[Federal Register Volume 79, Number 142 (Thursday, July 24, 2014)]
[Notices]
[Pages 43108-43114]
[FR Doc No: 2014-17398]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72641; File No. SR-NYSEArca-2014-64]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting
Approval of Proposed Rule Change To List and Trade Shares of the ARK
Innovation ETF, ARK Genomic Revolution ETF, ARK Industrial Innovation
ETF, and ARK Web x.0 ETF Under NYSE Arca Equities Rule 8.600

July 18, 2014.

I. Introduction

    On May 28, 2014, NYSE Arca, Inc. (``Exchange'' or ``NYSE Arca'')
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 proposed rule change to
list and trade shares (``Shares'') of the following under NYSE Arca
Equities Rule 8.600, which governs the listing and trading of Managed
Fund Shares on the Exchange: ARK Innovation ETF, ARK Genomic Revolution
ETF, ARK Industrial Innovation ETF, and ARK Web x.0 ETF (individually,
``Fund'' and, collectively, ``Funds''). The proposed rule change was
published for comment in the Federal Register on June 10, 2014.\3\ The
Commission received no comments on the proposed rule change. This order
grants approval of the proposed rule change.
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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. 72314 (Jun. 4,
2014), 79 FR 33229 (``Notice'').
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II. Description of Proposed Rule Change

    The Exchange has made the following representations and statements
in describing each Fund and its respective investment strategies,
including other portfolio holdings and investment restrictions.\4\
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    \4\ The Commission notes that additional information regarding
the Trust, the Funds, and the Shares, including investment
strategies, risks, net asset value (``NAV'') calculation, creation
and redemption procedures, fees, portfolio holdings disclosure
policies, distributions, and taxes, among other information, is
included in the Notice and the Registration Statement, as
applicable. See Notice and Registration Statement, supra note 3 and
infra note 5, respectively.
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General

    The Shares will be offered by ARK ETF Trust (``Trust''), which is
organized as a Delaware statutory trust and is registered with the
Commission as an open-end management investment company.\5\ ARK
Investment Management LLC (``Adviser'') will serve as the investment
adviser to the Funds.\6\ Foreside Fund Services, LLC will be the
principal underwriter and distributor of the Funds' Shares. The Bank of
New York Mellon will serve as administrator, custodian and transfer
agent.
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    \5\ The Trust is registered under the Investment Company Act of
1940 (``1940 Act''). The Exchange states that on March 31, 2014, the
Trust filed with the Commission its registration statement on Form
N-1A under the Securities Act of 1933 (``Securities Act'') and under
the 1940 Act relating to the Funds (File Nos. 333-191019 and 811-
22883) (``Registration Statement''). In addition, according to the
Exchange, the Trust has obtained certain exemptive relief under the
1940 Act. See Investment Company Act Release No. 31009 (April 7,
2014) (File No. 812-14172).
    \6\ The Exchange states that the Adviser is not registered as a
broker-dealer and is not affiliated with a broker-dealer. The
Exchange states that in the event (a) the Adviser or any sub-adviser
becomes, or becomes newly affiliated with, a broker-dealer, or (b)
any new adviser or sub-adviser is, or becomes affiliated with, a
broker-dealer, it will implement a fire wall with respect to its
relevant personnel or broker-dealer affiliate, as applicable,
regarding access to information concerning the composition and/or
changes to a portfolio, and will be subject to procedures designed
to prevent the use and dissemination of material, non-public
information regarding such portfolio.
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ARK Genomic Revolution ETF

    The ARK Genomic Revolution ETF's investment objective will be long-
term growth of capital.
    The Fund will invest, under normal circumstances,\7\ primarily (at
least 80% of its assets) in domestic and foreign equity securities of
companies that are relevant to the Fund's investment theme of genomics.
Companies relevant to this theme are those that are focused on and are
expected to benefit from extending and enhancing the quality of human
and other life by incorporating technological and scientific
developments, improvements and advancements in genetics into their
business, such as by offering new products or services that rely on
genetic sequencing, analysis, synthesis, or instrumentation. These
companies may include ones that develop, produce, manufacture, or
significantly rely on bionic devices, bio-inspired computing,
bioinformatics, molecular medicine, and agricultural biology.
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    \7\ The term ``under normal circumstances'' includes, but is not
limited to, the absence of extreme volatility or trading halts in
the equity markets or the financial markets generally; operational
issues causing dissemination of inaccurate market information; or
force majeure type events such as systems failure, natural or man-
made disaster, act of God, armed conflict, act of terrorism, riot or
labor disruption, or any similar intervening circumstance.
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    In selecting companies that the Adviser believes are relevant to a
particular investment theme, it will seek

to identify, using its own internal research and analysis, companies
capitalizing on disruptive innovation or that are enabling the further
development of a theme in the markets in which they operate. The
Adviser's internal research and analysis will leverage insights from
diverse sources, including external research, to develop and refine its
investment themes and identify and take advantage of trends that have
ramifications for individual companies or entire industries. The
Adviser will use both ``top down'' (macro-economic and business cycle
analysis) and ``bottom up'' (valuation, fundamental, and quantitative
measures) approaches to select investments for the Fund.
    Under normal circumstances, substantially all of the Fund's assets
will be invested in equity securities, including common stocks,
partnership interests, business trust shares, and other equity
investments or ownership interests in business enterprises.\8\
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    \8\ At least 90% of each Fund's investments in equity securities
(including Global Depositary Receipts (``GDRs''), American
Depositary Receipts (``ADRs''), rights, warrants, and preferred
securities, discussed under ``Other Investments,'' below) will be in
securities that trade in markets that are members of the Intermarket
Surveillance Group (``ISG'') or are parties to a comprehensive
surveillance sharing agreement with the Exchange.
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    The Fund's investments will include issuers of micro-, small-,
medium-, and large-capitalizations. The Fund's investments in foreign
equity securities will be in both developed and emerging markets.\9\
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    \9\ The Adviser generally considers emerging market countries to
be developing market countries whose gross domestic product per
person is classified below ``high income'' by the World Bank.
Investments in emerging markets equity securities will not exceed
20% of a Fund's total assets.
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    The Fund will be concentrated in issuers in any industry or group
of industries in the health care sector. Issuers in the health care
sector include manufacturers and distributors of health care equipment
and supplies, owners and operators of health care facilities, health
maintenance organizations and managed health care plans, health care
providers, and issuers that provide services to health care providers.

ARK Industrial Innovation ETF

    The ARK Industrial Innovation ETF's investment objective will be
long-term growth of capital.
    The Fund will invest, under normal circumstances,\10\ primarily (at
least 80% of its assets) in domestic and foreign equity securities of
companies that are relevant to the Fund's investment theme of
industrial innovation. Companies relevant to this theme are those that
are expected to focus on and benefit from the development of new
products or services, technological improvements, and advancements in
scientific research related to, among other things, disruptive
innovation in energy (``energy transformation companies''), automation
and manufacturing (``automation transformation companies''), materials,
and transportation.\11\
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    \10\ See supra note 7.
    \11\ The Adviser will consider a company to be an energy
transformation company if it seeks to capitalize on innovations or
evolutions in: (i) Ways that energy is stored or used; (ii) the
discovery, collection and/or implementation of new sources of
energy, including unconventional sources of oil or natural gas; and/
or (iii) the production or development of new materials for use in
commercial applications of energy production, use or storage. The
Adviser will consider a company to be an automation transformation
company if it is focused on man capitalizing on the productivity of
machines, such as through the automation of functions, processes or
activities previously performed by human labor, or the use of
robotics to perform other functions, activities, or processes.
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    In selecting companies that the Adviser believes are relevant to a
particular investment theme, it will seek to identify, using its own
internal research and analysis, companies capitalizing on disruptive
innovation or that are enabling the further development of a theme in
the markets in which they operate. The Adviser's internal research and
analysis will leverage insights from diverse sources, including
external research, to develop and refine its investment themes and
identify and take advantage of trends that have ramifications for
individual companies or entire industries. The Adviser will use both
``top down'' (macro-economic and business cycle analysis) and ``bottom
up'' (valuation, fundamental, and quantitative measures) approaches to
select investments for the Fund.
    Under normal circumstances, substantially all of the Fund's assets
will be invested in equity securities, including common stocks,
partnership interests, business trust shares, and other equity
investments or ownership interests in business enterprises.\12\
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    \12\ See supra note 8.
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    The Fund's investments will include issuers of micro-, small-,
medium-, and large-capitalizations. The Fund's investments in foreign
equity securities will be in both developed and emerging markets.\13\
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    \13\ See supra note 9.
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    The Fund will be concentrated in issuers in any industry or group
of industries in the industrials \14\ and information technology
sectors.\15\
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    \14\ The industrials sector includes companies engaged in the
manufacture and distribution of capital goods, such as those used in
defense, construction and engineering, companies that manufacture
and distribute electrical equipment and industrial machinery, and
those that provide commercial and transportation services and
supplies.
    \15\ The information technology sector includes software
developers, providers of information technology consulting and
services, and manufacturers and distributors of computers,
peripherals, communications equipment, and semiconductors.
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ARK Innovation ETF

    The ARK Innovation ETF's investment objective will be long-term
growth of capital.
    The Fund will invest, under normal circumstances,\16\ primarily (at
least 65% of its assets) in domestic and foreign equity securities of
companies that are relevant to the Fund's investment theme of
disruptive innovation. Companies relevant to this theme are those that
rely on or benefit from the development of new products or services,
technological improvements, and advancements in scientific research
relating to the areas of genomics (``genomic companies''), industrial
innovation (``industrial innovation companies''), or the increased use
of shared technology, infrastructure, and services (``Web x.0
companies'').
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    \16\ See supra note 7.
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    In selecting companies that the Adviser believes are relevant to a
particular investment theme, it will seek to identify, using its own
internal research and analysis, companies capitalizing on disruptive
innovation or that are enabling the further development of a theme in
the markets in which they operate. The Adviser's internal research and
analysis will leverage insights from diverse sources, including
external research, to develop and refine its investment themes and
identify and take advantage of trends that have ramifications for
individual companies or entire industries. The types of companies that
the Adviser believes are genomic companies, industrial innovation
companies, or Web x.0 companies are listed below:
     Genomics companies are companies that are focused on and
are expected to benefit from extending and enhancing the quality of
human and other life by incorporating technological and scientific
developments in genetics into their business, such as by offering
products or services that rely on genetic sequencing, analysis,
synthesis, or instrumentation. These companies may include ones that
develop, produce,

manufacture, or significantly rely on bionic devices, bio-inspired
computing, bioinformatics, molecular medicine, and agricultural
biology.
     Industrial innovation companies are companies that are
focused on and are expected to benefit from the development of new
products or services, technological improvements, and advancements in
scientific research related to, among other things, disruptive
innovation in energy (energy transformation companies), automation and
manufacturing (automation transformation companies), materials, and
transportation.\17\
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    \17\ See supra note 11.
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     Web x.0 companies are companies that are focused on and
expected to benefit from shifting the bases of technology
infrastructure from hardware and software to the cloud, enabling mobile
and local services, such as companies that rely on or benefit from the
increased use of shared technology, infrastructure, and services. These
companies may also include ones that develop, use, or rely on
innovative payment methodologies, big data, the internet of things, and
social distribution and media.
    The Adviser will select investments for the Fund that represent its
highest-conviction investment ideas within the theme of disruptive
innovation, as described above, in constructing the Fund's portfolio.
The Adviser's process for identifying genomic companies, industrial
innovation companies, and Web x.0 companies will use both ``top down''
(macro-economic and business cycle analysis) and ``bottom up''
(valuation, fundamental, and quantitative measures) approaches. The
Adviser's highest-conviction investment ideas are those that it
believes present the best risk-reward opportunities.
    Under normal circumstances, substantially all of the Fund's assets
will be invested in equity securities, including common stocks,
partnership interests, business trust shares, and other equity
investments or ownership interests in business enterprises.\18\
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    \18\ See supra note 8.
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    The Fund's investments will include issuers of micro-, small-,
medium-, and large-capitalizations. The Fund's investments in foreign
equity securities will be in both developed and emerging markets.\19\
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    \19\ See supra note 9.
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    The Fund will be concentrated in issuers in any industry or group
of industries in the industrials \20\ and information technology \21\
sectors.
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    \20\ See supra note 14.
    \21\ See supra note 15.
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ARK Web x.0 ETF

    The ARK Web x.0 ETF's investment objective will be long-term growth
of capital.
    The Fund will invest, under normal circumstances,\22\ primarily (at
least 80% of its assets) in domestic and foreign equity securities of
companies that are relevant to the Fund's investment theme of Web x.0.
Companies relevant to this theme are focused on and expected to benefit
from shifting the bases of technology infrastructure from hardware and
software to the cloud, enabling mobile and local services, such as
companies that rely on or benefit from the increased use of shared
technology, infrastructure, and services. These companies may also
include ones that develop, use, or rely on innovative payment
methodologies, big data, the internet of things, and social
distribution and media.
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    \22\ See supra note 7.
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    In selecting companies that the Adviser believes are relevant to a
particular investment theme, it will seek to identify, using its own
internal research and analysis, companies capitalizing on disruptive
innovation or that are enabling the further development of a theme in
the markets in which they operate. The Adviser's internal research and
analysis will leverage insights from diverse sources, including
internal and external research, to develop and refine its investment
themes and identify and take advantage of trends that have
ramifications for individual companies or entire industries. The
Adviser will use both ``top down'' (macro-economic and business cycle
analysis) and ``bottom up'' (valuation, fundamental, and quantitative
measures) approaches to select investments for the Fund.
    Under normal circumstances, substantially all of the Fund's assets
will be invested in equity securities, including common stocks,
partnership interests, business trust shares, and other equity
investments or ownership interests in business enterprises.\23\
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    \23\ See supra note 8.
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    The Fund's investments will include issuers of micro-, small-,
medium-, and large-capitalizations. The Fund's investments in foreign
equity securities will be in both developed and emerging markets.\24\
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    \24\ See supra note 9.
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    The Fund will be concentrated in issuers in any group of industries
in the information technology sector.\25\ The Fund's investments may
include issuers in the telecommunications services sector.\26\
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    \25\ See supra note 15.
    \26\ The telecommunications services sector includes companies
that provide fixed-line or wireless telecommunication and data
transmission services.
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Other Investments

    While each Fund will invest, under normal circumstances, primarily
in the equity securities described above, each Fund may invest in other
investments, as described below. With the exception of the ARK
Innovation ETF, under normal circumstances, such other investments will
not exceed 20% of a Fund's assets. Regarding the ARK Innovation ETF,
under normal circumstances, such other investments will not exceed 35%
of the Fund's investments.
    Each Fund may invest no more than 35% of its assets in depositary
receipts (i.e., ADRs and GDRs), rights, warrants, preferred securities,
and convertible securities.
    ADRs and GDRs are securities typically issued by a bank or trust
company that evidence ownership of underlying securities issued by a
foreign corporation and entitle the holder to all dividends and capital
gains that are paid out on the underlying foreign securities. Rights
and warrants are option securities permitting their holders to
subscribe for other securities. Preferred securities are contractual
obligations that entail rights to distributions declared by the
issuer's board of directors, but may permit the issuer to defer or
suspend distributions for a certain period of time. ADRs may be traded
over the counter (``OTC'').\27\
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    \27\ See supra note 8.
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    Each Fund may invest in the securities of open-end or closed-end
investment companies, subject to applicable limitations under the 1940
Act. A Fund's investment in other investment companies may include
shares of exchange traded funds registered under the 1940 Act
(``ETFs''),\28\ closed-end investment companies (which include business
development companies), unit investment trusts, and other open-end
investment companies. In addition, the Funds may invest in other
exchange-traded products (``ETPs''), such as commodity pools,\29\ or
other entities that are traded on an exchange.
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    \28\ For purposes of this filing, ETFs, which will be listed on
a national securities exchange, include the following: Investment
Company Units (as described in NYSE Arca Equities Rule 5.2(j)(3));
Portfolio Depositary Receipts (as described in NYSE Arca Equities
Rule 8.100); and Managed Fund Shares (as described in NYSE Arca
Equities Rule 8.600).
    \29\ For purposes of this filing, ETPs include Trust Issued
Receipts (as described in NYSE Arca Equities Rule 8.200); Commodity-
Based Trust Shares (as described in NYSE Arca Equities Rule 8.201);
Currency Trust Shares (as described in NYSE Arca Equities Rule
8.202); Commodity Index Trust Shares (as described in NYSE Arca
Equities Rule 8.203); and Trust Units (as described in NYSE Arca
Equities Rule 8.500).

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    In addition, each Fund may use derivative instruments.
Specifically, the Funds may use options, futures, swaps, and forwards,
for hedging or risk management purposes or as part of its investment
practices. Derivative instruments are contracts whose value depends on,
or is derived from, the value of an underlying asset, reference rate,
or index. These underlying assets, reference rates, or indices may be
any one of the following: stocks, interest rates, currency exchange
rates, and stock indices.
    The options in which the Funds may invest may be exchanged-traded
or OTC. The exchange-traded options in which the Funds may invest will
trade on markets that are members of the ISG or parties to a
comprehensive surveillance sharing agreement with the Exchange. The
futures in which the Funds may invest will be exchange-traded. Each
Fund will not invest more than 10% of its assets in futures that trade
in markets that are not members of the ISG or parties to a
comprehensive surveillance sharing agreement with the Exchange. The
swaps in which the Funds will invest may be cleared swaps or non-
cleared. The Funds will collateralize their obligations with liquid
assets consistent with the 1940 Act and interpretations thereunder.
    The Funds will only enter into transactions in derivative
instruments with counterparties that the Adviser reasonably believes
are capable of performing under the contract and will post as
collateral as required by the counterparty. The Funds will seek, where
possible, to use counterparties, as applicable, whose financial status
is such that the risk of default is reduced; however, the risk of
losses resulting from default is still possible. The Adviser will
evaluate the creditworthiness of counterparties on a regular basis. In
addition to information provided by credit agencies, the Adviser will
review approved counterparties using various factors, which may include
the counterparty's reputation, the Adviser's past experience with the
counterparty, and the price/market actions of debt of the counterparty.
    The Funds may invest in currency forwards. A currency forward
transaction is a contract to buy or sell a specified quantity of
currency at a specified date in the future at a specified price, which
may be any fixed number of days from the date of the contract agreed
upon by the parties, at a price set at the time of the contract.
Currency forward contracts may be used to increase or reduce exposure
to currency price movements.
    The Funds may enter into futures contracts and options, including
options on futures contracts. Futures contracts generally provide for
the future sale by one party and purchase by another party of a
specified instrument, index, or commodity at a specified future time
and at a specified price. Futures contracts are standardized as to
maturity date and underlying instrument and are traded on futures
exchanges. An option is a contract that provides the holder the right
to buy or sell shares or futures at a fixed price, within a specified
period of time.
    The Funds may invest in participation notes (``P-Notes''). P-Notes
are issued by banks or broker-dealers and are designed to offer a
return linked to the performance of a particular underlying equity
security or market. P-Notes can have the characteristics or take the
form of various instruments, including, but not limited to,
certificates or warrants.
    Each Fund may invest in repurchase agreements with commercial
banks, brokers, or dealers and invest securities lending cash
collateral. A repurchase agreement is an agreement under which a Fund
acquires a money market instrument from a seller, subject to resale to
the seller at an agreed upon price and date.
    The Funds may invest in structured notes. A structured note is a
derivative security for which the amount of principal repayment and/or
interest payments is based on the movement of one or more ``factors.''
These factors include, but are not limited to, currency exchange rates,
interest rates (such as the prime lending rate or LIBOR), referenced
bonds, and stock indices.
    Each Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid assets (calculated at the time of investment),
including Rule 144A securities deemed illiquid by the Adviser
consistent with Commission guidance.\30\ Each Fund will monitor its
portfolio liquidity on an ongoing basis to determine whether, in light
of current circumstances, an adequate level of liquidity is being
maintained, and will consider taking appropriate steps in order to
maintain adequate liquidity if, through a change in values, net assets,
or other circumstances, more than 15% of each Fund's net assets are
held in illiquid assets. Illiquid assets include assets subject to
contractual or other restrictions on resale and other instruments that
lack readily available markets, as determined in accordance with
Commission staff guidance.
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    \30\ In reaching liquidity decisions, the Adviser may consider
the following factors: the frequency of trades and quotes for the
asset; the number of dealers wishing to purchase or sell the asset
and the number of other potential purchasers; dealer undertakings to
make a market in the asset; and the nature of the asset and the
nature of the marketplace in which it trades (e.g., the time needed
to dispose of the asset, the method of soliciting offers, and the
mechanics of transfer).
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    Each Fund will be classified as a ``non-diversified'' investment
company under the 1940 Act and therefore may concentrate its
investments in any particular industry or group of industries, such
that: (i) ARK Genomic Revolution ETF will concentrate in securities of
issuers having their principal business activities in any industry or
group of industries in the health care sector; (ii) ARK Innovation ETF
will concentrate in securities of issuers having their principal
business activities in any industry or group of industries in the
health care sector, the industrials sector, the information technology
sector, or the telecommunications services sector; (iii) ARK Industrial
Innovation ETF will concentrate in securities of issuers having their
principal business activities in any industry or group of industries in
the industrials sector or the information technology sector; and (iv)
ARK Web x.0 ETF will concentrate in securities of issuers having their
principal business activities in any industry or group of industries in
the information technology sector or the telecommunications services
sector. Each Fund will consider an issuer to have its ``principal
business activities'' in an industry or group of industries if the
issuer derives more than 50% of its revenues from a business considered
to be a part of such industry or group of industries according to a
third party's industry classification system or that of the Adviser.
    The Funds intend to qualify for and to elect treatment as a
separate regulated investment company under Subchapter M of the
Internal Revenue Code.
    Each Fund may take a temporary defensive position (investments in
cash or cash equivalents) in response to adverse market, economic,
political, or other conditions.\31\ Cash equivalents

include short-term high quality debt securities and money market
instruments, such as commercial paper, certificates of deposit,
bankers' acceptances, U.S. Government securities, repurchase agreements
and bonds that are rated BBB or higher, and shares of short-term fixed
income or money market funds.
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    \31\ Circumstances under which a Fund may temporarily depart
from its normal investment process include, but are not limited to,
extreme volatility or trading halts in the equity markets or the
financial markets generally; operational issues causing
dissemination of inaccurate market information; or force majeure
type events such as systems failure, natural or man-made disaster,
act of God, armed conflict, act of terrorism, riot or labor
disruption or any similar intervening circumstance.
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III. Discussion and Commission's Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of Section 6 of the Act \32\
and the rules and regulations thereunder applicable to a national
securities exchange.\33\ In particular, the Commission finds that the
proposal is consistent with Section 6(b)(5) of the Act,\34\ 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. The Commission notes that the Funds and the Shares must
comply with the initial and continued listing criteria in NYSE Arca
Equities Rule 8.600 for the Shares to be listed and traded on the
Exchange.
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    \32\ 15 U.S.C. 78f.
    \33\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \34\ 15 U.S.C. 78f(b)(5).
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    The Commission finds that the proposal to list and trade the Shares
on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the
Act,\35\ which sets forth Congress' 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. Quotation and last-
sale information for the Shares will be available via the Consolidated
Tape Association (``CTA'') high-speed line. In addition, an indicative
optimized portfolio value (``IOPV''),\36\ which is the Portfolio
Indicative Value as defined in NYSE Arca Equities Rule 8.600(c)(3),
relating to each Fund will be widely disseminated every fifteen seconds
during the NYSE Arca Core Trading Session by one or more major market
data vendors.\37\ On each business day, before commencement of trading
in Shares in the Core Trading Session on the Exchange, the Adviser will
disclose on its Web site the identities and quantities of the portfolio
of securities and other assets (``Disclosed Portfolio'') held by the
Funds that will form the basis for each Fund's calculation of NAV at
the end of the business day.\38\ In addition, a basket composition
file, which includes the security names and share quantities, if
applicable, required to be delivered in exchange for a Fund's Shares,
together with estimates and actual cash components, will be publicly
disseminated daily prior to the opening of the New York Stock Exchange
(``NYSE'') via the National Securities Clearing Corporation. The NAV of
each Fund will be determined each business day as of the close of
trading (ordinarily 4:00 p.m., Eastern Time on the NYSE.\39\
Information regarding market price and trading volume of the Shares
will be continually available on a real-time basis throughout the day
on brokers' computer screens and other electronic services. Information
regarding the previous day's closing price and trading volume
information for the Shares will be published daily in the financial
section of newspapers. Quotation and last-sale information for
underlying securities that are exchange-listed, including equities
(including common stock, partnership interests, and business trust
shares, as well as depositary receipts (excluding ADRs traded OTC and
GDRs), rights, warrants, preferred securities, ETFs, and ETPs
(collectively, ``Exchange Traded Equities'')), will be available via
the CTA high-speed line and from the securities exchange on which they
are listed. Quotation and last-sale information for GDRs will be
available from the securities exchange on which they are listed.
Information relating to futures and options on futures also will be
available from the exchange on which such instruments are traded.
Information relating to exchange-traded options will be available via
the Options Price Reporting Authority. Quotation information from
brokers and dealers or pricing services will be available for ADRs
traded OTC, investment company securities (other than ETFs), including
closed end investment companies, unit investment trusts and open-end
investment companies, non-exchange-traded derivatives, including
forwards, swaps, and certain options, and fixed income securities,
including P-Notes, structured notes, debt securities, money market
instruments, such as commercial paper, certificates of deposit,
bankers' acceptances, U.S. Government securities, repurchase
agreements, bonds and convertible securities, and

shares of short-term fixed income or money market funds. Pricing
information regarding each asset class in which the Funds will invest
is generally available through nationally recognized data services
providers through subscription agreements. The Funds' Web site will
include a form of the prospectus for the Funds and additional data
relating to NAV and other applicable quantitative information for each
Fund.
---------------------------------------------------------------------------

    \35\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
    \36\ According to the Exchange, the IOPV calculations are
estimates of the value of the Funds' NAV per Share using market data
converted into U.S. dollars at the current currency rates. The IOPV
price is based on quotes and closing prices from the securities'
local market and may not reflect events that occur subsequent to the
local market's close. Premiums and discounts between the IOPV and
the market price may occur. This should not be viewed as a ``real-
time'' update of the NAV per Share of the Funds, which is calculated
only once a day.
    \37\ According to the Exchange, several major market data
vendors display and/or make widely available IOPVs published on CTA
or other data feeds.
    \38\ On a daily basis, the Adviser will disclose for each
portfolio security and other financial instrument of the Funds the
following information on the Funds' Web site: Ticker symbol (if
applicable), name of security and/or financial instrument, number of
shares, if applicable, and dollar value of financial instruments and
securities held in the portfolio, and percentage weighting of the
security and financial instrument in the portfolio. The Web site
information will be publicly available at no charge.
    \39\ The NAV per Share for each Fund will be computed by
dividing the value of the net assets of the Fund (the value of its
total assets less total liabilities) by the total number of Shares
outstanding. Expenses and fees will be accrued daily and taken into
account for purposes of determining NAV. According to the Exchange,
price information for exchange-traded equity securities, including
equity securities of domestic and foreign companies, such as common
stock, partnership interests, business trust shares, ETFs and ETPs,
as well as depositary receipts (excluding ADRs traded OTC), rights,
warrants, and preferred securities, will be taken from the exchange
where the security or asset is primarily traded. ADRs traded OTC
will be valued on the basis of the market closing price on the
exchange where the stock of the foreign issuer that underlies the
ADR is listed. Investment company securities (other than ETFs),
including closed end investment companies, unit investment trusts,
and other open-end investment companies, will be valued at NAV,
utilizing pricing services. Non-exchange-traded derivatives,
including forwards, swaps, and certain options, will normally be
valued on the basis of quotes obtained from brokers and dealers or
independent pricing services using data reflecting the earlier
closing of the principal markets for those assets. Prices obtained
from independent pricing services use information provided by market
makers or estimates of market values obtained from yield data
relating to investments or securities with similar characteristics.
Exchange-traded options (excluding options on futures) will be
valued at market closing price. Futures and options on futures will
be valued at the settlement price determined by the applicable
exchange. Fixed income securities generally trade in the OTC market
rather than on a securities exchange. A Fund will generally value
these portfolio securities, including P-Notes, structured notes,
debt securities, money market instruments, such as commercial paper,
certificates of deposit, bankers' acceptances, U.S. Government
securities, repurchase agreements, bonds and convertible securities,
and shares of short-term fixed income or money market funds by
relying on independent pricing services. A Fund's pricing services
will use valuation models or matrix pricing to determine current
value. In general, pricing services use information with respect to
comparable bond and note transactions, quotations from bond dealers,
or by reference to other securities that are considered comparable
in such characteristics as rating, interest rate, maturity date,
option adjusted spread models, prepayment projections, interest rate
spreads, and yield curves. Matrix price is an estimated price or
value for a fixed-income security and is considered a form of fair
value pricing.
---------------------------------------------------------------------------

    The Commission further 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 and
to prevent trading when a reasonable degree of transparency cannot be
assured. The Exchange will obtain a representation from the issuer of
the Shares that the NAV per Share for each Fund will be calculated
daily and that the NAV and the Disclosed Portfolio for each Fund will
be made available to all market participants at the same time. Trading
in Shares of the Funds will be halted if the circuit breaker parameters
in NYSE Arca Equities Rule 7.12 have been reached or because of market
conditions or for reasons that, in the view of the Exchange, make
trading in the Shares inadvisable,\40\ and trading in the Shares will
be subject to NYSE Arca Equities Rule 8.600(d)(2)(D), which sets forth
additional circumstances under which trading in the Shares of a Fund
may be halted. The Exchange states that it has a general policy
prohibiting the distribution of material, non-public information by its
employees. Consistent with NYSE Arca Equities Rule 8.600(d)(2)(B)(ii),
the Reporting Authority must implement and maintain, or be subject to,
procedures designed to prevent the use and dissemination of material,
non-public information regarding the actual components of a Fund's
portfolio. In addition, the Exchange states that the Adviser is not
registered as, nor affiliated with, a broker-dealer.\41\ The Exchange
represents that trading in the Shares will be subject to the existing
trading surveillances, administered by the Financial Industry
Regulatory Authority (``FINRA'') on behalf of the Exchange, which are
designed to detect violations of Exchange rules and applicable federal
securities laws.\42\ The Exchange further represents that these
procedures are adequate to properly monitor Exchange-trading of the
Shares in all trading sessions and to deter and detect violations of
Exchange rules and federal securities laws applicable to trading on the
Exchange. Moreover, prior to the commencement of trading, the Exchange
states that it will inform its Equity Trading Permit Holders in an
Information Bulletin of the special characteristics and risks
associated with trading the Shares.
---------------------------------------------------------------------------

    \40\ These reasons may include: (1) The extent to which trading
is not occurring in the securities and/or the financial instruments
comprising the Disclosed Portfolio of the Funds; or (2) whether
other unusual conditions or circumstances detrimental to the
maintenance of a fair and orderly market are present. With respect
to trading halts, the Exchange may consider all relevant factors in
exercising its discretion to halt or suspend trading in the Shares
of the Funds.
    \41\ See supra note 6. The Exchange states that an investment
adviser to an open-end fund is required to be registered under the
Investment Advisers Act of 1940 (``Advisers Act''). As a result, the
Adviser and its related personnel are subject to the provisions of
Rule 204A-1 under the Advisers Act relating to codes of ethics. This
Rule requires investment advisers to adopt a code of ethics that
reflects the fiduciary nature of the relationship to clients, as
well as compliance with other applicable securities laws.
Accordingly, procedures designed to prevent the communication and
misuse of non-public information by an investment adviser must be
consistent with Rule 204A-1 under the Advisers Act. In addition,
Rule 206(4)-7 under the Advisers Act makes it unlawful for an
investment adviser to provide investment advice to clients unless
such investment adviser has (i) adopted and implemented written
policies and procedures reasonably designed to prevent violation, by
the investment adviser and its supervised persons, of the Advisers
Act and the Commission rules adopted thereunder; (ii) implemented,
at a minimum, an annual review regarding the adequacy of the
policies and procedures established pursuant to subparagraph (i)
above and the effectiveness of their implementation; and (iii)
designated an individual (who is a supervised person) responsible
for administering the policies and procedures adopted under
subparagraph (i) above.
    \42\ The Exchange states that FINRA surveils trading on the
Exchange pursuant to a regulatory services agreement and that the
Exchange is responsible for FINRA's performance under this
regulatory services agreement.
---------------------------------------------------------------------------

    The Exchange represents that the Shares are deemed to be equity
securities, thus rendering trading in the Shares subject to the
Exchange's existing rules governing the trading of equity securities.
In support of this proposal, the Exchange has made representations,
including the following:
    (1) The Shares will conform to the initial and continued listing
criteria under NYSE Arca Equities Rule 8.600.
    (2) The Exchange has appropriate rules to facilitate transactions
in the Shares during all trading sessions.
    (3) FINRA, on behalf of the Exchange, will communicate as needed
regarding trading in the Shares and underlying Exchange Traded
Equities, exchange traded options and futures with other markets and
other entities that are members of the ISG, and FINRA, on behalf of the
Exchange, may obtain trading information regarding trading in the
Shares and underlying Exchange Traded Equities, exchange traded options
and futures from such markets and other entities. In addition, the
Exchange may obtain information regarding trading in the Shares and
underlying Exchange Traded Equities, exchange traded options and
futures from markets and other entities that are members of ISG or with
which the Exchange has in place a comprehensive surveillance sharing
agreement.
    (4) At least 90% of each Fund's investments in equity securities
(including GDRs and ADRs) will be in securities that trade in markets
that are members of the ISG or are parties to a comprehensive
surveillance sharing agreement with the Exchange. The exchange-traded
options in which the Funds may invest will trade on markets that are
members of the ISG or parties to a comprehensive surveillance sharing
agreement with the Exchange. Each Fund will not invest more than 10% of
its assets in futures that trade in markets that are not members of the
ISG or parties to a comprehensive surveillance sharing agreement with
the Exchange.
    (5) Prior to the commencement of trading, the Exchange will inform
its Equity Trading Permit Holders in an Information Bulletin of the
special characteristics and risks associated with trading the Shares.
Specifically, the Information Bulletin will discuss the following: (a)
The procedures for purchases and redemptions of Shares in creation
units (and that Shares are not individually redeemable); (b) NYSE Arca
Equities Rule 9.2(a), which imposes a duty of due diligence on its
Equity Trading Permit Holders to learn the essential facts relating to
every customer prior to trading the Shares; (c) the risks involved in
trading the Shares during the Opening and Late Trading Sessions when an
updated Portfolio Indicative Value will not be calculated or publicly
disseminated; (d) how information regarding the Portfolio Indicative
Value is disseminated; (e) the requirement that Equity Trading Permit
Holders deliver a prospectus to investors purchasing newly issued
Shares prior to or concurrently with the confirmation of a transaction;
and (f) trading information.
    (6) For initial and continued listing, the Funds will be in
compliance with Rule 10A-3 under the Act,\43\ as provided by NYSE Arca
Equities Rule 5.3.
---------------------------------------------------------------------------

    \43\ 17 CFR 240.10A-3.
---------------------------------------------------------------------------

    (7) Each Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid assets (calculated at the time of investment),
including Rule 144A securities deemed illiquid by the

Adviser consistent with Commission guidance.
    (8) Under normal market circumstances, ARK Genomic Revolution ETF,
ARK Industrial Innovation ETF, and ARK Web x.0 ETF will each invest at
least 80% of its assets in equity securities. Under normal market
circumstances, ARK Innovation ETF will invest at least 65% of its
assets in equity securities.
    (9) Investments in emerging markets equity securities will not
exceed 20% of a Fund's total assets.
    (10) Each Fund's investments will be consistent with its respective
investment objective in accordance with the 1940 Act and will not be
used to enhance leverage. Each Fund's investments will not be used to
seek performance that is the multiple or inverse multiple (i.e., 2Xs or
3Xs) of the Fund's broad-based securities market index (as defined in
Form N-1A).
    (11) The Funds will only enter into transactions in derivative
instruments with counterparties that the Adviser reasonably believes
are capable of performing under the contract and will post as
collateral as required by the counterparty. The Funds will seek, where
possible, to use counterparties, as applicable, whose financial status
is such that the risk of default is reduced; however, the risk of
losses resulting from default is still possible. The Adviser will
evaluate the creditworthiness of counterparties on a regular basis. In
addition to information provided by credit agencies, the Adviser will
review approved counterparties using various factors, which may include
the counterparty's reputation, the Adviser's past experience with the
counterparty and the price/market actions of debt of the counterparty.
    (12) A minimum of 100,000 Shares for each Fund will be outstanding
at the commencement of trading on the Exchange.

This approval order is based on all of the Exchange's representations,
including those set forth above and in the Notice, and the Exchange's
description of the Funds.

    For the foregoing reasons, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act \44\ and the
rules and regulations thereunder applicable to a national securities
exchange.
---------------------------------------------------------------------------

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

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\45\ that the proposed rule change (SR-NYSEArca-2014-64) be, and it
hereby is, approved.

    \45\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\46\
---------------------------------------------------------------------------

    \46\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-17398 Filed 7-23-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: May 25, 2011 (Volume 76, Number 101)]
[Notices]
[Page 30369-30370]
[DOCID:fr25my11-88]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0532]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Experimental Study of Nutrition
Facts Label Formats

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Experimental Study of Nutrition
Facts Label Formats'' has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 17, 2010
(75 FR 70266), the Agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it

displays a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0682.
The approval expires on April 30, 2013. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: May 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12844 Filed 5-24-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 54 (Tuesday, March 20, 2012)]
[Notices]
[Pages 16235-16237]
[FR Doc No: 2012-6691]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0247]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Guidance for Industry on Formal Meetings With Sponsors
and Applicants for Prescription Drug User Fee Act Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
contained in the guidance for industry on formal meetings with sponsors
and applicants for Prescription Drug User Fee Act (PDUFA) products.

DATES: Submit either electronic or written comments on the collection
of information by May 21, 2012.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,

before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on Formal Meetings With Sponsors and Applicants
for PDUFA Products--(OMB Control Number 0910-0429)--Extension

    This information collection approval request is for FDA guidance on
the procedures for formal meetings between FDA and sponsors or
applicants regarding the development and review of PDUFA products. The
guidance describes procedures for requesting, scheduling, conducting,
and documenting such formal meetings. The guidance provides information
on how the Agency will interpret and apply section 119(a) of the Food
and Drug Administration Modernization Act of 1997 (FDAMA), specific
PDUFA goals for the management of meetings associated with the review
of human drug applications for PDUFA products, and provisions of
existing regulations describing certain meetings (Sec. Sec.  312.47 and
312.82 (21 CFR 312.47 and 312.82)).
    The guidance describes two collections of information: The
submission of a meeting request containing certain information and the
submission of an information package in advance of the formal meeting.
Agency regulations at Sec. Sec.  312.47(b)(1)(ii), (b)(1)(iv), and
(b)(2) describe information that should be submitted in support of a
request for an End-of-Phase 2 meeting and a Pre-NDA meeting. The
information collection provisions of Sec.  312.47 have been approved by
OMB (OMB control number 0910-0014). However, the guidance provides
additional recommendations for submitting information to FDA in support
of a meeting request. As a result, FDA is submitting additional
estimates for OMB approval.

A. Request for a Meeting

    Under the guidance, a sponsor or applicant interested in meeting
with the Center for Drug Evaluation and Research (CDER) or the Center
for Biologics Evaluation and Research (CBER) should submit a meeting
request to the appropriate FDA component as an amendment to the
underlying application. FDA regulations (Sec. Sec.  312.23, 314.50, and
601.2 (21 CFR 312.23, 314.50, and 601.2)) state that information
provided to the Agency as part of an Investigational New Drug
Application (IND), New Drug Application (NDA), or Biological License
Application (BLA) must be submitted with an appropriate cover form.
Form FDA 1571 must accompany submissions under INDs and Form FDA 356h
must accompany submissions under NDAs and BLAs. Both forms have valid
OMB control numbers as follows: FDA Form 1571--OMB control number 0910-
0014 and FDA Form 356h--OMB control number 0910-0338.
    In the guidance document, CDER and CBER ask that a request for a
formal meeting be submitted as an amendment to the application for the
underlying product under the requirements of Sec. Sec.  312.23, 314.50,
and 601.2; therefore, requests should be submitted to the Agency with
the appropriate form attached, either Form FDA 1571 or Form FDA 356h.
The Agency recommends that a request be submitted in this manner for
two reasons: (1) To ensure that each request is kept in the
administrative file with the entire underlying application and (2) to
ensure that pertinent information about the request is entered into the
appropriate tracking databases. Use of the information in the Agency's
tracking databases enables the Agency to monitor progress on the
activities attendant to scheduling and holding a formal meeting and to
ensure that appropriate steps will be taken in a timely manner.
    Under the guidance, the Agency requests that sponsors and
applicants include in meeting requests certain information about the
proposed meeting. Such information includes:
     Information identifying and describing the product;
     The type of meeting being requested;
     A brief statement of the purpose of the meeting;
     A list of objectives and expected outcomes from the
meeting;
     A preliminary proposed agenda;
     A draft list of questions to be raised at the meeting;
     A list of individuals who will represent the sponsor or
applicant at the meeting;
     A list of Agency staff requested to be in attendance;
     The approximate date that the information package will be
sent to the Agency; and
     Suggested dates and times for the meeting.
    This information will be used by the Agency to determine the
utility of the meeting, to identify Agency staff necessary to discuss
proposed agenda items, and to schedule the meeting.

B. Information Package

    A sponsor or applicant submitting an information package to the
Agency in advance of a formal meeting should provide summary
information relevant to the product and supplementary information
pertaining to any issue raised by the sponsor, applicant, or Agency.
The Agency recommends that information packages generally include:
     Identifying information about the underlying product;
     A brief statement of the purpose of the meeting;
     A list of objectives and expected outcomes of the meeting;
     A proposed agenda for the meeting;
     A list of specific questions to be addressed at the
meeting;
     A summary of clinical data that will be discussed (as
appropriate);
     A summary of preclinical data that will be discussed (as
appropriate); and
     Chemistry, manufacturing, and controls information that
may be discussed (as appropriate).
    The purpose of the information package is to provide Agency staff
the opportunity to adequately prepare for the meeting, including the
review of relevant data concerning the product. Although FDA reviews
similar information in the meeting request, the information package
should provide updated data that reflect the most current and accurate
information available to the sponsor or applicant. The Agency finds
that reviewing such information is critical to achieving a productive
meeting.
    The collection of information described in the guidance reflects
the current and past practice of sponsors and applicants to submit
meeting requests as amendments to INDs, NDAs, and BLAs and to submit
background information prior to a scheduled meeting. Agency regulations
currently permit such requests and recommend the submission of an
information package before an End-of-Phase 2 meeting (Sec. Sec.
312.47(b)(1)(ii) and (b)(1)(iv)) and a Pre-NDA meeting (Sec.
312.47(b)(2)).

    1. Description of Respondents: A sponsor or applicant for a drug or
biological product who requests a formal meeting with the Agency
regarding the development and review of a PDUFA product.
    2. Burden Estimate: Provided below is an estimate of the annual
reporting burden for the submission of meeting requests and information
packages under the guidance.

C. Request For a Formal Meeting

    Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 975 sponsors and
applicants (respondents) request approximately 2,014 formal meetings
with CDER annually and approximately 127 respondents request
approximately 253 formal meetings with CBER annually regarding the
development and review of a PDUFA product. The hours per response,
which is the estimated number of hours that a respondent would spend
preparing the information to be submitted with a meeting request in
accordance with the guidance, is estimated to be approximately 10
hours. Based on FDA's experience, the Agency expects it will take
respondents this amount of time to gather and copy brief statements
about the product and a description of the purpose and details of the
meeting.

D. Information Package

    Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 756 respondents
submitted approximately 1,394 information packages to CDER annually and
approximately 112 respondents submitted approximately 203 information
packages to CBER annually prior to a formal meeting regarding the
development and review of a PDUFA product. The hours per response,
which is the estimated number of hours that a respondent would spend
preparing the information package in accordance with the guidance, is
estimated to be approximately 18 hours. Based on FDA's experience, the
Agency expects it will take respondents this amount of time to gather
and copy brief statements about the product, a description of the
details for the anticipated meeting, and data and information that
generally would already have been compiled for submission to the
Agency.
    As stated earlier, the guidance provides information on how the
Agency will interpret and apply section 119(a) of FDAMA, specific PDUFA
goals for the management of meetings associated with the review of
human drug applications for PDUFA products, and provisions of existing
regulations describing certain meetings (Sec. Sec.  312.47 and 312.82).
The information collection provisions in Sec.  312.47 concerning End-
of-Phase 2 meetings and Pre-NDA meetings have been approved by OMB (OMB
control number 0910-0014). However, the guidance provides additional
recommendations for submitting information to FDA in support of a
meeting request. As a result, FDA is submitting for OMB approval these
additional estimates.

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of
Meeting requests and information     Number of     responses per   Total annual   Average burden    Total hours
            packages                respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
                                                Meeting Requests
----------------------------------------------------------------------------------------------------------------
CDER............................             975            2.06           2,014              10          20,140
CBER............................             127            1.99             253              10           2,530
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          22,670
----------------------------------------------------------------------------------------------------------------
                                              Information Packages
----------------------------------------------------------------------------------------------------------------
CDER............................             756            1.84           1,394              18          25,092
CBER............................             112            1.81             203              18           3,654
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          28,746
                                 -------------------------------------------------------------------------------
        Grand Total.............  ..............  ..............  ..............  ..............          51,416
----------------------------------------------------------------------------------------------------------------

    Dated: March 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6691 Filed 3-19-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: October 10, 2008 (Volume 73, Number 198)]
[Notices]
[Page 60309]
[DOCID:fr10oc08-104]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1794-DR]

Mississippi; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Mississippi (FEMA-1794-DR), dated September 22, 2008,
and related determinations.

DATES: Effective Date: September 26, 2008.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Mississippi is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the catastrophe declared a major disaster by the President in his
declaration of September 22, 2008.

    Hancock and Harrison Counties for Individual Assistance (already
designated for Public Assistance).
    Washington County for Individual Assistance and Public
Assistance.

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

R. David Paulison,
Administrator, Federal Emergency Management Agency.
 [FR Doc. E8-24091 Filed 10-9-08; 8:45 am]

BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 205 (Tuesday, October 23, 2012)]
[Rules and Regulations]
[Pages 64718-64720]
[FR Doc No: 2012-26002]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0939]
RIN 1625-AA00

Safety Zone; Steam Ship Col. James M. Schoonmaker Relocation
Project, Maumee River, Toledo, OH

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary Safety Zone on the
waters of Maumee River, Toledo, Ohio, in support of the relocation of
S/S Col. James M. Schoonmaker (hereinafter referred to as `the
Schoonmaker'). This temporary safety zone will encompass all waters of
the Maumee River within a 100 yard radius of the Schoonmaker as it
makes its transit from International Park to Skyway Marina. This
temporary Safety Zone is necessary to protect persons operating around
the area.

DATES: This regulation is effective from 10:00 a.m. on October 27, 2012
until 4:00 p.m. on November 3, 2012.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2012-0939 and are available online by going to
http://www.regulations.gov, inserting USCG-2011-0195 in the ``Keyword''
box, and then clicking ``Search.'' This material is also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Mallorie Schell, Prevention Department, MSU Toledo,
Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable and
contrary to the public interest. Although the Coast Guard has known
about the relocation of the Schoonmaker for several weeks, only
recently did the Coast Guard become aware of an expected high volume of
spectator vessel traffic. Consequently, the need for this safety zone
was not identified until there was insufficient time to allow a full
comment period to run. Thus, waiting for a comment period to run prior
to enforcing this safety zone would inhibit the Coast Guard's ability
to protect the public and vessels from the hazards associated with the
heightened spectator activity associated with the relocation of the
Schoonmaker.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. For the same reasons discussed
above about not publishing an NPRM, the Coast Guard finds that waiting
for a 30 day notice period to run would be impracticable and contrary
to the public interest.

B. Basis and Purpose

    The legal basis for the rule is the Coast Guard's authority to
establish regulated navigation areas and limited access areas: 33
U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064;
Department of Homeland Security Delegation No. 0170.1.
    The Great Lakes Historical Society (GLHS) is relocating the
Schoonmaker from International Park to Skyway Marina. This relocation
is scheduled for October 27, 2012. If the relocation of the vessel on
October 27 is cancelled for any reason, this safety zone will be
effective and enforced from 10:00 a.m. until 4:00 p.m. on October 28,
2012. Likewise, if relocation on October 28th is cancelled, this safety
zone will be effective and enforced from 10:00 a.m. until 4:00 p.m. on
November 3, 2012. In light of the expected volume of spectator
activity, the Captain of the Port Detroit has determined that this
operation could pose certain public hazards, such as the increased risk
of collisions.

C. Discussion of Rule

    With aforementioned hazards in mind, the Captain of the Port
Detroit has determined that a safety zone is necessary to ensure the
safety of participants and vessels during the operation. The temporary
safety zone established herein will be effective and enforced from
10:00 a.m. until 4:00 p.m. on October 27, 2012. If the relocation of
the vessel on October 27 is cancelled for any reason, this safety zone
will be effective and enforced from 10:00 a.m. until 4:00 p.m. on
October 28, 2012. Likewise, if relocation on October 28 is cancelled,
this safety zone will be effective and enforced from 10:00 a.m. until
4:00 p.m. on November 3, 2012.
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port, Sector Detroit
or his designated on scene representative. The Captain of the Port,
Sector Detroit or his designated on scene representative may be
contacted via VHF Channel 16. All persons and vessels allowed to enter
the safety zone shall comply with the instructions of the Coast Guard
Captain of the Port, designated on scene patrol personnel, or operation
personnel.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented

by Executive Order 13563, Improving Regulation and Regulatory Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of Executive Order 12866 or under section 1 of
Executive Order 13563. The Office of Management and Budget has not
reviewed it under these Orders. It is not ``significant'' under the
regulatory policies and procedures of the Department of Homeland
Security (DHS). We conclude that this rule is not a significant
regulatory action because we anticipate that it will have minimal
impact on the economy, will not interfere with other agencies, will not
adversely alter the budget of any grant or loan recipients, and will
not raise any novel legal or policy issues. The temporary safety zone
created by this rule will be relatively small and enforced for a
relatively short time. Also, the temporary safety zone is designed to
minimize its impact on navigable waters. Furthermore, the temporary
safety zone has been designed to allow vessels to transit around it.
Thus, restrictions on vessel movement within that particular area are
expected to be minimal. Under certain conditions, moreover, vessels may
still transit through the temporary safety zone.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The Coast Guard
certifies under 5 U.S.C. 605(b) that this rule will not have a
significant economic impact on a substantial number of small entities.
This rule will affect the following entities, some of which may be
small entities: the owners or operators of vessels intending to transit
through the Maumee River, OH between 10:00 a.m. and 4:00 p.m. on
October 27 or 28 or November 3, 2012.
    This temporary safety zone will not have a significant economic
impact on a substantial number of small entities for the following
reasons: this rule will be in effect for only approximately six hours.
In the event that this temporary safety zone affects shipping,
commercial vessels may request permission from the Captain of the Port,
Sector Detroit to transit through the safety zone. The Coast Guard will
give notice to the public via a Broadcast Notice to Mariners that the
regulation is in effect.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If this rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

7. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

8. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

9. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

10. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

11. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

12. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

13. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone and, therefore, it is
categorically excluded from further review under paragraph (34)(g) of
Figure 2-1 of the Commandant Instruction. An environmental analysis
checklist supporting this determination and a Categorical Exclusion
Determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR Part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapters 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0939 as follows:

Sec.  165.T09-0939  Safety Zone; Steam Ship Col. James M. Schoonmaker
relocation project, Maumee River, Toledo, OH.

    (a) Location. The following area is a temporary safety zone: all
waters of the Maumee River within a 100 yard radius of the S/S Col.
James M. Schoonmaker as it makes its transit from International Park at
position 41[deg]38'30.00'' N; 083[deg]31'55.50'' W to Skyway Marina at
approximate position 41[deg]39'26.30'' N; 083[deg]30'55.25'' W. All
geographic coordinates are North American Datum of 1983 (NAD 83).
    (b) Effective and Enforcement Period. This regulation is effective
from 10:00 a.m. on October 27, 2012 until 4:00 p.m. on November 3,
2012. It will be enforced from 10:00 a.m. until 4:00 p.m. on October
27, 2012. If the relocation of the vessel on October 27 is cancelled
for any reason, this safety zone will be effective and enforced from
10:00 a.m. until 4:00 p.m. on October 28, 2012. Likewise, if a
relocation on October 28 is cancelled, this safety zone will be
effective and enforced from 10:00 a.m. until 4:00 p.m. on November 3,
2012.
    (c) Definitions. The following definitions apply to this section:
    (1) ``On-scene Representative'' means any Coast Guard Commissioned,
warrant, or petty officer designated by the Captain of the Port Detroit
to monitor a safety zone, permit entry into the zone, give legally
enforceable orders to persons or vessels within the zones, and take
other actions authorized by the Captain of the Port.
    (2) ``Public vessel'' means vessels owned, chartered, or operated
by the United States, or by a State or political subdivision thereof.
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transiting, or anchoring within
this safety zone is prohibited unless authorized by the Captain of the
Port Detroit, or his designated representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Detroit or his designated
representative. All persons and vessels must comply with the
instructions of the Coast Guard Captain of the Port or his designated
representative. Upon being hailed by the U.S. Coast Guard by siren,
radio, flashing light or other means, the operator of a vessel shall
proceed as directed.
    (3) All vessels must obtain permission from the Captain of the Port
or his designated representative to enter, move within, or exit the
safety zone established in this section when this safety zone is
enforced. Vessels and persons granted permission to enter the safety
zone must obey all lawful orders or directions of the Captain of the
Port or a designated representative. While within a safety zone, all
vessels must operate at the minimum speed necessary to maintain a safe
course.
    (e) Exemption. Public vessels, as defined in paragraph (b) of this
section, are exempt from the requirements in this section.

    Dated: October 11, 2012.
D.V. Smith,
Commander, U.S. Coast Guard, Acting Captain of the Port Detroit.
[FR Doc. 2012-26002 Filed 10-22-12; 8:45 am]
BILLING CODE 9110-04-P


November 21, 2017 MEMORANDUM TO: 		Air Docket EPA-HQ-OAR-2017-0655 SUBJECT:	Summary of Net Energy Impacts of Reduced-Oil Sorghum Dried Distillers Grains with Solubles (DDGS) on Livestock

Table 1: Net Energy Impacts of Reduced-Oil Sorghum Dried Distillers Grains with Solubles (DDGS) on Livestock

Net Energy  Full-Oil Sorghum DDGS (kcal/kg) Reduced-Oil Sorghum DDGS (kcal/kg) Beef, growing 2144 1924 Beef, finishing 2011 1830 Dairy 1855 1873 Swine 2394 2053 Poultry 2283 2135

Table 1 above provides net energy values for livestock fed with both full-oil and reduced-oil sorghum DDGS. These values have been calculated by the National Sorghum Producers using ratios from the impacts of reducing oil in corn distillers grains, as there currently exists no scientific literature on feeding values of reduced-oil sorghum DDGS. The values above show net energy of livestock on a kilocalorie per kilogram of DDGS basis. Net energy measures the energy that is available to a livestock animal after it has consumed, digested, and metabolized feed, and it includes the energy lost as a result of heat produced from these processes.   While the petitioner expects beef, swine, and poultry net energy to decrease with the use of reduced-oil sorghum DDGS, there are other factors in the case of poultry and swine that may lead livestock producers to substitute reduced-sorghum oil DDGS for feed at equal rates as full-oil sorghum DDGS. As detailed in the Notice, full-oil distillers grains with solubles (DGS) typically contain higher levels of free fatty acids and thus may have a negative impact on the fat digestion of poultry and swine.  For dairy cattle, net energy is expected to slightly increase when reduced-oil sorghum DDGS is fed instead of full-oil sorghum DDGS.