[Federal Register Volume 76, Number 44 (Monday, March 7, 2011)]
[Notices]
[Pages 12374-12380]
[FR Doc No: 2011-5064]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 29591; 812-13759]

Eaton Vance Management, et al.; Notice of Application

March 1, 2011.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (``Act'') for an exemption from sections
2(a)(32), 5(a)(1), 22(d) and 22(e) of the Act and rule 22c-1 under the
Act, under sections 6(c) and 17(b) of the Act for an exemption from
sections 17(a)(1) and (a)(2) of the Act, and under section 12(d)(1)(J)
of the Act for an exemption from sections 12(d)(1)(A) and (B) of the
Act.

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Applicants: Eaton Vance Management (``EVM''), Eaton Vance ETF Trust
(the ``Trust'') and Foreside Fund Services, LLC.

Summary of Application: Applicants request an order that permits: (a)
Series of certain actively managed open-end management investment
companies to issue shares (``Shares'') redeemable in large aggregations
only (``Creation Units''); (b) secondary market transactions in Shares
to occur at negotiated market prices; (c) certain series to pay
redemption proceeds, under certain circumstances, more than seven days
from the tender of Shares for redemption; (d) certain affiliated
persons of the series to deposit securities into, and receive
securities from, the series in connection with the purchase and
redemption of Creation Units; and (e) certain registered management
investment companies and unit investment trusts outside of the same
group of investment companies as the series to acquire Shares.

DATES: Filing Dates: The application was filed on March 5, 2010, and
amended on August 10, 2010 and February 25, 2011.

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 March 28, 2011, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, 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. Applicants: EVM and the Trust,
Two International Place, Boston, MA 02110; Foreside Fund Services, LLC,
Three Canal Plaza, Suite 100, Portland, ME 04101.

FOR FURTHER INFORMATION CONTACT: Barbara T. Heussler, Senior Counsel,
at<PHONE_NUMBER> or Jennifer L. Sawin, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Office of Investment Company
Regulation).

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 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 will be registered as an open-end management
investment company under the Act and is a statutory trust organized
under the laws of Delaware. The Trust will initially offer five
actively-managed investment series: Eaton Vance Enhanced Short Maturity
ETF, Eaton Vance Government Limited Maturity ETF, Eaton Vance
Intermediate Municipal Bond ETF, Eaton Vance Prime Limited Maturity ETF
and Eaton Vance Short Term Municipal Bond ETF (together, the ``Initial
Funds''). The investment objectives of Eaton Vance Enhanced Short
Maturity ETF, Eaton Vance Government Limited Maturity ETF and Eaton
Vance Prime Limited Maturity ETF will be to seek maximum current
income, consistent with preservation of capital and daily liquidity.
The investment objectives of Eaton Vance Intermediate Municipal Bond
ETF and Eaton Vance Short Term Municipal Bond ETF will be to seek
attractive tax-exempt income, consistent with preservation of capital.
    2. Applicants request that the order apply to the Initial Funds and
any future series of the Trust or of other open-end management
companies that may utilize active management investment strategies
(``Future Funds''). Any Future Fund will (a) advised by EVM or an
entity controlling, controlled by, or under common control with EVM
(together with EVM, an ``Advisor''), and (b) comply with the terms and
conditions of the application.\1\ The Initial Funds and Future Funds
together are the ``Funds''. Each Fund will consist of a portfolio of
securities (including fixed income securities and/or equity securities)
and/or currencies (``Portfolio Instruments'').\2\ Funds may also invest
in ``Depositary Receipts''. A Fund will not invest in any Depositary
Receipts that the Advisor deems to be illiquid or for which pricing
information is not readily available.\3\ Each Fund will operate as an
actively managed exchange-traded fund (``ETF''). The Future Funds might
include one or more ETFs which invest in other open-end and/or closed-
end investment companies and/or ETFs.
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    \1\ All entities that currently intend to rely on the 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. An Investing Fund (as defined below) may rely on the
order only to invest in Funds and not in any other registered
investment company. Each Fund will comply with the disclosure
requirements adopted by the Commission in Investment Company Act
Release No. 28584 (Jan. 13, 2009).
    \2\ Neither the Initial Funds nor any Future Fund will invest in
options contracts, futures contracts or swap agreements.
    \3\ Depositary Receipts are typically issued by a financial
institution, a ``depositary'', and evidence ownership in a security
or pool of securities that have been deposited with the depositary.
No affiliated persons of applicants will serve as the depositary
bank for any Depositary Receipts held by a Fund.
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    3. EVM, a Massachusetts corporation, will be the investment advisor
to the Initial Funds. Each Advisor is or will be registered as an
``investment adviser'' under the Investment Advisers Act of 1940 (the
``Advisers Act''). The Advisor may retain investment advisers as sub-
advisers in connection with the Funds

(each, a ``Subadvisor''). Any Subadvisor will be registered under the
Advisers Act. A registered broker-dealer under the Securities Exchange
Act of 1934 (``Exchange Act''), which may be an affiliate of the
Advisor, will act as the distributor and principal underwriter of the
Funds (``Distributor''). Foreside Fund Services, LLC will serve as the
initial Distributor.
    4. Applicants anticipate that a Creation Unit will consist of at
least 50,000 Shares and that the price of a Share will range from $20
to $200. All orders to purchase Creation Units must be placed with the
Distributor by or through a party that has entered into a participant
agreement with the Distributor and the transfer agent of the Trust
(``Authorized Participant'') with respect to the creation and
redemption of Creation Units. An Authorized Participant is either: (a)
A broker or dealer registered under the Exchange Act (``Broker'') or
other participant in the Continuous Net Settlement System of the
National Securities Clearing Corporation, a clearing agency registered
with the Commission and affiliated with the Depository Trust Company
(``DTC''), or (b) a participant in the DTC (such participant, ``DTC
Participant''). The Initial Funds and certain Future Funds will
generally be purchased entirely for cash and will generally be redeemed
in-kind for specified Portfolio Instruments (``Redemption
Instruments''). However, the Trust reserves the right to accept and
deliver Creation Units of the Initial Funds and any Future Fund by
means of an in-kind tender of specified instruments (``Deposit
Instruments'') and to permit cash redemptions.\4\ In-kind purchases and
in-kind redemptions will be accompanied by an amount of cash specified
by the Advisor (``Cash Amount''). The Deposit Instruments and the Cash
Amount collectively are referred to as the ``Creation Deposit.'' The
Cash Amount is a cash payment designed to ensure that the net asset
value of a Creation Deposit is identical to the net asset value of the
Creation Unit it is used to purchase. The Trust may permit, in its
discretion, with respect to one or more Funds, under certain
circumstances, an in-kind purchaser or redeemer to substitute cash in
lieu of depositing or receiving some or all of the requisite Deposit or
Redemption Instruments.\5\
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    \4\ Applicants state that in determining whether a particular
Fund will be selling or redeeming Creation Units on a cash or in-
kind basis, the key consideration will be the benefit which would
accrue to Fund investors. In many cases, particularly to the extent
the Deposit Instruments are less liquid, investors may benefit by
the use of all cash creations because the Advisor would execute
trades rather than Market Makers (as defined below). Applicants
believe that the Advisor may be able to obtain better execution in
bond transactions due to its size, experience and potentially
stronger relationships in the fixed income markets. With respect to
redemptions, tax considerations may warrant in-kind redemptions
which do not result in a taxable event for the Fund.
    \5\ On each Business Day (as defined below), prior to the
opening of trading on the Stock Exchange (as defined below), the
estimated All-Cash Payment for each Fund or a list of the required
Deposit Instruments to be included in the Creation Deposit for each
Fund, as applicable, the previous day's Cash Amount, and the
estimated Cash Amount for the current day, will be made available.
The Stock Exchange will disseminate every 15 seconds throughout the
trading day through the facilities of the Consolidated Tape
Association an amount representing, on a per Share basis, the sum of
the current value of the Portfolio Instruments.
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    5. An investor purchasing or redeeming a Creation Unit from a Fund
may be charged a fee (``Transaction Fee'') to protect existing
shareholders of the Funds from the dilutive costs associated with the
purchase and redemption of Creation Units.\6\ All orders to purchase
Creation Units will be placed with the Distributor and the Distributor
will transmit all purchase orders to the relevant Fund. The Distributor
will be responsible for delivering a prospectus (``Prospectus'') to
those persons purchasing Creation Units and for maintaining records of
both the orders placed with it and the confirmations of acceptance
furnished by it.
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    \6\ Where a Fund permits an in-kind purchaser to substitute cash
in lieu of depositing one or more Deposit Instruments, the purchaser
may be assessed a higher Transaction Fee to offset the cost to the
Fund of buying those particular Deposit Instruments.
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    6. Shares will be listed and traded at negotiated prices on a
national securities exchange as defined in section 2(a)(26) of the Act
(the ``Stock Exchange'') and traded in the secondary market. Applicants
expect that Stock Exchange specialists (``Specialists'') or market
makers (``Market Makers'') will be assigned to Shares. The price of
Shares trading on the Stock Exchange will be based on a current bid/
offer market. Transactions involving the purchases and sales of Shares
on the Stock Exchange will be subject to customary brokerage
commissions and charges.
    7. Applicants expect that purchasers of Creation Units will include
arbitrageurs. Specialists or Market Makers, acting in their unique role
to provide a fair and orderly secondary market for Shares, also may
purchase Creation Units for use in their own market making
activities.\7\ Applicants expect that secondary market purchasers of
Shares will include both institutional and retail investors.\8\
Applicants expect that arbitrage opportunities created by the ability
to continually purchase or redeem Creation Units at their net asset
value should ensure that the Shares will not trade at a material
discount or premium in relation to net asset value per common share
(``NAV'').
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    \7\ If Shares are listed on NASDAQ, no Specialist will be
contractually obligated to make a market in Shares. Rather, under
NASDAQ's listing requirements, two or more Market Makers will be
registered in Shares and required to make a continuous, two-sided
market or face regulatory sanctions.
    \8\ Shares will be registered in book-entry form only. DTC or
its nominee will be the record or registered owner of all
outstanding Shares. Beneficial ownership of Shares will be shown on
the records of DTC or DTC Participants.
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    8. Shares may be redeemed only if tendered in Creation Units.
Redemption requests must be placed by or through an Authorized
Participant. Applicants currently contemplate that Creation Units of
the Initial Funds will be redeemed principally in-kind (together with a
Cash Amount).\9\ To the extent a Fund utilizes in-kind redemptions,
Shares in Creation Units will be redeemable on any Business Day, which
is defined to include any day that the Trust is open for business as
required by section 22(e) of the Act, for the Redemption Instruments,
which will be the same as the Deposit Instruments deposited by
investors purchasing Creation Units on the same day, except for the
limited exceptions noted below. The redeeming investor will also
usually pay to the Fund a Transaction Fee.
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    \9\ To the extent consistent with other investment limitations,
the Funds may invest in mortgage- or asset-backed securities,
including a ``to-be-announced transaction'' or ``TBA Transactions''.
Each Fund intends to substitute a cash-in-lieu amount to replace any
Deposit Instrument or Redemption Instrument that is a TBA
Transaction. A TBA Transaction is a method of trading mortgage-
backed securities. In a TBA Transaction, the buyer and seller agree
upon general trade parameters such as agency, settlement date, par
amount and price. The actual pools delivered generally are
determined two days prior to the settlement date. The amount of
substituted cash in the case of TBA Transactions will be equivalent
to the value of the TBA Transaction listed as a Deposit Instrument
or Redemption Instrument.
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    9. Applicants state that in accepting Deposit Instruments and
satisfying redemptions with Redemption Instruments, the Funds must
comply with the federal securities laws, including that the Deposit
Instruments and Redemption Instruments are sold in transactions that
would be exempt from registration under the Securities Act.\10\ To the
extent in-kind purchases and redemptions are utilized, the Deposit

Instruments and Redemption Instruments will correspond pro rata to the
Fund portfolio, except that there may be minor differences between a
basket of Deposit Instruments or Redemption Instruments and a true pro
rata slice of a Fund's portfolio solely when (A) it is impossible to
break up bonds beyond certain minimum sizes needed for transfer and
settlement or, (B) in the case of equity securities, rounding is
necessary to eliminate fractional shares or lots that are not tradeable
round lots.\11\
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    \10\ In accepting Deposit Instruments and satisfying redemptions
with Redemption Instruments that are restricted securities eligible
for resale pursuant to rule 144A under the Securities Act, the Funds
will comply with the conditions of Rule 144A.
    \11\ A tradeable round lot for an equity security will be the
standard unit of trading in that particular type of security in its
primary market.
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    10. Neither the Trust nor any Fund will be marketed or otherwise
held out as a ``mutual fund''. Instead, each Fund will be marketed as
an ``actively-managed exchange-traded fund.'' Any advertising material
where features of obtaining, buying or selling Creation Units are
described or where there is reference to redeemability will prominently
disclose that Shares are not individually redeemable and that owners of
Shares may acquire Shares from a Fund and tender those Shares for
redemption to a Fund in Creation Units only.
    11. The Funds' Web site, which will be publicly available prior to
the public offering of Shares, will include the Prospectus and
additional quantitative information updated on a daily basis,
including, on a per Share basis for each Fund, the prior Business Day's
NAV and the market closing price or mid-point of the bid/ask spread at
the time of the calculation of such NAV (``Bid/Ask Price''), and a
calculation of the premium or discount of the market closing price or
Bid/Ask Price against such NAV. On each Business Day, before
commencement of trading in Shares on the Stock Exchange, the Fund will
disclose on its Web site the identities and quantities of the Portfolio
Instruments and other assets held by the Fund that will form the basis
for the Fund's calculation of NAV at the end of the Business Day.\12\
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    \12\ Applicants note that under accounting procedures followed
by the Funds, trades made on the prior Business Day (``T'') will be
booked and reflected in NAV on the current Business Day (``T+1'').
Accordingly, the Funds will be able to disclose at the beginning of
the Business Day the portfolio that will form the basis for the NAV
calculation at the end of the Business Day.
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Applicants' Legal Analysis

    1. Applicants request an order under section 6(c) of the Act for an
exemption from sections 2(a)(32), 5(a)(1), 22(d) and 22(e) of the Act
and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act
for an exemption from sections 17(a)(1) and 17(a)(2) of the Act, and
under section 12(d)(1)(J) of the Act for an exemption from sections
12(d)(1)(A) and (B) of the Act.
    2. Section 6(c) of the Act provides that the Commission may exempt
any person, security or transaction, or any class of persons,
securities or transactions, from any provisions of the Act, if and to
the extent that 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.
Section 17(b) of the Act authorizes the Commission to exempt a proposed
transaction from section 17(a) of the Act if evidence establishes that
the terms of the transaction, including the consideration to be paid or
received, are reasonable and fair and do not involve overreaching on
the part of any person concerned, and the proposed transaction is
consistent with the policies of the registered investment company and
the general provisions of the Act. 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.

Sections 5(a)(1) and 2(a)(32) of the Act

    3. Section 5(a)(1) of the Act defines an ``open-end company'' as a
management investment company that is offering for sale or has
outstanding any redeemable security of which it is the issuer. Section
2(a)(32) of the Act defines a redeemable security as any security,
other than short-term paper, under the terms of which the holder, upon
its presentation to the issuer, is entitled to receive approximately a
proportionate share of the issuer's current net assets, or the cash
equivalent. Because Shares will not be individually redeemable,
applicants request an order that would permit the Trust to register as
an open-end management investment company and redeem Shares in Creation
Units only. Applicants state that investors may purchase Shares in
Creation Units from each Fund and redeem Creation Units from each Fund.
Applicants further state that because the market price of Creation
Units will be disciplined by arbitrage opportunities, investors should
be able to sell Shares in the secondary market at prices that do not
vary substantially from their NAV.

Section 22(d) of the Act and Rule 22c-1 Under the Act

    4. Section 22(d) of the Act, among other things, prohibits a dealer
from selling a redeemable security that is currently being offered to
the public by or through a principal underwriter, except at a current
public offering price described in the prospectus. Rule 22c-1 under the
Act generally requires that a dealer selling, redeeming, or
repurchasing a redeemable security do so only at a price based on its
NAV. Applicants state that secondary market trading in Shares will take
place at negotiated prices, not at a current offering price described
in the Prospectus, and not at a price based on NAV. Thus, purchases and
sales of Shares in the secondary market will not comply with section
22(d) of the Act and rule 22c-1 under the Act. Applicants request an
exemption under section 6(c) from these provisions.
    5. Applicants assert that the concerns sought to be addressed by
section 22(d) of the Act and rule 22c-1 under the Act with respect to
pricing are equally satisfied by the proposed method of pricing Shares.
Applicants maintain that while there is little legislative history
regarding section 22(d), its provisions, as well as those of rule 22c-
1, appear to have been designed to (a) prevent dilution caused by
certain riskless-trading schemes by principal underwriters and contract
dealers, (b) prevent unjust discrimination or preferential treatment
among buyers resulting from sales at different prices, and (c) assure
an orderly distribution system of investment company shares by
eliminating price competition from Brokers offering shares at less than
the published sales price and repurchasing shares at more than the
published redemption price.
    6. Applicants believe that none of these purposes will be thwarted
by permitting Shares to trade in the secondary market at negotiated
prices. Applicants state that (a) secondary market trading in Shares
does not involve the Funds as parties and cannot result in dilution of
an investment in Shares, and (b) to the extent different prices exist
during a given trading day, or from day to day, such variances occur as
a result of third-party market forces, such as supply and demand.
Therefore, applicants assert that secondary market transactions in
Shares will not lead to discrimination or preferential treatment among
purchasers. Finally, applicants contend that the proposed distribution
system will be orderly because arbitrage activity should ensure that
the

difference between the market price of Shares and their NAV remains
narrow.

Section 22(e) of the Act

    7. Section 22(e) of the Act generally prohibits a registered
investment company from suspending the right of redemption or
postponing the date of payment of redemption proceeds for more than
seven days after the tender of a security for redemption. Applicants
observe that settlement of redemptions of Creation Units of Funds
holding non-U.S. investments (``Global Funds'') is contingent not only
on the settlement cycle of the U.S. securities markets but also on the
delivery cycles present in foreign markets in which those Funds invest.
Applicants have been advised that, under certain circumstances, the
delivery cycles for transferring Portfolio Instruments to redeeming
investors, coupled with local market holiday schedules, will require a
delivery process of up to 12 calendar days. Applicants therefore
request relief from section 22(e) in order to provide payment or
satisfaction of redemptions within the maximum number of calendar days
required for such payment or satisfaction in the principal local
markets where transactions in the Portfolio Instruments of each Global
Fund customarily clear and settle, but in all cases no later than 12
calendar days following the tender of a Creation Unit. With respect to
Future Funds that are Global Funds, applicants seek the same relief
from section 22(e) only to the extent that circumstances exist similar
to those described in the application. Except as disclosed in the SAI
for a Fund, deliveries of redemption proceeds for Global Funds are
expected to be made within seven days.\13\
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    \13\ Rule 15c6-1 under the Exchange Act requires that most
securities transactions be settled within three business days of the
trade date. Applicants acknowledge that no relief obtained from the
requirements of section 22(e) will affect any obligations that they
have under rule 15c6-1.
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    8. Applicants submit that Congress adopted section 22(e) to prevent
unreasonable, undisclosed or unforeseen delays in the actual payment of
redemption proceeds. Applicants state that allowing redemption payments
for Creation Units of a Fund to be made within a maximum of 12 calendar
days would not be inconsistent with the spirit and intent of section
22(e). Applicants state the SAI will disclose those local holidays
(over the period of at least one year following the date of the SAI),
if any, that are expected to prevent the delivery of redemption
proceeds in seven calendar days and the maximum number of days needed
to deliver the proceeds for each affected Global Fund.
    9. Applicants are not seeking relief from section 22(e) with
respect to Global Funds that do not effect creations or redemptions in-
kind.

Section 12(d)(1) of the Act

    10. Section 12(d)(1)(A) of the Act 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, or
any other broker or dealer from selling its 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.
    11. Applicants request relief to permit Investing Funds (as defined
below) to acquire Shares in excess of the limits in section 12(d)(l)(A)
of the Act and to permit the Funds, their principal underwriters and
any Brokers to sell Shares to Investing Funds in excess of the limits
in section 12(d)(l)(B) of the Act. Applicants request that these
exemptions apply to: (a) Any Fund that is currently or subsequently
part of the same ``group of investment companies'' as the Initial Funds
within the meaning of section 12(d)(1)(G)(ii) of the Act as well as any
principal underwriter for the Funds and any Brokers selling Shares of a
Fund to an Investing Fund; and (b) each management investment company
or unit investment trust registered under the Act that is not part of
the same ``group of investment companies'' as the Funds and that enters
into a FOF Participation Agreement (as defined below) with a Fund (such
management investment companies are referred to herein as ``Investing
Management Companies,'' such unit investment trusts are referred to
herein as ``Investing Trusts,'' and Investing Management Companies and
Investing Trusts together are referred to herein as ``Investing
Funds'').\14\ Investing Funds do not include the Funds. Each Investing
Trust will have a sponsor (``Sponsor'') and each Investing Management
Company will have an investment adviser within the meaning of section
2(a)(20)(A) of the Act (``Investing Fund Advisor'') that does not
control, is not controlled by or under common control with the Advisor.
Each Investing Management Company may also have one or more investment
advisers within the meaning of section 2(a)(20)(B) of the Act (each, an
``Investing Fund Sub-Advisor''). Each Investing Fund Advisor and any
Investing Fund Sub-Advisor will be registered as an investment adviser
under the Advisers Act.
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    \14\ Applicants anticipate that there may be Investing Funds
that are not part of the same group of investment companies as the
Funds but may be subadvised by an Advisor.
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    12. Applicants submit that the proposed conditions to the requested
relief are designed to address the concerns underlying the limits in
section 12(d)(1), which include concerns about undue influence,
excessive layering of fees and overly complex structures.
    13. Applicants propose a condition to prohibit an Investing Fund or
Investing Fund Affiliate \15\ from causing an investment by an
Investing Fund in a Fund to influence the terms of services or
transactions between an Investing Fund or an Investing Fund Affiliate
and the Fund or Fund Affiliate. Applicants propose a condition to limit
the ability of the Investing Fund Advisor, or Sponsor, any person
controlling, controlled by or under common control with such Advisor or
Sponsor, and any investment company or issuer that would be an
investment company but for sections 3(c)(l) or 3(c)(7) of the Act that
is advised or sponsored by the Investing Fund Advisor, the Sponsor, or
any person controlling, controlled by, or under common control with
such Advisor or Sponsor (``Investing Fund's Advisory Group'') from
(individually or in the aggregate) controlling a Fund within the
meaning of section 2(a)(9) of the Act. The same prohibition would apply
to any Investing Fund Sub-Advisor, any person controlling, controlled
by, or under common control with the Investing Fund Sub-Advisor, and
any investment company or issuer that would be an investment company
but for sections 3(c)(l) or 3(c)(7) of the Act (or portion of such
investment company or issuer) advised or

sponsored by the Investing Fund Sub-Advisor or any person controlling,
controlled by or under common control with the Investing Fund Sub-
Advisor (``Investing Fund's Sub-Advisory Group'').
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    \15\ An ``Investing Fund Affiliate'' is defined as the Investing
Fund Advisor, Investing Fund Sub-Advisor, Sponsor, promoter and
principal underwriter of an Investing Fund, and any person
controlling, controlled by or under common control with any of these
entities. A ``Fund Affiliate'' is defined as an investment adviser,
promoter or principal underwriter of a Fund and any person
controlling, controlled by or under common control with any of these
entities.
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    14. Applicants propose other conditions to limit the potential for
an Investing Fund and certain affiliates of an Investing Fund
(including Underwriting Affiliates) to exercise undue influence over a
Fund and certain of its affiliates, including that no Investing Fund or
Investing Fund Affiliate (except to the extent it is acting in its
capacity as an investment adviser to a Fund) will cause a Fund to
purchase a security in an offering of securities during the existence
of an underwriting or selling syndicate of which a principal
underwriter is an Underwriting Affiliate (``Affiliated Underwriting'').
An ``Underwriting Affiliate'' is a principal underwriter in any
underwriting or selling syndicate that is an officer, director, member
of an advisory board, Investing Fund Advisor, Investing Fund Sub-
Advisor, employee or Sponsor of the Investing Fund, or a person of
which any such officer, director, member of an advisory board,
Investing Fund Advisor or Investing Fund Sub-Advisor, employee or
Sponsor is an affiliated person. An Underwriting Affiliate does not
include any person whose relationship to the Fund is covered by section
10(f) of the Act.
    15. Applicants propose several conditions to address the concerns
regarding layering of fees and expenses. Applicants note that the board
of directors or trustees of any Investing Management Company, including
a majority of the directors or trustees who are not ``interested
persons'' within the meaning of section 2(a)(19) of the Act
(``disinterested directors or trustees''), will be required to find
that the advisory fees charged under the contract are based on services
provided that will be in addition to, rather than duplicative of,
services provided under the advisory contract of any Fund in which the
Investing Management Company may invest. In addition, an Investing Fund
Advisor, trustee of an Investing Trust (``Trustee'') or Sponsor, as
applicable, will waive fees otherwise payable to it by the Investing
Fund in an amount at least equal to any compensation (including fees
received pursuant to any plan adopted by a Fund under rule 12b-1 under
the Act) received from a Fund by the Investing Fund Advisor, Trustee or
Sponsor or an affiliated person of the Investing Fund Advisor, Trustee
or Sponsor, other than any advisory fees paid to the Investing Fund
Advisor, Trustee or Sponsor or its affiliated person by a Fund, in
connection with the investment by the Investing Fund in the Fund.
Applicants also propose a condition to prevent any sales charges or
service fees on shares of an Investing Fund from exceeding the limits
applicable to a fund of funds set forth in NASD Conduct Rule 2830.\16\
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    \16\ Any references to NASD Conduct Rule 2830 include any
successor or replacement rule to NASD Conduct Rule that may be
adopted by FINRA.
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    16. Applicants submit that the proposed arrangement will not create
an overly complex fund structure. Applicants note that a Fund will be
prohibited from acquiring securities of any investment company or
company relying on sections 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 permitted by exemptive relief from the Commission permitting the
Fund to purchase shares of other investment companies for short-term
cash management purposes.
    17. To ensure that the Investing Funds understand and comply with
the terms and conditions of the requested order, any Investing Fund
that intends to invest in a Fund in reliance on the requested order
will be required to enter into a participation agreement (``FOF
Participation Agreement'') with the Fund. The FOF Participation
Agreement will include an acknowledgment from the Investing Fund that
it may rely on the order only to invest in the Funds and not in any
other investment company.

Sections 17(a)(1) and (2) of the Act

    18. Section 17(a) of the Act generally prohibits an affiliated
person of a registered investment company, or an affiliated person of
such a person (``second tier affiliate''), from selling any security to
or purchasing any security from the company. Section 2(a)(3) of the Act
defines ``affiliated person'' to include 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 and any
person directly or indirectly controlling, controlled by, or under
common control with, the other person. Section 2(a)(9) of the Act
defines ``control'' as the power to exercise a controlling influence
over the management or policies of a company and provides that a
control relationship will be presumed where one person owns more than
25% of another person's voting securities. Each Fund may be deemed to
be controlled by an Advisor and hence affiliated persons of each other.
In addition, the Funds may be deemed to be under common control with
any other registered investment company (or series thereof) advised by
an Advisor (an ``Affiliated Fund'').
    19. Applicants request an exemption under sections 6(c) and 17(b)
of the Act from sections 17(a)(1) and 17(a)(2) of the Act to permit in-
kind purchases and redemptions of Creation Units by persons that are
affiliated persons or second tier affiliates of the Funds solely by
virtue of one or more of the following: (a) Holding 5% or more, or in
excess of 25% of the outstanding Shares of one or more Funds; (b)
having an affiliation with a person with an ownership interest
described in (a); or (c) holding 5% or more, or more than 25% of the
Shares of one or more Affiliated Funds.\17\ Applicants also request an
exemption in order to permit a Fund to sell its Shares to and redeem
its Shares from, and engage in the in-kind transactions that would
accompany such sales and redemptions with, certain Investing Funds of
which the Funds are affiliated persons or a second-tier affiliates.\18\
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    \17\ Applicants are not seeking relief from section 17(a) for,
and the requested relief will not apply to, transactions where a
Fund could be deemed an affiliated person, or an affiliated person
of an affiliated person, of an Investing Fund because an investment
adviser to the Funds is also an investment adviser to an Investing
Fund.
    \18\ Applicants expect most Investing Funds will purchase Shares
in the secondary market and will not purchase Creation Units
directly from a Fund. To the extent that purchases and sales of
Shares occur in the secondary market and not through principal
transactions directly between an Investing Fund and a Fund, relief
from section 17(a) would not be necessary. However, the requested
relief would apply to direct sales of Shares in Creation Units by a
Fund to an Investing Fund and redemptions of those Shares. The
requested relief is intended to cover the in-kind transactions that
may accompany such sales and redemptions.
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    20. Applicants assert that no useful purpose would be served by
prohibiting such affiliated persons from making in-kind purchases or
in-kind redemptions of Shares of a Fund in Creation Units. Absent the
unusual circumstances discussed in the application, the Deposit
Instruments and Redemption Instruments available for a Fund will be the
same for all purchases and redeemers, respectively, and will correspond
pro rata to the Fund's portfolio instruments. Both the deposit
procedures for in-kind purchases of Creation Units and the redemption
procedures for in-kind redemptions will be effected in exactly the same
manner for all purchases and redemptions. Deposit Instruments and
Redemption Instruments will be valued in the same manner as those
Portfolio Instruments currently held by the relevant Funds. Therefore,
applicants state that the in-

kind purchases and redemptions create no opportunity for affiliated
persons or the Applicants to effect a transaction detrimental to other
holders of Shares of that Fund. Applicants do not believe that in-kind
purchases and redemptions will result in abusive self-dealing or
overreaching of the Fund.
    21. Applicants also submit that the sale of Shares to and
redemption of Shares from an Investing Fund meets the standards for
relief under sections 17(b) and 6(c) of the Act. Applicants note that
any consideration paid for the purchase or redemption of Shares
directly from a Fund will be based on the NAV of the Fund in accordance
with policies and procedures set forth in the Fund's registration
statement.\19\ Absent the unusual circumstances discussed in the
application, the Deposit Instruments and Redemption Instruments
available for a Fund will be the same for all purchases and redeemers,
respectively, and will correspond pro rata to the Fund's portfolio
instruments. Applicants also state that the proposed transactions are
consistent with the general purposes of the Act and appropriate in the
public interest.
---------------------------------------------------------------------------

    \19\ Applicants acknowledge that the receipt of compensation by
(a) an affiliated person of an Investing Fund, or an affiliated
person of such person, for the purchase by the Investing Fund of
Shares of the Fund or (b) an affiliated person of a Fund, or an
affiliated person of such person, for the sale by the Fund of its
Shares to an Investing Fund, may be prohibited by section 17(e)(1)
of the Act. The FOF Participation Agreement also will include this
acknowledgment.
---------------------------------------------------------------------------

Applicants' Conditions

    Applicants agree that any order of the Commission granting the
requested relief will be subject to the following conditions:

A. Actively Managed Exchange-Traded Fund Relief

    1. As long as a Fund operates in reliance on the requested order,
the Shares of the Fund will be listed on a Stock Exchange.
    2. Neither the Trust nor any Fund will be advertised or marketed as
an open-end investment company or a mutual fund. Any advertising
material that describes the purchase or sale of Creation Units or
refers to redeemability will prominently disclose that the Shares are
not individually redeemable and that owners of the Shares may acquire
those Shares from the Fund and tender those Shares for redemption to
the Fund in Creation Units only.
    3. The Web site for the Funds, which is and will be publicly
accessible at no charge, will contain, on a per Share basis, for each
Fund the prior Business Day's NAV and the market closing price or Bid/
Ask Price, and a calculation of the premium or discount of the market
closing price or Bid/Ask Price against such NAV.
    4. On each Business Day, before commencement of trading in Shares
on the Stock Exchange, the Fund will disclose on its Web site the
identities and quantities of the Portfolio Instruments and other assets
held by the Fund that will form the basis for the Fund's calculation of
NAV at the end of the Business Day.
    5. The Advisor or any Subadvisor, directly or indirectly, will not
cause any Authorized Participant (or any investor on whose behalf an
Authorized Participant may transact with the Fund) to acquire any
Deposit Instrument for the Fund through a transaction in which the Fund
could not engage directly.
    6. The requested relief to permit ETF operations will expire on the
effective date of any Commission rule under the Act that provides
relief permitting the operation of actively-managed exchange-traded
funds.

B. Section 12(d)(1) Relief

    1. The members of the Investing Fund's Advisory Group will not
control (individually or in the aggregate) a Fund within the meaning of
section 2(a)(9) of the Act. The members of the Investing Fund's Sub-
Advisory Group will not control (individually or in the aggregate) a
Fund within the meaning of section 2(a)(9) of the Act. If, as a result
of a decrease in the outstanding voting securities of a Fund, the
Investing Fund's Advisory Group or the Investing Fund's Sub-Advisory
Group, each in the aggregate, becomes a holder of more than 25 percent
of the outstanding voting securities of a Fund, it will vote its Shares
of the Fund in the same proportion as the vote of all other holders of
the Fund's Shares. This condition does not apply to the Investing
Fund's Sub-Advisory Group with respect to a Fund for which the
Investing Fund Sub-Advisor or a person controlling, controlled by or
under common control with the Investing Fund Sub-Advisor acts as the
investment adviser within the meaning of section 2(a)(20)(A) of the
Act.
    2. No Investing Fund or Investing Fund Affiliate will cause any
existing or potential investment by the Investing Fund in a Fund to
influence the terms of any services or transactions between the
Investing Fund or an Investing Fund Affiliate and the Fund or a Fund
Affiliate.
    3. The board of directors or trustees of an Investing Management
Company, including a majority of the disinterested directors or
trustees, will adopt procedures reasonably designed to assure that the
Investing Fund Advisor and any Investing Fund Sub-Advisor are
conducting the investment program of the Investing Management Company
without taking into account any consideration received by the Investing
Management Company or an Investing Fund Affiliate from a Fund or a Fund
Affiliate in connection with any services or transactions.
    4. Once an investment by an Investing Fund in Shares of a Fund
exceeds the limit in section 12(d)(1)(A)(i) of the Act, the Board of a
Fund, including a majority of the disinterested Board members, will
determine that any consideration paid by the Fund to the Investing Fund
or an Investing Fund Affiliate in connection with any services or
transactions: (i) Is fair and reasonable in relation to the nature and
quality of the services and benefits received by the Fund; (ii) is
within the range of consideration that the Fund would be required to
pay to another unaffiliated entity in connection with the same services
or transactions; and (iii) does not involve overreaching on the part of
any person concerned. This condition does not apply with respect to any
services or transactions between a Fund and its investment adviser(s),
or any person controlling, controlled by or under common control with
such investment adviser(s).
    5. The Investing Fund Advisor, or Trustee or Sponsor, as
applicable, will waive fees otherwise payable to it by the Investing
Fund in an amount at least equal to any compensation (including fees
received pursuant to any plan adopted by a Fund under rule 12b-1 under
the Act) received from a Fund by the Investing Fund Advisor, or Trustee
or Sponsor, or an affiliated person of the Investing Fund Advisor, or
Trustee or Sponsor, other than any advisory fees paid to the Investing
Fund Advisor, or Trustee, or Sponsor, or its affiliated person by the
Fund, in connection with the investment by the Investing Fund in the
Fund. Any Investing Fund Sub-Advisor will waive fees otherwise payable
to the Investing Fund Sub-Advisor, directly or indirectly, by the
Investing Management Company in an amount at least equal to any
compensation received from a Fund by the Investing Fund Sub-Advisor, or
an affiliated person of the Investing Fund Sub-Advisor, other than any
advisory fees paid to the Investing Fund Sub-Advisor or its affiliated
person by the Fund, in connection with the investment by the Investing
Management Company in the Fund made at the direction of the Investing
Fund Sub-Advisor. In the event that the

Investing Fund Sub-Advisor waives fees, the benefit of the waiver will
be passed through to the Investing Management Company.
    6. No Investing Fund or Investing Fund Affiliate (except to the
extent it is acting in its capacity as an investment adviser to a Fund)
will cause a Fund to purchase a security in an Affiliated Underwriting.
    7. The Board of the Fund, including a majority of the disinterested
Board members, will adopt procedures reasonably designed to monitor any
purchases of securities by the Fund in an Affiliated Underwriting, once
an investment by an Investing Fund in the securities of the Fund
exceeds the limit of section 12(d)(1)(A)(i) of the Act, including any
purchases made directly from an Underwriting Affiliate. The Board will
review these purchases periodically, but no less frequently than
annually, to determine whether the purchases were influenced by the
investment by the Investing Fund in the Fund. The Board will consider,
among other things: (i) Whether the purchases were consistent with the
investment objectives and policies of the Fund; (ii) 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
(iii) whether the amount of securities purchased by the Fund in
Affiliated Underwritings and the amount purchased directly from an
Underwriting Affiliate have changed significantly from prior years. The
Board will take any appropriate actions based on its review, including,
if appropriate, the institution of procedures designed to assure that
purchases of securities in Affiliated Underwritings are in the best
interest of shareholders.
    8. Each Fund 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 Affiliated
Underwritings once an investment by an Investing Fund in the securities
of the Fund exceeds the limit of section 12(d)(1)(A)(i) of the Act,
setting forth from whom the securities were acquired, the identity of
the underwriting syndicate's members, the terms of the purchase, and
the information or materials upon which the Board's determinations were
made.
    9. Before investing in a Fund in excess of the limits in section
12(d)(1)(A), an Investing Fund will execute a FOF Participation
Agreement with the Fund stating that their respective boards of
directors or trustees and their investment advisers, or Trustee and
Sponsor, as applicable, 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 a Fund in excess of the limit
in section 12(d)(1)(A)(i), an Investing Fund will notify the Fund of
the investment. At such time, the Investing Fund will also transmit to
the Fund a list of the names of each Investing Fund Affiliate and
Underwriting Affiliate. The Investing Fund will notify the Fund of any
changes to the list as soon as reasonably practicable after a change
occurs. The Fund and the Investing Fund will maintain and preserve a
copy of the order, the FOF 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.
    10. Before approving any advisory contract under section 15 of the
Act, the board of directors or trustees of each Investing Management
Company, including a majority of the disinterested directors or
trustees, will find that the advisory fees charged under such contract
are based on services provided that will be in addition to, rather than
duplicative of, the services provided under the advisory contract(s) of
any Fund in which the Investing Management Company may invest. These
findings and their basis will be recorded fully in the minute books of
the appropriate Investing Management Company.
    11. Any sales charges and/or service fees charged with respect to
shares of an Investing Fund will not exceed the limits applicable to a
fund of funds as set forth in NASD Conduct Rule 2830.
    12. No Fund relying on this section 12(d)(1) relief will acquire
securities of any 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 permitted by
exemptive relief from the Commission permitting the Fund to purchase
shares of other investment companies for short-term cash management
purposes.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-5064 Filed 3-4-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 61 (Wednesday, March 30, 2022)]
[Notices]
[Page 18460]
[FR Doc No: 2022-06622]

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

Federal Aviation Administration

[DOT-OST-2022]

Research, Engineering, and Development Advisory Committee
(REDAC); Notice of Public Meeting

AGENCY: Federal Aviation Administration, Department of Transportation.

ACTION: Notice of public meeting.

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SUMMARY: This notice announces a meeting of the Research, Engineering,
and Development Advisory Committee (REDAC).

DATES: The meeting will be held on April 14, 2022, from 10:00 a.m.-5:00
p.m. EST.
    Requests for accommodations to a disability must be received by
March 31, 2022. Individuals requesting to speak during the meeting must
submit a written copy of their remarks to DOT by March 31, 2022.
Requests to submit written materials to be reviewed during the meeting
must be received no later than March 31, 2022.

ADDRESSES: The meeting will be held virtually. Virtual attendance
information will be provided upon registration. A detailed agenda will
be available on the REDAC internet website at http://www.faa.gov/go/redac at least one week before the meeting, along with copies of the
meeting minutes after the meeting.

FOR FURTHER INFORMATION CONTACT: Chinita Roundtree-Coleman, REDAC PM/
Lead, FAA/U.S. Department of Transportation, at [email protected] or<PHONE_NUMBER>. Any committee-related request should
be sent to the person listed in this section.

SUPPLEMENTARY INFORMATION:

I. Background

    The Research, Engineering, and Development Advisory Committee was
created under the Federal Advisory Committee Act (FACA), in accordance
with Public Law 100-591 (1988) and Public Law 101-508 (1990) to provide
advice and recommendations to the FAA Administrator in support of the
Agency's Research and Development (R&D) portfolio.

II. Agenda

    At the meeting, the agenda will cover the following topics:
     FAA Research and Development Strategies, Initiatives and
Planning,
     Impacts of emerging technologies, new entrant vehicles,
and dynamic operations within the National Airspace System.

III. Public Participation

    The U.S. Department of Transportation is committed to providing
equal access to this meeting for all participants. If you need
alternative formats or services because of a disability, such as sign
language, interpretation, or other ancillary aids, please contact the
person listed in the FOR FURTHER INFORMATION CONTACT section.
    There will be 45 minutes allotted for oral comments from members of
the public joining the meeting. To accommodate as many speakers as
possible, the time for each commenter may be limited. Individuals
wishing to reserve speaking time during the meeting must submit a
request at the time of registration, as well as the name, address, and
organizational affiliation of the proposed speaker. If the number of
registrants requesting to make statements is greater than can be
reasonably accommodated during the meeting, the FAA may conduct a
lottery to determine the speakers. Speakers are requested to submit a
written copy of their prepared remarks for inclusion in the meeting
records and circulation to REDAC members before the deadline listed in
the DATES section. All prepared remarks submitted on time will be
accepted and considered as part of the meeting's record. Any member of
the public may present a written statement to the committee at any
time.

    Issued in Washington, DC, on this 24th day of March.
Chinita Roundtree-Coleman,
REDAC PM/Lead, Federal Aviation Administration.
[FR Doc. 2022-06622 Filed 3-29-22; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)]
[Notices]
[Pages 6576-6577]
[FR Doc No: 2018-03041]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-2598]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
16, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section
for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 16, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date. Furthermore, any
interested person may petition FDA for a determination regarding
whether the applicant for extension acted with due diligence during the
regulatory review period by August 13, 2018. See ``Petitions'' in the
SUPPLEMENTARY INFORMATION section for more information.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-E-2598 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; BELEODAQ.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable

disclosure law. For more information about FDA's posting of comments to
public dockets, see 80 FR 56469, September 18, 2015, or access the
information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product BELEODAQ
(belinostat). BELEODAQ is a histone deacetylase inhibitor indicated for
the treatment of patients with relapsed or refractory peripheral T-cell
lymphoma. This indication is approved under accelerated approval based
on tumor response rate and duration of response. An improvement in
survival or disease-related symptoms has not been established.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the confirmatory
trial. Subsequent to this approval, the USPTO received a patent term
restoration application for BELEODAQ (U.S. Patent No. 6,888,027) from
Spectrum Pharmaceuticals, Inc., and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated October 15, 2015, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of BELEODAQ represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
BELEODAQ is 3,488 days. Of this time, 3,281 days occurred during the
testing phase of the regulatory review period, while 207 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: December 16, 2004. FDA has verified the Spectrum
Pharmaceuticals, Inc. claim that December 16, 2004, is the date the
investigational new drug application (NDA) became effective.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
9, 2013. The applicant claims December 8, 2013 as the date the NDA for
BELEODAQ was initially submitted. However, FDA records indicate that
NDA 206256 was submitted on December 9, 2013.
    3. The date the application was approved: July 3, 2014. FDA has
verified the applicant's claim that NDA 206256 was approved on July 3,
2014.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,779 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03041 Filed 2-13-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Proposed Rules]
[Pages 11723-11725]
[FR Doc No: 2014-04549]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0130; Directorate Identifier 2014-CE-005-AD]
RIN 2120-AA64

Airworthiness Directives; Alpha Aviation Concept Limited
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Alpha Aviation Concept Limited Model R2160 airplanes. This
proposed AD results from mandatory continuing airworthiness information
(MCAI) originated by an aviation authority of another country to
identify and correct an unsafe condition on an aviation

product. The MCAI describes the unsafe condition as the metal screen
shield over the ignition switch may ground out the ignition terminals.
We are issuing this proposed AD to require actions to address the
unsafe condition on these products.

DATES: We must receive comments on this proposed AD by April 17, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Alpha Aviation, 59 Hautapu Road, RD 1, Cambridge 3493, New Zealand;
telephone: +64 7 827 0528; fax: +64 7 929 2878; Internet:
www.alphaaviation.co.nz. You may review this referenced service
information at the FAA, Small Airplane Directorate, 901 Locust, Kansas
City, Missouri 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0130; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Karl Schletzbaum, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER> ; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-013;
Directorate Identifier 2014-CE-005-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The Civil Aviation Authority (CAA), which is the aviation authority
for New Zealand, has issued AD DCA/R2000/42, dated January 29, 2014
(referred to after this as ``the MCAI''), to correct an unsafe
condition for Alpha Aviation Concept Limited Model R2160 airplanes. The
MCAI states:

    The AD is prompted by an overseas DR300/180R aircraft accident
which occurred during take-off. Investigation revealed a distorted
metal screen shield which grounded the ignition switch terminals and
resulted in loss of engine power.
    Robin aircraft manufactured prior to 1985 were fitted with
ignition switches protected with a metal screen shield. With
subsequent radio and electrical system improvements ignition switch
shielding is no longer required, and most aircraft do not have metal
screen shielded ignition switches.
    This AD requires a one-time inspection of the ignition switch to
determine if a metal screen shield is installed, and depending on
findings, to modify or replace the ignition switch with a
serviceable part. The AD prohibits the installation of a metal
screen shield ignition switch on any aircraft.

You may examine the MCAI on the Internet at http://www.regulations.gov
by searching for and locating Docket No. FAA-2014-0130.

Relevant Service Information

    Alpha Aviation has issued Service Bulletin AA-SB-24-002, Revision
0, dated January 2014. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Costs of Compliance

    We estimate that this proposed AD will affect 10 products of U.S.
registry. We also estimate that it would take about 3 work-hours per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $2,550, or $255 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 3 work-hours and require parts costing $100, for a cost of
$355 per product. We have no way of determining the number of products
that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This proposed regulation is
within the scope of that authority because it addresses an unsafe
condition that is likely to exist or develop on products identified in
this rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

Alpha Aviation Concept Limited: Docket No. FAA-2014-0130;
Directorate Identifier 2014-CE-005-AD.

(a) Comments Due Date

    We must receive comments by April 17, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Alpha Aviation Concept Limited Model R2160
airplanes, serial numbers 001 through 378, certificated in any
category.

(d) Subject

    Air Transport Association of America (ATA) Code 74: Ignition.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as the metal screen
shield over the ignition switch may ground out the ignition
terminals. We are issuing this AD to prevent the ignition switch
metal screen from grounding out the ignition switch terminals, which
could cause the engine to shut down.

 (f) Actions and Compliance

    Unless already done, do the actions in paragraphs (f)(1) through
(f)(3) of this AD:
    (1) Within the next 50 hours time-in-service after the effective
date of this AD or within the next 3 months after the effective date
of this AD, whichever occurs first, inspect the airplane ignition
switch for the presence of a metal screen shield. Do the inspection
following the Accomplishment Instructions in Alpha Aviation Service
Bulletin AA-SB-24-002, Revision 0, dated January 2014.
    (2) If a metal screen is found during the inspection required in
paragraph (f)(1) of this AD, before further flight, modify or
replace the ignition switch following the Accomplishment
Instructions in Alpha Aviation Service Bulletin AA-SB-24-002,
Revision 0, dated January 2014.
    (3) As of the effective date of this AD, do not install an
ignition switch with a metal screen shield.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Karl Schletzbaum, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Before using any approved AMOC on
any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(h) Related Information

    Refer to MCAI Civil Aviation Authority (CAA) AD DCA/R2000/42,
dated January 29, 2014, for related information. You may examine the
MCAI on the Internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2014-0130. For service information
related to this AD, contact Alpha Aviation, 59 Hautapu Road, RD 1,
Cambridge 3493, New Zealand; telephone: +64 7 827 0528; fax: +64 7
929 2878; Internet: www.alphaaviation.co.nz. You may review this
referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.

    Issued in Kansas City, Missouri, on February 21, 2014.
Steven W. Thompson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-04549 Filed 2-28-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 16, 2010 (Volume 75, Number 50)]
[Notices]
[Page 12536-12537]
[DOCID:fr16mr10-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. DI10-8-000]

City of Tenakee Springs; Notice of Declaration of Intention and
Soliciting Comments, Protests, and/or Motions To Intervene

March 9, 2010.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Declaration of Intention.
    b. Docket No: DI10-8-000.
    c. Date Filed: March 1, 2010.
    d. Applicant: City of Tenakee Springs.
    e. Name of Project: Indian River Hydroelectric Project.
    f. Location: The proposed Indian River Hydroelectric Project will
be located on the Indian River near the City of Tenakee Springs, on
Chichagof Island, Sitka Borough, Alaska, affecting T. 47 S, R. 63 E,
secs. 15, 21, and 22, Copper River Meridian.
    g. Filed Pursuant to: Section 23(b)(1) of the Federal Power Act, 16
U.S.C. 817(b).
    h. Applicant Contact: Jeff Groves, 1503 W. 33rd Ave., 310,
Anchorage, AK 99503; telephone:<PHONE_NUMBER>; FAX:<PHONE_NUMBER>; e-
mail<EMAIL_ADDRESS>    i. FERC Contact: Any questions on this notice should be addressed
to Henry Ecton,<PHONE_NUMBER>, or E-mail address:
<EMAIL_ADDRESS>    j. Deadline for filing comments, protests, and/or motions: April 9,
2010.
    All documents may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at http://www.ferc.gov under the ``e-Filing'' link. If unable to
be filed electronically, documents may be paper-filed. To paper-file,
an original and eight copies should be filed with: Secretary, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426. For more information on how to submit these types of filings,
please go

to the Commission's Web site at http://www.ferc.gov.filing-
comments.asp.
    Please include the docket number (DI10-8-000) on any comments,
protests, and/or motions filed.
    k. Description of Project: The proposed run-of-river Indian River
Hydroelectric Project will consist of: (1) A 6-foot-high, 30-foot-wide
diversion structure, to be located at river mile (RM) 0.85; (2) a 40-
inch-diameter, 1,550-foot-long penstock; (3) a 30-foot-wide, 40-foot-
long, wood frame powerhouse, located at RM 0.55, housing a 250 kW
turbine-synchronous generator; (4) a 50-foot-long tailrace returning
flows back into Indian River; (5) a 5,900-foot-long transmission line;
and (6) appurtenant facilities.
    When a Declaration of Intention is filed with the Federal Energy
Regulatory Commission, the Federal Power Act requires the Commission to
investigate and determine if the interests of interstate or foreign
commerce would be affected by the proposed project. The Commission also
determines whether or not the project: (1) Would be located on a
navigable waterway; (2) would occupy or affect public lands or
reservations of the United States; (3) would utilize surplus water or
water power from a government dam; or (4) if applicable, has involved
or would involve any construction subsequent to 1935 that may have
increased or would increase the project's head or generating capacity,
or have otherwise significantly modified the project's pre-1935 design
or operation.
    l. Locations of the Application: Copies of this filing are on file
with the Commission and are available for public inspection. This
filing may be viewed on the Web at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via e-mail of new filings and issuances related to this or
other pending projects. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>,
or TTY, contact<PHONE_NUMBER>. A copy is also available for inspection
and reproduction at the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTESTS'', AND/
OR ``MOTIONS TO INTERVENE'', as applicable, and the Docket Number of
the particular application to which the filing refers. A copy of any
motion to intervene must also be served upon each representative of the
Applicant specified in the particular application.
    p. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-5646 Filed 3-15-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
[Rules and Regulations]
[Pages 29627-29628]
[FR Doc No: 2020-08862]

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

40 CFR Part 52

[EPA-R02-OAR-2019-0674; FRL-10007-94-Region 2]

Approval and Promulgation of Implementation Plans; New Jersey;
Negative Declaration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of New Jersey
for purposes of making a negative declaration regarding the October
2016 Oil and Natural Gas Control Techniques Guidelines (2016 Oil and
Gas CTG). This action is being taken in accordance with the
requirements of the Clean Air Act.

DATES: This final rule is effective on June 17, 2020.

ADDRESSES: The EPA has established a docket for this action under
Docket ID Number EPA-R02-OAR-2019-0674. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available electronically through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Omar Hammad, Environmental Protection
Agency, Region 2 Office, 290 Broadway, New York, New York 10007-1866,
at<PHONE_NUMBER>, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The SUPPLEMENTARY INFORMATION section is
arranged as follows:

Table of Contents

I. What is the background for the action?
II. What comments were received in response to the EPA's proposed
action?
III. What action is the EPA taking?
IV. Statutory and Executive Order Reviews

I. What is the background for this action?

    On May 13, 2019, the New Jersey Department of Environmental
Protection (NJDEP) submitted to the EPA, a State Implementation Plan
(SIP) revision consisting of a negative declaration for the 2016 Oil
and Gas CTG.
    Per the 2016 Oil and Gas CTG, the oil and natural gas industry
includes oil and natural gas operations involved in the extraction and
production of crude oil and natural gas, as well as the processing,
transmission, storage, and distribution of natural gas. For oil, the
industry includes all operations from the well to the point of custody
transfer at a petroleum refinery. For natural gas, the industry
includes all operations from the well to the customer.
    The NJDEP cross referenced the source operations covered in the
2016 Oil and Gas CTG and its applicability to New Jersey. New Jersey
asserts that there are no sources within its respective State that
would be subject to the 2016 Oil and Gas CTG. New Jersey asserts that
it is not anticipated that crude oil or natural gas extraction will be
occurring in New Jersey for the foreseeable future.
    On January 22, 2020 (85 FR 3556), the EPA published a notice of
proposed rulemaking that proposed to approve the State of New Jersey's
May 13, 2019 SIP submittal, for purposes of making a negative
declaration that no sources exist in the State of New Jersey that would
be subject to the 2016 Oil and Gas CTG. The reader is referred to EPA's
January 22, 2020, proposed action for more detailed background and
EPA's evaluation of New Jersey's SIP revision submittal.

II. What comments were received in response to the EPA's proposed
action?

    In response to the EPA's January 22, 2020, proposed rulemaking on
New Jersey's SIP revision submittal, the EPA is providing responses to
the comments that were received. The specific comments may be viewed
under Docket ID Number EPA-R02-OAR-2019-0674 on the http://www.regulations.gov website.
    Comment: This negative declaration would leave New Jersey at least
temporarily exempt from the October 2016 Oil and Natural Gas Control
Techniques Guidelines in a future scenario of discovering oil and/or
natural gas within the confines of New Jersey.
    Response: EPA has historically allowed states to submit a negative
declaration for a particular CTG category if the state finds that no
sources exist in the state which would be subject to that CTG. EPA has
addressed the idea of negative declarations numerous times and for
various NAAQS including in the General Preamble to the 1990
Amendments,\1\ the 2006 RACT Q&A Memo,\2\ and the 2008 Ozone
Implementation Rule.\3\ In each of these documents, EPA asserted that
if no sources exist in the nonattainment area for a particular CTG
category, the state would be allowed to submit a negative declaration
SIP revision.
---------------------------------------------------------------------------

    \1\ ``State Implementation Plans; General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990,''
(57 FR 13498 at 13512 (April 16, 1992)).
    \2\ ``RACT Qs & As--Reasonably Available Control Technology
(RACT): Questions and Answers'' Memorandum from William T. Harnett,
May 18, 2006.
    \3\ ``Implementation of the 2008 National Ambient Air Quality
Standards for Ozone: State Implementation Plan Requirements,'' (80
FR 12263 at 12278 (March 6, 2015)).
---------------------------------------------------------------------------

    Nothing in the Clean Air Act (CAA) or EPA's implementing rules or
guidance suggests that states must have a SIP approved regulation for a
category of CTG sources that does not exist in the state. Should a new
source of the type covered by the existing CTG be constructed in a
state after approval of a negative declaration, EPA expects the state
to develop a regulation and submit it to EPA for approval into the SIP
in accordance with the relevant timing provided for by the CAA. At this
time, because New Jersey does not have any sources subject to the 2016
Oil and Gas CTG, no regulation is required to be developed and
submitted to EPA for SIP approval.
    Comment: If EPA has or is in the process of withdrawing the CTG
then EPA shouldn't be requiring states to spend valuable time and
resources on this non-applicable ``requirement''. EPA should remove
this CTG and disapprove New Jersey's SIP as unnecessary as well as any
other state's SIP attempting to address this 2016 CTG.
    Response: This SIP submittal addresses a final document that EPA
announced on October 27, 2016, in the Federal Register (81 FR 74798)
``Release of Final Control Techniques Guidelines for the Oil and
Natural Gas Industry.'' This CTG is still in place. There is no final
action that withdraws this requirement. The State is addressing their
obligations in response to the final CTG with this submittal.
    Comment: ``It does not make sense for the state of New Jersey . . .
to be looking to get rid of more of the rules and regulations. This
seems like we are going backwards, away from the goal of making New
Jersey a cleaner state . . . I feel that the EPA should be taking a
closer look into the regulations the state of New Jersey is trying to
get around.''
    Response: This action does not remove any rules or regulations from
the New Jersey SIP. The negative

declaration simply asserts that no sources exist in the State of New
Jersey that are subject to the 2016 Oil and Gas CTG. The EPA has
reviewed New Jersey's submittal and agrees with the State's evaluation.

III. What action is the EPA taking?

    On May 13, 2019, the New Jersey Department of Environmental
Protection (NJDEP) submitted to the EPA a SIP revision consisting of a
negative declaration for the 2016 Oil and Gas CTG.
    The EPA is approving the revision to the SIP submitted by the State
to address the 2016 Oil and Gas CTG for the Ozone Transport Region and
nonattainment RACT requirements for both the 2008 and 2015 ozone
National Ambient Air Quality Standards and is approving their negative
declaration that no sources exist in the State of New Jersey that would
be subject to the 2016 Oil and Gas CTG.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:

     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993), and 13563 (76 FR 382, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempt under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

    In addition, this rulemaking action, pertaining to New Jersey's
Negative Declaration SIP submission, would not be approved to apply on
any Indian reservation land or in any other area where EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose any substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175 (65 FR 67249, November
9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

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

    Dated: April 21, 2020.
Peter Lopez,
Regional Administrator, Region 2.

    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart FF--New Jersey

0
2. In Sec.  52.1582, add paragraph (q) to read as follows:

Sec.  52.1582  Control strategy and regulations: Ozone.

* * * * *
    (q) Negative declarations. The State of New Jersey has certified to
the satisfaction of the EPA that no sources are located in the State
which are covered by the following Control Techniques Guidelines:
    (1) Oil and Natural Gas Industry (October 2016).
    (2) [Reserved]

[FR Doc. 2020-08862 Filed 5-15-20; 8:45 am]
BILLING CODE 6560-50-P