[Federal Register Volume 84, Number 34 (Wednesday, February 20, 2019)]
[Notices]
[Pages 5078-5079]
[FR Doc No: 2019-02708]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2512-079]

Hawks Nest Hydro, LLC; Notice of Comment Period Extension

    On December 12, 2018, the Commission issued a notice setting
January 12, 2019, as the end of the formal period to file comments,
motions to intervene, and protests for a Recreation Management Plan for
the Hawks Nest Hydroelectric Project No. 2512. The project is located
on the New River, just upstream of the confluence of the New and Gauley
Rivers, near the Town of Ansted in Fayette County, West Virginia. Due
to the funding lapse at certain federal agencies between

December 22, 2018 and January 25, 2019, the Commission is extending the
comment period until March 4, 2019.

    Dated: February 11, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-02708 Filed 2-19-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 141 (Tuesday, July 23, 2013)]
[Notices]
[Pages 44117-44119]
[FR Doc No: 2013-17675]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9836-4; Docket ID No. EPA-HQ-ORD-2006-0756]

Notice of a Public Comment Period on the Draft IRIS
Carcinogenicity Assessment for Ethylene Oxide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: EPA is announcing a 45-day public comment period on the draft
IRIS assessment titled, ``Evaluation of the Inhalation Carcinogenicity
of Ethylene Oxide'' (EPA/635/R-13/128a) and on the draft peer review
charge questions. The draft assessment and draft peer review charge
questions were prepared by the National Center for Environmental
Assessment (NCEA) within the EPA Office of Research and Development
(ORD). The 45-day public comment period on the draft Evaluation of the
Inhalation Carcinogenicity of Ethylene Oxide and on the draft peer
review charge questions begins on the day EPA posts the draft
assessment and the draft peer review charge questions on the IRIS Web
site and ends 45 days later. EPA anticipates posting the draft
assessment and draft charge questions on or around July 23, 2013.
Shortly after the draft carcinogenicity assessment is posted on the
IRIS Web site, EPA will initiate a peer review of the draft assessment,
which EPA anticipates will be undertaken by the Science Advisory Board.
EPA is releasing this draft carcinogenicity assessment for the purpose
of public comment. This draft assessment is not final, as described in
EPA's information quality guidelines, and it does not represent and
should not be construed to represent Agency policy or views.

DATES: The 45-day public comment period on the draft Evaluation of the
Inhalation Carcinogenicity of Ethylene Oxide and on the draft peer
review charge questions begins on the day EPA posts the draft
assessment and the draft peer review charge questions on the IRIS Web
site and ends 45 days later. The draft assessment and peer review
charge questions will be posted to the IRIS Web site at http://www.epa.gov/IRIS. Comments should be in writing and received by EPA
within 45 days after posting the draft carcinogenicity assessment and
the draft peer review charge questions on the IRIS Web site. EPA
anticipates posting the draft assessment and draft charge questions on
or around July 23, 2013.

ADDRESSES: The draft IRIS carcinogenicity assessment titled,
``Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide'' is
available primarily via the Internet on the IRIS Web site at http://www.epa.gov/IRIS. A limited number of paper copies are available from
the Information Management Team (Address: Information Management Team,
National Center for Environmental

Assessment [Mail Code: 8601P], U.S. Environmental Protection Agency,
1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone: 703-347-
8561; facsimile:<PHONE_NUMBER>). If you request a paper copy, please
provide your name, mailing address, and the draft assessment title.
Comments may be submitted electronically via http://www.regulations.gov, by email, by mail, by facsimile, or by hand
delivery/courier. Please follow the detailed instructions provided in
the SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the draft
assessment, please contact Jennifer Jinot, U.S. Environmental
Protection Agency, National Center for Environmental Assessment, Mail
Code 8623P, 1200 Pennsylvania Avenue NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The draft IRIS assessment of the inhalation carcinogenicity of
ethylene oxide was prepared by the National Center for Environmental
Assessment (NCEA) within the EPA Office of Research and Development
(ORD). The public has been provided an opportunity to comment on a
previous external review draft of the Evaluation of the Inhalation
Carcinogenicity of Ethylene Oxide. On September 22, 2006, EPA released
an external review draft ``Evaluation of the Carcinogenicity of
Ethylene Oxide'' (EPA/635/R-06/003) for public comment. This draft was
reviewed by EPA's Science Advisory Board on January 18 and 19, 2007.
The expert panel's final report, Review of the Office of Research and
Development (ORD) Draft Assessment entitled, ``Evaluation of the
Carcinogenicity of Ethylene Oxide'' (EPA-SAB-08-004), was made
available on December 21, 2007.
    The draft IRIS carcinogenicity assessment titled, ``Evaluation of
the Inhalation Carcinogenicity of Ethylene Oxide'' (EPA/635/R-13/128a)
has been revised in response to the peer review and public comments
received on the external review draft released in September 2006. This
notice announces a new public comment period on the current revised
draft carcinogenicity assessment in advance of an upcoming peer review
and in accordance with applicable information quality guidelines. The
external peer review comments and EPA responses on the previous draft
assessment are summarized in Appendix H of the draft. EPA is releasing
this revised draft assessment for the purposes of additional public
comment and subsequent peer review. This draft assessment is not final,
as described in EPA's information quality guidelines, and it does not
represent and should not be construed to represent Agency policy or
views.
    In addition to an opportunity for public comment announced in this
notice, EPA will initiate a peer review of the draft IRIS
carcinogenicity assessment and will announce the details of the peer
review in a separate Federal Register Notice. EPA seeks additional
external peer review on how the Agency responded to the SAB panel
recommendations, the exposure-response modeling of epidemiologic data,
including new analyses since the 2007 external peer review, and on the
adequacy, transparency, and clarity of the revised draft. The peer
review will include an opportunity for the public to address the peer
reviewers. EPA will announce the date, time and procedures for public
participation in the peer review meeting in a separate Federal Register
Notice and in an announcement on the IRIS Web site.

II. Information About IRIS

    EPA's IRIS Program is a human health assessment program that
evaluates quantitative and qualitative risk information on effects that
may result from exposure to chemical substances found in the
environment. Through the IRIS Program, EPA provides the highest quality
science-based human health information for more than 550 chemical
substances that can be used in human health risk assessments to support
the Agency's regulatory activities and decisions to protect public
health. When supported by available data, IRIS provides health effects
information and toxicity values for chronic health effects (including
cancer and effects other than cancer). Government agencies and others
combine IRIS toxicity values with exposure information to characterize
public health risks of chemical substances; this information is then
used to support risk management decisions designed to protect public
health.

III. How To Submit Comments to the Docket at http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2006-
0756, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Facsimile:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 28221T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460. The telephone number is
202-566-1752. If you provide comments by mail, please submit one
unbound original with pages numbered consecutively, and three copies of
the comments. For attachments, provide an index, number pages
consecutively with the comments, and submit an unbound original and
three copies.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Ave. NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Deliveries are only accepted during the
docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information. If you provide comments by
hand delivery, please submit one unbound original with pages numbered
consecutively, and three copies of the comments. For attachments,
provide an index, number pages consecutively with the comments, and
submit an unbound original and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2006-0756. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at http://www.regulations.gov, including any personal information provided,
unless comments include 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 http://www.regulations.gov or email. The
http://www.regulations.gov Web site is an ``anonymous access'' system,
which means that EPA will not know your identity or contact information
unless you provide it in the body of your comments. If you send email
comments directly to EPA without going through http://www.regulations.gov, your email address will be automatically captured
and included as part of the comments that are placed in the public
docket and made available on the Internet. If you

submit electronic comments, EPA recommends that you include your name
and other contact information in the body of your comments and with any
disk or CD-ROM you submit. If EPA cannot read your comments due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comments. Electronic files should
avoid the use of special characters and any form of encryption and be
free of any defects or viruses. For additional information about EPA's
public docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://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
at http://www.regulations.gov or in hard copy at the OEI Docket in the
EPA Headquarters Docket Center.

    Dated: July 15, 2013.
Abdel M. Kadry,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2013-17675 Filed 7-22-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 208 (Tuesday, October 27, 2020)]
[Notices]
[Pages 68111-68114]
[FR Doc No: 2020-23684]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90240; File No. SR-CboeBZX-2020-075]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Enhance
Its Drill-Through Protections and Make Other Clarifying Change

October 21, 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 October 9, 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. The Commission is publishing this
notice to solicit comments on the proposed rule change 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 Options'')
proposes to enhance its drill-through protections and make other
clarifying changes. The text of the proposed rule change is provided in
Exhibit 5.
    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
    The Exchange proposes to enhance its drill-through protections for
orders and make other clarifying changes. Currently, pursuant to Rule
21.17(d), the System will execute a marketable buy (sell) order,
respectively, up to a buffer amount above (below) the limit of the
Opening Collar or the national best offer (``NBO'') (national best bid
(``NBB'')), as applicable (the ``drill-through price''). The System
enters any order (or unexecuted portion) into the BZX Options Book at
the drill-through price for a specified period of time (determined by
the Exchange).\3\ At the end of the time period, the System cancels any
portion of the order not executed during that time period.
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    \3\ The current time period is two seconds, and the current
default amounts are available in the technical specifications
available at https://cdn.cboe.com/resources/membership/US_Options_BOE_Specification.pdf. Upon implementation of the
proposed rule change, the Exchange will likely reduce the length of
the time period and maintain the same buffer amounts.
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    The Exchange proposes to permit orders to rest in the BZX Options
Book for multiple time periods and at more

aggressive displayed prices during each time period.\4\ Specifically,
the System enters the order in the BZX Options Book with a displayed
\5\ price equal to the drill-through price (as discussed below, if an
order's limit price is less aggressive than the drill-through price,
the order will rest in the BZX Options Book at its limit price and
subject to the User's instructions, and the drill-through mechanism as
proposed to be amended would no longer apply to the order).\6\ The
order (or unexecuted portion) will rest in the BZX Options Book until
the earlier to occur of the order's full execution or the end of the
duration of the number of time periods.\7\ Following the end of each
period prior to the final period, the System adds (if a buy order) or
subtracts (if a sell order) one buffer amount to the drill-through
price displayed during the immediately preceding period (each new price
becomes the ``drill-through price'').\8\ The order (or unexecuted
portion) rests in the BZX Options Book at that new drill-through price
for the duration of the subsequent period. Following the end of the
final period, the System cancels the order (or unexecuted portion) not
executed during any time period. The Exchange has received feedback
from Users that the current application of the drill-through mechanism
is too limited. The Exchange believes this proposed rule change will
provide additional execution opportunities for these orders (or
unexecuted portions) while providing protection against execution at
prices that may be erroneous.
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    \4\ The Exchange will announce to Trading Permit Holders the
buffer amount, the number of time periods, and the length of the
time periods in accordance with the introductory paragraph of Rule
21.17. The Exchange notes that each time period will be the same
length (as designated by the Exchange), and the buffer amount
applied for each time period will be the same.
    \5\ Currently, the drill-through price is the price of orders in
the book. The proposed rule change clarifies that the drill-through
price is displayed, which is consistent with current functionality.
    \6\ See proposed Rule 21.17(d)(2).
    \7\ The Exchange will determine on a class-by-class basis the
number of time periods, which may not exceed five, and the length of
the time period, which may not exceed three seconds. See proposed
Rule 21.17(d)(2)(A). The proposed rule change adds class flexibility
so that the Exchange may determine different time periods and buffer
amounts for different classes, which may exhibit different trading
characteristics and have different market models.
    \8\ The System will apply a timestamp to the order (or
unexecuted portion) based on the time it enters or is re-priced in
the book for priority purposes. See proposed Rule 21.17(d)(2)(C).
This is consistent with the current drill-through functionality,
pursuant to which the System applies a timestamp to the order (or
unexecuted portion) based on the time it enters the book, modified
to reflect the multiple price levels at which an order may rest. See
current Rule 21.17(d).
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    For example, suppose the Exchange's market for a series in a class
with a 0.05 minimum increment is 0.90-1.00, represented by a quote for
10 contracts on each side (the quote offer is Quote A). The following
sell orders or quote offers for the series also rest in the BZX Options
Book:
     Order A: 10 contracts at 1.05;
     Quote B: 10 contracts at 1.10;
     Order B: 10 contracts at 1.15; and
     Order C: 20 contracts at 1.25.
    The market for away exchanges is 0.80-1.45. The Exchange's buffer
amount for the class is 0.10, the drill-through resting time period is
one second, and the number of time periods is three. The System
receives an incoming order to buy 100 at 1.40, which executes against
resting orders and quotes as follows: 10 Against Quote A at 1.00 (which
is the national best offer), 10 against Order A at 1.05, and 10 against
Quote B at 1.10. The System will not automatically execute any of the
remaining 70 contracts from the incoming buy order against Order B,
because 1.15 is more than 0.10 away from the national best offer at the
time of order entry of 1.00 and thus exceeds the drill-through price
check. The 70 unexecuted contracts then rest in the BZX Options Book
for one second at a price of 1.10 (the initial drill-through price). No
incoming orders are entered during that one-second time period to trade
against the remaining 70 contracts. The System then re-prices the buy
order in the BZX Options Book at a new drill-through price of 1.20
(drill-through price plus one buffer of 0.10). Ten contracts
immediately execute against Order B at a price of 1.15 (the buy order
is still handled as the ``incoming order'' that executes against the
resting Order B, and thus receives price improvement to 1.15). An
incoming order to sell 20 contracts at 1.20 enters the BZX Options Book
and executes against 20 of the resting contracts at that price. At the
end of the second one-second time period, there are 40 remaining
contracts. These contracts then rest in the BZX Options Book at a price
of 1.30 for the final one second time period. Twenty contracts
immediately execute against Order C at a price of 1.25. No incoming
orders are entered during that time period to trade against the
remaining 20 contracts. At the end of the final one-second time period,
the System cancels the remaining 20 contracts.
    The proposed rule change also makes certain clarifying and
nonsubstantive changes, including movement of certain terms and
provisions within Rule 21.17(d) due to the proposed rule changes
described above. First, the proposed rule change combines the
provisions in current subparagraphs (1) and (2) of Rule 21.17(d) into
proposed subparagraph (1). The drill-through protection in the
following subparagraphs of Rule 21.17(d) (currently and as proposed)
apply to orders that enter the BZX Options Book at the conclusion of
the opening auction and intraday in the same manner. Therefore, current
(and proposed) subparagraph (d)(2) apply to all orders that enter the
BZX Options Book as described in proposed subparagraph (d)(1) (current
subparagraphs (d)(1) and (2)). The proposed rule change clarifies that
the drill-through protection applies to all orders that would enter the
BZX Options Book at prices worse than the drill-through price,
including orders not executed during the opening auction and orders
entered intraday. This is consistent with and a clarification of
current functionality.
    Second, the proposed rule change adds clarifying language regarding
how the System handles orders for which the limit price is equal to or
less than (if a buy order) or greater than (if a sell order) the drill-
through price. Current Rule 21.17(d) contemplates that orders with
limit prices equal to or less aggressive than the drill-through price
will not be subject to the mechanism pursuant to which orders will rest
in the BZX Options Book for a time period and then be cancelled.
Specifically, Rule 21.17(d) states if a buy (sell) order would execute
or post to the BZX Options Book at a price higher (lower) than the
drill-through price, the System enters the order into the BZX Options
Book with a price equal to the drill-through price and rests for the
time period in accordance with the drill-through mechanism. Therefore,
currently, if the limit price of an order is less aggressive than or
equal to the drill-through price (i.e., if a buy (sell) order (or
unexecuted portion) would execute or enter the BZX Options Book at a
price lower (higher) than or equal to the drill-through price), the
order will rest in the BZX Options Book and the drill-through mechanism
stops (i.e., the time period will not occur and the System will not
cancel the order).
    The proposed rule change clarifies that notwithstanding the
provisions described above regarding an order resting in the BZX
Options Book for brief time periods at drill-through prices, if a buy
(sell) order's limit price equals or is less (greater) than the drill-
through price at any time during application of the drill-through
mechanism, the order rests in the BZX Options Book, subject to a User's

instructions,\9\ at its limit price and any remaining time period(s)
described above do not occur.\10\ If the drill-through price is equal
to or more aggressive than the order's limit price, the additional
protection of having the order rest in the BZX Options Book for a short
time period is not necessary given that the order will rest at the
limit price entered by the User (and thus an acceptable execution price
for that User). Additionally, displaying an order at a drill-through
price (a price at which execution is possible) worse than the limit
price of the order would be inconsistent with the terms of the order.
This is consistent with current functionality (updated to reflect the
proposed rule change to allow multiple time periods) and the definition
of limit orders and merely clarifies this in the Rules.
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    \9\ For example, the order will remain in force subject to any
time-in-force instruction applied to the order by the User upon
entry.
    \10\ See proposed Rule 21.17(d)(2)(D).
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\11\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \12\ requirements that the rules of an exchange be
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 regulating, clearing,
settling, processing information with respect to, and 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. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \13\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
    \13\ Id.
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    In particular, the Exchange believes the proposed enhancement to
the drill-through mechanism removes impediments to and perfects the
mechanism of a free and open market and a national market system, and,
in general, protects investors and the public interest. The proposed
rule change will permit orders (or unexecuted portions) to rest in the
BZX Options Book at different displayed prices for a brief but overall
longer period of time, which will provide market participants' orders
with additional execution opportunities while continuing to protect
them against execution at potentially erroneous prices. The proposed
enhancement to the drill-through protection is similar to current
drill-through functionality. The Exchange may determine the buffer
amount for orders and the time period in which orders may rest in the
BZX Options Book. The proposed rule change permits an order to rest at
multiples of the buffer amount, which would have the same effect as the
Exchange setting a larger buffer amount. For example, if the Exchange
set a buffer amount of $0.75, that would allow orders to execute at any
price no further than $0.75 away from the NBBO at the time of order
entry (including at prices $0.25 and $0.50 away from the NBBO at the
time of order entry). This allows for the same potential execution
prices that would be possible if the Exchange set a buffer of $0.25 and
three time periods under the proposed rule change. While the overall
time period for which an order may rest in the BZX Options Book may be
longer than the currently permissible time period, the longer time
period will still be relatively brief (maximum of 15 seconds). The
Exchange notes it may maintain the same buffer amounts that are in
place today. However, rather than increase the buffer amount at one
time, the proposed rule change adds the overall larger buffer amount
incrementally over a potentially overall longer time period. While this
may permit executions at prices farther away from the NBBO at the time
of order entry, it will still never permit executions at prices through
orders' limit prices. This will provide execution opportunities for
orders at incremental amounts away from the NBBO over a slightly longer
time period and thus against a potentially larger number of orders.
Users also have the ability to cancel orders prior to the completion of
the time periods if they do not want the orders resting for a longer
period of time.
    The Exchange believes the proposed clarifying and nonsubstantive
changes to the drill-through protection rules protect investors by
adding transparency to the rules regarding the drill-through
functionality. These changes are consistent with current functionality
and thus do not impact the applicability of the drill-through mechanism
to orders.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange does not
believe that the proposed rule change will impose any burden on
intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act because the enhanced drill-
through protection will apply to all marketable orders in the same
manner. Users may cancel orders resting on the BZX Options Book during
the drill-through time periods.
    The Exchange does not believe that the proposed rule change will
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act because it
relates solely to how and when marketable orders will rest on the BZX
Options Book. The proposed enhancement to the drill-through protection
is consistent with the current protection and provides orders subject
to the protection with additional execution opportunities while
providing continued protection against execution against potentially
erroneous prices.
    The Exchange believes the proposed rule change would ultimately
provide all market participants with additional execution opportunities
when appropriate while providing protection from erroneous execution.
The Exchange believes the proposal will enhance risk protections, the
individual firm benefits of which flow downstream to counterparties
both at the Exchange and at other options exchanges, which increases
systemic protections as well. The Exchange believes enhancing risk
protections will allow Users to enter orders and quotes with further
reduced fear of inadvertent exposure to excessive risk, which will
benefit investors through increased liquidity for the execution of
their orders. Without adequate risk management tools, such as the one
proposed to be enhanced in this filing, Trading Permit Holders could
reduce the amount of order flow and liquidity they provide. Such
actions may undermine the quality of the markets available to customers
and other market participants. Accordingly, the proposed rule change is
designed to encourage Trading Permit Holders to submit additional order
flow and liquidity to the Exchange. The proposed flexibility may
similarly provide additional execution opportunities, which further
benefits liquidity in potentially volatile markets. In addition,

providing Trading Permit Holders with more tools for managing risk will
facilitate transactions in securities because, as noted above, Trading
Permit Holders will have more confidence protections are in place that
reduce the risks from potential system errors and market events.
    The proposed clarifying and nonsubstantive changes are consistent
with current functionality and are intended to add clarity to the
Rules, and thus the Exchange expects those changes to have no
competitive impact.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \14\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\15\
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    \14\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or 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 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 SRCboeBZX-2020-075 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-2020-075. 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-2020-075 and should be submitted
on or before November 17, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-23684 Filed 10-26-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 187 (Thursday, September 30, 2021)]
[Notices]
[Pages 54215-54217]
[FR Doc No: 2021-21317]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0983]

Fee Rate for Using a Material Threat Medical Countermeasure
Priority Review Voucher in Fiscal Year 2022

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rate for using a material threat medical
countermeasure (MCM) priority review voucher for fiscal year (FY) 2022.
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the
21st Century Cures Act (Cures Act), authorizes FDA to determine and
collect material threat MCM priority review user fees for certain
applications for review of human drug products when those applications
use a material threat MCM priority review voucher. These vouchers are
awarded to the sponsors of material threat MCM applications that meet
all the requirements of this program and upon FDA approval of such
applications. The amount of the fee for using a material threat MCM
priority review voucher is determined each FY based on the difference
between the average cost incurred by FDA to review a human drug
application designated as priority review in the previous FY, and the
average cost incurred in the review of an application that is not
subject to priority review in the previous FY. This notice establishes
the material threat MCM priority review fee rate for FY 2022 and
outlines the payment procedures for such fees.

FOR FURTHER INFORMATION CONTACT: Lola Olajide, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
61077B, Beltsville, MD 20705-4304,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 3086 of the Cures Act (Pub. L. 114-255) added section 565A
to the FD&C Act (21 U.S.C. 360bbb-4a). In section 565A of the FD&C Act,
Congress encouraged development of material threat MCMs by offering
additional incentives for obtaining FDA approval of such products.
Under section 565A of the FD&C Act, the sponsor of an eligible material
threat MCM application (as defined in section 565A(a)(4)) shall receive
a priority review voucher upon approval of the material threat MCM
application. The recipient of a material threat MCM priority review
voucher may either use the voucher for a future human drug application
submitted to FDA under section 505(b)(1) of the FD&C Act (21 U.S.C.
355(b)(1)) or section 351(a) of the Public Health Service Act (42
U.S.C. 262(a)), or transfer (including by sale) the voucher to another
party. The voucher may be transferred repeatedly until it ultimately is
used for a human drug application submitted to FDA under section
505(b)(1) of the FD&C Act or section 351(a) of the Public Health
Service Act. A priority review is a review conducted with a
Prescription Drug User Fee Act (PDUFA) goal date of 6 months after the
receipt or filing date, depending on the type of application.
Information regarding PDUFA goals is available at: https://www.fda.gov/media/99140/download.
    The sponsor that uses a material threat MCM priority review voucher
is entitled to a priority review of its eligible human drug
application, but must pay FDA a material threat MCM priority review
user fee in addition to any user fee required by PDUFA for the
application. Information regarding the material threat MCM priority
review voucher program is available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions.
    This notice establishes the material threat MCM priority review fee
rate for FY 2022 at $1,266,651 and outlines FDA's payment procedures
for material threat MCM priority review user fees.

This rate is effective on October 1, 2021, and will remain in effect
through September 30, 2022.

II. Material Threat Medical Countermeasure Priority Review User Fee
Rate for FY 2022

    FDA interprets section 565A(c)(2) of the FD&C Act as requiring that
FDA determine the amount of the material threat MCM priority review
user fee each fiscal year based on the difference between the average
cost incurred by FDA in the review of a human drug application subject
to priority review in the previous fiscal year, and the average cost
incurred by FDA in the review of a human drug application that is not
subject to priority review in the previous fiscal year.
    A priority review is a review conducted with a PDUFA goal date of 6
months after the receipt or filing date, depending on the type of
application. As described in the PDUFA goals letter, FDA has committed
to reviewing and acting on 90 percent of the applications granted
priority review status within this expedited timeframe. Normally, an
application for a human drug product will qualify for priority review
if the product is intended to treat a serious condition and, if
approved, would provide a significant improvement in safety or
effectiveness. An application that does not receive a priority
designation receives a standard review. As described in the PDUFA goals
letter, FDA has committed to reviewing and acting on 90 percent of
standard applications within 10 months of the receipt or filing date,
depending on the type of application. A priority review involves a more
intensive level of effort and a higher level of resources than a
standard review.
    FDA is setting a fee for FY 2022, which is to be based on standard
cost data from the previous fiscal year, FY 2021. However, the FY 2021
submission cohort has not been closed out yet, thus the cost data for
FY 2021 are not complete. The latest year for which FDA has complete
cost data is FY 2020. Furthermore, because FDA has never tracked the
cost of reviewing applications that get priority review as a separate
cost subset, FDA estimated this cost based on other data that the
Agency has tracked. The Agency expects all applications that received
priority review would contain clinical data. The application categories
with clinical data for which FDA tracks the cost of review are: (1) New
drug applications (NDAs) for a new molecular entity (NME) with clinical
data and (2) biologics license applications (BLAs).
    The total cost for FDA to review NME NDAs with clinical data and
BLAs in FY 2020 was $227,248,467. There was a total of 86 applications
in these two categories (53 NME NDAs with clinical data and 33 BLAs).
(Note: These numbers exclude the President's Emergency Plan for AIDS
Relief NDAs; no investigational new drug review costs are included in
this amount.) Of these applications 55 (35 NDAs and 20 BLAs) received
priority review and the remaining 31 (18 NDAs and 13 BLAs) received
standard reviews. Because a priority review compresses a review
schedule that ordinarily takes 10 months into 6 months, FDA estimates
that a multiplier of 1.67 (10 months / 6 months) should be applied to
non-priority review costs in estimating the effort and cost of a
priority review as compared to a standard review. This multiplier is
consistent with published research on this subject, which supports a
priority review multiplier in the range of 1.48 to 2.35 (Ref. 1). Using
FY 2020 figures, the costs of a priority and standard review are
estimated using the following formula:

(55 [alpha] x 1.67) + (31 [alpha]) = $227,248,467

where ``[alpha]'' is the cost of a standard review and ``[alpha] times
1.67'' is the cost of a priority review. Using this formula, the cost
of a standard review for NME NDAs and BLAs is calculated to be
$1,849,804 (rounded to the nearest dollar) and the cost of a priority
review for NME NDAs and BLAs is 1.67 times that amount, or $3,089,173
(rounded to the nearest dollar). The difference between these two cost
estimates, or $1,239,369, represents the incremental cost of conducting
a priority review rather than a standard review.
    For the FY 2022 fee, FDA will need to adjust the FY 2020
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2021, to adjust the FY 2020 amount
for cost increases in FY 2021. That adjustment, published in the
Federal Register on August 16, 2021 (86 FR 45732), setting FY 2022
PDUFA fees, is 2.2013 percent for the most recent year, not compounded.
Increasing the FY 2020 incremental priority review cost of $1,239,369
by 2.2013 percent (or 0.022013) results in an estimated cost of
$1,266,651 (rounded to the nearest dollar). This is the material threat
MCM priority review user fee amount for FY 2022 that must be submitted
with a priority review voucher for a human drug application in FY 2022,
in addition to any PDUFA fee that is required for such application.

III. Fee Rate Schedule for FY 2022

    The fee rate for FY 2022 is set out in table 1:

Table 1--Material Threat Medical Countermeasure Priority Review Schedule
                               for FY 2022
------------------------------------------------------------------------
                                                         Priority review
                      Fee category                         fee rate for
                                                             FY 2022
------------------------------------------------------------------------
Application submitted with a material threat MCM             $1,266,651
 priority review voucher in addition to the normal
 PDUFA fee.............................................
------------------------------------------------------------------------

IV. Implementation of Material Threat Medical Countermeasure Priority
Review User Fee

    Under section 565A(c)(4)(A) of the FD&C Act, the priority review
user fee is due upon submission of a human drug application for which
the priority review voucher is used. Section 565A(c)(4)(B) of the FD&C
Act specifies that the application will be considered incomplete if the
priority review user fee and all other applicable user fees are not
paid in accordance with FDA payment procedures. In addition, section
565A(c)(4)(C) specifies that FDA may not grant a waiver, exemption,
reduction, or refund of any fees due and payable under this section of
the FD&C Act.
    The material threat MCM priority review fee established in the new
fee schedule must be paid for any application with a priority review
voucher that is received on or after October 1, 2021. This fee must be
paid in addition to any other fee due under PDUFA. Payment must be made
in U.S. currency by electronic check, check, bank draft, wire transfer,
credit card, or U.S. postal money order payable to the order of the
Food and Drug Administration. The preferred payment method is online
using electronic check (Automated Clearing House (ACH) also known as
eCheck). Secure electronic payments can be submitted using the

User Fees Payment Portal at https://userfees.fda.gov/pay. (Note: Only
full payments are accepted. No partial payments can be made online.)
Once you search for your invoice, select ``Pay Now'' to be redirected
to Pay.gov. Note that electronic payment options are based on the
balance due. Payment by credit card is available for balances that are
less than $25,000. If the balance exceeds this amount, only the ACH
option is available. Payments must be made using U.S. bank accounts as
well as U.S. credit cards.
    FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA website after the
user fee ID number is generated.
    If paying by paper check, the user fee identification (ID) number
should be included on the check, followed by the words ``Material
Threat Medical Countermeasure Priority Review'' or ``MCMPRV.'' All
paper checks must be in U.S. currency from a U.S. bank made payable and
mailed to: Food and Drug Administration, P.O. Box 979107, St. Louis, MO
63197-9000.
    If checks are sent by a courier that requests a street address, the
courier can deliver the checks to: U.S. Bank, Attention: Government
Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only. If you have any
questions concerning courier delivery, contact the U.S. Bank at 314-
418-4013. This telephone number is only for questions about courier
delivery). The FDA post office box number (P.O. Box 979107) must be
written on the check. If needed, FDA's tax identification number is 53-
0196965.
    If paying by wire transfer, please reference your unique user fee
ID number when completing your transfer. The originating financial
institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required to add that
amount to the payment to ensure that the invoice is paid in full. The
account information is as follows: U.S. Dept. of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY 10045, Account Number: 75060099,
Routing Number: 021030004, SWIFT: FRNYUS33.

V. Reference

    The following reference is on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852,<PHONE_NUMBER>, and is available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
it is not available electronically at https://www.regulations.gov as
this reference is copyright protected. FDA has verified the website
address, as of the date this document publishes in the Federal
Register, but websites are subject to change over time.

1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, ``Developing Drugs
for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313-
324, 2006, available at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.25.2.313.

    Dated: September 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21317 Filed 9-29-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 43 (Tuesday, March 5, 2019)]
[Rules and Regulations]
[Pages 7810-7813]
[FR Doc No: 2019-03856]

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

Coast Guard

33 CFR Parts 100, 110, 147, and 165

[Docket No. USCG-2018-1049]

Navigation and Navigable Waters; Technical, Organizational, and
Conforming Amendments

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: This final rule makes non-substantive technical and conforming
amendments to existing Coast Guard regulations. The Coast Guard is
issuing this technical amendment to conform to the changes made by the
Frank LoBiondo Coast Guard Authorization Act of 2018, which
redesignated existing United States Code provisions into new Titles and
sections. This technical amendment updates the statutory authority
citations for Coast Guard regulations that establish safety zones,
security zones, special local regulations, regulated navigation areas,
and anchorages. This rule will have no substantive effect on the
regulated public.

DATES: This final rule is effective March 5, 2019.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket number USCG-2018-1049, which is available
at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For information about this document
call or email Kate Sergent, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Abbreviations
II. Discussion of the Rule
III. Regulatory History
IV. Basis and Purpose
V. Regulatory Analyses
    A. Regulatory Planning and Review
    B. Small Entities
    C. Assistance for Small Entities
    D. Collection of Information
    E. Federalism
    F. Unfunded Mandates Reform Act
    G. Taking of Private Property
    H. Civil Justice Reform
    I. Protection of Children
    J. Indian Tribal Governments
    K. Energy Effects
    L. Technical Standards
    M. Environment

I. Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
OMB Office of Management and Budget
Sec.  Section
U.S.C. United States Code

II. Discussion of the Rule

    On December 4, 2018, Congress enacted the Frank LoBiondo Coast
Guard Authorization Act of 2018 (Pub. L. 115-282). The Frank LoBiondo
Coast Guard Authorization Act of 2018 redesignated multiple provisions
within Titles 14, 33, 46, and 50 of the United States Code in an effort
reorganize these Titles. The Coast Guard often uses the affected
statutory provisions as authority for issuing regulations related to
maritime safety and security.
    Most significantly, the Frank LoBiondo Coast Guard Authorization
Act of 2018 redesignated the Ports and Waterways Safety Act provisions
previously located in 33 U.S.C. 1221 through 1236, and with an
exception not relevant to this rule, moved those provisions without
substantive change into Chapter 700 of Title 46 of the United States
Code.\1\ The new Chapter 700 of Title 46 is titled ``Ports and
Waterways Safety''. This rule replaces the old statutory authority
citations with their correct statutory authorities.
---------------------------------------------------------------------------

    \1\ The Act moved 33 U.S.C. 1223a, which governs the use of
electronic charts, to 46 U.S.C. 3105.
---------------------------------------------------------------------------

    The Coast Guard periodically issues technical, organizational, and
conforming amendments to existing regulations in title 33 of the CFR.
These ``technical amendments'' provide the public with more accurate
and current regulatory information, but do not change the effect on the
public of any Coast Guard regulations.
    This rule updates the authority citations for the following parts
of title 33 of the CFR: 100, 110, 147, and 165. This rule also updates
in text citations to statutory authorities that were moved by the Frank
LoBiondo Coast Guard Authorization Act. The Coast Guard is updating
only these CFR parts with this final rule because we frequently issue
temporary regulations to protect marine events that rely on the
statutory authorities previously located in 33 U.S.C. 1221 through 1236
and 50 U.S.C. 191. These safety-oriented regulations include safety
zones, security zones, regulated navigation areas, special local
regulations, safety zones on the outer continental shelf, and anchorage
grounds. The Coast Guard will update all of our other affected
regulations and their authority citations in one or more future
rulemakings.

III. Regulatory History

    We did not publish a notice of proposed rulemaking for this rule.
Under Title 5 of the United States Code (U.S.C.), Section 553(b)(A),
the Coast Guard finds that this final rule is exempt from notice and
public comment rulemaking requirements because these changes involve
rules of agency organization, procedure, or practice. In addition, the
Coast Guard finds that notice and comment procedures are unnecessary
for this final rule under 5 U.S.C. 553(b)(B), as this rule consists of
only technical and editorial corrections and these changes will have no
substantive effect on the public. Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that, for the same reasons, good cause exists for making
this final rule effective upon publication in the Federal Register.

IV. Basis and Purpose

    This final rule makes technical and editorial corrections in parts
100, 110, 147, and 165 of title 33 of the CFR. These changes are
necessary to update the authority citations for existing regulations
and make other non-substantive amendments that improve the clarity of
the CFR. This rule does not create or change any substantive
requirements.
    This final rule is issued under the authority of 5 U.S.C. 552(a)
and 553; 14 U.S.C. 102 and 503; and Department of Homeland Security
Delegation No. 0170.1.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on these statutes or Executive orders.

A. Regulatory Planning and Review

    Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review) direct agencies to assess
the costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. Executive Order 13771 (Reducing Regulation and Controlling
Regulatory Costs) directs agencies to reduce regulation and control
regulatory costs and provides that ``for every one new regulation
issued, at least two prior regulations be identified for elimination,
and that the cost of planned regulations be prudently managed and
controlled through a budgeting process.''
    The Office of Management and Budget (OMB) has not designated this
rule a significant regulatory action under section 3(f) of Executive
Order 12866. Accordingly, OMB has not reviewed it. Because this rule is
not a significant regulatory action, this rule is exempt from the
requirements of Executive Order 13771. See the OMB Memorandum titled
``Guidance Implementing Executive Order 13771, titled `Reducing
Regulation and Controlling Regulatory Costs' '' (April 5, 2017). This
rule involves non-substantive changes and internal agency practices and
procedures; it will not impose any additional costs on the public or
the government. The qualitative benefit of the non-substantive changes
is increased clarity of regulations and their authority. The increased
clarity of the CFR is created by the correction of errors, removing
outdated references, and correcting citations to match current
statutory text.

B. Small Entities

    Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    This rule is not preceded by a notice of proposed rulemaking.
Therefore, it is

exempt from the requirements of the Regulatory Flexibility Act (5
U.S.C. 601-612). The Regulatory Flexibility Act does not apply when
notice and comment rulemaking is not required.

C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996, Public Law 104-121, we offer to assist small
entities in understanding this rule so that they can better evaluate
its effects on them and participate in the rulemaking. The Coast Guard
will not retaliate against small entities that question or complain
about this rule or any policy or action of the Coast Guard.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247).

D. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520. This final rule
will not change any of the burdens in the collections currently
approved by OMB.

E. Federalism

    A rule has implications for federalism under Executive Order 13132
(Federalism) if it has a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under Executive Order 13132 and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.

F. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-1538,
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Although this rule will not result
in such expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

G. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630 (Governmental
Actions and Interference with Constitutionally Protected Property
Rights).

H. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988 (Civil Justice Reform) to minimize litigation,
eliminate ambiguity, and reduce burden.

I. Protection of Children

    We have analyzed this rule under Executive Order 13045 (Protection
of Children from Environmental Health Risks and Safety Risks). This
rule is not an economically significant rule and will not create an
environmental risk to health or risk to safety that might
disproportionately affect children.

J. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175 (Consultation and Coordination with Indian Tribal Governments),
because it will not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

K. Energy Effects

    We have analyzed this rule under Executive Order 13211 (Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use). We have determined that it is not a
``significant energy action'' under that order because it is not a
``significant regulatory action'' under Executive Order 12866 and is
not likely to have a significant adverse effect on the supply,
distribution, or use of energy.

L. Technical Standards

    The National Technology Transfer and Advancement Act, codified as a
note to 15 U.S.C. 272, directs agencies to use voluntary consensus
standards in their regulatory activities unless the agency provides
Congress, through OMB, with an explanation of why using these standards
would be inconsistent with applicable law or otherwise impractical.
Voluntary consensus standards are technical standards (e.g.,
specifications of materials, performance, design, or operation; test
methods; sampling procedures; and related management systems practices)
that are developed or adopted by voluntary consensus standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

M. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have concluded that this
action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. A
final Record of Environmental Consideration supporting this
determination is available in the docket where indicated in the
ADDRESSES section of this preamble. This final rule involves non-
substantive technical, organizational, and conforming amendments to
existing Coast Guard regulations. Therefore, this rule is categorically
excluded under paragraph L54 of Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. 01. Paragraph L54 pertains to regulations
which are editorial or procedural.

List of Subjects

33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

33 CFR Part 110

    Anchorage grounds.

33 CFR Part 147

    Continental shelf, Marine safety, Navigation (water).

33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR parts 100, 110, 147, and 165 as follows:

Title 33--Navigation and Navigable Waters

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 is revised to read as follows:

    Authority: 46 U.S.C. 70041; 33 CFR 1.05-1.

Sec.  100.35  [Amended]

0
2. In Sec.  100.35(c), remove the text ``33 U.S.C. 1233'' and add in
its place the text ``46 U.S.C. 70041''.

Sec.  100.1401   [Amended]

0
3. In Sec.  100.1401(e), remove the text ``33 U.S.C. 1233'' and add in
its place the text ``46 U.S.C. 70041''.

PART 110--ANCHORAGE REGULATIONS

0
4. The authority citation for part 110 is revised to read as follows:

    Authority: 33 U.S.C. 471, 2071, 46 U.S.C. 70034; 33 CFR 1.05-1;
Department of Homeland Security Delegation No. 0170.1.

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5. In Sec.  110.1a, revise the section heading and paragraph (a)
introductory text to read as follows:

Sec.  110.1a  Anchorages under Ports and Waterways Safety provisions.

    (a) The anchorages listed in this section are regulated under 46
U.S.C. Chapter 700, ``Ports and Waterways Safety'':
* * * * *

PART 147--SAFETY ZONES

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6. The authority citation for part 147 is revised to read as follows:

    Authority: 14 U.S.C. 544; 43 U.S.C. 1333; 33 CFR 1.05-1;
Department of Homeland Security Delegation No. 0170.1.

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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7. The authority citation for part 165 is revised to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

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8. In part 165:
0
a. Revise all references to ``33 U.S.C. 1226'' to read ``46 U.S.C.
70116''.
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b. Revise all references to ``33 U.S.C. 1231'' to read ``46 U.S.C.
70034''.
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c. Revise all references to ``33 U.S.C. 1232'' to read ``46 U.S.C.
70036''.
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d. Revise all references to ``50 U.S.C. 191'' to read ``46 U.S.C.
70051''.
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e. Revise all references to ``50 U.S.C. 192'' to read ``46 U.S.C.
70052''.

Sec.  165.9  [Amended]

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9. Amend Sec.  165.9 as follows:
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a. In paragraph (b), remove the text ``the Ports and Waterways Safety
Act, 33 U.S.C. 1221-1232'' and add in its place the text ``46 U.S.C.
70001-70041''.
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b. In paragraph (c):
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i. Remove the text ``the Ports and Waterways Safety Act, 33 U.S.C.
1221-1232'' and add in its place the text ``46 U.S.C. Chapter 700'';
and
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ii. Remove the text ``50 U.S.C. 191-195'' and add in its place the text
``46 U.S.C. 70051-54''.

Sec.  165.838   [Amended]

0
10. Amend Sec.  165.838 as follows:
0
a. In paragraph (b)(5), remove the text ``the Ports and Waterways
Safety Act, 33 U.S.C. 1221 et seq.'' and add in its place the text ``46
U.S.C. Chapter 700''.
0
b. In paragraph (i), remove the text ``the Ports and Waterways Safety
Act, 33 U.S.C. 1221 et seq.'' and add in its place the text ``46 U.S.C.
70036 and 70041''.

    Dated: February 27, 2019.
Katia Kroutil,
Chief, Office of Regulations and Administrative Law, U.S. Coast Guard.
[FR Doc. 2019-03856 Filed 3-4-19; 8:45 am]
 BILLING CODE 9110-04-P