[Federal Register Volume 82, Number 90 (Thursday, May 11, 2017)]
[Notices]
[Pages 22042-22044]
[FR Doc No: 2017-09522]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80606; File No. SR-NYSEArca-2017-05]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Instituting
Proceedings To Determine Whether To Approve or Disapprove a Proposed
Rule Change To List and Trade Shares of Direxion Daily Crude Oil Bull
3x Shares and Direxion Daily Crude Oil Bear 3x Shares Under NYSE Arca
Equities Rule 8.200

May 5, 2017.

I. Introduction

    On January 23, 2017, NYSE Arca, Inc. (``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) \1\ of the Securities
Exchange Act of 1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ a
proposed rule change to list and trade shares (``Shares'') of Direxion
Daily Crude Oil Bull 3x Shares and Direxion Daily Crude Oil Bear 3x
Shares (each a ``Fund,'' and collectively the ``Funds'') under NYSE
Arca Equities Rule 8.200. The proposed rule change was published for
comment in the Federal Register on February 7, 2017.\4\ On March 16,
2017, pursuant to Section 19(b)(2) of the Act,\5\ the Commission
designated a longer period within which to approve the proposed rule
change, disapprove the proposed rule change, or institute proceedings
to determine whether to disapprove the proposed rule change.\6\ The
Commission has received no comments on the proposed rule change. This
order institutes proceedings under Section 19(b)(2)(B) of the Act \7\
to determine whether to approve or disapprove the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
    \4\ See Securities Exchange Act Release No. 79916 (February 1,
2017), 82 FR 9608 (``Notice'').
    \5\ 15 U.S.C. 78s(b)(2).
    \6\ See Securities Exchange Act Release No. 80265 (March 22,
2017), 82 FR 14778. The Commission designated May 8, 2017 as the
date by which the Commission shall either approve or disapprove, or
institute proceedings to determine whether to disapprove, the
proposed rule change.
    \7\ 15 U.S.C. 78s(b)(2)(B).
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II. Exchange's Description of the Proposal

    The Exchange proposes to list and trade Shares of the Funds under
NYSE Arca Equities Rule 8.200, Commentary .02, which governs the
listing and trading of Trust Issued Receipts.\8\ Each Fund is a series
of the Direxion Shares ETF Trust II (``Trust''), a Delaware statutory
trust.\9\ The Trust and the Funds are managed and controlled by
Direxion Asset Management, LLC (``Sponsor'').\10\ Bank of New York
Mellon will be the custodian and transfer agent for the Funds. U.S.
Bancorp Fund Services, LLC is the administrator for the Funds. Foreside
Fund Services, LLC serves as the distributor of the Shares.
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    \8\ Commentary .02 to NYSE Arca Equities Rule 8.200 applies to
Trust Issued Receipts that invest in ``Financial Instruments.'' The
term ``Financial Instruments,'' as defined in Commentary .02(b)(4)
to NYSE Arca Equities Rule 8.200, means any combination of
investments, including cash; securities; options on securities and
indices; futures contracts; options on futures contracts; forward
contracts; equity caps, collars, and floors; and swap agreements.
    \9\ According to the Exchange, on December 14, 2016, the Trust
filed with the Commission a registration statement on Form S-1 under
the Securities Act of 1933, as amended, relating to the Funds (File
No. 333-215091) (``Registration Statement'').
    \10\ According to the Exchange, the Sponsor is registered as a
commodity pool operator with the Commodity Futures Trading
Commission and is a member of the National Futures Association. See
Notice, supra note 4, 82 FR at 9608.
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    The Exchange has made the following representations and statements
in describing the Funds and their investment strategies, including the
Funds' portfolio holdings and investment restrictions.\11\
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    \11\ The Commission notes that additional information regarding
the Trust, the Funds, and the Shares, including investment
strategies, risks, net asset value (``NAV'') calculation, creation
and redemption procedures, fees, availability of information,
trading rules and halts, surveillance, information bulletins,
distributions, and taxes, among other information, is included in
the Notice and the Registration Statement, as applicable. See Notice
and Registration Statement, supra notes 4 and 9, respectively.
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A. Investment Objectives of the Funds

    The investment objective of the Direxion Daily Crude Oil Bull 3X
Shares is to seek, on a daily basis,\12\ investment results that
correspond (before fees and expenses) to a multiple three times (3x) of
the daily performance of the Bloomberg WTI Crude Oil Subindex\SM\ (a
subindex of the Bloomberg Commodity Index\SM\) (``Benchmark'').\13\ The
investment objective of the Direxion Daily Crude Oil Bear 3X Shares is
to seek, on a daily basis,\14\ investment results that correspond
(before fees and expenses) to three times (3x) the inverse of the
performance of the Benchmark. The Benchmark is intended to reflect the
performance of crude oil as measured by the price of West Texas
Intermediate crude oil futures contracts traded on the New York
Mercantile Exchange (which is part of the Chicago Mercantile Exchange),
including the impact of rolling,\15\ without regard to income earned on
cash positions. According to the Exchange, the Funds will not be
directly linked to the ``spot'' price of crude oil.\16\
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    \12\ According to the Exchange, the Funds do not seek to achieve
their investment objectives over a period greater than a single
trading day. The Exchange states that a single trading day is
measured from the time a Fund calculates its NAV to the time of a
Fund's next NAV calculation. The Exchange states that the return of
a Fund for a period longer than a single trading day is the result
of its return for each day compounded over the period and thus will
usually differ from a Fund's multiple times the return of the
Benchmark for the same period. See Notice, supra note 4, 82 FR at
9609.
    \13\ According to the Exchange, the Benchmark is a ``rolling
index,'' which means that the index does not take physical
possession of any commodities. See id. at 9609 n.7.
    \14\ See supra note 12.
    \15\ The Exchange states that futures contracts held by the
Funds near expiration are generally closed out and replaced by
contracts with a later expiration as required by the Benchmark. The
Exchange states that this process is referred to as ``rolling,'' and
that the Funds do not intend to hold futures contracts through
expiration, but instead to ``roll'' their respective positions. See
Notice, supra note 4, 82 FR at 9609 n.8.
    \16\ See id. at 9609.
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B. Investments of the Funds

    In seeking to achieve the Funds' investment objectives, the
Exchange states that the Sponsor will utilize a mathematical approach
to determine the type, quantity, and mix of investment positions that
the Sponsor believes, in combination, should produce daily returns
consistent with the Funds' respective objectives.\17\ The Sponsor would
rely on a pre-determined model to generate orders that result in
repositioning the Funds' investments in accordance with their
respective investment objectives.
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    \17\ See id.
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    According to the Exchange, each Fund will seek to achieve its
investment objectives by investing, under normal market conditions,\18\
substantially all of

its assets in oil futures contracts traded in the U.S. and listed
options on such contracts (such futures contracts and options are
collectively referred to as ``Futures Contracts''). The Funds'
investments in Futures Contracts will be used to produce economically
``leveraged'' or ``inverse leveraged'' investment results for the
Funds.
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    \18\ The Exchange states that the term ``normal market
conditions'' includes, but is not limited to, the absence of trading
halts in the applicable financial markets generally; operational
issues (e.g., systems failure) causing dissemination of inaccurate
market information; or force majeure type events such as natural or
manmade disaster, act of God, armed conflict, act of terrorism, riot
or labor disruption or any similar intervening circumstance. See id.
at 9609 n.11.
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    In the event position or accountability limits are reached with
respect to Futures Contracts,\19\ each Fund may obtain exposure to the
Benchmark through investment in swap transactions and forward contracts
referencing the Benchmark or other benchmarks the Sponsor believes
should be closely correlated to the performance of each Fund's
benchmark, such as the Energy Select Sector Index or the S&P Oil & Gas
Exploration & Production Select Industry Index (such swap transactions
and forward contracts are collectively referred to as ``Financial
Instruments''). To the extent that the Trust invests in Financial
Instruments, it would first make use of exchange-traded Financial
Instruments, if available. If an investment in exchange-traded
Financial Instruments is unavailable, then the Trust would invest in
Financial Instruments that clear through derivatives clearing
organizations that satisfy the Trust's criteria, if available. If an
investment in cleared Financial Instruments is unavailable, then the
Trust would invest in other Financial Instruments, including uncleared
Financial Instruments in the over-the-counter (``OTC'') market. The
Funds may also invest in Financial Instruments if the market for a
specific futures contract experiences emergencies (e.g., natural
disaster, terrorist attack, or an act of God) or disruptions (e.g., a
trading halt or a flash crash) that prevent or make it impractical for
a Fund to obtain the appropriate amount of investment exposure using
Futures Contracts.
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    \19\ According to the Exchange, U.S. futures exchanges have
established accountability levels and position limits on the maximum
net long or net short Futures Contracts in commodity interests that
any person or group of persons under common trading control (other
than as a hedge, which an investment by a Fund is not) may hold,
own, or control. These levels and position limits apply to the
Futures Contracts that each Fund would invest in to meet its
investment objective. According to the Exchange, in addition to
accountability levels and position limits, U.S. futures exchanges
also set daily price fluctuation limits on Futures Contracts. The
daily price fluctuation limit establishes the maximum amount that
the price of a Futures Contract may vary either up or down from the
previous day's settlement price. See id. at 9609.
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    The Funds will invest such that each Fund's exposure to the
Benchmark will consist substantially of Futures Contracts. The Funds'
remaining net assets may be invested in cash or cash equivalents and/or
U.S. Treasury securities or other high credit quality, short-term
fixed-income or similar securities (such as shares of money market
funds and collateralized repurchase agreements) for direct investment
or as collateral for the Funds' investments.
    The Funds do not intend to hold Futures Contracts through
expiration, but instead to ``roll'' their respective positions.\20\
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    \20\ The Exchange states that when the market for these
contracts is such that the prices are higher in the more distant
delivery months than in the nearer delivery months, the sale during
the course of the ``rolling process'' of the more nearby contract
would take place at a price that is lower than the price of the more
distant contract. This pattern of higher futures prices for longer
expiration Futures Contracts is referred to as ``contango.''
Alternatively, when the market for these contracts is such that the
prices are higher in the nearer months than in the more distant
months, the sale during the course of the ``rolling process'' of the
more nearby contract would take place at a price that is higher than
the price of the more distant contract. This pattern of higher
futures prices for shorter expiration futures contracts is referred
to as ``backwardation.'' According to the Exchange, the presence of
contango in certain Futures Contracts at the time of rolling could
adversely affect a Fund with long positions, and positively affect a
Fund with short positions. Similarly, the presence of backwardation
in certain futures contracts at the time of rolling such contracts
could adversely affect a Fund with short positions and positively
affect a Fund with long positions. See id.
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    The Exchange states that the Funds do not expect to have leveraged
exposure greater than three times (3x) the Funds' net assets. Thus, the
maximum margin held at a Future Commission Merchant would not exceed
three times the margin requirement for either Fund.\21\
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    \21\ See id.
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    The Exchange represents that not more than 10% of the net assets of
a Fund in the aggregate invested in Futures Contracts shall consist of
Futures Contracts whose principal market is not a member of the
Intermarket Surveillance Group or is a market with which the Exchange
does not have in place a comprehensive surveillance sharing agreement.

III. Proceedings To Determine Whether To Approve or Disapprove SR-
NYSEArca-2017-05 and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Act \22\ to determine whether the proposed rule
change should be approved or disapproved. Institution of such
proceedings is appropriate at this time in view of the legal and policy
issues raised by the proposed rule change. Institution of proceedings
does not indicate that the Commission has reached any conclusions with
respect to any of the issues involved. Rather, as described below, the
Commission seeks and encourages interested persons to provide comments
on the proposed rule change.
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    \22\ 15 U.S.C. 78s(b)(2)(B).
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    Pursuant to Section 19(b)(2)(B) of the Act,\23\ the Commission is
providing notice of the grounds for disapproval under consideration.
The Commission is instituting proceedings to allow for additional
analysis of the proposed rule change's consistency with Section 6(b)(5)
of the Act, which requires, among other things, that the rules of a
national securities exchange be ``designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade,'' and ``to protect investors and the public
interest.'' \24\
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    \23\ Id.
    \24\ 15 U.S.C. 78f(b)(5).
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    Under the proposal, each Fund will seek to achieve its investment
objective by investing in Financial Instruments, which, according to
the Exchange, could include uncleared OTC swap transactions and forward
contracts.\25\ The Exchange states that each Fund's total portfolio
composition will be disclosed each business day that the Exchange is
open for trading on the Funds' Web site. The Web site disclosure will
include, with respect to the Futures Contracts and Financial
Instruments, their name, percentage weighting, and value. The
Commission seeks commenters' views on the sufficiency of the
information that would be provided with respect to each Fund's
Financial Instruments, and whether the information will allow market
participants to value these interests intraday.
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    \25\ See Notice, supra note 4, at 9609.
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    In addition, under the proposal, the investment objective of the
Direxion Daily Crude Oil Bull 3X Shares is to seek, on a daily basis,
investment results that correspond (before fees and expenses) to a
multiple three times (3x) of the daily performance of the Benchmark,
and the investment objective of the Direxion Daily Crude Oil Bear 3X
Shares is to seek, on a daily basis, investment results that correspond
(before fees and expenses) to three times (3x) the inverse of the
performance of the Benchmark. The Exchange's filing does not address
whether the value of the Benchmark will be publicly disseminated, and,
if

so, by whom and how often. The Commission seeks commenters' views on
the sufficiency of the Exchange's discussion regarding dissemination of
the value of the Benchmark on which the investment objectives of the
Funds are based.
    Furthermore, in its filing the Exchange fails to include a
representation that all statements and representations in the proposal
regarding the applicability of Exchange listing rules specified in the
proposal shall constitute continued listing requirements for listing
the Shares on the Exchange.\26\ The Commission seeks commenter's views
on whether the Exchange's statements in the filing relating to the
applicability of continued listing requirements for listing and trading
of the Shares on the Exchange are sufficient to support a determination
that the listing and trading of the Shares would be consistent with
Section 6(b)(5) of the Act.
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    \26\ The Commission notes that the Exchange has made this
representation in other proposed rule changes to list and trade
Trust Issued Receipts. See, e.g., Amendment No. 1 to Securities
Exchange Act Release No. 79917 (February 1, 2017), 82 FR 9620
(February 7, 2017) (SR-NYSEArca-2017-07), available at: https://www.sec.gov/comments/sr-nysearca-2017-07/nysearca201707-1630210-137426.pdf; Amendment No. 2 to Securities Exchange Act Release No.
79742 (January 5, 2017), 82 FR 3366 (January 11, 2017) (SR-NYSEArca-
2016-173), available at: https://www.sec.gov/comments/sr-nysearca-2016-173/nysearca2016173-1678044-149322.pdf.
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IV. Procedure: Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
issues identified above, as well as any other concerns they may have
with the proposal. In particular, the Commission invites the written
views of interested persons concerning whether the proposal is
consistent with Section 6(b)(5) or any other provision of the Act, or
the rules and regulations thereunder. Although there do not appear to
be any issues relevant to approval or disapproval that would be
facilitated by an oral presentation of views, data, and arguments, the
Commission will consider, pursuant to Rule 19b-4, any request for an
opportunity to make an oral presentation.\27\
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    \27\ Section 19(b)(2) of the Act, as amended by the Securities
Act Amendments of 1975, Pub. L. 94-29 (June 4, 1975), grants the
Commission flexibility to determine what type of proceeding--either
oral or notice and opportunity for written comments--is appropriate
for consideration of a particular proposal by a self-regulatory
organization. See Securities Act Amendments of 1975, Senate Comm. on
Banking, Housing & Urban Affairs, S. Rep. No. 75, 94th Cong., 1st
Sess. 30 (1975).
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    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposal should be approved or
disapproved by June 12, 2017. Any person who wishes to file a rebuttal
to any other person's submission must file that rebuttal by June 26,
2017. The Commission asks that commenters address the sufficiency of
the Exchange's statements in support of the proposal, which are set
forth in the Notice,\28\ in addition to any other comments they may
wish to submit about the proposed rule change.
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    \28\ See supra note 4.
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    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2017-05 on the subject line.

Paper Comments

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

All submissions should refer to File Numbers SR-NYSEArca-2017-05. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2017-05 and should
be submitted on or before June 12, 2017 Rebuttal comments should be
submitted by June 26, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\29\
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    \29\ 17 CFR 200.30-3(a)(57).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-09522 Filed 5-10-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)]
[Notices]
[Pages 14635-14636]
[FR Doc No: 2018-06758]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9976-19--Region 8]

Public Water System Supervision Program Revision for the State of
Montana

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Public notice is hereby given that the state of Montana has
revised its Public Water System Supervision (PWSS) Program by adopting
federal regulations for the Revised Total Coliform Rule (RTCR) that
correspond to the National Primary Drinking Water Regulations (NPDWR).
The EPA has reviewed Montana's regulations and determined they are no
less stringent than the federal regulations. The EPA is proposing to
approve Montana's primacy revision for the RTCR.
    This approval action does not extend to public water systems in
Indian country. Please see Supplementary Information, Item B.

DATES: Any member of the public is invited to request a public hearing
on this determination by May 7, 2018. Please see SUPPLEMENTARY
INFORMATION, Item C, for details. Should no timely and appropriate
request for a hearing be received, and the Regional Administrator (RA)
does not elect to hold a hearing on his/her own motion, this
determination shall become applicable May 7, 2018. If a public hearing
is requested and granted, then this determination shall not become
applicable until such time following the hearing as the RA issues an
order affirming or rescinding this action.

ADDRESSES: Requests for a public hearing should be addressed to: Robert
Clement, Drinking Water Unit B (8WP-SDB), EPA, Region 8, 1595 Wynkoop
Street, Denver, CO 80202-1129.
    All documents relating to this determination are available for
inspection at: EPA, Region 8, Drinking Water Unit (7th Floor), 1595
Wynkoop Street, Denver, Colorado.

FOR FURTHER INFORMATION CONTACT: Robert Clement, Drinking Water Unit B
(8WP-SDB), EPA, Region 8, 1595 Wynkoop Street, Denver, CO 80202-1129,
phone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In accordance with the provisions of section
1413 of the Safe Drinking Water Act (SDWA), 42 U.S.C. 300g-2, and 40
CFR 142.13, public notice is hereby given that the state of Montana has
revised its PWSS program by adopting federal regulations for the RTCR
that correspond to the NPDWR in 40 CFR parts 141 and 142. The EPA has
reviewed Montana's regulations and determined they are no less
stringent than the federal regulations. The EPA is proposing to approve
Montana's primacy revision for the RTCR.
    This approval action does not extend to public water systems in
Indian country as defined in 18 U.S.C. 1151. Please see SUPPLEMENTARY
INFORMATION, Item B.

A. Why are revisions to State programs necessary?

    States with primary PWSS enforcement authority must comply with the
requirements of 40 CFR part 142 to maintain primacy. They must adopt
regulations that are at least as stringent as the NPDWRs at 40 CFR
parts 141 and 142, as well as adopt all new and revised NPDWRs in order
to retain primacy (40 CFR 142.12(a)).

B. How does this action affect Indian country (18 U.S.C. 1151) in
Montana?

    EPA's approval of the drinking water standards Montana submitted
extends to public water systems in Montana with the exception of those
public water systems that are within Indian country, as defined in 18
U.S.C. 1151. Indian country lands within the exterior boundaries of the
following Indian reservations located within Montana: The Blackfeet,
Crow, Flathead, Fort Belknap, Fort Peck, Northern Cheyenne and Rocky
Boys Indian Reservations; any land held in trust by the United States
for an Indian tribe; and any other areas which are ``Indian country''
within the meaning of 18 U.S.C. 1151. EPA or eligible Indian tribes, as
appropriate, will retain PWSS program responsibilities over public
water systems in Indian country.

C. Requesting a Hearing

    Any member of the public may request a hearing on this
determination within thirty (30) days of this notice. All requests
shall include the following information: Name, address, and telephone
number of the individual, organization, or other entity requesting a
hearing; a brief statement of interest and information to be submitted
at the hearing; and a signature of the interested individual or
responsible official, if made on behalf of an organization or other
entity. Frivolous or insubstantial requests for a hearing may be denied
by the RA.
    Notice of any hearing shall be given not less than fifteen (15)
days prior to the time scheduled for the hearing and will be made by
the RA in the Federal Register and in a newspaper of general

circulation in the state. A notice will also be sent to both the
person(s) requesting the hearing and the state. The hearing notice will
include a statement of purpose of the hearing, information regarding
time and location for the hearing, and the address and telephone number
where interested persons may obtain further information. The RA will
issue an order affirming or rescinding the determination upon review of
the hearing record.
    Please bring this notice to the attention of any persons known by
you to have an interest in this determination.

     Dated: March 8, 2018.
Douglas H. Benevento,
Regional Administrator, Region 8.
[FR Doc. 2018-06758 Filed 4-4-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 79 (Wednesday, April 24, 2013)]
[Notices]
[Page 24309]
[FR Doc No: 2013-09400]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

List of Special Permit Applications Delayed

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of Applications Delayed more than 180 days.

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SUMMARY: In accordance with the requirements of 49 U.S.C. 5117(c),
PHMSA is publishing the following list of special permit applications
that have been in process for 180 days or more. The reason(s) for delay
and the expected completion date for action on each application is
provided in association with each identified application.

FOR FURTHER INFORMATION CONTACT: Ryan Paquet, Director, Office of
Hazardous Materials Special Permits and Approvals, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, East Building, PHH-30, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

Key to ``Reason for Delay''

    1. Awaiting additional information from applicant
    2. Extensive public comment under review
    3. Application is technically complex and is of significant impact
or precedent-setting and requires extensive analysis.
    4. Staff review delayed by other priority issues or volume of
special permit applications.

Meaning of Application Number Suffixes

N--New application
M--Modification request
R--Renewal Request
P--Party to Exemption Request

    Issued in Washington, DC, on April 9, 2013.
Donald Burger,
Chief, General Approvals and Permits.

------------------------------------------------------------------------
                                            Reason for   Estimated date
  Application No.         Applicant           delay       of completion
------------------------------------------------------------------------
                     New Special Permit Applications
------------------------------------------------------------------------
15650-N...........  JL Shepherd &                    3        05-31-2013
                     Associates, San
                     Fernando, CA.
15720-N...........  Digital Wave                   3,1        05-31-2013
                     Corporation,
                     Centennial, CO.
15725-N...........  Toray Composites                 4        05-31-2013
                     (America), Tacoma,
                     WA.
15727-N...........  Blackhawk                        4        05-31-2013
                     Helicopters, El
                     Cajon, CA.
------------------------------------------------------------------------
                  Renewal Special Permits Applications
------------------------------------------------------------------------
14455-R...........  EnergySolutions, LLC,            3        04-30-2013
                     Columbia, SC.
14832-R...........  Trinity Industries,              3        05-31-2013
                     Inc., Dallas, TX.
15228-R...........  FedEx Express,                   3        05-31-2013
                     Memphis, TN.
------------------------------------------------------------------------

[FR Doc. 2013-09400 Filed 4-23-13; 8:45 am]
BILLING CODE 4910-60-M


[Federal Register Volume 85, Number 125 (Monday, June 29, 2020)]
[Notices]
[Page 38882]
[FR Doc No: 2020-13911]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-2125-000]

WGP Redwood Holdings, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
WGP Redwood Holdings, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is July 13, 2020.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: June 23, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-13911 Filed 6-26-20; 8:45 am]
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[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)]
[Notices]
[Page 31540]
[FR Doc No: 2020-11174]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4499-DR; Docket ID FEMA-2020-0001]

Oregon; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Oregon (FEMA-4499-DR), dated March 28, 2020,
and related determinations.

DATES: The declaration was issued March 28, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated March 28, 2020, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the emergency conditions in the State of
Oregon resulting from the Coronavirus Disease 2019 (COVID-19)
pandemic beginning on January 20, 2020, and continuing, are of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Oregon.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide assistance for emergency
protective measures (Category B), including direct Federal
assistance, under the Public Assistance program throughout the
State. Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Michael F. O'Hare, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Oregon have been designated as
adversely affected by this major disaster:

    Emergency protective measures (Category B) not authorized under
other Federal statutes, including direct Federal assistance, under
the Public Assistance program at 75 percent federal funding for all
areas in the State of Oregon.

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

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-11174 Filed 5-22-20; 8:45 am]
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[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Rules and Regulations]
[Pages 52970-52972]
[FR Doc No: 2018-22784]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2018-N-3595]

Medical Devices; General and Plastic Surgery Devices;
Classification of the Hemostatic Device for Intraluminal
Gastrointestinal Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the hemostatic device for intraluminal gastrointestinal use into class
II (special controls). The special controls that apply to the device
type are identified in this order and will be part of the codified
language for the hemostatic device for intraluminal gastrointestinal
use's classification. We are taking this action because we have
determined that classifying the device into class II (special controls)
will provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective October 19, 2018. The classification was
applicable on May 7, 2018.

FOR FURTHER INFORMATION CONTACT: Maegen Colehour, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G423, Silver Spring, MD, 20993-0002, 301-
796-6436, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the hemostatic device for
intraluminal gastrointestinal use as class II (special controls), which
we have determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application to market a substantially equivalent
device (see 21 U.S.C. 360c(i), defining ``substantial equivalence'').
Instead, sponsors can use the less-burdensome 510(k) process, when
necessary, to market their device.

II. De Novo Classification

    On March 9, 2017, Wilson-Cook Medical, Inc. submitted a request for
De Novo classification of the Hemospray[supreg] Endoscopic Hemostat.
FDA reviewed the request in order to classify the device under the
criteria for classification set forth in section 513(a)(1) of the FD&C
Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on May 7, 2018, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 878.4456. We have named
the generic type of device hemostatic device for intraluminal
gastrointestinal use, and it is identified as a prescription device
that is endoscopically applied to the upper and/or lower
gastrointestinal tract and is intended to produce hemostasis via
absorption of fluid or by other means.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures

required to mitigate these risks in table 1.

 Table 1--Hemostatic Device for Intraluminal Gastrointestinal Use Risks
                         and Mitigation Measures
------------------------------------------------------------------------
           Identified risks                   Mitigation measures
------------------------------------------------------------------------
Bleeding:
     Inability to achieve      In vivo performance testing, Non-
     hemostasis                         clinical performance testing,
     Recurrence of bleeding..   and Labeling.
Infection............................  Sterilization validation, Shelf
                                        life testing, and Labeling.
Adverse tissue reaction..............  In vivo performance testing, Non-
                                        clinical performance testing,
                                        Biocompatibility evaluation, and
                                        Labeling.
Obstruction of gastrointestinal (GI)   In vivo performance testing and
 tract.                                 Labeling.
GI distension or perforation.........  In vivo performance testing and
                                        Labeling.
Vascular obstruction:
     Ischemia                  In vivo performance testing, Non-
     Emboli formation........   clinical performance testing,
                                        and Labeling.
Tissue trauma........................  In vivo performance testing, Non-
                                        clinical performance testing,
                                        and Labeling.
Improper device use..................  In vivo performance testing and
                                        Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. We encourage sponsors to consult with us if they wish to
use a non-animal testing method they believe is suitable, adequate,
validated, and feasible. We will consider if such an alternative method
could be assessed for equivalency to an animal test method. This device
is subject to premarket notification requirements under section 510(k)
of the FD&C Act.
    At the time of classification, hemostatic devices for intraluminal
gastrointestinal use are for prescription use only. Prescription
devices are exempt from the requirement for adequate directions for use
for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C.
352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR
801.109 are met (referring to 21 U.S.C. 352(f)(1)).

III. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in 21 CFR part 820, regarding
quality system regulations, have been approved under OMB control number
0910-0073; the collections of information in part 807, subpart E,
regarding premarket notification submissions, have been approved under
OMB control number 0910-0120; and the collections of information in 21
CFR part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  878.4456 to subpart E to read as follows:

Sec.  878.4456  Hemostatic device for intraluminal gastrointestinal
use.

    (a) Identification. A hemostatic device for intraluminal
gastrointestinal use is a prescription device that is endoscopically
applied to the upper and/or lower gastrointestinal tract and is
intended to produce hemostasis via absorption of fluid or by other
physical means.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The device must be demonstrated to be biocompatible.
    (2) Performance data must support the sterility and pyrogenicity of
the device.
    (3) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
    (4) In vivo performance testing must demonstrate that the device
performs as intended under anticipated conditions of use. The testing
must evaluate the following:
    (i) The ability to deliver the hemostatic material to the bleeding
site;
    (ii) The ability to achieve hemostasis in a clinically relevant
model of gastrointestinal bleeding; and
    (iii) Safety endpoints, including thromboembolic events, local and
systemic toxicity, tissue trauma, gastrointestinal tract obstruction,
and bowel distension and perforation.
    (5) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be evaluated:
    (i) Materials characterization of all components must demonstrate
the device meets established specifications, which must include
compositional identity and purity, characterization of

impurities, physical characteristics, and reactivity with fluids.
    (ii) Performance testing must demonstrate the mechanical integrity
and functionality of the system used to deliver the device and
demonstrate the device meets established specifications, including
output pressure for propellant-based systems.
    (6) Labeling must include:
    (i) Information identifying and explaining how to use the device
and its components; and
    (ii) A shelf life.

    Dated: October 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22784 Filed 10-18-18; 8:45 am]
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