specifically noted that it ``is not applying a `cannot be
manipulated' standard; instead, the Commission is examining whether
the proposal meets the requirements of the Exchange Act and,
pursuant to its Rules of Practice, places the burden on the listing
exchange to demonstrate the validity of its contentions and to
establish that the requirements of the Exchange Act have been met.''
Id. at 37582.
---------------------------------------------------------------------------

(a) Manipulation of the ETP
    According to the Sponsor's research presented above, the Bitcoin
Futures market is the leading market for bitcoin price formation. Where
Bitcoin Futures lead the price in the spot market such that a potential
manipulator of the bitcoin spot market (beyond just the constituents of
the Index \91\) would have to participate in the Bitcoin Futures
market, it follows that a potential manipulator of the Shares would
similarly have to transact in the Bitcoin Futures market because the
Index is based on spot prices. Further, the Trust only allows for in-
kind creation and redemption, which, as further described below,
reduces the potential for manipulation of the Shares through
manipulation of the Index or any of its individual constituents, again
emphasizing that a potential manipulator of the Shares would have to
manipulate the entirety of the bitcoin spot market, which is led by the
Bitcoin Futures market. As such, the Exchange believes that part (a) of
the significant market test outlined above is satisfied and that common
membership in ISG between the Exchange and CME would assist the listing
exchange in detecting and deterring misconduct in the Shares.
---------------------------------------------------------------------------

    \91\ As further described below, the ``Index'' for the Fund is
the S&P Bitcoin Index. The current exchange composition of the Index
is Binance, Bitfinex, Bitflyer, Bittrex, Bitstamp, Coinbase Pro,
Gemini, HitBTC, Huobi, Kraken, KuCoin, and Poloniex.
---------------------------------------------------------------------------

(b) Predominant Influence on Prices in Spot and Bitcoin Futures
    The Exchange and Sponsor also believe that trading in the Shares
would not be the predominant force on prices in the Bitcoin Futures
market or spot market for a number of reasons, including the
significant volume in the Bitcoin Futures market, the size of bitcoin's
market cap, and the significant liquidity available in the spot market.
In addition to the Bitcoin Futures market data points cited above, the
spot market for bitcoin is also very liquid.
(c) Other Means To Prevent Fraudulent and Manipulative Acts and
Practices
    As noted above, the Commission also permits a listing exchange to
demonstrate that ``other means to prevent fraudulent and manipulative
acts and practices'' are sufficient to justify dispensing with the
requisite surveillance-sharing agreement. The Exchange and Sponsor
believe that such conditions are present. According to the Sponsor, a
significant portion of the considerations around crypto pricing have
historically stemmed from a lack of consistent pricing across markets.
However, according to the Sponsor's research, cross-exchange spreads in
Bitcoin have been declining consistently over the past several years.
Based on the daily Bitcoin price series from several popular
centralized exchanges \92\ the Sponsor has calculated the largest
cross-exchange percentage spread (labelled as %C-Spread) by deducting
the highest or maximum price
---------------------------------------------------------------------------

    \92\ The exchanges include Binance, Bitfinex, Bithumb, Bitstamp,
Cexio, Coinbase, Coinone, Gateio, Gemini, HuobiPro, itBit, Kraken,
Kucoin, and OKEX.
---------------------------------------------------------------------------

BILLING CODE 8011-01-P
[GRAPHIC] [TIFF OMITTED] TN16AU23.018

    (P) at time t from the lowest or minimum, and dividing by the
lowest across all exchanges (i). Formally, this is expressed as:
    The results show a clear and sharp decline in the %C-Spread,
indicating that the Bitcoin market has become more efficient as cross-
exchange prices have converged over time.

[GRAPHIC] [TIFF OMITTED] TN16AU23.019

    In addition, the magnitude of outlier % C-spreads has also declined
over time. This boxplot shows that, not only did the median value of
the %C-Spread decline over time, but also the extreme outlier values.
For instance, the maximum %C-Spread for 2017, 2018, 2019, 2020, 2021,
2022 and 2023 are 29.14%, 14.12%, 8.54%, 6.04%, 3.65%, 5.56% and 0.63%,
respectively. The market has experienced a 22.68% year-on-year decline
in the annual median %C-Spread indicating a greater degree of Bitcoin
price convergence across exchanges and a more efficient market.
[GRAPHIC] [TIFF OMITTED] TN16AU23.020

    The dispersion ([sigma]) of Bitcoin Prices has also declined over
the same period. This chart shows the 7-day rolling standard deviation
of the %C-Spread from January 1, 2017 to February 1, 2023. The
Sponsor's research finds that the dispersion in Bitcoin prices across
all exchanges has decreased over time, indicating that prices on all
the considered exchanges converge towards the intrinsic average much
more efficiently. This suggests that the market has become better at
quickly reaching a consensus price for Bitcoin.
    As the pricing of the crypto market becomes increasingly efficient,
pricing methodologies become more accurate and less susceptible to
manipulation. The clustering of prices across a variety of sources
within the primary market points towards robust price discovery
mechanisms and efficient arbitrage.
[GRAPHIC] [TIFF OMITTED] TN16AU23.021

    It is very important to note that the cross-exchange spreads, and
therefore the process of price discovery in the Bitcoin market has
improved significantly over time despite the market experiencing rather
uniform albeit sinusoidal volatility. This can be shown in the graphs
below where we can clearly observe a slightly decreasing yet consistent
level of volatility in the Bitcoin market based on daily and hourly
returns across the considered exchanges. Again, this further supports
the argument that the Bitcoin market has exhibited significant
improvements in terms of price discovery over time, irrespective and
despite of the volatility of the asset itself, which can be attributed
to efficient arbitrage operations.

[GRAPHIC] [TIFF OMITTED] TN16AU23.022

    One factor that has contributed to the overall efficiency of, and
improved price discovery within the Bitcoin market is the increase in
the number of participants, and subsequently, the total dollar amount
allocated to this market. This can be illustrated by the following
chart, which shows the number of wallet addresses holding Bitcoin from
January 2016 to February 2023.

[GRAPHIC] [TIFF OMITTED] TN16AU23.023

    The large number of participants in the Bitcoin market has
manifested itself in high liquidity in the market. This is exhibited in
the following chart, which shows the daily aggregated dollar notional
of the bid and ask order books within the first 100 price levels across
several of the largest centralized crypto exchanges from February 2022
to January 2023. Specifically, the dollar notional that is allocated
closest to the mid price has hovered between $2.6 million and $12
million over that period.
[GRAPHIC] [TIFF OMITTED] TN16AU23.024

    An increased notional order book suggests that there is a higher
degree of consensus among investors regarding the price of Bitcoin.
Moreover, this market characteristic hampers any attempt of price
manipulation by any single large entity.
    As a robustness check, the Sponsor investigates whether the dollar
notional in the order book changes significantly prior to and post an
extreme price event. Specifically, for events constituting large
increases in the price of Bitcoin, if the ask (or sell) side of the
order book experiences a significant shrinkage in

the dollar notional right before the event, then this may be an
indication of market manipulation whereby the ask-side of the order
book becomes sufficiently thin for a large order to move the price
upward. Similarly, for events constituting large decreases in the price
of Bitcoin, if the bid (or buy) side of the order book experiences a
significant shrinkage in the dollar notional prior to such events, then
this may be an indication of market manipulation whereby the thinner
bid-side of the order book may potentially lead to significant downward
price movements.
    Using the top and bottom 0.1% of hourly price changes from February
2022 to February 2023 as events of extreme upward and downward market
movements, respectively, the Sponsor plotted the bid (left charts) and
ask (right charts) dollar notional of the Bitcoin order book within a
six-hour window around these events in the chart below, which shows the
results for extreme upward price movements. The extreme price events
(indicated by the dashed green lines) perfectly coincide with the
decrease in dollar notional of the ask-side of the order book. This is
indicative of an efficient market, whereby large market movements are
quickly and dynamically absorbed by a thick orderbook. Moreover, the
dollar notional on the ask side after the event is replenished back to
its pre-event level, which implies that market participants' reactions
are quick to restore the market back to its equilibrium level.
BILLING CODE 8011-01-P
[GRAPHIC] [TIFF OMITTED] TN16AU23.025

    The same results and conclusions are found for extreme downward
price movements. The charts below show that such price events perfectly
coincide with shrinkages on the bid side of the order book (left
charts), indicating an

efficient and dynamic Bitcoin market. Moreover, the bid-side of the
order book after the event is also restored back to its pre-event
level, which suggests that the market is symmetrically efficient in
moving back to equilibrium.
[GRAPHIC] [TIFF OMITTED] TN16AU23.026

BILLING CODE 8011-01-C
    The Exchange is proposing to take additional steps to those
described above to supplement its ability to obtain information that
would be helpful in detecting, investigating, and deterring fraud and
market manipulation in the Commodity-Based Trust Shares. On June 21,
2023, the Exchange reached an agreement on terms with Coinbase, Inc.
(``Coinbase''), an operator of a United States-based spot trading
platform for Bitcoin that represents a substantial portion of US-based
and USD denominated Bitcoin trading,\93\ to enter into a surveillance-
sharing agreement (``Spot BTC SSA'') and executed an associated term
sheet. Based on this agreement on terms, the Exchange and Coinbase will
finalize and execute a definitive agreement that the parties expect to
be executed prior to allowing trading of the Commodity-Based Trust
Shares.
---------------------------------------------------------------------------

    \93\ According to a Kaiko Research report dated June 26, 2023,
Coinbase represented roughly 50% of exchange trading volume in USD-
BTC trading on a daily basis during May 2023.
---------------------------------------------------------------------------

    The Spot BTC SSA is expected to be a bilateral surveillance-sharing
agreement between the Exchange and Coinbase that is intended to
supplement the Exchange's market surveillance program. The Spot BTC SSA
is expected to have the hallmarks of a surveillance-sharing agreement
between two members of the ISG, which would give the Exchange
supplemental access to data regarding spot Bitcoin trades on Coinbase
where the Exchange determines it is necessary as part of its
surveillance program for the

Commodity-Based Trust Shares.\94\ This means that the Exchange expects
to receive market data for orders and trades from Coinbase, which it
will utilize in surveillance of the trading of Commodity-Based Trust
Shares. In addition, the Exchange can request further information from
Coinbase related to spot bitcoin trading activity on the Coinbase
exchange platform, if the Exchange determines that such information
would be necessary to detect and investigate potential manipulation in
the trading of the Commodity-Based Trust Shares.\95\
---------------------------------------------------------------------------

    \94\ For additional information regarding ISG and the hallmarks
of surveillance-sharing between ISG members, see https://isgportal.org/overview.
    \95\ The Exchange also notes that it already has in place ISG-
like surveillance sharing agreement with Cboe Digital Exchange, LLC
and Cboe Clear Digital, LLC.
---------------------------------------------------------------------------

    Finally, offering only in-kind creation and redemption will provide
unique protections against potential attempts to manipulate the Shares.
While the Sponsor believes that the Index which it uses to value the
Trust's bitcoin is itself resistant to manipulation based on the
methodology further described below, the fact that creations and
redemptions are only available in-kind makes the manipulability of the
Index significantly less important. Specifically, because the Trust
will not accept cash to buy bitcoin in order to create new shares or,
barring a forced redemption of the Trust or under other extraordinary
circumstances, be forced to sell bitcoin to pay cash for redeemed
shares, the price that the Sponsor uses to value the Trust's bitcoin is
not particularly important.\96\ When authorized participants are
creating with the Trust, they need to deliver a certain number of
bitcoin per share (regardless of the valuation used) and when they're
redeeming, they can similarly expect to receive a certain number of
bitcoin per share. As such, even if the price used to value the Trust's
bitcoin is manipulated (which the Sponsor believes that its methodology
is resistant to), the ratio of bitcoin per Share does not change and
the Trust will either accept (for creations) or distribute (for
redemptions) the same number of bitcoin regardless of the value. This
not only mitigates the risk associated with potential manipulation, but
also discourages and disincentivizes manipulation of the Index because
there is little financial incentive to do so.
---------------------------------------------------------------------------

    \96\ While the Index will not be particularly important for the
creation and redemption process, it will be used for calculating
fees.
---------------------------------------------------------------------------

(ii) Designed To Protect Investors and the Public Interest
    The Exchange believes that the proposal is designed to protect
investors and the public interest. Over the past several years, U.S.
investor exposure to bitcoin through OTC Bitcoin Funds has grown into
the tens of billions of dollars and more than a billion dollars of
exposure through Bitcoin Futures ETFs. With that growth, so too has
grown the quantifiable investor protection issues to U.S. investors
through roll costs for Bitcoin Futures ETFs and premium/discount
volatility and management fees for OTC Bitcoin Funds. The Exchange
believes that the concerns related to the prevention of fraudulent and
manipulative acts and practices have been sufficiently addressed to be
consistent with the Act and, to the extent that the Commission
disagrees with that assertion, also believes that such concerns are now
outweighed by these investor protection concerns. As such, the Exchange
believes that approving this proposal (and comparable proposals)
provides the Commission with the opportunity to allow U.S. investors
with access to bitcoin in a regulated and transparent exchange-traded
vehicle that would act to limit risk to U.S. investors by: (i) reducing
premium and discount volatility; (ii) reducing management fees through
meaningful competition; (iii) reducing risks and costs associated with
investing in Bitcoin Futures ETFs and operating companies that are
imperfect proxies for bitcoin exposure; and (iv) providing an
alternative to custodying spot bitcoin.
Commodity-Based Trust Shares
    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 on the Exchange pursuant to the initial and
continued listing criteria in Exchange Rule 14.11(e)(4). 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. Trading of the Shares through the
Exchange will be subject to the Exchange's surveillance procedures for
derivative products, including Commodity-Based Trust Shares. The issuer
has represented to the Exchange that it will advise the Exchange of any
failure by the Trust or the Shares to comply with the continued listing
requirements, and, pursuant to its obligations under section 19(g)(1)
of the Exchange Act, the Exchange will surveil for compliance with the
continued listing requirements. If the Trust or the Shares are not in
compliance with the applicable listing requirements, the Exchange will
commence delisting procedures under Exchange Rule 14.12. The Exchange
may obtain information regarding trading in the Shares and listed
bitcoin derivatives 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.
Availability of Information
    The Exchange also believes that the proposal promotes market
transparency in that a large amount of information is currently
available about bitcoin and will be available regarding the Trust and
the Shares. In addition to the price transparency of the Index, the
Trust will provide information regarding the Trust's bitcoin holdings
as well as additional data regarding the Trust. The Trust will provide
an IIV per Share updated every 15 seconds, as calculated by the
Exchange or a third-party financial data provider during the Exchange's
Regular Trading Hours (9:30 a.m. to 4:00 p.m. E.T.). The IIV will be
calculated by using the prior day's closing NAV per Share as a base and
updating that value during Regular Trading Hours to reflect changes in
the value of the Trust's bitcoin holdings during the trading day.
    The IIV disseminated during Regular Trading Hours should not be
viewed as an actual real-time update of the NAV, which will be
calculated only once at the end of each trading day. The IIV will be
widely disseminated on a per Share basis every 15 seconds during the
Exchange's Regular Trading Hours by one or more major market data
vendors. In addition, the IIV will be available through on-line
information services.
    The website for the Trust, which will be publicly accessible at no
charge, will contain the following information: (a) the current NAV per
Share daily and the prior business day's NAV and the reported closing
price; (b) the BZX Official Closing Price in relation to the NAV as of
the time the NAV is calculated and a calculation of the premium or
discount of such price against such NAV; (c) data in chart form
displaying the frequency distribution of discounts and premiums of the
Official Closing Price against the NAV, within appropriate ranges for
each of the four previous calendar quarters (or for the life of the
Trust, if shorter); (d) the prospectus; and (e) other applicable
quantitative information. The Trust will

also disseminate the Trust's holdings on a daily basis on the Trust's
website. The price of bitcoin will be made available by one or more
major market data vendors, updated at least every 15 seconds during
Regular Trading Hours. Information about the Index, including key
elements of how the Index is calculated, will be publicly available at
https://www.spglobal.com/spdji/en/indices/digital-assets/sp-bitcoin-index/.
    The NAV for the Trust will be calculated by the Administrator once
a day and will be disseminated daily to all market participants at the
same time. Quotation and last-sale information regarding the Shares
will be disseminated through the facilities of the CTA.
    Quotation and last sale information for bitcoin is widely
disseminated through a variety of major market data vendors, including
Bloomberg and Reuters, as well as the Index. Information relating to
trading, including price and volume information, in bitcoin is
available from major market data vendors and from the exchanges on
which bitcoin are traded. Depth of book information is also available
from bitcoin exchanges. The normal trading hours for bitcoin exchanges
are 24 hours per day, 365 days per year.
    In sum, the Exchange believes that this proposal is consistent with
the requirements of section 6(b)(5) of the Act, that this filing
sufficiently demonstrates that the CME Bitcoin Futures market
represents a regulated market of significant size, and that on the
whole the manipulation concerns previously articulated by the
Commission are sufficiently mitigated to the point that they are
outweighed by investor protection issues that would be resolved by
approving this proposal.
    The Exchange believes that the proposal is, in particular, designed
to protect investors and the public interest. The investor protection
issues for U.S. investors has grown significantly over the last several
years, through roll costs for Bitcoin Futures ETFs and premium/discount
volatility and management fees for OTC Bitcoin Funds. As discussed
throughout, this growth investor protection concerns need to be re-
evaluated and rebalanced with the prevention of fraudulent and
manipulative acts and practices concerns that previous disapproval
orders have relied upon. Finally, the Exchange notes that in addition
to all of the arguments herein which it believes sufficiently establish
the CME Bitcoin Futures market as a regulated market of significant
size, it is logically inconsistent to find that the CME Bitcoin Futures
market is a significant market as it relates to the CME Bitcoin Futures
market, but not a significant market as it relates to the bitcoin spot
market for the numerous reasons laid out above.
    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 and trading of
an additional exchange-traded product that will enhance competition
among both market participants and listing venues, to the benefit of
investors and the marketplace.

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

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

III. Proceedings To Determine Whether To Approve or Disapprove SR-
CboeBZX-2023-028, as Modified by Amendment No. 3, and Grounds for
Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to section
19(b)(2)(B) of the Act \97\ to determine whether the proposed rule
change, as modified by Amendment No. 3, should be approved or
disapproved. Institution of proceedings is appropriate at this time in
view of the legal and policy issues raised by the proposed rule change,
as discussed below. 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, as modified by Amendment No. 3.
---------------------------------------------------------------------------

    \97\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

    Pursuant to section 19(b)(2)(B) of the Act,\98\ 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'' and ``to protect investors and the
public interest.'' \99\
---------------------------------------------------------------------------

    \98\ Id.
    \99\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission asks that commenters address the sufficiency of the
Exchange's statements in support of the proposal, which are set forth
in Amendment No. 3, in addition to any other comments they may wish to
submit about the proposed rule change, as modified by Amendment No. 3.
In particular, the Commission seeks comment on the following questions
and asks commenters to submit data where appropriate to support their
views:
    1. What are commenters' views on whether the proposed Trust and
Shares would be susceptible to manipulation? What are commenters' views
generally on whether the Exchange's proposal is designed to prevent
fraudulent and manipulative acts and practices? What are commenters'
views generally with respect to the liquidity and transparency of the
bitcoin markets, the bitcoin markets' susceptibility to manipulation,
and thus the suitability of bitcoin as an underlying asset for an
exchange-traded product?
    2. Based on data and analysis provided and the academic research
cited by the Exchange,\100\ do commenters agree with the Exchange that
the CME, on which CME Bitcoin Futures trade, represents a regulated
market of significant size related to spot bitcoin?\101\ What are
commenters' views on whether there is a reasonable likelihood that a
person attempting to manipulate the Shares would also have to trade on
the CME to manipulate the Shares? Do commenters agree with the
Exchange's assertion that trading in the Shares would not be the
predominant force on prices in the CME Bitcoin Futures market or spot
market, due to ``the significant volume in the Bitcoin Futures market,
the size of bitcoin's market cap, and the significant liquidity
available in the spot market''? \102\
---------------------------------------------------------------------------

    \100\ See supra Item II.A.
    \101\ See id.
    \102\ See id.
---------------------------------------------------------------------------

    3. The Exchange states that bitcoin is resistant to price
manipulation and that other means to prevent fraudulent and
manipulative acts and practices ``exist to justify dispensing with the
requisite surveillance sharing agreement'' with a regulated market of
significant size related to spot bitcoin.\103\ In support of its
assertion, the Exchange provides data

and analysis \104\ to indicate that the spot bitcoin market is
``increasingly efficient,'' with ``high liquidity'' and a ``higher
degree of consensus among investors regarding the price of [b]itcoin,''
making it ``less susceptible to manipulation.'' \105\ Do commenters
believe the Exchange has shown that the bitcoin market is resistant to
price manipulation?
---------------------------------------------------------------------------

    \103\ See id.
    \104\ See id.
    \105\ See id.
---------------------------------------------------------------------------

    4. The Exchange also states that it will execute a surveillance-
sharing agreement with Coinbase that is intended to supplement the
Exchange's market surveillance program. According to the Exchange, the
agreement is ``expected to have the hallmarks of a surveillance-sharing
agreement between two members of the ISG, which would give the Exchange
supplemental access to data regarding spot [b]itcoin trades on Coinbase
where the Exchange determines it is necessary as part of its
surveillance program for the Commodity-Based Trust Shares.'' \106\
Based on the description of the surveillance-sharing agreement as
provided by the Exchange herein, what are commenters' views of such an
agreement if finalized and executed? Do commenters agree with the
Exchange's assertion that such an agreement with Coinbase would be
``helpful in detecting, investigating, and deterring fraud and
manipulation in the Commodity-Based Trust Shares''? \107\
---------------------------------------------------------------------------

    \106\ See id. The Exchange states that ``[t]his means that the
Exchange expects to receive market data for orders and trades from
Coinbase, which it will utilize in surveillance of the trading of
Commodity-Based Trust Shares.'' Id.
    \107\ See id.
---------------------------------------------------------------------------

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, and
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.\108\
---------------------------------------------------------------------------

    \108\ Section 19(b)(2) of the Act, as amended by the Securities
Act Amendments of 1975, Public Law 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).
---------------------------------------------------------------------------

    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposed rule change, as modified by
Amendment No. 3, should be approved or disapproved by September 6,
2023. Any person who wishes to file a rebuttal to any other person's
submission must file that rebuttal by September 20, 2023.
    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-CboeBZX-2023-028 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-2023-028. 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 (https://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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-CboeBZX-2023-028 and should
be submitted on or before September 6, 2023. Rebuttal comments should
be submitted by September 20, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\109\
---------------------------------------------------------------------------

    \109\ 17 CFR 200.30-3(a)(12); 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-17603 Filed 8-15-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Rules and Regulations]
[Pages 37153-37154]
[FR Doc No: 2015-15951]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2014-1069; Airspace Docket No. 14-ANM-11]

Amendment of Class D and Class E Airspace, Revocation of Class E
Airspace; Salem, OR

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action modifies Class D airspace, Class E surface area
airspace, Class E airspace extending upward from 700 feet above the
surface, and removes Class E surface area airspace designated as an
extension at McNary Field, Salem, OR. After reviewing the airspace, the
FAA found it necessary to increase the airspace areas for the safety
and management of Instrument Flight Rules (IFR) operations during
Standard Instrument Approach Procedures (SIAPs) at the airport.

DATES: Effective 0901 UTC, August 20, 2015. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Y, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. The Order is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15. For further
information, you can contact the Airspace Policy and ATC Regulations
Group, Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC, 29591; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Steve Haga, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA, 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes controlled airspace at McNary Field, Salem, OR.

History

    On May 1, 2015, the FAA published in the Federal Register a notice
of proposed rulemaking (NPRM) to modify Class D airspace, Class E
surface area airspace, Class E airspace extending upward from 700 feet
above the surface, and remove Class E surface area airspace designated
as an extension at McNary Field, Salem, OR (80 FR 24858). Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received.
    Class D and Class E airspace designations are published in
paragraph 5000, 6002, 6004, and 6005, respectively, of FAA Order
7400.9Y, dated August 6, 2014, and effective September 15, 2014, which
is incorporated by reference in 14 CFR 71.1. The Class D and Class E
airspace designations listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Y, airspace Designations and
Reporting Points, dated August 6, 2014, and effective September 15,
2014. FAA Order 7400.9Y is publicly available as listed in the
ADDRESSES section of this final rule. FAA Order 7400.9Y lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 modifies Class D airspace, Class E surface area airspace, Class
E airspace extending upward from 700 feet above the surface, and
removes Class E surface area airspace as an extension at McNary Field,
Salem, OR. A review of the airspace revealed an increase and
reconfiguration of the airspace is needed for IFR operations due to
cancellation of the Turno non-directional radio beacon (NDB) and
cancellation of the NDB approach. Class D airspace and Class E surface
area airspace extends upward from the surface to and including 2,700
feet within a 4-mile radius northeast of McNary Field, within a 6.2-
mile radius southeast of the airport, and within an 8.1-mile radius
southeast to northwest of the airport, excluding airspace within 1.2
miles of Independence State Airport, OR. Class E airspace extending
upward from 700 feet above the surface is amended to within a 6.5-mile
radius northeast of McNary Field, within an 8.2-mile radius southeast
of the airport, and within a 9.1-mile radius southeast to northwest of
the airport, excluding airspace within 1.2 miles of Independence State
Airport, OR. This action enhances the safety and management of
controlled airspace within the NAS.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Y,
Airspace Designations and Reporting Points, dated August 6, 2014, and
effective September 15, 2014, is amended as follows:

Paragraph 5000 Class D airspace.

* * * * *

ANM OR D Salem, OR [Modified]

Salem, McNary Field, OR
    (Lat. 44[deg]54'34'' N., long. 123[deg]00'09'' W.)
Independence, Independence State Airport, OR
    (Lat. 44[deg]52'01'' N., long. 123[deg]11'54'' W.)

    That airspace extending upward from the surface to and including
2,700 feet MSL within a 4-mile radius of McNary Field from the
330[deg] bearing from the airport clockwise to the 074[deg] bearing,
and that airspace within a 6.2-mile radius of McNary Field from the
074[deg] bearing from the airport clockwise to the 150[deg] bearing,
and that airspace within a 8.1-mile radius of McNary Field from the
150[deg] bearing from the airport clockwise to the 330[deg] bearing,
excluding that airspace within 1.2 miles of Independence State
Airport, OR. This Class D airspace area is effective during the
specific dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Airport/Facility Directory.

Paragraph 6002 Class E Airspace Designated as Surface Areas.

* * * * *

ANM OR E2 Salem, OR [Modified]

Salem, McNary Field, OR
    (Lat. 44[deg]54'34'' N., long. 123[deg]00'09'' W.)
Independence, Independence State Airport, OR
    (Lat. 44[deg]52'01'' N., long. 123[deg]11'54'' W.)

    That airspace extending upward from the surface within a 4-mile
radius of McNary Field from the 330[deg] bearing from the airport
clockwise to the 074[deg] bearing, and that airspace within a 6.2-
mile radius of McNary Field from the 074[deg] bearing from the
airport clockwise to the 150[deg] bearing, and that airspace within
a 8.1-mile radius of McNary Field from the 150[deg] bearing from the
airport clockwise to the 330[deg] bearing, excluding that airspace
within 1.2 miles of Independence State Airport, OR. This Class E
airspace area is effective during the specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Airport/
Facility Directory.

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D or Class E Surface Area.

* * * * *

ANM OR E4 Salem, OR [Removed]

Paragraph 6005 Class E Airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ANM OR E5 Salem, OR [Modified]

Salem, McNary Field, OR
    (Lat. 44[deg]54'34'' N., long. 123[deg]00'09'' W.)
Independence, Independence State Airport, OR
    (Lat. 44[deg]52'01'' N., long. 123[deg]11'54'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of McNary Field from the 330[deg] bearing
from the airport clockwise to the 074[deg] bearing, and that
airspace within a 8.2-mile radius of McNary Field from the 074[deg]
bearing from the airport clockwise to the 150[deg] bearing, and that
airspace within a 9.1-mile radius of McNary Field from the 150[deg]
bearing from the airport clockwise to the 330[deg] bearing,
excluding that airspace within 1.2 miles of Independence State
Airport, OR.

    Issued in Seattle, Washington, on June 22, 2015.
Christopher Ramirez,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2015-15951 Filed 6-29-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Notices]
[Page 17158]
[FR Doc No: 2019-08301]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0765; FRL-9992-33-ORD]

Board of Scientific Counselors Executive Committee Meeting--June
2019

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting.

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

SUMMARY: Pursuant to the Federal Advisory Committee Act the U.S.
Environmental Protection Agency (EPA), Office of Research and
Development (ORD), gives notice of a meeting of the Board of Scientific
Counselors (BOSC) Executive Committee (EC).

DATES: The meeting will be held on Thursday, June 27, 2019, from 8:30
a.m. to 5:30 p.m., and Friday, June 28, 2019, from 8:30 a.m. until 2:00
p.m. All times noted are Eastern Time and approximate. The meeting may
adjourn early if all business is finished. Attendees should register by
June 20 at https://www.eventbrite.com/e/us-epa-bosc-executive-committee-meeting-tickets-58436808066. Requests for making oral
presentations at the meeting will be accepted up to one business day
before the meeting. Comments may be submitted through Tuesday, June 25,
2019.

ADDRESSES: The meeting will be held at the EPA's Research Triangle Park
Main Campus Facility, Room C-112, 109 T.W. Alexander Drive, Research
Triangle Park, North Carolina 27711. Submit your comments to Docket ID
No. EPA-HQ-ORD-2015-0765 by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email: Send comments by electronic mail (email) to:
[email protected], Attention Docket ID No. EPA-HQ-ORD-2015-0765.
     Fax: Fax comments to:<PHONE_NUMBER>, Attention Docket ID
No. EPA-HQ-ORD-2015-0765.
     Mail: Send comments by mail to: Board of Scientific
Counselors (BOSC) Executive Committee Docket, Mail Code: 2822T, 1301
Constitution Ave. NW, Washington, DC 20004, Attention Docket ID No.
EPA-HQ-ORD-2015-0765.
     Hand Delivery or Courier: Deliver comments to: EPA Docket
Center (EPA/DC), Room 3334, William Jefferson Clinton West Building,
1301 Constitution Ave. NW, Washington, DC, Attention Docket ID No. EPA-
HQ-ORD-2015-0765. Note: This is not a mailing address. Deliveries are
only accepted during the docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: The EPA's policy is that all comments received will
be included in the public docket without change and may be made
available online at www.regulations.gov including any personal
information provided unless the comment includes information claimed to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or email. The www.regulations.gov website is an ``anonymous access''
system, which means the EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to the EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the internet. If you submit an electronic
comment, the EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should avoid the use
of special characters, any form of encryption, and be free of any
defects or viruses. For additional information about the EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/dockets/.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Board of Scientific
Counselors Executive Committee Docket, EPA/DC, William Jefferson
Clinton West Building, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the ORD Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer (DFO)
via mail at: Tom Tracy, Mail Code 8104R, Office of Science Policy,
Office of Research and Development, U.S. Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; via phone/
voice mail at:<PHONE_NUMBER>; via fax at:<PHONE_NUMBER>; or via email
at: [email protected].

SUPPLEMENTARY INFORMATION: General Information: The meeting is open to
the public. Any member of the public interested in receiving a draft
agenda, attending the meeting, or making a presentation at the meeting
may contact Tom Tracy, the Designated Federal (DFO), via any of the
contact methods listed in the FOR FURTHER INFORMATION CONTACT section
above. Individuals making an oral presentation will be limited to a
total of three minutes.
    For security purposes, all attendees must provide their names to
the DFO by registering online at https://www.eventbrite.com/e/us-epa-bosc-executive-committee-meeting-tickets-58436808066 by June 25, 2019,
and must go through a metal detector, sign in with the security desk,
and show REAL ID Act-compliant government-issued photo identification
to enter the building. Attendees are encouraged to arrive at least 15
minutes prior to the start of the meeting to allow enough time for
security screening. Proposed agenda items for the meeting include but
are not limited to the following: Overview of materials provided to the
subcommittee, review of charge questions, overview and illustrations of
SHC's draft Strategic Research Action Plan and research topics, and
subcommittee deliberations.
    Information on Services for Individuals with Disabilities: For
information on access or services for individuals with disabilities,
please contact Tom Tracy<PHONE_NUMBER> or [email protected]. To
request accommodation of a disability, please contact Tom Tracy,
preferably at least ten days prior to the meeting, to give the EPA as
much time as possible to process your request.

    Dated April 2, 2019.
Kathleen Deener,
Acting Director, Office of Science Policy.
[FR Doc. 2019-08301 Filed 4-23-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 196 (Wednesday, October 9, 2019)]
[Notices]
[Page 54137]
[FR Doc No: 2019-22022]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP19-1590-001.
    Applicants: Honeoye Storage Corporation.
    Description: Compliance filing Compliance Filing Adoption of NAESB
Version 3.1 to be effective 11/1/2019.
    Filed Date: 9/27/19.
    Accession Number: 20190927-5084.
    Comments Due: 5 p.m. ET 10/9/19.

    Docket Numbers: RP19-1601-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: MidAmerican Energy Services--
Negotiated Rate Agreement Filing to be effective 11/1/2019.
    Filed Date: 9/27/19.
    Accession Number: 20190927-5000.
    Comments Due: 5 p.m. ET 10/9/19.

    Docket Numbers: RP19-1602-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Tenaska Marketing Ventures--
Negotiated Rate Agreement Filing to be effective 11/1/2019.
    Filed Date: 9/27/19.
    Accession Number: 20190927-5001.
    Comments Due: 5 p.m. ET 10/9/19.

    Docket Numbers: RP19-1603-000.
    Applicants: Stingray Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Stingray Non-Conforming
Agreements to be effective 10/27/2019.
    Filed Date: 9/27/19.
    Accession Number: 20190927-5024.
    Comments Due: 5 p.m. ET 10/9/19.

    Docket Numbers: RP19-1604-000.
    Applicants: Portland Natural Gas Transmission System.
    Description: Compliance filing PXP Phase II Compliance Filing to be
effective 11/1/2019.
    Filed Date: 9/27/19.
    Accession Number: 20190927-5025.
    Comments Due: 5 p.m. ET 10/9/19.

    Docket Numbers: RP19-1605-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Compliance filing Penalty Revenue Crediting Report
from January through June 2019.
    Filed Date: 9/27/19.
    Accession Number: 20190927-5030.
    Comments Due: 5 p.m. ET 10/9/19.

    Docket Numbers: RP19-1606-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Pipeline Safety and Greenhouse
Gas Cost Adjustment Mechanism--2019 to be effective 11/1/2019.
    Filed Date: 9/27/19.
    Accession Number: 20190927-5041.
    Comments Due: 5 p.m. ET 10/9/19.

    Docket Numbers: RP19-1608-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: Sec.  4(d) Rate Filing: GT&C Sec 42 Tracker Filing
(11/2019) to be effective 11/1/2019.
    Filed Date: 9/27/19.
    Accession Number: 20190927-5055.
    Comments Due: 5 p.m. ET 10/9/19.

    Docket Numbers: RP19-1609-000.
    Applicants: Dauphin Island Gathering Partners.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Filing--
Fieldwood 9-27-2019 to be effective 10/1/2019.
    Filed Date: 9/27/19.
    Accession Number: 20190927-5060.
    Comments Due: 5 p.m. ET 10/9/19.

    Docket Numbers: RP19-1610-000.
    Applicants: Dominion Energy Transmission, Inc.
    Description: Sec.  4(d) Rate Filing: DETI--Modifications to GT&C
for the Construction of Facilities to be effective 10/28/2019.
    Filed Date: 9/27/19.
    Accession Number: 20190927-5072.
    Comments Due: 5 p.m. ET 10/9/19.

    Docket Numbers: RP19-1611-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--MC Global
911524 to Eco-Energy 8959558 eff 10-1-19 to be effective 10/1/2019.
    Filed Date: 9/27/19.
    Accession Number: 20190927-5088.
    Comments Due: 5 p.m. ET 10/9/19.

    Docket Numbers: RP19-1612-000.
    Applicants: MoGas Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: MoGas Negotiated Rate Tariff
Filing to be effective 10/1/2019.
    Filed Date: 9/27/19.
    Accession Number: 20190927-5142.
    Comments Due: 5 p.m. ET 10/9/19.

    Docket Numbers: RP19-1613-000.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.
    Description: Sec.  4(d) Rate Filing: MNUS FRQ 2019 Filing to be
effective 11/1/2019.
    Filed Date: 9/27/19.
    Accession Number: 20190927-5143.
    Comments Due: 5 p.m. ET 10/9/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and Sec.  385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
may be considered, but intervention is necessary to become a party to
the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 2, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-22022 Filed 10-8-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85965-85966]
[FR Doc No: 2016-28653]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-4669 and FDA-2015-E-4659]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by January
30, 2017. 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 May 30, 2017. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2015-E-4669 and FDA-2015-E-4659 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; IXINITY.'' Received
comments will be placed in the dockets and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets

Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human 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 the USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
biological product will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product IXINITY
(Coagulation Factor IX (recombinant)). IXINITY is indicated for control
and prevention of bleeding episodes and for perioperative management,
in adults and children >=12 years of age with hemophilia B. Subsequent
to this approval, the USPTO received patent term restoration
applications for IXINITY (U.S. Patent Nos. 7,645,602 and 8,603,823)
from the University of North Carolina at Chapel Hill, and the USPTO
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated March 10, 2016, FDA advised
the USPTO that this human biological product had undergone a regulatory
review period and that the approval of IXINITY represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
IXINITY is 2,437 days. Of this time, 1,318 days occurred during the
testing phase of the regulatory review period, while 1,119 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: August 28,
2008. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on August 28,
2008.
    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): April 6, 2012. The applicant claims April
5, 2012, as the date the biologics license application (BLA) for
IXINITY (BLA 125426) was initially submitted. However, FDA records
indicate that BLA 125426 was submitted on April 6, 2012.
    3. The date the application was approved: April 29, 2015. FDA has
verified the applicant's claim that BLA 125426 was approved on April
29, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,526 days or 505 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). 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.
To meet its burden, the petition must be timely (see DATES) and 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.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28653 Filed 11-28-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 15 (Tuesday, January 26, 2021)]
[Notices]
[Pages 7182-7183]
[FR Doc No: 2021-01654]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2019-0151]

Pipeline Safety: Request for Special Permit; Natural Gas Pipeline
Company of America, LLC

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

ACTION: Notice.

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

SUMMARY: PHMSA is publishing this notice to solicit public comments on
a request for special permit received from the Natural Gas Pipeline
Company of America, LLC (NGPL). The special permit request is seeking
relief from compliance with certain requirements in the Federal
pipeline safety regulations. At the conclusion of the 30-day comment
period, PHMSA will review the comments received from this notice as
part of its evaluation to grant or deny the special permit request.

DATES: Submit any comments regarding this special permit request by
February 25, 2021.

ADDRESSES: Comments should reference the docket number for this special
permit request and may be submitted in the following ways:
     E-Gov Website: http://www.Regulations.gov. This site
allows the public to enter comments on any Federal Register notice
issued by any agency.
     Fax: 1-202-493-2251.
     Mail: Docket Management System: U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Docket Management System: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays.
    Instructions: You should identify the docket number for the special
permit request you are commenting on at the beginning of your comments.
If you submit your comments by mail, please submit two (2) copies. To
receive confirmation that PHMSA has received your comments, please
include a self-addressed stamped postcard. Internet users may submit
comments at http://www.Regulations.gov.
    Note: There is a privacy statement published on http://www.Regulations.gov. Comments, including any personal information
provided, are posted without changes or edits to http://www.Regulations.gov.
    Confidential Business Information: Confidential Business
Information (CBI) is commercial or financial information that is both
customarily and actually treated as private by its owner. Under the
Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from
public disclosure. If your comments responsive to this notice contain
commercial or financial information that is customarily treated as
private, that you actually treat as private, and that is relevant or
responsive to this notice, it is important that you clearly designate
the submitted comments as CBI. Pursuant to 49 Code of Federal
Regulations (CFR) 190.343, you may ask PHMSA to give confidential
treatment to information you give to the agency by taking the following
steps: (1) Mark each page of the original document submission
containing CBI as ``Confidential''; (2) send PHMSA, along with the
original document, a second copy of the original document with the CBI
deleted; and (3) explain why the information you are submitting is CBI.
Unless you are notified otherwise, PHMSA will treat such marked
submissions as confidential under the FOIA, and they will not be placed
in the public docket of this notice. Submissions containing CBI should
be sent to Kay McIver, DOT, PHMSA-PHP-80, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001. Any commentary PHMSA receives that is not
specifically designated as CBI will be placed in the public docket for
this matter.

FOR FURTHER INFORMATION CONTACT:
    General: Ms. Kay McIver by telephone at<PHONE_NUMBER>, or by email
at<EMAIL_ADDRESS>    Technical: Mr. Steve Nanney by telephone at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: PHMSA received a special permit request from
NGPL, a subsidiary of Kinder Morgan, Inc., seeking a waiver from the
requirements of 49 CFR 192.611(a) and (d): Change in class location:

Confirmation or revision of maximum allowable operating pressure, and
49 CFR 192.619(a): Maximum allowable operating pressure: Steel or
plastic pipelines. This special permit is being requested in lieu of
pipe replacement or pressure reduction for 10 pipeline segments
totaling 21,141 feet (approximately 4 miles) of 30-inch diameter pipe
on the Gulf Coast Line #1 and the Gulf Coast Line #2 Pipelines, located
in Polk County, Texas. The proposed special permit will allow operation
of the original Class 1 pipe in the Class 3 locations.
    The proposed special permit would allow NGPL to uprate the Gulf
Coast Line #1 and Gulf Coast Line #2 Pipelines from a current 715
pounds per square inch gauge (psig) maximum allowable operating
pressure (MAOP) to an 858 psig MAOP. The pipeline MAOP uprating is for
a new NGPL 2021 contractual obligation to deliver 300,000 dekatherms
per day of incremental natural gas volumes to the Cheniere Corpus
Christi, Texas Liquefied Natural Gas Terminal.
    The Gulf Coast Line #1 Pipeline was constructed between 1951 and
1973. The Gulf Coast Line #2 Pipeline was constructed between 1962 and
1982.
    The special permit request, proposed special permit with
conditions, and Draft Environmental Assessment (DEA) for the NGPL Gulf
Coast Lines #1 and #2 Pipelines are available for review and public
comments in Docket No. PHMSA-2019-0151. PHMSA invites interested
persons to review and submit comments on the special permit request and
DEA in the docket. Please include any comments on potential safety and
environmental impacts that may result if the special permit is granted.
Comments may include relevant data.
    Before issuing a decision on the special permit request, PHMSA will
evaluate all comments received on or before the comments closing date.
Comments received after the closing date will be evaluated, if it is
possible to do so without incurring additional expense or delay. PHMSA
will consider each relevant comment it receives in making its decision
to grant or deny this special permit request.

    Issued in Washington, DC, under authority delegated in 49 CFR
1.97.
Alan K. Mayberry,
Associate Administrator for Pipeline Safety.
[FR Doc. 2021-01654 Filed 1-25-21; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 85, Number 235 (Monday, December 7, 2020)]
[Notices]
[Page 78851]
[FR Doc No: 2020-26810]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2020-0052; FRL-10017-72]

Pesticide Product Registration; Receipt of Applications for New
Uses (November 2020)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has received applications to register a new use for a
pesticide product containing currently registered active ingredients.
Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), EPA is hereby providing notice of receipt and opportunity to
comment on these applications.

DATES: Comments must be received on or before January 6, 2021.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number and the File Symbol of the EPA registration
number of interest as shown in the body of this document, by one of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets/about-epa-dockets.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), main telephone number:<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>The mailing address is: Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001. As part of the mailing address, include the
contact person's name, division, and mail code.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Registration Applications

    EPA has received applications to register new uses for pesticide
products containing currently registered active ingredients. Pursuant
to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA
is hereby providing notice of receipt and opportunity to comment on
these applications. Notice of receipt of these applications does not
imply a decision by the Agency on these applications.

Notice of Receipts--New Uses

    EPA Registration Numbers: 87895-2 and 87895-4. Docket ID number:
EPA-HQ-OPP-2020-0600. Applicant: AgLogic Chemical, LLC., 121 S Estes
Dr. Ste. 101, Chapel Hill, NC 27514. Active ingredient: Aldicarb.
Product type: Insecticide. Proposed uses: Oranges and grapefruit in
Florida and Texas. Contact: RD.

    Authority: 7 U.S.C. 136 et seq.

    Dated: November 20, 2020.
Hamaad Syed,
Acting Director, Information Technology and Resources Management
Division, Office of Pesticide Programs.
[FR Doc. 2020-26810 Filed 12-4-20; 8:45 am]
BILLING CODE 6560-50-P