[Federal Register: February 15, 2008 (Volume 73, Number 32)]
[Notices]
[Page 8917-8921]
[DOCID:fr15fe08-118]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57294; File No. SR-NYSEArca-2007-78]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Order Granting Accelerated Approval of Proposed Rule Change to
Trade Units of the United States Heating Oil Fund, LP and the United
States Gasoline Fund, LP Pursuant to Unlisted Trading Privileges

February 8, 2008.
    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 July 30, 2007, NYSE Arca, Inc. (``Exchange''), through its wholly-
owned subsidiary NYSE Arca Equities, Inc. (``NYSE Arca Equities''),
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been substantially prepared by the Exchange. This order provides
notice of the proposed rule change and approves the proposal 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, through its wholly-owned subsidiary NYSE Arca
Equities, proposes to trade pursuant to unlisted trading privileges
(``UTP'') units (``Units'') of the United States Heating Oil Fund, LP
(``USHO'') and the United States Gasoline Fund, LP (``USG'') (each, a
``Partnership,'' and collectively ``Partnerships'') pursuant to NYSE
Arca Equities Rule 8.300. The text of the proposed rule change is
available on the Exchange's Web site at http://www.nyse.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 Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item III below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    Under NYSE Arca Equities Rule 8.300, the Exchange may propose to
list and/or trade pursuant to UTP ``Partnership Units.'' The Exchange
proposes to trade the Units pursuant to UTP under NYSE Arca Equities
Rule 8.300.
    Each Unit represents ownership of a fractional undivided beneficial
interest in the net assets of each of USHO or USG. Each Partnership is
a commodity pool that will issue Units that may be purchased and sold
on the Exchange. The net assets of each of USHO and USG will consist of
investments in futures contracts based on heating oil, gasoline, crude
oil, and other petroleum-based fuels and natural gas that are traded on
the New York Mercantile Exchange (``NYMEX''), Intercontinental Exchange
(``ICE Futures'') or other U.S. and foreign exchanges (collectively,
``Futures Contracts''). The Commission has approved the listing and
trading of the Units on the American Stock Exchange LLC (``Amex'').\3\
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    \3\ See Securities Exchange Act Release No. 57188 (January 23,
2008) (SR-Amex-2007-70) (approving Amex's proposal to list and trade
the Units). See also Securities Exchange Act Release No. 57042
(December 26, 2007), 73 FR 514 (January 3, 2008) (SR-Amex-2007-70)
(providing notice of Amex's proposal to list and trade the Units)
(``Amex Proposal'').
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    Detailed information regarding the Partnerships; the investment
strategies, objectives, and policies of the Partnerships; the
petroleum-based fuels market; the structure, management, and regulation
of the Partnerships; accountability levels and position limits; the
Indicative Partnership Value (as defined herein); the manner in which
the Units will be offered and sold; calculation methodologies; and
arbitrage can be found in the Amex Proposal and in the respective
Registration Statements regarding the offering of the Units filed with
the Commission under the Securities Act of 1933.\4\
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    \4\ See USHO's Registration Statement on Form S-1 filed on April
19, 2007 (File No. 333-142211); USG's Registration Statement on Form
S-1 filed on April 18, 2007 (File No. 333-142206).
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Dissemination and Availability of Information About the Underlying
Futures Contracts and the Units
    As set forth in the Amex Proposal, the daily settlement prices for
the NYMEX-traded Futures Contracts are publicly available at http://www.nymex.com.
 Quote and last-sale information for the Futures

Contracts are widely disseminated through a variety of market data
vendors worldwide, including Bloomberg and Reuters. In addition, real-
time futures data is available by subscription from Reuters and
Bloomberg. NYMEX also provides delayed futures information on current
and past trading sessions and market news free of charge on its Web
site. The specific contract specifications for the Futures Contracts
are also available on the NYMEX Web site and the ICE Futures Web site
at http://www.icefutures.com.

    Amex will disseminate through the facilities of the Consolidated
Tape Association (``CTA'') an updated Indicative Partnership Value
(``Indicative Partnership Value''), which will be disseminated on a
per-Unit basis at least every 15 seconds during regular Amex trading
hours of 9:30 a.m. to 4:15 p.m. Eastern Time (``ET''). In addition,
shortly after 4 p.m. ET on each business day, the Administrator, Amex,
and the General Partner will disseminate the Basket Amount \5\ for
orders placed during that day, together with the net asset value
(``NAV'') for the Units.\6\ The Indicative Partnership Value will be
calculated based on the Treasuries and cash required for creations and
redemptions (i.e., NAV per limit x 100,000) adjusted to reflect the
price changes of the relevant Benchmark Futures Contract.
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    \5\ See infra note 14.
    \6\ E-mail from Tim Malinowski, Director, NYSE Euronext, to
Geoffrey Pemble, Special Counsel, Division of Trading and Markets,
Commission, dated February 1, 2008 (``NYSE Arca Confirmation'').
According to the Amex Proposal, Amex will obtain a representation
from each Partnership that its NAV per Unit will be calculated daily
and made available to all market participants at the same time. See
Amex Proposal, supra note 3.
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    The Indicative Partnership Value is based on open-outcry trading of
the relevant Benchmark Futures Contract on the NYMEX. Open-outcry
trading on the NYMEX closes at 2:30 p.m. ET while NYMEX's energy
futures contracts are traded on the Chicago Mercantile Exchanges CME
Globex[supreg] electronic trading platform on a 24-hour basis.\7\ After
the close of trading on the NYNEX at 2:30 p.m. ET, the Indicative
Partnership Value will reflect changes to the relevant Benchmark
Futures Contract as provided for through CME Globex. The value of the
relevant Benchmark Futures Contract will be available on a 15-second
delayed basis during the time the Units trade on the Exchange.\8\
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    \7\ CME Globex operates on a 24-hour basis each trading day.
    \8\ See NYSE Arca Confirmation, supra note 6.
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    While the NYMEX is open for trading, the Indicative Partnership
Value can be expected to closely approximate the value per Unit of the
Basket Amount. However, during NYSE Arca Marketplace trading hours when
the Futures Contracts have ceased trading, spreads and resulting
premiums or discounts may widen and therefore increase the difference
between the price of the Units and the NAV of the Units. The Indicative
Partnership Value on a per-Unit basis disseminated from 9:30 a.m. to
4:15 p.m. ET should not be viewed as a real-time update of the NAV,
which is calculated only once a day.
    Quotations and last-sale information regarding the Units will be
disseminated through the facilities of the CTA and the Consolidated
Quote High Speed Lines.\9\ Amex intends to disseminate for each
Partnership on a daily basis information with respect to the Indicative
Partnership Value, recent NAV, Units outstanding, and the Basket
Amount. Amex will also make available on its Web site the following
information: (1) The prior business day's NAV and the reported closing
price; (2) the mid-point of the bid-ask price in relation to the NAV as
of the time the NAV is calculated (``Bid-Ask price''); \10\ (3)
calculation of the premium or discount of such price against such NAV;
(4) data in chart form displaying the frequency distribution of
discounts and premiums of the Bid-Ask Price against the NAV, within
appropriate ranges for each of the four previous calendar quarters; (5)
the prospectus and the most recent periodic reports filed with the SEC
or required by the CFTC for each of the Partnerships; (6) the daily
trading volume and closing price of the Units;

and (7) other applicable quantitative information.
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    \9\ See id.
    \10\ The Bid-Ask Price of Units is determined using the highest
bid and lowest offer as of the time of calculation of the NAV.
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    USHO's and USG's total portfolio composition will be disclosed,
each business day that Amex is open for trading, on their respective
Web sites at http://www.unitedstatesheatingoilfund.com and http://www.unitedstatesgasolinefund.com.
 USHO's Web site disclosure of
 disclosure of
applicable, the name and value of each Heating Oil Interest,\11\ the
specific types and characteristics of such Heating Oil Interests,
Treasuries,\12\ and the amount of cash and cash equivalents held in the
portfolio of USHO. USG's Web site disclosure of portfolio holdings will
be made available daily and will include, as applicable, the name and
value of each Gasoline Interest,\13\ the specific types and
characteristics of such Gasoline Interests, Treasuries, and the amount
of cash and cash equivalents held in the portfolio of USG. The public
Web site disclosure of the portfolio composition of each of USHO and
USG will coincide with the disclosure by Brown Brothers Harriman & Co.
(the ``Administrator'') of the NAV for the Units and the Basket Amount
\14\ (for orders placed during the day) for each Partnership on each
business day.
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    \11\ Heating Oil Interests are defined as investments in Futures
Contracts and other heating-oil-related investments, such as cash-
settled options on Futures Contracts, forward contracts for heating
oil, and over-the-counter (``OTC'') contracts that are based on the
price of heating oil, oil, and other petroleum-based fuels, Futures
Contracts, and indices based on the foregoing. See Amex Proposal,
supra note 3, 73 FR at 514.
    \12\ Treasuries are defined as short-term obligations of the
United States of two years or less. See id.
    \13\ Gasoline Interests are defined as investments in Futures
Contracts and other gasoline-related investments, such as cash-
settled options on Futures Contracts, forward contracts for
gasoline, and OTC transactions that are based on the price of
gasoline, oil, and other petroleum-based fuels, Futures Contracts,
and indices based on the foregoing. See id.
    \14\ See id., 73 FR at 519 (defining Basket Amount as the amount
of Treasuries and/or cash equal to the NAV per Unit times 100,000
Units required for the purchase of a basket of Units).
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Trading Rules
    The Exchange deems the Units to be equity securities, thus
rendering trading in the Units subject to its existing rules governing
the trading of equity securities. The Exchange represents that the
Units will trade on the NYSE Arca Marketplace from 4 a.m. to 8 p.m. ET.
The Exchange represents that it has appropriate rules to facilitate
transactions in the Units during all trading sessions.
    To facilitate surveillance, NYSE Arca Equities Rule 8.300(e) sets
forth certain restrictions on ETP Holders acting as registered Market
Makers in Units. NYSE Arca Equities Rule 8.300(e)(2)-(3) requires that
an ETP Holder acting as a registered Market Maker in the Units provide
the Exchange with necessary information relating to its trading in
underlying assets or commodities, related futures or options on
futures, or any other related derivatives. NYSE Arca Equities Rule
8.300(e)(4) prohibits the ETP Holder acting as a registered Market
Maker in the Units 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 asset or commodity, related futures or options on futures,
or any other related derivative (including the Units). In addition,
NYSE Arca Equities Rule 8.300(e)(1) prohibits the ETP Holder acting as
a registered Market Maker in the Units from being affiliated with a
market maker in the underlying asset or commodity, 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.
Trading Halts
    The Exchange may consider all relevant factors in exercising its
discretion to halt or suspend trading in the Units. Trading may be
halted because of market conditions or for reasons that, in the view of
the Exchange, make trading in the Units inadvisable. These may include:
(1) The extent to which trading is not occurring in the underlying
Futures Contracts, or (2) whether other unusual conditions or
circumstances detrimental to the maintenance of a fair and orderly
market are present. In addition, trading in Units could be halted
pursuant to the Exchange's ``circuit breaker'' rule \15\ or by the halt
or suspension of trading of the underlying securities.
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    \15\ See NYSE Arca Equities Rule 7.12.
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    In addition, the Exchange represents that it will cease trading the
Units of a Partnership if: (a) The listing market stops trading the
Units because of a regulatory halt similar to a halt based on NYSE Arca
Equities Rule 7.12; or (b) the listing market delists the Units.
Additionally, the Exchange may cease trading the Units if such other
event shall occur or condition exists which in the opinion of the
Exchange makes further dealings on the Exchange inadvisable. UTP
trading in the Units is also governed by the trading halts provisions
of NYSE Arca Equities Rule 7.34 relating to temporary interruptions in
the calculation or wide dissemination of an Indicative Partnership
Value or the value of an underlying Benchmark Futures Contract.\16\
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    \16\ NYSE Arca Equities Rule 7.34(a) literally addresses
temporary interruptions in the calculation or wide dissemination of
the Indicative Intra-Day Value and the value of an underlying index.
The Units of each Partnership, however, do not have an underlying
index, but have an underlying Benchmark Futures Contract. Therefore,
the Exchange hereby represents that the provisions in NYSE Arca
Equities Rule 7.34(a) that address interruptions in the calculation
or wide dissemination of the value of an underlying index shall also
apply to interruptions in the calculation or wide dissemination of
the value of an underlying Benchmark Futures Contract.
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Surveillance
    The Exchange intends to utilize its existing surveillance
procedures applicable to derivative products to monitor trading in the
Units. The Exchange represents that these procedures are adequate to
properly monitor Exchange trading of the Units in all trading sessions
and to deter and detect violations of Exchange rules.
    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.
    The Exchange may obtain information via the Intermarket
Surveillance Group (``ISG'') from other exchanges that are members or
affiliates of the ISG.\17\ In addition, the Exchange has an Information
Sharing Agreement in place with NYMEX and ICE Futures for the purpose
of providing information in connection with trading in or related to
futures contracts traded on NYMEX and ICE Futures, respectively. To the
extent that a Partnership invests in Heating Oil Interests or Gasoline
Interests traded on other exchanges, the Exchange will seek to enter
into information sharing agreements with those particular exchanges.
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    \17\ For a list of the current members and affiliate members of
ISG, see http://www.isgportal.com.

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    In addition, the Exchange also has a general policy prohibiting the
distribution of material, non-public information by its employees.
Information Bulletin
    Prior to the commencement of trading, the Exchange will inform its
ETP Holders in an Information Bulletin (``Bulletin'') of the special
characteristics and risks associated with trading the Units.
Specifically, the

Bulletin will discuss the following: (1) The risks involved in trading
the Units during the Opening and Late Trading Sessions when an updated
Indicative Partnership Value will not be calculated or publicly
disseminated; (2) the procedures for purchases and redemptions of Units
in Baskets (and that Units are not individually redeemable); (3) NYSE
Arca Equities Rule 9.2(a); \18\ (4) how information regarding the
Indicative Partnership Value is disseminated; (5) the requirement that
ETP Holders deliver a prospectus to investors purchasing newly issued
Units prior to or concurrently with the confirmation of a transaction;
and (6) trading information.
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    \18\ NYSE Arca Equities Rule 9.2(a) provides that an ETP Holder,
before recommending a transaction, must have reasonable grounds to
believe that the recommendation is suitable for the customer based
on any facts disclosed by the customer as to his other security
holdings and as to his financial situation and needs. Further, the
rule provides, with a limited exception, that prior to the execution
of a transaction recommended to a non-institutional customer the ETP
Holder shall make reasonable efforts to obtain information
concerning the customer's financial status, tax status, investment
objectives, and any other information that it believes would be
useful to make a recommendation. See Securities Exchange Act Release
No. 54045 (June 26, 2006), 71 FR 37971 (July 3, 2006) (SR-PCX-2005-
115).
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    In addition, the Bulletin will reference that each Partnership is
subject to various fees and expenses; there is no regulated source of
last-sale information regarding physical commodities; the Commission
has no jurisdiction over the trading of heating oil, gasoline, crude
oil, natural gas, or other petroleum-based fuels; and the CFTC has
regulatory jurisdiction over the trading of heating oil-based and
gasoline-based futures contracts and related options. The Bulletin will
also discuss any exemptive, no-action, or interpretive relief granted
by the Commission from any rules under the Act, and will disclose the
trading hours of the Units of each Partnership and that the NAV for the
Units will be calculated after 4 p.m. ET each trading day.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with section 6(b) of the Act,\19\ in general, and furthers the
objectives of section 6(b)(5),\20\ 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 facilitating transactions in
securities, and to remove impediments to and perfect the mechanism of a
free and open market and a national market system.
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    \19\ 15 U.S.C. 78f(b).
    \20\ 15 U.S.C. 78f(b)(5).
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    In addition, the Exchange believes that the proposed rule change is
consistent with Rule 12f-5 under the Act \21\ because it deems the
Units to be equity securities, thus rendering the Units subject to the
Exchange's rules governing the trading of equity securities.
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    \21\ 17 CFR 240.12f-5.
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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

    Written comments on the proposed rule change were neither solicited
nor received.

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-2007-78 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2007-78. 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 the filing also will be available for
inspection and copying at the principal office of NYSE Arca. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2007-78 and should
be submitted on or before March 7, 2008.

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

    After careful review, 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.\22\ In particular, the Commission finds that the proposed
rule change is consistent with section 6(b)(5) of the Act,\23\ which
requires that an exchange have rules designed, among other things, 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 believes that this proposal should benefit
investors by increasing competition among markets that trade the Units.
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    \22\ 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).
    \23\ 15 U.S.C. 78f(b)(5).
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    In addition, the Commission finds that the proposal is consistent
with section 12(f) of the Act,\24\ which permits an exchange to trade,
pursuant to UTP, a security that is listed and registered on another
exchange.\25\ The Commission

notes that it approved the original listing and trading of the Units on
Amex.\26\ The Commission also finds that the proposal is consistent
with Rule 12f-5 under the Act,\27\ which provides that an exchange
shall not extend UTP to a security unless the exchange has in effect a
rule or rules providing for transactions in the class or type of
security to which the exchange extends UTP. The Exchange has
represented that it meets this requirement because it deems the Units
to be equity securities, thus rendering trading in the Units subject to
the Exchange's existing rules governing the trading of equity
securities.
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    \24\ 15 U.S.C. 78l(f).
    \25\ Section 12(a) of the Act, 15 U.S.C. 78l(a), generally
prohibits a broker-dealer from trading a security on a national
securities exchange unless the security is registered on that
exchange pursuant to Section 12 of the Act. Section 12(f) of the Act
excludes from this restriction trading in any security to which an
exchange ``extends UTP.'' When an exchange extends UTP to a
security, it allows its members to trade the security as if it were
listed and registered on the exchange even though it is not so
listed and registered.
    \26\ See supra note 3.
    \27\ 17 CFR 240.12f-5.
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    The Commission further believes that the proposal is consistent
with section 11A(a)(1)(C)(iii) of the Act,\28\ 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. Quotations and last-sale information regarding the Units
will be disseminated through the facilities of the CTA and Consolidated
Quote High Speed Lines. The daily settlement prices for the Futures
Contracts are publicly available on various Web sites, and market data
vendors and news publications publish futures prices and related data,
including quotation and last-sale information for the Futures
Contracts. Amex will disseminate through the facilities of the CTA an
updated Indicative Partnership Value on a per-Unit basis at least every
15 seconds during regular Amex trading hours. Amex intends to
disseminate for each Partnership on a daily basis information with
respect to the Indicative Partnership Value, the NAV, the number of
Units outstanding, the Basket Amount, and daily trading volumes and
closing prices of the Units. Finally, USHO's and USG's total portfolio
composition will be disclosed, each business day that the Amex is open
for trading, on their respective Web sites.
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    \28\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
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    The Commission also believes that the Exchange's trading halt rules
are reasonably designed to prevent trading in the Units when
transparency is impaired. If the listing market halts trading when the
Indicative Fund Value is not being calculated or disseminated, the
Exchange would halt trading in the Units. The Exchange has represented
that it would follow the procedures with respect to trading halts set
forth in NYSE Arca Equities Rule 7.34.
    The Commission notes that, if the Units should be delisted by the
listing exchange, the Exchange would no longer have authority to trade
the Units pursuant to this order.
    In support of this proposal, the Exchange has made the following
representations:
    1. The Exchange's surveillance procedures are adequate to properly
monitor Exchange trading of the Units in all trading sessions and to
deter and detect violations of Exchange rules.
    2. Prior to the commencement of trading, the Exchange would inform
its ETP Holders in an Information Bulletin of the special
characteristics and risks associated with trading the Units, including
risks inherent with trading the Units during the Opening and Late
Trading Sessions when the updated Indicative Partnership Value is not
calculated and disseminated, and of suitability recommendation
requirements.
    3. The Information Bulletin also would discuss the requirement that
ETP Holders deliver a prospectus to investors purchasing newly issued
Units prior to or concurrently with the confirmation of a transaction.
    4. Trading in the Units will be subject to NYSE Arca Equities Rule
8.300(e), which sets forth certain restrictions on ETP Holders acting
as registered Market Makers in Units to facilitate surveillance.
    This approval order is based on these representations.
    The Commission finds good cause for approving this proposal before
the thirtieth day after the publication of notice thereof in the
Federal Register. As noted previously, the Commission previously found
that the listing and trading of the Units on Amex is consistent with
the Act.\29\ The Commission presently is not aware of any regulatory
issue that should cause it to revisit that finding or would preclude
the trading of the Units on the Exchange pursuant to UTP. Therefore,
accelerating approval of this proposal should benefit investors by
creating, without undue delay, additional competition in the market for
the Units.
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    \29\ See supra note 3.
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V. Conclusion

    It is therefore ordered, pursuant to section 19(b)(2) of the
Act,\30\ that the proposed rule change (SR-NYSEArca-2007-78) thereto,
be and it hereby is, approved on an accelerated basis.
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    \30\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\31\
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    \31\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-2822 Filed 2-14-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Rules and Regulations]
[Pages 58334-58335]
[FR Doc No: 2017-26656]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0143; Airspace Docket No. 17-AGL-5]

Amendment of Class E Airspace, Stevens Point, WI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule, correction.

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SUMMARY: This action corrects a final rule published in the Federal
Register

of November 1, 2017 that modifies Class E airspace extending upward
from 700 feet above the surface at Stevens Point Municipal Airport,
Stevens Point, WI, to accommodate new standard instrument approach
procedures for instrument flight rules operations at the airport. The
FAA identified that the latitude coordinate was incorrect.

DATES: Effective 0901 UTC, February 1, 2018. The Director of the
Federal Register approves this incorporation by reference action under
Title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Walter Tweedy, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a final rule in the Federal Register (82 FR
50503, November 1, 2017) Docket No. FAA-2017-0143, modifying Class E
airspace extending upward from 700 feet above the surface at Stevens
Point Municipal Airport, Stevens Point, WI.
    Subsequent to publication, the FAA found that the geographic
coordinates for the airport were incorrect. This action amends the
latitude coordinate in the airspace designation.
    Class E airspace designations are published in paragraph 6005,
respectively, of FAA Order 7400.11B, dated August 2, 2017, and
effective September 15, 2017, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.

Correction to Final Rule

    Accordingly, pursuant to the authority delegated to me, in the
Federal Register of November 1, 2017 (82 FR 50503) FR Doc. 2017-23434,
Amendment of Class E Airspace; Stevens Point, WI, is corrected as
follows:

Sec.  71.1  [Amended]

AGL WI E5 Stevens Point, WI [Corrected]

0
On page 50504 column 1, line 59, remove ``Lat. 44[deg]32'43'' N.'' and
add in its place ``Lat. 44[deg]32'42'' N.''

    Issued in Fort Worth, Texas, on December 1, 2017.
Christopher L. Southerland,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-26656 Filed 12-11-17; 8:45 am]
BILLING CODE 4910-13-P


TPEM participation levels have sharply decreased from 1462 engines and equipment manufacturers during the last ICR review to 107 now. This is because the program is coming to an end in 2021 and most participants exhausted their allowances early in the program. See section (4)(b)(i)(9) TPEM for details.

       As discussed in section (4)(b)(i)(10), there are regulatory provisions for a variety of special circumstances, from testing and display exemptions to national security. EPA's Imports and TPEM Help Desks, which also handle those provisions, receive about 3,272 questions from manufacturers and the public every year. Table 11 (Excel file) estimates the number of respondents that submitted applications and reports for special provisions covered under this ICR. In the previous ICR, EPA mistakenly factored in all calls and emails serviced by our help desks to the burden calculations without realizing that those calls included requests for information about programs not covered in this collection.

		(6)(d)(iii) Total Number of Reports per Respondent

	The number of reports each respondent submits per year varies depending on several factors, such as: (1) number of engine families certified each model year and their projected production, (2) the requirements of any compliance program each family must comply with, (3) the number of corrections to the application for certification needed throughout the year; and (4) whether the respondent elects to participate in TPEM or other special provisions, such as testing or display exemptions.  The total number of responses for this collection has been calculated at 2,913 by a total of 468 respondent for an average number of responses per respondent of 6.2; as shown in Table 19. There is a sharp decline in the number of respondents and responses for two reasons: (1) As previously mentioned, TPEM has ended for many former respondents. The program was/is available at different times for different power categories and according to emissions standards. The program has already ended for the most popular categories and will end altogether in 2021; (2) The number of respondents to special provisions has been adjusted down. In the previous ICR, EPA mistakenly accounted calls serviced by our help desks for special provisions not covered in this ICR.

                  Table 19
Total Estimated Number of Reports

 6(e) Bottom Line Burden Hours and Cost Tables

          6(e)(i)  Respondent Tally

                                    Table 20
                       Summary by IC and Respondent Tally

           (ii)  The Agency Tally

             Number of Respondents:
             Total Hours Per Year: 	       59,904
             Total Labor Cost:  		$5,297,438
             Total Annual Capital Costs: 		  $0
             Total Annual O&M Costs:  	   $934,000
             Total Costs: 			$4,426,425

    6(f) Change in Burden

    There is a net decrease of 73,137 hours in the total estimated burden for ICR 1684.20 from the burden currently identified in the OMB Inventory of Approved ICR Burdens of 3,880 for the previous ICR 1684.18.  This net decrease occurs despite the incorporation of four other ICRs into ICR 1684.20 as discussed in Section 1(b) of this document. Table 21 shows the change in the number of responses and burden in this ICR and the reasons for those changes. As mentioned in Section 6(d)(i), there is a sharp reduction in respondents in ICs #3 and #4 due to:
 A 92% decrease in TPEM respondents as the program phases out. According to 2017 data, there are 107 companies currently participating in TPEM as opposed to 1,462 respondents estimated during the previous ICR review (ICR 1684.18). Program availability varies by power category and schedule of emissions standards. The most popular Tier 3 period of availability has already ended for all but one power category. TPEM will end altogether in 2021.
 Respondents' heavy reliance on carry-over testing data: 78% of all engine families certified in the past two years are carry-over families, an important increase from 56% in the previous ICR.
 Other reductions were achieved by eliminating duplication. For example, in the previous ICR, EPA mistakenly accounted calls serviced by our help desks for special provisions not covered in this ICR.

                                    Table 21
                              Change Burden per IC

    6(g) Burden Statement

 	The annual public reporting and recordkeeping burden for this collection of information is 273 hours per respondent.  Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency.  This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.  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.  The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

	To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OAR-2007-1182, which is available for online viewing at www.regulations.gov,  or in person viewing at the Air and Radiation Docket in the EPA Docket Center (EPA/DC), WJC Federal Building West, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C.  The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Air and Radiation Docket is<PHONE_NUMBER>.  An electronic version of the public docket is available at www.regulations.gov. This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically.  When in the system, select "search," then key in the Docket ID Number identified above.  Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention:  Desk Office for EPA.  Please include the EPA Docket ID No. EPA-HQ-OAR-2007-1182 and OMB control number 2060-0287 in any correspondence.


[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Notices]
[Pages 49774-49775]
[FR Doc No: 2011-20399]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Cellular, Tissue and Gene Therapies Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 22 and 23,
2011, from 8 a.m. to 5 p.m.
    Location: Hilton Hotel, Washington, DC North/Gaithersburg, 620
Perry Pkwy., Gaithersburg, MD 20977,<PHONE_NUMBER>. For those unable to
attend in person, the meeting will also be available by Web cast. On
September 22, 2011, the link for the Web cast is available at http://fda.yorkcast.com/webcast/Viewer/?peid=637f14248dca4236a5f9a3b622e6501e1d. On September 23, 2011, the
link for the Web cast is available at http://fda.yorkcast.com/webcast/Viewer/?peid=2e8b3eb7638d42ca9652c328a854efb51d.
    Contact Person: Gail Dapolito or Sheryl Clark (HFM-71), Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20853,<PHONE_NUMBER>, or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area), and follow the prompts to the desired center or
product area. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a

previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On September 22, 2011, the committee will discuss BLA
125397, Umbilical Cord Blood, New York Blood Center, indicated for
hematologic malignancies, bone marrow failure, primary immunodeficiency
diseases, beta thalassemia, Hurler syndrome, Krabbe disease, and X-
linked adrenoleukodystrophy. On September 23, 2011, the Committee will
discuss HDE BH110018, CliniMACS CD34 Selection System, Miltenyi Biotec,
for processing allogeneic HLA-matched hematopoietic progenitor cells-
apheresis (HPC-C) from a related donor to obtain a CD34\+\ Cell
population intended for hematopoietic reconstitution following a
Myeloablative preparative regimen without the need for additional
graft-vs-host disease (GVHD) prophylaxis in patients with acute
myelogenous leukemia in first or second morphologic complete remission.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
September 15, 2011. Oral presentations from the public will be
scheduled on September 22, 2011, between approximately 11 a.m. and 12
noon and on September 23, 2011, between approximately 11:30 a.m. and
12:30 p.m. Those individuals interested in making formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before September 7, 2011. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by September
8, 2011.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Gail Dapolito at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20399 Filed 8-10-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 121 (Wednesday, June 24, 2015)]
[Notices]
[Pages 36367-36372]
[FR Doc No: 2015-15450]

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

[Investment Company Act Release No. 31683; 812-14425]

Amplify Investments LLC and Amplify ETF Trust; Notice of
Application

June 18, 2015.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application for an order under section 12(d)(1)(J)
of the Investment Company Act of 1940 (the ``Act'') for exemptions from
sections 12(d)(1)(A), (B), and (C) of the Act, under sections 6(c) and
17(b) of the Act for an exemption from section 17(a) of the Act, and
under section 6(c) of the Act for an exemption from rule 12d1-2(a)
under the Act.

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    Summary of the Application: Applicants request an order that would
(a) permit certain registered open-end management investment companies
that operate as ``funds of funds'' to acquire shares of certain
registered open-end management investment companies, registered closed-
end management investment companies, business development companies, as
defined by section 2(a)(48) of the Act (``business development
companies''), and registered unit investment trusts that are within or
outside the same group of investment companies as the acquiring
investment companies and (b) permit certain registered open-end
management investment companies relying on rule 12d1-2 under the Act to
invest in certain financial instruments.
    Applicants: Amplify Investments LLC (``Adviser'') and Amplify ETF
Trust (``Trust'').
    Filing Dates: The application was filed on February 20, 2015.
    Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on July 13, 2015, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090. Adviser and Trust, 3250 Lacey
Road, Suite 130, Downers Grove, Illinois 60515.

FOR FURTHER INFORMATION CONTACT:  Kieran G. Brown, Senior Counsel, at
(202) 551-6773, or James M. Curtis, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or for an
applicant using the ``Company'' name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Applicants' Representations

    1. The Trust is organized as a Massachusetts business trust and
intends to register with the Commission as an open-end management
investment company. The Trust intends to have multiple series which
pursue distinct investment objectives and strategies.\1\ The Adviser, a
Delaware limited liability company, is a registered investment adviser
under the Investment Advisers Act of 1940. The Adviser, or an entity
controlling, controlled by, or under common control with the Adviser,
will serve as the investment adviser to each of the Funds.\2\
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    \1\ The Applicants request that the order apply not only to any
existing series of the Trust, but that the order also extend to any
future series of the Trust, and any other existing or future
registered open-end management investment companies and any series
thereof that are part of the same group of investment companies, as
defined in section 12(d)(1)(G)(ii) of the Act, as the Trust and are
advised by the Adviser or any other investment adviser controlling,
controlled by, or under common control with the Adviser (together
with the series of the Trust, each series a ``Fund,'' and
collectively, the ``Funds''). All entities that currently intend to
rely on the requested order are named as applicants. Any other
entity that relies on the order in the future will comply with the
terms and conditions of the application.
    \2\ All references to the term ``Adviser'' include successors-
in-interest to the Adviser. A successor-in-interest is limited to an
entity that results from a reorganization into another jurisdiction
or a change in the type of business organization.
---------------------------------------------------------------------------

    3. Applicants request relief to the extent necessary to permit: (a)
A Fund (each, a ``Fund of Funds,'' and collectively, the ``Funds of
Funds'') to acquire shares of registered open-end management investment
companies (each an ``Unaffiliated Open-End Investment Company''),
registered closed-end management investment companies, business
development companies (each registered closed-end management investment
company and each business development company, an ``Unaffiliated
Closed-End Investment Company'' and, together with the Unaffiliated
Open-End Investment Companies, the ``Unaffiliated Investment
Companies''), and registered unit investment trusts (``UITs'') (the
``Unaffiliated Trusts,'' and collectively with the Unaffiliated
Investment Companies, the ``Unaffiliated Funds''), in each case, that
are not part of the same ``group of investment companies'' as the Funds
of Funds; \3\ (b) the Unaffiliated Funds, their principal underwriters
and any broker or dealer registered under the Securities Exchange Act
of 1934 (the ``1934 Act'') (``Broker'') to sell shares of such
Unaffiliated Funds to the Funds of Funds; (c) the Funds of Funds to
acquire shares of other registered investment companies, including
open-end management investment companies and series thereof, closed-end
management investment companies and UITs, as well as business
development companies (if any), in the same group of investment
companies as the Funds of Funds (collectively, the ``Affiliated
Funds,'' and, together with the Unaffiliated Funds, the ``Underlying
Funds''); \4\ and (d) the Affiliated Funds, their principal
underwriters and any Broker to sell shares of the Affiliated Funds to
the Funds of Funds.\5\ Applicants also request an order under sections
6(c) and 17(b) of the Act to exempt applicants from section 17(a) to
the extent necessary to permit Underlying Funds organized as open-end
management investment companies and UITs to sell their shares to Funds
of Funds and redeem their shares from Funds of Funds.
---------------------------------------------------------------------------

    \3\ For purposes of the request for relief, the term ``group of
investment companies'' means any two or more investment companies,
including closed-end investment companies and business development
companies, that hold themselves out to investors as related
companies for purposes of investment and investor services.
    \4\ Certain of the Underlying Funds may be registered under the
Act as either UITs or open-end management investment companies and
have obtained exemptions from the Commission necessary to permit
their shares to be listed and traded on a national securities
exchange at negotiated prices and, accordingly, to operate as
exchange-traded funds (collectively, ``ETFs'' and each, an ``ETF'').
In addition, certain of the Underlying Funds may in the future
pursue, their investment objectives through a master-feeder
arrangement in reliance on section 12(d)(1)(E) of the Act. In
accordance with condition 12, a Fund of Funds may not invest in an
Underlying Fund that operates as a feeder fund unless the feeder
fund is part of the same ``group of investment companies'' as its
corresponding master fund or the Fund of Funds. If a Fund of Funds
invests in an Affiliated Fund that operates as a feeder fund and the
corresponding master fund is not within the same ``group of
investment companies'' as the Fund of Funds and Affiliated Fund, the
master fund would be an Unaffiliated Fund for purposes of the
application and its conditions.
    \5\ Applicants state that they do not believe that investments
in business development companies present any particular
considerations or concerns that may be different from those
presented by investments in registered closed-end investment
companies.
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    4. Applicants also request an exemption under section 6(c) from
rule 12d1-2 under the Act to permit any existing or future Fund of
Funds that relies on section 12(d)(1)(G) of the Act (``Section
12(d)(1)(G) Fund of Funds'') and that otherwise complies with rule
12d1-2 under the Act, to also invest, to the extent consistent with its
investment objective(s), policies, strategies and limitations, in other
financial instruments that may not be securities within the meaning of
section 2(a)(36) of the Act (``Other Investments'').

Applicants' Legal Analysis

A. Section 12(d)(1)

    1. Section 12(d)(1)(A) of the Act, in relevant part, prohibits a
registered investment company from acquiring shares of an investment
company if the securities represent more than 3% of the total
outstanding voting stock of the acquired company, more than 5% of the
total assets of the acquiring company, or, together with the securities
of any other investment companies, more than 10% of the total assets of
the acquiring company. Section 12(d)(1)(B) of the Act prohibits a
registered open-end investment company, its principal underwriter, and
any Broker from selling the investment company's shares to another
investment company if the sale will cause the acquiring company to own
more than 3% of the acquired company's voting stock, or if the sale
will cause more than 10% of the acquired company's voting stock to be
owned by investment companies generally. Section 12(d)(1)(C) prohibits
an investment company from acquiring any security issued by a
registered closed-end investment company if such acquisition would
result in the acquiring company, any other investment companies having
the same investment adviser, and companies controlled by such
investment companies, collectively, owning more than 10% of the
outstanding voting stock of the registered closed-end investment
company.
    2. Section 12(d)(1)(J) of the Act provides that the Commission may
exempt any person, security, or transaction, or any class or classes of
persons, securities or transactions, from any provision of section
12(d)(1) if the exemption is consistent with the public

interest and the protection of investors. Applicants request an
exemption under section 12(d)(1)(J) of the Act from the limitations of
sections 12(d)(1)(A), (B) and (C) to the extent necessary to permit:
(i) The Funds of Funds to acquire shares of Underlying Funds in excess
of the limits set forth in section 12(d)(1)(A) and (C) of the Act; and
(ii) the Underlying Funds, their principal underwriters and any Broker
to sell shares of the Underlying Funds to the Funds of Funds in excess
of the limits set forth in section 12(d)(1)(B) of the Act.
    3. Applicants state that the proposed arrangement will not give
rise to the policy concerns underlying sections 12(d)(1)(A), (B), and
(C), which include concerns about undue influence by a fund of funds
over underlying funds, excessive layering of fees, and overly complex
fund structures. Accordingly, applicants believe that the requested
exemption is consistent with the public interest and the protection of
investors.
    4. Applicants submit that the proposed structure will not result in
the exercise of undue influence by a Fund of Funds or its affiliated
persons over the Underlying Funds. Applicants assert that the concern
about undue influence does not arise in connection with a Fund of
Funds' investment in the Affiliated Funds because they are part of the
same group of investment companies. To limit the control a Fund of
Funds or Fund of Funds Affiliate \6\ may have over an Unaffiliated
Fund, applicants propose a condition prohibiting the Adviser and any
person controlling, controlled by or under common control with the
Adviser, and any investment company and any issuer that would be an
investment company but for section 3(c)(1) or section 3(c)(7) of the
Act advised or sponsored by the Adviser or any person controlling,
controlled by or under common control with the Adviser (collectively,
the ``Group'') from controlling (individually or in the aggregate) an
Unaffiliated Fund within the meaning of section 2(a)(9) of the Act. The
same prohibition would apply to any other investment adviser within the
meaning of section 2(a)(20)(B) of the Act to a Fund of Funds (``Sub-
Adviser'') and any person controlling, controlled by or under common
control with the Sub-Adviser, and any investment company or issuer that
would be an investment company but for section 3(c)(1) or 3(c)(7) of
the Act (or portion of such investment company or issuer) advised or
sponsored by the Sub-Adviser or any person controlling, controlled by
or under common control with the Sub-Adviser (collectively, the ``Sub-
Adviser Group'').
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    \6\ A ``Fund of Funds Affiliate'' is the Adviser, any Sub-
Adviser, promoter or principal underwriter of a Fund of Funds, as
well as any person controlling, controlled by or under common
control with any of those entities. An ``Unaffiliated Fund
Affiliate'' is an investment adviser(s), sponsor, promoter or
principal underwriter of any Unaffiliated Fund or any person
controlling, controlled by or under common control with any of those
entities.
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    5. With respect to closed-end Underlying Funds, applicants note
that although closed-end funds may not be unduly influenced by a
holder's right of redemption, closed-end Underlying Funds may be unduly
influenced by a holder's ability to vote a large block of stock. To
address this concern, applicants submit that, with respect to a Fund's
investment in an Unaffiliated Closed-End Investment Company, (i) each
member of the Group or Sub-Adviser Group that is an investment company
or an issuer that would be an investment company but for section
3(c)(1) or 3(c)(7) of the Act will vote its shares of the Unaffiliated
Closed-End Investment Company in the manner prescribed by section
12(d)(1)(E) of the Act and (ii) each other member of the Group or Sub-
Adviser Group will vote its shares of the Unaffiliated Closed-End
Investment Company in the same proportion as the vote of all other
holders of the same type of such Unaffiliated Closed-End Investment
Company's shares. Applicants state that, in this way, an Unaffiliated
Closed-End Investment Company will be protected from undue influence by
a Fund of Funds through the voting of the Unaffiliated Closed-End
Investment Company's shares.
    6. Applicants propose other conditions to limit the potential for
undue influence over the Unaffiliated Funds, including that no Fund of
Funds or Fund of Funds Affiliate (except to the extent it is acting in
its capacity as an investment adviser to an Unaffiliated Investment
Company or sponsor to an Unaffiliated Trust) will cause an Unaffiliated
Fund to purchase a security in an offering of securities during the
existence of any underwriting or selling syndicate of which a principal
underwriter is an Underwriting Affiliate (``Affiliated
Underwriting'').\7\
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    \7\ An ``Underwriting Affiliate'' is a principal underwriter in
any underwriting or selling syndicate that is an officer, director,
trustee, advisory board member, investment adviser, sub-adviser or
employee of the Fund of Funds, or a person of which any such
officer, director, trustee, investment adviser, sub-adviser, member
of an advisory board or employee is an affiliated person. An
Underwriting Affiliate does not include any person whose
relationship to an Unaffiliated Fund is covered by section 10(f) of
the Act.
---------------------------------------------------------------------------

    7. To further ensure that an Unaffiliated Investment Company
understands the implications of a Fund of Funds' investment under the
requested exemptive relief, prior to its investment in the shares of an
Unaffiliated Investment Company in excess of the limit of section
12(d)(1)(A)(i) of the Act, a Fund of Funds and the Unaffiliated
Investment Company will execute an agreement stating, without
limitation, that each of their boards of directors or trustees (each, a
``Board'') and their investment advisers understand the terms and
conditions of the order and agree to fulfill their responsibilities
under the order (the ``Participation Agreement''). Applicants note that
an Unaffiliated Investment Company (including an ETF or an Unaffiliated
Closed-End Investment Company) would also retain its right to reject
any initial investment by a Fund of Funds in excess of the limits in
section 12(d)(1)(A)(i) of the Act by declining to execute the
Participation Agreement with the Fund of Funds. In addition, an
Unaffiliated Investment Company (other than an ETF or Unaffiliated
Closed-End Investment Company whose shares are purchased by a Fund of
Funds in the secondary market) will retain its right at all times to
reject any investment by a Fund of Funds. Finally, solely upon notice
to a Fund of Funds, an Unaffiliated Investment Company could terminate
a Participation Agreement with the Fund of Funds effective at the end
of the notice period specified in the Participation Agreement.
    8. Applicants state that they do not believe that the proposed
arrangement will result in excessive layering of fees. The Board of
each Fund of Funds, including a majority of the trustees who are not
``interested persons'' within the meaning of section 2(a)(19) of the
Act (the ``Independent Trustees''), will find that the management or
advisory fees charged under a Fund of Funds' advisory contract are
based on services provided that are in addition to, rather than
duplicative of, services provided under the advisory contract(s) of any
Underlying Fund in which the Fund of Funds may invest. In addition, the
Adviser will waive fees otherwise payable to it by a Fund of Funds in
an amount at least equal to any compensation (including fees received
pursuant to any plan adopted by an Unaffiliated Investment Company
under rule 12b-1 under the Act) received from an Unaffiliated Fund by
the Adviser, or an affiliated person of the Adviser, other than any
advisory fees paid to the Adviser or an affiliated person of the

Adviser by the Unaffiliated Investment Company, in connection with the
investment by the Fund of Funds in the Unaffiliated Fund.
    9. Applicants further state that any sales charges and/or service
fees charged with respect to shares of a Fund of Funds will not exceed
the limits applicable to funds of funds set forth in in rule 2830 of
the Conduct Rules of the NASD (``NASD Conduct Rule 2830'').\8\
---------------------------------------------------------------------------

    \8\ Any references to NASD Conduct Rule 2830 include any
successor or replacement Financial Industry Regulatory Authority
rule to NASD Conduct Rule 2830.
---------------------------------------------------------------------------

    10. Applicants submit that the proposed arrangement will not create
an overly complex fund structure. Applicants note that no Underlying
Fund will acquire securities of any other investment company or company
relying on section 3(c)(1) or 3(c)(7) of the Act in excess of the
limits contained in section 12(d)(1)(A) of the Act, except in certain
circumstances identified in condition 12 below.

B. Section 17(a)

    1. Section 17(a) of the Act generally prohibits sales or purchases
of securities between a registered investment company and any
affiliated person of the company. Section 2(a)(3) of the Act defines an
``affiliated person'' of another person to include (a) any person
directly or indirectly owning, controlling, or holding with power to
vote, 5% or more of the outstanding voting securities of the other
person; (b) any person 5% or more of whose outstanding voting
securities are directly or indirectly owned, controlled, or held with
power to vote by the other person; and (c) any person directly or
indirectly controlling, controlled by, or under common control with the
other person.
    2. Applicants state that the Funds of Funds and the Affiliated
Funds may be deemed to be under the common control of the Adviser and,
therefore, affiliated persons of one another. Applicants also state
that the Funds of Funds and the Underlying Funds organized as open-end
management investment companies and UITs may also be deemed to be
affiliated persons of one another if a Fund of Funds owns 5% or more of
the outstanding voting securities of one or more of such Underlying
Funds. Applicants state that the sale of shares by Underlying Funds
organized as open-end management investment companies and UITs to the
Funds of Funds and the purchase of those shares from the Funds of Funds
by such Underlying Funds (through redemptions) could be deemed to
violate section 17(a).\9\
---------------------------------------------------------------------------

    \9\ Applicants acknowledge that receipt of any compensation by
(a) an affiliated person of a Fund of Funds, or an affiliated person
of such person, for the purchase by the Fund of Funds of shares of
an Underlying Fund or (b) an affiliated person of an Underlying
Fund, or an affiliated person of such person, for the sale by the
Underlying Fund of its shares to a Fund of Funds may be prohibited
by section 17(e) (1) of the Act. The Participation Agreement also
will include this acknowledgement.
---------------------------------------------------------------------------

    3. Section 17(b) of the Act authorizes the Commission to grant an
order permitting a transaction otherwise prohibited by section 17(a) if
it finds that (i) the terms of the proposed transaction are fair and
reasonable and do not involve overreaching on the part of any person
concerned; (ii) the proposed transaction is consistent with the
policies of each registered investment company concerned; and (iii) the
proposed transaction is consistent with the general purposes of the
Act. Section 6(c) of the Act permits the Commission to exempt any
person or transactions from any provision of the Act if such exemption
is necessary or appropriate in the public interest and consistent with
the protection of investors and the purposes fairly intended by the
policy and provisions of the Act.
    4. Applicants submit that the proposed transactions satisfy the
standards for relief under sections 17(b) and 6(c) of the Act.
Applicants state that the terms of the transactions are reasonable and
fair and do not involve overreaching. Applicants state that the terms
upon which an Underlying Fund that is an open-end management investment
company will sell its shares to or purchase its shares from a Fund of
Funds will be in accordance with the rules and regulations under the
Act.\10\ Applicants also state that the proposed transactions will be
consistent with the policies of each Fund of Funds and Underlying Fund,
and with the general purposes of the Act.
---------------------------------------------------------------------------

    \10\ Applicants note that a Fund of Funds generally would
purchase and sell shares of an Underlying Fund that operates as an
ETF through secondary market transactions rather than through
principal transactions with the Underlying Fund. Applicants
nevertheless request relief from sections 17(a)(1) and (2) to permit
each Fund of Funds that is an affiliated person, or an affiliated
person of an affiliated person, as defined in section 2(a)(3) of the
Act, of an ETF to purchase or redeem shares from the ETF. Applicants
are not seeking relief from section 17(a) for, and the requested
relief will not apply to, transactions where an ETF could be deemed
an affiliated person, or an affiliated person of an affiliated
person, of a Fund of Funds because an investment adviser to the ETF
or an entity controlling, controlled by or under common control with
the investment adviser to the ETF is also an investment adviser to
the Fund of Funds. Applicants note that a Fund of Funds will
purchase and sell shares of an Underlying Fund that is a closed-end
fund through secondary market transactions at market prices rather
than through principal transactions with the closed-end fund.
Accordingly, applicants are not requesting section 17(a) relief with
respect to principal transactions with closed-end funds (including
business development companies).
---------------------------------------------------------------------------

C. Other Investments by Section 12(d)(1)(G) Funds of Funds

    1. Section 12(d)(1)(G) of the Act provides that section 12(d)(1)
will not apply to securities of an acquired company purchased by an
acquiring company if: (i) The acquiring company and acquired company
are part of the same ``group of investment companies,'' as defined in
section 12(d)(1)(G)(ii) of the Act; (ii) the acquiring company holds
only securities of acquired companies that are part of the same ``group
of investment companies,'' as defined in section 12(d)(1)(G)(ii) of the
Act, government securities, and short-term paper; (iii) the aggregate
sales loads and distribution-related fees of the acquiring company and
the acquired company are not excessive under rules adopted pursuant to
section 22(b) or section 22(c) of the Act by a securities association
registered under section 15A of the 1934 Act or by the Commission; and
(iv) the acquired company has a policy that prohibits it from acquiring
securities of registered open-end management investment companies or
registered UITs in reliance on section 12(d)(1)(F) or (G) of the Act.
    2. Rule 12d1-2 under the Act permits a registered open-end
investment company or a registered UIT that relies on section
12(d)(1)(G) of the Act to acquire, in addition to securities issued by
another registered investment company in the same group of investment
companies, government securities, and short-term paper: (1) Securities
issued by an investment company that is not in the same group of
investment companies, when the acquisition is in reliance on section
12(d)(1)(A) or 12(d)(1)(F) of the Act; (2) securities (other than
securities issued by an investment company); and (3) securities issued
by a money market fund, when the investment is in reliance on rule
12d1-1 under the Act. For the purposes of rule 12d1-2, ``securities''
means any security as defined in section 2(a)(36) of the Act.
    3. Applicants state that the proposed arrangement would comply with
rule 12d1-2 under the Act, but for the fact that the Section
12(d)(1)(G) Funds of Funds may invest a portion of their assets in
Other Investments. Applicants request an order under section 6(c) of
the Act for an exemption from rule 12d1-2(a) to allow the Section
12(d)(1)(G) Funds of Funds to invest in Other Investments. Applicants
assert that permitting a Section 12(d)(1)(G) Fund of Funds to invest in
Other Investments as described in the

application would not raise any of the concerns that section 12(d)(1)
of the Act was intended to address.
    4. Consistent with its fiduciary obligations under the Act, a
Section 12(d)(1)(G) Fund of Funds' Board will review the advisory fees
charged by the Section 12(d)(1)(G) Fund of Funds' investment adviser(s)
to ensure that the fees are based on services provided that are in
addition to, rather than duplicative of, services provided pursuant to
the advisory agreement of any investment company in which the Section
12(d)(1)(G) Fund of Funds may invest.

Applicants' Conditions

A. Investments by Funds of Funds in Underlying Funds

    Applicants agree that the order granting the requested relief to
permit Funds of Funds to invest in Underlying Funds shall be subject to
the following conditions:
    1. The members of the Group will not control (individually or in
the aggregate) an Unaffiliated Fund within the meaning of section
2(a)(9) of the Act. The members of a Sub-Adviser Group will not control
(individually or in the aggregate) an Unaffiliated Fund within the
meaning of section 2(a)(9) of the Act. With respect to a Fund's
investment in an Unaffiliated Closed-End Investment Company, (i) each
member of the Group or Sub-Adviser Group that is an investment company
or an issuer that would be an investment company but for section
3(c)(1) or 3(c)(7) of the Act will vote its shares of the Unaffiliated
Closed-End Investment Company in the manner prescribed by section
12(d)(1)(E) of the Act and (ii) each other member of the Group or Sub-
Adviser Group will vote its shares of the Unaffiliated Closed-End
Investment Company in the same proportion as the vote of all other
holders of the same type of such Unaffiliated Closed-End Investment
Company's shares. If, as a result of a decrease in the outstanding
voting securities of any other Unaffiliated Fund, the Group or a Sub-
Adviser Group, each in the aggregate, becomes a holder of more than 25
percent of the outstanding voting securities of such Unaffiliated Fund,
then the Group or the Sub-Adviser Group will vote its shares of the
Unaffiliated Fund in the same proportion as the vote of all other
holders of the Unaffiliated Fund's shares. This condition will not
apply to a Sub-Adviser Group with respect to an Unaffiliated Fund for
which the Sub-Adviser or a person controlling, controlled by or under
common control with the Sub-Adviser acts as the investment adviser
within the meaning of section 2(a)(20)(A) of the Act (in the case of an
Unaffiliated Investment Company) or as the sponsor (in the case of an
Unaffiliated Trust).
    2. No Fund of Funds or Fund of Funds Affiliate will cause any
existing or potential investment by the Fund of Funds in an
Unaffiliated Fund to influence the terms of any services or
transactions between the Fund of Funds or a Fund of Funds Affiliate and
the Unaffiliated Fund or an Unaffiliated Fund Affiliate.
    3. The Board of each Fund of Funds, including a majority of the
Independent Trustees, will adopt procedures reasonably designed to
ensure that its Adviser and any Sub-Adviser to the Fund of Funds are
conducting the investment program of the Fund of Funds without taking
into account any consideration received by the Fund of Funds or Fund of
Funds Affiliate from an Unaffiliated Investment Company or Unaffiliated
Trust or any Unaffiliated Fund Affiliate of such Unaffiliated
Investment Company or Unaffiliated Trust in connection with any
services or transactions.
    4. Once an investment by a Fund of Funds in the securities of an
Unaffiliated Investment Company exceeds the limit of section
12(d)(1)(A)(i) of the Act, the Board of the Unaffiliated Investment
Company, including a majority of the Independent Trustees, will
determine that any consideration paid by the Unaffiliated Investment
Company to a Fund of Funds or a Fund of Funds Affiliate in connection
with any services or transactions: (a) Is fair and reasonable in
relation to the nature and quality of the services and benefits
received by the Unaffiliated Investment Company; (b) is within the
range of consideration that the Unaffiliated Investment Company would
be required to pay to another unaffiliated entity in connection with
the same services or transactions; and (c) does not involve
overreaching on the part of any person concerned. This condition does
not apply with respect to any services or transactions between an
Unaffiliated Investment Company and its investment adviser(s), or any
person controlling, controlled by, or under common control with such
investment adviser(s).
    5. No Fund of Funds or Fund of Funds Affiliate (except to the
extent it is acting in its capacity as an investment adviser to an
Unaffiliated Investment Company or sponsor to an Unaffiliated Trust)
will cause an Unaffiliated Fund to purchase a security in any
Affiliated Underwriting.
    6. The Board of an Unaffiliated Investment Company, including a
majority of the Independent Trustees, will adopt procedures reasonably
designed to monitor any purchases of securities by the Unaffiliated
Investment Company in an Affiliated Underwriting once an investment by
a Fund of Funds in the securities of the Unaffiliated Investment
Company exceeds the limit of section 12(d)(1)(A)(i) of the Act,
including any purchases made directly from an Underwriting Affiliate.
The Board of the Unaffiliated Investment Company will review these
purchases periodically, but no less frequently than annually, to
determine whether the purchases were influenced by the investment by
the Fund of Funds in the Unaffiliated Investment Company. The Board of
the Unaffiliated Investment Company will consider, among other things:
(a) Whether the purchases were consistent with the investment
objectives and policies of the Unaffiliated Investment Company; (b) how
the performance of securities purchased in an Affiliated Underwriting
compares to the performance of comparable securities purchased during a
comparable period of time in underwritings other than Affiliated
Underwritings or to a benchmark such as a comparable market index; and
(c) whether the amount of securities purchased by the Unaffiliated
Investment Company in Affiliated Underwritings and the amount purchased
directly from an Underwriting Affiliate have changed significantly from
prior years. The Board of the Unaffiliated Investment Company will take
any appropriate actions based on its review, including, if appropriate,
the institution of procedures designed to ensure that purchases of
securities in Affiliated Underwritings are in the best interests of
shareholders.
    7. Each Unaffiliated Investment Company will maintain and preserve
permanently, in an easily accessible place, a written copy of the
procedures described in the preceding condition, and any modifications
to such procedures, and will maintain and preserve for a period of not
less than six years from the end of the fiscal year in which any
purchase in an Affiliated Underwriting occurred, the first two years in
an easily accessible place, a written record of each purchase of
securities in an Affiliated Underwriting once an investment by a Fund
of Funds in the securities of an Unaffiliated Investment Company
exceeds the limit of section 12(d)(1)(A)(i) of the Act, setting forth
(1) the party from whom

the securities were acquired, (2) the identity of the underwriting
syndicate's members, (3) the terms of the purchase, and (4) the
information or materials upon which the determinations of the Board of
the Unaffiliated Investment Company were made.
    8. Prior to its investment in shares of an Unaffiliated Investment
Company in excess of the limit set forth in section 12(d)(1)(A)(i) of
the Act, the Fund of Funds and the Unaffiliated Investment Company will
execute a Participation Agreement stating, without limitation, that
their Boards and their investment advisers understand the terms and
conditions of the order and agree to fulfill their responsibilities
under the order. At the time of its investment in shares of an
Unaffiliated Investment Company in excess of the limit set forth in
section 12(d)(1)(A)(i), a Fund of Funds will notify the Unaffiliated
Investment Company of the investment. At such time, the Fund of Funds
will also transmit to the Unaffiliated Investment Company a list of the
names of each Fund of Funds Affiliate and Underwriting Affiliate. The
Fund of Funds will notify the Unaffiliated Investment Company of any
changes to the list as soon as reasonably practicable after a change
occurs. The Unaffiliated Investment Company and the Fund of Funds will
maintain and preserve a copy of the order, the Participation Agreement,
and the list with any updated information for the duration of the
investment and for a period of not less than six years thereafter, the
first two years in an easily accessible place.
    9. Before approving any advisory contract under section 15 of the
Act, the Board of each Fund of Funds, including a majority of the
Independent Trustees, shall find that the advisory fees charged under
the advisory contract are based on services provided that are in
addition to, rather than duplicative of, services provided under the
advisory contract(s) of any Underlying Fund in which the Fund of Funds
may invest. Such finding, and the basis upon which the finding was
made, will be recorded fully in the minute books of the appropriate
Fund of Funds.
    10. The Adviser will waive fees otherwise payable to it by a Fund
of Funds in an amount at least equal to any compensation (including
fees received pursuant to any plan adopted by an Unaffiliated
Investment Company pursuant to rule 12b-1 under the Act) received from
an Unaffiliated Fund by the Adviser, or an affiliated person of the
Adviser, other than any advisory fees paid to the Adviser or its
affiliated person by the Unaffiliated Investment Company, in connection
with the investment by the Fund of Funds in the Unaffiliated Fund. Any
Sub-Adviser will waive fees otherwise payable to the Sub-Adviser,
directly or indirectly, by the Fund of Funds in an amount at least
equal to any compensation received by the Sub-Adviser, or an affiliated
person of the Sub-Adviser, from an Unaffiliated Fund, other than any
advisory fees paid to the Sub-Adviser or its affiliated person by the
Unaffiliated Investment Company, in connection with the investment by
the Fund of Funds in the Unaffiliated Fund made at the direction of the
Sub-Adviser. In the event that the Sub-Adviser waives fees, the benefit
of the waiver will be passed through to the Fund of Funds.
    11. Any sales charges and/or service fees charged with respect to
shares of a Fund of Funds will not exceed the limits applicable to
funds of funds set forth in NASD Conduct Rule 2830.
    12. No Underlying Fund will acquire securities of any other
investment company or company relying on section 3(c)(1) or 3(c)(7) of
the Act, in excess of the limits contained in section 12(d)(1)(A) of
the Act, except to the extent that such Underlying Fund: (a) Acquires
such securities in compliance with section 12(d)(1)(E) of the Act and
either is an Affiliated Fund or is in the same ``group of investment
companies'' as its corresponding master fund; (b) receives securities
of another investment company as a dividend or as a result of a plan of
reorganization of a company (other than a plan devised for the purpose
of evading section 12(d)(1) of the Act); or (c) acquires (or is deemed
to have acquired) securities of another investment company pursuant to
exemptive relief from the Commission permitting such Underlying Fund
to: (i) Acquire securities of one or more investment companies for
short-term cash management purposes or (ii) engage in inter-fund
borrowing and lending transactions.

B. Other Investments by Section 12(d)(1)(G) Funds of Funds

    Applicants agree that the order granting the requested relief to
permit Section 12(d)(1)(G) Funds of Funds to invest in Other
Investments shall be subject to the following condition:
    1. Applicants will comply with all provisions of rule 12d1-2 under
the Act, except for paragraph (a)(2) to the extent that it restricts
any Section 12(d)(1)(G) Fund of Funds from investing in Other
Investments as described in the application.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Brent J. Fields,
Secretary.
[FR Doc. 2015-15450 Filed 6-23-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20229-20230]
[FR Doc No: 2015-08635]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0543]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Waiver of In Vivo
Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral
Dosage Form Products and Type A Medicated Articles

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 15,
2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0575.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in
Soluble Powder Oral Dosage Form Products and Type A Medicated
Articles--21 CFR 514.1(b)(7-8) (OMB Control Number 0910-0575)--
Extension

    The Center for Veterinary Medicine (CVM) issued guidance for
industry (GFI) #171 entitled ``Waivers of In Vivo Demonstration of
Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form
Products and Type A Medicated Articles'' to describe the procedures
that the Agency recommends for the review of requests for waiver of in
vivo demonstration of bioequivalence for generic soluble powder oral
dosage form products and Type A medicated articles.
    The Generic Animal Drug and Patent Term Registration Act (GADPTRA)
of 1988 (Pub. L. 100-670) permitted generic animal drug manufacturers
to copy those pioneer animal drug products that were no longer subject
to patent or other marketing exclusivity protection. The approval for
marketing these generic products is based, in part, upon a
demonstration of bioequivalence between the generic product and pioneer
product. This guidance clarifies circumstances under which FDA believes
the demonstration of bioequivalence required by the statute does not
need to be established on the basis of in vivo studies for soluble
powder oral dosage form products and Type A medicated articles. The
data submitted in support of the waiver request are necessary to
validate the waiver decision. The requirement to establish
bioequivalence through in vivo studies (blood level bioequivalence or
clinical endpoint bioequivalence) may be waived for soluble powder oral
dosage form products or Type A medicated articles in either of two
alternative ways. A biowaiver may be granted if it can be shown that
the generic soluble powder oral dosage form product or Type A medicated
article contains the same active and inactive ingredient(s) and is
produced using the same manufacturing processes as the approved
comparator product or article. Alternatively, a biowaiver may be
granted without direct comparison to the pioneer product's formulation
and manufacturing process if it can be shown that the active
pharmaceutical ingredient(s) (API) is the same as the pioneer product,
is soluble, and that there are no ingredients in the formulation likely
to cause adverse pharmacologic effects. For the purpose of evaluating
soluble powder oral dosage form products and Type A medicated articles,
solubility can be demonstrated in one of two ways: ``USP definition''
approach or ``Dosage adjusted'' approach. The respondents for this
collection of information are pharmaceutical companies manufacturing
animal drugs. FDA estimates the burden for this collection of
information as follows in Tables 1 and 2 of this document. The source
of the above data is records of generic drug applications over the past
10 years.
    In the Federal Register of January 12, 2015 (80 FR 1506), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received, however it did not
respond to any of the four information collection topics solicited and
is therefore not addressed by the Agency.
    FDA estimates the burden of this collection of information as
follows:

                    Table 1--Estimated Annual Reporting Burden for Water Soluble Powders \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 CVM Guidance for industry #171      Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Same formulation/manufacturing                 1               1               1               5               5
 process approach...............
Same API/solubility approach....               5               5               5              10              50
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............              55
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                  Table 2--Estimated Annual Reporting Burden for Type A Medicated Articles \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 CVM Guidance for industry #171      Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Same formulation/manufacturing                 2               2               2               5              10
 process approach...............

Same API/solubility approach....              10              10              10              20             200
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             210
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: April 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08635 Filed 4-14-15; 8:45 am]
 BILLING CODE 4164-01-P