[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Rules and Regulations]
[Pages 16203-16206]
[FR Doc No: 2014-06375]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R01-OAR-2012-0707; A-1-FRL-9908-37-Region 1]

Approval and Promulgation of State Plans (Negative Declarations)
for Designated Facilities and Pollutants: Connecticut, Maine, New
Hampshire, and Vermont; Withdrawal of State Plan for Designated
Facilities and Pollutants: New Hampshire; Technical Corrections to
Approved State Plans (Negative Declarations): Rhode Island and Vermont

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
negative declarations for hospital/medical/infectious waste
incinerators (HMIWI) for the State of Connecticut and the State of New
Hampshire and negative declarations for sewage sludge incinerators
(SSI) for the State of Maine and the State of Vermont. EPA is also
approving the withdrawal of a previously-approved State Plan for HMIWI
in the State of New Hampshire. Lastly, EPA is making technical
corrections to Clean Air Act Sections 111(d) and 129 State Plan
(Negative Declaration) approvals for Other Solid Waste Incinerators
(OSWI) for the State of Rhode Island and the State of Vermont.

DATES: This direct final rule will be effective May 27, 2014, unless
EPA receives adverse comments by April 24, 2014. If adverse comments
are received, EPA will publish a timely withdrawal of the direct final
rule in the Federal Register informing the public that the rule will
not take effect.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R01-OAR-2012-0707 by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``Docket Identification Number EPA-R01-OAR-2012-0707'',
Ida E. McDonnell, U.S. Environmental Protection Agency, EPA New England
Regional Office, Office of Ecosystem Protection, Air Permits, Toxics, &
Indoor Programs Unit, 5 Post Office Square--Suite 100, (Mail code
OEP05-2), Boston, MA 02109-3912.
    5. Hand Delivery or Courier. Deliver your comments to: Ida E.
McDonnell, U.S. Environmental Protection Agency, EPA New England
Regional Office, Office of Ecosystem Protection, Air Permits, Toxics, &
Indoor Programs Unit, 5 Post Office Square--Suite 100, (Mail code
OEP05-2), Boston, MA 02109-3912. Such deliveries are only accepted
during the Regional Office's normal hours of operation. The Regional
Office's official hours of business are Monday through Friday, 8:30
a.m. to 4:30 p.m., excluding legal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R01-OAR-
2012-0707. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through www.regulations.gov, or
email, information that you consider to be CBI or otherwise protected.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy at Office of Ecosystem Protection, U.S. Environmental
Protection Agency, EPA New England Regional Office, 5 Post Office
Square--Suite 100, Boston, MA. EPA requests that if at all possible,
you contact the contact listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 to 4:30, excluding
legal holidays.
    In addition, copies of the state submittal and EPA's technical
support document are also available for public inspection during normal
business

hours, by appointment at the Bureau of Air Management, Department of
Energy and Environmental Protection, State Office Building, 79 Elm
Street, Hartford, CT 06106-1630; Bureau of Air Quality Control,
Department of Environmental Protection, First Floor of the Tyson
Building, Augusta Mental Health Institute Complex, Augusta, ME 04333-
0017; Air Resources Division, Department of Environmental Services, 6
Hazen Drive, P.O. Box 95, Concord, NH 03302-0095; Office of Air
Resources, Department of Environmental Management, 235 Promenade
Street, Providence, RI 02908-5767; Vermont Department of Environmental
Conservation, Air Pollution Control Division, One National Life Drive,
Davis (North) Building 2nd Floor, Montpelier, VT 05620-3802).

FOR FURTHER INFORMATION CONTACT: Patrick Bird, Air Permits, Toxics, &
Indoor Programs Unit, Air Programs Branch, Office of Ecosystem
Protection, U.S. Environmental Protection Agency, Region 1, 5 Post
Office Square, Mail Code: OEP05-2, Boston, MA 02109-0287. The telephone
number is<PHONE_NUMBER>. Mr. Bird can also be reached via electronic
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.
    Organization of this document. The following outline is provided to
aid in locating information in this preamble.

I. Background
II. Hospital/Medical/Infectious Waste Incinerators
    A. Connecticut
    B. New Hampshire
III. Sewage Sludge Incinerators
    A. Maine
    B. Vermont
IV. Other Solid Waste Incinerators
    A. Rhode Island
    B. Vermont
V. Final Actions
VI. Statutory and Executive Order Reviews

I. Background

    Sections 111(d) and 129 of the Clean Air Act (the Act) require
submittal of state plans to control certain pollutants (designated
pollutants) at existing solid waste combustion facilities (designated
facilities) whenever standards of performance have been established
under section 111(b) for new sources of the same source category and
EPA has established emission guidelines for such existing sources. If a
state fails to submit a satisfactory plan, the Act provides EPA the
authority to prescribe a plan for regulating designated pollutants at
designated facilities. The EPA-prescribed plan, also known as a federal
plan, is generally delegated to states with designated facilities but
no EPA-approved state-specific plan. If no such designated facilities
exist within a state's jurisdiction, a state may submit a negative
declaration in lieu of a state plan.

II. Hospital/Medical/Infectious Waste Incinerators

    New source performance standards (NSPS) for new stationary source
hospital/medical/infectious waste incinerators (HMIWI) and emission
guidelines (EG) for existing source HMIWI were originally promulgated
on September 15, 1997 (62 FR 48348). The rule underwent a number of
revisions and amendments throughout the 2000s and was most recently
finalized on April 4, 2011 (76 FR 18407). EG for existing HMIWI are
applicable to units for which construction commenced on or before
December 1, 2008 or for which modification or reconstruction commenced
no later than April 6, 2010. EG for existing HMIWI are codified at 40
CFR Part 60, Subpart Ce.

A. Connecticut

    EPA inventoried one existing HMIWI in the State of Connecticut;
however the unit, owned by Bristol-Myers Squibb Company and located at
their Wallingford, CT facility, was rendered inoperable in early
September 2012. An inspection conducted on September 24, 2012 by the
Connecticut Department of Energy & Environmental Protection (CT DEEP)
confirmed the HMIWI was rendered inoperable, and therefore no longer
subject to HMIWI EG.
    CT DEEP intended to request delegation of the HMIWI federal plan.
With the closure of its only existing HMIWI unit, CT DEEP submitted a
negative declaration on January 25, 2013 indicating no existing HMIWI
operate within the State of Connecticut.

B. New Hampshire

    On August 8, 2011, the New Hampshire Department of Environmental
Services (NH DES) submitted a negative declaration certifying no
existing HMIWI operate within the State of New Hampshire. EPA published
approval of a New Hampshire State Plan for existing HMIWI on February
8, 2000 (65 FR 6008), and the August 2011 negative declaration could
not be approved until the State Plan was withdrawn by the State. On
September 9, 2011, NH DES formally requested EPA to withdraw the State
Plan for existing HIMWI, citing the closure of all HMIWI units in the
State. EPA requested documentation of the closure of certain HMIWI that
operated into the late 2000s. NH DES complied with this request, and on
October 9, 2012, submitted an updated negative declaration. The October
2012 negative declaration included supporting documents which
demonstrated the units in question were permanently shut down and
rendered inoperable. Furthermore, NH DES submitted documents citing RSA
125-N-6, a state regulation enacted by the General Court of New
Hampshire which prohibits the reactivation of closed HMIWIs or the
construction of new HMIWIs.

III. Sewage Sludge Incinerators

    NSPS for sewage sludge incinerators (SSI) for which construction
commenced after October 14, 2010 or modification or reconstruction
commenced after September 21, 2011 and EGs for existing SSI constructed
on or before October 14, 2010 were promulgated by EPA on March 21, 2011
(76 FR 15372). The EG for existing SSI are codified at 40 CFR Part 60,
Subpart MMMM.

A. Maine

    Maine Department of Environmental Protection (ME DEP) submitted a
negative declaration on July 20, 2012 certifying no existing SSI
operate within the State of Maine. ME DEP air and water licensing staff
confirmed the absence of existing SSI within the State's jurisdiction
prior to its submittal of the negative declaration.

B. Vermont

    Vermont Department of Environmental Conservation submitted a
negative declaration on February 10, 2012 certifying no existing SSI
operate within the State of Vermont.

IV. Other Solid Waste Incinerators

    NSPS for other solid waste incinerators (OSWI) for which
construction commenced after December 9, 2004 or modifications or
reconstruction commenced on or after June 16, 2006 and EGs for existing
OSWI constructed on or before December 9, 2004 were promulgated by EPA
on December 16, 2005 (70 FR 74870). The EG for existing OSWI are
codified at 40 CFR Part 60, Subpart FFFF.
    EPA became aware of two clerical errors inadvertently codified
under 40 CFR Part 62, Subpart OO (Rhode Island) and UU (Vermont). The
following paragraphs explain the errors in greater detail and discuss
the corrective actions EPA is making in today's Federal Register.

A. Rhode Island

    On April 6, 2007, EPA approved a negative declaration in lieu of a
state plan for existing OSWI in the State of Rhode Island (72 FR
17027). The approved regulatory text at 40 CFR 62.9995 incorrectly
states:

``On November 8, 2006, the Rhode Island Department of Environmental
Management submitted a letter certifying that there are no existing
other solid waste incineration units in the state subject to the
emission guidelines under part 60, subpart EEEE of this chapter.''

    40 CFR Part 60, Subpart EEEE refers to NSPS affecting new or
modified OSWI. 40 CFR 62.9995 must be amended by removing reference to
Subpart EEEE and adding reference to EG applicable to existing OSWI
codified at 40 CFR Part 60, Subpart FFFF.

B. Vermont

    On September 13, 2006, EPA approved a negative declaration in lieu
of a state plan for existing OSWI in the State of Vermont (71 FR
53972). The approved regulatory text at 40 CFR 62.11490 incorrectly
states:

``On June 30, 2006, the Vermont Department of Environmental
Conservation submitted a letter certifying that there are no existing
other solid waste incineration units in the state subject to the
emission guidelines under part 60, subpart EEEE of this chapter.''

    40 CFR Part 60, Subpart EEEE refers to NSPS affecting new or
modified OSWI. 40 CFR 62.11490 must be amended by removing reference to
Subpart EEEE and adding reference to EG applicable to existing OSWI
codified at 40 CFR Part 60, Subpart FFFF.

V. Final Actions

    EPA is approving the negative declarations for HMIWI for the State
of Connecticut and the State of New Hampshire and negative declarations
for SSI for the State of Maine and the State of Vermont. The negative
declarations satisfy the requirements of 40 CFR 62.06 and will serve in
lieu of CAA section 111(d)/129 state plans for the specified states and
source categories.
    EPA is approving the NH DES request for withdrawal of the New
Hampshire HMIWI State Plan. NH DES has successfully demonstrated that
no existing HMIWI operate within the State. The negative declaration
submitted by NH DES for existing HMIWI (also being approved in today's
action) will serve in lieu of a state plan.
    Lastly, EPA is approving technical corrections to 40 CFR Part 62,
Subpart OO (Rhode Island) and UU (Vermont). This action corrects
clerical errors made during the approval of OSWI State Plans (Negative
Declarations) for the State of Rhode Island and the State of Vermont.
    EPA is publishing these actions without prior proposal because the
Agency views these as noncontroversial amendments and anticipates no
adverse comments. However, in the proposed rules section of this
Federal Register publication, EPA is publishing a separate document
that will serve as the proposal to approve the negative declarations,
State Plan withdrawal, and technical corrections should relevant
adverse comments be filed. This rule will be effective May 27, 2014
without further notice unless the Agency receives relevant adverse
comments by April 24, 2014.
    If the EPA receives such comments, then EPA will publish a document
withdrawing the final rule and informing the public that the rule will
not take effect. All public comments received will then be addressed in
a subsequent final rule based on the proposed rule. The EPA will not
institute a second comment period on the proposed rule. All parties
interested in commenting on the proposed rule should do so at this
time. If no such comments are received, the public is advised that this
rule will be effective on May 27, 2014 and no further action will be
taken on the proposed rule. Please note that if EPA receives adverse
comment on an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, EPA may adopt
as final those provisions of the rule that are not the subject of an
adverse comment.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a 111(d)/
129 plan submission that complies with the provisions of the CAA and
applicable Federal regulations. 40 CFR 62.04. Thus, in reviewing
111(d)/129 plan submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because this direct final rulemaking is not approved to apply in Indian
country located in the state, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United

States Court of Appeals for the appropriate circuit by May 27, 2014.
Filing a petition for reconsideration by the Administrator of this
final rule does not affect the finality of this action for the purposes
of judicial review nor does it extend the time within which a petition
for judicial review may be filed, and shall not postpone the
effectiveness of such rule or action. Parties with objections to this
direct final rule are encouraged to file a comment in response to the
parallel notice of proposed rulemaking for this action published in the
proposed rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that EPA can withdraw this direct final rule and address the comment in
the proposed rulemaking. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 62

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.

    Dated: February 27, 2014.
H. Curtis Spalding,
 Regional Administrator, EPA New England.

    40 CFR part 62 is amended as follows:

PART 62--APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED
FACILITIES AND POLLUTANTS

0
1. The authority citation for part 62 continues to read as follows:

     Authority:  42 U.S.C. 7401 et seq.

Subpart H--Connecticut

0
2. Add Sec.  62.1725 and an undesignated heading to subpart H to read
as follows:

Air Emissions From Existing Hospital/Medical/Infectious Waste
Incineration Units

Sec.  62.1725  Identification of plan--negative declaration

    On January 25, 2013, the State of Connecticut Department of Energy
and Environmental Protection submitted a letter certifying no Hospital/
Medical/Infectious Waste Incineration units subject to 40 CFR part 60,
subpart Ce operate within its jurisdiction.

Subpart U--Maine

0
3. Add Sec.  62.4990 and a new undesignated center heading to subpart U
to read as follows:

Air Emissions From Existing Sewage Sludge Incineration Units

Sec.  62.4990  Identification of plan--negative declaration.

    On July 20, 2012, the State of Maine Department of Environmental
Protection submitted a letter certifying no Sewage Sludge Incineration
units subject to 40 CFR part 60, subpart MMMM operate within its
jurisdiction.

Subpart EE--New Hampshire

Sec.  62.7325  [Amended]

0
4. Amend Sec.  62.7325 by removing and reserving paragraphs (b)(2) and
(c)(2).
0
5. Revise Sec.  62.7450 to read as follows:

Sec.  62.7450  Identification of plan--negative declaration.

    On August 2, 2011, September 9, 2011, and October 9, 2012 the State
of New Hampshire Department of Environmental Services submitted letters
certifying no Hospital/Medical/Infectious Waste Incineration units
subject to 40 CFR part 60, subpart Ce operate within its jurisdiction.

Subpart OO--Rhode Island

0
6. Revise Sec.  62.9995 to read as follows:

Sec.  62.9995  Identification of plan--negative declaration.

    On November 8, 2006, The State of Rhode Island Department of
Environmental Management submitted a letter certifying no Other Solid
Waste Incineration units subject to 40 CFR part 60, subpart FFFF
operate within its jurisdiction.

Subpart UU--Vermont

0
7. Revise Sec.  62.11490 to read as follows:

Sec.  62.11490  Identification of plan--negative declaration.

    On June 30, 2006, the State of Vermont Department of Environmental
Conservation submitted a letter certifying no Other Solid Waste
Incineration units subject to 40 CFR part 60, subpart FFFF operate
within its jurisdiction.

0
8. Add Sec.  62.11495 and an undesignated center heading to subpart UU
to read as follows:

Air Emissions From Existing Sewage Sludge Incinerators

Sec.  62.11495  Identification of plan--negative declaration.

    On February 10, 2012, the State of Vermont Department of
Environmental Conservation submitted a letter certifying no Sewage
Sludge Incineration units subject to 40 CFR part 60, subpart MMMM
operate within its jurisdiction.

[FR Doc. 2014-06375 Filed 3-24-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 243 (Wednesday, December 20, 2023)]
[Notices]
[Pages 88186-88191]
[FR Doc No: 2023-27917]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-99175; File No. SR-PEARL-2023-69]

Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend the MIAX
Pearl Equities Fee Schedule

December 14, 2023.
    Pursuant to the provisions of 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 December 12, 2023, MIAX PEARL, LLC (``MIAX
Pearl'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') a 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 is filing a proposal to amend the fee schedule (the
``Fee Schedule'') applicable to MIAX Pearl Equities, an equities
trading facility of the Exchange.
    The text of the proposed rule change is available on the Exchange's
website at https://www.miaxglobal.com/markets/us-options/pearl-options/rule-filings, at MIAX Pearl's principal office, 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 amend the Fee Schedule to: (1) amend
Section 1)d) to modify the volume requirement in Tier 1 of the Remove
Volume Tiers \3\ applicable to executions of orders in securities
priced at or above $1.00 per share that remove liquidity from the
Exchange (``Removed Volume'') and eliminate Remove Volume Tier 2 and
the corresponding fee; and (2) amend Section 1)f) to modify the
expiration month (referred to herein as the ``sunset period'') for the
Step-Up Added Liquidity Rebate. The Exchange originally filed this
proposal on November 30, 2023 (SR-PEARL-2023-67). On December 12, 2023,
the Exchange withdrew SR-PEARL-2023-67 and refiled this proposal with
minor changes.
---------------------------------------------------------------------------

    \3\ See Fee Schedule, Section 1)d).
---------------------------------------------------------------------------

Remove Volume Tiers Table Changes
    Currently the Exchange charges a fee of $0.00295 per share for
executions of Removed Volume on the Exchange in securities priced at or
above $1.00 per share, except for executions of Removed Volume that
execute at the midpoint for non-displayed Midpoint Peg Orders \4\ in
all Tapes.\5\ The Exchange also offers a tiered pricing structure in
Section 1)d) of the Fee Schedule, Remove Volume Tiers, which provides
reduced fees for executions of Removed Volume on the Exchange in
securities priced at or above $1.00 per share based on certain volume
thresholds achieved by Equity Members.\6\ To achieve the reduced fees
of the Remove Volume Tiers, Equity Members must, (i) for Tier 1,
achieve an average daily volume (``ADV'') \7\ that is equal to or
greater than 0.10% of the total consolidated volume (``TCV'') \8\ and
execute at least 1,000 shares of added liquidity during the month; and
(ii) for Tier 2, achieve an ADV that is equal to or greater than 0.15%
of TCV and execute at least 1,000 shares of added liquidity during the
month. Equity Members that qualify for the discounted rates of the
Remove Volume Tiers in a particular month will be charged the lower fee
according to the threshold tier achieved instead of the standard Remove
Volume fee of $0.00295 per share for executions of orders in securities
priced at or above $1.00 per share in that particular month.
---------------------------------------------------------------------------

    \4\ See 2614(a)(3)(i)(A) for the definition of Midpoint Peg
Order.
    \5\ See Fee Schedule, Section 1)a) and Liquidity Indicator Codes
RA, Ra, RB, Rb, RC, Rc, Rp, RR, Rr, RT, and Rt.
    \6\ The term ``Equity Member'' is a Member authorized by the
Exchange to transact business on MIAX Pearl Equities. See Exchange
Rule 1901.
    \7\ ``ADV'' means average daily volume calculated as the number
of shares added or removed, combined, per day. ADV is calculated on
a monthly basis. See the Definitions Section of the Fee Schedule.
The Exchange excludes from its calculation of ADV shares added or
removed on any day that the Exchange's system experiences a
disruption that lasts for more than 60 minutes during regular
trading hours, on any day with a scheduled early market close, and
on the ``Russell Reconstitution Day'' (typically the last Friday in
June). Routed shares are also not included in the ADV calculation.
See id.
    \8\ ``TCV'' means total consolidated volume calculated as the
volume in shares reported by all exchanges and reporting facilities
to a consolidated transaction reporting plan for the month for which
the fees apply. The Exchange excludes from its calculation of TCV
volume on any given day that the Exchange's system experiences a
disruption that lasts for more than 60 minutes during Regular
Trading Hours, on any day with a scheduled early market close, and
on the ``Russell Reconstitution Day'' (typically the last Friday in
June). See the Definitions Section of the Fee Schedule.
---------------------------------------------------------------------------

    The Exchange proposes to increase the ADV requirement in Remove
Volume Tier 1 from 0.10% to now be 0.20% of TCV. The Exchange also
proposes to eliminate Remove Volume Tier 2 from the Fee Schedule.
Accordingly, with the proposed changes, to achieve the reduced fee of
Remove Volume Tier 1, Equity Members must achieve an ADV that is equal
to or greater than 0.20% of TCV and execute at least 1,000 shares of
added liquidity during the month.
    The purpose of this change is for business and competitive reasons.
The Exchange notes that despite the modest increase in volume ADV
requirement and elimination of Remove Volume Tier 2, the Exchange's
reduced fee and requirements to achieve Remove Volume Tier 1 remain
competitive with the fees to remove liquidity in securities priced at
or above $1.00 per share charged by other equity exchanges, including
other equity exchanges that also have reduced fees for meeting certain
criteria for removing liquidity.\9\
---------------------------------------------------------------------------

    \9\ See MEMX LLC (``MEMX'') Equities Fee Schedule, available at
https://info.memxtrading.com/equities-trading-resources/us-equities-fee-schedule/ (providing standard remove volume fee of $0.0030 per
share and reduced Liquidity Removal Tier fee of $0.00295 per share
so long as a member achieves an ADV greater than or equal to 0.60%
of TCV and a Removed Volume ADV greater than or equal to 0.30% of
TCV); see also Cboe EDGX Equities Fee Schedule, available at https://www.cboe.com/us/equities/membership/fee_schedule/edgx/ (providing a
standard fee of $0.0030 per share to remove liquidity in securities
priced at or above $1.00 per share, Remove Volume Tier 1 fee of
$0.0029 per share to remove liquidity in securities priced at or
above $1.00 per share so long as the member achieves an ADAV greater
than or equal to 0.25% of TCV).
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Step-Up Added Liquidity Rebate
    The Exchange currently provides a standard rebate of ($0.0024) \10\
per share for executions of orders in securities priced at or above
$1.00 per share that add displayed liquidity to the Exchange. The
Exchange also currently offers various volume-based tiers and
incentives through which an Equity Member may receive an enhanced
rebate for executions of orders that add displayed liquidity to the
Exchange by achieving the specified criteria that corresponds to a
particular tier/incentive.
---------------------------------------------------------------------------

    \10\ Rebates are indicated by parentheses. See the General Notes
Section of the Fee Schedule.
---------------------------------------------------------------------------

    In particular, the Exchange adopted a volume based pricing
incentive, referred to as the ``Step-Up Added Liquidity Rebate,'' in
which qualifying Equity Members receive an enhanced rebate of ($0.0031)
per share for executions of orders in securities priced at or above
$1.00 per share that add displayed liquidity to the Exchange.\11\ The
enhanced rebate provided by the Step-Up Added Liquidity Rebate applies
to Liquidity Indicator Codes AA (adds liquidity, displayed order, Tape
A), AB (adds liquidity, displayed order, Tape B) and AC (adds
liquidity, displayed order, Tape C).\12\
---------------------------------------------------------------------------

    \11\ See Securities Exchange Act Release No. 95614 (August 26,
2022), 87 FR 53813 (September 1, 2022) (SR-PEARL-2022-33).
    \12\ See Fee Schedule, Section 1)f), Step-Up Added Liquidity
Rebate, and Section 1)b), Liquidity Indicator Codes and Associated
Fees.
---------------------------------------------------------------------------

    Equity Members qualify for the Step-Up Added Liquidity Rebate by
achieving a ``Step-Up ADAV as a % of TCV'' \13\ of at least 0.03% over
the baseline month of May 2023. Average daily added volume (``ADAV'')
means average daily added volume calculated as the number of shares
added per day.\14\ For example, if an Equity Member had an ADAV as a
percent of TCV of 0.01% in May 2023, then that Equity Member has to
achieve an ADAV as a percent of TCV equal to or greater

than 0.04% in any subsequent month in order to qualify for the Step-Up
Added Liquidity Rebate. Currently, the Step-Up Added Liquidity Rebate
will expire no later than November 30, 2023.\15\
---------------------------------------------------------------------------

    \13\ The term ``Step-Up ADAV as a % of TCV'' means ADAV as a
percent of TCV in the relevant baseline month subtracted from the
current month's ADAV as a percent of TCV. See the Definitions
Section of the Fee Schedule. The Exchange notes that the Step-Up
Added Liquidity Rebate does not apply to executions of orders in
securities priced below $1.00 per share or executions of orders that
constitute added non-displayed liquidity.
    \14\ See the Definitions Section of the Fee Schedule. ADAV and
ADV are calculated on a monthly basis. See id.
    \15\ See Fee Schedule, Section 1)f).
---------------------------------------------------------------------------

    The Exchange now proposes to amend Section 1)f) of the Fee Schedule
so that the criteria to qualify for the Step-Up Added Liquidity Rebate
will expire no later than December 31, 2023.\16\ The Exchange will
issue an alert to market participants should the Exchange determine
that the Step-Up Added Liquidity Rebate will expire earlier than
December 31, 2023, or if the Exchange determines to amend the criteria
or rate applicable to the Step-Up Added Liquidity Rebate prior to the
end of the sunset period. The Exchange notes that at least one other
competing equities exchange provides a similar ``sunset period'' for
one of its enhanced rebates subject to the same baseline month as the
Exchange proposes.\17\
---------------------------------------------------------------------------

    \16\ The Exchange notes that at the end of the sunset period,
the Step-Up Added Liquidity Rebate will no longer apply unless the
Exchange files another 19b-4 Filing with the Commission to amend the
criteria terms.
    \17\ See MEMX Equities Fee Schedule, Liquidity Provision Tiers
table and corresponding footnotes ``*'' through ``***'', supra note
9.
---------------------------------------------------------------------------

    The Exchange does not propose any other changes to the qualifying
criteria for Equity Members to receive the Step-Up Added Liquidity
Rebate. The Exchange also does not propose to amend the amount of the
enhanced rebate of ($0.0031) per share for Equity Members that qualify
for the Step-Up Added Liquidity Rebate. Finally, the Exchange does not
propose to change the baseline ADAV of 0.00% of TCV used for firms that
become Equity Members of the Exchange after May 2023 for the purpose of
the Step-Up Added Liquidity Rebate calculation.
    This change simply extends the sunset period from November 30, 2023
until December 31, 2023. The Exchange believes that the Step-Up Added
Liquidity Rebate will continue to provide an incentive for Equity
Members to strive for higher ADAV on the Exchange (above their ADAV in
the baseline month of May 2023) to receive the enhanced rebate for
qualifying executions of orders in securities priced at or above $1.00
per share that add displayed liquidity to the Exchange. The Exchange
believes that with the extension of the sunset period the Step-Up Added
Liquidity Rebate will continue to encourage the submission of
additional displayed added liquidity to the Exchange, thereby promoting
price discovery and contributing to a deeper and more liquid market,
which benefits all market participants and enhances the attractiveness
of the Exchange as a trading venue.
    The purpose of this change is for business and competitive reasons.
Several competing equities exchanges continue to use a baseline month's
volume for their members as the requirements for higher rebates/lower
fees that is an older month than the Exchange's baseline month of May
2023 and many of those exchanges do not have a sunset provision.\18\ By
extending the sunset period, the Exchange will be able to continue to
compete with the enhanced rebates offered by competing exchanges that
use older baseline months' volume in their requirements for the higher
rebates/lower fees.
---------------------------------------------------------------------------

    \18\ See NYSE Arca Equities Fee Schedule, Section VII, Step Up
Tiers table, footnote ``(b),'' available at https://www.nyse.com/publicdocs/nyse/markets/nyse-arca/NYSE_Arca_Marketplace_Fees.pdf
(providing enhanced rebate of $0.0036 per share on all LMM add
volume if the ETP Holder, together with its affiliates, executes
Tape B adding ADV that is at least 40% over the ETP Holder's adding
ADV in Q3 2019, as a percentage of Tape B CADV with no sunset
provision); Cboe BYX Equities Fee Schedule, Step-Up Tier table,
available at https://www.cboe.com/us/equities/membership/fee_schedule/byx/ (providing reduced fee if the member has a
combined Step-Up Auction ADV and Step-Up ADAV from April 2022
greater than or equal to 3,000,000 and the member has a combined
Auction ADV and ADAV greater than or equal to 0.25% of TCV with no
sunset provision).
---------------------------------------------------------------------------

Implementation
    The proposed changes are immediately effective.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Fee Schedule
is consistent with Section 6(b) of the Act \19\ in general, and
furthers the objectives of Section 6(b)(4) of the Act \20\ in
particular, in that it is an equitable allocation of reasonable fees
and other charges among its Equity Members and issuers and other
persons using its facilities and is not designed to permit unfair
discrimination between customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78f(b).
    \20\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange operates in a highly fragmented and competitive market
in which market participants can readily direct their order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. More specifically, the
Exchange is only one of sixteen registered equities exchanges, and
there are a number of alternative trading systems and other off-
exchange venues, to which market participants may direct their order
flow. Based on publicly available information, no single registered
equities exchange had more than approximately 15.58% of the total
market share of executed volume of equities trading for the month of
November 2023.\21\ Thus, in such a low-concentrated and highly
competitive market, no single equities exchange possesses significant
pricing power in the execution of order flow, and the Exchange
represented approximately 2.08% of the overall equities market share
for the month of November 2023.\22\ The Commission and the courts have
repeatedly expressed their preference for competition over regulatory
intervention in determining prices, products, and services in the
securities markets. In Regulation NMS, the Commission highlighted the
importance of market forces in determining prices and SRO revenues and
also recognized that current regulation of the market system ``has been
remarkably successful in promoting market competition in its broader
forms that are most important to investors and listed companies.'' \23\
---------------------------------------------------------------------------

    \21\ See the ``Market Share'' section of the Exchange's website,
available at https://www.miaxglobal.com/ (last visited December 12,
2023).
    \22\ See id.
    \23\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37499 (June 29, 2005).
---------------------------------------------------------------------------

    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
shift order flow or discontinue to reduce use of certain categories of
products, in response to new or different pricing structures being
introduced into the market. Accordingly, competitive forces constrain
the Exchange's transaction fees and rebates, and market participants
can readily trade on competing venues if they deem pricing levels at
those other venues to be more favorable. The Exchange believes the
proposal reflects a reasonable and competitive pricing structure
designed to continue to incentivize market participants to direct
additional orders that add liquidity to the Exchange in securities
priced at or above $1.00 per share, which the Exchange believes would
deepen liquidity and promote market quality on the Exchange to the
benefit of all market participants.
    The Exchange notes that volume-based incentives and discounts (such
as tiers) have been widely adopted by exchanges (including the
Exchange), and believes they are reasonable, equitable and not unfairly
discriminatory because they are available to all Equity Members on an
equal basis, provide additional benefits or discounts that are
reasonably related

to the value of an exchange's market quality associated with higher
levels of market activity (such as higher levels of liquidity provision
and/or growth patterns), and the introduction of higher volumes of
orders into the price and volume discovery process.
    The Exchange believes its proposal to increase the ADV requirement
in Remove Volume Tier 1 and eliminate Remove Volume Tier 2 from the Fee
Schedule is reasonable, equitably allocated and not unfairly
discriminatory because the reduced fee for Remove Volume Tier 1 will
continue to be available to all Equity Members on an equal basis, and
is reasonably designed to encourage Equity Members to maintain or
increase their order flow. The Exchange believes that even with this
proposal, the reduced fee of Remove Volume Tier 1 will continue to
promote price discovery, enhance liquidity and market quality, and
contribute to a more robust and well-balanced market ecosystem on the
Exchange to the benefit of all Equity Members and market participants.
    Further, the Exchange believes its proposal to increase the ADV
requirement in Remove Volume Tier 1 from 0.10% to now be 0.20% of TCV
and eliminate Remove Volume Tier 2 is reasonable, equitably allocated
and not unfairly discriminatory because, despite the modest increase in
ADV requirement and elimination of Remove Volume Tier 2, the Exchange's
reduced fee and requirements to achieve Remove Volume Tier 1 remain
competitive with the fees to remove liquidity in securities priced at
or above $1.00 per share charged by other equity exchanges, including
other equity exchanges that also have reduced fees for meeting certain
criteria for removing liquidity.\24\
---------------------------------------------------------------------------

    \24\ See supra note 9.
---------------------------------------------------------------------------

    The Exchange believes that the Step-Up Added Liquidity Rebate, as
modified by the proposed change to the sunset period, is reasonable,
equitable and not unfairly discriminatory as the Step-Up Added
Liquidity Rebate will continue to be available to all Equity Members on
an equal basis, and is reasonably designed to encourage Equity Members
to maintain or increase their order flow in liquidity-adding volume.
The Exchange believes this will continue to promote price discovery,
enhance liquidity and market quality, and contribute to a more robust
and well-balanced market ecosystem on the Exchange to the benefit of
all Equity Members and market participants.
    In addition, the Exchange believes its proposal is reasonable
because several competing equities exchanges continue to use a baseline
month's volume for their members as the requirement for higher rebates/
lower fees that is an older month than the Exchange's baseline month of
May 2023 and many of those exchanges do not have a sunset
provision.\25\ By extending the sunset period, the Exchange will be
able to continue to compete with the enhanced rebates offered by
competing exchanges that use older baseline months' volume in their
requirements for the higher rebates/lower fees.
---------------------------------------------------------------------------

    \25\ See supra note 18.
---------------------------------------------------------------------------

    The Exchange believes it is reasonable, equitable and not unfairly
discriminatory to amend the sunset period in the Fee Schedule for the
Step-Up Added Liquidity Rebate because it will provide clarity to
Equity Members that, unless the Exchange determines to amend or
otherwise modify the Step-Up Added Liquidity Rebate, the Step-Up Added
Liquidity Rebate will expire at the end of the sunset period. This will
allow Equity Members to take into account that the enhanced rebate
provided for by the Step-Up Added Liquidity Rebate may be discontinued
at the end of sunset period unless the Exchange announces otherwise and
files a revised proposal with the Commission. The Exchange further
notes that it will issue an alert to market participants should the
Exchange determine that the Step-Up Added Liquidity Rebate will expire
earlier than December 31, 2023, or if the Exchange determines to amend
the criteria or rate applicable to the Step-Up Added Liquidity Rebate
prior to the end of the sunset period.

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

    The Exchange believes that the proposed change will not impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.
Intramarket Competition
    The Exchange believes that its proposal will not impose any burden
on intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange believes the Step-
Up Added Liquidity Rebate, as modified by this proposal, will continue
to incentivize Equity Members to submit additional orders that add
liquidity to the Exchange, thereby contributing to a deeper and more
liquid market and promoting price discovery and market quality on the
Exchange to the benefit of all market participants and enhancing the
attractiveness of the Exchange as a trading venue, which the Exchange
believes, in turn, would continue to encourage market participants to
direct additional order flow to the Exchange. Greater liquidity
benefits all Equity Members by providing more trading opportunities and
encourages Equity Members to send additional orders to the Exchange,
thereby contributing to robust levels of liquidity, which benefits all
market participants. As described above, the Exchange believes its
proposal to increase the ADV requirement in Remove Volume Tier 1 from
0.10% to now be 0.20% of TCV and eliminate Remove Volume Tier 2 allows
the Exchange's reduced Removed Volume fee to remain competitive with
the fees to remove liquidity in securities priced at or above $1.00 per
share charged by other equity exchanges, including other equity
exchanges that also have reduced fees for meeting certain criteria for
removing liquidity.\26\ Similarly, the opportunity to qualify for the
proposed new Step-Up Added Liquidity Rebate, and thus receive the
proposed rebate for qualifying executions of orders in securities
priced at or above $1.00 per share that add displayed volume will
continue to be available to all Equity Members that meet the associated
volume requirement, and the Exchange believes the proposed extension of
the sunset period is reasonably related to the enhanced market quality
that the Step-Up Added Liquidity Rebate is designed to promote.
Accordingly, the Exchange does not believe the proposed changes would
impose any burden on intramarket competition that is not necessary or
appropriate in furtherance of the purpose of the Act.
---------------------------------------------------------------------------

    \26\ See supra note 9.
---------------------------------------------------------------------------

    The Exchange believes its proposal to extend the sunset period in
the Fee Schedule for the Step-Up Added Liquidity Rebate will not impose
any burden on intramarket competition not necessary or appropriate in
furtherance of the purposes of the Act because it will provide clarity
to Equity Members that, unless the Exchange determines to amend or
otherwise modify the Step-Up Added Liquidity Rebate, the Step-Up Added
Liquidity Rebate will be discontinued at the end of the sunset period.
This will allow Equity Members to take into account that the enhanced
rebate provided for by the Step-Up Added Liquidity Rebate may be
discontinued at the end of the sunset period unless the Exchange
announces otherwise. The Exchange further notes that it will issue an
alert to market participants should the Exchange determine that the
Step-Up Added

Liquidity Rebate will expire earlier than December 31, 2023, or if the
Exchange determines to amend the criteria or rate applicable to the
Step-Up Added Liquidity Rebate prior to the end of the sunset period.
Intermarket Competition
    The Exchange believes its proposal will benefit competition, and
the Exchange notes that it operates in a highly competitive market.
Equity Members have numerous alternative venues they may participate on
and direct their order flow to, including fifteen other equities
exchanges and numerous alternative trading systems and other off-
exchange venues. As noted above, based on publicly available
information, no single registered equities exchange had more than
approximately 15.58% of the total market share of executed volume of
equities trading for the month of November 2023.\27\ Thus, in such a
low-concentrated and highly competitive market, no single equities
exchange possesses significant pricing power in the execution of order
flow, and the Exchange represented approximately 2.08% of the overall
market for the month of November 2023.\28\ Moreover, the Exchange
believes that the ever-shifting market share among the exchanges from
month to month demonstrates that market participants can shift order
flow in response to new or different pricing structures being
introduced to the market. Accordingly, competitive forces constrain the
Exchange's transaction fees and rebates generally, including with
respect to the criteria for Equity Members to achieve Remove Volume
Tier 1 and the Step-Up Added Liquidity Rebate, and market participants
can readily choose to send their orders to other exchanges and off-
exchange venues if they deem rebate criteria at those other venues to
be more favorable.
---------------------------------------------------------------------------

    \27\ See supra note 21.
    \28\ See id.
---------------------------------------------------------------------------

    As described above, the proposed changes represent a competitive
proposal through which the Exchange is seeking to continue to encourage
additional order flow to the Exchange through a volume-based incentive
that is comparable to the criteria for volume-based incentives adopted
by at least one other competing exchange that has a similar sunset
period for a specific enhanced rebate that adds liquidity to that
market.\29\ Accordingly, the Exchange believes that its proposal would
not burden, but rather promote, intermarket competition by enabling it
to better compete with other exchanges that offer similar pricing
incentives to market participants that achieve certain volume criteria
and thresholds.
---------------------------------------------------------------------------

    \29\ See supra note 17.
---------------------------------------------------------------------------

    Additionally, the Commission has repeatedly expressed its
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. Specifically,
in Regulation NMS, the Commission highlighted the importance of market
forces in determining prices and SRO revenues and, also, recognized
that current regulation of the market system ``has been remarkably
successful in promoting market competition in its broader forms that
are most important to investors and listed companies.'' \30\ The fact
that this market is competitive has also long been recognized by the
courts. In NetCoalition v. Securities and Exchange Commission, the D.C.
circuit stated: ``[n]o one disputes that competition for order flow is
`fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their routing agents, have a wide range of choices of where to
route orders for execution'; [and] `no exchange can afford to take its
market share percentages for granted' because `no exchange possesses a
monopoly, regulatory or otherwise, in the execution of order flow from
broker dealers' . . .''.\31\ Accordingly, the Exchange does not believe
its proposed pricing changes impose any burden on competition that is
not necessary or appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \30\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005).
    \31\ See NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSE-2006-21)).
---------------------------------------------------------------------------

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\32\ and Rule 19b-4(f)(2) \33\ thereunder.
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 necessary or appropriate
in the public interest, for the protection of investors, or 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.
---------------------------------------------------------------------------

    \32\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \33\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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 (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-PEARL-2023-69 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-PEARL-2023-69. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All

submissions should refer to file number SR-PEARL-2023-69 and should be
submitted on or before January 10, 2024.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\34\
---------------------------------------------------------------------------

    \34\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-27917 Filed 12-19-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 182 (Wednesday, September 21, 2022)]
[Notices]
[Page 57741]
[FR Doc No: 2022-20372]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95781; File No. SR-MRX-2022-07]

Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of
Withdrawal of Proposed Rule Change To Amend Options 7, Section 5 To Add
Membership Fees

September 15, 2022.
    On June 29, 2022, Nasdaq MRX, LLC (``MRX'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 \1\ and Rule
19b-4 thereunder,\2\ a proposed rule change to assess membership fees.
The proposed rule change was published for comment in the Federal
Register on July 18, 2022.\3\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 95264 (July 12,
2022), 87 FR 42767.
---------------------------------------------------------------------------

    On August 25, 2022, MRX withdrew the proposed rule change (SR-MRX-
2022-07).
---------------------------------------------------------------------------

    \4\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\4\
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-20372 Filed 9-20-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Notices]
[Pages 33554-33555]
[FR Doc No: 2017-15219]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket No. NHTSA-2017-0051]

Reports, Forms, and Record Keeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Request for public comment on proposed collection of
information.

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

SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatements of previously approved collections. This
document describes the collection of information for which NHTSA
intends to seek OMB approval.

DATES: Comments must be received on or before September 18, 2017.

ADDRESSES: You may submit comments identified by DOT Docket Number
NHTSA-2017-0051 using any of the following methods:
    Electronic submissions: Go to http://www.regulations.gov. Follow
the online instructions for submitting comments.
    Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590.
    Hand Delivery: West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Fax: 1-202-493-2251.
    Each submission must include the agency name and the docket number
for this notice. Note that all comments received will be posted without
change to http://www.regulations.gov, including any personal
information provided.

FOR FURTHER INFORMATION CONTACT: Kathy J. Sifrit, Contracting Officer's
Representative, Office of Behavioral Safety Research (NPD-320),
National Highway Traffic Safety Administration, 1200 New Jersey Avenue
SE, W46-466, Washington, DC 20590. Dr. Sifrit's phone number is 202-
366-0868, and her email address is<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulations (at 5 CFR
1320.8(d)), an agency must ask for public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) How to enhance the quality, utility, and clarity of the
information to be collected; and
    (iv) How to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks public comment on
the following proposed collection of information:
    Title: Older Driver Rearview Video Systems.
    Type of Request: New information collection.
    OMB Clearance Number: None.
    Form Number: NHTSA Forms 1398 and 1399.
    Requested Expiration Date of Approval: 3 years from date of
approval.
    Summary of the Collection of Information: The National Highway
Traffic Safety Administration (NHTSA) proposes to collect information
from older licensed drivers about their driving performance, driving
habits, and levels of familiarity with rearview video systems (RVSs),
and to measure their ability to avoid obstacles while backing using an
RVS as compared to using only mirrors and shoulder checks. Following

initial data collection, the research team will develop a training
protocol based on common errors participants made during the first
study segment. During the training segment of the study, a new sample
of participants will complete backing tasks similar to those in the
first segment. Then participants will be randomly assigned to either a
training group or a placebo group. Following training all participants
will again complete a series of backing tasks. Analyses will test
whether the training improved drivers' ability to use the RVS
appropriately. This research would give the traffic safety community
greater insight into the extent to which older drivers are able to use
RVSs effectively and whether training in proper use of the devices
improves their ability to use the systems to back safely.
    Study participation will be voluntary and will be solicited among
residents of residential communities, senior centers, and/or service-
or faith-based organizations in the southeastern Pennsylvania area
through community newsletters and other community media. Interested
older adults will attend a public meeting to learn about the research
opportunity including inclusion and exclusion criteria. Following the
meeting, interested older adults will provide their name and telephone
number on a signup sheet. A project assistant will then call
individuals on the signup sheet and conduct a brief telephone pre-
screening to ensure that all participants meet inclusion and exclusion
criteria; the project assistant will also answer questions about study
participation. For interested candidate participants who meet inclusion
criteria, the project assistant will make appointments to conduct
either a controlled, off-road backing performance evaluation or a
training protocol evaluation, at a mutually convenient time. At the
beginning of the appointment, the project assistant will obtain a
signature from each participant on an informed consent. A driving
rehabilitation specialist (DRS) will then conduct the off-road backing
performance evaluation or training protocol evaluation. Participants
will then receive compensation of $100 for study participation.
    Throughout the project, the privacy of all participants would be
protected. Access to the participants' data would be controlled using
password-protection for both the computer and the files. Personally-
identifiable information, such as participants' postal addresses, would
be kept separate from the data collected and would be stored in a wall
safe in password-protected folders on an external hard drive that is
only accessible to study staff who need to access such information. In
addition, all participant data would be reported in aggregate, and
identifying information would not be used in any reports resulting from
this data collection effort. Rigorous de-identification procedures
would be used to prevent participants from being identified through
reconstructive means.
    Description of the Need for the Information and Proposed Use of the
Information--NHTSA was established by the Highway Safety Act of l970
(23 U.S.C. 101) to carry out a Congressional mandate to reduce deaths,
injuries, and economic losses resulting from motor vehicle crashes on
the Nation's highways. As part of this mandate, NHTSA is authorized to
conduct research as a foundation for the development of traffic safety
programs.
    A 2014 final rule issued by NHTSA (Federal Motor Vehicle Safety
Standard No. 111, ``Rear visibility'') requires rear visibility
technology in all new vehicles with a Gross Vehicle Weight Rating
(GVWR) under 10,000 pounds by May 2018, but the anticipated safety
gains depend in part on the extent to which drivers understand and use
the technology as intended. This study has two purposes. The first
purpose is to assess the driving performance of adults 50 and older
using mirrors and an RVS while operating a motor vehicle in reverse.
The second purpose is to develop, implement, and assess the
effectiveness of an RVS training protocol. Findings will provide
information about whether people ages 50 and older differ in backing
performance when using RVS versus only mirrors, whether elements of RVS
use are particularly difficult for this cohort, and whether RVS
training improves older drivers' ability to avoid obstacles while
backing. NHTSA will use the information to inform recommendations to
the driving public regarding safe backing practices.
    Description of the Likely Respondents (Including Estimated Number,
and Proposed Frequency of Response to the Collection of Information)--
Respondents will include independently living licensed drivers, age 50
and older, in the southeastern Pennsylvania area. It is estimated that
300 one-time telephone conversations will be conducted with those who
sign up after the public meeting, to yield 200 participants. Of the 200
participants, 120 will complete a one-time controlled, off-road backing
performance evaluation that will inform the development of the
training. The remaining 80 will complete the one-time training protocol
evaluation.
    Estimate of the Total Annual Reporting and Record Keeping Burden
Resulting from the Collection of Information--The total estimated
burden for this information collection is 365 hours. The 300 telephone
pre-screening will average 15 minutes in length including introduction,
qualifying questions, potential participant questions, logistical
questions, and conclusion for an estimated total burden of 75 hours.
For the 120 participants who complete the controlled, off-road backing
performance evaluation, the estimated average burden is 75 minutes (15
minutes for the informed consent form plus 60 minutes for the backing
evaluation) for a total estimate of 150 hours. For the 80 participants
who complete the training protocol evaluation, the estimated average
burden is 105 minutes because of the additional 30 minutes for training
(or placebo) for a total estimate of 140 hours. Participants will incur
no costs from the data collection and participants will incur no record
keeping burden and no record keeping cost from the information
collection.

    Authority:  44 U.S.C. Section 3506(c)(2)(A).

    Issued in Washington, DC on July 17, 2017.
Jeff Michael,
Associate Administrator, Research and Program Development.
[FR Doc. 2017-15219 Filed 7-19-17; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 87, Number 244 (Wednesday, December 21, 2022)]
[Notices]
[Pages 78110-78111]
[FR Doc No: 2022-27710]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-P-1189]

Canned Tuna Deviating From Identity Standard; Amendment of
Temporary Marketing Permit

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending
StarKist Co.'s temporary permit to market test canned tuna. The
temporary permit is amended to add one additional manufacturing
location. This amendment will allow the applicant to continue to test
market and collect data on consumer acceptance of the test product.

FOR FURTHER INFORMATION CONTACT: Marjan Morravej, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 20, 2014 (79
FR 35362), we issued a notice announcing that we had issued a temporary
permit to StarKist Co., 225 North Shore Dr., Pittsburgh, PA 15212, to
market test products identified as canned tuna products. The permit
allowed for the test product to be manufactured at Galapesca S.A., Km.
12.5 Via A Duale, Guayaquil, Ecuador, and StarKist Samoa Co., 368 Atu'u
Rd., Pago Pago, American Samoa 96799. We issued the permit to
facilitate market testing of products that deviate from the
requirements of the standard of identity for canned tuna in 21 CFR
161.190, which was issued under section 401 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 341).
    In the Federal Register of March 7, 2016 (81 FR 11813), we issued a
notice announcing that we were extending the temporary market permit
issued to StarKist Co., among other parties. The extension allows the
applicants to continue to measure consumer acceptance of the products
and assess the commercial feasibility of the products, in support of a
petition to

amend the standard of identity for canned tuna. The new expiration date
of the permit will be either the effective date of a final rule
amending the standard of identity for canned tuna that may result from
the petition or 30 days after denial of the petition.
    In the Federal Register of March 5, 2021 (86 FR 12954), we issued a
notice announcing that we were amending the temporary permit issued to
StarKist Co. to allow the test product to be manufactured at three
additional plants: Tropical Canning (Thailand) Public Co., LTD., 1/1
M.2 T.Thungyai, Hatyai, Songkhla 90110, Thailand; ISA Value Co., Ltd.,
44/4 Moo1, Petchkasem Road, Yaicha, Sampran, Nakornpathom 73110,
Thailand; and Tri-Marine (Solomon Islands), Soltuna Ltd., 1 Tuna Dr.,
Noro, Western Province, Solomon Islands, and to increase the amount of
test product to 213,500,000 pounds (96,841,971 kilograms).
    In the Federal Register of December 28, 2021 (86 FR 73789), we
issued a notice announcing that we were amending the temporary permit
issued to StarKist Co. to increase the amount of test product to be
market tested to 217,900,000 pounds (98,837,777 kilograms) in retail
cans of various sizes and to allow the test product to be manufactured
at one additional plant: Soci[eacute]t[eacute] De Conserverie en
Afrique (SCA S.A.), Nouveau Quai de Peche-Mole 10-BP 782, Dakar,
Senegal.
    Under our regulations at 21 CFR 130.17(f), we are amending the
temporary permit issued to StarKist Co. to allow the test product to be
manufactured at one additional plant: RD Foods Americas, 48 S Franklin
Turnpike, Suite 204, Ramsey, NJ 07446 USA. All other conditions and
terms of this permit remain the same.

    Dated: December 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27710 Filed 12-20-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 14, 2009 (Volume 74, Number 92)]
[Notices]
[Page 22751-22752]
[DOCID:fr14my09-44]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0188]

Determination That DECADRON Tablets and Nine Other Drug Products
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined that the
10 drug products listed in this document were not withdrawn from sale
for reasons of safety or effectiveness. This determination means that
FDA will not begin procedures to withdraw approval of abbreviated new
drug applications (ANDAs) that refer to these drug products, and it
will allow FDA to continue to approve ANDAs that refer to the products
as long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. Sponsors of ANDAs do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(7)),
which requires FDA to publish a list of all approved drugs. FDA
publishes this list as part of the ``Approved Drug Products With
Therapeutic Equivalence Evaluations,'' which is generally known as the
``Orange Book.'' Under FDA regulations, a drug is withdrawn from the
list if the agency withdraws or suspends approval of the drug's NDA or
ANDA for reasons of safety or effectiveness, or if FDA determines that
the listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved; (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved; and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for reasons
of safety or effectiveness, the agency will initiate proceedings that
could result in the withdrawal of approval of the ANDAs that refer to
the listed drug.
    FDA has become aware that the drug products listed in the table in
this document are no longer being marketed. (As requested by the
applicant, FDA withdrew approval of NDA 18-821 for REGLAN
(metoclopramide) Oral Solution in the Federal Register of October 10,
2002 (67 FR 63107).)

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 11-664               DECADRON                 Merck & Co., P.O. Box
                          (dexamethasone)          4, BLA-20, West
                          Tablets, 0.5 milligram   Point, PA 19486
                          (mg) and 0.75 mg
------------------------------------------------------------------------
NDA 15-229               AMICAR (aminocaproic     Xanodyne
                          acid) Injection, 250     Pharmaceuticals,
                          mg/milliliter (mL)       Inc., One Riverfront
                                                   Pl., Newport, KY
                                                   41071-4563
------------------------------------------------------------------------

NDA 16-636               NARCAN (naloxone         Endo Pharmaceuticals,
                          hydrocholoride (HCl))    Inc., 100 Painters
                          Injection, 0.02 mg/mL,   Dr., Chadds Ford, PA
                          0.4 mg/mL, and 1 mg/mL   19317
------------------------------------------------------------------------
NDA 16-929               FUDR (floxuridine)       Hospira, Inc., 275
                          Injection, 500 mg/vial   North Field Dr., Lake
                                                   Forest, IL 60045
------------------------------------------------------------------------
NDA 18-538               LOZOL (indapamide)       Sanofi-Aventis U.S.,
                          Tablets, 1.25 mg and     55 Corporate Blvd.,
                          2.5 mg                   P.O. Box 5925,
                                                   Bridgewater, NJ 08807
------------------------------------------------------------------------
NDA 18-821               REGLAN (metaclopramide   A.H. Robins Co., c/o
                          HCl) Oral Solution,      Wyeth-Ayerst
                          equivalent to (EQ) 5     Research, P.O. Box
                          mg base/5 mL             8299, Philadelphia,
                                                   PA 19101-8299
------------------------------------------------------------------------
NDA 18-831               TRACRIUM (atracurium     Hospira, Inc.
                          besylate) Injection,
                          10 mg/mL
------------------------------------------------------------------------
NDA 18-831               TRACRIUM (atracurium     Do.
                          besylate) Preservative
                          Free Injection, 10 mg/
                          mL
------------------------------------------------------------------------
NDA 19-080               PROSOM (estazolam)       Abbott Laboratories,
                          Tablets, 1 mg and 2 mg   200 Abbott Park Rd.,
                                                   D-491, AP30-1E,
                                                   Abbott Park, IL 60064-
                                                   6157
------------------------------------------------------------------------
NDA 20-397               ZANAFLEX (tizanidine     Acorda Therapeutics,
                          HCL) Tablets, EQ 2 mg    15 Skyline Dr.,
                          base                     Hawthorne, NY 10532
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. Additional ANDAs that refer to these products may also be
approved by the agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for these drug
products should be revised to meet current standards, the agency will
advise ANDA applicants to submit such labeling.

    Dated: May 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-11217 Filed 5-13-09; 8:45 am]

BILLING CODE 4160-01-S


Document has been coded “C” Claimed Confidential Must be Requested
under the Freedom of Information Act.


[Federal Register Volume 80, Number 154 (Tuesday, August 11, 2015)]
[Notices]
[Pages 48092-48093]
[FR Doc No: 2015-19688]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: PR15-40-000.
    Applicants: Kinder Morgan Keystone Gas Storage LLC.
    Description: Submits tariff filing per 284.123(e) + (g): DART
Implementation Filing to be effective 10/1/2015; Filing Type: 1280.
    Filed Date: 7/31/15.
    Accession Number: 20150731-5093.
    Comments Due: 5 p.m. ET 8/21/15

    284.123(g) Protests Due: 5 p.m. ET 9/29/15.

    Docket Numbers: RP15-1179-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Section 4(d) Rate Filing: Negotiated Rate--J Aron to
be effective 9/1/2015.
    Filed Date: 8/4/15.
    Accession Number: 20150804-5042.
    Comments Due: 5 p.m. ET 8/17/15.

    Docket Numbers: RP15-1180-000.
    Applicants: Rager Mountain Storage Company LLC.
    Description: Compliance filing Lending and Parking Service--
Compliance Filing to be effective 9/3/2015.
    Filed Date: 8/3/15.
    Accession Number: 20150803-5288.
    Comments Due: 5 p.m. ET 8/17/15.

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

    Dated: August 5, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-19688 Filed 8-10-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Pages 59399-59401]
[FR Doc No: 2021-23392]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1021]

Notice to Public of Website Location of Center for Devices and
Radiological Health Fiscal Year 2022 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the website location where the Agency will post two lists of
guidance documents that the Center for Devices and Radiological Health
(CDRH or the Center) intends to publish in fiscal year (FY) 2022. In
addition, FDA has established a docket where interested persons may
comment on the priority of topics for guidance, provide comments and/or
propose draft language for those topics, suggest topics for new or
different guidance documents, comment on the applicability of guidance
documents that have issued previously, and provide any other comments
that could benefit the CDRH guidance program and its engagement with
stakeholders. This feedback is critical to the CDRH guidance program to
ensure that we meet stakeholders' needs.

DATES: Submit either electronic or written comments by November 26,
2021.

ADDRESSES: 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 December 27, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 27, 2021. 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-2012-N-1021 for ``Notice to Public of website Location of CDRH
Fiscal Year 2021 Proposed Guidance Development.'' 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, 240-
402-7500.
     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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    During negotiations on the Medical Device User Fee Amendments of
2012, Title II, Food and Drug Administration Safety and Innovation Act
(Pub. L. 112-144), FDA agreed to meet a variety of quantitative and
qualitative goals intended to help get safe and effective medical
devices to market more quickly. Among these commitments included:
     Annually posting a list of priority medical device
guidance documents that the Agency intends to publish within 12 months
of the date this list is published each fiscal year (the ``A-list''),
and
     Annually posting a list of device guidance documents that
the Agency intends to publish, as the Agency's guidance-development
resources permit each fiscal year (the ``B-list'').
    The Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA
Reauthorization Act of 2017 (Pub. L. 115-52), maintained these
commitments.
    In addition, to ensure that final guidance documents continue to
provide stakeholders with the Agency's current thinking, CDRH annually
conducts a staged review of previously issued final guidances in
collaboration with stakeholders. CDRH intends to annually provide lists
of previously issued final guidances that are subject to review through
FY 2025 so that by 2025, FDA and stakeholders will have assessed the
applicability of all guidances older than 10 years. For instance, in
the annual notice for FY 2023, CDRH expects to provide a list of the
final guidance documents that issued in 2013, 2003, 1993, and 1983; the
annual notice for FY 2024 is expected to provide a list of the final
guidance documents that issued in 2014, 2004, 1994, and 1984, and so
on.
    FDA welcomes comments on any or all of the guidance documents on
the lists as explained in 21 CFR 10.115(f)(5). FDA has established
Docket No. FDA-2012-N-1021 where comments on the FY 2022 lists, draft
language for guidance documents on those topics, suggestions for new or
different guidances, and relative priority of guidance documents may be
submitted and shared with the public (see ADDRESSES). FDA believes this
docket is a valuable tool for receiving information from interested
persons. FDA anticipates that feedback from interested persons will
allow CDRH to better prioritize and more efficiently draft guidances to
meet the needs of the Agency and our stakeholders.
    In addition to posting the lists of prioritized device guidance
documents, CDRH has identified as a priority, and has devoted resources
to, finalization of draft guidance documents. To assure the timely
completion or reissuance of draft guidances, in FY 2015 CDRH committed
to performance goals for current and future draft guidance documents.
For draft guidance documents issued after October 1, 2014, CDRH
committed to finalize, withdraw, reopen the comment period, or issue
new draft guidance on the topic for 80 percent of the documents within
3 years of the close of the comment period and for the remaining 20
percent, within 5 years. As part of MDUFA IV commitments, FDA
reaffirmed this commitment, as resources permit.
    Fulfillment of these commitments will be reflected through the
issuance of updated guidance on existing topics, withdrawal of
guidances that no longer reflect FDA's current thinking on a particular
topic, and annual updates to the A-list and B-list announced in this
notice.

II. CDRH Guidance Development Initiatives

A. Metrics for FY 2021 A-List and B-List Publication

    Stakeholder feedback on guidance priorities is important to ensure
that the CDRH guidance program meets the needs of stakeholders. The
feedback received on the FY 2021 list was mostly in agreement, and CDRH
continued to work toward issuing the guidances on this list. In FY
2021, CDRH published 11 of 27 guidances on the FY 2021 list (8 from the
A-list, 3 from the B-list). In addition, FDA is committed to providing
timely guidance to support response efforts to the Coronavirus Disease
2019 (COVID-19) pandemic. As such, FDA has shifted resources to issue 5
guidances and 8 guidance revisions in FY 2021, as well as to support
other activities to address the pandemic.

B. Finalization of Draft Guidance Documents

    Of the 29 draft guidances issued FY 2016 onward, CDRH finalized 79
percent within 3 years of the comment period close and 86 percent
within 5 years. In addition, in FY 2021, 5 draft guidances issued prior
to October 1, 2015, remain for which no action has been taken yet, and
CDRH has been continuing to work towards taking an action on these
remaining draft guidances.
    Looking forward, in FY 2022, CDRH will strive to finalize,
withdraw, or reopen the comment period for 50 percent of existing draft
guidances issued prior to October 1, 2016.

C. Applicability of Previously Issued Final Guidance

    At the website where CDRH has posted the ``A-list'' and ``B-list''
for FY 2021, CDRH has also posted a list of final guidance documents
that issued in 2012, 2002, 1992, and 1982 for our annual review of
previously issued final guidances. CDRH is interested in external
feedback on whether any of these final guidances should be revised or
withdrawn. In addition, for guidances that are recommended for
revision, information explaining the need for revision, such as the
impact and risk to public health associated with not revising the
guidance, would also be helpful as the Center considers potential
action with respect to these guidances. CDRH will consider the comments
received from this retrospective review when determining priorities for
updating guidance documents and will revise these as resources permit.
    Consistent with the Good Guidance Practices regulation at 21 CFR

10.115(f)(4), CDRH would appreciate suggestions that CDRH revise or
withdraw an already existing guidance document. We request that the
suggestion clearly explain why the guidance document should be revised
or withdrawn and, if applicable, how it should be revised. While we are
requesting feedback on the list of previously issued final guidances
located in the annual agenda website, feedback on any guidance is
appreciated and will be considered.
    In FY 2021, CDRH received comments regarding guidances issued in
2011, 2001, 1991, and 1981 and has withdrawn 1 guidance document
because the guidance document was determined to no longer represent the
Agency's current thinking. The revision of several guidance documents
is also being considered as resources permit.

III. Website Location of Guidance Lists

    This notice announces the website location of the document that
provides the A- and B- lists of guidance documents, which CDRH is
intending to publish during FY 2022. To access these two lists, visit
FDA's website at https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development. We note that the topics on this and past
guidance priority lists may be removed or modified based on current
priorities, as well as comments received regarding these lists.
Furthermore, FDA and CDRH priorities are subject to change at any time
(e.g., newly identified safety issues). The Agency is not required to
publish every guidance on either list if the resources needed would be
to the detriment of meeting quantitative review timelines and statutory
obligations. In addition, the Agency is not precluded from issuing
guidance documents that are not on either list.

    Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23392 Filed 10-26-21; 8:45 am]
BILLING CODE 4164-01-P