guidance Documents

    The purpose of this public hearing is to (1) solicit public comment
on the five draft guidance documents described in section I that FDA
has issued to facilitate implementation of GDUFA and (2) recommend
future policy priorities, including recommendations for additional
guidance topics to facilitate GDUFA implementation. We are soliciting
comments from interested members of the public, including industry,
consumers, patient groups, caregivers, and health care professionals,
on the following topics related to GDUFA implementation guidances:
    1. Are there comments on the five draft guidances described in
section I?
    2. Are there GDUFA implementation issues related to the five draft
guidances described in section I that have not been addressed?
    3. What other GDUFA implementation topics need the development of
guidance?
    4. Are there any topics or issues related to generic drug
development other than those related to GDUFA implementation that need
the development of guidance?

B. GDUFA Implementation Related to Generic Drug Exclusivity

    Another purpose of this hearing is also to solicit feedback on
issues that may arise in FDA's consideration of 180-day exclusivity
provided for in section 505(j)(5)(B)(iv) of the FD&C Act.
    Timing of ANDA approval is directly affected by an applicant's
eligibility for 180-day exclusivity, and thus FDA's consideration of
any issues related to 180-day exclusivity is a component of approval
actions. FDA decisions regarding 180-day exclusivity are fact-specific,
and the facts that have the potential to determine eligibility for
exclusivity may shift up to the time when an ANDA that is eligible for
180-day exclusivity, or another ANDA

referencing the same listed drug, is ready for approval.
    With the enactment of GDUFA, FDA will take actions on pending
applications consistent with the timeframes agreed upon in the GDUFA
Commitment Letter. In this hearing, we are seeking input on possible
processes FDA might introduce under GDUFA for making determinations on
180-day exclusivity, as described in the following questions. When
submitting input on the questions provided in this document, we
encourage commenters to consider FDA's statutory and regulatory
authorities, including any restrictions on FDA's authority to disclose
certain information related to unapproved ANDAs. We are seeking comment
on the following topics:
    1. Should FDA's consideration of eligibility for 180-day
exclusivity for a specific drug product be a public process, including
consideration of whether a first applicant has forfeited its
eligibility for exclusivity under section 505(j)(5)(D) of the FD&C Act?
If a public process is advisable, would it be so in all instances, or
is there a subset of circumstances in which the process should be
public? Also, what administrative mechanisms would best facilitate such
a process?
    2. Legal challenges to FDA's decisions on 180-day exclusivity often
must be resolved on an expedited basis which can be inconvenient for
the parties and the court. What legal or regulatory mechanisms, if any,
are available to better facilitate FDA's determination of and orderly
resolution of sponsors' challenges to 180-day exclusivity
determinations?
    3. Are there other topics related to 180-day exclusivity on which
you would like to comment?
    4. Are there topics related to 180-day exclusivity that would
benefit from FDA guidance?

C. GDUFA Implementation and Potential First Generics

    The GDUFA Commitment Letter also provides that certain ANDAs may be
identified at the date of submission for expedited review, including
ANDAs for ``first generic products for which there are no blocking
patents or exclusivities on the reference listed drug.'' \3\ Subsequent
to GDUFA's enactment, FDA has received numerous individual stakeholder
comments on what should qualify as a first generic ANDA for the
purposes of expedited review. These comments reflect a range of
options, for example, from a broad definition that would prioritize
review of all ANDAs for each strength of a Reference Listed Drug
submitted for which there is not already an approved ANDA at the time
of submission, to a more narrow definition under which only ANDAs that
contain a paragraph IV certification and qualify as a ``first
applicant'' under section 505(j)(5)(B)(iv)(II)(bb) of the FD&C Act
would be designated as a first generic eligible for expedited review.
In addition, several stakeholders have indicated that depending on the
criteria FDA applies, first generic status could or should change over
time based on other external factors, for example, withdrawal or
rescission of approval of another applicant's ANDA, or shifts in the
patent or exclusivity landscape (for example, an unsuccessful patent
challenge).
---------------------------------------------------------------------------

    \3\ GDUFA Commitment Letter, at 15.
---------------------------------------------------------------------------

    In order to meet the goals in the GDUFA Commitment letter with
respect to expedited ANDA review, we will be prioritizing ANDA review
consistent with the recently issued Manual of Policies and Procedures
(MAPP) 5240.3 Rev. 1: Prioritization of the Review of Original ANDAs,
Amendments, and Supplements, and MAPP 5200.4: Criteria and Procedures
for Managing the Review of Original ANDAs, Amendments and
Supplements.\4\ In order to meet the goals of the GDUFA Commitment
Letter related to first generics in particular, in a manner that best
effectuates the intent of the negotiators, we are seeking comment on
the following questions:
---------------------------------------------------------------------------

    \4\ http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/.
_____________________________________-

    1. What specific criteria should FDA apply to identify an ANDA as a
first generic eligible for expedited ANDA review?
    2. Are there other topics related to first generics eligible for
expedited review on which you would like to comment?

III. Attendance, Registration, and Presentations

    Attendance is free and on a first-come, first-served basis. We
recommend that you register early because seating is limited.
    If you wish to attend the hearing and/or make an oral presentation
at the hearing, please register and/or send a request for oral
presentation by email to<EMAIL_ADDRESS>by September 3,
2014. The email should contain complete contact information for each
attendee, including name, title, affiliation, address, email address,
and telephone number. Those without email access may register by
contacting Shaniece Bowens or Connie Wisner by September 3, 2014 (see
FOR FURTHER INFORMATION CONTACT).
    Individuals and organizations with common interests should
consolidate or coordinate their presentations and request time for a
joint presentation. FDA will do its best to accommodate requests to
speak and will determine the amount of time allotted for each oral
presentation, and the approximate time that each oral presentation is
scheduled to begin. These individuals should identify the section and
the number of each question they wish to address (see section II) in
their presentation to help FDA organize the presentations.
    FDA will notify registered presenters of their scheduled
presentation times, and make available an agenda at http://www.fda.gov/Drugs/NewsEvents/ucm265628.htm approximately 2 weeks before the public
hearing. Once FDA notifies registered presenters of their scheduled
times, presenters should submit an electronic copy of their
presentation to<EMAIL_ADDRESS>by September 9, 2014.
Persons registered to make an oral presentation should check in before
the hearing and are encouraged to arrive early to ensure the designated
order of presentation times.
    If you need special accommodations because of a disability, please
contact Shaniece Bowens or Connie Wisner (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the hearing.

IV. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Office of Generic Drugs
and other relevant Agency components. Under Sec.  15.30(f), the hearing
is informal and the rules of evidence do not apply. No participant may
interrupt the presentation of another participant. Only the presiding
officer and panel members may question any person during or at the
conclusion of each presentation (Sec.  15.30(e)). Public hearings under
part 15 are subject to FDA's policy and procedures for electronic media
coverage of FDA's public administrative proceedings (21 CFR part 10,
subpart C) (Sec.  10.203(a)). Under Sec.  10.205, representatives of
the electronic media may be permitted, subject to certain limitations,
to videotape, film, or otherwise record FDA's public administrative
proceedings, including presentations by participants. The hearing will
be transcribed as stipulated in Sec.  15.30(b).

(See section VI for more details.) To the extent that the conditions
for the hearing as described in this document conflict with any
provisions set out in part 15, this notice acts as a waiver of those
provisions as specified in Sec.  15.30(h).

V. Request for Comments

    Regardless of attendance at the public hearing, interested persons
may submit either electronic comments to http://www.regulations.gov or
written comments to the Division of Dockets Management (see ADDRESSES).
It is only necessary to send one set of comments. Identify comments
with the docket number found in brackets in the heading of this
document. To ensure consideration, submit comments by (see DATES).
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.

VI. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see ADDRESSES). A transcript will
also be available in either hard copy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: August 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19632 Filed 8-15-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Notices]
[Pages 17619-17621]
[FR Doc No: 2014-06886]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71774; File No. SR-CBOE-2014-020]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change Relating to Certain CBOE Real-Time Data Feeds and
a New Book Depth Data Feed

March 24, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on March 11, 2014, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I and II below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \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

    Chicago Board Options Exchange, Incorporated (the ``Exchange'' or
``CBOE'') proposes to (i) update the description of the data included
in certain CBOE real-time data feeds and (ii) offer a book depth data
feed for CBOE listed options. The text of the proposed rule change is
available on the Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to (i) update the
description of the data included in the following CBOE real-time data
feeds: BBO Data Feed, Complex Order Book (``COB'') Data Feed and
Flexible Exchange option (``FLEX'') Data Feed, and (ii) offer a book
depth data feed for CBOE listed options.
BBO, COB and FLEX Data Feeds
    The BBO Data Feed is a real-time, low latency data feed that
includes CBOE ``BBO data'' and last sale data.\3\ The BBO and last sale
data contained in the BBO Data Feed is identical to the data that CBOE
sends to the Options Price Reporting Authority (``OPRA'') for
redistribution to the public.\4\ The BBO Data Feed is made available by
CBOE's affiliate Market Data Express, LLC (``MDX'').
---------------------------------------------------------------------------

    \3\ The BBO Data Feed includes the ``best bid and offer,'' or
``BBO'', consisting of all outstanding quotes and standing orders at
the best available price level on each side of the market, with
aggregate size (``BBO data,'' sometimes referred to as ``top-of-book
data''). Data with respect to executed trades is referred to as
``last sale'' data. See Securities Exchange Act Release No. 69438
(April 23, 2013), 78 FR 25334 (April 30, 2013).
    \4\ The Exchange notes that MDX makes available to Customers the
BBO data and last sale data that is included in the BBO Data Feed no
earlier than the time at which the Exchange sends that data to OPRA.
A ``Customer'' is any entity that receives the BBO Data Feed, either
directly from MDX's system or through a connection to MDX provided
by an approved redistributor (i.e., a market data vendor or an
extranet service provider) and then distributes it externally or
uses it internally.
---------------------------------------------------------------------------

    The BBO Data Feed also includes certain data that is not included
in the data sent to OPRA, namely, (i) totals of customer versus non-
customer contracts at the BBO, (ii) All-or-None contingency orders
priced better than or equal to the BBO, (iii) BBO data and last sale
data for complex strategies (e.g., spreads, straddles, buy-writes,
etc.), (iv) BBO data and last sale data for FLEX options traded on the
CBOE FLEX Hybrid Trading System, including BBO data and last sale data
for FLEX complex strategies (collectively, ``FLEX BBO data''), and (v)
expected opening price (``EOP'') and expected opening size (``EOS'')
information that is disseminated prior to the opening of the market and
during trading rotations (collectively, ``EOP/EOS data'').
    The COB Data Feed is a real-time data feed that includes data
regarding the Exchange's Complex Order Book and related complex order
information. The COB Data Feed includes BBO quotes and identifying
information for all CBOE-traded complex order strategies, as well as
all executed CBOE complex order trades (and identifies whether the
trade was a customer trade, or whether a complex order in the COB is a
customer order).\5\ The FLEX Data Feed is a real-time data feed that
includes FLEX BBO data, as described above.\6\ The COB and FLEX Data
Feeds are both made available by MDX and are subsets of the BBO Data
Feed.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 70118 (August 5,
2013), 78 FR 48757 (August 9, 2013).
    \6\ See Securities Exchange Act Release No. 69438 (April 23,
2013), 78 FR 25334 (April 30, 2013).
---------------------------------------------------------------------------

    The Exchange, through MDX, plans to make additional data available
in the BBO, COB and FLEX Data Feeds and therefore proposes to update
the description of the data included in the feeds. Specifically, the
Exchange proposes to add end-of-day (``EOD'') summary messages and
recap messages to the feeds. EOD summary messages are messages that
will be disseminated after the close of a trading session that will
include summary information about trading in CBOE listed options. Such
information includes product name, opening price, high and low price
during the trading session and last sale price. Recap messages are
messages that will be disseminated during a trading session any time
there is a change in the open, high, low or last sale price of a CBOE
listed option. In addition to open, high, low and last sale prices,
such messages will also include product name and total volume traded in
the product during the trading session.
    At this time, the Exchange does not intend to amend the fees for
the BBO and COB Data Feeds. The FLEX Data Feed is currently made
available at no charge.

Book Depth Data Feed
    The Exchange proposes to make available, through MDX, a real-time,
low latency data feed that includes all outstanding quotes and standing
orders up to the first five price levels on each side of the market,
with aggregate size (``Book Depth Data Feed'').\7\ The Book Depth Data
Feed will also include all of the other data contained in the BBO Data
Feed (as described above), including last sale data and BBO and book
depth data for complex strategies.\8\ The data in the Book Depth Data
Feed would be refreshed periodically during the trading session.
---------------------------------------------------------------------------

    \7\ The Exchange notes that MDX will make available the BBO and
last sale data that is included in the Book Depth Data Feed no
earlier than the time at which the Exchange sends that data to OPRA.
    \8\ With the introduction of the Book Depth Data Feed, the COB
Data Feed would also be enhanced to include book depth data for
complex strategies.
---------------------------------------------------------------------------

    The Exchange will file a separate proposed rule change to establish
the fees to be charged by MDX for the Book Depth Data Feed.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\9\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \10\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, 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. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \11\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers because the enhanced BBO, COB and FLEX Data Feeds
and the Book Depth Data Feed would be made available by MDX to any
market participant that wishes to subscribe to any of the feeds.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
    \11\ Id.
---------------------------------------------------------------------------

    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. The Exchange believes that this proposal is in keeping with those
principles by promoting increased transparency through the
dissemination of useful data and also by clarifying its availability to
market participants. The Exchange believes that updating the
description of the BBO, COB and FLEX Data Feeds will benefit users by
making clearer what data is included in each feed. The Exchange
believes offering the Book Depth Data Feed will increase transparency,
help attract order flow and provide investors with additional
information that may help to inform their trading decisions.

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

    CBOE 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 proposal to update the
description of the BBO, COB and FLEX Data Feeds is intended not to
address any competitive issue but rather to reflect the data that is
included in the feeds. The Exchange notes other exchanges offer depth
of market products similar to the Book Depth Data Feed. For example,
BATS offers Multicast PITCH, which is their depth of market and last
sale feed similar to the Book Depth Data Feed. The International
Securities Exchange offers a data feed that shows the top five price
levels entitled Depth of Market. NASDAQ OMX PHLX offers a Depth of
Market data feed that includes full depth of quotes and orders and last
sale data for options listed on PHLX. NASDAQ Options Market offers a
product entitled ``NASDAQ ITCH-to-Trade Options'' (ITTO) that is
similar to the Book Depth Data Feed. NYSE offers market data products
entitled ``NYSE ArcaBook for Amex Options'' and ``NYSE ArcaBook for
Arca Options'' that include top-of-book, last sale and depth of quote
data. In addition, the OPRA data feed is a significant competitive
alternative to both the BBO Data Feed and the Book Depth Data Feed.
    The Exchange believes the enhanced BBO, COB and FLEX Data Feeds and
the Book Depth Data Feed will help to attract new users and new order
flow to the Exchange, thereby improving the Exchange's ability to
compete in the market for options order flow and executions.

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

    The Exchange neither solicited nor received comments on 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:
    A. Significantly affect the protection of investors or the public
interest;
    B. impose any significant burden on competition; and
    C. 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 \12\ and
Rule 19b-4(f)(6) \13\ thereunder.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay so that the proposal may become operative immediately
upon filing. The Exchange has stated that it does not intend to amend
the fees for the BBO and COB Data Feeds, that the FLEX Data Feed is
currently made available at no charge, and that the proposed Book Depth
Data Feed mostly includes data already made available by the Exchange
through the BBO Data Feed. The Commission believes that waiving the 30-
day operative delay is consistent with the protection of investors and
the public interest, because such waiver will enable market
participants to receive more market data via the Exchange's new and
existing data feeds at no charge. For this reason, the Commission
hereby waives the 30-day operative delay requirement and designates the
proposed rule change to be operative upon filing.\14\
---------------------------------------------------------------------------

    \14\ For purposes only of waiving the operative delay for this
proposal, the Commission has 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. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2014-020 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-CBOE-2014-020. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal offices of the Exchange.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-CBOE-2014-020,
and should be submitted on or before April 18, 2014.
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-06886 Filed 3-27-14; 8:45 am]
BILLING CODE 8011-01-P


test solutions.
•
Solvent (if other than water):  Justification of the choice of solvent,
and characterization of solvent (nature, concentration used).
Test conditions:
•
Operational records:  These consist of observations pertaining to
the functioning of the test system and the supporting environment
and infrastructure.  Typical records include: ambient temperature,
test temperature, photoperiod, status of critical components of the
exposure system (e.g. pumps, cycle counters, pressures), flow
rates, water levels, stock bottle changes, and feeding records.
General water quality parameters include: pH, DO, conductivity,
total iodine, alkalinity, and hardness.
•
Deviations from the test method:  This information should include
any information or narrative descriptions of deviations from the test
method.
Results:
•
Biological observations and data:  These include daily observations
of mortality, food consumption, abnormal swimming behavior,
lethargy, loss of equilibrium, malformations, lesions, etc.
Observations and data collected at predetermined intervals include:
developmental stage, hind limb length, snout vent length, and wet
weight.
Page 19

•
Statistical analytical techniques and justification of techniques used:
Results of the statistical analysis preferably in tabular form,
methods for determining whether outliers exist, and justification for
not using outliers.
•
Histological data:  These include narrative descriptions, as well as
graded severity and incidence scores of specific observations, as
detailed in the histopathology guidance document.
•
Ad hoc observations:  These observations should include narrative
descriptions of the study that do not fit into the previously described
categories.
(2)
Data reporting. Appendix 2 contains daily data collection spreadsheets
that can be used as guidance for raw data entry and for calculations of
summary statistics.  Additionally, reporting tables are provided that are
convenient for communicating summaries of endpoint data.  Reporting
tables for histological assessments can be found in Appendix 2.  Similar
electronic templates for the AMA can be accessed on EPA’s OPPTS
Harmonized Test Guidelines website and in the public docket (Ref. 14).
(3)
Guidance on Performance Criteria for Optimal Data Quality.
Generally, gross deviations from the test method will likely result in sub-
optimal data for interpretation or reporting.  Therefore, the following criteria
in Table 4 have been developed as guidance for determining the quality of
the test performed, and the general performance of the control organisms.
Table 4. Performance Criteria for the AMA.
Criterion
Acceptable limits
Test concentrations
Maintained at ≤ 20% CV (variability of measured test
concentration) over the 21 day test
Mortality in controls
≤10% - mortality in any one replicate in the controls should
not exceed 2 tadpoles
Minimum median developmental stage of
controls at end of test
57
Spread of development stage in control
group
The 10
<s>th</s>
and the 90
<s>th</s>
percentile of the development stage
distribution should not differ by more than 4 stages
Dissolved Oxygen
≥ 40% air saturation*
pH
pH should be maintained between 6.5-8.5.  The inter-
replicate/inter-treatment differentials should not exceed 0.5.
Water temperature
22º
±
1ºC - the inter-replicate/inter-treatment differentials
should not exceed 0.5 ºC
Test concentrations (non-control) without
overt toxicity
≥ 2
Replicate performance
≤ 2 replicates across the test can be compromised
If a carrier solvent is used, both a solvent control and clean
water control must be used and results reported
Special conditions for use of a solvent
Statistically significant differences between solvent control
and water control groups are treated specially.  See below
for more information
Page 20

Criterion
Acceptable limits
Representative chemical analyses before and after renewal
must be reported
Ammonia levels must be measured immediately prior to
renewal
All water quality parameters listed in Table 1 of Appendix 1
must be measured immediately prior to renewal
Special conditions for static renewal system
Renewal period must not exceed 72 hours
Appropriate feeding schedule (50% of the daily food ration
of Sera Micron ®)
*Aeration of water can be maintained through bubblers.  It is recommended to set bubblers at
levels that do not create undue stress on the tadpoles.
(4)
Test Validity. Achieving the following goals will likely deem a test to be
considered acceptable/valid:
(i)
Valid experiment in a test determined to be negative for
thyroid activity:
…
For any given treatment (including controls), mortality should
not exceed 10%.  For any given replicate, mortality should not
exceed three tadpoles, otherwise the replicate may be
considered compromised.
…
At least two treatment levels, with all four uncompromised
replicates, should be available for analysis.
…
At least two treatment levels without overt toxicity should be
available for analysis.
(ii)
Valid experiment in a test determined to be positive for thyroid
activity:
…
Mortality of no more than two tadpoles/replicate in the
control group should occur.
(5)
Decision logic for the conduct of the AMA. Decision logic was
developed for the AMA to provide logical assistance in the conduct and
interpretation of the results of the bioassay (see flow chart in Figure 3).
The decision logic, in essence, weighs the endpoints in that advanced
development, asynchronous development, and thyroid histopathology are
weighed heavily, while delayed development, snout-vent length and wet
body weight, parameters that can potentially be affected by general
toxicity, are weighted less heavily.
Page 21

Figure 3. Decision Logic for the Conduct of the AMA.
Conduct AMA
High Quality
Experiment
Likely
Thyroid Inactive:
Stop
Remarkable Histological Effects
NO
NO
Advanced Development
YES*
NO
Asynchronous Development
YES
Likely Thyroid Active
NO
YES*
Likely Thyroid Active
YES
Likely Thyroid Active
Repeat Study
*Histology may be required by some regulatory authorities despite significant differences in
advanced and asynchronous development.  The entity performing this test is encouraged to
consult the necessary authorities prior to the performing the test to determine which endpoints
are required.
(i)
Advanced development (determined using developmental
stage, SVL and HLL).  Advanced development is only known to
occur through effects which are thyroid hormone related.  These
may be peripheral tissue effects such as direct interaction with the
thyroid hormone receptor (such as with T4) or effects which alter
circulating thyroid hormone levels.  In either case, this is considered
sufficient evidence to indicate that the chemical has thyroid activity.
Advanced development is evaluated in one of two ways.  First, the
general developmental stage can be evaluated using the
standardized approach detailed in Nieuwkoop and Faber (Ref. 9).
Second, specific morphological features may be quantified, such as
hind limb length, at both days 7 and 21, which is positively
associated with agonistic effects on the thyroid hormone receptor.
If statistically significant advances in development or hind limb
length occur, then the test indicates that the chemical is likely
thyroid active.
Page 22

The evaluation of test animals for the presence of accelerated
development relative to the control population will be based on
results of statistical analyses performed for the following four
endpoints:
-
hind limb length (normalized by SVL) on study day 7
-
hind limb length  (normalized by SVL) on study day 21
-
developmental stage on study day 7
-
developmental stage on study day 21
Statistical analyses of hind limb length should be performed based
on measurements of the length of the left hind limb.  Hind limb
length is normalized by taking the ratio of hind limb length to snout-
to-vent length of an individual.  The means of the normalized values
for each treatment level are then compared.  Acceleration of
development is indicated by a significant increase in the mean hind
limb length (normalized) in a chemical treatment group compared to
the control group on study day 7 and/or study day 21 (see
Appendix 3).
Statistical analyses of developmental stage should be performed
based on determination of developmental stages according to the
morphological criteria described by Nieuwkoop and Faber (Ref. 8).
Acceleration of development is indicated when the multi-quantal
analysis detects a significant increase of developmental stage
values in a chemical treatment group compared to the control group
on study day 7 and/or study day 21.
In the AMA test method, a significant effect on any of the four
endpoints mentioned above is regarded sufficient for a positive
detection of accelerated development.  That is, significant effects
on hind limb length at a specific time point do not require
corroboration by significant effects on hind limb length at the
alternative time point, nor by significant effects on developmental
stage at this specific time point.  In turn, significant effects on
developmental stage at a specific time point do not require
corroboration by significant effects on developmental stage at the
alternative time point, nor by significant effects on hind limb length
at this specific time point.  The weight of evidence for accelerated
development will nevertheless increase if significant effects are
detected for more than one endpoint.
(ii)
Asynchronous development (determined using developmental
stage criteria). Asynchronous development is characterized by
disruption of the relative timing of the morphogenesis or
development of different tissues within a single tadpole.  The
inability to clearly establish the developmental stage of an organism
using the suite of morphological endpoints considered typical of any
Page 23

given stage indicates that the tissues are developing
asynchronously through metamorphosis.  Asynchronous
development is an indicator of thyroid activity.  The only known
modes of action causing asynchronous development are through
effects of chemicals on peripheral thyroid hormone action and/or
thyroid hormone metabolism in developing tissues such as is
observed with deiodinase inhibitors.
The evaluation of test animals for the presence of asynchronous
development relative to the control population is based on gross
morphological assessment of test animals on study day 7 and study
day 21.
The description of normal development of X. laevis by Nieuwkoop
and Faber (Ref. 9) provides the framework for identifying a
sequential order of normal tissue remodelling.  The term
“asynchronous development” refers specifically to those deviations
in tadpole gross morphological development that disallow the
definitive determination of a developmental stage according to the
criteria of Nieuwkoop and Faber (Ref. 9) because key
morphological landmarks show characteristics of different stages.
As implicated by the term “asynchronous development”, only cases
showing deviations in the progress of remodelling of specific
tissues relative to the progress of remodelling of other tissues
should be considered.  Some classical phenotypes include delay or
absence of fore limb emergence despite normal or advanced
development of hind limbs and tail tissues, or the precocious
resorption of gills relative to the stage of hind limb morphogenesis
and tail resorption.  An animal will be recorded as showing
asynchronous development if it cannot be assigned to a stage
because it fails to meet a majority of the landmark developmental
criteria for a given Niewkoop and Faber stage (Ref. 9), or if there is
extreme delay or acceleration of one or more key features (e.g., tail
completely resorbed, but forelimbs not emerged).  This assessment
is performed qualitatively and should examine the full suite of
landmark features listed by Nieuwkoop and Faber (Ref. 9).
However it is not necessary to record the developmental stage of
the various landmark features of animals being observed.  Animals
recorded as showing asynchronous development are not assigned
to a Nieuwkoop and Faber (Ref. 9) development stage.
Thus, a central criterion for designating cases of abnormal
morphological development as “asynchronous development” is that
the relative timing of tissue remodelling and tissue morphogenesis
is disrupted whereas the morphology of affected tissues is not
overtly abnormal.  One example to illustrate this interpretation of
Page 24

gross morphological abnormalities is that retarded hind limb
morphogenesis relative to development of other tissues fulfills the
criterion of “asynchronous development” whereas cases showing
missing hind limbs, abnormal digits (e.g., ectrodactyly, polydactyly),
or other overt limb malformations should not be considered as
“asynchronous development”.
In this context, the major morphological landmarks that should be
evaluated for their coordinated metamorphic progress should
include hind limb morphogenesis, fore limb morphogenesis, fore
limb emergence, the stage of tail resorption (particularly the
resorption of the tail fin), and head morphology (e.g., gill size and
stage of gill resorption, lower jaw morphology, protrusion of
Meckel’s cartilage).
Dependent on the mode of chemical action, different gross
morphological phenotypes can occur. Some classical phenotypes
include delay or absence of fore limb emergence despite normal or
advanced development of hind limbs and tail tissues, precocious
gill resorption relative to hind limb and tail remodelling.
(iii)
Histopathology. If the chemical does not accelerate development
or cause asynchronous development, then histopathology of the
thyroid glands is evaluated using the available guidance document
(Ref. 10).  Developmental retardation, in the absence of toxicity, is
a strong indicator of anti-thyroid activity, but the developmental
stage analysis is less sensitive and less diagnostic than the
histopathological analysis of the thyroid glands.  Therefore,
conducting histopathological analyses of the thyroid glands is
required in this case.  Effects on thyroid gland histology have been
demonstrated in the absence of developmental effects.  If changes
in thyroid histopathology occur, then the chemical is considered to
be thyroid active.  If no developmental delays or histological lesions
are observed in the thyroid glands, then the chemical is considered
to be thyroid inactive.  The rationale for this decision is that the
thyroid glands are under the influence of TSH and any chemical
which alters circulating thyroid hormone sufficiently to alter TSH
secretion will result in histopathological changes in the thyroid
glands.  Various modes and mechanisms of action can alter
circulating thyroid hormone.  So, while thyroid hormone level is
indicative of a thyroid related effect, it is insufficient to determine
which mode or mechanism of action is related to the response.
Because this endpoint is not amenable to basic statistical
approaches, the determination of an effect associated with
exposure to a chemical shall be made through expert opinion by a
pathologist.
Page 25

(iv)
Delayed development (determined using developmental stage,
HLL, BW, SVL). Delayed development can occur through anti-
thyroidal mechanisms and through indirect toxicity.  Mild
developmental delays coupled with overt signs of toxicity likely
indicate a non-specific toxic effect.  Evaluation of non-thyroidal
toxicity is an essential element of the test to reduce the probability
of false positive outcomes.  Excessive mortality is an obvious
indication that other toxic mechanisms are occurring.  Similarly,
mild reductions in growth, as determined by wet weight and/or SVL
length, also suggest non-thyroidal toxicity.  Apparent increases in
growth are commonly observed with compounds that negatively
affect normal development.  Consequently, the presence of larger
animals does not necessarily indicate non-thyroidal toxicity.
However, growth should never be solely relied upon to determine
thyroid toxicity.  Rather, growth, in conjunction with developmental
stage and thyroid histopathology, should be used to determine
thyroid activity.  Other endpoints should also be considered in
determining overt toxicity including edema, hemorrhagic lesions,
lethargy, reduced food consumption, erratic/altered swimming
behavior, etc.  If all test concentrations exhibit signs of overt
toxicity, the test compound must be re-evaluated at lower test
concentrations before determining whether the compound is
potentially thyroid active or thyroid inactive.
Statistically significant developmental delays, in absence of other
signs of overt toxicity, indicate that the chemical is thyroid active
(antagonistic).  In the absence of strong statistical responses, this
outcome may be augmented with results from thyroid
histopathology.
(6)
Statistical analyses. Statistical analyses of the data should preferably
follow procedures described in the document Current Approaches in the
Statistical Analysis of Ecotoxicity Data: A Guidance to Application (Ref
12).  For all continuous quantitative endpoints (HHL, SVL, wet weight)
consistent with a monotone dose-response, the Jonckheere-Terpstra test
should be applied in step-down manner to establish a significant treatment
effect.
For continuous endpoints that are not consistent with a monotone dose-
response, the data should be assessed for normality (preferably using the
Shapiro-Wilk or Anderson-Darling test) and variance homogeneity
(preferably using the Levene test).  Both tests are performed on the
residuals from an ANOVA.  Expert judgment can be used in lieu of these
formal tests for normality and variance homogeneity, though formal tests
are preferred.  Where non-normality or variance heterogeneity is found, a
normalizing, variance stabilizing transformation should be sought. If the
data (perhaps after a transformation) are normally distributed with
Page 26

Page 27
homogeneous variance, a significant treatment effect is determined from
Dunnett’s test.  If the data (perhaps after a transformation) are normally
distributed with heterogeneous variance, a significant treatment effect is
determined from the Tamhane-Dunnett or T3 test or from the Mann-
Whitney-Wilcoxon U test.  Where no normalizing transformation can be
found, a significant treatment effect is determined from the Mann-Whitney-
Wilcoxon U test using a Bonferroni-Holm adjustment to the p-values.  The
Dunnett test is applied independently of any ANOVA F-test and the Mann-
Whitney test is applied independently of any overall Kruskall-Wallis test.
Significant mortality is not expected but should be assessed from the step-
down Cochran-Armitage test where the data are consistent with dose-
response monotonicity, and otherwise from Fisher’s Exact test with a
Bonferroni-Holm adjustment.
A significant treatment effect for developmental stage is determined from
the step-down application of the Jonckheere-Terpstra test applied to the
replicate medians. Alternatively, and preferably, the multi-quantal
Jonckheere test from the 20
th
to the 80
th
percentile should be used for
effect determination, as it takes into account changes to the distribution
profile.
The appropriate unit of analysis is the replicate so the data consist of
replicate medians if the Jonckheere-Terpstra or Mann-Whitney U test is
used, or the replicate means if Dunnett’s test is used.  Dose-response
monotonicity can be assessed visually from the replicate and treatment
means or medians or from formal tests such as previously described (Ref.