[Federal Register: May 30, 2006 (Volume 71, Number 103)]
[Notices]
[Page 30706-30712]
[DOCID:fr30my06-107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53849; File No. SR-NYSE-2006-20]

Self-Regulatory Organizations; New York Stock Exchange, Inc. (n/
k/a New York Stock Exchange LLC); Order Granting Accelerated Approval
of Proposed Rule Change and Amendment No. 1 Thereto To List and Trade
Index-Linked Securities of Barclays Bank PLC Linked to the Performance
of the GSCI[supreg] Total Return Index

May 22, 2006.

I. Introduction

    On March 13, 2006, the New York Stock Exchange, Inc. (n/k/a New
York Stock Exchange LLC) (``NYSE'' or ``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposal to list and trade Index-Linked
Securities (the ``Notes'') of Barclays Bank PLC (``Barclays'') linked
to the performance of the GSCI[supreg] Total Return Index (the
``Index''). On March 27, 2006, NYSE filed Amendment No. 1 to the
proposed rule change. The proposed rule change was published for
comment in the Federal Register on April 24, 2006.\3\ The Commission

received no comments regarding the proposal. This order approves the
proposed rule change, as amended, on an accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 53658 (April 14,
2006), 71 FR 21064 (``Notice'').
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II. Description of the Proposal

    The NYSE proposes to list and trade the Notes that will track the
performance of the Index pursuant to Section 703.19 (``Other
Securities'') of the NYSE Listed Company Manual (``Manual''). Barclays
intends to issue the Notes under the name ``iPath\SM\ Exchange-Traded
Notes.'' The Exchange believes that the Notes will conform to the
initial listing standards for equity securities under Section 703.19 of
the Manual because Barclays is an affiliate of Barclays PLC,\4\ an
Exchange listed company in good standing. Under Section 703.19 of the
Manual, the Exchange may approve for listing and trading securities not
otherwise covered by the criteria of Sections 1 and 7 of the Manual,
provided the issue is suited for auction market trading.\5\ The Notes
will have a minimum life of one year, the minimum public market value
of the Notes at the time of issuance will exceed $4 million, there will
be at least one million Notes outstanding, and there will be at least
400 holders at the time of issuance.
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    \4\ The issuer of the Notes, Barclays, is an affiliate of an
Exchange-listed company (Barclays PLC) and not an Exchange-listed
company itself. However, Barclays, though an affiliate of Barclays
PLC, would exceed the Exchange's earnings and minimum tangible net
worth requirements in Section 102 of the Manual. Additionally, the
Exchange states that the Notes, when combined with the original
issue price of all other Note offerings of the issuer that are
listed on a national securities exchange (or association), does not
exceed 25% of the issuer's net worth. Telephone conference between
Florence E. Harmon, Senior Special Counsel, Division of Market
Regulation (``Division''), Commission, and John Carey, Assistant
General Counsel, Exchange, on April 11, 2006 (``April 11 Telephone
Conference'').
    \5\ See Securities Exchange Act Release No. 28217 (July 18,
1990), 55 FR 30056 (July 24, 1990) (SR-NYSE-90-30).
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    The Notes are a series of medium-term debt securities of Barclays
that provide for a cash payment at maturity or upon earlier exchange at
the holder's option, based on the performance of the Index. The
principal amount of each Note is $50. The Notes will trade on the
Exchange's equity trading floor, and the Exchange's existing equity
trading rules will apply to trading in the Notes. The Notes will not
have a minimum principal amount that will be repaid and, accordingly,
payment on the Notes prior to or at maturity may be less than the
original issue price of the Notes. In fact, the value of the Index must
increase for the investor to receive at least the $50 principal amount
per Note at maturity or upon exchange or redemption. If the value of
the Index decreases or does not increase sufficiently to offset the
investor fee (described below), the investor will receive less, and
possibly significantly less, than the $50 principal amount per Note. In
addition, holders of the Notes will not receive any interest payments
from the Notes. The Notes will have a term of 30 years. The Notes are
not callable.\6\
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    \6\ April 11 Telephone Conference.
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Description of ``GSCI'' and the Index

    The investment objective of the Notes is to track the Index. The
value of the Index is derived from the separate, but related Goldman
Sachs Commodity Index (``GSCI[supreg]'').\7\ Both indexes are described
below and in more detail in the Notice.\8\
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    \7\ Telephone conference between Florence E. Harmon, Senior
Special Counsel, Division, Commission, and John Carey, Assistant
General Counsel, Exchange, on April 14, 2006 (``April 14 Telephone
Conference'').
    \8\ The methodology for determining the composition and
weighting of the GSCI[supreg] and for calculating its value is
described in more detail in the Notice. See supra, note 3.
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    The Index was established in May 1991 and is designed to be a
diversified benchmark for physical commodities as an asset class. The
Index reflects the excess returns that are potentially available
through an unleveraged investment in the contracts comprising the
GSCI[supreg] plus the Treasury Bill rate of interest that could be
earned on funds committed to the trading of the underlying
contracts.\9\ The value of the Index, on any given day, reflects (i)
the price levels of the contracts included in the GSCI[supreg] (which
represents the value of the GSCI[supreg]); (ii) the ``contract daily
return,'' which is the percentage change in the total dollar weight of
the GSCI[supreg] from the previous day to the current day; and (iii)
the Treasury Bill rate of interest that could be earned on funds
committed to the trading of the underlying contracts.
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    \9\ The Treasury Bill rate of interest used for purposes of
calculating the index on any day is the 91-day auction high rate for
U.S. Treasury Bills, as reported on Telerate page 56, or any
successor page, on the most recent of the weekly auction dates prior
to such day.
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    The GSCI[supreg], upon which the Index is based, is a proprietary
index on a production-weighted basket of futures contracts on physical
commodities traded on futures exchanges in major industrialized
countries.\10\ The GSCI[supreg] is designed to be a measure of the
performance over time of the markets for these commodities. The only
commodities represented in the GSCI[supreg] are those physical
commodities on which active and liquid contracts are traded on
regulated futures exchanges in major industrialized countries. The
commodities represented in the GSCI[supreg] are weighted, on a
production basis, to reflect their relative significance (in the view
of the Index Sponsor, in consultation with the Policy Committee) to the
world economy. The fluctuations in the value of the GSCI[supreg] are
intended generally to correlate with changes in the prices of such
physical commodities in global markets. Futures contracts on the
GSCI[supreg], and options on such futures contracts, are currently
listed for trading on the Chicago Mercantile Exchange.
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    \10\ The criteria for index composition, contract expirations,
component replacements, and valuation are set forth in more detail
in the Notice. See Notice, supra, note 3. Currently, Index
components trade on U.S. futures exchanges, the London Metals
Exchange (``LME''), or the Intercontinental Exchange (formerly known
as the International Petroleum Exchange, which now operates its
futures business through ICE Futures), with whom NYSE has
comprehensive surveillance sharing arrangements.
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    The contracts to be included in the GSCI[supreg] must satisfy
several sets of eligibility criteria established by the Index
Sponsor.\11\ First, the Index Sponsor identifies those contracts that
meet the general criteria for eligibility. Second, the contract volume
and weight requirements are applied and the number of contracts is
determined, which serves to reduce the list of eligible contracts. At
that point, the list of designated contracts for the relevant period is
complete.
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    \11\ See GSCI[supreg] Manual at http://www.gs.com/gsci. Goldman,

Sachs & Co. is the Index Sponsor for both the Index and the
GSCI[supreg]. Telephone conference between Florence E. Harmon,
Senior Special Counsel, Division, Commission, and Michael Cavalier,
Assistant General Counsel, Exchange, on April 13, 2006 (``April 13
Telephone Conference'').
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    The value of the GSCI[supreg] on any given day is equal to the
total dollar weight of the GSCI[supreg] divided by a normalizing
constant that assures the continuity of the GSCI[supreg] over time. The
total dollar weight of the GSCI[supreg] is the sum of the dollar weight
of each index component. The dollar weight of each such index component
on any given day is equal to:
     The daily contract reference price,
     Multiplied by the appropriate contract production weights
(``CPWs''), and
     During a roll period, the appropriate ``roll weights''
(discussed below).\12\
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    \12\ If the price is not made available or corrected by 4 p.m.
New York time, the Index Sponsor, if it deems such action to be
appropriate under the circumstances, will determine the appropriate
daily contract reference price for the applicable futures contract
in its reasonable judgment for purposes of the relevant GSCI[supreg]
calculation. If such actions by the Index Sponsor are implemented on
more than a temporary basis, the Exchange will contact the
Commission staff and, as necessary, file a proposed rule change
pursuant to Rule 19b-4, seeking Commission approval to continue to
trade the Notes. Unless approved for continued trading, the Exchange
would commence delisting proceedings. See ``Continued Listing
Criteria,'' infra. Telephone conference between Florence Harmon,
Senior Special Counsel, Division, Commission; John Carey, Assistant
General Counsel, Exchange; and Michael Cavalier, Assistant General
Counsel, Exchange, on April 10, 2006 (``April 10 Telephone
Conference'').

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    These factors, along with the contract daily return for each Index
component, are described in more detail in the Notice. Additionally,
this information is publicly available each business day on the Index
Sponsor's Web site at http://www.gs.com/gsci \13\ and the relevant

futures exchanges, and/or from major market data vendors. However, if
the volume of trading in the relevant contract, as a multiple of the
production levels of the commodity, is below specified thresholds, the
CPW of the contract is reduced until the threshold is satisfied. This
is designed to ensure that trading in each contract is sufficiently
liquid relative to the production of the commodity.
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    \13\ The CPWs are available in the GSCI[reg] manual on the
GSCI[supreg] Web site (http://www.gs.com/gsci) and are published on

Reuters. The roll weights are not published but can be determined
from the rules in the GSCI Manual. Telephone conference between
Florence Harmon, Senior Special Counsel, Division, Commission, John
Carey, Assistant General Counsel, Exchange, and Heather Shemilt,
Goldman Sachs & Co., on May 18, 2006 (``May 18 Telephone
Conference'').
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    The composition of the GSCI[supreg] is reviewed on a monthly basis
by the Index Sponsor and, if the multiple of any contract is below the
prescribed threshold, the composition of the GSCI is reevaluated, based
on the criteria and weighting procedures.\14\ This procedure is
undertaken to allow the GSCI[supreg] to shift from contracts that have
lost substantial liquidity into more liquid contracts during the course
of a given year.\15\ As a result, it is possible that the composition
or weighting of the GSCI[supreg] will change on one or more of these
monthly Valuation Dates. In addition, regardless of whether any changes
have occurred during the year, the Index Sponsor reevaluates the
composition of the GSCI[supreg] at the conclusion of each year, based
on the above criteria. Other commodities that satisfy such criteria, if
any, will be added to the GSCI[supreg]. Commodities included in the
GSCI[supreg] which no longer satisfy such criteria, if any, will be
deleted.
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    \14\ The Index Sponsor, Goldman, Sachs & Co., which calculates
and maintains the GSCI[supreg] and the Index, is a broker-dealer.
Therefore, appropriate firewalls must exist around the personnel who
have access to information concerning changes and adjustment to an
index and the trading personnel of the broker-dealer. Accordingly,
the Index Sponsor has represented that it (i) has implemented and
maintained procedures reasonably designed to prevent the use and
dissemination by personnel of the Index Sponsor, in violation of
applicable laws, rules and regulations, of material non-public
information relating to changes in the composition or method of
computation or calculation of the Index and (ii) periodically checks
the application of such procedures as they relate to such personnel
of the Index Sponsor directly responsible for such changes. In
addition, the Policy Committee members are subject to written
policies with respect to material, non-public information. Telephone
conversation between Florence Harmon, Senior Special Counsel,
Division, Commission; John Carey, Assistant General Counsel,
Exchange; and Michael Cavalier, Assistant General Counsel, Exchange,
on April 14, 2006 (``April 14 Telephone Conference II'') and May 18
Telephone Conference.
    \15\ See also ``Contract Expirations'' in Notice, supra, note 3.
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    The Index Sponsor has established a Policy Committee to assist it
with the operation of the GSCI[supreg].\16\ The principal purpose of
the Policy Committee is to advise the Index Sponsor with respect to,
among other things, the calculation of the GSCI[supreg], the
effectiveness of the GSCI[supreg] as a measure of commodity futures
market performance, and the need for changes in the composition or the
methodology of the GSCI[supreg]. The Policy Committee acts solely in an
advisory and consultative capacity. All decisions with respect to the
composition, calculation and operation of the GSCI[supreg] and the
Index are made by the Index Sponsor.\17\
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    \16\ The component selections for the GSCI[supreg] would
obviously affect the Index. Telephone conference between Florence
Harmon, Senior Special Counsel, Division, Commission, and Michael
Cavalier, Assistant General Counsel, Exchange, on April 12, 2006
(``April 12 Telephone Conference'').
    \17\ The Policy Committee members are subject to written
policies with respect to material, non-public information. Telephone
conference between Florence Harmon, Senior Special Counsel,
Division, Commission, and Michael Cavalier, Assistant General
Counsel, Exchange, on May 15, 2006 (``May 15 Telephone
Conference'').
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    The Index Sponsor makes the official calculations of the
GSCI[supreg]. While the intraday and closing values of the GSCI [reg]
(and the Index) are calculated by Goldman, Sachs & Co., a broker-
dealer, a number of factors provide for the independent verification of
these intraday and closing values.\18\ This calculation is performed
continuously and is reported on Reuters page GSCI[supreg] (or any
successor or replacement page) and will be updated on Reuters at least
every 15 seconds during business hours on each day on which the offices
of the Index Sponsor in New York City are open for business (a ``GSCI
Business Day'').\19\ The settlement price for the Index is also
reported on Reuters page GSCI[supreg] (or any successor or replacement
page) on each GSCI Business Day between 4 p.m. and 6 p.m., New York
time.
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    \18\ The Index Sponsor calculates the level of the Index
intraday and at the end of the day. The intraday calculation is
based on feeds of real-time data relating to the underlying
commodities and updates intermittently approximately every 15
seconds. In the GSCI market, trades are quoted or settled against
the end-of-day value, not against the value at any other particular
time of the day. With respect to the end-of-day closing level of the
index, the Index Sponsor uses independent feeds from at least two
vendors for each of the underlying commodities in the index to
verify closing prices and limit moves. A number of commodities
market participants independently verify the correctness of the
disseminated intraday Index value and closing Index value.
Additionally, the closing Index values are audited by a major
independent accounting firm. May 18 Telephone Conference.
    \19\ Additionally, this intraday index value of the Index will
be updated and disseminated at least every 15 seconds by a major
market data vendor during the time the Notes trade on the Exchange.
April 13 Telephone Conference. The intraday information with respect
to the Index (and GSCI[supreg]) reported on Reuters is derived
solely from trading prices on the principal trading markets for the
various Index components. For example, the Index currently includes
contracts traded on ICE Futures and the LME, both of which are
located in London and consequently have trading days that end
several hours before those of the U.S.-based markets on which the
rest of the Index components are traded. During the portion of the
New York trading day when ICE Futures and LME are closed, the last
reported prices for Index Components traded on ICE Futures or LME
are used to calculate the intraday Index information disseminated on
Reuters.
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Indicative Value

    An intraday ``Indicative Value'' meant to approximate the intrinsic
economic value of the Notes will be calculated and published via the
facilities of the Consolidated Tape Association (``CTA'') every 15
seconds throughout the NYSE trading day on each day on which the Notes
are traded on the Exchange. Additionally, Barclays or an affiliate will
calculate and publish the closing Indicative Value of the Notes on each
trading day at http://www.ipathetn.com.

    The Indicative Value will not reflect price changes to the price of
an underlying commodity between the close of trading of the futures
contract at the relevant futures exchange and the close of trading on
the NYSE at 4 p.m. New York time.\20\ The value of the Notes may
accordingly be influenced by non-concurrent trading hours between the
NYSE and the various futures exchanges on which the futures contracts
based on the Index commodities are traded.
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    \20\ April 10 Telephone Conference. The Notice includes a chart
of the trading hours for each of the futures contract components in
the Index. See Notice, supra, note 3.
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    While the market for futures trading for each of the Index
commodities is open, the Indicative Value can be expected to closely
approximate the redemption value of the Notes. However, during NYSE
trading hours when relevant futures contracts have ceased trading,
spreads and resulting premiums or discounts may widen, and therefore,
increase the difference between the price of the Notes and their
redemption value. The Indicative Value disseminated during NYSE trading

hours should not be viewed as a real time update of the redemption
value.

Valuation and Redemption of Notes

    Holders who have not previously redeemed their Notes will receive a
cash payment at maturity equal to the principal amount of their Notes
times the index factor on the Final Valuation Date (as defined below)
minus the investor fee on the Final Valuation Date. The ``index
factor'' on any given day will be equal to the closing value of the
Index on that day divided by the initial index level. The index factor
on the Final Valuation Date will be equal to the final index level
divided by the initial index level. The ``initial index level'' is the
closing value of the Index on the date of issuance of the Notes (the
``Trade Date''), and the ``final index level'' is the closing value of
the Index on the Final Valuation Date. The investor fee is equal to
0.75% per year times the principal amount of a holder's Notes times the
index factor, calculated on a daily basis in the following manner: the
investor fee on the Trade Date will equal zero. On each subsequent
calendar day until maturity or early redemption, the investor fee will
increase by an amount equal to 0.75% times the principal amount of a
holder's Notes times the index factor on that day (or, if such day is
not a trading day, the index factor on the immediately preceding
trading day) divided by 365. The investor fee is the only fee holders
will be charged in connection with their ownership of the Notes.
    Prior to maturity, holders may redeem their Notes on any Redemption
Date (defined below) during the term of the Notes, provided that they
present at least 50,000 Notes for redemption, or they act through a
broker or other financial intermediaries (such as a bank or other
financial institution not required to register as a broker-dealer to
engage in securities transactions) that are willing to bundle their
Notes for redemption with other investors' Notes. If a holder chooses
to redeem his Notes on a Redemption Date, such holder will receive a
cash payment on such date equal to the principal amount of his Notes
times the index factor on the applicable Valuation Date (defined below)
minus the investor fee on the applicable Valuation Date. A ``Redemption
Date'' is the third business day following a Valuation Date (other than
the Final Valuation Date (defined below)). A ``Valuation Date'' is each
Thursday from the first Thursday after issuance of the Notes until the
last Thursday before maturity of the Notes (the ``Final Valuation
Date'') inclusive (or, if such date is not a trading day, the next
succeeding trading day), unless the calculation agent determines that a
market disruption event, as described below, occurs or is continuing on
that day.\21\ In that event, the Valuation Date for the maturity date
or corresponding Redemption Date, as the case may be, will be the first
following trading day on which the calculation agent determines that a
market disruption event does not occur and is not continuing. In no
event, however, will a Valuation Date be postponed by more than five
trading days.\22\
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    \21\ Barclays will serve as the initial calculation agent for
the Notes.
    \22\ If a ``market disruption event'' (which affects the
Valuation Date) is of more than a temporary nature, the Exchange
will file a proposed rule change pursuant to Rule 19b-4 under the
Act. Unless approved for continued trading, the Exchange would
commence delisting proceedings. See ``Continued Listing Criteria,''
infra. April 10 Telephone Conference.
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    To redeem their Notes, holders must instruct their broker or other
person through whom they hold their Notes to take the following steps:
     Deliver a notice of redemption to Barclays via e-mail by
no later than 11 a.m. New York time on the business day prior to the
applicable Valuation Date. If Barclays receives such notice by the time
specified in the preceding sentence, it will respond by sending the
holder a confirmation of redemption;
     Deliver the signed confirmation of redemption to Barclays
via facsimile in the specified form by 4 p.m. New York time on the same
day. Barclays must acknowledge receipt in order for the confirmation to
be effective; and
     Transfer such holder's book-entry interest in its Notes to
the trustee, The Bank of New York, on Barclays' behalf at or prior to
10 a.m. New York time on the applicable Redemption Date (the third
business day following the Valuation Date).\23\
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    \23\ April 10 Telephone Conference.
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    If holders elect to redeem their Notes, Barclays may request that
Barclays Capital Inc. (a broker-dealer) purchase the Notes for the cash
amount that would otherwise have been payable by Barclays upon
redemption. In this case, Barclays will remain obligated to redeem the
Notes if Barclays Capital Inc. fails to purchase the Notes. Any Notes
purchased by Barclays Capital Inc. may remain outstanding for trading
on the Exchange.
    If an event of default occurs and the maturity of the Notes is
accelerated, Barclays will pay the default amount in respect of the
principal of the Notes at maturity. Additionally, in the event of a
disruption, adjustment, discontinuance, or substitution of the Index,
the calculation agent has discretion as to the computation methodology
and adjustments. However, in such case, the Exchange will file a
proposed rule change pursuant to Rule 19b-4 under the Act. Unless
approved for continued trading, the Exchange would commence delisting
proceedings.\24\
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    \24\ See ``Continued Listing Criteria,'' infra. April 10
Telephone Conference.
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Continued Listing Criteria

    The Exchange prohibits the initial and/or continued listing of any
security that is not in compliance with Rule 10A-3 under the Act.\25\
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    \25\ 17 CFR 240.10A-3; see also 15 U.S.C. 78a.
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    The Exchange will delist the Notes:
     If, following the initial twelve month period from the
date of commencement of trading of the Notes, the Notes have more than
60 days remaining until maturity and (i) there are fewer than 50
beneficial holders of the Notes for 30 or more consecutive trading
days; (ii) if fewer than 50,000 Notes remain issued and outstanding; or
(iii) if the market value of all outstanding Notes is less than
$1,000,000;
     If the Index value ceases to be calculated or available
during the time the Notes trade on the Exchange on at least every 15
second basis through one or more major market data vendors;\26\
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    \26\ The Exchange confirmed that the Index value (along with the
GSCI[supreg] index value) will be disseminated at least every 15
seconds by one or more major market data vendors during the time the
Notes trade on the Exchange. The Exchange also confirmed these
indexes have daily settlement values that are widely disclosed.
Telephone conference between Florence E. Harmon, Senior Special
Counsel, Division, Commission, and Michael Cavalier, Assistant
General Counsel, Exchange, on April 13, 2006 (``April 13 Telephone
Conference'').
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     If, during the time the Notes trade on the Exchange, the
Indicative Value ceases to be available on a 15 second delayed basis;
or
     If such other event shall occur or condition exists which
in the opinion of the Exchange makes further dealings on the Exchange
inadvisable.
    Additionally, the Exchange will file a proposed rule change
pursuant to Rule 19b-4 under the Act \27\ seeking approval to continue
trading the Notes and unless approved, the Exchange will commence
delisting the Notes if:
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    \27\ 17 CFR 240.19b-4.
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     The Index Sponsor substantially changes either the Index
component selection methodology or the weighting methodology;\28\
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    \28\ This would include the Index Sponsor's current examination
of the conditions under which an instrument traded on an electronic
platform, rather than a traditional futures contract traded on a
traditional futures exchange should be included in the GSCI[supreg]
and how the composition of the GSCI[supreg] should respond to rapid
shifts in liquidity between such instruments and contracts currently
included in the GSCI[supreg].

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     If a new component is added to the Index (or pricing
information is used for a new or existing component) that constitutes
more than 10% of the weight of the Index with whose principal trading
market the Exchange does not have a comprehensive surveillance sharing
agreement;\29\ or
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    \29\ Therefore, only 10% of the weight of all of the
GSCI[supreg] (and thus the Index components) could not be subject to
comprehensive surveillance sharing arrangements with the Exchange.
April 10 Telephone Conference.
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     If a successor or substitute index is used in connection
with the Notes. The filing will address, among other things the listing
and trading characteristics of the successor or substitute index and
the Exchange's surveillance procedures applicable thereto.

Trading Rules

    The Exchange's existing equity trading rules will apply to trading
of the Notes. The Notes will trade between the hours of 9:30 a.m. and 4
p.m. New York time and will be subject to the equity margin rules of
the Exchange.\30\
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    \30\ See NYSE Rule 431.
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(1) Trading Halts
    The Exchange will cease trading the Notes if there is a halt or
disruption in the dissemination of the Index value or the Indicative
Value.\31\ The Exchange will also cease trading the Notes if a ``market
disruption event'' occurs that is of more than a temporary nature.\32\
In the event that the Exchange is open for business on a day that is
not a GSCI Business Day, the Exchange will not permit trading of the
Notes on that day.
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    \31\ In the event the Index value or Indicative Value is no
longer calculated or disseminated, the Exchange would immediately
contact the Commission to discuss measures that may be appropriate
under the circumstances.
    \32\ In the event a ``market disruption event'' occurs that is
of more than a temporary nature, the Exchange would immediately
contact the Commission to discuss measures that may be appropriate
under the circumstances.
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(2) Specialist Trading Obligations
    Pursuant to new Supplementary Material .10 to NYSE Rule 1301B, the
provisions of NYSE Rules 1300B(b) and 1301B would be applied to certain
securities listed on the Exchange pursuant to Section 703.19 (``Other
Securities'') of the Exchange's Manual. Specifically, NYSE Rules
1300B(b) and 1301B will apply to securities listed under Section 703.19
of the Manual where the price of such securities is based in whole or
part on the price of (a) a commodity or commodities; (b) any futures
contracts or other derivatives based on a commodity or commodities; or
(c) any index based on either (a) or (b) above.
    As a result of application of NYSE Rule 1300B(b), the specialist in
the Notes, the specialist's member organization and other specified
persons will be prohibited under paragraph (m) of NYSE Rule 105
Guidelines from acting as market maker or functioning in any capacity
involving market-making responsibilities in the Index components, the
commodities underlying the Index components, or options, futures or
options on futures on the Index, or any other derivatives
(collectively, ``derivative instruments'') based on the Index or based
on any Index component or any physical commodity underlying an Index
component. If the member organization acting as specialist in the Notes
is entitled to an exemption under NYSE Rule 98 from paragraph (m) of
NYSE Rule 105 Guidelines, then that member organization could act in a
market making capacity in the Index components, the commodities
underlying the Index components, or derivative instruments based on the
Index or based on any Index component or commodity underlying an Index
component, other than as a specialist in the Notes themselves, in
another market center.
    Under NYSE Rule 1301B(a), the member organization acting as
specialist in the Notes (a) will be obligated to conduct all trading in
the Notes in its specialist account, (subject only to the ability to
have one or more investment accounts, all of which must be reported to
the Exchange); (b) will be required to file with the Exchange and keep
current a list identifying all accounts for trading in the Index
components or the physical commodities underlying the Index components,
or derivative instruments based on the Index or based on the Index
components or the physical commodities underlying the Index components,
which the member organization acting as specialist may have or over
which it may exercise investment discretion; and (c) will be prohibited
from trading in the Index components or the physical commodities
underlying the Index components, or derivative instruments based on the
Index or based on the Index components or the physical commodities
underlying the Index components, in an account in which a member
organization acting as specialist, controls trading activities which
have not been reported to the Exchange as required by NYSE Rule 1301B.
    Under NYSE Rule 1301B(b), the member organization acting as
specialist in the Notes will be required to make available to the
Exchange such books, records or other information pertaining to
transactions by the member organization and other specified persons for
its or their own accounts in the Index components or the physical
commodities underlying the Index components, or derivative instruments
based on the Index or based on the Index components or the physical
commodities underlying the Index components, as may be requested by the
Exchange. This requirement is in addition to existing obligations under
Exchange rules regarding the production of books and records.
    Under NYSE Rule 1301B(c), in connection with trading the Index
components or the physical commodities underlying the Index components,
or derivative instruments based on the Index or based on the Index
components or the physical commodities underlying the Index components,
the specialist could not use any material nonpublic information
received from any person associated with a member or employee of such
person regarding trading by such person or employee in the Index
components or the physical commodities underlying the Index components,
or derivative instruments based on the Index or based on the Index
components or the physical commodities underlying the Index components.

Surveillance

    The Exchange represents that its surveillance procedures are
adequate to properly monitor the trading of the Notes and the Index
components. The Exchange will rely upon existing NYSE surveillance
procedures governing equities with respect to surveillance of the
Notes. The Exchange believes that these procedures are adequate to
monitor Exchange trading of the Notes and to detect violations of
Exchange rules, consequently deterring manipulation. In this regard,
the Exchange has the authority under NYSE Rules 476 and Rule 1301B to
request the Exchange specialist in the Notes to provide NYSE Regulation
with information that the specialist uses in connection with pricing
the Notes on the Exchange, including specialist proprietary or other
information regarding securities, commodities, futures, options on
futures or other derivative instruments. The Exchange believes it also
has authority to request any other information from its members--
including floor brokers,

specialists and ``upstairs'' firms--to fulfill its regulatory
obligations.
    With regard to the Index components, the Exchange can obtain market
surveillance information, including customer identity information, with
respect to transactions occurring on the New York Mercantile Exchange
(``NYMEX''), the Kansas City Board of Trade, ICE Futures, and the LME,
pursuant to its comprehensive information sharing agreements with each
of those exchanges. All of the other trading venues on which current
Index components are traded are members of the Intermarket Surveillance
Group (``ISG''), and the Exchange therefore has access to all relevant
trading information with respect to those contracts without any further
action being required on the part of the Exchange. All these
surveillance arrangements constitute comprehensive surveillance sharing
arrangements.\33\
---------------------------------------------------------------------------

    \33\ April 14 Telephone Conference.33
---------------------------------------------------------------------------

Suitability

    Pursuant to NYSE Rule 405, the Exchange will impose a duty of due
diligence on its members and member firms to learn the essential facts
relating to every customer prior to trading the Notes.\34\ With respect
to suitability recommendations and risks, the Exchange will require
members, member organizations and employees thereof recommending a
transaction in the Notes: (a) To determine that such transaction is
suitable for the customer; and (b) to have a reasonable basis for
believing that the customer can evaluate the special characteristics
of, and is able to bear the financial risks of, such transaction.
---------------------------------------------------------------------------

    \34\ NYSE Rule 405 requires that every member, member firm or
member corporation use due diligence to learn the essential facts
relative to every customer and to every order or account accepted.
---------------------------------------------------------------------------

Information Memorandum

    The Exchange will, prior to trading the Notes, distribute an
information memorandum to the membership providing guidance with regard
to member firm compliance responsibilities (including suitability
recommendations) when handling transactions in the Notes. The
information memorandum will note to members language in the prospectus
used by Barclays in connection with the sale of the Notes regarding
prospectus delivery requirements for the Notes. Specifically, in the
initial distribution of the Notes,\35\ and during any subsequent
distribution of the Notes, NYSE members will deliver a prospectus to
investors purchasing from such distributors.\36\ The information
memorandum will discuss the special characteristics and risks of
trading this type of security. Specifically, the information
memorandum, among other things, will discuss what the Notes are, how
the Notes are redeemed, applicable Exchange rules, dissemination of
information regarding the Index value and the Indicative Value, trading
information and applicable suitability rules.
---------------------------------------------------------------------------

    \35\ The Registration Statement reserves the right to do
subsequent distributions of these Notes.
    \36\ April 10 Telephone Conference.
---------------------------------------------------------------------------

    The information memorandum will also notify members and member
organizations about the procedures for redemptions of Notes and that
Notes are not individually redeemable but are redeemable only in
aggregations of at least 50,000 Notes.
    The information memorandum will also reference the fact that there
is no regulated source of last sale information regarding physical
commodities and that the SEC has no jurisdiction over the trading of
physical commodities, such as aluminum, gold, crude oil, heating oil,
corn and wheat, or the futures contracts on which the value of the
Notes is based, and that the Commodity Futures Trading Commission has
no regulatory jurisdiction over the trading of certain foreign based
futures contracts.\37\
---------------------------------------------------------------------------

    \37\ April 14 Telephone Conference.
---------------------------------------------------------------------------

    The information memorandum will also discuss other exemptive or no-
action relief under the Act provided by the Commission staff.\38\
---------------------------------------------------------------------------

    \38\ April 10 Telephone Conference.
---------------------------------------------------------------------------

III. Discussion and Commission's Findings

    After careful consideration, the Commission finds that the proposed
rule change, as amended, is consistent with the requirements of the Act
and the rules and regulations thereunder applicable to a national
securities exchange.\39\ In particular, the Commission finds that the
proposed rule change, as amended, is consistent with the requirements
of section 6(b)(5) of the Act,\40\ which requires, among other things,
that the Exchange's rules be designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system and, in general,
to protect investors and the public interest.
---------------------------------------------------------------------------

    \39\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \40\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

A. Surveillance

    Information sharing agreements with primary markets are an
important part of a self-regulatory organization's ability to monitor
for trading abuses in derivative products. The Commission believes that
the Exchange's comprehensive surveillance sharing agreements with the
NYMEX, the Kansas City Board of Trade, ICE Futures, and the LME for the
purpose of providing information in connection with trading of the
Notes and the Index components create the basis for the NYSE to monitor
for fraudulent and manipulative practices in the trading of the Notes.
The Exchange represents that all of the other trading venues on which
current Index components are traded are members of the ISG, and the
Exchange has access to all relevant trading information with respect to
those contracts without any further action. In addition, the Exchange
represents that it will delist the Notes if a new component is added to
the Index (or pricing information is used for a new or existing
component) that constitutes more than 10% of the weight of the Index
with whose principal trading market the Exchange does not have a
comprehensive surveillance sharing agreement.
    Moreover, NYSE Rules 476 and 1301B requires Exchange specialists,
upon the Exchange's request, to provide NYSE Regulation with
information that the specialist uses in connection with pricing the
Notes on the Exchange, including specialist proprietary or other
information regarding securities, commodities, futures, options on
futures, or other derivative instruments. Furthermore, the Exchange
believes that it also has the authority to request any other
information from its member--including floor brokers, specialists and
``upstairs'' firms--to fulfill its regulatory obligations. The
Commission believes that these rules provide the NYSE with the tools
necessary to adequately surveil trading in the Notes.

B. Dissemination of Information

    The Commission believes that sufficient venues exist for obtaining
reliable information so that investors in the Notes can monitor the
underlying Index relative to the Indicative Value of their Notes. There
is a considerable amount of information about the Index and its
components available through public Web sites and professional
subscription services, including Reuters and Bloomberg. Real time
information about the trading of the component

futures contracts and their daily settlement prices are available from
one or more major market data vendors, and in some cases, the
underlying futures exchanges. The official calculation of the Index
made by the Index Sponsor is performed continuously and is reported on
Reuters page GSCI (or any successor or replacement page) and will be
updated on Reuters at least 15 seconds during business hours during the
time the Notes trade on the Exchange. The settlement price for the
Index is also reported on Reuters page GSCI (or any successor or
replacement page) on each GSCI Business Day between 4 p.m. and 6 p.m.,
New York time. While the Index is calculated by a broker-dealer, a
number of independent sources verify both the intraday and closing
Index values. The calculation methodology is public and transparent,
and the factors included in the Index calculation, such as the CPWs,
are available in the GSCI Manual found on GSCI's Web site at http://www.gs.com/gsci
 and are published on Reuters. The roll weights are not

published but can be determined from the rules in the GSCI Manual.\41\
---------------------------------------------------------------------------

    \41\ May 18 Telephone Conference.
---------------------------------------------------------------------------

    While the Indicative Value will not reflect price changes of an
underlying commodity between the close of trading of the futures
contract at the relevant futures exchange and the close of trading on
the NYSE at 4 p.m. New York time, the Exchange represents that the
Indicative Value will be calculated and published via the facilities of
the CTA every 15 seconds throughout the NYSE trading day on each day
the Notes are traded on the Exchange. In addition, Barclays or an
affiliate will calculate and publish the closing Indicative Value of
the Notes on each trading day at http://www.ipathetn.com.

C. Listing and Trading

    The Commission finds that the Exchange's proposed rules and
procedures for the listing and trading of the proposed Notes are
consistent with the Act. The Notes will trade as equity securities
subject to NYSE rules including, among others, rules governing equity
margins, specialist responsibilities, account opening, and customer
suitability requirements. The Commission believes that the listing and
delisting criteria for the Notes should help to maintain a minimum
level of liquidity and therefore minimize the potential for
manipulation of the Notes. The Exchange represents that it would file a
proposed rule change, pursuant to Rule 19b-4,\42\ if the Index Sponsor
materially changes the composition of both the GSCI[reg] and the Index,
the methodology of calculating the value of the GSCI[reg] and the
Index, or any other policies relevant to the Index. Finally, the
Commission notes that the Information Memorandum that the Exchange will
distribute will inform members and member organizations about the
terms, characteristics and risks in trading the Notes, including their
prospectus delivery obligations.
---------------------------------------------------------------------------

    \42\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

D. Accelerated Approval

    The Commission finds good cause, pursuant to section 19(b)(2) of
the Act,\43\ for approving the proposed rule change, as amended, prior
to the thirtieth day after the date of publication of notice in the
Federal Register. The Commission notes that the proposal is consistent
with the listing and trading standards in NYSE Rule 703.19. The
Commission does not believe that the proposed rule change, as amended,
raises novel regulatory issues. Consequently, the Commission believes
that it is appropriate to permit investors to benefit from the
flexibility afforded by trading these products as soon as possible.
---------------------------------------------------------------------------

    \43\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    Accordingly, the Commission finds that there is good cause,
consistent with section 6(b)(5) of the Act,\44\ to approve the proposal
on an accelerated basis.
---------------------------------------------------------------------------

    \44\ 15 U.S.C. 78s(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to section 19(b)(2) of the Act,
that the proposed rule change (SR-NYSE-2006-20), as amended, be, and it
hereby is, approved on an accelerated basis.
---------------------------------------------------------------------------

    \45\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\45\
Nancy M. Morris,
Secretary.
 [FR Doc. E6-8239 Filed 5-26-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 79, Number 209 (Wednesday, October 29, 2014)]
[Notices]
[Pages 64378-64379]
[FR Doc No: 2014-25705]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC15-13-000.
    Applicants: Limon Wind III, LLC.
    Description: Application of Limon Wind III, LLC for Authorization
Under Section 203 of the Federal Power Act and Request for Expedited
Action.
    Filed Date: 10/20/14.
    Accession Number: 20141020-5189.
    Comments Due: 5 p.m. ET 11/10/14.

    Docket Numbers: EC15-14-000.
    Applicants: American Transmission Company LLC.
    Description: Application for Authority to Acquire Transmission
Facilities Under Section 203 of the FPA of American Transmission
Company LLC.
    Filed Date: 10/20/14.
    Accession Number: 20141020-5203.
    Comments Due: 5 p.m. ET 11/10/14.

    Docket Numbers: EC15-15-000.
    Applicants: Hoopeston Wind, LLC.
    Description: Hoopeston Wind Application for Approval Under Section
203 of the Federal Power Act and Request for Expedited Treatment and
Shortened Comment Period.
    Filed Date: 10/21/14.
    Accession Number: 20141021-5056.
    Comments Due: 5 p.m. ET 11/12/14.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER14-2497-001.
    Applicants: Idaho Power Company.
    Description: Compliance filing per 35: Amendment to OATT Order No.
792 Compliance Filing--SGIP/SGIA to be effective 12/31/9998.
    Filed Date: 10/21/14.
    Accession Number: 20141021-5131.
    Comments Due: 5 p.m. ET 11/12/14.

    Docket Numbers: ER14-2573-001.
    Applicants: New York Independent System Operator, Inc.
    Description: Compliance filing per 35: NYISO compliance in response
to deficiency letter w/SGIA/SGIP tariff revisions to be effective 12/
31/9998.
    Filed Date: 10/21/14.
    Accession Number: 20141021-5146.
    Comments Due: 5 p.m. ET 11/12/14.

    Docket Numbers: ER14-2583-001.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Compliance filing per 35: Response to FERC's Letter
Regarding the Deficiency of a Filing to be effective 12/31/9998.
    Filed Date: 10/21/14.
    Accession Number: 20141021-5152.
    Comments Due: 5 p.m. ET 11/12/14.

    Docket Numbers: ER15-46-000.
    Applicants: Dragon Energy, LLC.
    Description: Supplement to October 6, 2014 Dragon Energy, LLC
tariff filing.
    Filed Date: 10/14/14.
    Accession Number: 20141014-5498.
    Comments Due: 5 p.m. ET 11/4/14.

    Docket Numbers: ER15-135-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Revisions to the OATT re DR Operational Resource RPM Transition
Mechanism to be effective 12/19/2014.
    Filed Date: 10/20/14.
    Accession Number: 20141020-5160.
    Comments Due: 5 p.m. ET 11/10/14.

    Docket Numbers: ER15-136-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Original Service Agreement No. 4012; Queue W1-003-006;Z1-100-102 to be
effective 9/18/2014.
    Filed Date: 10/20/14.
    Accession Number: 20141020-5165.
    Comments Due: 5 p.m. ET 11/10/14.

    Docket Numbers: ER15-137-000.
    Applicants: Northern States Power Company, a Wisconsin corporation.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 2014-
10-21 CDTT-TREMPLO-BNGR-BLMR-ACIF NOCs to be effective 10/31/2014.
    Filed Date: 10/21/14.
    Accession Number: 20141021-5082.
    Comments Due: 5 p.m. ET 11/12/14.

    Docket Numbers: ER15-138-000.
    Applicants: Michigan Electric Transmission Company, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): CIAC
Agreement with Wolverine Power Supply Cooperative to be effective 12/
22/2014.
    Filed Date: 10/21/14.
    Accession Number: 20141021-5091.
    Comments Due: 5 p.m. ET 11/12/14.

    Docket Numbers: ER15-139-000.
    Applicants: Palo Duro Wind Interconnection Services, LLC.
    Description: Baseline eTariff Filing per 35.1: Palo Duro Wind
Interconnection Services, LLC Amended and Restated SFA to be effective
10/22/2014 under ER15-139 Filing Type: 390.
    Filed Date: 10/21/14.
    Accession Number: 20141021-5111.
    Comments Due: 5 p.m. ET 11/12/14.

    Docket Numbers: ER15-140-000.
    Applicants: Dry Lake Wind Power II LLC.
    Description: Tariff Withdrawal per 35.15: Cancellation to be
effective 12/20/2014.
    Filed Date: 10/21/14.
    Accession Number: 20141021-5119.
    Comments Due: 5 p.m. ET 11/12/14.

    Docket Numbers: ER15-141-000.
    Applicants: California Independent System Operator C, AES
Huntington Beach, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Request
for Approval of Extension of Contract Term to be effective 1/1/2015.
    Filed Date: 10/21/14.
    Accession Number: 20141021-5149.
    Comments Due: 5 p.m. ET 11/12/14.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern

time on the specified comment date. Protests may be considered, but
intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 21, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-25705 Filed 10-28-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 99 (Tuesday, May 25, 2021)]
[Notices]
[Pages 28113-28115]
[FR Doc No: 2021-11022]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4751]

FDA Reauthorization Act Implementation Guidance for Pediatric
Studies of Molecularly Targeted Oncology Drugs; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``FDARA
Implementation Guidance for Pediatric Studies of Molecularly Targeted
Oncology Drugs.'' This guidance addresses early planning for pediatric
evaluation of certain molecularly targeted oncology drugs, including
biological products, for which original new drug applications (NDAs)
and biologics license applications (BLAs) are expected to be submitted
to FDA, in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act
of 2017 (FDARA). Early pediatric evaluation of certain molecularly
targeted oncology drugs as required by the FD&C Act is expected to
accelerate the creation of an informed pediatric development plan and
ultimately the development of promising drugs for pediatric patients.
This guidance finalizes the draft guidance entitled ``FDARA
Implementation Guidance for Pediatric Studies of Molecularly Targeted
Oncology Drugs'' issued on December 13, 2019, and finalizes certain
material related to implementation of FDARA that was included in the
draft guidance entitled ``Pediatric Study Plans for Oncology Drugs:
Questions and Answers'' issued on January 16, 2020. Accordingly, FDA
does not intend to finalize the draft guidance entitled ``Pediatric
Study Plans for Oncology Drugs: Questions and Answers,'' which is now
withdrawn.

DATES: The announcement of the guidance is published in the Federal
Register on May 25, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-4751 for ``FDARA Implementation Guidance for Pediatric
Studies of Molecularly Targeted Oncology Drugs.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9

a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Gregory Reaman, Oncology Center of
Excellence, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 2202, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``FDARA Implementation Guidance for Pediatric Studies of
Molecularly Targeted Oncology Drugs.'' This guidance addresses early
planning for pediatric evaluation of certain molecularly targeted
oncology drugs (including biological products) for which original NDAs
and BLAs are expected to be submitted to FDA, in accordance with the
provisions of section 505B of the FD&C Act (21 U.S.C. 355c). Section
505B of the FD&C Act (also referred to as the Pediatric Research Equity
Act or PREA) was amended by FDARA.
    The amendments to section 505B require pediatric evaluation of
certain molecularly targeted oncology drugs, with the goal of helping
address the needs of pediatric patients with cancer. FDARA amended
section 505B of the FD&C Act to require--for original applications
submitted on or after August 18, 2020--pediatric investigations of
certain targeted cancer drugs with new active ingredients, based on
molecular mechanism of action rather than clinical indication.
Specifically, if an original NDA or BLA is submitted on or after August
18, 2020, for a new active ingredient, and the drug or biological
product that is the subject of the application is intended for
treatment of an adult cancer and directed at a molecular target FDA
determines to be substantially relevant to the growth or progression of
a pediatric cancer, reports on the molecularly targeted pediatric
cancer investigation required under section 505B(a)(3) of the FD&C Act
must be submitted with the marketing application, unless the
requirement is waived or deferred (sections 505B(a)(1)(B) and (a)(3)(C)
of the FD&C Act).
    This guidance provides recommendations on regulatory considerations
related to the amendments to section 505B of the FD&C Act, including
information on molecular targets, factors FDA intends to consider in
the determination of whether a molecular target is substantially
relevant to the growth or progression of a pediatric cancer,
information regarding the molecular target lists, recommendations on
the content of the initial pediatric study plan and description of
recommended study(ies), additional considerations for rare cancers,
information pertaining to oncology drug combination regimens, and
considerations regarding planned waivers and deferrals. In addition,
the guidance includes information regarding global implications of, and
the importance of international collaboration regarding, pediatric
oncology studies.
    This guidance finalizes the draft guidance entitled ``FDARA
Implementation Guidance for Pediatric Studies of Molecularly Targeted
Oncology Drugs,'' issued on December 13, 2019 (see 84 FR 68174). This
guidance also finalizes certain recommendations related to
implementation of FDARA section 504 that was included in the draft
guidance entitled ``Pediatric Study Plans for Oncology Drugs:
Transitional Information Until Full Implementation of FDARA Section 504
Questions and Answers,'' issued on January 16, 2020 (85 FR 2746). FDA
considered comments received on both of these draft guidances as this
guidance was finalized. Changes from the draft to the final guidance
include the following: Describing additional safeguards for children in
clinical investigations (see 21 CFR part 50, subpart D), providing
information sources that have been used in the development of the
molecular target lists, describing information that should be included
in a request for a meeting regarding early advice on pediatric
development for oncology projects subject to the amended provisions,
and providing additional information and clarification regarding
planned waivers and deferrals. Recommendations that were finalized in
this guidance from the draft guidance entitled ``Pediatric Study Plans
for Oncology Drugs: Transitional Information Until Full Implementation
of FDARA Section 504 Questions and Answers'' include the following:
Clarifying that a supplemental application does not trigger the
requirement to submit reports on the molecularly targeted pediatric
cancer

investigation and describing considerations for initial pediatric study
plans for oncology drug combination regimens. In addition, editorial
changes were made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``FDARA Implementation Guidance for
Pediatric Studies of Molecularly Targeted Oncology Drugs.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR parts 50 and 56 have been approved under OMB
control number 0910-0130; the collections of information in 21 CFR part
314 have been approved under OMB control number 0910-0001; the
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014; the collections of information in 21 CFR
part 601 have been approved under OMB control number 0910-0338; the
collections of information in FDA's draft guidance for industry
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants
of PDUFA Products'' have been approved under OMB control number 0910-
0429; and the collections of information pertaining to submission of a
biologics license application under section 351(k) of the Public Health
Service Act and the draft guidance for industry entitled ``Formal
Meetings Between the FDA and Sponsors or Applicants of BsUFA Products''
have been approved under OMB control number 0910-0719.

III. Electronic Access

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

    Dated: May 18, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11022 Filed 5-24-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Notices]
[Page 55380]
[FR Doc No: 2011-22817]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Docket Nos. ER11-2256-000; ER11-3149-000; ER11-3856-000; ER11-4384-
000; ER11-4384-000]

 California Independent System Operator Corporation; Notice of
FERC Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that on the following dates members of its staff will
participate in teleconferences and meetings to be conducted by the
California Independent System Operator (CAISO). The agenda and other
documents for the teleconferences and meetings are available on the
CAISO's Web site, http://www.caiso.com.

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

------------------------------------------------------------------------
September 1, 2011.........................  Fall 2011 Release Market
                                             Simulation, Renewables
                                             Integration Market and
                                             Product Review.
September 6, 2011.........................  Release User Group, Flexible
                                             Ramping Constraint Draft
                                             Tariff Language, Circular
                                             Scheduling Straw Proposal.
September 7, 2011.........................  Settlements and Market
                                             Clearing User Group, ISO
                                             Stakeholder Symposium,
                                             Congestion Revenue Rights.
September 8, 2011.........................  Fall 2011 Release Market
                                             Simulation, ISO Stakeholder
                                             Symposium Market Update.
September 12, 2011........................  Fall 2011 Release Market
                                             Simulation, Renewables
                                             Integration Market and
                                             Product Review.
September 13, 2011........................  Technical User Group, Local
                                             Market Power Mitigation
                                             Enhancements.
September 14, 2011........................  Settlements and Market
                                             Clearing User Group,
                                             Congestion Revenue Rights,
                                             Market Performance and
                                             Planning Forum, Outage
                                             Management System Business
                                             Requirements.
September 15, 2011........................  Fall 2011 Release Market
                                             Simulation.
------------------------------------------------------------------------

    Sponsored by the CAISO, the teleconferences and meetings are open
to all market participants, and staff's attendance is part of the
Commission's ongoing outreach efforts. The teleconferences and meetings
may discuss matters at issue in the above captioned dockets.
    For further information, contact Saeed Farrokhpay at
<EMAIL_ADDRESS>(916) 294-0322 or Maury Kruth at
<EMAIL_ADDRESS>(916) 294-0275.

    Dated: August 31, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-22817 Filed 9-6-11; 8:45 am]
BILLING CODE 6717-01-P


Note to Docket from Mary Tom Kissell 26 February 2004 During the period of January 2003 through 26 February 26, 2004, EPA representatives, Mary Tom Kissell and K. C. Hustvedt, communicated with various stakeholders concerning the proposed PCWP MACT. The stakeholders included industry trade associations such as AF& PA and CPA, environmental groups such as NRDC, trade journals, States, PCWP facilities, consultants, vendors, and attornies. EPA representatives clarified proposed provisions and discussed changes EPA was contemplating.


[Federal Register: September 28, 2005 (Volume 70, Number 187)]
[Notices]
[Page 56755-56757]
[DOCID:fr28se05-205]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52479; File No. SR-ISE-2004-04]

Self-Regulatory Organizations; International Securities Exchange,
Inc.; Notice of Filing of Proposed Rule Change and Amendments No. 1 and
2 Relating to Exposure Periods in the Facilitation and Solicited Order
Mechanisms

September 21, 2005.
    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 February 23, 2004, the International Securities Exchange, Inc.
(``ISE'' 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
Exchange. On September 7, 2005, the ISE filed Amendment No. 1 to the
proposed rule change.\3\ On September 20, 2005, the ISE filed Amendment
No. 2 to the

proposed rule change.\4\ The Commission is publishing this notice to
solicit comments on the proposed rule change, as amended, from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 superseded and replaced ISE's original
filing in its entirety.
    \4\ Amendment No. 2 corrected a non-substantive typographical
error in the text of the proposed rule change, and two incorrect
references in footnotes to the Form 19b-4 for Amendment No. 1 and
Exhibit 1 thereto.
---------------------------------------------------------------------------

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

    The Exchange is proposing to decrease the exposure period in its
Facilitation and Solicited Order Mechanisms from 10 seconds to three
seconds. The text of the proposed rule change is as follows (italics
indicates additions; [brackets] indicate deletions): \5\
---------------------------------------------------------------------------

    \5\ There were no changes to the text of the proposed rule
change in Amendment No. 1. However, the proposal was updated in
Amendment No. 1 to reflect changes in the text of ISE Rule 716 that
occurred since the initial proposal was submitted. The Purpose
section of the filing was also updated.
---------------------------------------------------------------------------

* * * * *

Rule 716. Block Trades

    (a) through (e) no change.

Supplementary Material to Rule 716

    .01 through .03 no change.
    .04 The time given to Members to enter Responses under paragraph
(c)(1) shall be thirty (30) seconds. The time given to Members to enter
Responses under paragraph (d)(1) and Responses under paragraph (e)(1)
shall be [ten (10)] three (3) seconds.
    .05 through .08 no change.
* * * * *

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 ISE 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
    Electronic Access Members that seek to execute their customer
orders as principal (facilitations) or to execute their customer orders
against orders they solicit from other broker-dealers (solicitations)
may use the Facilitation and Solicited Order Mechanisms contained in
ISE Rule 716 or the Price Improvement Mechanism contained in ISE Rule
723. All three of these mechanisms expose orders to the market to give
other market participants an opportunity to participate in the trade.
Currently, the exposure period for the Facilitation and Solicited Order
Mechanisms is ten seconds under ISE Rule 716, while the exposure period
for the Price Improvement Mechanism is only three seconds under ISE
Rule 723. The purpose of this proposed rule change is to reduce the
exposure period for the Facilitation and Solicited Order Mechanisms
from ten seconds to three seconds.\6\
---------------------------------------------------------------------------

    \6\ ISE Rule 716 originally required that orders be exposed in
the Facilitation Mechanism for 30 seconds. In September 2002, the
Commission approved reducing this exposure period from 30 seconds to
ten seconds. See Securities Exchange Act Release No. 46514
(September 18, 2002), 67 FR 60627 (September 25, 2005) (approving
File No. SR-ISE-2001-19). The Solicited Order Mechanism was approved
in June 2004 with an exposure period of ten seconds. See Securities
Exchange Act Release No. 49943 (June 30, 2004), 69 FR 41317 (July 8,
2004) (approving File No. SR-ISE-2001-22). The Price Improvement
Mechanism was approved in December 2004 with the three-second
exposure period. See Securities Exchange Act Release No. 50819
(December 8, 2004), 69 FR 75093 (December 15, 2004) (approving File
No. SR-ISE-2003-06).
---------------------------------------------------------------------------

    When it approved the three-second exposure period for the Price
Improvement Mechanism, the Commission concluded that, in light of the
ISE's fully electronic marketplace, the three-second exposure period
gave participants sufficient time to compete for orders. The ISE
believes that there is no reason for the exposure periods to be
different among the three mechanisms, since members are notified of the
orders and enter their interest in trading with the orders in the same
technical manner. Moreover, the Price Improvement Mechanism is an
interactive auction where members receive and can respond to multiple
price updates within the three second period, whereas members only
receive one message at the start of an auction with respect to orders
executed through the Facilitation and Solicited Order Mechanisms.
Indeed, the ISE believes that exposing orders for ten seconds rather
than three in its fully electronic market adds risk to the orders being
exposed without providing any offsetting benefit to the orders.
2. Basis
    The basis under the Act for this proposed rule change is found in
Section 6(b)(5),\7\ in that the proposed rule change is designed to
promote just and equitable principles of trade, remove impediments to
and perfect the mechanisms of a free and open market and a national
market system and, in general, to protect investors and the public
interest, in that the proposal will allow orders to be executed through
the Facilitation and Solicited Order Mechanisms in a more timely and
efficient manner.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-ISE-2004-04 on the subject line.

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.
    All submissions should refer to File Number SR-ISE-2004-04. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the ISE. 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-ISE-2004-04 and should be submitted on or before October
19, 2005.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

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

Jonathan G. Katz,
Secretary.
 [FR Doc. E5-5243 Filed 9-27-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Notices]
[Pages 30127-30128]
[FR Doc No: 2023-09880]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0015; FRL-10897-01-OCSPP]

Pesticide Emergency Exemptions; Agency Decisions and State and
Federal Agency Crisis Declarations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has granted emergency exemptions under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use of
pesticides as listed in this notice. The exemptions were granted during
the period October 1, 2022, to March 31, 2023, to control unforeseen
pest outbreaks.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed at the end of
the emergency exemption.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0015, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is<PHONE_NUMBER>. Please review the
visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.

II. Background

    EPA has granted emergency exemptions to the following State and
Federal agencies. The emergency exemptions may take the following form:
Crisis, public health, quarantine, or specific.
    Under FIFRA section 18 (7 U.S.C. 136p), EPA can authorize the use
of a pesticide when emergency conditions exist. Authorizations
(commonly called emergency exemptions) are granted to State and Federal
agencies and are of four types:
    1. A ``specific exemption'' authorizes use of a pesticide against
specific pests for a specific crop/site on a limited acreage, or other
unit for treatment (e.g., square footage, cartons of produce in a
particular State. Most emergency exemptions are specific exemptions.
    2. ``Quarantine'' and ``public health'' exemptions are emergency
exemptions issued for quarantine or public health purposes. These are
requested less frequently than specific exemptions.
    3. A ``crisis exemption'' is initiated by a State or Federal agency
(and is concurred upon by EPA) when there is insufficient time to
request and obtain EPA permission for emergency use of a pesticide
under one of the other types of emergency exemptions.
    EPA may deny an emergency exemption request: If the State or
Federal agency cannot demonstrate that an emergency exists, if the use
poses unacceptable risks to the environment, or if EPA cannot reach a
conclusion that the proposed pesticide use is likely to result in ``a
reasonable certainty of no harm'' to human health, including exposure
of infants and children to residues of the pesticide.
    If the emergency use of the pesticide on a food or feed commodity
would result in pesticide chemical residues, EPA establishes a time-
limited tolerance meeting the ``reasonable certainty of no harm
standard'' of the Federal Food, Drug, and Cosmetic Act (FFDCA).
    In this document: EPA identifies the State or Federal agency
granted the exemption, the type of exemption, the pesticide authorized,
the pests, the crop or use for which authorized, number of acres or
other unit for treatment (if applicable), and the effective date of the
exemption. EPA also gives the Federal Register citation for the time-
limited tolerance, if any, and notes when a Notice of Receipt (if
required under 40 CFR 166.24) was published in the Federal Register.

III. Emergency Exemptions

A. U.S. States and Territories

California
Department of Pesticide Regulation
    Specific exemption: EPA authorized the use of kasugamycin on a
maximum of 102,000 acres of almond trees to control bacterial blast.
Time-limited tolerances in connection with a previous action are
established in 40 CFR 180.614(b). This authorization was effective
February 1, 2023.
Louisiana
Department of Agriculture and Forestry
    Specific exemption: EPA authorized the use of triclopyr on a
maximum of 450,000 acres of sugarcane to control

divine nightshade. A time-limited tolerance in connection with this
action is established in 40 CFR 180.417(b). The authorization was
effective October 3, 2022.
Massachusetts
Department of Agricultural Resources
    Specific exemption: EPA authorized the use of pronamide on a
maximum of 5,000 acres of cranberries to control dodder. A time-limited
tolerance in connection with this action is established in 40 CFR
180.317(b). The authorization was effective April 15, 2023.
Texas
Department of Agriculture
    Quarantine exemption: EPA authorized the use of thiamethoxam on a
maximum of 190,000 acres of commercial rice fields to control the rice
delphacid. Time-limited tolerances in connection with this action are
established for thiamethoxam in 40 CFR 180.565(b). Section 18 use of
thiamethoxam on rice results in potential clothianidin (a major
metabolite of thiamethoxam) residues that, when combined with the
residues from the Section 3 use of clothianidin on rice, requires an
increase in the tolerance for residues of clothianidin in rice.
Therefore, a time-limited tolerance is established in 40 CFR
180.586(b), to support this emergency use. The authorization was
effective October 12, 2022.

B. Federal Departments and Agencies

United States Department of Agriculture
Animal and Plant Health Inspector Service
    Quarantine exemptions: EPA authorized the use of a mixture of
sodium hypochlorite and propylene glycol in freezing temperatures to
decontaminate hard, nonporous outdoor surfaces associated with poultry
facilities infected with Newcastle disease virus. The authorization was
effective October 18, 2022.
    EPA authorized the use of a mixture of potassium peroxymonosulfate
and propylene glycol for disinfection of hard, nonporous surfaces
associated with poultry facilities infected with Newcastle disease
virus. The authorization was effective December 20, 2022.
    EPA authorized the use of methyl bromide to fumigate post-harvest
unlabeled imported/domestic commodities to prevent the introduction/
spread of any new or recently introduced foreign pest(s) to any U.S.
geographical location. The authorization was effective March 3, 2023.
National Aeronautics and Space Administration
    Specific exemption: EPA authorized the use of ortho-phthaldehyde,
immobilized to a porous resin, to treat the International Space Station
(ISS) internal active thermal control system (IATCS) coolant for
control of aerobic and microaerophilic water bacteria and unidentified
gram-negative rods. This specific exemption was granted because,
without this use, the ISS would have no means to control organisms in
the IATCS since there are no registered alternatives available that
meet the required criteria. The emergency request proposed a use of a
new (unregistered) chemical. In accordance with the requirements at 40
CFR 166.24(a)(1), a notice of receipt published in the Federal Register
on September 26, 2022, to allow a public comment period that closed on
October 6, 2022. The authorization was effective October 7, 2022.
    Authority: 7 U.S.C. 136 et seq.

    Dated: April 26, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2023-09880 Filed 5-9-23; 8:45 am]
BILLING CODE 6560-50-P