UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                 NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY                              2000 TRAVERWOOD ROAD                            ANN ARBOR, MI  48105-2498

									          	OFFICE OF 										AIR AND RADIATION

November 23, 2010

MEMORANDUM

SUBJECT:	Meeting with Clean Energy

FROM:	Angela Cullen, Mechanical Engineer

TO:		Docket EPA-HQ-OAR-2010-0162

This memorandum documents a teleconference held on Friday, November 12, 2010 and Wednesday, November 17, 2010 between EPA and Clean Energy, NGV America, and Westport and included the following individuals:

Natural Gas Interests:  Todd Campbell, David Bookbinder, Karen Hamberg, Jonathon Burke, Charlie Carr, Scott Baser, Michael Evans, Camela Krebs, and Jeff Clarke

EPA: Byron Bunker, Angela Cullen, Julian Davis, Alan Stout, Chuck Moulis, Cle Jackson, and Don Kopinski

The groups discussed how natural gas engines were proposed to be regulated, including clarification on whether a natural gas engine would be subject to the spark-ignition or compression-ignition GHG standards, advanced technology credits, and upstream emissions of natural gas.


[Federal Register: April 24, 2009 (Volume 74, Number 78)]
[Notices]
[Page 18771-18777]
[DOCID:fr24ap09-109]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59781; File No. SR-NYSEArca-2009-28]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Order Granting Accelerated Approval of Proposed Rule Change
Relating to Listing and Trading of Shares of the ETFS Silver Trust

April 17, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 6, 2009, NYSE Arca, Inc. (``NYSE Arca'' or the ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons and is approving the proposed rule change on an accelerated
basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to list and trade shares (``Shares'') of the
ETFS Silver Trust (the ``Trust'') pursuant to NYSE Arca Equities Rule
8.201. The text of the proposed rule change is available on the
Exchange's Web site at http://www.nyx.com, at the Exchange's principal
office and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to list and trade the Shares under NYSE Arca
Equities Rule 8.201. Under NYSE Arca Equities Rule 8.201, the Exchange
may propose to list and/or trade pursuant to unlisted trading
privileges (``UTP'') ``Commodity-Based Trust Shares.'' \3\ The
Commission has previously approved listing on the Exchange under Rule
8.201 shares of the iShares Silver Trust and the streetTRACKS Gold
Trust,\4\ and, prior to their listing on the Exchange, approved listing
of the iShares Silver Trust on the American Stock Exchange LLC (now
known as ``NYSE Amex LLC'').\5\ In addition, the Commission has
approved trading of the iShares Silver Trust and the streetTRACKS Gold
Trust on the Exchange pursuant to UTP.\6\
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    \3\ Commodity-Based Trust Shares are securities issued by a
trust that represent investors' discrete identifiable and undivided
beneficial ownership interest in the commodities deposited into the
Trust.
    \4\ See Securities Exchange Act Release Nos. 58956 (November 14,
2008), 73 FR 71074 (November 24, 2008) (SR-NYSEArca-2008-124)
(approving listing on the Exchange of the iShares Silver Trust);
56224 (August 8, 2007) 72 FR 45850 (August 15, 2007) (SR-NYSEArca-
2007-76) (approving listing on the Exchange of the streetTRACKS Gold
Trust).
    \5\ See Securities Exchange Act Release No. 53521 (March 20,
2006), 71 FR 14967 (March 24, 2006) (SR-Amex-2005-72).
    \6\ See Securities Exchange Act Release Nos. 53520 (March 20,
2006), 71 FR 14977 (March 24, 2006) (SR-PCX-2005-117) (approving
trading on the Exchange pursuant to UTP of the iShares Silver
Trust); 51245 (February 23, 2005), 70 FR 10731 (March 4, 2005) (SR-
PCX-2004-117) (approving trading on the Exchange of the streetTRACKS
Gold Trust pursuant to UTP).
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    The Trust will issue ETFS Silver Shares (``Shares'') which
represent units of fractional undivided beneficial interest in and
ownership of the Trust. The investment objective of the Trust is for
the Shares to reflect the performance of the price of silver bullion,
less the Trust's expenses.\7\
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    \7\ See the Registration Statement for the ETFS Silver Trust on
Form S-1, filed with the Commission on March 20, 2009 (No. 333-
156307). The descriptions of the Trust, the Shares and the silver
market contained herein are based on the Registration Statement.
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    ETFS Services USA LLC is the sponsor of the Trust,\8\ Bank of New
York Mellon is the trustee of the Trust (``Trustee''),\9\ and HSBC Bank
U.S.A., N.A.is the custodian of the Trust (``Custodian'').\10\
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    \8\ See e-mail from Michael Cavalier, Chief Counsel, NYSE
Euronext, to Christopher W. Chow, Special Counsel, Commission, dated
April 14, 2009.
    \9\ The Trustee is generally responsible for the day-to-day
administration of the Trust. This includes (1) selling the Trust's
silver as needed to pay the Trust's expenses (silver sales are
expected to occur approximately monthly in the ordinary course), (2)
calculating the net asset value (``NAV'') of the Trust and the NAV
per Share, (3) receiving and processing orders from Authorized
Participants to create and redeem Baskets and coordinating the
processing of such orders with the Custodian and The Depository
Trust Company (``DTC'') and (4) monitoring the Custodian.
    \10\ The Custodian is responsible for the safekeeping of the
Trust's silver deposited with it by Authorized Participants in
connection with the creation of Baskets. The Custodian also
facilitates the transfer of silver in and out of the Trust through
silver accounts it will maintain for Authorized Participants and the
Trust. The Custodian is a market maker, clearer and approved weigher
under the rules of the London Bullion Market Association (``LBMA'').
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    The Exchange represents that the Shares satisfy the requirements of
Rule 8.201 and thereby qualify for listing on the Exchange.\11\
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    \11\ With respect to application of Rule 10A-3 (17 CFR 240.10A-
3) under the Act, the Trust relies on the exemption contained in
Rule 10A-3(c)(7).
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Global Over-The-Counter Market
    According to the Registration Statement, the global trade in silver
consists of Over-the-Counter (``OTC'') transactions in spot, forwards,
and options and other derivatives, together with exchange-traded
futures and options.
    The OTC silver market includes spot, forward, and option and other
derivative transactions conducted on a principal-to-principal basis.
While this is a global, nearly 24-hour per day market, its main centers
are London (the biggest venue), New York and Zurich.
    Market makers, as well as others in the OTC market, trade with each
other and with their clients on a principal-to-principal basis. All
risks and issues of credit are between the parties directly involved in
the transaction. Market makers include the market-making members of the
LBMA, the trade association that acts as the coordinator for activities
conducted on behalf of its members and other participants in the London
bullion market. The eleven market-making members of the LBMA are:
Barclays Bank plc, Deutsche Bank AG, HSBC Bank USA, N.A. (through its
London branch), Goldman Sachs International, JPMorgan Chase Bank,
ScotiaMocatta (a division of the Bank of Nova Scotia),
Soci[eacute]t[eacute] G[eacute]n[eacute]rale, Mitsui & Co. Precious
Metals Inc., Bear Stearns Forex Inc., Royal Bank of Canada, and UBS AG.
The OTC market provides a relatively flexible market in terms of
quotes, price, size, destinations for delivery and other factors.
Bullion dealers customize transactions to meet clients' requirements.
The OTC market has no formal structure and no open-outcry meeting
place.

    The main centers of the OTC market are London, New York and Zurich.
Mining companies, central banks, manufacturers of jewelry and
industrial products, together with investors and speculators, tend to
transact their business through one of these market centers. Centers
such as Dubai and several cities in the Far East also transact
substantial OTC market business, typically involving jewelry and small
bars (1 kilogram or less). Bullion dealers have offices around the
world and most of the world's major bullion dealers are either members
or associate members of the LBMA. Of the eleven market-making members
of the LBMA, six offer clearing services. There are a further 59 full
members, plus a number of associate members around the world. These
numbers may change from time to time as new members are added and
existing members drop out.
The London Bullion Market
    Although the market for physical silver is distributed globally,
most OTC market trades are cleared through London. In addition to
coordinating market activities, the LBMA acts as the principal point of
contact between the market and its regulators. A primary function of
the LBMA is its involvement in the promotion of refining standards by
maintenance of the ``London Good Delivery Lists,'' which are the lists
of LBMA accredited melters and assayers of silver. The LBMA also
coordinates market clearing and vaulting, promotes good trading
practices and develops standard documentation.\12\
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    \12\ Terms relating to the Trust and the Shares referred to, but
not defined, herein are defined in the Registration Statement.
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    The term ``loco London'' silver refers to silver physically held in
London that meets the specifications for weight, dimensions, fineness
(or purity), identifying marks (including the assay stamp of a LBMA
acceptable refiner) and appearance set forth in ``The Good Delivery
Rules for Gold and Silver Bars'' published by the LBMA. Silver bars
meeting these requirements are described in the Trust's prospectus as
``London Good Delivery Bars.'' The unit of trade in London is the troy
ounce, whose conversion between grams is: 1,000 grams = 32.1507465 troy
ounces and 1 troy ounce = 31.1034768 grams. A London Good Delivery Bar
is acceptable for delivery in settlement of a transaction on the OTC
market. A London Good Delivery must contain between 750 ounces and 1100
ounces of silver with a minimum fineness (or purity) of 999.0 parts per
1000. A London Good Delivery Bar must also bear the stamp of one of the
refiners who are on the LBMA-approved list. Unless otherwise specified,
the silver spot price always refers to that of a London Good Delivery
Bar. Business is generally conducted over the phone and through
electronic dealing systems.
    Once daily during London trading hours there is a fix (``London
Fix'') which provides reference silver prices for that day's trading.
According to the Registration Statement, many long-term contracts will
be priced on the basis of the London Fix, and market participants will
usually refer to this price when looking for a basis for valuations.
The London Fix is the most widely used benchmark for daily silver
prices and is quoted by various financial information sources.
    Three market making members of the LBMA conduct the Silver Fixing
meeting under the chairmanship of The Bank of Nova Scotia-ScotiaMocatta
by telephone at 12 noon London time each working day. The other two
members of the Silver Fixing are Deutsche Bank AG and HSBC Bank USA,
NA.
    Orders are placed either with one of the three fixing members or
with another bullion dealer who will then be in contact with a fixing
member during the fixing. The fixing members net-off all orders when
communicating their net interest at the fixing. The fix begins with the
fixing chairman suggesting a ``trying price,'' reflecting the market
price prevailing at the opening of the fix. This is relayed by the
fixing members to their dealing rooms which have direct communication
with all interested parties. Any market participant may enter the
fixing process at any time, or adjust or withdraw his order. The silver
price is adjusted up or down until all the buy and sell orders are
matched, at which time the price is declared fixed. All fixing orders
are transacted on the basis of this fixed price, which is instantly
relayed to the market through various media. According to the
Registration Statement, the London Fix is widely viewed as a full and
fair representation of all market interest at the time of the fix.
Futures Exchanges
    According to the Registration Statement, the most significant
silver futures exchanges are the COMEX, operated by Commodities
Exchange, Inc., a subsidiary of New York Mercantile Exchange, Inc.
(``NYMEX''), and the Tokyo Commodity Exchange (TOCOM). Trading on these
exchanges is based on fixed delivery dates and transaction sizes for
the futures and options traded. Trading costs on these exchanges is
negotiable. The Exchange represents that, as a matter of practice, only
a small percentage of the futures market turnover ever comes to
physical delivery of the silver represented by the contracts traded.
Both COMEX and TOCOM permit trading on margin. COMEX operates through a
central clearance system. TOCOM has a similar clearance system. In each
case, the exchange acts as a counterparty for each member for clearing
purposes.
Market Regulation
    The global silver markets are overseen and regulated by both
governmental and self-regulatory organizations. In addition, certain
trade associations have established rules and protocols for market
practices and participants. In the United Kingdom, responsibility for
the regulation of the financial market participants, including the
major participating members of the LBMA, falls under the authority of
the Financial Services Authority (``FSA'') as provided by the Financial
Services and Markets Act 2000 (``FSM Act''). Under this act, all UK-
based banks, together with other investment firms, are subject to a
range of requirements, including fitness and properness, capital
adequacy, liquidity, and systems and controls.
    The FSA is responsible for regulating investment products,
including derivatives, and those who deal in investment products.
Regulation of spot, commercial forwards, and deposits of gold and
silver not covered by the FSM Act is provided for by The London Code of
Conduct for Non-Investment Products, which was established by market
participants in conjunction with the Bank of England.
    The TOCOM has authority to perform financial and operational
surveillance on its members' trading activities, scrutinize positions
held by members and large-scale customers, and monitor the price
movements of futures markets by comparing them with cash and other
derivative markets' prices. To act as a Futures Commission Merchant
Broker, a broker must obtain a license from Japan's Ministry of
Economy, Trade and Industry (METI), the regulatory authority that
oversees the operations of the TOCOM.
    According to the Registration Statement, the Trust will not trade
in silver futures contracts on COMEX or on any other futures exchange.
The Trust will take delivery of physical silver that complies with the
LBMA silver delivery rules. Because the Trust will not trade in silver
futures contracts on any futures exchange, the Trust will not be
regulated by the Commodity Futures Trading Commission (``CFTC'') under
the Commodity Exchange Act (``CEA'')

as a ``commodity pool,'' and will not be operated by a CFTC-regulated
commodity pool operator. Investors in the Trust will not receive the
regulatory protections afforded to investors in regulated commodity
pools, nor may COMEX or any futures exchange enforce its rules with
respect to the Trust's activities. In addition, investors in the Trust
will not benefit from the protections afforded to investors in silver
futures contracts on regulated futures exchanges.
Product Description
    The activities of the Trust will be limited to (1) issuing Baskets
(as defined below) of Shares in exchange for the silver deposited with
the Custodian as consideration, (2) selling silver as necessary to
cover the Sponsor's Fee, Trust expenses not assumed by the Sponsor and
other liabilities, and (3) delivering silver in exchange for Baskets of
Shares surrendered for redemption. The Trust will not be actively
managed. It will not engage in any activities designed to obtain a
profit from, or to ameliorate losses caused by, changes in the price of
silver.
    The investment objective of the Trust is for the Shares to reflect
the performance of the price of silver bullion, less the Trust's
expenses. The Shares are intended to constitute a simple and cost-
effective means of making an investment similar to an investment in
silver. An investment in physical silver requires expensive and
sometimes complicated arrangements in connection with the assay,
transportation, warehousing and insurance of the metal. Although the
Shares will not be the exact equivalent of an investment in silver,
they provide investors with an alternative that allows a level of
participation in the silver market through the securities market.
    According to the Registration Statement, the Trust is not
registered as an investment company under the Investment Company Act of
1940 and is not required to register under such act. The Trust will not
hold or trade in commodity futures contracts regulated by the CEA, as
administered by the CFTC. According to the Registration Statement, the
Trust is not a commodity pool for purposes of the CEA, and the Sponsor
and Trustee are not subject to regulation as a commodity pool operator
or a commodity trading adviser in connection with the Shares.
Creation and Redemption Process
    Issuances of Shares will be made only in baskets of 100,000 shares
or multiples thereof (``Baskets'').\13\ The Trust will issue and redeem
Baskets daily, by or through registered broker-dealers that have
entered into participant agreements (each, an ``Authorized
Participant'') \14\ with the Trustee. The creation and redemption of
Baskets will only be made in exchange for the delivery to the Trust or
the distribution by the Trust of the amount of silver and any cash
represented by the Baskets being created or redeemed, the amount of
which will be based on the combined net asset value (``NAV'') of the
number of Shares included in the Baskets being created or redeemed
determined on the day the order to create or redeem Baskets is properly
received.
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    \13\ Initially, each Share represents one ounce of silver.
    \14\ An ``Authorized Participant'' is a person who (1) is a
registered broker-dealer or other securities market participant such
as a bank or other financial institution which is not required to
register as a broker-dealer to engage in securities transactions,
(2) is a participant in DTC, (3) has entered into a Participant
Agreement with the Trustee and the Sponsor, and (4) has established
an Authorized Participant Unallocated Account with the Custodian.
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    The total deposit required to create each Basket (the ``Creation
Basket Deposit'') will be an amount of silver and cash, if any, that is
in the same proportion to the total assets of the Trust (net of
estimated accrued but unpaid fees, expenses and other liabilities) on
the date the order to purchase is properly received as the number of
Shares to be created under the purchase order is in proportion to the
total number of Shares outstanding on the date the order is received.
The Sponsor anticipates that in the ordinary course of the Trust's
operations a cash deposit will not be required for the creation of
Baskets.\15\
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    \15\ The amount of any required cash deposit is determined as
follows. The estimated unpaid fees, expenses and liabilities of the
Trust accrued through the purchase order date are subtracted from
any cash held or receivable by the Trust as of the purchase order
date. The remaining amount is divided by the number of Shares
outstanding immediately before the purchase order date and then
multiplied by the number of Shares being created pursuant to the
purchase order. If the resulting amount is positive, this amount is
the required cash deposit. If the resulting amount is negative, the
amount of the required silver deposit will be reduced by the number
of fine ounces of silver equal in value to that resulting amount,
determined at the price of silver used in calculating the NAV of the
Trust on the purchase order date.
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    The amount of the required silver deposit is determined by dividing
the number of ounces of silver held by the Trust by the number of
Baskets outstanding, as adjusted for estimated accrued but unpaid fees
and expenses, as described in the Registration Statement.
    The Shares will not be individually redeemable but will only be
redeemable in Basket size. To redeem, an Authorized Participant will be
required to accumulate enough Shares to constitute a Basket (i.e.,
100,000 Shares). Redeeming Authorized Participants will receive an
allocation of silver to their accounts, in accordance with procedures
set forth in the Registration Statement. Shares will be registered in
book-entry form through DTC.
    The Exchange states that the Creation Basket Deposit necessary for
the creation of a Basket will slightly diminish each day depending on
the Trust's daily expense accrual and the market price of silver. The
initial Creation Basket Deposit will be a specified number of ounces of
silver (with each Share initially representing one ounce of silver). On
each day that the Exchange is open for regular trading, The Bank of New
York Mellon will adjust the quantity of silver constituting the
Creation Basket Deposit as appropriate to reflect sales of silver
needed for payment of the Sponsor's fee (which is similar to an expense
ratio) and any extraordinary expenses or liabilities not assumed by the
Sponsor. The Bank of New York Mellon will determine the Creation Basket
Deposit for a given business day by subtracting the daily expense
accrual from the previous day's total ounces of silver in the Trust and
then dividing the number of Baskets outstanding. Fractions of an ounce
of silver smaller than .001 will be disregarded.
    The creation/redemption process in connection with the Shares is an
in-kind exchange of silver for Shares, rather than an exchange of
silver for cash. Except for the accrual of the Sponsor's fee or
extraordinary expenses or liabilities, the process is based entirely on
the delivery of silver in exchange for Shares. Thus, throughout each
business day, the Exchange states that the actual number of ounces
required for the Creation Basket Deposit usually will not change even
though the value of the Creation Basket Deposit may change based on the
market price of silver.
Valuation of Silver, Definition of Net Asset Value and Adjusted Net
Asset Value (``ANAV'')
    According to the Registration Statement, as of the London Fix on
each day that the Exchange is open for regular trading or, if there is
no London Fix on such day or the London Fix has not been announced by
12 noon New York time on such day, as of 12 noon New York time on such
day (the ``Evaluation Time''), the Trustee will

evaluate the silver held by the Trust and determine both the ANAV and
the NAV of the Trust.
    At the Evaluation Time, the Trustee will value the Trust's silver
on the basis of that day's London Fix or, if no London Fix is made on
such day or has not been announced by the Evaluation Time, the next
most recent London Fix determined prior to the Evaluation Time will be
used, unless the Trustee, in consultation with the Sponsor, determines
that such price is inappropriate as a basis for evaluation. In the
event the Trustee and the Sponsor determine that the London Fix or last
prior London Fix is not an appropriate basis for evaluation of the
Trust's silver, they shall identify an alternative basis for such
evaluation to be employed by the Trustee.\16\
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    \16\ The Exchange, pursuant to Rule 7.12, has discretion to halt
trading in the Shares if the London Fix is not determined or
available for an extended time period based on extraordinary
circumstances or market conditions.
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    Once the value of the silver has been determined, the Trustee will
subtract all estimated accrued but unpaid fees, expenses and other
liabilities of the Trust from the total value of the silver and all
other assets of the Trust (other than any amounts credited to the
Trust's reserve account, if established). The resulting figure is the
ANAV of the Trust. The ANAV of the Trust is used to compute the
Sponsor's Fee.
    To determine the Trust's NAV, the Trustee will subtract the amount
of estimated accrued but unpaid fees computed by reference to the ANAV
of the Trust and to the value of the silver held by the Trust from the
ANAV of the Trust. The resulting figure is the NAV of the Trust. The
Trustee will also determine the NAV per Share by dividing the NAV of
the Trust by the number of the Shares outstanding as of the close of
trading on the Exchange (which includes the net number of any Shares
created or redeemed on such evaluation day).
    Shortly after 4 p.m. E.T. each business day, the Trust will
disseminate the NAV for the Shares and the Creation Basket Deposit (for
orders properly placed by 4 during the day). The Creation Basket
Deposit and NAV will be publicly available simultaneously to all market
participants and will be communicated to all Authorized Participants
via facsimile or electronic mail message and on the Trust's Web site.
The Exchange also will disclose the NAV on its Web site.
Liquidity
    The Exchange states that the amount of the discount or premium in
the trading price relative to the NAV per Share may be influenced by
the non-concurrent trading hours between the major silver markets and
the Exchange. While the Shares will trade on the Exchange from 4 a.m.
to 8 p.m. E.T., liquidity in the OTC market for silver will be reduced
after the close of the major world silver markets, including London,
Zurich, and the COMEX. As a result, trading spreads and the resulting
premium or discount on the Shares may widen as a result of reduced
liquidity.
Availability of Information Regarding Silver Prices
    Although the spot price of silver will not be disseminated over the
facilities of CTA, the last sale price for the Shares, as is the case
for all equity securities traded on the Exchange will be disseminated
over the CTA's Network B. In addition, there is a considerable amount
of silver \17\ price and market information available on public Web
sites and through professional and subscription services. Investors may
obtain on a 24-hour basis silver pricing information based on the spot
price of an ounce of silver from various financial information service
providers, such as Reuters and Bloomberg. In addition, the daily London
silver fix is also disseminated by various market data vendors and is
available from the LBMA's Web site. Reuters and Bloomberg provide at no
charge on their Web sites delayed information regarding the spot price
of silver and last sale prices of silver futures contracts and related
options, as well as information about news and developments in the
silver market. Reuters and Bloomberg also offer a professional service
to subscribers for a fee that provides information on silver prices
directly from market participants.\18\ Complete real-time data for
silver futures contracts and options prices traded on the COMEX is
available by subscription from Reuters and Bloomberg and also on a
delayed basis free of charge on the NYMEX Web site at http://
www.nymex.com. The Exchange also notes that there are a variety of
other public Web sites providing information on silver, ranging from
those specializing in precious metals to sites maintained by major
newspapers, such as The Wall Street Journal. Current silver spot prices
are also generally available with bid/ask spreads from silver bullion
dealers.\19\
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    \17\ The period of greatest liquidity in the silver market is
typically that time of the day when trading in the European time
zones overlaps with trading in the United States, which is when OTC
market trading in New York, London, Zurich and other centers
coincides with futures and options trading on the COMEX division of
the NYMEX. This period lasts for approximately four hours each New
York business day morning.
    \18\ In addition, ICAP's EBS platform also provides an
electronic trading platform to institutions such as bullion banks
and dealers for the trading of spot silver, as well as a feed of
live streaming prices to market data subscribers. Approximately 1.5
million ounces in gold, 10 million ounces in silver and $190 billion
a day in spot foreign exchange transactions is traded each day over
the EBS trading platform. See http://www.icap.com.
    \19\ The silver spot price is indicative only, constructed using
a variety of sources to compile a spot price that is intended to
represent a theoretical quote that might be obtained from a market
maker from time to time.
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Availability of Information Regarding Shares
    The Web site for the Trust, which will be publicly accessible at no
charge, will contain the following information: (a) The prior business
day's NAV and the reported closing price; (b) the mid-point of the bid-
ask price in relation to the NAV as of the time the NAV is calculated
(the ``Bid-Asked Price''); (c) calculation of the premium or discount
of such price against such NAV; (d) data in chart form displaying the
frequency distribution of discounts and premiums of the Bid-Ask Price
against the NAV,\20\ within appropriate ranges for each of the four
previous calendar quarters; (e) the Creation Basket Deposit; (f) the
Prospectus; and (g) other applicable quantitative information.
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    \20\ The bid-ask price of Shares is determined using the highest
bid and lowest offer as of the time of calculation of the NAV.
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    As described above, the NAV for the Trust will be calculated and
disseminated daily.
    The Exchange also will disseminate for the Trust on a daily basis
by means of CTA/CQ High Speed Lines information with respect to the
Indicative Trust Value (as discussed below), recent NAV, and shares
outstanding. The Exchange will also make available on its Web site
daily trading volume, closing prices, NAV and the Creation Basket
Deposit. The London silver fix price is readily available from the LBMA
at http://www.lbma.org.uk, automated quotation systems, published or
other public sources, or online information services such as Bloomberg
or Reuters. In addition, the Exchange will provide a hyperlink on its
Web site at http://www.nyx.com to the Trust's Web site at http://
www.etfsecurities.com.
Dissemination of Indicative Trust Value
    The Trustee will calculate the NAV of the Trust once each trading
day. In addition, the Trust will cause to be made available on a daily
basis the required amount of silver to be

deposited in connection with the issuance of Shares in Basket size.
    In order to provide updated information relating to the Trust for
use by investors, professionals, and Authorized Persons wishing to
create or redeem Shares, the Exchange will disseminate through the
facilities of CTA an updated Indicative Trust Value (``ITV''). The
Indicative Trust Value will be disseminated on a per Share basis at
least every 15 seconds during the Exchange's Core Trading Session (9:30
a.m. to 4 p.m. ET). The Indicative Trust Value, as calculated by the
Exchange or a third party financial data provider, will be calculated
based on the amount of silver required for creations and redemptions
and a price of silver derived from updated bids and offers indicative
of the spot price of silver from silver dealer pricing.\21\ The ITV on
a per Share basis disseminated during the Exchange's Core Trading
Session should not be viewed as a real time update of the NAV, which is
calculated only once a day.
---------------------------------------------------------------------------

    \21\ See e-mail from Michael Cavalier, Chief Counsel, NYSE Arca,
to Christoper W. Chow, Special Counsel, Commission, dated April 9,
2009.
---------------------------------------------------------------------------

    The Exchange believes that dissemination of the Indicative Trust
Value based on the amount of silver required for a Basket Aggregation
provides additional information that is not otherwise available to the
public and is useful to professionals and investors in connection with
Shares trading on the Exchange or the creation or redemption of Shares.
Termination Events
    The Trustee will terminate and liquidate the Trust if the aggregate
market capitalization of the Trust, based on the closing price for the
Shares, was less than $350 million (as adjusted for inflation) at any
time after the first anniversary after the Trust's formation and the
Trustee receives, within six months after the last of those trading
days, notice from the Sponsor of its decision to terminate the Trust.
The Trustee will terminate the Trust if the CFTC determines that the
Trust is a commodities pool under the CEA. The Trustee may also
terminate the Trust upon the agreement of the owners of beneficial
interests in the Shares (``Shareholders'') owning at least 75% of the
outstanding Shares. Additional termination events are described in the
Registration Statement.
Criteria for Initial and Continued Listing
    The Trust will be subject to the criteria in Rule 8.201(d) for
initial and continued listing of the Shares.
    It is anticipated that a minimum of 100,000 Shares will be required
to be outstanding at the start of trading. The minimum number of shares
required to be outstanding is comparable to requirements that have been
applied to previously listed shares of the iShares Silver Trust, the
streetTRACKS Gold Trust, the iShares COMEX Gold Trust and exchange-
traded funds. It is anticipated that the initial price of a Share will
be approximately $10.00. The Exchange believes that the anticipated
minimum number of Shares outstanding at the start of trading is
sufficient to provide adequate market liquidity.
Trading Rules
    The Exchange deems the Shares to be equity securities, thus
rendering trading in the Fund subject to the Exchange's existing rules
governing the trading of equity securities. Trading in the Shares on
the Exchange will occur in accordance with NYSE Arca Equities Rule
7.34(a). The Exchange has appropriate rules to facilitate transactions
in the Shares during all trading sessions. The minimum trading
increment for Shares on the Exchange will be $0.01.
    Further, NYSE Arca Equities Rule 8.201 sets forth certain
restrictions on ETP Holders acting as registered Market Makers in the
Shares to facilitate surveillance. Pursuant to NYSE Arca Equities Rule
8.201(h), an ETP Holder acting as a registered Market Maker in the
Shares is required to provide the Exchange with information relating to
its trading in the underlying silver, related futures or options on
futures, or any other related derivatives. NYSE Arca Equities Rule
8.201(i) prohibits an ETP Holder acting as a registered Market Maker in
the Shares from using any material nonpublic information received from
any person associated with an ETP Holder or employee of such person
regarding trading by such person or employee in the underlying silver,
related futures or options on futures or any other related derivative
(including the Shares). In addition, NYSE Arca Equities Rule 8.201(g)
prohibits an ETP Holder acting as a registered Market Maker in the
Shares from being affiliated with a market maker in the underlying
silver, related futures or options on futures or any other related
derivative unless adequate information barriers are in place, as
provided in NYSE Arca Equities Rule 7.26.
    As a general matter, the Exchange has regulatory jurisdiction over
its ETP Holders and their associated persons, which include any person
or entity controlling an ETP Holder, as well as a subsidiary or
affiliate of an ETP Holder that is in the securities business. A
subsidiary or affiliate of an ETP Holder that does business only in
commodities or futures contracts would not be subject to Exchange
jurisdiction, but the Exchange could obtain information regarding the
activities of such subsidiary or affiliate through surveillance sharing
agreements with regulatory organizations of which such subsidiary or
affiliate is a member.
    With respect to trading halts, the Exchange may consider all
relevant factors in exercising its discretion to halt or suspend
trading in the Shares. Trading on the Exchange in the Shares may be
halted because of market conditions or for reasons that, in the view of
the Exchange, make trading in the Shares inadvisable. These may
include: (1) the extent to which conditions in the underlying silver
market have caused disruptions and/or lack of trading, or (2) whether
other unusual conditions or circumstances detrimental to the
maintenance of a fair and orderly market are present. In addition,
trading in Shares will be subject to trading halts caused by
extraordinary market volatility pursuant to the Exchange's ``circuit
breaker'' rule.\22\
---------------------------------------------------------------------------

    \22\ See NYSE Arca Equities Rule 7.12.
---------------------------------------------------------------------------

Surveillance
    The Exchange intends to utilize its existing surveillance
procedures applicable to derivative products (including Commodity-Based
Trust Shares) to monitor trading in the Shares. The Exchange represents
that these procedures are adequate to properly monitor Exchange trading
of the Shares in all trading sessions and to deter and detect
violations of Exchange rules and applicable federal securities laws.
    The Exchange's current trading surveillance focuses on detecting
securities trading outside their normal patterns. When such situations
are detected, surveillance analysis follows and investigations are
opened, where appropriate, to review the behavior of all relevant
parties for all relevant trading violations. Also, pursuant to NYSE
Arca Equities Rule 8.201(h), the Exchange is able to obtain information
regarding trading in the Shares and the underlying silver, silver
futures contracts, options on silver futures, or any other silver
derivative, through ETP Holders acting as registered Market Makers, in
connection with such ETP Holders' proprietary or customer trades which
they effect on any relevant market. In addition, the Exchange may
obtain trading information via the Intermarket Surveillance Group
(``ISG'')

from other exchanges who are members of the ISG.\23\ Also, the Exchange
has an Information Sharing Agreement with NYMEX for the purpose of
sharing information in connection with trading in or related to COMEX
silver futures contracts.
---------------------------------------------------------------------------

    \23\ A list of ISG members is available at http://
www.isgportal.org. The Exchange notes that TOCOM is not an ISG
member and the Exchange does not have in place a comprehensive
surveillance sharing agreement with such market.
---------------------------------------------------------------------------

Information Bulletin
    Prior to the commencement of trading, the Exchange will inform its
ETP Holders in an Information Bulletin of the special characteristics
and risks associated with trading the Shares. Specifically, the
Information Bulletin will discuss the following: (1) The procedures for
purchases and redemptions of Shares in Baskets (including noting that
Shares are not individually redeemable and that silver is a wasting
asset); (2) NYSE Arca Equities Rule 9.2(a), which imposes a duty of due
diligence on its ETP Holders to learn the essential facts relating to
every customer prior to trading the Shares; (3) how information
regarding the ITV is disseminated; (4) the requirement that ETP Holders
deliver a prospectus to investors purchasing newly issued Shares prior
to or concurrently with the confirmation of a transaction; (5) the
possibility that trading spreads and the resulting premium or discount
on the Shares may widen as a result of reduced liquidity of silver
trading during the Core and Late Trading Sessions after the close of
the major world silver markets, and (6) trading information. For
example, the Information Bulletin will advise ETP Holders, prior to the
commencement of trading, of the prospectus delivery requirements
applicable to the Trust. The Exchange notes that investors purchasing
Shares directly from the Trust (by delivery of the Creation Basket
Deposit) will receive a prospectus. ETP Holders purchasing Shares from
the Trust for resale to investors will deliver a prospectus to such
investors.
    In addition, the Information Bulletin will reference that the Trust
is subject to various fees and expenses described in the Registration
Statement. The Information Bulletin will also reference the fact that
there is no regulated source of last sale information regarding
physical silver, that the Commission has no jurisdiction over the
trading of silver as a physical commodity, and that the CFTC has
regulatory jurisdiction over the trading of silver futures contracts
and options on silver futures contracts.
    The Information Bulletin will also discuss any relief, if granted,
by the Commission or the staff from any rules under the Act.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \24\ of
the Act in general and furthers the objectives of Section 6(b)(5) \25\
in particular in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transaction in
securities, and, in general to protect investors and the public
interest. The Exchange believes that the proposal will facilitate the
listing and trading of an additional type of commodity-based product
that will enhance competition among market participants, to the benefit
of investors and the marketplace.
---------------------------------------------------------------------------

    \24\ 15 U.S.C. 78f(b).
    \25\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

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

III. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2009-28 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2009-28. 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, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-NYSEArca-2009-28 and should
be submitted on or before May 15, 2009.

IV. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\26\ In particular, the Commission believes that the proposal
is consistent with Section 6(b)(5) \27\ in particular, in that it is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transaction in securities, and, in general to protect investors and the
public interest. The listing and trading of an additional type of

commodity-based product should enhance competition among market
participants and thereby benefit investors and the marketplace.
---------------------------------------------------------------------------

    \26\ In approving this 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).
    \27\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission believes that the proposal to list and trade the
Shares on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of
the Act,\28\ which sets forth Congress's finding that it is in the
public interest and appropriate for the protection of investors and the
maintenance of fair and orderly markets to assure the availability to
brokers, dealers, and investors of information with respect to
quotations for and transactions in securities. The Exchange will make
available, through the facilities of the CTA, the last sale price
information for the Shares. In addition, the Exchange will disseminate
each day through the facilities of the CTA the number of Shares
outstanding and the ITV on a per-Share basis at least every 15 seconds
from 9:30 a.m. to 4 p.m. ET. The Web site for the Trust, which will be
publicly accessible, contains information related to the NAV, including
the Bid-Asked Price, the Creation Basket Deposit, calculation
information and data related to the premium or discount of the Bid-
Asked Price against the NAV, the Prospectus, and other applicable
quantitative information, including trading volume data, NAV, and
closing prices. Shortly after 4 p.m. ET each business day, the Trust
will disseminate the NAV for the Shares, and the Creation Basket
Deposit. Information on silver prices and markets is available on
public Web sites and through professional and subscription services,
and investors may obtain on a 24-hour basis silver pricing information
based on the spot price of an ounce of silver from various financial
information service providers. Complete real-time data for silver
futures contracts and options prices traded on the COMEX is available
by subscription from information services such as Reuters or Bloomberg,
and information on silver is available from published or other public
sources. NYMEX also provides delayed futures and options information
free of charge.
---------------------------------------------------------------------------

    \28\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
---------------------------------------------------------------------------

    Furthermore, the Commission believes that the proposal to list and
trade the Shares is reasonably designed to promote fair disclosure of
information that may be necessary to price the Shares appropriately.
The Commission notes that the Exchange has represented that the Trustee
will calculate, and the Trust will disseminate, the NAV per Share
daily, and make the NAV available to all market participants at the
same time. In addition, NYSE Arca Equities Rule 8.201(i) provides that,
in connection with trading in an underlying physical commodity, related
commodity futures or options on commodity futures, or any other related
commodity derivative, including Commodity-Based Trust Shares, an ETP
Holder acting as a Market Maker (as defined in NYSE Arca Equities Rule
1.1(u)) in the Shares is restricted from using any material non-public
information received from any person associated with such ETP Holder
regarding by such person in the underlying physical commodity, related
commodity futures or options on commodity futures, or other related
commodity derivatives.
    The Commission also believes that the Exchange's trading halt rules
are reasonably designed to prevent trading in the Shares when
transparency is impaired. NYSE Arca Equities Rule 8.201(e)(2) provides
that, when the Exchange is the listing market, if the value of the
underlying commodity or ITV is no longer calculated or available on at
least a 15-second delayed basis, the Exchange would consider suspending
trading in the Shares. The Exchange has further represented that
trading on the Exchange in the Shares may be halted because of market
conditions or for reasons that, in the view of the Exchange, make
trading in the Shares inadvisable. These may include: (1) The extent to
which conditions in the underlying silver market have caused
disruptions and/or lack of trading; or (2) whether other unusual
conditions or circumstances detrimental to the maintenance of a fair
and orderly market are present. In addition, trading in Shares will be
subject to trading halts caused by extraordinary market volatility
pursuant to the Exchange's ``circuit breaker'' rule. NYSE Arca Equities
Rule 8.201(e)(2) also provides that the Exchange may seek to delist the
Shares in the event the value of the underlying silver or the ITV is no
longer calculated or available as required.
    The Commission further believes that the trading rules and
procedures to which the Shares will be subject pursuant to this
proposal are consistent with the Act. The Exchange has represented that
any securities listed pursuant to this proposal will be deemed equity
securities, and subject to existing Exchange rules governing the
trading of equity securities.
    In support of this proposal, the Exchange has made representations,
including:
    (1) The Exchange's surveillance procedures are adequate to deter
and detect violations of Exchange rules and applicable federal
securities laws.
    (2) The Exchange will distribute an Information Bulletin, the
contents of which are more fully described above, to ETP Holders in
connection with the trading of the Shares.
    This approval order is conditioned on the Exchange's
representations.
    The Commission finds good cause, pursuant to Section 19(b)(2) of
the Act,\29\ for approving the proposed rule change prior to the 30th
day after the date of publication of notice in the Federal Register.
The Exchange's proposal to list and trade the Shares does not present
any novel or significant regulatory issues. Previously, the Commission
approved a proposal by the Exchange to list and trade shares of another
trust that holds silver bullion pursuant to NYSE Arca Equities Rule
8.201.\30\
---------------------------------------------------------------------------

    \29\ 15 U.S.C. 78s(b)(2).
    \30\ See Securities Exchange Act Release No. 58956 (November 14,
2008), 73 FR 71074 (November 24, 2008) (SR-NYSEArca-2008-124)
(approving listing and trading of shares of the iShares Silver
Trust). See also Securities Exchange Act Release No. 53521 (March
20, 2006); 71 FR 14967 (March 24, 2006) (SR-Amex-2005-072)
(approving listing and trading of shares of the iShares Silver Trust
on the American Stock Exchange LLC).
---------------------------------------------------------------------------

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\31\ that the proposed rule change (SR-NYSEArca-2009-28) be, and it
hereby is, approved on an accelerated basis.
---------------------------------------------------------------------------

    \31\ 15 U.S.C. 78s(b)(2).

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

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

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-9385 Filed 4-23-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33527-33528]
[FR Doc No: 2015-14433]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-1656]

Determination of Regulatory Review Period for Purposes of Patent
Extension; XELJANZ

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for XELJANZ and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Campus, Rm. 3180, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product XELJANZ
(tofacitinib citrate). XELJANZ is indicated for the treatment of adult
patients with moderately to severely active rheumatoid arthritis who
have had an inadequate response or intolerance to methotrexate.
Subsequent to this approval, the USPTO received a patent term
restoration application for XELJANZ (U.S. Patent No. RE41,783) from
Pfizer Inc., and the USPTO requested FDA's assistance in determining
this patent's eligibility for patent term restoration. In a letter
dated March 26, 2014, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of XELJANZ represented the first permitted commercial marketing or use
of the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
XELJANZ is 3,947 days. Of this time, 3,564 days occurred during the
testing phase of the regulatory review period, while 383 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: January 18, 2002. FDA has verified the applicant's claim
that the date the investigational new drug application became effective
was on January 18, 2002.

    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: October
21, 2011. FDA has verified the applicant's claim that the new drug
application (NDA) for XELJANZ (NDA 203214) was submitted on October 21,
2011.
    3. The date the application was approved: November 6, 2012. FDA has
verified the applicant's claim that NDA 203214 was approved on November
6, 2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 5 years of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by August 11, 2015. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by December 9, 2015. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14433 Filed 6-11-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 217 (Thursday, November 10, 2022)]
[Notices]
[Pages 67898-67899]
[FR Doc No: 2022-24550]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2022-0843; FRL-10363-01-OCSPP]

Science Advisory Committee on Chemicals (SACC); Request for
Nominations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) invites the public
to nominate scientific experts from a diverse range of disciplines to
be considered for appointment to the Science Advisory Committee on
Chemicals (SACC), established pursuant to the Toxic Substances Control
Act (TSCA). EPA anticipates appointing new SACC members by mid-2023 due
to expiring membership terms. Sources in addition to this Federal
Register notice may be utilized to solicit nominations and identify
candidates. Any interested person or organization may nominate
qualified individuals to be considered prospective candidates to the
committee by following the instructions provided in this document.
Individuals may also self-nominate.

DATES: Nominations must be received on or before December 12, 2022.

ADDRESSES: Submit your nominations, identified by the docket
identification (ID) number EPA-HQ-OPPT-2022-0843, through the Federal
e-Rulemaking Portal at https://www.regulations.gov. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. More information about the dockets is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Tamue L. Gibson, MS, Designated
Federal Officer (DFO) and Acting Executive Secretary, telephone number:
(202) 564-7642; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to those involved in the manufacture,
processing, distribution, disposal, and/or those interested in the
assessment of risks involving chemical substances and mixtures. Since
other entities may also be interested, the Agency has not attempted to
describe all the specific entities that may be affected by this action.
If you have any questions regarding the applicability of this action to
a particular entity, consult the DFO listed under FOR FURTHER
INFORMATION CONTACT.

B. What should I consider as I prepare my nominations for EPA?

    1. Submitting CBI.
    Do not submit CBI information to EPA through regulations.gov or
email. If your nomination contains any information that you consider to
be CBI or otherwise protected, please contact the DFO listed under FOR
FURTHER INFORMATION CONTACT to obtain special instructions before
submitting your nomination. Information properly marked as CBI will not
be disclosed except in accordance with the procedures set forth in 40
CFR part 2.
    2. Request for nominations.
    As part of a broader process for developing a pool of candidates
for membership to the SACC, the EPA Peer Review and Ethics Branch
(PREB) staff solicits the public and stakeholder communities for
nominations of prospective candidates. Any interested person or
organization may nominate qualified individuals to be considered

as prospective candidates. Individuals may also self-nominate.

II. Background

    The SACC is a federal advisory committee, established in December
2016 pursuant to TSCA section 2625(o), and chartered under the Federal
Advisory Committee Act (FACA), 5 U.S.C. Appendix 2. EPA established the
SACC to provide independent advice and recommendations to the EPA
Administrator on the scientific basis for risk assessments,
methodologies, and approaches relating to implementation of TSCA. The
SACC members serve as Special Government Employees (SGEs) or Regular
Government Employees (RGEs). The SACC expects to meet approximately 4
to 6 times per year, or as needed and approved by the DFO. Currently,
there are 17 SACC members, with eight membership terms that will expire
over the next year. Therefore, EPA anticipates appointing up to eight
new members to the SACC by mid-2023.

III. Nominations

    In accordance with Executive Order 14035 of June 25, 2021, entitled
``Diversity, Equity, Inclusion, and Accessibility in the Federal
Workforce'' (86 FR 34593, June 30, 2021), EPA values and welcomes
opportunities to increase diversity, equity, inclusion and
accessibility on its federal advisory committees. In an effort to
obtain nominations of diverse candidates, EPA encourages nominations of
women and men of all racial and ethnic groups that draw from the full
diversity of the Nation. Any interested person or organization may
nominate qualified persons to be considered for appointment to this
advisory committee. Individuals also may self-nominate. Nominations may
be submitted in electronic format in accordance with the instructions
under ADDRESSES.
    Nominations should include candidates who have demonstrated high
levels of competence, knowledge, and expertise in scientific/technical
fields relevant to chemical safety and risk assessment. In particular,
the nominees should include representation of the following
disciplines, including, but not limited to: Human health and ecological
risk assessment, biostatistics, epidemiology, pediatrics,
physiologically based pharmacokinetics (PBPK), toxicology and pathology
(including neurotoxicology, developmental/reproductive toxicology, and
carcinogenesis), and the relationship of chemical exposures to women,
children, and other potentially exposed or susceptible subpopulations.
    To be considered, all nominations should include the following
information: Current contact information for the nominee (including the
nominee's name, organization, current business address, email address,
and daytime telephone number); the disciplinary and specific areas of
expertise of the nominee; and, when available, a biographical sketch of
the nominee indicating current position, educational background;
research activities; and recent service on other federal advisory
committees and national or international professional organizations.
Persons having questions about the nomination process should contact
the DFO listed under FOR FURTHER INFORMATION CONTACT.
    The DFO will acknowledge receipt of nominations. The names and
biographical sketches of nominees identified by respondents to this
Federal Register notice, other sources for nominations, and any
additional candidates identified by EPA Staff, will be posted in a List
of Candidates in the docket at https://www.regulations.gov and on the
SACC website at https://www.epa.gov/tsca-peer-review. The availability
of the list also will be announced through the Office of Chemical
Safety and Pollution Prevention (OCSPP)'s listservs. You may subscribe
to these listservs at the following website: https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101. Public comments on the List of Candidates
will be accepted for 30 days from the date the list is posted. The
public will be requested to provide relevant information or other
documentation on nominees that the EPA should consider in evaluating
candidates.

IV. Selection Criteria

    In addition to scientific expertise, in selecting members, EPA will
consider the differing perspectives and the breadth of collective
experience needed to address EPA's charge to the SACC, as well as the
following:
     Background and experiences that would contribute to the
diversity of scientific viewpoints on the committee, including
professional experiences in government, labor, public health, public
interest, animal protection, industry, and other groups, as the EPA
Administrator determines to be advisable (e.g., geographical location;
social and cultural backgrounds; and professional affiliations).
     Skills and experience working on committees and advisory
panels including demonstrated ability to work constructively and
effectively in a committee setting.
     Absence of financial conflicts of interest or the
appearance of a loss of impartiality.
     Willingness to commit adequate time for the thorough
review of materials provided to the committee.
     Availability to participate in committee meetings.
    Authority: 15 U.S.C. 2625 et seq; 5 U.S.C. Appendix 2 et seq.

    Dated: November 5, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2022-24550 Filed 11-9-22; 8:45 am]
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[Federal Register: April 28, 2006 (Volume 71, Number 82)]
[Proposed Rules]
[Page 25123-25124]
[DOCID:fr28ap06-22]

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

40 CFR Part 52

[EPA-R04-OAR-2003-TN-0001, EPA-R04-OAR-2004-TN-0001-200413(b); FRL-
8163-2]

Approval and Promulgation of Implementation Plans: Revisions to
the Tennessee Nitrogen Oxides Budget and Allowance Trading Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve two State Implementation Plan
(SIP) revisions to the Tennessee Department of Environment and
Conservation's Nitrogen Oxides (NOX) Budget Trading Program
(Trading Program) submitted October 27, 2003, and December 10, 2003, by
the State of Tennessee. The first revision corrects a miscalculation in
Tennessee's NOX trading budget for non-electric generating
units (non-EGUs) resulting from the use of an incorrect control
efficiency percentage for one of the Trading Program's non-EGU
sources--an Eastman Chemical Company boiler. The correction of this
miscalculation results in a 147 tons per season (tps) increase in
Tennessee's NOX trading budget for non-EGUs--making its non-
EGU trading budget 5,666 tps, instead of 5,519 tps, and increasing
Tennessee's total State-wide NOX budget from 163,928 tpy to
164,075 tpy. Based on this correction, Tennessee's second revision
reallocates trading allowances to Eastman Chemical Company--increasing
the NOX trading allowances from 416 tps to 549 tps for the
Eastman Chemical Company boiler.
    In the Final Rules section of this Federal Register, EPA is
approving the State's SIP revisions as a direct final rule without
prior proposal because the Agency views these as noncontroversial
submittals and anticipates no adverse comments. A detailed rationale
for the approval is set forth in the direct final rule. If no
significant, material, and adverse comments are received in response to
this rule, no further activity is contemplated. If EPA receives adverse
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period on
this document. Any parties interested in commenting on this document
should do so at this time.

DATES: Written comments must be received on or before May 30, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2003-TN-0001 or EPA-R04-OAR-2004-TN-0001, by one of the following
methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2003-TN-0001 or EPA-R04-OAR-2004-TN-0001'',
Regulatory Development Section, Air Planning Branch, Air, Pesticides
and Toxics Management Division, U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960.
    Hand Delivery or Courier: Stacy DiFrank, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. Such deliveries are only
accepted during the Regional Office's normal hours of operation. The
Regional Office's official hours of business are Monday through Friday,
8:30 to 4:30, excluding Federal holidays. Please see the direct final
rule which is located in the Rules section of

this Federal Register for detailed instructions on how to submit
comments.

FOR FURTHER INFORMATION CONTACT: Stacy DiFrank, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. The telephone number is (404)
562-9042. Ms. DiFrank can also be reached via electronic mail at
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: For additional information, see the direct
final rule which is published in the Rules section of this Federal
Register.

    Dated: April 19, 2006.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 06-4022 Filed 4-27-06; 8:45 am]

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[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Rules and Regulations]
[Pages 21470-21472]
[FR Doc No: 2016-08272]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2016-0003; FRL-9944-83-Region 10]

Approval and Promulgation of Implementation Plans; Spokane,
Washington: Second 10-Year PM10 Limited Maintenance Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving the
limited maintenance plan submitted on January 4, 2016, by the State of
Washington for the Spokane area, which includes the cities of Spokane,
Spokane Valley, Millwood and surrounding unincorporated areas in
Spokane County, Washington. This plan addresses the second 10-year
maintenance period for particulate matter with an aerodynamic diameter
less than or equal to a nominal 10 micrometers (PM10). A
limited maintenance plan is used to meet Clean Air Act requirements for
formerly designated nonattainment areas that meet certain qualification
criteria. The EPA determined that Washington's submittal meets the
limited maintenance plan criteria. The Spokane area currently has
monitored PM10 levels well below the National Ambient Air
Quality Standards (NAAQS) and levels have not increased since the area
was redesignated to attainment in 2005. The EPA is also approving minor
updates to the Spokane Regional Clean Air Agency (SRCAA) regulations
controlling PM10 related to the maintenance plan.

DATES: This final rule is effective May 12, 2016.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R10-OAR-2016-0003. All documents in the docket are
listed on the http://www.regulations.gov Web site. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information the
disclosure of which is restricted by statute. Certain other material,
such as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through http://www.regulations.gov or in hard copy at the Air Programs Unit, Office of
Air, Waste and Toxics, EPA Region 10, 1200 Sixth Avenue, Seattle, WA,
98101. The EPA requests that if at all possible, you contact the
individual listed in the FOR FURTHER INFORMATION CONTACT section to
view the hard copy of the docket. You may view the hard copy of the
docket Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding Federal
holidays.

FOR FURTHER INFORMATION CONTACT: For information please contact Jeff
Hunt at<PHONE_NUMBER><EMAIL_ADDRESS>or by using the above EPA,
Region 10 address.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background Information
II. Final Action
III. Incorporation by Reference
IV. Statutory and Executive Orders Review

I. Background Information

    On February 26, 2016, the EPA proposed to approve the limited
maintenance plan submitted by the State of Washington, on January 4,
2016, for the Spokane PM10 area, including minor regulatory
changes associated with the limited maintenance plan (81 FR 9793). An
explanation of the Clean Air Act requirements, a detailed analysis of
the submittal, and the EPA's reasons for proposing approval were
provided in the notice of proposed rulemaking, and will not be restated
here. The public comment period for this proposed rule ended on March
28, 2016. The EPA received no comments on the proposal.

II. Final Action

    The EPA is approving the limited maintenance plan submitted by the
State of Washington, on January 4, 2016, for the Spokane
PM10 area. The EPA's approval of this limited maintenance
plan satisfies the Clean Air Act requirements for the second 10-year
period in the Spokane PM10 area. Additionally, the EPA is
approving and incorporating by reference updated versions of supporting
regulations, specifically SRCAA Regulation I, sections 6.05, 6.14, and
6.15. These regulatory changes update and clarify the general
PM10 control measures, including minor revisions to the
emission reduction strategies for both paved and unpaved roads.

III. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
regulations described in the amendments to 40 CFR part 52 set forth
below. The EPA has made, and will continue to make, these documents
generally available electronically through http://www.regulations.gov
and/or in hard copy at the appropriate EPA office (see the ADDRESSES
section of this preamble for more information).

IV. Statutory and Executive Orders Review

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Clean Air Act
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because this action does not involve technical standards; and
     does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because it will not impose substantial direct costs on tribal
governments or preempt tribal law. This SIP revision is not approved to
apply in Indian reservations in the State or any other area where the
EPA or an Indian tribe has demonstrated that a tribe has jurisdiction.
Consistent with EPA policy, the EPA provided a consultation opportunity
to the Spokane Tribe in a letter dated May 21, 2015. The EPA did not
receive a request for consultation.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 13, 2016. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

     Dated: April 1, 2016.
Dennis J. McLerran,
Regional Administrator, Region 10.

    For the reasons set forth in the preamble, 40 CFR part 52 is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for Part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart WW--Washington

0
2. In Sec.  52.2470:
0
a. Amend paragraph (c), Table 9 ``Additional Regulations Approved for
Spokane Regional Clean Air Agency (SRCAA) Jurisdiction ``, by revising
entries ``6.05'', ``6.14'', and ``6.15''.
0
b. Amend paragraph (e), Table 2 ``Attainment, Maintenance, and Other
Plans'', by adding an entry to the end of the table.
    The revisions and addition read as follows:

Sec.  52.2470  Identification of plan.

* * * * *
    (c) * * *

                         Table 9--Additional Regulations Approved for the Spokane Regional Clean Air Agency (SRCAA) Jurisdiction
 [Applicable in Spokane County, excluding facilities subject to Energy Facilities Site Evaluation Council (EFSEC) jurisdiction, Indian reservations and
 any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, and facilities subject to the applicability sections of
                                               WAC 173-400-700, 173-405-012, 173-410-012, and 173-415-012]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                State/local
       State/local citation              Title/subject        effective date            EPA approval date                       Explanations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Spokane Regional Clean Air Agency Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Regulation I--Article VI--Emissions Prohibited
--------------------------------------------------------------------------------------------------------------------------------------------------------
6.05.............................  Particulate Matter and           04/10/04  04/12/16 [Insert Federal Register     Except 6.05(A).
                                    Preventing Particulate                     citation].
                                    Matter from Becoming
                                    Airborne.
6.14.............................  Standards for Control of         06/03/07  04/12/16 [Insert Federal Register     ....................................
                                    Particulate Matter on                      citation].
                                    Paved Surfaces.
6.15.............................  Standards for Control of         06/03/07  04/12/16 [Insert Federal Register     ....................................
                                    Particulate Matter on                      citation].
                                    Unpaved Roads.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
    (e) * * *

                                                    Table 2--Attainment, Maintenance, and Other Plans
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                    Applicable geographic       State
       Name of SIP Provision        or nonattainment area  submittal date             EPA approval date                         Explanations
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Particulate Matter (PM10) 2nd 10-   Spokane..............          1/4/16  4/12/16 [Insert Federal Register        .....................................
 Year Limited Maintenance Plan.                                             citation].
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2016-08272 Filed 4-11-16; 8:45 am]
 BILLING CODE 6560-50-P