[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Pages 12975-12976]
[FR Doc No: 2011-5310]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-E-0332]

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

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 CERVARIX 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 Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human biological product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 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. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks 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 biological product will include all of the testing
phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human biological product
CERVARIX (human papillomavirus bivalent (types 16 and 18) vaccine).
CERVARIX is indicated for prevention of the following diseases caused
by oncogenic human papillomavirus types 16 and 18: cervical cancer;
cervical intraepithelial neoplasia grade 2 or sores and adenocarcinoma
in situ; and cervical intraepithelial neoplasia grade 1. Subsequent to
this approval, the Patent and Trademark Office received a patent term
restoration application for CERVARIX (U.S. Patent No. 7,351,533) from
MedImmune, LLC., and the Patent and Trademark Office requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated October 26, 2010, FDA advised the Patent
and Trademark Office that this human biological product had undergone a
regulatory review period and that the approval of CERVARIX represented
the first permitted commercial marketing or use of the product.
Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
CERVARIX is 4,027 days. Of this time, 3,094 days occurred during the
testing phase of the regulatory review period, while 933 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 (21 U.S.C. 355(i)) became effective: October 9,
1998. The applicant claims September 8, 1998, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was October 9, 1998,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): March 29, 2007. FDA has verified the
applicant's claim that the biologics license application (BLA) for
CERVARIX (BLA 125259/0) was submitted on March 29, 2007.
    3. The date the application was approved: October 16, 2009. FDA has
verified the applicant's claim that BLA 125259/0 was approved on
October 16, 2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 562 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by May 9, 2011. 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 September 5, 2011. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written

comments and written petitions. It is only necessary to send one set of
comments. It is no longer necessary to send three copies of mailed
comments. However, if you submit a written petition, you must submit
three copies of the petition. Identify comments with the docket number
found in brackets in the heading of this document.
    Comments and petitions that have not been made publicly available
on http://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 14, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-5310 Filed 3-8-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Pages 41644-41650]
[FR Doc No: 2020-14868]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89234; File No. SR-CboeBZX-2020-053]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing of a Proposed Rule Change, as Modified by Amendment No. 1, To
List and Trade Shares of the 2x Long VIX Futures ETF, a Series of VS
Trust, Under Rule 14.11(f)(4) (``Trust Issued Receipts'')

July 6, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 23, 2020, Cboe BZX Exchange, Inc. (``Exchange'' or ``BZX'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. On June 26, 2020, BZX filed
Amendment No. 1 to the proposed rule change. The Commission is
publishing this notice to solicit comments on the proposed rule change,
as modified by Amendment No. 1, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe BZX Exchange, Inc. (the ``Exchange'' or ``BZX'') is filing
with the Securities and Exchange Commission (``Commission'') a proposed
rule change to list and trade shares of the 2x Long VIX Futures ESTF, a
series of VS Trust, under Rule 14.11(f)(4) (``Trust Issued Receipts'').
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    This Amendment No. 1 to SR-CboeBZX-2020-053 amends and replaces in
its entirety the proposal as originally submitted on June 23, 2020. The
Exchange submits this Amendment No. 1 in order to clarify certain
points and add additional details to the proposal.
    The Exchange proposes to list and trade Shares of the 2x Long VIX
Futures ETF (the ``Fund'') under Rule 14.11(f)(4), which governs the
listing

and trading of Trust Issued Receipts \3\ on the Exchange.\4\
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    \3\ Rule 14.11(f)(4) applies to Trust Issued Receipts that
invest in ``Financial Instruments.'' The term ``Financial
Instruments,'' as defined in Rule 14.11(f)(4)(A)(iv), 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.
    \4\ The Commission approved BZX Rule 14.11(f)(4) in Securities
Exchange Act Release No. 68619 (January 10, 2013), 78 FR 3489
(January 16, 2013) (SR-BZX-2012-044).
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    The Fund will seek to provide a return that is 200% of the return
of its benchmark index for a single day. As further described below,
the benchmark index seeks to offer long exposure to market volatility
through publicly traded futures markets. The benchmark for the Fund is
the Long VIX Futures Index (the ``Index'' or ticker symbol LONGVOL).\5\
The Index measures the daily performance of a theoretical portfolio of
first- and second-month futures contracts on the Cboe Volatility Index
(``VIX'').\6\
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    \5\ The Index is sponsored by Cboe Global Indexes (the ``Index
Sponsor''). The Index Sponsor is not a registered broker-dealer, but
is affiliated with a broker-dealer. The Index Sponsor has
implemented and will maintain a fire wall with respect to the
broker-dealer affiliate regarding access to information concerning
the composition and/or changes to the Index. In addition, the Index
Sponsor has implemented and will maintain procedures that are
designed to prevent the use and dissemination of material, non-
public information regarding the Index.
    \6\ The VIX is an index designed to measure the implied
volatility of the S&P 500 over 30 days in the future. The VIX is
calculated based on the prices of certain put and call options on
the S&P 500. The VIX is reflective of the premium paid by investors
for certain options linked to the level of the S&P 500.
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    The Fund will primarily invest in VIX futures contracts traded on
the Cboe Futures Exchange, Inc. (``CFE'') (hereinafter referred to as
``VIX Futures Contracts'') based on components of the Index to pursue
its investment objective. In the event accountability rules, price
limits, position limits, margin limits or other exposure limits are
reached with respect to VIX Futures Contracts, Volatility Shares LLC
(the ``Sponsor'') may cause the Fund to obtain exposure to the Index
through Over-the-Counter (OTC) swaps referencing the Index or
particular VIX Futures Contracts comprising the Index (hereinafter
referred to as ``VIX Swap Agreements''). The Fund may also invest in
VIX Swap Agreements if the market for a specific VIX 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) or
in situations where the Sponsor deems it impractical or inadvisable to
buy or sell VIX Futures Contracts (such as during periods of market
volatility or illiquidity).
    The Sponsor, a Delaware limited liability company, serves as the
Sponsor of VS Trust (the ``Trust''). The Sponsor is a commodity pool
operator.\7\ Tidal ETF Services LLC serves as the administrator (the
``Administrator'') and U.S. Bank National Association serves as
custodian of the Fund and its Shares. U.S. Bancorp Fund Services, LLC
serves as the sub-administrator (the ``Sub-Administrator'') and
transfer agent. Wilmington Trust Company, a Delaware trust company, is
the sole trustee of the Trust.
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    \7\ The Fund expects to file a registration statement on Form S-
1 under the Securities Act of 1933 in the very near future. The Fund
will not be listed on the Exchange until such time as there is an
effective registration statement for the Fund.
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    If the Sponsor to the Trust issuing the Trust Issued Receipts is
affiliated with a broker-dealer, such Sponsor to the Trust shall erect
and maintain a ``fire wall'' between the Sponsor and the broker-dealer
with respect to access to information concerning the composition and/or
changes to the Fund's portfolio. The Sponsor is not a broker-dealer or
affiliated with a broker-dealer. In the event that (a) the Sponsor
becomes a broker-dealer or newly affiliated with a broker-dealer, or
(b) any new sponsor is a broker-dealer or becomes affiliated with a
broker-dealer, it will implement and maintain a fire wall with respect
to its relevant personnel or such broker-dealer affiliate, as
applicable, regarding access to information concerning the composition
and/or changes to the portfolio, and will be subject to procedures
designed to prevent the use and dissemination of material non-public
information regarding the portfolio.
    The VIX Swap Agreements in which the Fund may invest may be cleared
or non-cleared. The Fund will collateralize its obligations with Cash
and Cash Equivalents \8\ consistent with the 1940 Act and
interpretations thereunder.
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    \8\ For purposes of this proposal, the term ``Cash and Cash
Equivalents'' shall have the definition provided in Exchange Rule
14.11(i)(4)(C)(iii), applicable to Managed Fund Shares.
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    The Fund will only enter into VIX Swap Agreements with
counterparties that the Sponsor reasonably believes are capable of
performing under the contract and will post as collateral as required
by the counterparty. The Fund will seek, where possible, to use
counterparties, as applicable, whose financial status is such that the
risk of default is reduced; however, the risk of losses resulting from
default is still possible. The Sponsor will evaluate the
creditworthiness of counterparties on a regular basis. In addition to
information provided by credit agencies, the Sponsor will review
approved counterparties using various factors, which may include the
counterparty's reputation, the Sponsor's past experience with the
counterparty and the price/market actions of debt of the counterparty.
    The Fund may use various techniques to minimize OTC counterparty
credit risk including entering into arrangements with its
counterparties whereby both sides exchange collateral on a mark-to-
market basis. Collateral posted by the Fund to a counterparty in
connection with uncleared VIX Swap Agreements is generally held for the
benefit of the counterparty in a segregated tri-party account at the
custodian to protect the counterparty against non-payment by the Fund.
    In addition to VIX Swap Agreements, if the Fund is unable to meet
its investment objective through investments in VIX Futures Contracts,
the Fund may also obtain exposure to the Index through listed VIX
options contracts traded on the Cboe Exchange, Inc. (``Cboe'')
(hereinafter referred to as ``VIX Options Contracts'').
    The Fund may also invest in Cash and Cash Equivalents that may
serve as collateral in the above referenced VIX Futures Contracts, VIX
Swap Agreements, and VIX Option Contracts (collectively referred to as
the ``VIX Derivative Products'').
    If the Fund is successful in meeting its objective, its value
(before fees and expenses) on a given day should gain approximately
200% of the return of its benchmark index for a single day. Conversely,
its value (before fees and expenses) should lose approximately 200% of
the return of its benchmark index for a single day when it declines.
The Fund primarily acquires long exposure to the VIX through VIX
Futures Contracts, such that the Fund has exposure intended to
approximate 200% of the return of the Index at the time of the net
asset value (``NAV'') calculation of the Fund. However, as discussed
above, in the event that the Fund is unable to meet its investment
objective solely through the investment of VIX Futures Contracts, it
may invest in VIX Swap Agreements or VIX Options Contracts. The Fund
may also invest in Cash or Cash Equivalents that may serve as
collateral to the Fund's investments in VIX Derivative Products.
    The Fund is not actively managed by traditional methods, which
typically involve effecting changes in the composition of a portfolio
on the basis of judgments relating to economic, financial and market
considerations

with a view toward obtaining positive results under all market
conditions. Rather, the Fund will seek to remain fully invested at all
times in VIX Derivative Products (and Cash and Cash Equivalents as
collateral) \9\ that provide exposure to the Index consistent with its
investment objective without regard to market conditions, trends or
direction.
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    \9\ Supra note 8.
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    In seeking to achieve the Fund's investment objective, the Sponsor
uses a mathematical approach to investing. Using this approach, the
Sponsor determines the type, quantity and mix of investment positions
that the Sponsor believes in combination should produce daily returns
consistent with the Fund's objective. The Sponsor relies upon a pre-
determined model to generate orders that result in repositioning the
Fund's investments in accordance with its investment objective.

VIX Futures Contracts

    The Index is comprised of, and the value of the Fund will be based
on, VIX Futures Contracts. VIX Futures Contracts are measures of the
market's expectation of the level of VIX at certain points in the
future, and as such will behave differently than current, or spot, VIX,
as illustrated below.
    While the VIX represents a measure of the current expected
volatility of the S&P 500 over the next 30 days, the prices of VIX
Futures Contracts are based on the current expectation of what the
expected 30-day volatility will be at a particular time in the future
(on the expiration date). For example, a VIX Futures Contract purchased
in March that expires in May, in effect, is a forward contract on what
the level of the VIX, as a measure of 30-day implied volatility of the
S&P 500, will be on the May expiration date. The forward volatility
reading of the VIX may not correlate directly to the current volatility
reading of the VIX because the implied volatility of the S&P 500 at a
future expiration date may be different from the current implied
volatility of the S&P 500. As a result, the Index and the Fund should
be expected to perform very differently from the VIX or 200% of the VIX
Index over all periods of time. To illustrate, on December 4, 2019, the
VIX closed at a price of 14.8 and the price of the February 2020 VIX
Futures Contracts expiring on February 19, 2020 was 18.125. In this
example, the price of the VIX represented the 30-day implied, or
``spot,'' volatility (the volatility expected for the period from
December 5, 2019 to January 5, 2020) of the S&P 500 and the February
VIX Futures Contracts represented forward implied volatility (the
volatility expected for the period from February 19 to March 19, 2020)
of the S&P 500.
Long VIX Futures Index
    The Index is designed to express the daily performance of a
theoretical portfolio of first- and second-month VIX Futures Contracts
(the ``Index Components''), with the price of each VIX Futures Contract
reflecting the market's expectation of future volatility. The Index
seeks to reflect the returns that are potentially available from
holding an unleveraged long position in first- and second- month VIX
Futures Contracts. While the Index does not correspond to the VIX, the
value of the Index, and by extension the Fund, will generally rise as
the VIX rises and fall as the VIX falls. Further, as described above,
because VIX Futures Contracts correlate to future volatility readings
of VIX, while the VIX itself correlates to current volatility, the
Index and the Fund should be expected to perform significantly
different from the VIX.
    Unlike the Index, the VIX, which is not a benchmark for the Fund,
is calculated based on the prices of put and call options on the S&P
500, which are traded exclusively on Cboe.
Calculation of the Index
    The Index employs rules for selecting the Index Components and a
formula to calculate a level for the Index from the prices of these
components. Specifically, the Index Components represent the prices of
the two near-term VIX Futures Contracts, replicating a position that
rolls the nearest month VIX Futures Contract to the next month VIX
Futures Contract on a daily basis in equal fractional amounts. This
results in a constant weighted average maturity of approximately one
month. The roll period usually begins on the Wednesday falling 30
calendar days before the S&P 500 option expiration for the following
month (the ``Cboe VIX Monthly Futures Settlement Date''), and runs to
the Tuesday prior to the subsequent month's Cboe VIX Monthly Futures
Settlement Date.
    The level of the Index will be published at least every 15 seconds
both in real time from 9:30 a.m. to 4:00 p.m. ET and at the close of
trading on each Business Day \10\ by Bloomberg and Reuters.
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    \10\ A ``Business Day'' means any day other than a day when any
of BZX, Cboe, CFE or other exchange material to the valuation or
operation of the Fund, or the calculation of the VIX, options
contracts underlying the VIX, VIX Futures Contracts or the Index is
closed for regular trading.
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Purchases and Redemptions of Creation Units
    The Fund will create and redeem Shares from time to time only in
large blocks of a specified number of Shares or multiples thereof
(``Creation Units''). A Creation Unit is a block of at least 10,000
Shares. Except when aggregated in Creation Units, the Shares are not
redeemable securities.
    On any Business Day, an authorized participant may place an order
with the Sub-Administrator to create one or more Creation Units.\11\
The total cash payment required to create each Creation Unit is the NAV
of at least 10,000 Shares of the Fund on the purchase order date plus
the applicable transaction fee.
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    \11\ Authorized participants have a cut-off time of 2:00 p.m. ET
to place creation and redemption orders.
---------------------------------------------------------------------------

    The procedures by which an authorized participant can redeem one or
more Creation Units mirror the procedures for the purchase of Creation
Units. On any Business Day, an authorized participant may place an
order with the Sub-Administrator to redeem one or more Creation Units.
The redemption proceeds from the Fund consist of the cash redemption
amount. The cash redemption amount is equal to the NAV of the number of
Creation Unit(s) of the Fund requested in the authorized participant's
redemption order as of the time of the calculation of a Fund's NAV on
the redemption order date, less transaction fees.
Availability of Information Regarding the Shares
    The NAV for the Fund's Shares will be calculated by the Sub-
Administrator once each Business Day and will be disseminated daily to
all market participants at the same time.\12\ Pricing information for
the Shares will be available on the Fund's website at
www.volatilityshares.com, including: (1) The prior Business Day's
reported NAV, the closing market price or the bid/ask price, daily
trading volume, and a calculation of the premium and discount of the
closing market price or bid/ask price against the NAV; and (2) data in
chart format displaying the frequency distribution of discounts and
premiums of the daily closing price against the NAV, within appropriate
ranges, for each of the four previous calendar quarters.
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    \12\ NAV means the total assets of the Fund including, but not
limited to, all Cash and Cash Equivalents or other debt securities
less total liabilities of the Fund, consistently applied under the
accrual method of accounting. The Fund's NAV is calculated at 4:00
p.m. ET.

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    The closing prices and settlement prices of the Index Components
(i.e., the first- and second-month VIX Futures Contracts) will also be
readily available from the websites of CFE (http://www.cfe.cboe.com),
automated quotation systems, published or other public sources, or on-
line information services such as Bloomberg or Reuters. Complete real-
time data for component VIX Futures Contracts underlying the Index is
available by subscription from Reuters and Bloomberg. Specifically, the
level of the Index will be published at least every 15 seconds both in
real time from 9:30 a.m. to 4:00 p.m. ET and at the close of trading on
each Business Day by Bloomberg and Reuters.
    The CFE also provides delayed futures information on current and
past trading sessions and market news free of charge on its website.
The specific contract specifications of Index Components (i.e., first-
month and second-month VIX Futures Contracts) underlying the Index are
also available on Bloomberg and Reuters.
    Quotation and last-sale information regarding the Shares will be
disseminated through the facilities of the Consolidated Tape
Association (``CTA''). Quotation and last-sale information regarding
VIX Futures Contracts and VIX Options Contracts will be available from
the exchanges on which such instruments are traded. Quotation and last-
sale information relating to VIX Options Contracts will also be
available via the Options Price Reporting Authority. Quotation and
last-sale information for VIX Swap Agreements will be available from
nationally recognized data services providers, such as Reuters and
Bloomberg, through subscription agreements or from a broker-dealer who
makes markets in such instruments. Quotation and last-sale information
for VIX Swap Agreements will be valued on the basis of quotations or
equivalent indication of value supplied by a third- party pricing
service or broker-dealer who makes markets in such instruments. Pricing
information regarding Cash Equivalents in which the Fund will invest is
generally available through nationally recognized data services
providers, such as Reuters and Bloomberg, through subscription
agreements.
    In addition, the Fund's website at www.volatilityshares.com will
display the end of day closing Index level, and NAV per Share for the
Fund. The Fund will provide website disclosure of portfolio holdings
daily and will include, as applicable, the notional value (in U.S.
dollars) of VIX Derivative Products, and characteristics of such
instruments, as well as Cash and Cash Equivalents held in the portfolio
of the Fund. This website disclosure of the portfolio composition of
the Fund will occur at the same time as the disclosure by the Fund of
the portfolio composition to authorized participants so that all market
participants are provided portfolio composition information at the same
time. The same portfolio information will be provided on the public
website as well as in electronic files provided to authorized
participants.
    In addition, in order to provide updated information relating to
the Fund for use by investors and market professionals, an updated
Intraday Indicative Value (``IIV'') will be calculated. The IIV is an
indicator of the value of the Fund's holdings, which include the VIX
Derivative Products and Cash and Cash Equivalents less liabilities of
the Fund at the time the IIV is disseminated. The IIV will be
calculated and widely disseminated by one or more major market data
vendors every 15 seconds throughout Regular Trading Hours.\13\
---------------------------------------------------------------------------

    \13\ As defined in Rule 1.5(w), the term ``Regular Trading
Hours'' means the time between 9:30 a.m. and 4:00 p.m. ET.
---------------------------------------------------------------------------

    In addition, the IIV will be published on the Exchange's website
and will be available through on-line information services such as
Bloomberg and Reuters.
    The IIV disseminated during Regular Trading Hours should not be
viewed as an actual real time update of the NAV, which is calculated
only once a day. The IIV also should not be viewed as a precise value
of the Shares.
    Additional information regarding the Fund and the Shares, including
investment strategies, risks, creation and redemption procedures, fees,
portfolio holdings, disclosure policies, distributions and taxes will
be included in the registration statement.
Initial and Continued Listing
    The Shares of the Fund will conform to the initial and continued
listing criteria under BZX Rule 14.11(f)(4). The Exchange represents
that, for initial and continued listing, the Fund and the Trust must be
in compliance with Rule 10A-3 under the Act. A minimum of 100,000
Shares of the Fund will be outstanding at the commencement of trading
on the Exchange. The Exchange will obtain a representation from the
Sponsor of the Shares that the NAV per Share for the Fund will be
calculated daily and will be made available to all market participants
at the same time.
Trading Halts
    With respect to trading halts, the Exchange may consider all
relevant factors in exercising its discretion to halt or suspend
trading in the Shares of the Fund. The Exchange will halt trading in
the Shares under the conditions specified in BZX Rule 11.18. Trading
may be halted because of market conditions or for reasons that, in the
view of the Exchange, make trading in the Shares inadvisable. These may
include: (1) The extent to which trading is not occurring in the
securities and/or the financial instruments composing the daily
disclosed portfolio of the Fund; or (2) whether other unusual
conditions or circumstances detrimental to the maintenance of a fair
and orderly market are present.
Trading Rules
    The Exchange deems the Shares to be equity securities, thus
rendering trading in the Shares subject to the Exchange's existing
rules governing the trading of equity securities. The Exchange will
allow trading in the Shares from 8:00 a.m. until 8:00 p.m. ET and has
the appropriate rules to facilitate transactions in the Shares during
all trading sessions. As provided in BZX Rule 11.11(a), the minimum
price variation for quoting and entry of orders in securities traded on
the Exchange is $0.01, with the exception of securities that are priced
less than $1.00, for which the minimum price variation for order entry
is $0.0001.
Surveillance
    Trading of the Shares through the Exchange will be subject to the
Exchange's surveillance procedures for derivative products, including
Trust Issued Receipts. All of the VIX Futures Contracts and VIX Options
Contracts held by the Fund will trade on markets that are a member of
ISG or affiliated with a member of ISG or with which the Exchange has
in place a comprehensive surveillance sharing agreement.\14\ The
Exchange, FINRA, on behalf of the Exchange, or both will communicate
regarding trading in the Shares and the underlying listed instruments,
including listed derivatives held by the Fund, with the ISG, other
markets or entities who are members or affiliates of the ISG, or with
which the Exchange has entered into a comprehensive surveillance
sharing agreement. In addition, the

Exchange, FINRA, on behalf of the Exchange, or both may obtain
information regarding trading in the Shares and the underlying listed
instruments, including listed derivatives, held by the Fund from
markets and other entities that are members of ISG or with which the
Exchange has in place a comprehensive surveillance sharing agreement.
The Exchange also has a general policy prohibiting the distribution of
material, non-public information by its employees. All statements and
representations made in this filing regarding the Index composition,
description of the portfolio or reference assets, limitations on
portfolio holdings or reference assets, dissemination and availability
of reference the Index, reference asset, and IIV, and the applicability
of Exchange rules specified in this filing shall constitute continued
listing requirements for the Fund. The issuer has represented to the
Exchange that it will advise the Exchange of any failure by the Fund or
the Shares to comply with the continued listing requirements, and,
pursuant to its obligations under Section 19(g)(1) of the Act, the
Exchange will surveil for compliance with the continued listing
requirements. If the Fund or the Shares are not in compliance with the
applicable listing requirements, the Exchange will commence delisting
procedures under Exchange Rule 14.12.
---------------------------------------------------------------------------

    \14\ For a list of the current members and affiliate members of
ISG, see www.isgportal.com. The Exchange notes that not all
components of the Fund's holdings may trade on markets that are
members of ISG or with which the Exchange has in place a
comprehensive surveillance sharing agreement.
---------------------------------------------------------------------------

Information Circular
    Prior to the commencement of trading, the Exchange will inform its
members in an Information Circular of the special characteristics and
risks associated with trading the Shares. Specifically, the Information
Circular will discuss the following: (1) the procedures for purchases
and redemptions of Shares in Creation Units (and that Shares are not
individually redeemable); (2) BZX Rule 3.7, which imposes suitability
obligations on Exchange members with respect to recommending
transactions in the Shares to customers; (3) Interpretation and Policy
.01 of BZX Rule 3.7 which imposes a duty of due diligence on its
Members to learn the essential facts relating to every customer prior
to trading the shares; \15\ (4) how information regarding the IIV and
the Fund's holdings is disseminated; (5) the risks involved in trading
the Shares during the Pre-Opening \16\ and After Hours Trading Sessions
\17\ when an updated IIV will not be calculated or publicly
disseminated; (6) the requirement that members deliver a prospectus to
investors purchasing newly issued Shares prior to or concurrently with
the confirmation of a transaction; and (7) trading information.
---------------------------------------------------------------------------

    \15\ Specifically, in part, Interpretation and Policy .01 of
Rule 3.7 states ``[n]o Member shall recommend to a customer a
transaction in any such product unless the Member has a reasonable
basis for believing at the time of making the recommendation that
the customer has such knowledge and experience in financial matters
that he may reasonably be expected to be capable of evaluating the
risks of the recommended transaction and is financially able to bear
the risks of the recommended position.
    \16\ The Pre-Opening Session is from 8:00 a.m. to 9:30 a.m. ET.
    \17\ The After Hours Trading Session is from 4:00 p.m. to 8:00
p.m. ET.
---------------------------------------------------------------------------

    Further, the Exchange states that FINRA has implemented increased
sales practice and customer margin requirements for FINRA members
applicable to inverse, leveraged and inversed leveraged securities
(which include the Shares) and options on such securities, as described
in FINRA Regulatory Notices 09-31 (June 2009), 09-53 (August 2009), and
09-65 (November 2009) (collectively, ``FINRA Regulatory Notices'').
Members that carry customer accounts will be required to follow the
FINRA guidance set forth in these notices. As noted above, the Fund
will seek to provide a return that is 200% of the return of its
benchmark index for a single day. The Fund does not seek to achieve its
primary investment objective over a period of time greater than a
single day. The return of the Fund for a period longer than a single
day is the result of its return for each day compounded over the period
and usually will differ in amount and possibly even direction from the
Fund's multiple times the return of the Fund's Benchmark for the same
period. These differences can be significant.
    In addition, the Information Circular will advise members, prior to
the commencement of trading, of the prospectus delivery requirements
applicable to the Fund. Members purchasing Shares from the Fund for
resale to investors will deliver a prospectus to such investors. The
Information Circular will also discuss any exemptive, no-action and
interpretive relief granted by the Commission from any rules under the
Act.
    In addition, the Information Circular will reference that the Fund
is subject to various fees and expenses described in the Fund's
registration statement. The Information Circular will also disclose the
trading hours of the Shares of the Fund and the applicable NAV
calculation time for the Shares. The Information Circular will disclose
that information about the Shares of the Fund will be publicly
available on the Fund's website.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with Section
6(b) of the Act \18\ in general and Section 6(b)(5) of the Act \19\ in
particular in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78f.
    \19\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change is designed to
prevent fraudulent and manipulative acts and practices in that the
Shares will be listed and traded on the Exchange pursuant to the
initial and continued listing criteria in Exchange Rule 14.11(f). The
Exchange believes that its surveillance procedures are adequate to
properly monitor the trading of the Shares on the Exchange during all
trading sessions and to deter and detect violations of Exchange rules
and the applicable federal securities laws. If the Sponsor to the Trust
issuing the Trust Issued Receipts is affiliated with a broker-dealer,
such Sponsor to the Trust shall erect and maintain a ``fire wall''
between the Sponsor and the broker-dealer with respect to access to
information concerning the composition and/or changes to the Fund's
portfolio. The Sponsor is not a broker-dealer or affiliated with a
broker-dealer. In the event that (a) the Sponsor becomes a broker-
dealer or newly affiliated with a broker-dealer, or (b) any new sponsor
is a broker-dealer or becomes affiliated with a broker-dealer, it will
implement and maintain a fire wall with respect to its relevant
personnel or such broker-dealer affiliate, as applicable, regarding
access to information concerning the composition and/or changes to the
portfolio, and will be subject to procedures designed to prevent the
use and dissemination of material non-public information regarding the
portfolio. The Exchange, FINRA, on behalf of the Exchange, or both may
obtain information regarding trading in the Shares and the underlying
VIX Futures Contracts and VIX Options Contracts via the ISG from other
exchanges who are members or affiliates of the ISG or with which the
Exchange

has entered into a comprehensive surveillance sharing agreement. In
addition, the Exchange also has a general policy prohibiting the
distribution of material, non-public information by its employees.
    The proposed rule change is designed to promote just and equitable
principles of trade and to protect investors and the public interest in
that the Exchange will obtain a representation from the issuer of the
Shares that the NAV will be calculated daily and that the NAV and the
Fund's holdings will be made available to all market participants at
the same time. In addition, a large amount of information is publicly
available regarding the Fund and the Shares, thereby promoting market
transparency. Moreover, the IIV will be disseminated by one or more
major market data vendors at least every 15 seconds during Regular
Trading Hours. On each Business Day, before commencement of trading in
Shares during Regular Trading Hours, the Fund will disclose on its
website the holdings that will form the basis for the Fund's
calculation of NAV at the end of the Business Day. Pricing information
will be available on the Fund's website including: (1) The prior
Business Day's reported NAV, the closing market price or the bid/ask
price, daily trading volume, and a calculation of the premium and
discount of the closing market price or bid/ask price against the NAV;
and (2) data in chart format displaying the frequency distribution of
discounts and premiums of the daily closing price against the NAV,
within appropriate ranges, for each of the four previous calendar
quarters. Additionally, information regarding market price and trading
of the Shares will be continually available on a real-time basis
throughout the day on brokers' computer screens and other electronic
services, and quotation and last sale information for the Shares will
be available on the facilities of the CTA. The website for the Fund
will include a form of the prospectus for the Fund and additional data
relating to NAV and other applicable quantitative information. Trading
in Shares of the Fund will be halted under the conditions specified in
Exchange Rule 11.18. Trading may also be halted because of market
conditions or for reasons that, in the view of the Exchange, make
trading in the Shares inadvisable. Finally, trading in the Shares will
be subject to 14.11(f)(4)(C)(ii), which sets forth circumstances under
which Shares of the Fund may be halted. In addition, as noted above,
investors will have ready access to information regarding the Fund's
holdings, the IIV, and quotation and last sale information for the
Shares.
    Quotation and last-sale information regarding the Shares will be
disseminated through the facilities of the CTA. Quotation and last-sale
information regarding VIX Futures Contracts and VIX Options Contracts
will be available from the exchanges on which such instruments are
traded. Quotation and last-sale information relating to VIX Options
Contracts will also be available via the Options Price Reporting
Authority. Quotation and last-sale information for VIX Swap Agreements
will be available from nationally recognized data services providers,
such as Reuters and Bloomberg, through subscription agreements or from
a broker-dealer who makes markets in such instruments. Quotation and
last-sale information for VIX Swap Agreements will be valued on the
basis of quotations or equivalent indication of value supplied by a
third- party pricing service or broker-dealer who makes markets in such
instruments. Pricing information regarding Cash Equivalents in which
the Fund will invest is generally available through nationally
recognized data services providers, such as Reuters and Bloomberg,
through subscription agreements.
    The proposed rule change is designed to perfect the mechanism of a
free and open market and, in general, to protect investors and the
public interest in that it will facilitate the listing and trading of
an additional type of exchange-traded product that will enhance
competition among market participants, to the benefit of investors and
the marketplace. As noted above, the Exchange has in place surveillance
procedures relating to trading in the Shares and may obtain information
via ISG from other exchanges that are members of ISG or with which the
Exchange has entered into a comprehensive surveillance sharing
agreement. In addition, as noted above, investors will have ready
access to information regarding the Fund's holdings, the IIV, and
quotation and last sale information for the Shares.
    For the above reasons, the Exchange believes that the proposed rule
change is consistent with the requirements of Section 6(b)(5) of the
Act.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purpose of the Act. The Exchange notes that the
proposed rule change, rather will facilitate the listing of an
additional exchange-traded product on the Exchange, which will enhance
competition among listing venues, to the benefit of issuers, investors,
and the marketplace more broadly.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    A. By order approve or disapprove such proposed rule change, or
    B. institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as modified by Amendment No. 1, is consistent with the Act.
Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CboeBZX-2020-053 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 Number SR-CboeBZX-2020-053. 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 website (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 website 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. Persons submitting comments are cautioned that we do
not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
CboeBZX-2020-053 and should be submitted on or before July 31, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-14868 Filed 7-9-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 46 (Friday, March 8, 2013)]
[Notices]
[Pages 15026-15030]
[FR Doc No: 2013-05391]

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

Federal Emergency Management Agency

[Docket ID FEMA-2013-0006]

Solicitation for Comments Regarding Current Procedures To Request
Emergency and Major Disaster Declarations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: On Tuesday, January 29, 2013, President Obama signed the Sandy
Recovery Improvement Act of 2013, which includes a provision amending
the Robert T. Stafford Disaster Relief and Emergency Assistance Act to
provide federally recognized Indian tribal governments the option to
make a request directly to the President for a Federal emergency or
major disaster declaration, or to seek assistance, as they do
presently, under a declaration for a State. In support of preliminary
implementation of this provision, the Federal Emergency Management
Agency (FEMA) is engaging in a comprehensive consultation effort with
federally recognized Indian tribal governments. To initiate that
consultation, FEMA is soliciting comments regarding FEMA procedures for
declaration requests from Indian tribal governments.

DATES: Comments must be received by April 22, 2013.

ADDRESSES: Comments must be identified by docket ID FEMA-2013-0006 and
may be submitted by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments.
    Mail: Regulatory Affairs Division, Office of Chief Counsel, Federal
Emergency Management Agency, Room 835, 500 C Street SW., Washington, DC
20472-3100.

FOR FURTHER INFORMATION CONTACT: Jessica Stewart, Federal Emergency
Management Agency, 500 C Street SW., Washington, DC 20472, 202-646-
3888.

SUPPLEMENTARY INFORMATION

I. Public Participation

    Instructions: All submissions received must include the agency name
and docket ID. Regardless of the method used for submitting comments or
material, all submissions will be posted, without change, to the
Federal eRulemaking Portal at http://www.regulations.gov, and will
include any personal information you provide. Therefore, submitting
this information makes it public. You may wish to read the Privacy Act
notice, which can be viewed by clicking on the ``Privacy Notice'' link
in the footer of http://www.regulations.gov.
    You may submit your comments and material by the methods specified
in the ADDRESSES section of this notice. Please submit your comments
and any supporting material by only one means to avoid the receipt and
review of duplicate submissions.
    Docket: A copy of this notice is available in docket ID FEMA-2013-
0006. For access to the docket to read background documents or comments
received, go to the Federal eRulemaking Portal at http://www.regulations.gov, click on ``Advanced Search,'' then enter ``FEMA-
2013-0006'' in the ``By Docket ID'' box, then select ``FEMA'' under
``By Agency,'' and then click ``Search.'' Submitted comments may also
be inspected at FEMA, Office of Chief Counsel, Regulatory Affairs
Division, 500 C Street SW., Washington, DC 20472-3100.

II. Background

    The Robert T. Stafford Disaster Relief and Emergency Assistance Act
(Stafford Act) authorizes the President to make certain Federal
assistance available to support State, tribal, and local efforts to
respond to and recover from a disaster. The President makes disaster
assistance available after he declares that an emergency or major
disaster has occurred and that Federal assistance is needed to
supplement State and local government resources. In the past, the
Stafford Act allowed only the Governor of a State to make a request for
a declaration by the President for an emergency or major disaster.
    On Tuesday, January 29, 2013, President Obama signed the Sandy
Recovery Improvement Act of 2013, that included a provision amending
the Stafford Act to provide Federally recognized Indian tribal
governments the option to choose whether to make a request directly to
the President for a Federal emergency or major disaster declaration, or
to seek assistance, as they do presently, under a declaration for a
State.
    Specifically, the amendment permits the ``Chief Executive'' of an
``affected Indian tribal government'' to submit a request for a
declaration to the President that a major disaster or emergency exists
consistent with the requirements listed in Stafford Act section 401
(major disasters) and 501 (emergencies). The amendment also stipulates
that an Indian tribal government may be eligible to receive assistance
through a declaration made by the President at the request of a State,
so long as the Indian tribal government does not receive a separate
declaration from the President for the same incident.
    FEMA plans to establish a pilot program for managing requests from
Indian tribal governments; during development of this pilot program,
FEMA will engage in a comprehensive consultation effort with Indian
tribal governments.

III. Current Requirements and Processes for State Declaration Requests

    Below you will find an explanation of the current regulatory
requirements (located in Title 44 of the Code of Federal Regulations)
for a Governor's request for an emergency or major disaster declaration
and the factors FEMA uses to make a recommendation to the President
about whether supplemental Federal assistance is needed. These
regulations are currently framed with respect to States.
    As an initial step in consultation with Indian tribal governments
and outreach to other stakeholders, FEMA asks Indian tribal governments
for their thoughts and comments on how these requirements and factors
may or may not be appropriate as applied to requests from Indian tribal
governments during the pilot program. The input provided will inform
the development of the pilot program to process declaration requests
from Indian tribal governments. FEMA welcomes comments on any or all of
the topics addressed in this Notice. Comments are also welcomed on any
other issues that may not be covered in the below topics.

Types of Declarations and Assistance

    Stafford Act assistance is intended to supplement State and local
resources. States must establish in their requests that the event is of
such severity and magnitude that effective response is beyond the
capabilities of the State and the affected local governments. (42
U.S.C. 5121(2))
    Emergency Declarations: Emergency Declarations are to supplement
efforts in providing short-term emergency services, such as the
protection of lives,

property, public health, and safety, or to lessen or avert the threat
of a catastrophe. (42 U.S.C. 5191)
    Major Disaster Declaration: A major disaster declaration may
provide a wide range of Federal assistance programs for individuals and
public infrastructure, including funds for both emergency and permanent
work. (42 U.S.C. 5170)
    Types of FEMA disaster assistance that may be made available by
major disaster declarations:
     Individual Assistance--Assistance to individuals and
households. (More information can be found at: https://www.fema.gov/individual-assistance-program-tools) (42 U.S.C. 5174);
     Public Assistance--Assistance to State, Indian tribal and
local governments and certain private nonprofit organizations for
emergency work and the repair or replacement of disaster-damaged
facilities. (More information can be found at: https://www.fema.gov/public-assistance-local-state-tribal-and-non-profit) (42 U.S.C. 5170b
and 5172); and
     Hazard Mitigation Assistance--Assistance to State and
local governments and certain private nonprofit organizations for
actions taken to prevent or reduce long term risk to life and property
from natural hazards. (More information can be found at https://www.fema.gov/hazard-mitigation-assistance) (42 U.S.C. 5170c).

Preliminary Damage Assessments

    In support of requests for a major disaster declaration,
Preliminary Damage Assessments (PDAs) are conducted to estimate the
extent of the disaster and its impact on individuals and public
facilities. A PDA is not required for an emergency declaration request.
The PDA team may be comprised of personnel from FEMA, the State's
emergency management agency, Territorial, Indian tribal and affected
local government officials and other Federal agencies (e.g., the U.S.
Small Business Administration). The team's work begins with assessing
the emergency costs incurred by the units of government, the uninsured
damage to public facilities, and the impacts on individuals' lives,
homes and businesses. This information is included in the Governor's
request to the President.

Requirements for Submitting Declaration Requests

    Governors submit declaration requests to the President through the
appropriate FEMA Regional Administrator. The Stafford Act requires a
Governor of an affected State to base his/her declaration request on
the finding that the disaster is of such severity and magnitude that
effective response is beyond the capabilities of the State and the
affected local governments and that Federal assistance is necessary.
The Governor must also take appropriate response action under State
law, direct execution of the State's emergency plan, have or will
commit resources to alleviate the results for the disaster, and certify
that the State will comply with all cost sharing requirements.
    In order for FEMA to make Public Assistance, Individual Assistance,
and Hazard Mitigation available to eligible areas, Governors must have
the following agreements and/or plans:

--In order to receive Public Assistance, Governors must have an
approved Administrative Plan. (44 CFR 206.207).
--In order to receive Public Assistance Categories C-G and Hazard
Mitigation Grant Program assistance, States must have an approved or
approvable State mitigation plan. (44 CFR 201.4(a)).
--In order to receive Other Needs Assistance under the Individual and
Household Program, Governors must choose an administrator to provide
the assistance and, depending on the choice, have an approved Other
Needs Assistance Administrative Plan. (44 CFR 206.120).
     [cir] Within 72 hours of a disaster declaration, a State may
submit modifications of the Administrative Plan. (44 CFR 206.120(e)).

--States and local governments must comply with the ``Uniform
Requirements for Grants and Cooperative Agreements to State and Local
Governments.'' (44 CFR Part 13).

    FEMA is soliciting comments on whether there are circumstances that
may prevent a Chief Executive of an Indian tribal government from
complying with these current requirements and processes for declaration
requests during the pilot program.

IV. Other Needs Assistance Administrative Plan Requirement for
Individuals and Households Program

    The Federal Assistance to Individuals and Households Program (IHP)
(44 CFR 206.110-206.120) provides financial assistance, such as funding
to repair damaged homes or replacement of household items, and if
necessary, direct assistance to eligible individuals and households.
IHP is intended to help disaster-impacted individuals and households
who have uninsured or under-insured housing and other needs and are
unable to meet such expenses or needs through other means.
    Housing Assistance under IHP is administered directly by FEMA.
However, the delivery of Other Needs Assistance (ONA) under IHP is
contingent upon the State choosing an ONA Administrative Option. The
State may either request FEMA to administer ONA or they may request a
grant so they can administer ONA. Currently, most States opt to have
FEMA administer ONA instead of choosing to administer it themselves. In
order for eligible disaster survivors to receive assistance for
clothing, personal property, transportation and other non-housing
related needs, States must select an option for administering ONA.
    FEMA is soliciting comments on whether there are circumstances that
may prevent a Chief Executive of an Indian tribal government from
selecting an ONA Administrative Option during the pilot program. In
addition, FEMA welcomes comments on the ability of an Indian tribal
government to administer ONA on its own.

V. Mitigation Plan Requirement

    The Stafford Act requires Indian tribal governments to have a FEMA-
approved mitigation plan as a condition of receipt of hazard mitigation
assistance (42 U.S.C. 5165). Assistance programs impacted include
Public Assistance Categories C-G and the Hazard Mitigation Grant
Program. The State or Tribal Mitigation Plan outlines processes for
identifying the natural hazards, risks, and vulnerabilities of the
area, as well as actions to reduce losses from future disasters (44 CFR
201.7).
    For States that do not have a FEMA-approved State Mitigation Plan,
FEMA allows 30 days from the date of the declaration for the State to
submit to FEMA an approved or approvable State Mitigation Plan.
    FEMA welcomes comments on whether 30 days is an appropriate amount
of time for Indian tribal governments to submit an approved or
approvable Tribal Mitigation Plan during the pilot program. FEMA also
welcomes comments on whether there are circumstances that may prevent
an Indian tribal government from submitting a Tribal Mitigation Plan,
or a request for an extension within this time.

VI. Timelines To Submit Declaration Requests

    FEMA's regulations require a Governor to submit a request for an
emergency or major disaster declaration within 30 days of the date of
the incident. FEMA's regulations allow

Governors to request additional time to submit emergency and major
disaster declaration requests. The extension request must be submitted
within 30 days after the incident and must include a reason for the
additional time needed.
    FEMA is soliciting comments to determine whether 30 days is an
appropriate amount of time for the Chief Executive of an Indian tribal
government to submit a request or ask for an extension during the pilot
program. FEMA welcomes comments on whether there are circumstances that
may prevent the Chief Executive of an Indian tribal government from
submitting such a request, or a request for an extension within this
time.

VII. Public Assistance

    The Stafford Act recognizes that primary responsibility for
emergency management is at the local level; thus, Stafford Act
assistance is intended to be available only as a supplement to other
governmental and non-governmental resources. The Act instructs
Governors to base their declaration requests on the finding that the
disaster is of such severity and magnitude that effective response is
beyond the capabilities of the State and the affected local governments
and that Federal assistance is necessary. The Stafford Act is not
intended to provide assistance for every event that impacts a State or
county, so FEMA established evaluation factors based on this principle.
    When Governors request that the President declare a major disaster
which authorizes Public Assistance, FEMA uses the following criteria to
make a recommendation to the President whether assistance is warranted.
     Estimated cost of the assistance.
     Localized impacts.
     Insurance coverage in force.
     Hazard Mitigation.
     Recent multiple disasters.
     Programs of other Federal assistance.

Estimated Cost of the Assistance

    For State requests, FEMA evaluates the estimated cost of Federal
and non-Federal public assistance against the statewide population, to
give some measure of the per capita impact within the State. This
provides a sense of proportional impact of on the population of the
State. We use a figure of $1.37 per capita (FY13) as an indicator that
the disaster is of such size that might warrant Federal assistance
(adjusted annually based on the Consumer Price Index).
    FEMA is soliciting comments on whether the estimated cost of
assistance is an appropriate factor to evaluate Indian tribal
government requests for Public Assistance during the pilot program.
FEMA welcomes comments on whether requests should be evaluated based on
per capita, and if not, how Indian tribal government population size
should be considered. FEMA also welcomes comments on what
considerations FEMA should evaluate in determining the appropriate
damage indicators for Indian tribal government requests.
    FEMA has also established a minimum of $1 million in public
assistance estimated damages per disaster, based on the belief that we
can reasonably expect even the least populated States to cover this
level of public assistance damage.
    FEMA is soliciting comments on whether an Indian tribal government
can reasonably be expected to cover that level of public assistance
damage during the pilot program. FEMA welcomes comments on whether
there should be a similar, if lower, minimum threshold applied to
Indian tribal government requests. FEMA also welcomes comments on
whether such a minimum damage amount should depend on the population of
the requesting Indian tribal government, and/or on other information.

Localized Impacts

    For State requests, FEMA evaluates the impact of the disaster at
the county and local government level, as well as the impact on
American Indian/Alaska Native (AI/AN) Indian tribal government levels.
This is because, at times, there are extraordinary concentrations of
damages that might warrant Federal assistance, even if the statewide
per capita is not met. This is particularly true in situations where
critical facilities are involved, or where localized per capita impacts
might be extremely high.

Insurance Coverage in Force

    For State requests, FEMA considers the amount of insurance coverage
that is in force, or should have been in force, as required by law and
regulation at the time of the disaster.

Hazard Mitigation

    For State requests, FEMA also considers the extent to which State
and local government measures contributed to the reduction of disaster
damages for the disaster under consideration.

Recent Multiple Disasters

    For State requests, FEMA evaluates the 12-month disaster history to
better understand the overall impact on the State or locality. FEMA
considers declarations under the Stafford Act, as well as declarations
made by the Governor, and the extent to which the State has spent its
own funds on those disasters.

Programs of Other Federal Assistance

    For State requests, FEMA also considers the programs of other
Federal agencies because at times, their programs of assistance might
more appropriately meet the needs created by the disaster.
    FEMA is soliciting comments on whether these factors (localized
impacts, insurance coverage in force, hazard mitigation, recent
multiple disasters, and programs of other Federal assistance) are
appropriate for the evaluation of Indian tribal government requests for
Public Assistance during the pilot program. FEMA also welcomes comments
on whether there are additional factors that may be appropriate for
FEMA to consider when evaluating the level of impact and tribal
capability to respond to and recover from an event for Public
Assistance requests from Indian tribal governments.

VIII. Individual Assistance

    When the Governor of a State requests that the President declare a
major disaster that authorizes Individual Assistance, FEMA uses the
following criteria to determine whether Federal assistance is needed.
     Concentration of damages.
     Trauma.
     Special populations.
     Voluntary agency assistance.
     Insurance.

Concentration of Damages

    For State requests, FEMA evaluates the concentrations of damages to
individuals. High concentrations of damages generally indicate a
greater need for Federal assistance than widespread and scattered
damages throughout a State.

Trauma

    FEMA considers the degree of trauma to a State and to communities.
Some of the conditions that might cause trauma are:
     Large numbers of injuries or deaths;
     Large scale disruption of normal community functions and
services; and
     Emergency needs such as extended or widespread loss of
power or water.

Special Populations

    FEMA considers whether special populations, such as low-income, the
elderly, or the unemployed are affected, and whether they may have a
greater need for assistance. FEMA also

considers the effect on American Indian and Alaskan Native tribal
populations in the event that there are any unique needs for people in
these governmental entities.

Voluntary Agency Assistance

    FEMA considers the extent to which voluntary agencies and State or
local programs meet the needs of the disaster survivors.

Insurance

    FEMA considers the amount of insurance coverage because, by law,
Federal disaster assistance cannot duplicate insurance coverage.
    FEMA is soliciting comments on whether these Individual Assistance
factors are appropriate for FEMA to consider when evaluating an Indian
tribal government request for Individual Assistance during the pilot
program. FEMA also welcomes comments on whether there are additional
factors that may be appropriate for FEMA to consider when evaluating
Indian tribal government requests for Individual Assistance.

IX. Designating Areas Eligible for Assistance, Definition of Tribal
Lands

    After the President declares that an emergency or major disaster
exists in a State, areas within the State are designated as eligible
for assistance. FEMA's regulatory definition of ``designated area''
eligible for assistance under each program (Public Assistance,
Individual Assistance, and the Hazard Mitigation Grant Program) is
``any emergency or major disaster-affected portion of a State which has
been determined eligible for Federal assistance.'' (44 CFR 206.2(a)(4))
In practice, FEMA typically identifies counties, parishes, independent
cities, and Indian tribal governments as ``designated areas'' eligible
for assistance.
    FEMA is soliciting comments on how FEMA should designate Tribal
areas eligible for assistance for any or each of the FEMA assistance
programs (Public Assistance, Individual Assistance, and the Hazard
Mitigation Grant Program) and what FEMA should use as the definition of
Tribal lands during the pilot program.

X. Appeals

    When a request for an emergency or major disaster declaration is
denied, the Governor may appeal the decision. The appeal must be
submitted within 30 days of the date of the letter denying the request.
The Governor can make only one appeal. The Governor should include in
the appeal additional information which supports his/her request for
supplemental Federal assistance.
    When certain areas that were requested by the Governor are not
designated, the Governor or Governor's Authorized Representative may
appeal the decision. The appeal must be submitted within 30 days of the
date of the letter denying the request. The Governor has only one
appeal. The Governor or the Governor's Authorized Representative should
include in the appeal additional information which supports his/her
request.
    When types of assistance that are requested by the Governor are not
authorized, the Governor may appeal the decision. The appeal must be
submitted within 30 days of the date of the letter denying the request.
The Governor has only one appeal. The Governor should include in the
appeal additional information which supports his/her request.
    FEMA is soliciting comments on whether this same appeal process
would be appropriate for Tribal requests during the pilot program.

XI. Cost Share Adjustments

    The Stafford Act directs FEMA to pay ``not less than'' 75-percent
of the eligible costs for essential assistance (Stafford Act Section
403, 42 U.S.C. 5170b), repair, restoration, and replacement of damaged
facilities (Stafford Act Section 406, 42 U.S.C. 5172), and debris
removal (Stafford Act Section 407, 42 U.S.C. 5173). FEMA's regulations
outline the criteria FEMA uses to recommend to the President an
adjustment to the Federal cost share.
    FEMA will recommend the President adjust the Federal cost share
from 75-percent to not more than 90 percent when actual Federal
obligations under the Stafford Act meet or exceed $133 (2013) per
capita of State population. When recommending a cost share adjustment
to the President, FEMA also considers the impact of major disaster
declarations in the State during the previous 12-months.
    If warranted by the needs of the disaster, FEMA may recommend up to
100 percent Federal funding for emergency work under section 403 of the
Stafford Act (essential assistance) and section 407 of the Stafford Act
(debris removal), including direct Federal assistance, for a limited
time in the initial days of the disaster irrespective of the per capita
impact.
    FEMA is soliciting comments on whether the per capita threshold
used for States would be appropriate for evaluating whether to
recommend a cost share adjustment for Tribal declarations during the
pilot program. FEMA also welcomes comments on what other factors may be
appropriate for FEMA to consider when evaluating potential cost share
adjustments for Tribal declarations.

XII. Notification of State and Tribes

    Once the President has made a declaration determination (e.g.,
emergency, major disaster, denial), the Regional Administrator will
notify the Governor as well as other Federal agencies and other
interested parties.
    FEMA is soliciting comments on how FEMA can ensure that all
interested parties, including the Governors of affected States, the
Chief Executive of affected Indian tribal governments, and other
Federal agencies are properly notified and informed regarding
declaration requests and determinations during the pilot program.

XIII. Disaster Unemployment Assistance

    Disaster Unemployment Assistance (DUA) (44 CFR 206.141 and 20 CFR
625) provides unemployment benefits and re-employment services to
individuals who have become unemployed as a result of a major disaster
and who are not eligible for regular State unemployment insurance (UI).
FEMA has delegated to the Secretary of Labor the responsibility of
administering the DUA program and payment of DUA benefit assistance.
    Under the current program regulations, applicants are required to
first apply and exhaust UI through the State workforce agency. Levels
of UI are based on State formulas, which may be different for each
State.
    FEMA is soliciting comments on an Indian tribal government's
ability to administer DUA and the use of State workforce agency to
apply for regular UI in the absence of a tribal equivalent of a
workforce agency during the pilot program.

XIV. Disaster Legal Services

    Disaster Legal Services (DLS) (44 CFR 206.164) provides legal
assistance to low-income individuals who, prior to or as a result of
the disaster, are unable to secure legal services adequate to meet
their disaster-related needs. These services are typically provided to
survivors through an agreement with the Young Lawyers Division of the
American Bar Association.
    FEMA is soliciting comments on the current access to legal services
during disasters, if Indian tribal governments have a relationship with
the Young Lawyers Division of the American Bar Association, and/or
restrictions on who

can provide legal advice to tribal members during the pilot program.

    Authority: Pub. L. 113-2.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-05391 Filed 3-7-13; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 137 (Tuesday, July 19, 2022)]
[Notices]
[Pages 43021-43022]
[FR Doc No: 2022-15366]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-483-000]

Texas Eastern Transmission, LP; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on July 1, 2022, Texas Eastern Transmission, LP
(Texas Eastern), 5400 Westheimer Court, Houston, Texas 77056, filed in
the above referenced docket a prior notice pursuant to Section 157.205
and 157.208 of the Federal Energy Regulatory Commission's regulations
under the Natural Gas Act and the blanket certificate issued by the
Commission in Docket No. CP82-535-000,\1\ seeking authorization to: (i)
replace and reconfigure a segment of 30-inch-diameter pipeline,
including the installation of appurtenant facilities, on its Line 16 at
a crossing underneath the Neches River ship channel, in Jefferson and
Orange Counties, Texas to accommodate the deepening of the Sabine-
Neches Waterway planned by the Sabine-Neches Navigation District and
the U.S. Army Corps of Engineers; and (ii) discontinue use of a total
of approximately 2,723 feet of existing 30-inch-diameter pipeline.
Specifically, Texas Eastern proposes to install approximately 2,752
feet of new 30-inch diameter pipeline in the right-of-way adjacent to
the current Line 16 pipeline segment, but at greater depth. The
proposed replacement is estimated to cost approximately $25,000,000,
all as more fully set forth in the request which is on file with the
Commission and open to public inspection.
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    \1\ Texas Eastern Transmission Corp., 21 FERC ] 62,199 (1982).
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    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 protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions concerning this application should be directed to
Estela D. Lozano, Director, Regulatory, Texas Eastern Transmission, LP,
P.O. Box 1642, Houston, Texas 77251-1642, by telephone at (713) 627-
4522, by fax at<PHONE_NUMBER>, or by email at
[email protected].

Public Participation

    There are three ways to become involved in the Commission's review
of this project: you can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on September 12,
2022. How to file protests, motions to intervene, and comments is
explained below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\2\ any person \3\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
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    \2\ 18 CFR 157.205.
    \3\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
---------------------------------------------------------------------------

    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\4\ and must be submitted by
the protest deadline, which is September 12, 2022. A protest may also
serve as a motion to intervene so long as the protestor states it also
seeks to be an intervenor.
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    \4\ 18 CFR 157.205(e).
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Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \5\ and the regulations under the NGA \6\ by the
intervention deadline for the project, which is September 12, 2022. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
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    \5\ 18 CFR 385.214.
    \6\ 18 CFR 157.10.
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    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before September 12, 2022. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP22-483-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website

(www.ferc.gov) under the link to Documents and Filings. New eFiling
users must first create an account by clicking on ``eRegister.'' You
will be asked to select the type of filing you are making; first select
General'' and then select ``Protest'', ``Intervention'', or ``Comment
on a Filing.'' The Commission's eFiling staff are available to assist
you at<PHONE_NUMBER> or [email protected]
    (2) You can file a paper copy of your submission. Your submission
must reference the Project docket number CP22-483-000.
    To mail via USPS, use the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.
    To mail via any other courier, use the following address: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at: Estela D.
Lozano, Director, Regulatory, Texas Eastern Transmission, LP, P.O. Box
1642, Houston, Texas 77251-1642, by telephone at<PHONE_NUMBER>, by fax
at<PHONE_NUMBER>, or by email at [email protected]. Any
subsequent submissions by an intervenor must be served on the applicant
and all other parties to the proceeding. Contact information for
parties can be downloaded from the service list at the eService link on
FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: July 13, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-15366 Filed 7-18-22; 8:45 am]
BILLING CODE 6717-01-P