[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Notices]
[Pages 13905-13907]
[FR Doc No: 2020-04866]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6644]

Fiscal Year 2020 Generic Drug Regulatory Science Initiatives;
Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``FY 2020 Generic
Drug Regulatory Science Initiatives.'' The purpose of the public
workshop is to provide an overview of the status of regulatory science
initiatives for generic drugs and an opportunity for public input on
these initiatives. FDA is seeking this input from a variety of
stakeholders--industry, academia, patient advocates, professional
societies, and other interested parties--as it fulfills its commitment
under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to
develop an annual list of regulatory science initiatives specific to
generic drugs. FDA will take the information it obtains from the public
workshop into account in developing its fiscal year (FY) 2021
regulatory science initiatives.

DATES: The public workshop will be held on May 4, 2020, from 8:30 a.m.
to 4:30 p.m. Submit either electronic or written comments on this
public workshop by June 4, 2020. See the SUPPLEMENTARY INFORMATION
section for registration date and information.

ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31, Conference Center, the
Great Room (Rm. 1503, sections B and C), Silver Spring, MD 20993-0002.
Entrance for the public workshop participants (non-FDA employees) is
through Bldg. 1, where routine security check procedures will be
performed. For parking and security information, please refer to
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before June 4, 2020. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of June 4, 2020. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically,

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-6644 for ``FY 2020 Generic Drug Regulatory Science
Initiatives; Public Workshop; Request for Comments.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Stephanie Choi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4732, Silver Spring, MD 20993, 240-402-
7960<EMAIL_ADDRESS>or Robert Lionberger, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402-
7957<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In July 2012, Congress passed the Generic Drug User Fee Amendments
of 2012 (GDUFA I) (Pub. L. 112-144). GDUFA I was designed to enhance
public access to safe, high-quality generic drugs and to modernize the
generic drug program. To support this goal, FDA agreed in the GDUFA I
commitment letter \1\ to work with industry and interested stakeholders
on identifying regulatory science initiatives specific to generic drugs
for each fiscal year covered by GDUFA I.
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    \1\ The GDUFA I commitment letter is available at https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf.
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    In August 2017, GDUFA I was reauthorized until September 2022
through GDUFA II (Pub. L. 115-52). In the GDUFA II commitment
letter,\2\ FDA agreed to conduct annual public workshops ``to solicit
input from industry and stakeholders for inclusion in an annual list of
GDUFA II [r]egulatory [s]cience initiatives.'' The public workshop
scheduled for May 4, 2020, seeks to fulfill this agreement.
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    \2\ The GDUFA II commitment letter is available at https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf.
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II. Topics for Discussion at the Public Workshop

    The purpose of the public workshop is to obtain input from industry
and other interested stakeholders on the identification of generic drug
regulatory science initiatives for FY 2021.
    FDA is particularly interested in receiving input in the following
four topic areas:

1. Post-market surveillance of generic drugs
2. Drug-device combination products
3. In vitro bioequivalence methods
4. Data analysis and model-based bioequivalence

    FDA will consider all comments made at this workshop or received
through the docket (see ADDRESSES) as it develops its FY 2021
regulatory science initiatives. Information concerning the regulatory
science initiatives for generic drugs can be found at https://www.fda.gov/gdufaregscience.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please provide
complete contact information for each attendee, including name, title,
affiliation, address, email, and telephone to
<EMAIL_ADDRESS>For planning purposes, please also
indicate in the email: (1) Whether attendance will be by webcast or in
person and (2) the desired breakout session of attendance. Four
breakout sessions will be held concurrently in the afternoon based on
the following 4 areas: (1) Post-market surveillance of generic drugs,
(2) drug-device combination drug products, (3) in-vitro bioequivalence
methods, and (4) data analysis and model-based bioequivalence.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register online by April 3, 2020, midnight Eastern Time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will

receive confirmation when they have been accepted.
    If you need special accommodations due to a disability, please
contact Stephanie Choi (see FOR FURTHER INFORMATION CONTACT) no later
than April 3, 2020.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session for a
specific breakout session, and which topic(s) you wish to address. We
will do our best to accommodate requests to make public comments (and
requests to participate in the focused sessions). Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and request time for a joint
presentation, or submit requests for designated representatives to
participate in the focused sessions. Following the close of
registration, we will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin,
and will select and notify participants by April 10, 2020. All requests
to make oral presentations must be received by the close of
registration on April 3, 2020, midnight Eastern Time. If selected for
presentation, any presentation materials must be emailed to
<EMAIL_ADDRESS>no later than April 24, 2020,
midnight Eastern Time. No commercial or promotional material will be
permitted to be presented or distributed at the public workshop.
    Persons attending FDA's workshops are advised that FDA is not
responsible for providing access to electrical outlets.
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. Please register online by April 3, 2020, midnight
Eastern Time to attend the workshop remotely. Please note that remote
attendees will not be able to speak or make presentations during the
public comment session or during any other session of the workshop. To
join the main sessions of the workshop via the webcast, please go to
https://collaboration.fda.gov/gdrsipw2020/. Webcast information for the
four breakout sessions will be provided separately via email upon
successful registration.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov or at https://www.fda.gov/gdufaregscience. It may
be viewed at the Dockets Management Staff (see ADDRESSES). A link to
the transcript will also be available on the internet at https://www.fda.gov/gdufaregscience.

    Dated: March 4, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04866 Filed 3-9-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 133 (Wednesday, July 11, 2018)]
[Notices]
[Page 32113]
[FR Doc No: 2018-14772]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-178-000]

PJM Interconnection, L.L.C.; Notice of Institution of Section 206
Proceeding and Refund Effective Date

    On June 29, 2018, the Commission instituted a proceeding in Docket
No. EL18-178-000, pursuant to section 206 of the Federal Power Act
(FPA), 16 U.S.C. 824e (2012), to determine the just and reasonable
replacement rate, based on its finding that PJM Interconnection,
L.L.C.'s currently effective Open Access Transmission Tariff is unjust,
unreasonable, and unduly discriminatory or preferential. Calpine
Corporation v. PJM Interconnection, L.L.C., 163 FERC ] 61,236 (2018).
    The refund effective date in Docket No. EL18-178-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.
    Any interested person desiring to be heard in Docket No. EL18-178-
000 must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory Commission, 888 First
Street NE, Washington, DC 20426, in accordance with Rule 214 of the
Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21
days of the date of issuance of the order.

    Dated: July 2, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-14772 Filed 7-10-18; 8:45 am]
 BILLING CODE P


[Federal Register Volume 82, Number 104 (Thursday, June 1, 2017)]
[Notices]
[Pages 25443-25446]
[FR Doc No: 2017-11369]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80793; File No. SR-NYSEMKT-2017-29]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing of
Proposed Rule Change To Eliminate Requirements That Will Be Duplicative
of CAT

May 26, 2017.
    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 May 15, 2017, NYSE MKT LLC (``NYSE MKT'' or the ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III 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

    The Exchange proposes to delete subsections (a)(1)-(13) of Rule
956NY (Record of Orders) of the Options Rules as these Rules collect
information for the consolidated options audit trail system (``COATS'')
that are duplicative of the data collection requirements of the CAT NMS
Plan. The Exchange will announce the date for the retirement of COATS
in a regulatory notice that will be published once the options
exchanges determine that the thresholds for accuracy and reliability
described below have been met and that the Plan Processor is
sufficiently meeting all of its obligations under the CAT NMS Plan. The
proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, 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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
Background
    Bats BYX Exchange, Inc., Bats BZX Exchange, Inc., Bats EDGA
Exchange, Inc., Bats EDGX Exchange, Inc., BOX Options Exchange LLC, C2
Options Exchange, Incorporated, CBOE, Chicago Stock Exchange, Inc.,
Financial Industry Regulatory Authority, Inc. (``FINRA''), Investors'
Exchange LLC, Miami International Securities Exchange, LLC, MIAX PEARL,
LLC, NASDAQ BX, Inc., Nasdaq GEMX, LLC, Nasdaq ISE, LLC, Nasdaq MRX,
LLC,\3\ NASDAQ PHLX LLC, The NASDAQ Stock Market LLC, New York Stock
Exchange LLC, the Exchange, NYSE Arca, Inc. and NYSE National, Inc.\4\
(collectively, the ``Participants'') filed with the Commission,
pursuant to Section 11A of the Exchange Act \5\ and Rule 608 of
Regulation NMS thereunder,\6\ the CAT

NMS Plan.\7\ The Participants filed the Plan to comply with Rule 613 of
Regulation NMS under the Exchange Act.\8\ The Plan was published for
comment in the Federal Register on May 17, 2016,\9\ and approved by the
Commission, as modified, on November 15, 2016.\10\
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    \3\ ISE Gemini, LLC, ISE Mercury, LLC and International
Securities Exchange, LLC have been renamed Nasdaq GEMX, LLC, Nasdaq
MRX, LLC, and Nasdaq ISE, LLC, respectively. See Securities Exchange
Act Release No. 80248 (March 15, 2017), 82 FR 14547 (March 21, 2017)
(SR-ISEGemini-2017-13); Securities Exchange Act Release No. 80326
(March 29, 2017), 82 FR 16460 (April 4, 2017) (SR-ISEMercury-2017-
05); and Securities Exchange Act Release No. 80325 (March 29, 2017),
82 FR 16445 (April 4, 2017) (SR-ISE-2017-25).
    \4\ National Stock Exchange, Inc. has been renamed NYSE
National, Inc. See Securities Exchange Act Release No. 79902
(January 30, 2017), 82 FR 9258 (February 3, 2017) (SR-NSX-2016-16).
    \5\ 15 U.S.C. 78k-1.
    \6\ 17 CFR 242.608.
    \7\ See Letter from the Participants to Brent J. Fields,
Secretary, Commission, dated September 30, 2014; and Letter from
Participants to Brent J. Fields, Secretary, Commission, dated
February 27, 2015. On December 24, 2015, the Participants submitted
an amendment to the CAT NMS Plan. See Letter from Participants to
Brent J. Fields, Secretary, Commission, dated December 23, 2015.
    \8\ 17 CFR 242.613.
    \9\ Securities Exchange Act Release No. 77724 (April 27, 2016),
81 FR 30614 (May 17, 2016) (File No. 4-698).
    \10\ Securities Exchange Act Release No. 79318 (Nov. 15, 2016),
81 FR 84696 (November 23, 2016) (File No. 4-698) (``Approval
Order'').
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    The Plan is designed to create, implement and maintain a CAT that
would capture customer and order event information for orders in NMS
Securities and OTC Equity Securities, across all markets, from the time
of order inception through routing, cancellation, modification, or
execution in a single consolidated data source. Pursuant to Appendix C
of the CAT NMS Plan, each Participant is required to conduct analyses
of which of its existing trade and order data rules and systems require
the collection of information that is duplicative of information
collected for the CAT.\11\ In addition, among other things, Section C.9
of Appendix C to the Plan, as modified by the Commission, requires each
Participant to ``file with the SEC the relevant rule change filing to
eliminate or modify its duplicative rules within six (6) months of the
SEC's approval of the CAT NMS Plan.'' \12\ The Plan notes that ``the
elimination of such rules and the retirement of such systems [will] be
effective at such time as CAT Data meets minimum standards of accuracy
and reliability.'' \13\
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    \11\ Appendix C of CAT NMS Plan, Approval Order at 85010.
    \12\ Id.
    \13\ Id.
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    After conducting its analysis of its rules in accordance with the
CAT NMS Plan, the Exchange determined that the information collected
for COATS is intended to be collected by the CAT. Therefore, the
Exchange believes that COATS will no longer be necessary once the CAT
is operational and certain accuracy and reliability standards are met.
Accordingly, the Exchange submits this proposed rule change to delete
subsections (a)(1)-(13) of Rule 956NY of the Options Rules, which set
forth certain requirements related to COATS. Discussed below is a
description of the duplicative rule requirements as well as the
timeline for eliminating the duplicative rule.
    If the Commission approves the proposed rule change, the rule text
will be effective; however, the amendments will not be implemented
until the Exchange, in conjunction with the other options exchanges,
publishes a notice announcing the date for the retirement of COATS. As
noted below, such a notice would be published once the options
exchanges determine that the thresholds for accuracy and reliability
described below have been met and that the Plan Processor is
sufficiently meeting all of its obligations under the CAT NMS Plan.
Duplicative COATS Requirements
    COATS was developed to comply with an order of the Commission
requiring the Exchange, in coordination with other exchanges, to
``design and implement'' COATS to ``enable the options exchanges to
reconstruct markets promptly, effectively surveil them and enforce
order handling, firm quote, trade reporting and other rules.'' \14\ The
options exchanges utilize COATS to collect and review data regarding
options orders, quotes and transactions.
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    \14\ See Section IV.B.e.(v) of the Commission's Order
Instituting Public Administrative Proceedings Pursuant to Sections
19(h)(1) of the Securities Exchange Act of 1934, Making Findings and
Imposing Remedial Sanctions (the ``Order''). See Securities Exchange
Act Release No. 43268 (September 11, 2000) and Administrative
Proceeding File No. 3-10282. As noted, the Plan is designed to
create, implement and maintain a CAT that would capture customer and
order event information for orders in NMS Securities and OTC Equity
Securities, across all markets, from the time of order inception
through routing, cancellation, modification, or execution in a
single consolidated data source. The Exchange has already adopted
rules to enforce compliance by its Industry Members, as applicable,
with the provisions of the Plan. See Securities Exchange Act Release
No. 80256 (March 15, 2017), 82 FR 14526 (March 21, 2017) (SR-
NYSEMKT-2017-02) (Order Approving Proposed Rule Changes to Adopt
Consolidated Audit Trail Compliance Rules). Once the CAT is fully
operational, it will be appropriate to delete Exchange rules
implemented to comply with the Order as duplicative of the CAT.
Accordingly, the Exchange believes that the Exchange would continue
to be in compliance with the requirements of the Order once the CAT
is fully operational and the COATS rules are deleted.
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    The Exchange has determined that the requirements of subsections
(a)(1)-(13) of Rule 956NY, which implement certain requirements related
to COATS, are duplicative of information available in the CAT and thus
will no longer be necessary once the CAT is operational.\15\
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    \15\ Rule 956NY requires ATP Holders to maintain and preserve a
record of every order and of any other instructions given or
received for the purchase or sale of options contracts, including
the terms and conditions of the orders (such as whether the order is
a market or limit order), the order entry date and time, and the
date and time of any modification of the terms of the order or
cancellation of the order, or other specific data elements. The
Exchange proposes to replace the current data elements in
subsections (a)(1)-(13) with the phrase ``the elements required by
the Rule 6800 Series.''
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    The Participants have provided COATS technical specifications to
the Plan Processor for the CAT for use in developing the Technical
Specifications for the CAT, and the Participants are working with the
Plan Processor to include the necessary COATS data elements in the CAT
Technical Specifications. Accordingly, although the Technical
Specifications for the CAT have not yet been finalized, the Exchange
and the other options exchanges propose to eliminate COATS in
accordance with the proposed timeline discussed below.
Timeline for Elimination of Duplicative Rules
    The CAT NMS Plan states that the elimination of rules that are
duplicative of the requirements of the CAT and the retirement of the
related systems should be effective at such time as CAT Data meets
minimum standards of accuracy and reliability.\16\ As discussed below,
the Exchange and the other options exchanges believe that COATS may be
retired at a date after all Industry Members are reporting to the CAT
when the proposed error rate thresholds have been met, and the Exchange
has determined that its usage of the CAT Data has not revealed material
issues that have not been corrected, confirmed that the CAT includes
all data necessary to allow the Exchange to continue to meet its
surveillance obligations, and confirmed that the Plan Processor is
sufficiently meeting all of its obligations under the CAT NMS Plan.
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    \16\ See Appendix C of CAT NMS Plan, Approval Order at 85010.
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    The Exchange believes COATS should not be retired until all
Participants and Industry Members that report data to COATS are
reporting comparable data to the CAT. In this way, the Exchange will
continue to have access to the necessary data to perform its regulatory
duties.
    The CAT NMS Plan requires that a rule filing to eliminate a
duplicative rule address whether ``the availability of certain data
from Small Industry Members two years after the Effective Date would
facilitate a more expeditious retirement of duplicative systems.'' \17\
The Exchange believes COATS should not be retired until all
Participants and Industry Members that report data to COATS are
reporting comparable data to the CAT. While the early submission of

options data to the CAT by Small Industry Members could expedite the
retirement of COATS, the Exchange believes that it premature to
consider such a change and that additional analysis would be necessary
to determine whether such early reporting by Small Industry Members
would be feasible.
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    \17\ Id.
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    The CAT NMS Plan requires that this rule filing address ``whether
individual Industry Members can be exempted from reporting to
duplicative systems once their CAT reporting meets specified accuracy
and reliability standards, including, but not limited to, ways in which
establishing cross-system regulatory functionality or integrating data
from existing systems and the CAT would facilitate such Individual
Industry Member exemptions.'' \18\
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    \18\ Id.
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    The Exchange believes that a single cut-over from COATS to CAT is
highly preferable to a firm-by-firm approach and is not proposing to
exempt members from the COATS requirements on a firm-by-firm basis. The
Exchange and the other options exchanges believe that providing such
individual exemptions to Industry Members would be inefficient, more
costly, and less reliable than the single cut-over. Providing
individual exemptions would require the options exchanges to create,
for a brief temporary period, a cross-system regulatory function and to
integrate data from COATS and the CAT to avoid creating any regulatory
gaps as a result of such exemptions. Such a function would be costly to
create and would give rise to a greater likelihood of data errors or
other issues. Given the limited time in which such exemptions would be
necessary, the Exchange and the other options exchanges do not believe
that such exemptions would be an appropriate use of limited resources.
The CAT NMS Plan also requires that a rule filing to eliminate a
duplicative rule to provide ``specific accuracy and reliability
standards that will determine when duplicative systems will be retired,
including, but not limited to, whether the attainment of a certain
Error Rate should determine when a system duplicative of the CAT can be
retired.'' \19\ The Exchange believes that it is critical that the CAT
Data be sufficiently accurate and reliable for the Exchange to perform
the regulatory functions that it now performs via COATS. Accordingly,
the Exchange believes that the CAT Data should meet specific
quantitative error rates, as well as certain qualitative requirements.
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    \19\ Id.
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    The Exchange and the other options exchanges believe that, before
COATS may be retired, the CAT would need to achieve a sustained error
rate for a period of at least 180 days of 5% or lower measured on a
pre-correction or as-submitted basis, and 2% or lower on a post-
correction basis (measured at T+5).\20\ The Exchange proposes to
measure the 5% pre-correction and 2% post-correction thresholds by
averaging the error rate across the period, not require a 5% pre-
correction and 2% post-correction maximum each day for 180 consecutive
days. The Exchange believes that measuring each of the thresholds over
the course of 180 days will ensure that the CAT consistently meets
minimum accuracy and reliability thresholds while also ensuring that
single-day measurements do not unduly affect the overall measurements.
The Exchange proposes to measure the appropriate error rates in the
aggregate, rather than firm-by-firm. In addition, the Exchange proposes
to measure the error rates for options only, not equity securities, as
only options are subject to COATS. The 2% and 5% error rates are in
line with the proposed retirement threshold for FINRA's Order Audit
Trail System (``OATS'').
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    \20\ The Plan requires that the Plan Processor must ensure that
regulators have access to corrected and linked order and Customer
data by 8:00 a.m. Eastern Time on T+5. See CAT NMS Plan, at C-15.
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    In addition to these minimum error rates before COATS can be
retired, the Exchange believes that during the minimum 180-day period
during which the thresholds are calculated, the Exchange's use of the
data in the CAT must confirm that (i) usage over that time period has
not revealed material issues that have not been corrected, (ii) the CAT
includes all data necessary to allow the Exchange to continue to meet
its surveillance obligations, and (iii) the Plan Processor is
sufficiently meeting all of its obligations under the CAT NMS Plan. The
Exchange believes this time period to use the CAT Data is necessary to
reveal any errors that may manifest themselves only after surveillance
patterns and other queries have been run and to confirm that the Plan
Processor is meeting its obligations and performing its functions
adequately.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\21\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\22\ in particular, because it
is designed to prevent fraudulent and manipulative acts and practices,
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 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.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78f(b).
    \22\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In particular, the Exchange believes that the proposed rule change
is consistent with the Exchange Act because it fulfills the obligation
in the CAT NMS Plan for the Exchange to submit a proposed rule change
to eliminate or modify duplicative rules. In approving the Plan, the
SEC noted that the Plan ``is necessary and appropriate in the public
interest, for the protection of investors and the maintenance of fair
and orderly markets, to remove impediments to, and perfect the
mechanism of a national market system, or is otherwise in furtherance
of the purposes of the Act.'' \23\ As this proposal implements the
Plan, the Exchange believes that this proposal furthers the objectives
of the Plan, as identified by the SEC, and is therefore consistent with
the Exchange Act.
---------------------------------------------------------------------------

    \23\ Approval Order at 84697.
---------------------------------------------------------------------------

    Moreover, the purpose of the proposed rule change is to eliminate
rules that require the submission of duplicative data to the Exchange.
The elimination of such duplicative requirements will reduce
unnecessary costs and other compliance burdens for the Exchange and its
members, and therefore, will enhance the efficiency of the securities
markets. Furthermore, the Exchange believes that the approach set forth
in the proposed rule change strikes the appropriate balance between
ensuring that the Exchange is able to continue to fulfill its statutory
obligation to protect investors and the public interest by ensuring its
surveillance of market activity remains accurate and effective while
also establishing a reasonable timeframe for elimination or
modification of its rules that will be rendered duplicative after
implementation of the CAT.

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 proposed change is not
designed to address any competitive issue but rather implement
provisions of the CAT NMS Plan approved by the Commission regarding the
elimination of rules and

systems that are duplicative the CAT, and is designed to assist the
Exchange in meeting its regulatory obligations pursuant to the Plan.
Similarly, all options exchanges are proposing the elimination of COATS
and their rules related to COATS to implement the requirements of the
CAT NMS Plan. Therefore, this is not a competitive rule filing and,
therefore, it does not raise competition issues between and among the
options exchanges and/or their members.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

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

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2017-29 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2017-29. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2017-29, and should
be submitted on or before June 22, 2017.
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-11369 Filed 5-31-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: February 4, 2010 (Volume 75, Number 23)]
[Notices]
[Page 5782-5783]
[DOCID:fr04fe10-50]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

January 28, 2010.
    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using
the eLibrary link. Enter the docket number, excluding the last three
digits, in the docket number field to access the document. For
assistance, please contact FERC, Online Support at
<EMAIL_ADDRESS>or toll free at (866 ) 208-3676, or for TTY,
contact<PHONE_NUMBER>.

----------------------------------------------------------------------------------------------------------------
                  Docket No.                      File Date                  Presenter or requestor
----------------------------------------------------------------------------------------------------------------
Prohibited:
    1. EL10-19-000...........................          1-6-10  Richard A. Drom.
Exempt:
    1. CP09-35-000...........................         1-12-10  Sarah King\1\.
----------------------------------------------------------------------------------------------------------------
\1\ One of several form letters (notes) from Sarah King, C. Porkinson, Leighton Johnson, James T. Water, et al.
  addressing the proposed Palomar Pipeline Project.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-2267 Filed 2-3-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 226 (Friday, November 25, 2022)]
[Notices]
[Pages 72500-72501]
[FR Doc No: 2022-25763]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4673-DR; Docket ID FEMA-2022-0001]

Florida; Amendment No. 10 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Florida (FEMA-4673-DR), dated September 29, 2022, and
related determinations.

DATES: This amendment was issued October 27, 2022.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Florida is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of September 29, 2022.

    Duval County for debris removal [Category A] and permanent work
[Categories C-G] (already designated for emergency protective
measures [Category B], including direct federal assistance, under
the Public Assistance program).
    Pinellas County for permanent work (Categories C-G) (already
designated for Individual Assistance and assistance for debris
removal and emergency protective measures [Categories A and B],
including direct federal assistance, under the Public Assistance
program).
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,

Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-25763 Filed 11-23-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 80, Number 169 (Tuesday, September 1, 2015)]
[Notices]
[Pages 52824-52832]
[FR Doc No: 2015-21562]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-9898; 34-75764/August 26, 2015]

Order Making Fiscal Year 2016 Annual Adjustments to Registration
Fee Rates

I. Background

    The Commission collects fees under various provisions of the
securities laws. Section 6(b) of the Securities Act of 1933
(``Securities Act'') requires the Commission to collect fees from
issuers on the registration of securities.\1\ Section 13(e) of the
Securities Exchange Act of 1934 (``Exchange Act'') requires the
Commission to collect fees on specified repurchases of securities.\2\
Section 14(g) of the Exchange Act requires the Commission to collect
fees on proxy solicitations and statements in corporate control
transactions.\3\ These provisions require the Commission to make annual
adjustments to the fee rates applicable under these provisions.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 77f(b).
    \2\ 15 U.S.C. 78m(e).
    \3\ 15 U.S.C. 78n(g).
---------------------------------------------------------------------------

II. Fiscal Year 2016 Annual Adjustment to Fee Rates

    Section 6(b)(2) of the Securities Act requires the Commission to
make an annual adjustment to the fee rate applicable under Section
6(b).\4\ The annual adjustment to the fee rate under Section 6(b) of
the Securities Act also sets the annual adjustment to the fee rates
under Sections 13(e) and 14(g) of the Exchange Act.\5\
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 77f(b)(2). The annual adjustments are designed to
adjust the fee rate in a given fiscal year so that, when applied to
the aggregate maximum offering price at which securities are
proposed to be offered for the fiscal year, it is reasonably likely
to produce total fee collections under Section 6(b) equal to the
``target fee collection amount'' specified in Section 6(b)(6)(A) for
that fiscal year.
    \5\ 15 U.S.C. 78m(e)(4) and 15 U.S.C. 78n(g)(4).
---------------------------------------------------------------------------

    Section 6(b)(2) sets forth the method for determining the annual
adjustment to the fee rate under Section 6(b) for fiscal year 2016.
Specifically, the Commission must adjust the fee rate under Section
6(b) to a ``rate that, when applied to the baseline estimate of the
aggregate maximum offering prices for [fiscal year 2016], is reasonably
likely to produce aggregate fee collections under [Section 6(b)] that
are equal to the target fee collection amount for [fiscal year 2016].''
That is, the adjusted rate is determined by dividing the ``target fee
collection amount'' for fiscal year 2016 by the ``baseline estimate of
the aggregate maximum offering prices'' for fiscal year 2016.
    Section 6(b)(6)(A) specifies that the ``target fee collection
amount'' for fiscal year 2016 is $550,000,000. Section 6(b)(6)(B)
defines the ``baseline estimate of the aggregate maximum offering
prices'' for fiscal year 2016 as ``the baseline estimate of the
aggregate maximum offering price at which securities are proposed to be
offered pursuant to registration statements filed with the Commission
during [fiscal year 2016] as determined by the Commission, after
consultation with the Congressional Budget Office and the Office of
Management and Budget . . . .''
    To make the baseline estimate of the aggregate maximum offering
price for fiscal year 2016, the Commission used a methodology similar
to that developed in consultation with the Congressional Budget Office
(``CBO'') and Office of Management and Budget (``OMB'') to project the
aggregate offering price for purposes of the fiscal years 2011 through
2015 annual adjustments.\6\ Using this methodology, the Commission
determines the ``baseline estimate of the aggregate maximum offering
price'' for fiscal year 2016 to be $ 5,463,538,056,703.\7\ Based on
this estimate, the Commission calculates the fee rate for fiscal 2016
to be $100.70 per million. This adjusted fee rate applies to Section
6(b) of the Securities Act, as well as to Sections 13(e) and 14(g) of
the Exchange Act.
---------------------------------------------------------------------------

    \6\ For the fiscal year 2011 estimate, the Commission used a
ten-year series of monthly observations ending in March 2011. For
fiscal years 2012-2016, the Commission used a ten-year series ending
in July of the applicable year.
    \7\ Appendix A explains how we determined the ``baseline
estimate of the aggregate maximum offering price'' for fiscal year
2016 using our methodology, and then shows the arithmetical process
of calculating the fiscal year 2016 annual adjustment based on that
estimate. The appendix includes the data used by the Commission in
making its ``baseline estimate of the aggregate maximum offering
price'' for fiscal year 2016.
---------------------------------------------------------------------------

III. Effective Dates of the Annual Adjustments

    The fiscal year 2016 annual adjustments to the fee rates applicable
under Section 6(b) of the Securities Act and Sections 13(e) and 14(g)
of the Exchange Act will be effective on October 1, 2015.\8\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 77f(b)(4), 15 U.S.C. 78m(e)(6) and 15 U.S.C.
78n(g)(6).
---------------------------------------------------------------------------

IV. Conclusion

    Accordingly, pursuant to Section 6(b) of the Securities Act and
Sections 13(e) and 14(g) of the Exchange Act,\9\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 77f(b), 78m(e) and 78n(g).
---------------------------------------------------------------------------

    It is hereby ordered that the fee rates applicable under Section
6(b) of the Securities Act and Sections 13(e) and 14(g) of the Exchange
Act shall be $100.70 per million effective on October 1, 2015.

    By the Commission.
Brent J. Fields,
Secretary.

Appendix A

    Congress has established a target amount of monies to be
collected from fees charged to issuers based on the value of their
registrations. This appendix provides the formula for determining
such fees, which the Commission adjusts annually. Congress has
mandated that the Commission determine these fees based on the
``aggregate maximum offering prices,'' which measures the aggregate
dollar amount of securities registered with the Commission over the
course of the year. In order to maximize the likelihood that the
amount of monies targeted by Congress will be collected, the fee
rate must be set to reflect projected aggregate maximum offering
prices. As a percentage, the fee rate equals the ratio of the target
amounts of monies to the projected aggregate maximum offering
prices.
    For 2016, the Commission has estimated the aggregate maximum
offering prices by projecting forward the trend established in the
previous decade. More specifically, an ARIMA model was used to
forecast the value of the aggregate maximum offering prices for
months subsequent to July 2015, the last month for which the
Commission has data on the aggregate maximum offering prices.
    The following sections describe this process in detail.

A. Baseline Estimate of the Aggregate Maximum Offering Prices for
Fiscal Year 2016.

    First, calculate the aggregate maximum offering prices (AMOP)
for each month in the sample (July 2005-July 2015). Next, calculate
the percentage change in the AMOP from month to month.
    Model the monthly percentage change in AMOP as a first order
moving average process. The moving average approach allows one to
model the effect that an exceptionally high (or low) observation of
AMOP tends to be followed by a more ``typical'' value of AMOP.
    Use the estimated moving average model to forecast the monthly
percent change in AMOP. These percent changes can then be applied to
obtain forecasts of the total dollar value of registrations. The
following is a more formal (mathematical) description of the
procedure:

    1. Begin with the monthly data for AMOP. The sample spans ten
years, from July 2005 to July 2015.
    2. Divide each month's AMOP (column C) by the number of trading
days in that month (column B) to obtain the average daily AMOP
(AAMOP, column D).
    3. For each month t, the natural logarithm of AAMOP is reported
in column E.
    4. Calculate the change in log(AAMOP) from the previous month as
[Delta]t = log (AAMOPt) -
log(AAMOPt-1). This approximates the percentage change.
    5. Estimate the first order moving average model
[Delta]t = [alpha] + [beta]et-1 +
et, where et denotes the forecast error for
month t. The forecast error is simply the difference between the
one-month ahead forecast and the actual realization of
[Delta]t. The forecast error is expressed as
et = [Delta]t - [alpha] -
[beta]et-1. The model can be estimated using standard
commercially available software. Using least squares, the estimated
parameter values are [alpha] = 0.0000405 and [beta] = -0.85241.
    6. For the month of August 2015 forecast
[Delta]t = 8/15 = [alpha] + [beta]et = 7/15.
For all subsequent months, forecast [Delta]t = [alpha].
    7. Calculate forecasts of log(AAMOP). For example, the forecast
of log(AAMOP) for October 2015 is given by
FLAAMOPt = 10/15 = log(AAMOPt = 7/15) +
[Delta] t = 8/15 +[Delta] t = 9/15 + [Delta]
t = 10/15.
    8. Under the assumption that et is normally
distributed, the n-step ahead forecast of AAMOP is given by
exp(FLAAMOPt + [sigma]n\2\/2), where
[sigma]n denotes the standard error of the n-step ahead
forecast.
    9. For October 2015, this gives a forecast AAMOP of $21.425
billion (Column I), and a forecast AMOP of $471.3 billion (Column
J).
    10. Iterate this process through September 2016 to obtain a
baseline estimate of the aggregate maximum offering prices for
fiscal year 2016 of $ 5,463,538,056,703.

B. Using the Forecasts From A To Calculate the New Fee Rate

    1. Using the data from Table A, estimate the aggregate maximum
offering prices between 10/01/15 and 9/30/16 to be
$5,463,538,056,703.
    2. The rate necessary to collect the target $550,000,000 in fee
revenues set by Congress is then calculated as: $550,000,000 /
$5,463,538,056,703 = 0.00010067.
    3. Round the result to the seventh decimal point, yielding a
rate of 0.0001007 (or $100.70 per million).
BILLING CODE 8011-01-P

[GRAPHIC] [TIFF OMITTED] TN01SE15.011

[GRAPHIC] [TIFF OMITTED] TN01SE15.012

[GRAPHIC] [TIFF OMITTED] TN01SE15.013

[GRAPHIC] [TIFF OMITTED] TN01SE15.014

[GRAPHIC] [TIFF OMITTED] TN01SE15.015

[GRAPHIC] [TIFF OMITTED] TN01SE15.016

[FR Doc. 2015-21562 Filed 8-31-15; 8:45 a.m.]
BILLING CODE 8011-01-C


[Federal Register Volume 86, Number 155 (Monday, August 16, 2021)]
[Proposed Rules]
[Pages 45699-45701]
[FR Doc No: 2021-17441]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 /
Proposed Rules

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0497]
RIN 1625-AA00

Safety Zone; Potomac River, Prince William County, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard is proposing to establish a temporary safety
zone for certain waters of the Potomac River. This action is necessary
to provide for the safety of life on these navigable waters near Cherry
Hill, in Prince William County, VA, during a fireworks display on
September 18, 2021 (with alternate date of September 19, 2021). This
proposed rulemaking would prohibit persons and vessels from being in
the safety zone unless authorized by the Captain of the Port Maryland-
National Capital Region or a designated representative. We invite your
comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before August 31, 2021.

ADDRESSES: You may submit comments identified by docket number USCG-
2021-0497 using the Federal Decision Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Mr. Ron Houck, Sector Maryland-
National Capital Region Waterways Management Division, U.S. Coast
Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On June 16, 2021, Tim's Rivershore Restaurant and Crabhouse of
Dumfries, VA, notified the Coast Guard that it will be conducting a
fireworks display from 9:30 p.m. to 10 p.m. on September 18, 2021, to
commemorate the permanent closing of the restaurant after operating for
many years. Details of the fireworks event were provided to the Coast
Guard on August 5, 2021. The fireworks are to be launched from a barge
in the Potomac River in approximate position latitude 38[deg]34'07.97''
N, longitude 077[deg]15'37.39'' W, located near Cherry Hill, in Prince
William County, VA. In the event of inclement weather, the fireworks
display will be scheduled for September 19, 2021. The COTP Maryland-
National Capital Region has determined that potential hazards
associated with the fireworks to be used in this display would be a
safety concern for anyone within 500 feet of the barge.
    The Coast Guard is requesting that interested parties provide
comments within a shortened comment period of 15 days instead of the
typical 30 days for this notice of proposed rulemaking. The Coast Guard
believes the 15-day comment period still provides for a reasonable
amount of time for interested parties to review the proposal and
provide informed comments on it while also ensuring that the Coast
Guard has time to review and respond to any significant comments and
have a final rule in effect in time for the scheduled event.
    The Coast Guard is proposing this rulemaking under authority in 46
U.S.C. 70034 (previously 33 U.S.C. 1231).

III. Discussion of Proposed Rule

    The COTP is proposing to establish a temporary safety zone from
8:30 p.m. on September 18, 2021, to 11 p.m. on September 19, 2021. The
safety zone would be enforced from 8:30 p.m. to 11 p.m. on September
18, 2021, or, if necessary due to inclement weather on September 18,
2021, from 8:30 p.m. to 11 p.m. on September 19, 2021. The safety zone
would cover all navigable waters of the Potomac River within 500 feet
of the fireworks barge in approximate position latitude
38[deg]34'07.97'' N, longitude 077[deg]15'37.39'' W, located near
Cherry Hill, in Prince William County, VA. The size of the zone and
duration of the regulation are intended to ensure the safety of vessels
and these navigable waters before, during, and after the fireworks
display.
    No vessel or person would be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. The regulatory text we are proposing appears at the end
of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 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. This NPRM has not been designated a ``significant
regulatory action'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size,
duration, and time-of-day of the safety zone, which would impact small
designated area of the Potomac River for a total no more than 2.5 total
enforcement-hours during the evening when vessel traffic is normally
low. This portion of the waterway supports mainly recreational vessel
traffic, which at its peak, occurs during the summer season. Moreover,
the Coast Guard will issue Local Notices to Mariners and a Broadcast
Notice to Mariners via VHF-FM marine channel 16 about the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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. The Coast Guard certifies under 5
U.S.C. 605(b) that this proposed rule would not have a significant
economic impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please call or email the person listed in the FOR FURTHER INFORMATION
CONTACT section. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has a substantial direct effect on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would 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. If
you believe this proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

E. 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. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a safety
zone lasting 2.5 total enforcement hours that would prohibit entry
within a portion of the Potomac River. Normally such actions are
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
preliminary Record of Environmental Consideration supporting this
determination is available in the docket. For instructions on locating
the docket, see the ADDRESSES section of this preamble. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2021-0497 in the
``SEARCH'' box and click ``SEARCH.'' Next, look for this document in
the Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of the proposed rule. We may
choose not to post off-topic, inappropriate, or duplicate comments that
we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

List of Subjects in 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 is
proposing to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues 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.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T05-0497 to read as follows:

Sec.  165.T05-0497   Safety Zone; Potomac River, Prince William County,
VA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Potomac River, within 500 feet of the fireworks barge in
approximate position latitude 38[deg]34'07.97'' N, longitude
077[deg]15'37.39'' W, located near Cherry Hill, in Prince William
County, VA. These coordinates are based on datum NAD 83.
    (b) Definitions. As used in this section--
    Captain of the Port (COTP) means the Commander, U.S. Coast Guard
Sector Maryland-National Capital Region.
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty officer, or other officer
operating a Coast Guard vessel and a Federal, State, and local officer
designated by or assisting the Captain of the Port Maryland-National
Capital Region (COTP) in the enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by telephone at<PHONE_NUMBER> or on Marine Band Radio
VHF-FM channel 16 (156.8 MHz). Those in the safety zone must comply
with all lawful orders or directions given to them by the COTP or the
COTP's designated representative.
    (d) Enforcement officials. The U.S. Coast Guard may be assisted in
the patrol and enforcement of the safety zone by Federal, State, and
local agencies.
    (e) Enforcement period. This section will be enforced from 8:30
p.m. to 11 p.m. on September 18, 2021. If necessary due to inclement
weather on September 18, 2021, it will be enforced from 8:30 p.m. to 11
p.m. on September 19, 2021.

    Dated: August 10, 2021.
David E. O'Connell,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2021-17441 Filed 8-13-21; 8:45 am]
BILLING CODE 9110-04-P