XV.  Comments on Production and Process Control System: Requirements for
Laboratory Operations

(Final Subpart J)

A.  Organization of Final Subpart J

     In the 2003 CGMP Proposal, the proposed requirements for production
and process controls for laboratory operations were set forth in
proposed § 111.60(a) through (d).  As shown in table 11, we are
reorganizing the requirements for laboratory operations into a distinct
subpart (final subpart J – Production and Process Control System:
Requirements for Laboratory Operations).  Table 11 lists the sections in
final subpart J and identifies the proposed sections that form the basis
of the final rule.

Table 11. - Derivation of Sections in Final Subpart J

Final Rule 	2003 CGMP Proposal

§ 111.303 What Are the Requirements Under this Subpart for Written
Procedures?	N/A

§ 111.310 What Are the Requirements for the Laboratory Facilities?	§
111.60(a)

§ 111.315 What Are the Requirements for Laboratory Control Processes?
§ 111.60(b)(1)

§ 111.320 What Requirements Apply to Laboratory Methods for Testing and
Examination?	§ 111.60(c) and § 111.60(d)

§ 111.325 Under This Subpart, What Records Must You Make and Keep?	§
111.60(b)(2) and § 111.60(b)(3)

B.  Highlights of the Changes to the

Proposed Requirements for Laboratory Operations

1.  Revisions

     The final rule applies to persons who manufacture, package, label,
or hold dietary supplements unless subject to an exclusion in § 111.1.

2.  Changes Associated With the Reorganization

     This subpart contains fewer details, compared to the 2003 CGMP
Proposal, regarding the requirements for collecting representative
samples and for testing, because these details are set forth elsewhere
in this final rule (i.e., in final §§ 111.75 and 111.80) and would be
redundant in final subpart J.

3.  Changes After Considering Comments

     The final rule:

•	Includes a new requirement to establish and follow written
procedures for laboratory operations, including written procedures for
the tests and examinations you conduct to determine whether or not
specifications are met.

•	Requires you to identify and use the appropriate “scientifically
valid method,” rather than an appropriate “validated testing
method,” for each established specification for which testing or
examination is required to determine whether the specification is met.

C.  What Are the Requirements Under This Subpart

for Written Procedures?

(Final § 111.303)

	We received many comments that recommended written procedures for
various provisions. We address the need for written procedures generally
in section IV.  We also respond to individual comments on specific
provisions in the same section.

	Final § 111.303 requires you to establish and follow written
procedures for laboratory operations, including written procedures for
the tests and examinations you conduct to determine whether
specifications are met.

D. What are the Requirements for the

Laboratory Facilities That You Use? (Final § 111.310)

     Final § 111.310 requires you to use adequate laboratory facilities
to perform whatever testing and examinations are necessary to determine
whether: (a) Components that you use meet specifications; (b) in-process
specifications are met as specified in the master manufacturing record;
and (c) dietary supplements that you manufacture meet specifications.
Final § 111.310(a) is substantially similar to proposed § 111.60(a).
The requirement for “adequate laboratory facilities” is to ensure
that the facilities used are designed and suitable for carrying out the
necessary tests and examinations.  Other CGMP requirements of this final
rule would apply to the manufacturer’s laboratory facilities, such as
subpart C, Physical Plant and Grounds, and subpart D, Equipment and
Utensils and should be considered in assessing the adequacy of the
laboratory facilities.  If the tests and examinations are carried out by
an outside laboratory, you will be responsible for ensuring that the
test and examinations are adequately performed.

     (Comment 272) One comment states that proposed § 111.60(a) would
be highly disruptive to the dietary supplement industry and would impose
a great burden on companies that traditionally rely on certification of
ingredient suppliers.  Some comments assert it would be redundant to
require testing by companies who are suppliers of dietary ingredients,
as well as by companies who receive the dietary supplements, to
determine whether the dietary ingredients meet specifications.

     (Response) The final rule already includes changes that address the
concerns raised by these comments.  As discussed in final § 111.75(a),
section X, the final rule permits the use of certificates of analysis
for specifications other than the identity of a dietary ingredient.

E. What Are the Requirements for Laboratory Control Processes? (Final §
111.315)

     Final § 111.315 sets forth the minimum laboratory control
processes that you must establish and follow.  These laboratory control
processes must be reviewed and approved by the quality control
personnelunit.

1.  Final § 111.315(a)

     Final § 111.315(a) requires the laboratory control processes you
establish and follow to include the use of criteria for establishing
appropriate specifications.  Final § 111.315(a) is identical to
proposed § 111.60(b)(1)(ii).

     We did not receive comments specific to proposed §
111.60(b)(1)(ii).

2.  Final § 111.315(b)

     Final § 111.315(b) requires you to establish and follow laboratory
control processes that are reviewed and approved by the quality control
personnelunit, including the use of sampling plans for obtaining
representative samples, in accordance with subpart E, of: (1)
Components, packaging, and labels; (2) in-process materials; (3)
finished batches of dietary supplements; (4) product you receive for
packaging or labeling as a dietary supplement (and for distribution
rather than for return to the supplier); and (5) packaged and labeled
dietary supplements.  Final § 111.315(b) derives from proposed §
111.60(b)(1)(iii)(A) through (b)(1)(iii)(E).

     Final § 111.315(b) combines the proposed requirements of §
111.60(b)(1)(iii)(A) and (b)(1)(iii)(D) for consistency with final §
111.80(a) which combines the requirements to collect representative
samples of components, packaging, and labels.  However, for consistency
with other requirements established by this final rule, we are
separating the requirements to collect representative samples of
“dietary supplements received” (which the final rule refers to as
“product that you receive for packaging or labeling as a dietary
supplement (and for distribution rather than for return to the
supplier,” or “received product) from the requirements to collect
representative samples of components.

(Comment 273)  Some comments note that proposed § 111.60(b)(1)(iii)
restates the requirements, already contained in proposed §
111.37(b)(11)(i) through (b)(11)(iv), that the quality control unit
collect representative samples.  These comments request proposed §
111.60(b)(1)(iii) be deleted, because it is more appropriately described
as a quality control function rather than as a laboratory function.

      (Response)  We disagree that the proposed requirement to use a
sampling plan is more appropriately described as a quality control
function than as a laboratory function.  Under both the proposed and the
final rule, the sampling plans that are part of the laboratory control
operations are subject to approval by the quality control unitpersonnel
(“unit” in the proposed rule) but are not developed by the quality
control personnelunit.  We are making no changes based on this comment.

      (Comment 274) One comment asserts sampling can be better
accomplished at the point of packaging rather than at a laboratory
remote from the packaging operation.

      (Response) This comment misinterprets proposed §
111.60(b)(1)(iii) which proposed to establish a process (i.e., the use
of a sampling plan) rather than to direct that a particular operating
unit (such as a laboratory) collect samples.  We are making no changes
based on this comment.

3.  Final § 111.315(c)

     Final § 111.315(c) requires the laboratory control processes you
establish and follow include use of criteria for selecting appropriate
examination and testing methods.  Final § 111.315(c) is identical to
proposed § 111.60(b)(1)(i).

     (Comment 275) One comment recommends that a contract laboratory
hired by a person who is subject to the final rule be able to determine
the specific type of test that is most appropriate.

     (Response) Nothing in the final rule would preclude you from
relying on the recommendation of the contract laboratory in selecting an
appropriate test or examination.  However, the manufacturer of the
dietary supplement has the responsibility to comply with these CGMP
requirements, including the requirement to select appropriate tests,
regardless of who conducts the tests.

4.  Final § 111.315(d)

     Final § 111.315(d) requires the laboratory control processes you
establish and follow to include use of criteria for selecting standard
reference materials used in performing tests and examinations.  Final §
111.315(d) derives from proposed § 111.60(b)(1)(iv).

     (Comment 276) Several comments support the use of standard
reference materials.  Some comments distinguish between a reference
standard (which they describe as a highly purified compound that is well
characterized and is used in quantitative assays for single chemical
entities) and a reference material (which they describe as similar to a
reference standard but with less specificity).  These comments urge us
to recognize the difference between reference standards and reference
materials and to require the use of both in the final rule.

     (Response) The comments that request we recognize a difference
between certain types of reference materials are consistent with
proposed § 111.60(b)(1)(iv) and with statements that we made in the
preamble to the 2003 CGMP Proposal.  We distinguished two general types
of reference materials: (1) Compendia reference standards that do not
require characterization; and (2) noncompendia standards that should be
of the highest purity that can be obtained by reasonable effort and that
should be thoroughly characterized to ensure their identity, purity,
quality, and strength.  We recommended you use compendia reference
standards whenever possible, and that you establish appropriately
characterized in-house materials prepared from representative lots if no
compendia reference standard exists.

    We also discussed reference materials from the perspective of the
type of test or examination.  For organoleptic examinations, we
described an authenticated plant reference material as material that has
been authenticated as the correct plant species and correct plant
part(s) by a qualified plant taxonomist.  For microscopic and chemical
tests (including calibration tests), we described a reference material
as a highly purified compound that is well characterized.

    To the extent that the comments are recommending that both compendia
reference standards and noncompendia reference standards comply with any
final rule, this final rule would allow for the use of both compendia
reference standards and noncompendia reference standards.  However, to
the extent that the comments are requesting this final rule require that
both types of reference materials be used, we disagree.  We see no
reason to require, for example, that a firm with access to compendia
standards be required to develop noncompendia standards.  Likewise,
given that we have acknowledged that noncompendia standards may be used,
we see no reason to require the use of compendia standards in all
circumstances.

     (Comment 277) One comment expresses confusion about the preamble
discussion of proposed § 111.60(b)(1)(iv) and suggests the preamble
specify that reference standards be established appropriate to the assay
procedure for which they are used.

     (Response) Reference materials should be appropriate to the assay
procedure for which they are used.

     (Comment 278) Several comments recommend we acknowledge certain
reference materials as authoritative sources for botanical ingredients,
such as American Herbal Pharmacopoeia, European Pharmacopoeia, and the
World Health Organization, in part because other sources include only a
limited number of botanicals as supplements.  In the comments’ view,
explicit acknowledgment by FDA would encourage manufacturers to use
independent standards, increase CGMP compliance, and show that
validation is not limited to quantitative chemical methods.

     (Response) We decline to acknowledge certain reference materials as
authoritative sources for botanical ingredients.  Such a request is
outside the scope of this final rule.

     (Comment 279) One comment believes we should designate USP to
develop appropriate standards.

     (Response) This comment is outside the scope of this final rule.

5.  Final § 111.315(e)

     Final § 111.315(e) requires that the laboratory control processes
you must establish and follow include use of test methods and
examinations in accordance with established criteria.  Final §
111.315(e) derives from proposed § 111.60(b)(1)(vi).

     We did not receive comments specific to proposed §
111.60(b)(1)(vi).

F. What Requirements Apply to

Laboratory Methods for Testing and Examination?

(Final § 111.320)

1. Final § 111.320(a)

     Final § 111.320(a) requires you to verify that laboratory
examination and testing methodologies are appropriate for their intended
use.  Final § 111.320(a) is identical to proposed § 111.60(c).

     (Comment 280) One comment states that this decision should be made
by a qualified person, whether in-house or at a contract laboratory.

     (Response) We agree.  Nothing in the final rule would preclude you
from relying on the judgment of a qualified person at a contract
laboratory to satisfy the requirements of final § 111.320(a).  We would
not consider that a recommendation from a contract laboratory is any
different from a recommendation from an operating unit of the
manufacturer.  However, the manufacturer of the dietary supplement has
the responsibility to comply with these CGMP requirements, including the
requirement to select appropriate tests, regardless of who conducts the
tests.

     (Comment 281) One comment suggests modifying proposed § 111.60(c)
to add “reference materials and/or reference standards” to the list
of elements that must be verified to be appropriate for their intended
use.

     (Response) If reference materials and reference standards are used
as part of the test or examination method, then such materials and
standards are already required to be verified under the language in
proposed § 111.60(c).  Thus, there is no need for the modification and
we decline to modify the language of final § 111.320(a).

2. Final § 111.320(b)

     Final § 111.320(b) requires you to identify and use the
appropriate scientifically valid method for each established
specification for which testing or examination is required to determine
whether the specification is met.  Final § 111.320(b) derives from
proposed § 111.60(d) which would require you to identify and use an
appropriate validated testing method for each established specification
for which testing is required to determine whether the specification is
met.  Final § 111.320(b) includes a provision associated with final §
111.75(h) which provides flexibility to use examinations as well as
tests to determine whether specifications are met.

(Comment 282) Many comments express concern about the amount of testing
required for the validation of the appropriate test method.  Several
comments object to the use of the terms “validations” and
“validated” which they assert have a specific meaning in a
pharmaceutical context and would be overly burdensome in this rule.
Other comments assert that methods already recognized as official
standards do not need to be “validated,” but simply “verified”
as to suitability.  Some comments suggest substituting “scientifically
valid testing method” for “appropriate validated testing method.”
One comment suggests “qualifications” replace “validations.”
Another comment suggests test methods need not be validated if they are
“proven to be suitable under actual conditions of use.”  Another
comment suggests adding “established by the manufacturer” after
“appropriate validated test method.”

     One comment recommends the final rule give companies the
flexibility to adopt the method most suitable to the ingredient they are
testing, regardless of whether the method is, or is not, an “official
method” such as those established by AOAC International or FDA.

      (Response) In the preamble to the 2003 CGMP Proposal (68 FR 12157
at 12208), we stated that test method validation determines whether a
newly-developed or existing test method is accurate, precise, and
specific for its intended purpose and involves evaluating the test
method on multiple occasions or in multiple test facilities.  We
explained that official methods, such as AOAC International methods, are
validated in collaborative studies using several laboratories under
identical conditions and that the AOAC International methods are often
cited as “official validated methods.”  We also explained that other
method validations are conducted in a single laboratory by repeating the
same test multiple times.  Typical validation characteristics include
accuracy, precision, specificity, detection limit, quantitation limit,
linearity, range, and robustness.

     The process of method validation discussed above is a formal
process for demonstrating that procedures are suitable for their
intended use.  Although all methods that are formally validated are
considered “scientifically valid,” other methods that are based on
scientific data or results published in, for example, scientific
journals, references, text books, or proprietary research can be
scientifically valid even if they are not formally “validated” in
collaborative studies

(68 FR 12157 at 12198).

     We agree that companies should have flexibility to adopt the method
most suitable to the ingredient they are testing.  Consistent with the
view that we expressed in the preamble to 2003 CGMP Proposal (68 FR
12157 at 12198), we believe that a scientifically valid method is one
that is accurate, precise, and specific for its intended purpose.  In
other words, a scientifically valid method is one that consistently does
what it is intended to do.

     Because we acknowledge that methods that are based on scientific
data or results published in, for example, scientific journals,
references, text books, or proprietary research can be scientifically
valid even if they are not formally “validated,” we are revising
proposed § 111.60(d).  Under final § 111.320(b) you must identify and
use an appropriate “scientifically valid method” (rather than a
“validated method”) for each established specification for which
testing or examination is required to determine whether the
specification is met.  However, we continue to recommend that you use
tests and examinations that already have been validated when such tests
are available.

      (Comment 283) One comment specifically asks how much modification
of a validated method is allowed before the method must be re-validated
by the laboratory.  The comment cites an example of moisture testing in
which the testing method needs to be modified to provide a more valid
moisture reading.

      (Response) In the preamble to the 2003 CGMP proposal (68 FR 12157
at 12209), we recommended that, if you modify an officially validated
method, you document the reason for the modification and have data to
show that the modified method produces results that are at least as
accurate and reliable as the established method for the material being
tested.  We also recommended that you have complete records of any
testing and standardization of laboratory reference standards, reagents,
and standard solutions that you use in your laboratory operations.  We
are making no changes to these recommendations in this final rule.

     (Comment 284) Several comments request the final rule incorporate
by reference authoritative sources of compendial methods.

     (Response) We decline this request for the reasons discussed in
response to comments 193 and 196.

G. Appropriate Test Method Validation

(Proposed § 111.60(b)(1)(v))

     Proposed § 111.60(b)(1)(v) would require the laboratory control
processes you establish and follow to include the use of appropriate
test method validations.  Because the final rule does not require that
you use a validated method for any tests or examinations that you
conduct, we are removing proposed § 111.60(b)(1)(v).

H. Under This Subpart, What Records must You

Make and Keep? (Final § 111.325)

     Final § 111.325 sets forth the requirements for records that the
quality control personnel unit must make and keep.

1. Final § 111.325(a)

     Final § 111.325(a) requires you to make and keep records required
under subpart J in accordance with subpart P.  Final § 111.325(a)
derives from proposed § 111.60(b)(3), which would require you to keep
laboratory examination and testing records in accordance with proposed
§ 111.125.  Because final § 111.303 requires you to establish and
follow written procedures for laboratory operations, the records you
must make and keep under final § 111.325 are not limited to laboratory
examination and testing records, but also include the written
procedures.  Final § 111.325(a) also includes editorial revisions
associated with the reorganization and editorial revisions for
consistency with the recordkeeping requirements in subparts P.

     We did not receive comments specific to proposed § 111.60(b)(3).

2. Final § 111.325(b)(1)

     The final rule includes a new requirement (final § 111.303) that
you establish and follow written procedures for laboratory operations,
including written procedures for the tests and examinations you conduct
to determine whether specifications are met.  Those written procedures
are records.  Therefore, final § 111.325(b)(1) requires you to make and
keep a record of the written procedures for laboratory operations,
including written procedures for the tests and examinations that you
conduct to determine whether specifications are met.

3. Final § 111.325(b)(2)

     Final § 111.325(b)(2) sets forth requirements for documenting that
you followed the laboratory methodology established in accordance with
this subpart.  Final § 111.325(b)(2)(i) requires that the person who
conducts the testing and examination document, at the time of
performance, that laboratory methodology established in accordance with
this subpart is followed.  Final § 111.325(b)(2)(ii) requires that the
documentation include the results of the testing and examination.  Final
§ 111.325(b)(2) derives from proposed § 111.60(b)(2) with revisions
associated with the reorganization.

     (Comment 285) One comment states that, without appropriate
documentation, there would be no assurance that the appropriate testing
was indeed performed and that the product’s identity, purity, quality,
strength, and composition are what they are represented to be.

     (Response)  We agree and have retained the requirement in this
final provision.

FDA-Internal-Confidential-Deliberative

Final Subpart J 9-28-05, 6-26-06, 3-30-07, 5-04-07

page   PAGE  817


[Federal Register Volume 82, Number 1 (Tuesday, January 3, 2017)]
[Notices]
[Pages 118-119]
[FR Doc No: 2016-31825]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0765; FRL-9957-77-ORD]

Board of Scientific Counselors Executive Committee; Notification
of Public Meeting and Public Comment

AGENCY: Environmental Protection Agency.

ACTION: Notification of public meeting and public comment.

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

SUMMARY: Pursuant to the Federal Advisory Committee Act, the U.S.
Environmental Protection Agency hereby provides notice that the Board
of Scientific Counselors (BOSC) Executive Committee (EC) will host a
public meeting at the EPA's Main Campus Facility, 109 T.W. Alexander
Drive, Research Triangle Park, North Carolina 27711. The meeting will
be held on Wednesday, January 11, 2017 from 9:00 a.m. till 6:00 p.m.,
Thursday, January 12, 2017 from 8:30 a.m. till 5:00 p.m. and Friday,
January 13, 2017 from 8:30 a.m. till 11:00 a.m. All times noted are
Eastern Time and are approximate. The primary discussions will focus on
the draft reports from the BOSC subcommittees: Air, Climate and Energy,
Chemical Safety for Sustainability, Safe and Sustainable Water
Resources, and Sustainable and Healthy Communities. The EC will also
deliberate on the four ORD Cross-Cutting Research Roadmap Annual
Reports: Environmental Justice, Climate Change, Children's
Environmental Health, and Nitrogen and Co-pollutant. There will be a
public comment period from 10:05 a.m. to 10:20 a.m. Wednesday, January
11, 2017. For information on registering to attend the meeting or to
provide public comment, please see the SUPPLEMENTARY INFORMATION
section.

DATES: The BOSC EC meeting will be held on Wednesday, January 11, 2017
from 9:00 a.m. till 6:00 p.m., Thursday, January 12, 2017 from 8:30
a.m. till 5:00 p.m. and Friday, January 13, 2017 from 8:30 a.m. till
11:00 a.m. All times noted are Eastern Time and are approximate.

FOR FURTHER INFORMATION CONTACT:  Questions or correspondence
concerning the meeting should be directed to Tom Tracy, Designated
Federal Officer, Environmental Protection Agency, by mail at 1200
Pennsylvania Avenue NW., (MC 8104 R), Washington, DC 20460; by
telephone at<PHONE_NUMBER>; fax at<PHONE_NUMBER>; or via email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Charter of the BOSC states that the
advisory committee shall provide independent advice to the
Administrator on technical and management aspects of the ORD's research
program. Additional information about the BOSC is available at: http://www2.epa.gov/bosc.
    Registration: In order to attend the meeting, you must register at
the following site: https://www.eventbrite.com/e/us-epa-2017-bosc-executive-committee-public-meeting-registration-30037268278. Once you
have completed the online registration, you will be contacted and
provided with the meeting information. In-person participant
registration will close on January 3, 2017. Virtual participant
registration will close on January 9, 2017.
    Oral Statements: Members of the public who wish to provide oral
comment during the meeting must preregister. Individuals or groups
making remarks during the public comment period will be limited to five
(5) minutes. To accommodate the number of people who want to address
the BOSC EC, only one representative of a particular community,
organization, or group will be allowed to speak.
    Written Statements: Written comments for the public meeting must be
received by Monday, January 9, 2017, and will be included in the
materials distributed to the BOSC EC prior to the meeting. Written
comments should be sent to Tom Tracy, Environmental Protection Agency,
via email at<EMAIL_ADDRESS>or by mail to 1200 Pennsylvania Avenue
NW., (MC 8104 R), Washington, DC 20460, or submitted through
regulations.gov, Docket ID No. EPA-HQ-ORD-2015-0765. Members of the
public should be aware that their personal contact information, if
included in any written comments, may be posted online at
regulations.gov.
    Information about Services for Individuals with Disabilities: For
information about access or services for individuals with disabilities,
please contact Tom Tracy, at<PHONE_NUMBER> or via email at
<EMAIL_ADDRESS>To request special accommodations, please contact
Tom Tracy no later than August 19, 2016, to give the Environmental
Protection Agency sufficient time to process your request. All requests
should be sent to the address, email, or phone number listed in the FOR
FURTHER INFORMATION section above.

    Dated: December 16, 2016.
Fred S. Hauchman
Director, Office of Science Policy.
[FR Doc. 2016-31825 Filed 12-30-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Notices]
[Pages 24877-24880]
[FR Doc No: 2021-09632]

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

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002]

Final Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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

SUMMARY: Flood hazard determinations, which may include additions or
modifications of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where
applicable, in the supporting Flood Insurance Study (FIS) reports have
been made final for the communities listed in the table below. The FIRM
and FIS report are the basis of the floodplain management measures that
a community is required either to adopt or to show evidence of having
in

effect in order to qualify or remain qualified for participation in the
Federal Emergency Management Agency's (FEMA's) National Flood Insurance
Program (NFIP). In addition, the FIRM and FIS report are used by
insurance agents and others to calculate appropriate flood insurance
premium rates for buildings and the contents of those buildings.

DATES: The date of August 24, 2021 has been established for the FIRM
and, where applicable, the supporting FIS report showing the new or
modified flood hazard information for each community.

ADDRESSES: The FIRM, and if applicable, the FIS report containing the
final flood hazard information for each community is available for
inspection at the respective Community Map Repository address listed in
the tables below and will be available online through the FEMA Map
Service Center at https://msc.fema.gov by the date indicated above.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the new or
modified flood hazard information for each community listed.
Notification of these changes has been published in newspapers of local
circulation and 90 days have elapsed since that publication. The Deputy
Associate Administrator for Insurance and Mitigation has resolved any
appeals resulting from this notification.
    This final notice is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the new or revised FIRM and FIS report available at the address
cited below for each community or online through the FEMA Map Service
Center at https://msc.fema.gov.
    The flood hazard determinations are made final in the watersheds
and/or communities listed in the table below.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Yavapai County, Arizona and Incorporated Areas
                         Docket No.: FEMA-B-2025
------------------------------------------------------------------------
Town of Dewey-Humboldt.................  Yavapai County Flood Control
                                          District, 1120 Commerce Drive,
                                          Prescott, AZ 86305.
Town of Prescott Valley................  Engineering Division, 7501 East
                                          Skoog Boulevard, 3rd Floor,
                                          Prescott Valley, AZ 86314.
Unincorporated Areas of Yavapai County.  Yavapai County Flood Control
                                          District, 1120 Commerce Drive,
                                          Prescott, AZ 86305.
------------------------------------------------------------------------
          Stanislaus County, California and Incorporated Areas
                         Docket No.: FEMA-B-2036
------------------------------------------------------------------------
City of Ceres..........................  City Hall, 2220 Magnolia
                                          Street, Ceres, CA 95307.
City of Modesto........................  City Hall, 10th Street Place,
                                          1010 10th Street, Modesto, CA
                                          95354.
City of Newman.........................  City Hall, 938 Fresno Street,
                                          Newman, CA 95360.
City of Patterson......................  City Hall, 1 Plaza Circle, 2nd
                                          Floor, Patterson, CA 95363.
Unincorporated Areas of Stanislaus       Stanislaus County & City of
 County.                                  Modesto Building, 1010 10th
                                          Street, Suite 3400, Modesto,
                                          CA 95354.
------------------------------------------------------------------------
             Pinellas County, Florida and Incorporated Areas
                         Docket No.: FEMA-B-1905
------------------------------------------------------------------------
City of Belleair Beach.................  City Hall, 444 Causeway
                                          Boulevard, Belleair Beach, FL
                                          33786.
City of Belleair Bluffs................  City Hall, 2747 Sunset
                                          Boulevard, Belleair Bluffs, FL
                                          33770.
City of Clearwater.....................  Municipal Services Building,
                                          Engineering Department, 100
                                          South Myrtle Avenue, Suite
                                          220, Clearwater, FL 33756.
City of Dunedin........................  Community Development Building,
                                          1415 Pinehurst Road, Unit F,
                                          Dunedin, FL 34698.
City of Gulfport.......................  Community Development
                                          Department, 5330 23rd Avenue
                                          South, Gulfport, FL 33707.
City of Indian Rocks Beach.............  City Hall, 1507 Bay Palm
                                          Boulevard, Indian Rocks Beach,
                                          FL 33785.
City of Largo..........................  City Hall, 201 Highland Avenue
                                          North, Largo, FL 33770.
City of Madeira Beach..................  Building Department, 300
                                          Municipal Drive, Madeira
                                          Beach, FL 33708.
City of Oldsmar........................  City Hall, Planning and
                                          Redevelopment Department, 100
                                          State Street West, Oldsmar, FL
                                          34677.
City of Pinellas Park..................  Planning and Development
                                          Services, 6051 78th Avenue
                                          North, Pinellas Park, FL
                                          33781.
City of Safety Harbor..................  Building Official's Department,
                                          750 Main Street, Safety
                                          Harbor, FL 34695.
City of Seminole.......................  City Hall, Community
                                          Development Department, 9199
                                          113th Street, Seminole, FL
                                          33772.
City of South Pasadena.................  Building Department, 6940
                                          Hibiscus Avenue South, South
                                          Pasadena, FL 33707.

City of St. Pete Beach.................  City Hall, Building Department,
                                          155 Corey Avenue, St. Pete
                                          Beach, FL 33706.
City of St. Petersburg.................  Municipal Services Center, 1
                                          4th Street North, St.
                                          Petersburg, FL
                                         33701.
City of Tarpon Springs.................  Building Department, 324 East
                                          Pine Street, Tarpon Springs,
                                          FL 34689.
City of Treasure Island................  City Hall, Community
                                          Improvement Department, 120
                                          108th Avenue, Treasure Island,
                                          FL 33706.
Town of Belleair.......................  Town Hall, 901 Ponce de Leon
                                          Boulevard, Belleair, FL 33756.
Town of Belleair Shore.................  City Clerk's Office, 1200 Gulf
                                          Boulevard, Belleair Shore, FL
                                          33786.
Town of Indian Shores..................  Building Department, 19305 Gulf
                                          Boulevard, Indian Shores, FL
                                          33785.
Town of Kenneth City...................  Town Hall, 6000 54th Avenue
                                          North, Kenneth City, FL 33709.
Town of North Redington Beach..........  Town Hall, 190 173rd Avenue
                                          East, North Redington Beach,
                                          FL 33708.
Town of Redington Beach................  Town Hall, 105 164th Avenue,
                                          Redington Beach, Florida
                                          33708.
Town of Redington Shores...............  Town Hall, Building Department,
                                          17425 Gulf Boulevard,
                                          Redington Shores, FL 33708.
Unincorporated Areas of Pinellas County  Pinellas County Building
                                          Department, 440 Court Street,
                                          Clearwater, FL 33756.
------------------------------------------------------------------------
                Gem County, Idaho and Incorporated Areas
                         Docket No.: FEMA-B-1969
------------------------------------------------------------------------
City of Emmet..........................  Public Works and Building
                                          Department, 601 East 3rd
                                          Street, Emmett, ID 83617.
Unincorporated Areas of Gem County.....  Gem County Development Services
                                          Department, 109 South McKinley
                                          Avenue, Emmett, ID 83617.
------------------------------------------------------------------------
             Wabaunsee County, Kansas and Incorporated Areas
                         Docket No.: FEMA-B-2018
------------------------------------------------------------------------
City of Alma...........................  City Hall, 326 Missouri Avenue,
                                          Alma, Kansas 66401.
City of Alta Vista.....................  City Hall, 521 Main Street,
                                          Alta Vista, Kansas 66834.
City of Eskridge.......................  City Hall, 110 South Main
                                          Street, Eskridge, Kansas
                                          66423.
City of Harveyville....................  City Hall, 274 West Oak Street,
                                          Harveyville, Kansas 66431.
City of McFarland......................  City Hall, 518 Rock Island
                                          Road, McFarland, Kansas 66501.
City of Paxico.........................  City Hall, 201 Newbury Avenue,
                                          Paxico, Kansas 66526.
Unincorporated Areas of Wabaunsee        Wabaunsee County Courthouse,
 County.                                  215 Kansas Avenue, Alma,
                                          Kansas 66401.
------------------------------------------------------------------------
               Mason County, Michigan (All Jurisdictions)
                         Docket No.: FEMA-B-2009
------------------------------------------------------------------------
Charter Township of Pere Marquette.....  Pere Marquette Charter Township
                                          Hall, 1699 South Pere
                                          Marquette Highway, Ludington,
                                          MI 49431.
City of Ludington......................  City Hall, 400 South Harrison
                                          Street, Ludington, MI 49431.
Township of Grant......................  Grant Township Hall, 835 West
                                          Hoague Road, Manistee, MI
                                          49660.
Township of Hamlin.....................  Hamlin Township Hall, 3775
                                          North Jebavy Drive, Ludington,
                                          MI 49431.
Township of Summit.....................  Summit Township Hall, 4879 West
                                          Deren Road, Ludington, MI
                                          49431.
------------------------------------------------------------------------
               Oceana County, Michigan (All Jurisdictions)
                         Docket No.: FEMA-B-2009
------------------------------------------------------------------------
Township of Benona.....................  Benona Township Hall, 7169 West
                                          Baker Road, Shelby, MI 49455.
Township of Claybanks..................  Claybanks Township Hall, 7577
                                          West Cleveland Road, New Era,
                                          MI 49446.
Township of Golden.....................  Golden Township Hall, 5527 West
                                          Fox Road, Mears, MI 49436.
Township of Pentwater..................  Township Office, 500 North
                                          Hancock Street, Pentwater, MI
                                          49449.
Township of Weare......................  Weare Township Hall, 6506 North
                                          Oceana Drive, Hart, MI 49420.
Village of Pentwater...................  Village Office, 327 South
                                          Hancock Street, Pentwater, MI
                                          49449.
------------------------------------------------------------------------
             Snyder County, Pennsylvania (All Jurisdictions)
                         Docket No.: FEMA-B-1977
------------------------------------------------------------------------
Borough of Selinsgrove.................  Borough Office, 1 North High
                                          Street, Selinsgrove, PA 17870.
Borough of Shamokin Dam................  Municipal Building, 42 West 8th
                                          Avenue, Shamokin Dam, PA
                                          17876.
Township of Chapman....................  Chapman Township Municipal
                                          Office, 1151 Wagner Hill Road,
                                          Port Trevorton, PA 17864.
Township of Monroe.....................  Monroe Township Municipal
                                          Building, 39 Municipal Drive,
                                          Selinsgrove, PA 17870.
Township of Penn.......................  Penn Township Municipal
                                          Building, 228 Clifford Road,
                                          Selinsgrove, PA 17870.
Township of Perry......................  Perry Town Hall, 18 Hoffman
                                          Hill Road, Mount Pleasant
                                          Mills, PA 17853.
Township of Union......................  Union Township Municipal
                                          Building, 1510 McNess Road,
                                          Port Trevorton, PA 17864.
------------------------------------------------------------------------

[FR Doc. 2021-09632 Filed 5-7-21; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 83, Number 242 (Tuesday, December 18, 2018)]
[Notices]
[Pages 64828-64829]
[FR Doc No: 2018-27291]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 7464-004]

Margaret Moser; Notice of Application for Surrender of Exemption,
Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:

    a. Type of Proceeding: Application for surrender of exemption.
    b. Project No.: 7464-004.
    c. Date Filed: December 2, 2018.
    d. Exemptee: Ms. Margaret Moser.
    e. Name of Project: Marden Brook Hydroelectric Project.
    f. Location: The exempted project is located on Marden Brook,
near the town of Lancaster, Coos County, New Hampshire.
    g. Filed Pursuant to: 18 CFR 4.102.
    h. Licensee Contact: Mr. Geoffrey or Lukas Moser, Box 116 RFD
No. 1, 574 North Road, Lancaster, NH 03584, or<PHONE_NUMBER>.
    i. FERC Contact: Ms. Diana Shannon,<PHONE_NUMBER>, or
<EMAIL_ADDRESS>    j. Deadline for filing comments, interventions, and protests is
30 days from the issuance date of this notice by the Commission. The
Commission strongly encourages electronic filing. Please file
motions to intervene, protests and comments using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name
and contact information at the end of your comments. For assistance,
please contact FERC Online Support at<EMAIL_ADDRESS>
(866) 208-3676 (toll free), or<PHONE_NUMBER> (TTY). In lieu of
electronic filing, please send a paper copy to: Secretary, Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426. The first page of any filing should include docket number P-
7464-004.
    k. Description of Project Facilities: The exempted run-of-river
project consists of: (1) A concrete gravity spillway with small
earth embankment sections on both sides, that includes a drainage
gate and low level sluice gate on the left side; (2) an intake
structure; (3) a buried steel penstock; and (4) a wheelhouse
containing an overshot water wheel with a total generating capacity
of approximately 3 kilowatts. The dam structure is approximately 6
feet high and creates an impoundment of less than 0.5 acre and
contains less than 1 acre-foot of storage.
    l. Description of Request: The project has not operated for some
time and the exemptee wishes to surrender the project. The exemptee
proposes to decommission the generating equipment and keep the
project features in place. No construction or ground disturbance
would result from the proposal.
    m. This filing may be viewed on the Commission's website at
http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket
number excluding the last three digits in the docket number field to
access the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email
of new filings and issuances related to this or other pending
projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction in the Commission's
Public Reference Room located at 888 First Street, NE, Room 2A,
Washington, DC 20426, or by calling<PHONE_NUMBER>.
    n. Individuals desiring to be included on the Commission's
mailing list should so indicate by writing to the Secretary of the
Commission.
    o. Comments, Protests, or Motions to Intervene: Anyone may
submit comments, a protest, or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210, .211, .212 and .214. In determining the appropriate action
to take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance
with the Commission's Rules may become a party to the proceeding.
Any comments, protests, or motions to intervene must be received on
or before the specified comment date for the particular application.
    p. Filing and Service of Responsive Documents: Any filing must
(1) bear in all capital letters the title ``COMMENTS'', ``PROTEST'',
or ``MOTION TO INTERVENE'' as applicable; (2) set forth in the
heading the name of the applicant and the project number of the
application to which the filing responds; (3) furnish the name,
address, and telephone number of the person protesting or
intervening; and (4) otherwise comply with the requirements of 18
CFR 385.2001 through 385.2005. All comments, motions to intervene,
or protests must set forth their evidentiary basis and otherwise
comply with the requirements of 18 CFR 4.34(b). All comments,
motions to intervene, or protests should relate to the surrender
application that is the subject of this notice. Agencies may obtain
copies of the application directly from the applicant. A copy of any
protest or motion to intervene must be served upon

each representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also
serve a copy of the document on that resource agency. A copy of all
other filings in reference to this application must be accompanied
by proof of service on all persons listed in the service list
prepared by the Commission in this proceeding, in accordance with 18
CFR 4.34(b) and 385.2010.
    q. Agency Comments--Federal, state, and local agencies are
invited to file comments on the described proceeding. If any agency
does not file comments within the time specified for filing
comments, it will be presumed to have no comments.

    Dated: December 11, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-27291 Filed 12-17-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Notices]
[Pages 46351-46352]
[FR Doc No: 2013-18352]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Trial Designs and Endpoints for Liver Disease Secondary to
Nonalcoholic Steatohepatitis; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug
Evaluation and Research in cosponsorship with the American Association
for the Study of Liver Diseases (AASLD) is announcing a 2-day public
workshop entitled ``Trial Designs and Endpoints for Liver Disease
Secondary to Nonalcoholic fatty liver disease (NAFLD).'' There are no
approved treatments for NAFLD and its complications of nonalcoholic
steatohepatitis (NASH) and liver fibrosis and cirrhosis. This workshop
will provide a forum to discuss trial design, including endpoints for
clinical trials in NAFLD, to promote efficient drug development in this
area and thus improved treatments for patients.
    Date and Time: The public workshop will be held on September 5 and
6, 2013, from 8 a.m. to 5 p.m.
    Location: The meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, in the Great
Room (room 1503), Silver Spring, MD 20993. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    Contact Person: Anissa Davis, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Registration: There is no fee to attend the public workshop, but
attendees must register online at http://www.aasld.org/additionalmeetings/Pages/aasldfdanash.aspx before September 1, 2013.
(FDA has verified this Web site address but is not responsible for
subsequent changes to the Web site after this document publishes in the
Federal Register.) Space is limited, and registration will be on a
first-come, first-served basis. Those without Internet access should
contact Anissa Davis (see Contact Person) to register. Onsite
registration will not be available.
    If you need special accommodations due to a disability, please
contact Anissa Davis (see Contact Person) at least 7 days in advance.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.

SUPPLEMENTARY INFORMATION: This workshop will provide a forum to
discuss the key issues in the design of clinical trials of drugs for
the treatment of liver disease secondary to NAFLD. Stakeholders,
including industry sponsors, those from academia, patients with NAFLD-
associated liver disease, and FDA, will be engaged to address
challenging issues related to selection of endpoints and assessment
methodologies in clinical trials. Trial design strategies and possible
candidates for endpoints will be explored. The state of knowledge of
the natural history of NAFLD will also be discussed.

    Dated: July 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18352 Filed 7-30-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 39 (Thursday, February 27, 2020)]
[Rules and Regulations]
[Pages 11284-11286]
[FR Doc No: 2020-03934]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0877; Product Identifier 2019-NM-146-AD; Amendment
39-19847; AD 2020-03-23]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 &
440) airplanes. This AD was prompted by a report that a fouling
condition was found between the generator power cables and the support
brackets of the auxiliary-aft fuel tank during production. This AD
requires a visual inspection of the generator power cables for damage,
installation of protective conduits and edging grommets, and applicable
corrective actions. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective April 2, 2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 2,
2020.

ADDRESSES: For service information identified in this final rule,
contact Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; Widebody Customer Response Center North
America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-
514-855-2999; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
internet http://www.bombardier.com. You may view this service
information at the FAA, Transport Standards Branch, 2200 South 216th
St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2019-0877.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0877; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations is U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Thomas Niczky, Aerospace Engineer,
Avionics and Electrical Systems Services Section, FAA, New York ACO
Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone
516-228-7347; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian AD CF-2019-22, dated May 27,
2019

(``Canadian AD CF-2019-22'') (also referred to as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for certain Bombardier, Inc., Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes. You may examine the MCAI in
the AD docket on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2019-0877.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Bombardier,
Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The
NPRM published in the Federal Register on December 2, 2019 (84 FR
65935). The NPRM was prompted by a report that a fouling condition was
found between the generator power cables and the support brackets of
the auxiliary-aft fuel tank during production. The NPRM proposed to
require a visual inspection of the generator power cables for damage,
installation of protective conduits and edging grommets, and applicable
corrective actions. The FAA is issuing this AD to address damage to the
insulation sleeve of the generator power cables that can potentially
cause a short circuit, arcing, and a malfunction of one or both main
generators. See the MCAI for additional background information.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA received no comments on the NPRM or
on the determination of the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed,
except for minor editorial changes. The FAA has determined that these
minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Bombardier has issued Service Bulletin 601R-24-131, dated June 28,
2012. This service information describes procedures for visual
inspection of the generator power cables for damage, installation of
protective insulation and edging grommets, and applicable corrective
actions. Corrective actions include repair. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 9 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
22 work-hours x $85 per hour = $1,870........................            $524           $2,394          $21,546
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data that would enable the
agency to provide cost estimates for the on-condition actions specified
in this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2020-03-23 Bombardier, Inc.: Amendment 39-19847; Docket No. FAA-
2019-0877; Product Identifier 2019-NM-146-AD.

(a) Effective Date

    This AD is effective April 2, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model CL-600-2B19 (Regional
Jet Series 100 & 440) airplanes, certificated in any category, as
identified in Bombardier Service Bulletin 601R-24-131, dated June
28, 2012.

(d) Subject

    Air Transport Association (ATA) of America Code 24, Electrical
power.

(e) Reason

    This AD was prompted by a report that a fouling condition was
found between the generator power cables and the support brackets of
the auxiliary-aft fuel tank during production. The FAA is issuing
this AD to address damage to the insulation sleeve of the generator
power cables that can potentially cause a short circuit, arcing, and
a malfunction of one or both main generators.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Within 18 months after the effective date of this AD, visually
inspect the generator power cables and wire strands for damage,
install protective conduits and edging grommets, and do all
applicable corrective actions, in accordance with the Accomplishment
Instructions of Bombardier Service Bulletin 601R-24-131, dated June
28, 2012. Do all applicable corrective actions before further
flight.

(h) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(i) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian AD CF-2019-22, dated May 27, 2019, for related
information. This MCAI may be found in the AD docket on the internet
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2019-0877.
    (2) For more information about this AD, contact Thomas Niczky,
Aerospace Engineer, Avionics and Electrical Systems Services
Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Bombardier Service Bulletin 601R-24-131, dated June 28,
2012.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; Widebody Customer Response Center
North America toll-free telephone 1-866-538-1247 or direct-dial
telephone 1-514-855-2999; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>internet http://www.bombardier.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on February 14, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-03934 Filed 2-26-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Notices]
[Pages 68885-68887]
[FR Doc No: 2023-22007]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98644; File No. SR-Phlx-2023-45]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
of Proposed Rule Change To Permit the Listing and Trading of P.M.-
Settled Nasdaq-100 Index Options With a Third-Friday-of-the-Month
Expiration

September 29, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 28, 2023, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to permit the listing and trading of p.m.-
settled Nasdaq-100 Index[supreg] options \3\ with a third-Friday-of-
the-month expiration.
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    \3\ Nasdaq-100 Index options trade under the symbol (``NDX'').
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    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/phlx/rules, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the 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
    Phlx proposes to amend its rules to permit the listing and trading
of p.m.-settled Nasdaq-100 Index options with a third-Friday-of-the-
month expiration date. The Exchange notes that p.m.-settled options
were recently approved and included a p.m.-settled third-Friday-of-the-
month expiration for trading of options based on 1/100 the value of the
Nasdaq-100 Index.\4\
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    \4\ See Securities Exchange Act Release No. 98451 (September 20,
2023), 88 FR 66088 (September 26, 2023) (SR-Phlx-2023-07) (Order
Granting Approval of a Proposed Rule Change, as Modified by
Amendment No. 1, to Make Permanent Certain P.M.-Settled Pilots).
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    By way of background, the Nasdaq-100 Index, a modified market
capitalization-weighted index, includes 100 of the largest non-
financial companies listed on The Nasdaq Stock Market LLC, based on
market capitalization. It does not contain securities of financial
companies including investment companies. Security types generally
eligible for the Nasdaq-100 Index include common stocks, ordinary
shares, American Depository Receipts, and tracking stocks. Security or
company types not included in the Nasdaq-100 Index are closed-end
funds, convertible debentures, exchange traded funds, limited liability
companies, limited partnership interests, preferred stocks, rights,
shares or units of beneficial interest, warrants, units and other
derivative securities.\5\ Today, the Exchange may list a.m.-settled
third-Friday-of-the-month expirations on Nasdaq-100 Index options.
Previously, Phlx received approval to permit the listing and trading,
on a pilot basis, of NASDAQ-100 options with p.m.-settled third-Friday-
of-the-month expiration dates.\6\ The Exchange extended the pilot
through May 6, 2019, and, subsequently through November 4, 2019,
because p.m.-settled options on the Nasdaq-100 Index had not yet been
listed by Phlx.\7\ The Exchange did not renew this Pilot a third time
and therefore the Pilot expired on November 4, 2019.\8\ Today, Cboe
Exchange, Inc. (``Cboe'') lists third-Friday p.m.-settled options on
the Standard & Poor's 500 Index (``S&P 500 Index'') under the symbol
``SPXW.'' \9\
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    \5\ A description of the Nasdaq-100 is available on Nasdaq's
website at https://indexes.nasdaqomx.com/docs/methodology_NDX.pdf.
    \6\ See Securities Exchange Act Release No. 81293 (August 2,
2017), 82 FR 37138 (August 8, 2017) (approving SR-Phlx-2017-04)
(Order Granting Approval of a Proposed Rule Change, as Modified by
Amendment Nos. 1 and 2, To Permit the Listing and Trading of P.M.-
Settled Nasdaq-100 Index Options on a Pilot Basis).
    \7\ See Securities Exchange Act Release Nos. 84685 (November 29,
2019), 83 FR 62942 (December 6, 2018) (SR-Phlx-2018-76) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
the Pilot Period for the Listing of P.M.-Settled Nasdaq-100 Index
Options Expiring on the Third Friday of the Month) and 85692 (April
18, 2019), 84 FR 17213 (April 24, 2019) (SR-Phlx-2019-16) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Extend
the Pilot Period for the Listing of P.M.-Settled Nasdaq-100 Index
Options Expiring on the Third Friday of the Month).
    \8\ See Securities Exchange Act Release No. 87517 (November 13,
2019), 84 FR 63910 (November 19, 2023) (SR-Phlx-2019-49) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Remove
Rule Text From Phlx Rule 1101A).
    \9\ Cboe also lists a.m.-settled S&P 500 Index options that have
standard third-Friday expirations. See Cboe Rule 4.10(e). Cboe's
third-Friday-of-the-month pilot was recently approved. See
Securities Exchange Act Release No. 98454 (September 20, 2023) (SR-
CBOE-2023-005) (Order Granting Approval of a Proposed Rule Change,
as Modified by Amendment No. 1, to Make Permanent the Operation of
the Program that Allows the Exchange to List P.M.-Settled Third
Friday-of-the-Month S&P 500 Stock Index Options (``SPX'') Series).
---------------------------------------------------------------------------

    At this time, the Exchange proposes to amend Options 4A, Section 12
to permit the listing of p.m.-settled third-Friday-of-the-month
Expiration Dates under the trading symbol ``NDXP.'' Today, the Exchange
may list a.m.-settled third-Friday-of-the-month expirations on Nasdaq-
100 Index options. With this proposal, the Exchange would have third-
Friday-of-the-month expirations on Nasdaq-100 Index options that are
both a.m.-settled and p.m.-settled on the same day. The conditions for
listing p.m.-settled third-Friday-of-the-month expirations on Nasdaq-
100 Index options will be similar to those for a.m.-settled third-
Friday-of-the-month expirations on Nasdaq-100 Index options.
    The proposed contract would use a $100 multiplier, and the minimum
trading increment would be $0.05 for options trading below $3.00 and
$0.10 for all other series.\10\ Strike price intervals would be set at
no less than $2.50.\11\ Consistent with existing rules for index
options, the Exchange would allow up to nine near-term expiration
months \12\ as well as LEAPS.\13\ The

product would have European-style exercise. Because the product is
based on the Nasdaq-100 Index there would be no position limits. Also,
today, the Exchange notes that it has the flexibility to open for
trading additional series in response to customer demand.\14\
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    \10\ See Options 3, Section 3, Minimum Increments.
    \11\ See Options 4A, Section 12(a)(3).
    \12\ The Exchange proposes the same expiration month options for
NDXP as are permitted for the Nasdaq-100 Index, since both options
classes are derived from the Nasdaq-100 Index.
    \13\ Options 4A, Section 12(b) provides that after a particular
class of stock index options has been approved for listing and
trading on the Exchange, the Exchange shall from time to time open
for trading series of options therein. Within each approved class of
stock index options, the Exchange shall open for trading a minimum
of one expiration month and series for each class of approved stock
index options and may also open for trading series of options having
not less than twelve and up to 60 months to expiration (long-term
options series) as provided in subparagraph (b)(2). Prior to the
opening of trading in any series of stock index options, the
Exchange shall fix the expiration month and exercise price of option
contracts included in each such series. Further, Options 4A, Section
12(b)(2) provides that the Exchange may list, with respect to any
class of stock index options or Nasdaq-100[supreg] Volatility Index
options, series of options having not less than twelve and up to 60
months to expiration, adding up to ten expiration months. Such
series of options may be opened for trading simultaneously with
series of options trading pursuant to this rule. Strike price
intervals and continuity rules shall not apply to such options
series until the time to expiration is less than twelve months. Bid/
ask differentials for long-term options contracts are specified
within Options 2, Section 4(c)(1)(A).
    \14\ Options 4A, Section 12(b)(1) provides that additional
series of stock index options of the same class may be opened for
trading on the Exchange when the Exchange deems it necessary to
maintain an orderly market, to meet customer demand or when the
market price of the underlying index moves more than five strike
prices from the initial exercise price or prices. The opening of a
new series of options shall not affect the series of options of the
same class previously opened. New series of options on an index may
be added until the beginning of the month in which the options
contract will expire. Due to unusual market conditions, the
Exchange, in its discretion, may add a new series of options on
indexes until the fourth business day prior to the business day of
expiration, or, in the case of an index option contract expiring on
a day that is not a business day, up to the fifth business day prior
to expiration.
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    NDXP options are series of the NDX options class. Currently, these
NDXP options may expire any day of the week, Mondays, Tuesdays,
Wednesdays, Thursdays, Fridays, as applicable (other than third-Friday-
of-the-month), and the last trading day of the month.\15\ Third-Friday
p.m.-settled options trading under the NDXP symbol will be a new type
of series under the Nasdaq-100 Index options class and not a new
options class, therefore all third-Friday p.m.-settled NDXP options
will be aggregated together with all other standard expirations for
applicable reporting and other requirements.\16\
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    \15\ See Options 3, Section 12(b)(5)(A).
    \16\ Options 3, Section 6(e) provides, ``Aggregation--Full
value, reduced value, micro index value, long term and quarterly
expiring options based on the same index shall be aggregated.
Reduced value or mini-size and micro index contracts shall be
aggregated with full value or full-size contracts and counted by the
amount by which they equal a full value contract (e.g., a hundredth
(1/100th)) value contracts equal one (1) full value contract).
Positions in Short Term Options Series and Quarterly Options Series
shall be aggregated with positions in options contracts of the same
index. Nonstandard Expirations (as provided for in Options 4A,
Section 5(b)(vii)) on a broad-based index shall be aggregated with
option contracts on the same broad-based index and shall be subject
to the overall position limit.''
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    As with the Nasdaq-100 Index, whenever the Exchange determines that
additional margin is warranted in light of the risks associated with an
under-hedged NDXP option position, including third-Friday-of-the-month
p.m.-settled NDXP, the Exchange may consider imposing additional margin
upon the account maintaining such under-hedged position pursuant to its
authority pursuant to under Exchange Rules Options 6E, Section 2. The
trading hours for NDXP, including third-Friday-of-the-month p.m.-
settled NDXP, will be from 9:30 a.m. to 4:15 p.m. Eastern Time.\17\
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    \17\ The Exchange notes that NDXP will ordinarily cease at 4:00
p.m. on the day on which the exercise-settlement value is
calculated.
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    The Exchange proposes to amend Options 4A, Section 12(a)(6) to
provide that in addition to a.m.-settled Nasdaq-100 Index options
approved for trading on the Exchange, the Exchange may also list
options on the Nasdaq-100 Index whose exercise settlement value is the
closing value of the Nasdaq-100 Index on the expiration day.\18\
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    \18\ The closing value of the Nasdaq-100 Index may change up
until 17:15 Easter Time due to corrections to prices of the
underlying component securities.
---------------------------------------------------------------------------

    The Exchange does not believe that any market disruptions will be
encountered with the introduction of Nasdaq-100 Index options with
third-Friday-of-the-month p.m.-settled expiration dates. The Exchange
will monitor for any such disruptions or the development of any factors
that could cause such disruptions.
    The adoption of trading third-Friday-of-the-month p.m.-settled
options on the Nasdaq-100 Index on the same exchange that lists third-
Friday-of-the-month a.m.-settled options on the Nasdaq-100 Index would
provide greater spread opportunities. This manner of trading in
different products allows a market participant to utilize different
expiration times, providing expanded trading opportunities. In the
options market currently, market participants regularly trade similar
or related products in conjunction with each other, which contributes
to overall market liquidity.
    The Exchange represents that it has sufficient capacity to handle
additional traffic associated with listing third-Friday-of-the-month
p.m.-settled options, and that it has in place adequate surveillance
procedures to monitor trading in these options thereby helping to
ensure the maintenance of a fair and orderly market.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\19\ in general, and with
Section 6(b)(5) of the Act,\20\ in that it is designed to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest; and is not designed to
permit unfair discrimination between customers, issuers, brokers, or
dealers, or to regulate by virtue of any authority conferred by the Act
matters not related to the purposes of the Act or the administration of
the Exchange. The Exchange believes that the proposed rule change is
also consistent with Section 6(b)(8) of the Act \21\ in that it does
not impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
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    \19\ 15 U.S.C. 78f.
    \20\ 15 U.S.C. 78f(b)(5).
    \21\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    P.M.-settled options were recently approved and included a p.m.-
settled third-Friday-of-the-month expiration for trading of options on
XND.\22\ Previously, Phlx received approval to permit the listing and
trading, on a pilot basis, of NASDAQ-100 options with p.m.-settled
third-Friday-of-the-month expiration dates.\23\ The Exchange extended
the pilot through May 6, 2019, and, subsequently through November 4,
2019, because p.m.-settled options on the NASDAQ-100 Index had not yet
been listed by Phlx.\24\ The Exchange did not renew this Pilot a third
time and therefore the Pilot expired on November 4, 2019.\25\ Today,
Cboe lists third-Friday p.m.-settled options on the S&P 500 Index under
the symbol ``SPXW.'' \26\ For these reasons, the Exchange desires to
list a p.m.-settled third-Friday-of-the-month expiration for trading of
options on the Nasdaq-100 Index. The Exchange believes that listing
this expiry would not have any adverse effects or impact on market
volatility and the operation of fair and orderly markets on the
underlying cash market at or near the

close of trading in its Nasdaq-100 Index options.
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    \22\ See supra note 4.
    \23\ See supra note 6.
    \24\ See supra note 7.
    \25\ See supra note 8.
    \26\ See supra note 9.
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    Specifically, the Exchange believes that the introduction of
Nasdaq-100 Index options with third-Friday-of-the-month p.m.-settled
expiration dates will attract order flow to the Exchange, increase the
variety of listed options to investors, and provide a valuable hedge
tool to investors. Further, the Exchange believes this proposal will
ensure market participants, particularly retail customers, have
seamless access to p.m.-settled Nasdaq-100 Index options expiring every
Friday of the month, which helps to remove impediments to and perfect
the mechanism of a free and open market. The Exchange believes the
proposed rule change will help to protect investors and the public
interest by allowing market participants to enter options positions
with the same underlying in one symbol that spans every Friday
expiration in a month, thus providing a more efficient way to gain
exposure and hedge risk.
    The adoption of trading third-Friday-of-the-month p.m.-settled
options on the Nasdaq-100 Index on the same exchange that lists third-
Friday-of-the-month a.m.-settled options on the Nasdaq-100 Index would
provide greater spread opportunities. This manner of trading in
different products allows a market participant to utilize different
expiration times, providing expanded trading opportunities. In the
options market currently, market participants regularly trade similar
or related products in conjunction with each other, which contributes
to overall market liquidity.
    Third-Friday p.m. settled options trading under the NDXP symbol
will be a new type of series under the Nasdaq-100 Index options class
and not a new options class, therefore all third-Friday p.m.-settled
NDXP options will be aggregated together with all other standard
expirations for applicable reporting and other requirements.\27\
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    \27\ See supra note 12.
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    The Exchange does not believe that any market disruptions will be
encountered with the introduction of Nasdaq-100 Index options with
third-Friday-of-the-month expiration dates. The Exchange will monitor
for any such disruptions or the development of any factors that could
cause such disruptions.
    Finally, the Exchange represents that it has sufficient capacity to
handle additional traffic associated with this new listing, and that it
has in place adequate surveillance procedures to monitor trading in
these options thereby helping to ensure the maintenance of a fair and
orderly market.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
    The Exchange does not believe the rule change will impose a burden
on intramarket competition because all market participants would have
access to p.m.-settled Nasdaq-100 Index options expiring every Friday
of the month and would be able to trade them under the NDXP symbol. The
proposal will not impose a burden on intermarket competition because
the options affected by this proposal are exclusive to the Exchange.
Other options exchange may elect to adopt a similar expiry for a
product listed on their markets.
    Additionally, the Exchange does not believe the proposal will
impose any burden on intermarket competition as market participants on
other exchanges are welcome to become members and trade at Phlx if they
determine that this proposed rule change has made Phlx more attractive
or favorable.

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

    No written comments were either solicited or received.

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

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

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change 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-Phlx-2023-45 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-Phlx-2023-45. 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-Phlx-2023-45 and should be
submitted on or before October 25, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\28\
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    \28\ 17 CFR 200.30-3(a)(12).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-22007 Filed 10-3-23; 8:45 am]
BILLING CODE 8011-01-P