[Federal Register: May 14, 2009 (Volume 74, Number 92)]
[Notices]
[Page 22798-22799]
[DOCID:fr14my09-91]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59863; File No. SR-NYSE-2009-47]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by New York Stock Exchange LLC To
Modify Certain Equity Transaction Fees and Rebates

May 5, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on April 30, 2009, New York Stock Exchange LLC (the ``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule changes as described in Items I,
II and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a et seq.
    \3\ 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 make a number of changes to its schedule
of equity transaction fees and rebates, with effect from May 1, 2009.
The text of the proposed rule change is available on the Exchange's Web
site (http://www.nyse.com), at the Exchange's Office of the Secretary,
and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of and basis for the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The NYSE has prepared summaries,
set forth in Sections A, B and C below, of the most significant aspects
of such statements.

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

1. Purpose
    The Exchange proposes to make a number of changes to its schedule
of equity transaction fees, with effect from May 1, 2009.
    The following are the proposed changes:
     Currently, the Exchange caps trading fees per transaction
at $120. This cap is being eliminated and there will no longer be any
limit on the trading fees that may be incurred in connection with a
transaction. The $120 trading fee cap per transaction will be retained
for market at-the-close and limit at-the-close orders.
     The price list does not currently indicate what fee is
charged when orders are executed at the close (except for market at-
the-close and limit at-the-close orders). The Exchange's practice has
been to not charge a fee when this happens and now proposes to
formalize this approach by clearly stating it in the price list.
     Designated Market Makers whose orders are executed at the
close receive a credit of $0.0005 per share. The Exchange now proposes
to provide (i) a credit of $0.0012 per share to floor brokers whose
orders are executed at the close and (ii) a credit of $0.0005 per share
to Supplemental Liquidity Providers whose orders are executed at the
close.
     Agency cross trades (i.e., a trade where a Member
Organization has customer orders to buy and sell an equivalent amount
of the same security) of 10,000 shares or more are currently free of
charge. The Exchange proposes to extend this approach to agency cross
trades of fewer than 10,000 shares, so that all agency cross trades
will be free of charge regardless of size.
    The subheading ``Transactions in stocks with a per share stock
price of $1.00 or less'' is modified to clarify that the fees under
that subheading actually apply only to transactions in stocks with a
price of less than $1.00. As amended, it reads ``Transactions in stocks
with a per share stock price less than $1.00.''
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 \4\ of the Act in general and furthers
the objectives of Section 6(b)(4) \5\ in particular, in that it is
designed provide for the equitable allocation of reasonable dues, fees
and other charges among its members and other persons using its
facilities. The Exchange believes that the proposal does not constitute
an inequitable allocation of dues, fees and other charges as all member
organizations will be subject to the same fee structure.
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    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purpose of the Act.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change is effective upon filing pursuant to
Section

19(b)(3)(A) \6\ of the Act and Rule 19b-4(f)(2) \7\ thereunder.
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    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2009-47 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2009-47. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such filing also
will be available for inspection and copying at the principal office of
the Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSE-2009-47 and should be submitted on or before June 4, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-11165 Filed 5-13-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Proposed Rules]
[Pages 64188-64190]
[FR Doc No: 2022-23044]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 147

[Docket Number USCG-2021-0475]
RIN 1625-AA00

Safety Zone; Horn Mountain Spar Outer Continental Shelf Facility,
Mississippi Canyon Block 127, Gulf of Mexico

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish a safety zone on the
navigable waters around the Horn Mountain Spar, located in Mississippi
Canyon Block 127 on the Outer Continental Shelf (OCS) in the Gulf of
Mexico. Establishing a safety zone around the facility will
significantly reduce the threat of allisions, collisions, security
breaches, oil spills, releases of natural gas, and thereby protect the
safety of life, property, and the environment. Only vessels measuring
less than 100 feet in length overall and not engaged in towing,
attending vessels, or those vessels specifically authorized by the
Eighth Coast Guard District Commander or a designated representative
are permitted to enter or remain in the safety zone. We invite your
comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before November 23, 2022.

ADDRESSES: You may submit comments identified by docket number USCG-
2021-0475 using the Federal eRulemaking Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email LCDR David Newcomb, District Eight
OCS, U.S. Coast Guard; telephone<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
OCS Outer Continental Shelf
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    Under the authority provided in 14 U.S.C. 544, 43 U.S.C. 1333, and
Department of Homeland Security Delegation No. 0170.1, 33 CFR part 147
permits the establishment of safety zones for facilities located on the
OCS for the purpose of protecting life, property and the marine
environment. The protections included in a safety zone established
under 33 CFR part 147 are promoting safety of life and property on the
facilities as well as their appurtenances and attending vessels and
also for the adjacent waters located in and around each facility.
Therefore, a safety zone under 33 CFR part 147 may also include
provisions to restrict, prevent, or control certain activities,
including access by vessels or persons to maintain safety of life,
property and the environment. Anadarko Petroleum Corporation requested
that the Coast Guard establish a safety zone around its facility
located in the deepwater area of the Gulf of Mexico on the OCS. The
Coast Guard determined that establishing a safety zone around this
facility will significantly reduce the threat of allisions, oil spills,
and releases of natural gas, and thereby protect the safety of life,
property, and the environment.

III. Discussion of Proposed Rule

    The safety zone proposed by this rulemaking is on the OCS in the
deepwater area of the Gulf of Mexico in Mississippi Canyon Block 127 at
the center point of N 28.866, W 88.056. The safety zone would be
permanent. For the purpose of safety zones established under 33 CFR
part 147, the deepwater area is considered to be waters of 304.8 meters
(1,000 feet) or greater depth extending to the limits of the Exclusive
Economic Zone (EEZ) contiguous to the territorial sea of the United
States and extending to a distance up to 200 nautical miles from the
baseline from which the breadth of the sea is measured. Navigation in
the vicinity of the safety zone consists of large commercial shipping
vessels, fishing vessels, cruise ships, tugs with tows and the
occasional recreational vessel. The deepwater area also includes an
extensive system of fairways.
    Only vessels measuring less than 100 feet in length overall and not
engaged in towing, attending vessels as defined in 33 CFR 147.20, or
those vessels specifically authorized by the Eighth Coast Guard
District Commander or a designated representative are permitted to
enter or remain in the safety zone.

The transit of other vessels into and through the safety zone area
would be prohibited. Requests for entry will be considered and reviewed
on a case-by-case basis. These proposed regulations are consistent with
the existing safety zones on other OCS platforms in the Gulf of Mexico.
Persons or vessels that require authorization to enter the safety zone
must request it from the Commander, Eighth Coast Guard District. If
permission is granted, all persons and vessels shall comply with the
instructions of the Commander or designated representative.

IV. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    Aligning with 33 CFR 147.15, the safety zone established will
extend to a maximum distance of 500 meters around the OCS facility
measured from each point on its outer edge, but may not interfere with
the use of recognized sea lanes essential to navigation. Vessel traffic
would be able to safely transit around the proposed safety zone, which
would impact a small designated area in the Gulf of Mexico, without
significant impediment to their voyage. This safety zone would reduce
the risk of allision with the platform and help protect the environment
from potential oil spills, in accordance with Coast Guard maritime
safety missions.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    This rulemaking may affect owners or operators of vessels intending
to transit or anchor in Mississippi Canyon 127, some of which might be
small entities.
    This safety zone would not have a significant economic impact on a
substantial number of small entities for the following reasons. Vessel
traffic could pass safely around the safety zone using an alternate
route. Use of an alternate route may cause minimal delay in reaching a
final destination, depending on other traffic in the area and vessel
speed. Vessels would also be able to request deviation from this
rulemaking to transit through the safety zone. Such requests will be
considered on a case-by-case basis and may be authorized by the
Commander, Eighth Coast Guard District or a designated representative.
Therefore, the Coast Guard expects any impact of this rulemaking
establishing a safety zone around an OCS facilities to be minimal, with
no significant economic impact on small entities.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this rulemaking would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rulemaking would
affect your small business, organization, or governmental jurisdiction
and you have questions concerning its provisions or options for
compliance, please call or email the person listed in the FOR FURTHER
INFORMATION CONTACT section. The Coast Guard will not retaliate against
small entities that question or complain about this proposed rule or
any policy or action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves the
establishment of a safety zone around an OCS facility to protect life,
property, and the marine environment. Normally such actions are
categorically excluded from further review under paragraph L60 of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
preliminary Record of Environmental Consideration supporting this
determination is available in the docket. For instructions on locating
the docket,

see the ADDRESSES section of this preamble. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

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

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2021-0475 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of the proposed rule. We may
choose not to post off-topic, inappropriate, or duplicate comments that
we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 147

    Continental shelf, Marine safety, Navigation (water).

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 147 as follows:

PART 147--SAFETY ZONES

0
1. The authority citation for part 147 continues to read as follows:

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

0
2. Add Sec.  147.875 to read as follows:

Sec.  147.875  Safety Zone; Horn Mountain Spar, Outer Continental Shelf
Facility, Mississippi Canyon 127.

    (a) Description. The area within 500 meters of the Horn Mountain
Spar in the deepwater area of the Gulf of Mexico at Mississippi Canyon
127 is a safety zone. The Horn Mountain Spar is located at:
    Latitude N 28.8660
    Longitude W 88.0562
    (b) Regulation. No vessel may enter or remain in this safety zone
except for the following:
    (1) An attending vessel as defined in 147.20;
    (2) A vessel under 100 feet in length overall not engaged in
towing; or
    (3) A vessel authorized by the Commander, Eighth Coast Guard
District or a designated representative.
    (c) Requests for Permission. Persons or vessels requiring
authorization to enter the safety zone must request permission from the
Commander, Eighth Coast Guard District or a designated representative.
If permission is granted, all persons and vessels shall comply with the
instructions of the Commander or designated representative.

    Dated: October 18, 2022.
Richard Timme,
RADM, U.S. Coast Guard, Commander, Coast Guard District Eight.
[FR Doc. 2022-23044 Filed 10-21-22; 8:45 am]
BILLING CODE 9110-04-P


Finally, Nuro must provide NHTSA with any additional information
about the event that NHTSA deems pertinent for determining either
crash or injury causation, including additional information related
to the ADS or remote operator system.

2. Periodic Reporting

    Beginning 90 days after the date of the exemption grant, and at
an interval of every 90 days thereafter, Nuro must submit to NHTSA's
OVSC a report detailing the operation of each R2X vehicle in
operation during that time period. This report may provide this
information either in aggregate or on a per-vehicle basis, but it
must include the following:
     A calculation of the total miles the vehicle has
traveled using the ADS during the report period, and heat maps of
the geofenced area in which the vehicle operates to illustrate
travel density. Nuro must provide the same information for miles
traveled using a remote operator.
     Detailed descriptions of any material changes made to
the R2X's Operational Design Domain (ODD) or ADS software during the
reporting period.
     Detailed descriptions of any incidents in which the R2X
has violated any local or state traffic law, whether operating using
the ADS or under remote operation.
     Detailed descriptions of any incidents in which the R2X
has experienced a sustained

acceleration of at least 0.7g on any axis for at least 150 ms, or of
any incidents in which the vehicle has an unexpected interaction
with humans or other objects (other than crashes that require
immediate reporting).
     Detailed descriptions of all instances in which a
public safety official, including law enforcement, has attempted to
interact with an R2X, such as to pull it over, or has contacted Nuro
regarding an attempted interaction with the R2X.
     Detailed descriptions of any ``minimal risk condition
fallback'' \94\ or ``remote operator takeover'' \95\ events that
have occurred, even if no crash has occurred. If the event has
occurred because the vehicle self-diagnosed a malfunction of a
vehicle system, the report must include a detailed description of
the cause and nature of the malfunction, and what remedial steps
were taken. If the event was caused by the vehicle encountering a
complex or unexpected driving situation, the report must include a
detailed timeline of the ADS's decision-making process that led to
the event, including any difficulties the ADS had in detecting and
classifying objects. For any remote operator takeover event, Nuro
must provide information about any technical issues encountered,
such as signal latency.
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    \94\ The term ``minimal risk condition fallback'' refers to a
situation in which the ADS pulls over using a ``failsafe
trajectory,'' as described on page 21 of Nuro's VSSA, which Nuro
submitted as an attachment to its comment. See Docket No. NHTSA-
2019-0017-0023.
    \95\ The term ``remote operator takeover'' refers to a situation
in which a remote operator takes control of a vehicle either because
the ADS recommends remote operation, or because the remote operator
deems it appropriate without being prompted by the ADS.
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    In addition, Nuro must make necessary staff available to meet
with NHTSA staff quarterly to discuss the status of its deployment
program.

3. Cybersecurity

     Nuro must have a documented cybersecurity incident
response plan that includes its risk mitigation strategies and the
incident notification requirements listed below.
     Nuro must cease operations of all R2X vehicles
immediately upon becoming aware of any cybersecurity incident \96\
involving the R2X and any systems connected to the R2X that has the
potential to impact the safety of the R2X.
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    \96\ As used in these terms, ``incident'' is defined as an
occurrence that jeopardizes the functionality, confidentiality,
integrity, or availability of a vehicle computing platform through
the potential use of an exploit. ``Exploit'' refers to an action
that takes advantage of a vulnerability to cause unintended or
unanticipated behavior to occur on computer software and/or
hardware.
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     No later than 24 hours after being made aware of a
cybersecurity incident, Nuro must inform NHTSA's Office of Defects
Investigations (ODI) of the incident. Nuro must also respond to any
additional requests for information from NHTSA on the cybersecurity
incident.
     Prior to resuming its operation of R2X vehicles
following the discovery of a cybersecurity incident, Nuro must
inform NHTSA of the steps it has taken to patch the vulnerability
and mitigate the risks associated with the incident, and receive
NHTSA approval to resume operation.

4. Other Conditions

     Nuro must be capable of issuing a ``stop order'' that
causes all deployed R2X vehicles to, as quickly as possible, cease
operations in a safe manner, in the event that NHTSA or Nuro
determines that the exempted vehicles present an unreasonable or
unforeseen risk to safety.
     Nuro must coordinate any planned deployment of the R2X
or change to the ADS/ODD with state and local authorities with
jurisdiction over the operation of the vehicle as required by the
laws or regulations of that jurisdiction.
     The R2X must comply with all state and local laws and
requirements at all times while in operation. Each vehicle must be
duly permitted, if applicable, and authorized to operate within all
properties and upon all roadways traversed.
     Nuro must maintain ownership and operational control
over the R2Xs that are built pursuant to this exemption for the life
of the vehicles.
     Nuro must create and maintain a hotline or other method
of communication for the public and Nuro employees to directly
communicate feedback or potential safety concerns about the R2X to
the company.

    Authority:  49 U.S.C. 30113 and 49 U.S.C. 30166; delegations of
authority at 49 CFR 1.95 and 49 CFR 501.4.

    Issued in Washington, DC, under authority delegated in 49 CFR
1.95 and 501.4.
James C. Owens,
Acting Administrator.

[FR Doc. 2020-02668 Filed 2-10-20; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 88, Number 91 (Thursday, May 11, 2023)]
[Notices]
[Pages 30356-30360]
[FR Doc No: 2023-10030]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97444; File No. SR-NFA-2023-01]

Self-Regulatory Organizations; National Futures Association;
Notice of Filing and Immediate Effectiveness of Proposed Change to NFA
Compliance Rule 2-9(c) and the Interpretive Notice Entitled ``NFA
Compliance Rule 2-9: FCM and IB Anti-Money Laundering Program''

May 5, 2023.
    Pursuant to section 19(b)(7) of the Securities Exchange Act of 1934
(``Exchange Act''),\1\ and Rule 19b-7 thereunder,\2\ notice is hereby
given that on March 28, 2023, National Futures Association (``NFA'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change described in Items I, II, and
III below, which Items have been prepared by NFA. 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)(7).
    \2\ 17 CFR 240.19b-7.
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    In its filing with the Commission (File No. SR-NFA-2023-01), NFA
stated the following: NFA also filed the proposed rule change with the
Commodity Futures Trading Commission (``CFTC'') in five separate
filings in October 2011, August 2012, June 2018, May 2020, and
September 2022; on October 13, 2011, NFA requested that the CFTC make a
determination that review of the proposed rule change of NFA included
in the October 2011 filing was not necessary; \3\ on November 16, 2011,
the CFTC notified NFA that it had determined not to review the proposed
rule change; \4\ on August 27, 2012, NFA

requested that the CFTC make a determination that review of the
proposed rule change of NFA included in the August 2012 filing was not
necessary; \5\ on August 27, 2013, the CFTC notified NFA that it had
determined not to review the proposed rule change; \6\ on June 15,
2018, NFA also filed a proposed rule change with the CFTC and requested
that the CFTC make a determination that review of the proposed rule
change of NFA was not necessary; \7\ by letter dated June 28, 2018, the
CFTC notified NFA of its determination not to review the proposed rule
change; \8\ on May 28, 2020, NFA filed a proposed rule change with the
CFTC and requested that the CFTC make a determination that review of
the proposed rule change of NFA was not necessary; \9\ in an email on
May 29, 2020, the CFTC requested clarification of NFA's proposed rule
change filed on May 28, 2020; \10\ by letter dated June 8, 2020, the
CFTC notified NFA of its determination not to review the proposed rule
change; \11\ on September 22, 2022, NFA filed a proposed rule change
with the CFTC and requested that the CFTC make a determination that
review of the proposed rule change of NFA was not necessary; \12\ by
letter dated October 19, 2022, the CFTC notified NFA of its
determination not to review the proposed rule change.\13\
---------------------------------------------------------------------------

    \3\ See letter dated October 13, 2011 from Thomas W. Sexton,
III, Senior Vice President and General Counsel, NFA, to David A.
Stawick, Office of the Secretariat, CFTC. This letter can be found
in Exhibit 5(a) of File No. SR-NFA-2023-01.
    \4\ See letter dated November 16, 2011 from Gary Barnett,
Director, Division of Swap Dealer and Intermediary Oversight, CFTC
to Thomas W. Sexton, Senior Vice President and General Counsel, NFA.
This letter can be found in Exhibit 5(b) of File No. SR-NFA-2023-01.
    \5\ See letter dated August 27, 2012 from Thomas W. Sexton, III,
Senior Vice President and General Counsel, NFA to David A. Stawick,
Office of the Secretariat, CFTC. This letter can be found in Exhibit
5(c) of File No. SR-NFA-2023-01.
    \6\ See letter dated August 27, 2013 from Gary Barnett,
Director, Division of Swap Dealer and Intermediary Oversight, CFTC
to Thomas W. Sexton, III, Senior Vice President and General Counsel,
NFA. This letter can be found in Exhibit 5(d) of File No. SR-NFA-
2023-01.
    \7\ See letter dated June 15, 2018 from Carol A. Wooding, Vice
President and General Counsel, NFA to Christopher J. Kirkpatrick,
Office of the Secretariat, CFTC. This letter can be found in Exhibit
5(e) of File No. SR-NFA-2023-01.
    \8\ See Letter dated June 28, 2018 from Matthew Kulkin,
Director, Division of Swap Dealer and Intermediary Oversight, CFTC
to Carol A. Wooding, Vice President and General Counsel, NFA. This
letter can be found in Exhibit 5(f) of File No. SR-NFA-2023-01.
    \9\ See letter dated May 28, 2020 from Carol A. Wooding, Senior
Vice President and General Counsel, NFA to Christopher J.
Kirkpatrick, Office of the Secretariat, CFTC. This letter can be
found in Exhibit 5(g) of File No. SR-NFA-2023-01.
    \10\ See email dated May 29, 2020 from Christopher W. Cummings,
Special Counsel, Division of Swap Dealer and Intermediary Oversight,
CFTC to Carol A. Wooding, Senior Vice President and General Counsel,
NFA. This correspondence can be found in Exhibit 5(h) of File No.
SR-NFA-2023-01.
    \11\ See letter dated June 8, 2020 from Joshua Sterling,
Director, Division of Swap Dealer and Intermediary Oversight, CFTC
to Carol A. Wooding, Senior Vice President and General Counsel, NFA.
This letter can be found in Exhibit 5(i) of File No. SR-NFA-2023-01.
    \12\ See letter dated September 22, 2022 from Carol A. Wooding,
Senior Vice President and General Counsel, NFA to Christopher J.
Kirkpatrick, Office of the Secretariat, CFTC. This letter can be
found in Exhibit 5(j) of File No. SR-NFA-2023-01.
    \13\ See letter dated October 19, 2022 from Amanda L. Olear,
Director, Market Participants Division, CFTC to Carol A. Wooding,
Senior Vice President and General Counsel, NFA. This letter can be
found in Exhibit 5(k) of File No. SR-NFA-2023-01.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Description and Text of the Proposed
Rule Change

    The proposed amendments to the Interpretive Notice entitled NFA
Compliance Rule 2-9: FCM and IB Anti-Money Laundering Program
(``Interpretive Notice'') update the Interpretive Notice to incorporate
changes the Financial Crimes Enforcement Network (``FinCEN'') made to
Bank Secrecy Act (``BSA'') regulations regarding suspicious activity
report (``SAR'') confidentiality, as well as advisories issued by
FinCEN regarding sharing SARs between and among affiliates.\14\ The
amendments also provide Members with additional guidance regarding the
timing of SAR filings and record retention requirements, the frequency
of the employee training and independent audit requirements and
incorporate existing BSA requirements related to Reports of Foreign
Bank and Financial Accounts and Reports of International Transportation
of Currency or Monetary Instruments. Further, the amendments revise the
references to the Code of Federal Regulations to reflect the adoption
of Chapter X for BSA requirements.\15\ (October 2011 Amendments)
---------------------------------------------------------------------------

    \14\ NFA notified Members of these changes through Notices to
Members outlining these new requirements at the time FinCEN
originally issued or adopted the requirements/advisories.
    \15\ See ``Transfer and Reorganization of Bank Secrecy Act
Regulations; Final Rule,'' 75 FR 65806 (Oct. 26, 2010).
---------------------------------------------------------------------------

    The amendments also revise the Customer Identification Program
(``CIP'') subsection of the Interpretive Notice, which describes
guidance that FinCEN and the CFTC issued in 2006 (FIN-2006-G004--
Frequently Asked Questions Regarding Customer Identification Programs
for Futures Commission Merchants and Introducing Brokers, February 14,
2006) related to CIP obligations with respect to omnibus accounts.\16\
Due to concerns that the language in NFA's Interpretive Notice could be
read to provide that a firm is never required to obtain information on
beneficial owners, the language was revised to indicate that for
omnibus accounts where the intermediary is the account holder, an FCM
should treat the intermediary as the customer and the FCM does not have
to apply its CIP requirements to the underlying beneficiary. (August
2012 Amendments).
---------------------------------------------------------------------------

    \16\ 31 CFR 1026.220(a)(2)(ii)(C) (2015).
---------------------------------------------------------------------------

    The proposed amendments to NFA Compliance Rule 2-9(c) as well as
the related Interpretive Notice incorporate changes FinCEN made to the
BSA regulations on May 11, 2016 that require financial institutions to
identify and verify the identity of beneficial owners of legal entity
(``LE'') customers and amend the Anti-Money Laundering Program
(``AML'') requirements for FCMs and IBs to require appropriate risk-
based procedures to conduct ongoing customer due diligence
(collectively, ``CDD Rule''). (June 2018 Amendments).
    The amendments also incorporate guidance issued by the Commission
[sic] in consultation with FinCEN to CFTC Interpretive Letter No. 19-18
entitled Interpretive Guidance Regarding Voice Broker Customer
Identification Program and Beneficial Ownership Rule Requirements. The
proposed amendments also made minor amendments to unrelated footnotes
to reflect technical citation changes and re-numbered existing
footnotes. (May 2020 Amendments).
    Moreover, the amendments also closely align NFA's Interpretive
Notice with the exact language included in the BSA and its implementing
regulations. Further, the amendments include the deletion of two
footnotes that are no longer applicable as well as amendments to other
footnotes that include outdated language and website links that are no
longer operable. (September 2022 Amendments).
    The text of the proposed amendments--October 2011 Amendments,
August 2012 Amendments, June 2018 Amendments, May 2020 Amendments, and
September 2022 Amendments--to the Interpretive Notice and NFA
Compliance Rule 2-9(c) is found in Exhibit 4.

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

    In its filing with the Commission, NFA 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. NFA 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
    Section 15A(k) of the Exchange Act \17\ makes NFA a national
securities association for the limited purpose of regulating the
activities of NFA Members who are registered as brokers or dealers in
security futures products under section 15(b)(11) of the Exchange
Act.\18\ NFA's Interpretive Notice and NFA Compliance Rule 2-9(c) apply
to all NFA Member FCMs and IBs and require them to develop and
implement an AML program reasonably designed to achieve and monitor a
Member's compliance with the requirements of the BSA and the
implementing regulations promulgated thereunder and could apply to NFA
Members registered as security futures brokers or dealers under section
15(b)(11) of the Exchange Act.\19\
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78o-3(k).
    \18\ 15 U.S.C. 78o(b)(11).
    \19\ Id.
---------------------------------------------------------------------------

    NFA is amending the Interpretive Notice to include amendments to
the BSA regulations that specify that the BSA's confidentiality
provisions prohibit FCMs and IBs from revealing any information which
would reveal the existence of a SAR. NFA's amendments also clarify that
the disclosure prohibition is not limited to the person involved in the
transaction that is the subject of the SAR, but rather applies to all
persons except as specifically authorized by the regulation. NFA's
amendments also incorporate FinCEN's guidance that permits FCMs and IBs
to share SARs or any information that would reveal the existence of a
SAR with an affiliate provided that the affiliate is subject to a SAR
regulation issued by FinCEN or another regulatory agency, including the
Board of Governors of the Federal Reserve System, the Federal Deposit
Insurance Corporation, the National Credit Union Administration, the
Office of the Comptroller of the Currency, the Office of Thrift
Supervision, and the SEC. NFA's amendments also add existing BSA
requirements related to the timing for filing a SAR, SAR documentation
retention requirements, FCM and IB requirements for filing a Report of
Foreign Bank and Financial Accounts, and the FCM requirements for
filing a Report of International Transportation of Currency or Monetary
Instruments. The amendments revise all references to the Code of
Federal Regulations to reflect the adoption of Chapter X for BSA
requirements.\20\
---------------------------------------------------------------------------

    \20\ See ``Transfer and Reorganization of Bank Secrecy Act
Regulations, Final Rule,'' 75 FR 65806 (Oct. 26, 2010).
---------------------------------------------------------------------------

    Moreover, the amendments also revise the CIP subsection of the
Interpretive Notice, which describes guidance that FinCEN and the CFTC
issued in 2006 (FIN-2006-G004--Frequently Asked Questions Regarding
Customer Identification Programs for Futures Commission Merchants and
Introducing Brokers, February 14, 2006) related to CIP obligations with
respect to omnibus accounts. Due to concerns that the language in NFA's
Interpretive Notice could be read to provide that a firm is never
required to obtain information on beneficial owners, the revised
language indicates that for omnibus accounts where an intermediary is
the account holder an FCM should treat the intermediary as the customer
and the FCM does not have to apply its CIP requirements to the
underlying beneficiary.\21\
---------------------------------------------------------------------------

    \21\ 31 CFR 1026.220(c)(2)(ii)(C) (2015).
---------------------------------------------------------------------------

    Further, on August 12, 2016, NFA notified Members of the upcoming
FinCEN CDD Rule requirements; instructed them to begin considering
modifications to their AML programs in order to comply with these new
requirements; and informed them that NFA Compliance Rule 2-9(c) and the
related Interpretive Notice would be updated to incorporate FinCEN's
new requirements. FCMs and IBs were required to comply with FinCEN's
CDD Rule on or before May 11, 2018.
    Currently, NFA Compliance Rule 2-9(c) requires an FCM's and IB's
AML program to, at a minimum, have four enumerated components--(1)
policies, procedures and internal controls reasonably designed to
assure compliance with the applicable provisions of the BSA and the
implementing regulations; \22\ (2) independent testing; (3) designation
of a compliance officer responsible for day-to-day compliance; and (4)
ongoing training for appropriate personnel. NFA is amending Compliance
Rule 2-9(c) and the Interpretive Notice to incorporate the fifth
component that FinCEN added to its AML Program Requirements that
requires firms to adopt and implement appropriate risk-based procedures
for conducting ongoing customer due diligence, including: (i)
understanding the nature and purpose of customer relationships for the
purpose of developing a customer risk profile; and (ii) conducting
ongoing monitoring to identify and report suspicious transactions, and,
on a risk basis, to maintain and update customer information.
---------------------------------------------------------------------------

    \22\ Without explanation, FinCEN also modified this component to
require that the policies, procedures, and internal controls be
designed to prevent the financial institution from being used for
money laundering or the financing of terrorist activities. NFA is
amending Compliance Rule 2-9(c) to incorporate this change.
---------------------------------------------------------------------------

    NFA is also amending the Interpretive Notice to add a separate
section requiring that FCMs and IBs establish and implement written
procedures that are reasonably designed to identify and verify the
identity of beneficial owners of LE customers. Specifically, in
accordance with FinCEN's requirements, the Interpretive Notice requires
FCM and IB Members to obtain certain identifying information, including
a required certification,\23\ from the natural person opening the
account on behalf of the LE. After a firm identifies the beneficial
owner(s), it is also required to verify the identity using risk-based
procedures that, at a minimum, contain the same elements as required
for verifying the identity of customers that are individuals under the
CIP requirements. As with CIP requirements, the CDD Rule and NFA's
Interpretive Notice permit a financial institution to enter into a
reliance agreement with another financial institution to perform these
obligations.
---------------------------------------------------------------------------

    \23\ Firms may choose to comply with the certification
requirement by using FinCEN's Certification Form (as adopted as an
appendix A to the rulemaking) or by obtaining the information
required by FinCEN's form, along with a certification by the natural
person regarding the accuracy of the information.
---------------------------------------------------------------------------

    NFA is further amending the Interpretive Notice to incorporate the
CDD Rule's new recordkeeping requirements for FCMs and IBs. Namely,
firms will be required to make and maintain records of all beneficial
owners and retain those records for five years after the account is
closed. Additionally, firms must also make and maintain records of the
description of the documents and any non-documentary methods used to
verify the identity of a beneficial owner for a period of five years
after the record was made. Firms are expected to use the beneficial
ownership information obtained to ensure they comply with Office of
Foreign Assets Controls (``OFAC'') Regulations and OFAC-administered
sanctions. NFA's amendments merely incorporate the requirements of
FinCEN's beneficial ownership rule and do not impose any additional
requirements on FCM and IB Members.
    Moreover, NFA is amending the Interpretive Notice to incorporate
CFTC guidance as provided in the July 22,

2019, CFTC Interpretive Letter No.19-18 entitled Interpretive Guidance
Regarding Voice Broker Customer Identification Program and Beneficial
Ownership Rule Requirements (``CFTC Interpretive Guidance'') addressing
FCMs' and IBs' compliance with applicable requirements of the BSA and
its implementing regulations related to CIP and Beneficial Ownership
and granting relief from the CIP and Beneficial Ownership requirements
to IBs that do not introduce an account to an FCM and do not have
customers or accounts for the purposes of the CIP rule. NFA amended
footnote 6 in the Interpretive Notice to provide a hyperlink to and a
brief description of the Interpretive Guidance and to clarify that
these IBs are not required to establish and implement a CIP or apply
Beneficial Ownership requirements with respect to their voice brokerage
business under NFA's Interpretive Notice. The footnote also clarifies
that these IBs are required to conduct suspicious activity reviews and
comply with other applicable NFA requirements using the information
available to them. NFA also amended the Interpretive Notice to more
closely align with the exact language in the BSA and its implementing
regulations in two unrelated footnotes (i.e., new footnotes 18 and 41)
to reflect technical citation changes, as well as amendments to make
required re-numbering of existing footnotes.
    Furthermore, NFA's amendments closely align NFA's Interpretive
Notice with the exact language included in the BSA and its implementing
regulations. These amendments also include the deletion of two
footnotes that are no longer applicable as well as amendments to other
footnotes that include outdated language and website links that are no
longer operable.
    Amendments to the Interpretive Notice were previously filed with
the SEC in SR-NFA-2006-03, Exchange Act Release No. 34-54956 (Dec. 18,
2006), 71 FR 77431 (Dec. 26. 2006); SR-NFA-2007-06 (withdrawn); SR-NFA-
2008-01, Exchange Act Release No. 34-57640 (Apr. 9, 2008), 73 FR 20341
(Apr. 15, 2008); and SR-NFA-2011-01 (withdrawn). This is the first
amendment filing for NFA Compliance Rule 2-9(c) since it was initially
filed with the SEC in SR-NFA-2002-03, Exchange Act Release No. 34-45887
(May 7, 2002), 67 FR 32072 (May 13, 2002).
2. Statutory Basis
    NFA believes that the proposed rule change is authorized by, and
consistent with section 15A(k)(2)(B) of the Exchange Act.\24\ That
section sets out requirements for rules of a futures association,
registered under section 17 of the Commodity Exchange Act, that are a
registered national securities association for the limited purpose of
regulating the activities of members who are registered as brokers or
dealers in security futures products pursuant to section 15(b)(11) of
the Exchange Act.\25\ Under section 15A(k)(2)(B) of the Exchange
Act,\26\ the rules of such a limited purpose national securities
association must be designed to prevent fraudulent and manipulative
acts and practices, to promote just and equitable principles of trade,
and, in general, to protect investors and the public interest in
connection with security futures products in a manner reasonably
comparable to the rules of a registered national securities association
applicable to securities futures products.
---------------------------------------------------------------------------

    \24\ 15 U.S.C. 78o-3(k)(2)(B).
    \25\ 15 U.S.C. 78o(b)(11).
    \26\ 15 U.S.C. 78o-3(k)(2)(B).
---------------------------------------------------------------------------

    NFA believes the proposed rule change would meet these requirements
by: specifying that the BSA's confidentiality provisions prohibit FCMs
and IBs from revealing any information which would reveal the existence
of a SAR; clarifying that the disclosure prohibition is not limited to
the person involved in the transaction that is the subject of the SAR,
but rather applies to all persons except as specifically authorized by
the BSA regulation; incorporating FinCEN's guidance that permits FCMs
and IBs to share SARs or any information that would reveal the
existence of a SAR with an affiliate provided that the affiliate is
subject to a SAR regulation issued by FinCEN or another regulatory
agency, including the Board of Governors of the Federal Reserve System,
the Federal Deposit Insurance Corporation, the National Credit Union
Administration, the Office of the Comptroller of the Currency, the
Office of Thrift Supervision and the SEC; clarifying timing
requirements for AML training and AML independent testing; adding
existing BSA requirements related to the timing for filing a SAR, SAR
documentation retention requirements, FCM and IB requirements for
filing a Report of Foreign Bank and Financial Accounts and the FCM
requirements for filing a Report of International Transportation of
Currency or Monetary Instruments; revising all references to the Code
of Federal Regulations to reflect the recent adoption of Chapter X for
BSA; and clarifying CIP responsibilities with respect to omnibus
accounts.
    The proposed rule change further protects investors and the public
interest in connection with security futures products by requiring FCMs
and IBs to modify their AML programs to incorporate FinCEN's new
regulations requiring financial institutions to identify and verify the
identity of beneficial owners of LE customers and to conduct ongoing
customer due diligence. Accordingly, NFA is amending Compliance Rule 2-
9(c) to modify language and to specifically require appropriate risk-
based procedures for conducting customer due diligence.
    Further, NFA is amending the Interpretive Notice to add a separate
section on identifying and verifying beneficial owners pursuant to
FinCEN requirements; to amend the suspicious activity reporting section
to add a requirement that FCMs and IBs develop risk-based ongoing CDD
procedures in accordance with FinCEN's requirements; to amend the
Ongoing Compliance Responsibilities--OFAC section to clarify that FCMs
and IBs should use the beneficial ownership information to help ensure
that they are in compliance with OFAC regulations; and to clarify that
voice broker IBs that negotiate/facilitate block futures and cleared
swap transactions do not have customers or accounts for purposes of the
CIP Rule and are not required to establish and implement a CIP or apply
Beneficial Ownership requirements with respect to their voice broker
business but still required to adopt and implement an AML program to
conduct suspicious activity reviews and comply with other applicable
NFA requirements using the information available to them. NFA is also
amending the Notice [sic] to more closely align the language with the
exact wording in the BSA and its implementing regulations.
    This proposal is not designed to regulate, by virtue of any
authority conferred by the Exchange Act, matters not related to the
purposes of the Exchange Act or the administration of the association.
To the extent that this proposal regulates activities and transactions
other than security futures, the authority for regulating those
activities and transactions comes from the Commodity Exchange Act
rather than securities laws.

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

    NFA does not believe that the proposed rule changes would impose
any burden on competition. With the exception of the amendment
clarifying

the timing requirements related to training of employees and the
independent audit, the amendments update the Notice [sic] to
incorporate or clarify requirements and guidance under the BSA, to
which NFA Member FCMs and IBs are currently subject. NFA also believes
that the amendment clarifying the timing of employee training and the
independent audit will not impose any burden on competition because FCM
and IB Members are currently required to have annual employee training
and an annual audit.
    At first glance, the rule change may appear to impose additional
burdens on FCMs and IBs. However, these new obligations have already
been imposed by rules adopted by FinCEN in order to prevent and detect
money laundering activities, and NFA's amendments merely incorporate
FinCEN's requirements into NFA's rules. The rule changes require FCMs
and IBs to identify and verify the identity of all beneficial owners of
LE customers, to adopt new recordkeeping requirements, to make and
maintain records of all beneficial owners, and to require appropriate
risk-based procedures to conduct ongoing customer due diligence. NFA
does not believe that the proposed rule change will result in any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Exchange Act.

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

    NFA did not publish the rule changes to the membership for comment.
NFA did not receive comment letters concerning the rule change. NFA
Member FCM and IB Advisory Committees fully supported the proposed
amendments to the Interpretive Notice and NFA Compliance Rule 2-9(c).

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

    NFA filed the proposed rule changes with the CFTC in five separate
filings filed on the following dates: October 13, 2011,\27\ August 27,
2013,\28\ June 15, 2018,\29\ May 28, 2020,\30\ and September 22,
2022.\31\ On November 16, 2011, August 27, 2013, June 28, 2018, and
June 8, 2020, the CFTC notified NFA that it had determined not to
review the proposed rule changes.\32\ However, as for the June 2018
Amendments, FinCEN's rule required FCMs and IBs to comply with the CDD
Rule on or before May 11, 2018. NFA did not concurrently file the
proposed rule changes with the SEC. Section 19(b)(7)(B) of the Act
provides that a proposed rule change filed with the SEC pursuant to
section 19(b)(7)(A) of the Act shall be filed concurrently with the
CFTC.
---------------------------------------------------------------------------

    \27\ See Letter dated October 13, 2011 from Thomas W. Sexton,
III, Senior Vice President and General Counsel, NFA to David A.
Stawick, Office of the Secretariat, CFTC.
    \28\ See Letter dated August 27, 2012 from Thomas W. Sexton,
III, Senior Vice President and General Counsel, NFA to David A.
Stawick, Office of the Secretariat, CFTC.
    \29\ See Letter dated June 15, 2018 from Carol A. Wooding, Vice
President and General Counsel, NFA to Christopher J. Kirkpatrick,
Office of the Secretariat, CFTC.
    \30\ See Letter dated May 28, 2020 from Carol A. Wooding, Senior
Vice President and General Counsel, NFA to Christopher J.
Kirkpatrick, Office of the Secretariat, CFTC.
    \31\ See Letter dated September 22, 2022 from Carol A. Wooding,
Senior Vice President and General Counsel, NFA to Christopher J.
Kirkpatrick, Office of the Secretariat, CFTC.
    \32\ See Letter dated November 16, 2011 from Gary Barnett,
Director, Division of Swap and Intermediary Oversight, CFTC to
Thomas W. Sexton, III, Senior Vice President and General Counsel,
NFA; Letter dated August 27, 2013 from Gary Barnett, Director
Division of Swap and Intermediary Oversight, CFTC to Thomas W.
Sexton, III, Senior Vice President and General Counsel, NFA; Letter
dated June 28, 2018 from Matthew Kulkin, Director Division of Swap
Dealer and Intermediary Oversight, CFTC to Carol A. Wooding, Vice
President and General Counsel, NFA; Letter dated June 8, 2020 from
Joshua Sterling, Director, Division of Swap Dealer and Intermediary
Oversight, CFTC to Carol A. Wooding, Senior Vice President and
General Counsel, NFA; and Letter dated October 19, 2022 from Amanda
L. Olear, Director, Market Participants Division, CFTC to Carol A.
Wooding, Senior Vice President and General Counsel, NFA.
---------------------------------------------------------------------------

    Section 19(b)(7)(C) of the Exchange Act provides, inter alia that
``[a]ny proposed rule change of a self-regulatory organization that has
taken effect pursuant to section 19(b)(7)(B) of the Exchange Act may be
enforced by such self-regulatory organization to the extent such rule
is not inconsistent with the provisions of the title, the rules and
regulations thereunder and applicable Federal law. At any time within
60 days of the date of effectiveness of the proposed rule change, the
Commission after consultation with the CFTC, may summarily abrogate the
proposed rule change and require that the proposed rule change be
refiled in accordance with the provisions of section 19(b)(1) of the
Exchange Act.

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 Exchange 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-NFA-2023-01 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-NFA-2023-01. 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
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of NFA. 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-NFA-2023-01 and
should be submitted on or before June 1, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\33\
---------------------------------------------------------------------------

    \33\ 17 CFR 200.30-3(a)(73).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-10030 Filed 5-10-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 170 (Friday, August 31, 2012)]
[Notices]
[Pages 53198-53199]
[FR Doc No: 2012-21568]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9004-8]

Environmental Impacts Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/compliance/nepa/.

Weekly receipt of Environmental Impact Statements
Filed 08/20/2012 Through 08/24/2012
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

SUPPLEMENTARY INFORMATION:  Starting October 1, 2012, EPA will not
accept paper copies or CDs of EISs for filing purposes; all submissions
on or after October 1, 2012 must be made through e-NEPA. While this
system eliminates the need to submit paper or CD copies to EPA to meet
filing requirements, electronic submission does not change requirements
for distribution of EISs for public review and comment. To begin using
e-NEPA, you must first register with EPA's electronic reporting site--
https://cdx.epa.gov/epa_home.asp.

EIS No. 20120276, Final EIS, BLM, CA, Bakersfield Proposed Resource
Management Plan, Madera, San Luis Obispo, Santa Barbara, Ventura,
Kings, Tulare, Fresno, and Kern Counties, CA, Review Period Ends: 10/
01/2012, Contact: Sue Porter<PHONE_NUMBER>.
EIS No. 20120277, Final EIS, NPS, 00, Appalachian National Scenic
Trail, Delaware Water Gap National Recreation Area, Middle Delaware
National Scenic and Recreational River, Susquehanna to Roseland 500kV
Transmission Line Right-of-Way and Special-Use-Permit, NJ and PA,
Review Period Ends: 10/01/2012, Contact: Morgan Elmer<PHONE_NUMBER>.
EIS No. 20120278, Draft EIS, USN, CA, LEGISLATIVE--Renewal of the
Chocolate Mountain Aerial Gunnery Range Land Withdrawal, Imperial and
Riverside Counties, CA, Comment Period Ends: 11/30/2012, Contact: Kelly
Finn<PHONE_NUMBER>.
EIS No. 20120279, Draft EIS, VA, CA, San Francisco Veterans Affairs
Medical Center (SFVAMC) Long Range Development Plan, Implementation,
Fort Miley, San Francisco County, CA, Comment Period Ends: 10/16/2012,
Contact: Allan Federman<PHONE_NUMBER>.
EIS No. 20120280, Draft EIS, BIA, FL, Seminole Tribe of Florida Fee-to-
Trust, Development of a Hotel/Resort and Retail Center of the Site,
Coconut Creek, Broward County, FL, Comment Period Ends: 10/15/2012,
Contact: Chester McGhee<PHONE_NUMBER>.
EIS No. 20120281, Final EIS, USFWS, CA, Santa Clara Valley Habitat
Conservation Plan, Issuance of an Incidental Take Permit, Santa Clara
County, CA, Review Period Ends: 10/01/2012 Contact: Mike Thomas 916-
414-6600.
EIS No. 20120282, Final EIS, NRC, NM, Fluoride Extraction Process and
Depleted Uranium Deconversion Plant, License Application to Construct,
Operate, and Decommission Phase 1, Lea County, NM, Review Period Ends:
10/01/2012, Contact: Asimios Malliakos<PHONE_NUMBER>.
EIS No. 20120283, Final EIS, FRA, VA, Richmond and the Hampton Roads
Passenger Rail Project, Tier I Proposed Higher Speed Intercity
Passenger Rail Service Improvements, VA, Review Period Ends: 10/01/
2012, Contact: John Winkle<PHONE_NUMBER>.
EIS No. 20120284, Draft EIS, USFS, CO, White River National Forest Oil
and Gas Leasing, Eagle, Garfield, Gunnison, Mesa, Moffat, Pitkin, Rio
Blanco, Routt, and Summit Counties, CO, Comment Period Ends: 10/30/
2012, Contact: David Francomb<PHONE_NUMBER>, ext. 3136.
EIS No. 20120285, Draft Supplement, FHWA, CA, Interstate 5 North Coast
Corridor Project, Construction of Improvements, from La Jolla Village
Drive in San Diego to Harbor Drive in

Oceanside/Camp Pendleton, New Information, San Diego County, CA,
Comment Period Ends: 10/15/2012, Contact: Manuel E. Sanchez 619-699-
7336.

Amended Notices

EIS No. 20120274, Draft EIS, USFS, AZ, Prescott National Forest Land
and Resource Management Plan, Yavapai and Coconino Counties, AZ,
Comment Period Ends: 11/28/2012, Contact: Mary C. Rasmussen 928-443-
8265. Revision to FR Notice Published 08/24/2012; Change Comment Period
Ending 10/08/2012 to 11/28/2012.
EIS No. 20120275, Draft EIS, USFS, MT, Wild Cramer Forest Health and
Fuels Reduction Project, Swan Lake Ranger District, Flathead National
Forest, Flathead County, MT, Comment Period Ends: 10/09/2012, Contact:
Richard Kehr<PHONE_NUMBER>. Revision to FR Notice Published 08/24/2012;
Change Comment Period Ending 10/08/2012 to 10/09/2012.

    Dated: August 28, 2012.
Cliff Rader,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2012-21568 Filed 8-30-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 212 (Friday, November 3, 2023)]
[Notices]
[Pages 75602-75604]
[FR Doc No: 2023-24290]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4372]

Medical Devices; Exemptions From Premarket Notification: Class II
Devices; Clinical Electronic Thermometers; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
identified certain class II clinical electronic thermometers that, when
finalized, will be exempt from premarket notification requirements,
subject to certain limitations. FDA is publishing this notice of that
determination and requesting public comment in accordance with the
procedures established by the 21st Century Cures Act. FDA will review
any comments submitted within the 60-day comment period and will
consider whether any modifications should be made to the exemption for
certain clinical electronic thermometers prior to publication of its
final determination in the Federal Register.

DATES: Either electronic or written comments on the notice must be
submitted by January 2, 2024.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 2, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-4372 for ``Medical Devices; Exemptions from Premarket
Notification: Class II Devices; Clinical Electronic Thermometers;
Request for Comments.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Madhusoodana Nambiar, Center for
Devices and Radiological Health, Food

and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5519,
Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of safety and effectiveness. Under the
Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295),
and the amendments of the Safe Medical Devices Act of 1990 (Pub. L.
101-629), devices are to be classified into class I (general controls)
if there is information showing that the general controls of the FD&C
Act are sufficient to assure safety and effectiveness; into class II
(special controls), if general controls, by themselves, are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide such assurance; and into class III (premarket
approval), if there is insufficient information to support classifying
a device into class I or class II and the device is a life sustaining
or life supporting device or is for a use which is of substantial
importance in preventing impairment of human health or presents a
potential unreasonable risk of illness or injury.
    Most generic types of devices that were on the market before the
date of the 1976 amendments (May 28, 1976) (generally referred to as
preamendments devices) have been classified by FDA under the procedures
set forth in section 513(c) and (d) of the FD&C Act through the
issuance of classification regulations into one of these three
regulatory classes. Devices introduced into interstate commerce for the
first time on or after May 28, 1976 (generally referred to as
postamendments devices) are classified through the premarket
notification process under section 510(k) of the FD&C Act (21 U.S.C.
360(k)). Section 510(k) of the FD&C Act and the implementing
regulations, part 807 of Title 21 of the Code of Federal Regulations
(CFR), require persons who intend to market a new device to submit a
premarket notification (510(k)) containing information that allows FDA
to determine whether the new device is ``substantially equivalent''
within the meaning of section 513(i) of the FD&C Act to a legally
marketed device that does not require premarket approval.
    The 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was signed
into law on December 13, 2016. Section 3054 of the Cures Act amended
section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the
FD&C Act requires FDA to publish in the Federal Register a notice
containing a list of each type of class II device that FDA determines
no longer requires a report under section 510(k) of the FD&C Act to
provide reasonable assurance of safety and effectiveness. FDA is
required to publish this notice within 90 days of the date of enactment
of the Cures Act and at least once every 5 years thereafter, as FDA
determines appropriate. Additionally, FDA must provide at least a 60-
day comment period for any such notice published under section
510(m)(1)(A) of the FD&C Act.
    FDA published the initial notice within the 90-day time frame in
the Federal Register of March 14, 2017 (82 FR 13609) and issued its
final determination of exemption of the devices in such notice in
accordance with section 510(m)(1)(B) of the FD&C Act in the Federal
Register of July 11, 2017 (82 FR 31976). FDA is publishing this notice
and requesting public comment in accordance with section 510(m)(1)(A)
of the FD&C Act. In a future final action, and after considering
comments, FDA intends to amend the codified language in the clinical
electronic thermometer regulation to reflect the final determination
with respect to exemption.

II. Factors FDA May Consider for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently
in the guidance the Agency issued on February 19, 1998, entitled
``Procedures for Class II Device Exemptions from Premarket
Notification, Guidance for Industry and CDRH Staff'' (``Class II 510(k)
Exemption Guidance'') (Ref. 1). Accordingly, FDA generally considers
the following factors to determine whether premarket notification is
necessary for class II devices: (1) the device does not have a
significant history of false or misleading claims or of risks
associated with inherent characteristics of the device; (2)
characteristics of the device necessary for its safe and effective
performance are well established; (3) changes in the device that could
affect safety and effectiveness will either (a) be readily detectable
by users by visual examination or other means such as routine testing,
before causing harm, or (b) not materially increase the risk of injury,
incorrect diagnosis, or ineffective treatment; and (4) any changes to
the device would not be likely to result in a change in the device's
classification. FDA may also consider that, even when exempting
devices, these devices would still be subject to the limitations on
exemptions.

III. Limitations on Exemptions

    FDA has determined that premarket notification is not necessary to
provide a reasonable assurance of safety and effectiveness for certain
class II clinical electronic thermometers subject to the limitations
outlined in table 1. This determination is based, in part, on the
Agency's knowledge of the device, including past experience and
relevant reports or studies on device performance (as appropriate), the
applicability of general and special controls, and the Agency's ability
to limit an exemption.

A. General Limitations of Exemptions

    FDA's proposal to grant an exemption from premarket notification
applies only to those devices that have existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type. After comment and issuance of a notice announcing
FDA's final determination, a manufacturer of a clinical electronic
thermometer would still be required to submit a premarket notification
to FDA before introducing a device or delivering it for introduction
into commercial distribution when the device meets any of the
conditions described in Sec.  880.9 (21 CFR 880.9).

B. Partial Limitations of Exemptions

    In addition to the general limitations, FDA may also partially
limit an exemption from premarket notification requirements to specific
devices within a listed device type when the initial Agency assessment
determines that the factors laid out in the Class II 510(k) Exemption
Guidance (Ref. 1) do not weigh in favor of exemption for all devices
within a generic type of device. In such situations where a partial
limitation of the exemption has been identified, FDA has determined
that premarket notification is necessary to provide a reasonable
assurance of safety and effectiveness for devices that fall outside of
the limitations. In table 1, for example, FDA is listing the proposed
exemption of clinical electronic thermometers but limits the exemption

to devices that are appropriately tested in accordance with specific
FDA-recognized standards (as outlined in the limitations) and excludes
clinical electronic thermometers with telethermographic and continuous
temperature measurement functions.
    Most contact and non-contact clinical electronic thermometers that
are appropriately tested in accordance with specific FDA-recognized
standards are well-understood devices; however, FDA considers premarket
notification requirements for clinical thermometers with
telethermographic and continuous temperature measurement functions to
be necessary to provide a reasonable assurance of safety and
effectiveness because such thermometers include newer technology that
may require additional testing beyond that specified in FDA-recognized
standards and have additional biocompatibility, interoperability,
electromagnetic compatibility, electrical safety, and sterility
considerations compared to clinical electronic thermometers without
these types of functions.

IV. Class II Device

    FDA is identifying the following class II device that, if
finalized, would no longer require premarket notification under section
510(k) of the FD&C Act, subject to the general limitations to the
exemptions found in Sec.  880.9:

                                            Table 1--Class II Devices
----------------------------------------------------------------------------------------------------------------
          21 CFR  section            Device description      Product code        Partial exemption limitation
----------------------------------------------------------------------------------------------------------------
880.2910..........................  Clinical electronic   FLL..............  Exemption is limited to the
                                     thermometer.                             following:
                                                                             1. Device is not a clinical
                                                                              thermometer with telethermography
                                                                              functions;
                                                                             2. Device is not a clinical
                                                                              thermometer with continuous
                                                                              temperature measurement functions;
                                                                              and
                                                                             3. Appropriate analysis and testing
                                                                              (such as outlined in the currently
                                                                              FDA-recognized editions of ISO
                                                                              80601-2-56 Medical electrical
                                                                              equipment--Part 2-56: Particular
                                                                              requirements for basic safety and
                                                                              essential performance of clinical
                                                                              thermometers for body temperature
                                                                              measurement, or ASTM E1965
                                                                              Standard Specification for
                                                                              Infrared Thermometers for
                                                                              Intermittent Determination of
                                                                              Patient Temperature, or ASTM E1112
                                                                              Standard Specification for
                                                                              Electronic Thermometer for
                                                                              Intermittent Determination of
                                                                              Patient Temperature, or ASTM E1104
                                                                              Standard Specification for
                                                                              Clinical Thermometer Probe Covers
                                                                              and Sheaths) must validate
                                                                              specifications and performance of
                                                                              the device.
----------------------------------------------------------------------------------------------------------------

    FDA will assign new product codes to clinical electronic
thermometers with telethermography functions and those with continuous
temperature measurement functions in order to ensure that these devices
can be identified distinctly from devices that will be exempt subject
to the partial limitations under the existing product code (i.e.,
exempt and non-exempt devices within a device type will have different
product codes).

V. Reference

    The following reference is on display in the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

    1. FDA Guidance, ``Procedures for Class II Device Exemptions
from Premarket Notification, Guidance for Industry and CDRH Staff,''
February 19, 1998, available at https://www.fda.gov/media/72685/download.

    Dated: October 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24290 Filed 11-2-23; 8:45 am]
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