[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85642-85643]
[FR Doc No: 2023-26985]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2851]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Time and Extent
Applications for Nonprescription Drug Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by January 8, 2024.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0688. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Time and Extent Applications for Nonprescription Drug Products

OMB Control Number 0910-0688--Revision

I. Background

    This information collection supports certain Agency regulations in
part 330 (21 CFR part 330) regarding over-the-counter (OTC) human drugs
and associated guidance. Specifically, FDA regulations in Sec. Sec.
330.14 and 330.15 (21 CFR 330.14 and 330.15) establish additional
criteria and procedures for classifying OTC drugs as generally
recognized as safe and effective and not misbranded. These regulations
provide that OTC drug products introduced into the U.S. market after
the OTC drug review began in 1972 and OTC drug products without any
marketing experience in the United States can be evaluated under the
OTC monograph system if the conditions (e.g., active ingredients) meet
certain ``time and extent'' criteria outlined in the regulations. The
regulations in Sec.  330.14 allow a sponsor to submit certain
information to the Agency in a time and extent application (TEA) for
use to determine eligibility of a condition for consideration in the
OTC monograph system.
    We developed the final guidance document entitled ``Time and Extent
Applications for Nonprescription Drug Products'' (September 2011)
(available from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/time-and-extent-applications-nonprescription-drug-products) to assist respondents with the
information collection provisions found in the regulations. The
guidance was issued consistent with our good guidance practice
regulations at 21 CFR 10.115, which provide for comment at any time.
The guidance explains what information an applicant should submit to
the Agency to request that a drug product be included in the OTC drug
monograph system. The guidance also discusses format and content
elements, and the process for submitting information, consistent with
the applicable regulations.

II. OTC Monograph Reform in the Coronavirus Aid, Relief, and Economic
Security Act

    The Coronavirus Aid, Relief, and Economic Security Act (CARES Act
(Pub. L. 116-136, Stat. 281)) signed March 27, 2020, included
provisions that govern the way certain OTC drugs are regulated in the
United States. The CARES Act added section 505G to the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h), which reforms and
modernizes the OTC drug review process, including establishing new
procedures for consideration of additions or changes to conditions
covered in OTC monographs. As a result of these revised statutory
provisions, we anticipate no submissions under Sec.  330.14. Our OTC
Monographs@FDA portal (https://dps.fda.gov/omuf) provides additional
information about OTC monograph drugs and the OTC drug review process.
    Consistent with section 505G(k)(3) of the FD&C Act, we plan to
withdraw the regulations supporting the TEA provisions in part 330 and
discontinue the related guidance document. When these actions occur, we
will also request discontinuation of the information collection
approved under OMB control number 0910-0688.
    In the Federal Register of August 8, 2023 (88 FR 53497), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
    21 CFR section; activity        Number of     responses per   Total annual    Average burden    Total hours
                                   respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Sec.   330.14(c) and (d); Time                1           ~1.29            1.29  861.78 hours              1,112
 and extent application and                                                       (861 hours and
 submission of information.                                                       47 minutes).
Sec.   330.14(f) and (i);
 Submission of safety and
 effectiveness data, including
 data and information listed in
 Sec.   330.10(a)(2), a listing
 of all serious adverse drug
 experiences that may have
 occurred (Sec.
 330.14(f)(2)), and an official
 or proposed compendial
 monograph (Sec.   330.14(i)).
Sec.   330.14(j) and (k);
 Submitter correspondence with
 FDA.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    As previously stated, as a result of the CARES Act statutory
provisions described above, we anticipate no TEA submissions. For
purposes of burden calculation, we assume one respondent as a
placeholder. The burden we attribute to reporting activities is assumed
to be distributed among the individual elements.
    Our estimated burden for the information collection reflects, as a
result of statutory requirements, a program change decrease of 6,894
hours and a corresponding decrease of 8 responses.

    Dated: December 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26985 Filed 12-7-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 216 (Thursday, November 9, 2023)]
[Rules and Regulations]
[Pages 77198-77200]
[FR Doc No: 2023-24717]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 864

[Docket No. FDA-2023-N-4487]

Medical Devices; Hematology and Pathology Devices; Classification
of the Container System for the Processing and Storage of Red Blood
Cell Components Under Reduced Oxygen Conditions

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the container system for the processing and storage of Red
Blood Cell components under reduced oxygen conditions into class II
(special controls). The special controls that apply to the device type
are identified in this order and will be part of the codified language
for the classification of the container system for the processing and
storage of Red Blood Cell components under reduced oxygen conditions.
We are taking this action because we have determined that classifying
the device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices.

DATES: This order is effective November 9, 2023. The classification was
applicable on September 15, 2023.

FOR FURTHER INFORMATION CONTACT: Karen Fikes, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the container system for the
processing and storage of Red Blood Cell components under reduced
oxygen conditions as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. The automatic assignment of class III occurs by
operation of law and without any action by FDA, regardless of the level
of risk posed by the new device. Any device that was not in commercial
distribution before May 28, 1976, is automatically classified as, and
remains within, class III and requires premarket approval unless and
until FDA takes an action to classify or reclassify the device (see 21
U.S.C. 360c(f)(1)). We refer to these devices as ``postamendments
devices'' because they were not in commercial distribution prior to the
date of enactment of the Medical Device Amendments of 1976, which
amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act; (see also 21 CFR part 860, subpart D). Section 207 of the
Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-
115) established the first procedure for De Novo classification.
Section 607 of the Food and Drug Administration Safety and Innovation
Act (Pub. L. 112-144) modified the De Novo application process by
adding a second procedure. A device sponsor may utilize either
procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
510(k) process, when necessary, to market their device.

II. De Novo Classification

    On January 5, 2022, FDA received Hemanext, Inc.'s request for De
Novo classification of the Hemanext One. FDA reviewed the request in
order to classify the device under the criteria for classification set
forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls,

provide reasonable assurance of the safety and effectiveness of the
device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review
of the information submitted in the request, we determined that the
device can be classified into class II with the establishment of
special controls. FDA has determined that these special controls, in
addition to the general controls, will provide reasonable assurance of
the safety and effectiveness of the device.
    Therefore, on September 15, 2023, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
864.9115.\1\ We have named the generic type of device container system
for the processing and storage of Red Blood Cell components under
reduced oxygen conditions, identified as a device intended for medical
purposes that is used to process and store Red Blood Cell components
and reduce oxygen levels in the storage environment.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

  Table 1--Container System for the Processing and Storage of Red Blood
   Cell Components Under Reduced Oxygen Conditions Risks to Health and
                           Mitigation Measures
------------------------------------------------------------------------
         Identified risks to health              Mitigation measures
------------------------------------------------------------------------
Toxicity that can result from contact of     Biocompatibility
 the component materials of the device with   evaluation.
 the red blood cells or patient's body.
Toxicity of leached materials, or residual   Extractables and leachables
 chemical sterilant, when in contact with     testing.
 red blood cells or transfused to patient.
Infection..................................  Sterilization validation;
                                              Endotoxin testing; and
                                              Container closure
                                              evaluation.
Transfusion of poor quality red blood cells  Nonclinical and clinical
 because of inadequate storage conditions     studies; Shelf-life
 or device malfunction.                       testing; and Performance
                                              testing.
Blood exposure because of device             Performance testing.
 malfunction.
Transfusion of poor quality red blood cells  Labeling.
 due to processing of Red Blood Cells
 components collected from donors with
 hemoglobin S.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act. At the time of
classification, container system for the processing and storage of Red
Blood Cell components under reduced oxygen conditions is for
prescription use only. Prescription devices are exempt from the
requirement for adequate directions for use for the layperson under
section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR
801.5, as long as the conditions of 21 CFR 801.109 are met.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in 21 CFR part 860, subpart D, regarding De Novo
classification have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 814, subparts A through
E, regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR part 801, regarding labeling, have been approved
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 864

    Blood, Medical devices, Packaging and containers.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
864 is amended as follows:

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

0
1. The authority citation for part 864 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  864.9115 to subpart J to read as follows:

Sec.  864.9115  Container system for the processing and storage of Red
Blood Cell components under reduced oxygen conditions.

    (a) Identification. A container system for the processing and
storage of Red Blood Cell components under reduced oxygen conditions is
a device intended for medical purposes that is used to process and
store Red Blood Cell components and reduce oxygen levels in the storage
environment.
    (b) Classification. Class II (special controls). The special
controls for this device are:

    (1) The intended use of the device must specify:
    (i) The Red Blood Cell components that can be processed and stored
including acceptable anticoagulants and additive solutions;
    (ii) The hold time after Red Blood Cell component collection;
    (iii) The processing capacity (volume) of the device; and
    (iv) The storage temperature and dating period of processed Red
Blood Cell components.
    (2) Studies must demonstrate that the device is biocompatible and
include detailed documentation of the biocompatibility evaluation.
    (3) Performance testing and nonclinical studies must include a
detailed study of leached materials extracted under conditions similar
to clinical usage of the device, and a toxicologic risk assessment of
those extracted or leached materials.
    (4) Performance testing must support sterility of the device and
include sterilization validation, endotoxin testing, and container
closure integrity evaluation.
    (5) Nonclinical and clinical studies must include evaluation of red
blood cell quality throughout the duration of storage based on in vitro
and in vivo studies, including hemolysis and red blood cell survival
and recovery.
    (6) Performance studies must include:
    (i) Detailed documentation of functional and mechanical testing,
including evaluation of oxygen and, if applicable, carbon dioxide
levels during Red Blood Cell components storage; and
    (ii) Detailed documentation of device shelf-life testing
demonstrating continued sterility, package integrity, and functionality
over the identified shelf life.
    (7) The labeling must include a contraindication against processing
Red Blood Cell components collected from donors with hemoglobin S.

    Dated: November 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24717 Filed 11-8-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 26, 2009 (Volume 74, Number 205)]
[Notices]
[Page 55052-55053]
[DOCID:fr26oc09-87]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0307 (formerly Docket No. 2007-D-0173)]

Guidance for Industry on Investigator Responsibilities--
Protecting the Rights, Safety, and Welfare of Study Subjects;
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Investigator
Responsibilities--Protecting the Rights, Safety, and Welfare of Study
Subjects.'' This guidance is intended to assist investigators in
meeting their responsibilities with respect to protecting human
subjects and ensuring the integrity of data in the conduct of clinical
investigations. The guidance also clarifies FDA's expectations
concerning the investigator's responsibility for supervising a clinical
study in which some study tasks are delegated to employees of the
investigator or to outside parties.

DATES:  Submit written or electronic comments on agency guidances at
any time.

ADDRESSES:  Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:  Joseph Griffin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4204, Silver Spring, MD 20993, 301-796-
2270<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Investigator Responsibilities--Protecting the Rights,
Safety, and Welfare of Study Subjects.'' Under the regulations in part
312 (21 CFR part 312) (Investigational New Drug Application) and part
812 (21 CFR part 812) (Investigational Device Exemptions), an
investigator is responsible for ensuring that a clinical investigation
is conducted according to the signed investigator statement, the

investigational plan, and applicable regulations; for protecting the
rights, safety, and welfare of subjects under the investigator's care;
and for the control of drugs, biological products, and devices under
investigation (Sec. Sec.  312.60 and 812.100). This guidance clarifies
the responsibilities of investigators in the conduct of clinical
investigations conducted under parts 312 and 812, particularly the
responsibilities to supervise the conduct of the clinical
investigation, and to protect the rights, safety, and welfare of study
participants in drug, biologic, and medical device clinical trials. The
guidance also provides recommendations on how investigators should
supervise the study-related actions of persons not in the direct employ
of the investigator, including certain study staff and parties
conducting associated testing and assessments.
    On May 10, 2007 (72 FR 26639), FDA issued a draft of this guidance
with the goal of received input from the public. During the
finalization of this guidance, FDA carefully considered all substantive
comments concerning the content of the guidance. During finalization,
FDA's major emphasis was on clarifying issues that were identified as
confusing and correcting apparent errors. These efforts resulted in
relatively minor changes throughout the guidance. FDA also removed a
significant amount of content from the background section because it
was duplicative of content in the guidance appendices. FDA also
reordered section III.A.3 of the guidance concerning adequate
supervision of the conduct of a clinical trial to make the sequence
more logical. We reversed the order of presentation so that the section
begins with the factors that may predispose to inadequate supervision,
and ends with the steps that could be taken to mitigate the potential
for inadequate supervision.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on investigator responsibilities. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 312 have been approved under OMB
control number 0910-0014; and the collections of information in part
812 have been approved under OMB control number 0910-0078. The
information requested for general investigator responsibilities is
covered by the collection of information in FDA's regulations for
investigational new drug applications (part 312) and investigational
device exemptions (part 812) and FDA Form 1572. The guidance also
refers to FDA's requirements in 21 CFR parts 11, 50, 54, and 56 for the
conduct of clinical trials of drugs, biologics, and medical devices.
The collections of information in 21 CFR part 11 have been approved
under OMB control number 0910-0303; the collections of information in
21 CFR part 54 have been approved under OMB control number 0910-0396;
and the collections of information in 21 CFR part 56 (including
information required under 21 CFR part 50) have been approved under OMB
control number 0910-0130. The collection of information for form FDA
3674 has been approved under OMB control number 0910-0616.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/default.htm, or http://
www.regulations.gov.

    Dated: October 20, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25629 Filed 10-23-09; 8:45 am]

BILLING CODE 4160-01-S


proposals submitted by the most active individual sponsors result in
negative abnormal returns and trigger sales by mutual funds that
voted against these proposals. See Nickolay Gantchev & Mariassunta
Giannetti, The costs and benefits of shareholder democracy: Gadflies
and low-cost activism, 34 Rev. Fin. Stud. 5629 (2021). Another paper
found a negative market reaction to shareholder proposals submitted
by labor unions in years that a new labor contract must be
negotiated. See John G. Matsusaka et al., Opportunistic Proposals by
Union Shareholders, 32 Rev. Fin. Stud. 3215 (2019).
    \123\ See, e.g., Chen Lin et al., Managerial entrenchment and
information production, 55 J. Fin. & Quantitative Analysis 2500
(2020); Laurent Bach & Daniel Metzger, How Do Shareholder Proposals
Create Value? (Working Paper, Mar. 1, 2017), available at https://ssrn.com/abstract=2247084.
    \124\ See, e.g., J. Robert Brown, Jr., Corporate Governance,
Shareholder Proposals, and Engagement Between Managers and Owners
(Univ. of Denv. Sturm Coll. of L., Working Paper No. 17-15, 2017),
available at https://ssrn.com/abstract=2957998.
---------------------------------------------------------------------------

    There are significant methodological and empirical challenges to
measuring the value of including a shareholder proposal in a company's
proxy statement and thus any potential benefits that may result from
the inclusion of additional shareholder proposals in the proxy
statement. For example, it is often difficult to isolate the effect of
a singular shareholder proposal on a company's stock price from the
effects of other items that are contemporaneously considered and voted
on at a shareholder meeting or from the effects of direct engagement
between shareholders and management. In addition, stock price changes
following a proposal submission or vote may capture various effects
such as signaling effects (e.g., the submission of a proposal may
signal that the targeted company is underperforming or that the initial
negotiations between the proponent and company failed), market
expectations regarding the voting outcome, and market expectations
regarding the probability of implementation of a proposal.
Nevertheless, academic literature has attempted to measure the value of
shareholder proposals and how this value varies with proposal topic and
proponent type by studying the stock price reaction around
announcements associated with shareholder proposals.\125\
---------------------------------------------------------------------------

    \125\ In the 2019 Proposing Release, the Commission summarized
the findings of empirical literature that examines whether proposals
are economically beneficial by studying short-run abnormal stock
returns around key events related to shareholder proposals. See 2019
Proposing Release, supra note 3, at 66495. The main events related
to shareholder proposals studies in academic literature comprise the
initial press announcement of submission of a shareholder proposal,
the proxy mailing date, and the date of the shareholder meeting. See
2020 Adopting Release, supra note 11, at 70285, for a description of
limitations associated with using short-term market reactions to
measure the benefits of shareholder proposals.
---------------------------------------------------------------------------

    At the same time, companies may bear both direct costs and
opportunity costs associated with the submission of a shareholder
proposal, and these costs may be passed on to shareholders.\126\

Several commenters to the 2020 amendments noted that no-action
correspondence represents the most substantial cost companies incur
related to shareholder proposals.\127\ Shareholders other than the
shareholder-proponent may also bear costs associated with their own
consideration of a shareholder proposal.\128\ Finally, shareholder-
proponents bear costs associated with preparing a shareholder proposal,
submitting a proposal to be included in a company's proxy statement
and, as applicable, engaging with management following proposal
submission.\129\
---------------------------------------------------------------------------

    \126\ In particular, to the extent applicable, companies incur
costs to: (i) review the proposal and address issues raised in the
proposal; (ii) engage in discussions with the shareholder-
proponent(s); (iii) print and distribute proxy materials, and
tabulate votes on the proposal; (iv) communicate with proxy advisory
firms and shareholders (e.g., proxy solicitation costs); (v) if they
intend to exclude the proposal, file a notice with the Commission;
and (vi) prepare a rebuttal to the submission to the Commission. See
2020 Adopting Release, supra note 11, at 70272-70275, for a detailed
discussion of the costs to companies. We recognize that there is
variation in the costs associated with responding to shareholder
proposals and that some costs that companies incur are mandatory,
while others are discretionary. As a result, the 2020 Adopting
Release used a range of estimates, $20,000-$150,000, as a measure of
the direct costs to companies associated with addressing a singular
shareholder proposal. See 2020 Adopting Release, supra note 11, at
70274. We also note that the cost of addressing a resubmission may
be lower than the cost of addressing a first-time proposal. See 2019
Proposing Release, supra note 3, at 66496. Lastly, the costs
associated with the submission of a shareholder proposal may include
opportunity costs and thus may be larger than the estimates used in
the 2020 Adopting Release. See 2020 Adopting Release, supra note 11,
at 70266 n.295.
    \127\ See 2020 Adopting Release, supra note 11, at 70272-70273
n. 332, 339.
    \128\ See 2020 Adopting Release, supra note 11, at 70276-70277,
for a detailed discussion of the costs to non-proponent
shareholders. Although these costs may be difficult to quantify,
many institutional investors retain proxy advisory firms to perform
a variety of services to reduce the burdens associated with proxy
voting decisions, including voting decisions on shareholder
proposals. We have limited data on fees charged by proxy voting
advisory firms but note that one such proxy advisory firm, ISS,
reports a fee ranging from $5,000 to above $1,000,000 per client on
Form ADV. However, we note that this fee covers a broad range of
services provided by ISS (e.g., voting services, governance
research, ratings provision, etc.) and includes proxy voting advice
services related to board elections and management proposals. See
2020 Adopting Release, supra note 11, at 70277 n.369, for a detailed
discussion of the costs to non-proponent shareholders. In addition
to costs associated with obtaining proxy voting advice for
institutional investors, retail shareholders may incur direct costs
and both retail and institutional non-proponent shareholders may
incur opportunity costs related to shareholder proposals. However,
we do not have data that would allow us to reliably estimate these
costs.
    \129\ Under Rule 14a-8(b)(iii), shareholder-proponents are
required to submit a written statement stating their availability to
discuss their proposal with the company. As a result, in addition to
the costs associated with proposal preparation, shareholder-
proponents may incur some costs associated with: (i) disclosing the
times the proponents will be available to communicate with
management as well as preparing to communicate and communicating
with management and (ii) the opportunity costs associated with
setting aside and spending time to communicate with management
instead of engaging in other activities. We do not have data that
would allow us to reliably estimate these costs.
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2. Rule 14a-8(i)(10)--Substantial Implementation
    As discussed in Section II.A.2, we are proposing to amend Rule 14a-
8(i)(10) to state that a proposal may be excluded as substantially
implemented ``[i]f the company has already implemented the essential
elements of the proposal.'' The proposed amendment's modification to
the definition of ``substantial implementation'' to focus on the
``essential elements'' of a proposal would set forth a more objective
and more specific standard for excluding proposals than the existing
rule language. By providing the staff with a more objective and
specific framework for analyzing the exclusion when reviewing and
responding to no-action requests, we believe that the amended standard
should result in no-action positions that are more predictable and
consistent than under the current rule. Increased transparency and
reduced uncertainty around the application of Rule 14a-8(i)(10) would
benefit companies by facilitating more informed decision-making when
considering whether to exclude a proposal.\130\ In particular,
companies may be better able to weigh the costs and benefits of seeking
a no-action letter, especially in instances in which the staff is
unlikely to agree with the application of the exclusion because a
company has implemented some but not all of the essential elements of
an earlier proposal. As we noted above, costs to companies associated
with no-action requests can be significant.\131\ In turn, to the extent
that companies seek no-action letters less frequently as a result of
the proposed amendment, because they conclude that seeking such letters
would not be successful, they may incur lower costs related to
shareholder proposal submissions. The proposed amendment could have a
greater effect on larger companies because a larger company is more
likely to receive a shareholder proposal and is also more likely on
average to submit a no-action request than a smaller company. On the
other hand, costs related to shareholder proposals may be a relatively
smaller percentage of the total cost of operations for larger companies
than for smaller companies.
---------------------------------------------------------------------------

    \130\ We recognize that some uncertainty regarding the
application of the substantial implementation exclusion may remain
because the determination of whether elements of a proposal are
essential may vary across proposals.
    \131\ Table 2 above shows that during the five-year period,
2017-2021, companies in the S&P 500 index received 75 percent of
submitted shareholder proposals. See also Soltes et al. (2017),
supra note 110 (finding that companies that submit no-action
requests proposals tend to be larger and receive more proposals on
average).
---------------------------------------------------------------------------

    The reduced uncertainty around proposal excludability could also
benefit shareholder-proponents by facilitating more informed decision-
making when considering whether to submit a proposal. In particular,
the ability to better predict the staff's no-action positions may allow
shareholder-proponents to avoid submitting proposals when the essential
elements have already been implemented by a company and that would be
unlikely to be permitted to go to a shareholder vote. In addition, the
increased transparency and reduced uncertainty of the application of
the proposed amendment coupled with companies potentially seeking no-
action letters less frequently may lead shareholder-proponents to
benefit from having to spend less time and fewer resources to reply to
companies' no-action requests.
    We expect that the proposed amendment will result in more
consistent determinations under Rule 14a-8(i)(10) across proposals and
over time. Current exclusion determinations can vary, which may
contribute to the variability in the number of shareholder proposals
included in companies' proxy statements.\132\ Consequently, we expect
the increased consistency of exclusion determinations resulting from
the proposed amendment to reduce the variability in the number of
shareholder proposals included in companies' proxy statements.
---------------------------------------------------------------------------

    \132\ See supra Section III.B.2.
---------------------------------------------------------------------------

    Whether the proposed amendment has an effect on the number of
proposals submitted and included in companies' proxy statements in any
given proxy season going forward depends on a number of factors,
including whether and how companies and shareholder-proponents change
their behavior as a result of the proposed amendment. While we do not
have data that would allow us to assess the extent to which companies
and shareholder-proponents may change their behavior in response to the
proposed amendment to Rule 14a-8(i)(10), we qualitatively describe
below how potential changes in behavior may impact the number of
proposals submitted and included in companies' proxy statements. In
particular, companies could modify their behavior around proposal
implementation or shareholder-proponents could modify their behavior
around proposal submission in response to this proposed amendment. For
example, companies might take into account that implementing the
essential elements of a prior proposal could preclude a subsequent
proposal with the same essential elements from being considered in a
future meeting, while implementation of some of the elements of a
proposal but not all of the essential elements could result in
recurring future votes on a proposal that contains essential elements
that were not implemented. However, we recognize that companies (and
shareholder-proponents) may continue to encounter some uncertainty when
seeking to determine whether the essential

elements of a prior proposal have been implemented. To the extent that
companies become more likely to implement all of the essential elements
of a proposal, the number of proposals included in companies' proxy
materials could decrease.
    Conversely, knowing that a proposal containing essential elements
that the company had not already implemented is unlikely to be
excludable under the amended standard, shareholder-proponents could
draft a proposal to focus on these essential elements and in turn,
increase the likelihood of this proposal appearing in a company's proxy
statement. Such changes in shareholder-proponent behavior could result
in an increase shareholder proposals submitted and included in
companies' proxy statements.
    Because we cannot reliably predict whether and the extent to which
companies and shareholder-proponents may change their behavior in
response to the proposed amendment to Rule 14a-8(i)(10), the effect of
the proposed amendment on the number of shareholder proposals and the
distribution of shareholder proposal types is unclear. Lastly, for
reasons explained above in Section III.C.1, we cannot reliably predict
whether any potential change in the number of shareholder proposals
submitted or included in companies proxy statements will result in net
benefits or costs to companies and shareholders.
3. Rule 14a-8(i)(11)--Duplication
    As discussed in Section II.B.2, we are proposing to amend Rule 14a-
8(i)(11) to indicate that a proposal ``substantially duplicates''
another proposal that will be included in the company's proxy materials
for the same meeting if it ``addresses the same subject matter and
seeks the same objective by the same means.'' We expect that the
proposed amendment would provide the staff a more objective and
specific framework for applying the duplication exclusion when
reviewing and responding to no-action requests than the existing rule
language, thereby reducing uncertainties with respect to the
application of the exclusion and promoting more predictable and
consistent determinations.\133\
---------------------------------------------------------------------------

    \133\ We recognize that some uncertainty regarding the
application of the duplication exclusion may remain because the
determination of whether the objectives or means of two or more
proposals are the same may vary across proposal characteristics.
---------------------------------------------------------------------------

    We expect the benefits to companies and their non-proponent
shareholders would be qualitatively similar to those described in
Section III.C.2 above with respect to Rule 14a-8(i)(10) because greater
predictability and certainty about the application of Rule 14a-8(i)(11)
could facilitate more informed decision-making around the submission of
a no-action request. For example, companies may be better able to weigh
the costs and benefits of seeking a no-action letter, especially in
instances where the staff is unlikely to agree with the application of
the exclusion because a proposal that the company is seeking to exclude
has a different subject matter or different objectives or means as
those in another proposal that is to be included in the proxy
statement, and is thus, not ``substantially duplicative.'' We note,
however, that quantitatively these benefits could be less pronounced
than those described in Section III.B.2 with respect to Rule 14a-
8(i)(10) since companies have been less likely to assert Rule 14a-
8(i)(11) as the basis for exclusion than Rule 14a-8(i)(10).\134\ Also,
for the same reasons as those described in Section III.B.2, this
proposed amendment may have a differential effect on larger and smaller
companies. The extent to which greater predictability and certainty
around determinations under the proposed amendment to Rule 14a-8(i)(11)
could benefit shareholder-proponents in drafting proposals would be
limited because proponents are unlikely to observe the content of other
proposals that are concurrently submitted for inclusion in the same
proxy statement during their own proposal preparation.\135\
---------------------------------------------------------------------------

    \134\ During the 2021, 2020, and 2019 proxy seasons, the staff
received 12, 9, and 16 no-action requests, respectively, asserting
the duplication exclusion. Companies asserted the duplication
exclusion in approximately five percent of no-action requests
submitted over these three proxy seasons. As of May 10, 2022, the
staff has received 22 no-action requests asserting the duplication
exclusion, accounting for approximately nine percent of no-action
requests submitted up until that point during the 2022 proxy season.
    \135\ We expect that the likelihood that proponents observe
concurrently submitted proposals has been further reduced with the
2020 amendments to Rule 14a-8(c), which limited the ability of a
single representative to submit multiple shareholder proposals on
behalf of multiple shareholders to the same meeting. See 2020
Adopting Release, supra note 11.
---------------------------------------------------------------------------

    Similarly to the discussion of the proposed Rule 14a-8(i)(10)
amendments above, we expect the proposed amendment to Rule 14a-8(i)(11)
to reduce the variability in the number of shareholder proposals
included in companies' proxy statements from one proxy season to the
next, but we cannot reliably predict how the number of shareholder
proposals submitted or included in companies' proxy statements might
change. In particular the number of shareholder proposals could change
to the extent that shareholder-proponents could modify their behavior
in response to this proposed amendment. For example, a shareholder-
proponent potentially could draft a proposal to be more particular
regarding its objectives or means so as to minimize the likelihood of
those objectives or means being deemed the same objectives or means as
those in another proposal that potentially could be submitted on the
same subject matter for the same shareholder meeting. However, the
possibility of such changes in proponent behavior likely would be
mitigated by proponents' consideration of the micromanagement exclusion
under Rule 14a-8(i)(7), among other considerations.\136\ While this
potential change in proponent behavior could result in more shareholder
proposals included in companies' proxy statements, we do not have data
that would allow us to assess the likelihood of proponent behavior
changes or quantify the potential increase in the number of proposals.
---------------------------------------------------------------------------

    \136\ See supra note 14.
---------------------------------------------------------------------------

    If the number of shareholder proposals included in companies' proxy
statements increases, the likelihood of multiple shareholder proposals
dealing with the same or similar subject matter but having different
objectives and/or means appearing in the same proxy statement could
increase. This change could lead to shareholder confusion or the need
for shareholders to spend additional time and resources to review and
compare the similar, but not duplicative, proposals.\137\ In addition,
companies may face implementation challenges and costs if shareholders
approve multiple similar, but not duplicative, proposals. However, if
shareholder consideration of similar, but not duplicative, proposals
leads to greater support for and improved likelihood of implementation
of a proposal that aligns more closely with the objectives of
shareholders, then shareholders could benefit.
---------------------------------------------------------------------------

    \137\ Institutional investors may choose to rely on proxy
advisory firms to analyze similar, but not duplicative, proposals
and determine whether they should vote on these proposals in a
similar way. See supra note 128.
---------------------------------------------------------------------------

4. Rule 14a-8(i)(12)--Resubmissions
    As discussed in Section II.C.2, we are proposing to amend Rule 14a-
8(i)(12) to revise the standard for what constitutes a resubmission
from a proposal that ``addresses substantially the same subject
matter'' as a prior proposal to a proposal that ``substantially
duplicates'' a prior proposal, defined the same way that phrase is
defined in the proposed

amendment to Rule 14a-8(i)(11).\138\ As with the proposed amendments to
Rule 14a-8(i)(10) and Rule 14a-8(i)(11) described above, we expect that
the proposed amendment would provide the staff with a more objective
and specific framework for applying the resubmission exclusion when
reviewing and responding to no-action requests than the existing rule
language, thereby reducing uncertainties with respect to the
application of the exclusion and promoting more predictable and
consistent determinations.
---------------------------------------------------------------------------

    \138\ See supra Section III.C.3.
---------------------------------------------------------------------------

    We expect the benefits to companies and their non-proponent
shareholders to be qualitatively similar to those described in Section
III.C.2 and Section III.C.3 above because greater predictability and
certainty about the application of Rule 14a-8(i)(12) could facilitate
more informed decision-making around the submission of a no-action
request. The proposed amendments could also benefit shareholder-
proponents by facilitating more informed decision-making when preparing
a shareholder proposal for submission. In particular, the ability to
better predict the staff's no-action positions may allow shareholder-
proponents to avoid spending time and resources on submitting a
proposal that substantially duplicates a prior proposal that has failed
to meet the rule's specified vote thresholds and that likely would be
excluded from a company's proxy statement. However, we do not expect
these benefits to companies and their shareholder-proponents to be
large because very few proposals are currently excluded from companies'
proxy statements on the basis of Rule 14a-8(i)(12).\139\
---------------------------------------------------------------------------

    \139\ During the 2021, 2020, and 2019 proxy seasons, the staff
received 2, 3, and 1 no-action requests, respectively, asserting the
resubmission exclusion. Companies asserted the resubmission
exclusion in less than one percent of no-action requests submitted
over these three proxy seasons. As of May 10, 2022, the staff has
received 11 no-action requests asserting the resubmission exclusion,
accounting for approximately five percent of no-action requests
submitted up until that point during the 2022 proxy season.
---------------------------------------------------------------------------

    Similarly to the discussion above of the proposed amendments to
Rule 14a-8(i)(10) and Rule 14a-8(i)(11), we cannot reliably predict the
extent to which shareholder-proponents might modify their behavior in
response to this proposed amendment, and we cannot quantify how the
number of proposals submitted and included in companies' proxy
statements could change as a result. However, we note that potential
changes in shareholder-proponents' behavior could increase the number
of proposals submitted and included in companies' proxy statements.
Currently, shareholder-proponents may refrain from submitting a
shareholder proposal dealing with substantially the same subject matter
as an earlier proposal if the earlier proposal failed to garner
sufficient levels of support to satisfy the resubmission thresholds
because they may recognize that such a proposal is likely to be
excluded from the company's proxy statement under Rule 14a-
8(i)(12).\140\ This appears to have led to a relatively low number of
no-action requests seeking to rely on the resubmission exclusion.\141\
Under the proposed amendment, a proponent could change the objective or
the means of a previously submitted proposal about the same subject
matter so as to allow for it to be considered an initial submission
instead of a resubmission. Shareholder-proponents might be more likely
to do this in instances where circumstances at the company have changed
from one year to the next and, due to those circumstances, where a
similar but not duplicative proposal may garner significantly more
votes than a prior proposal. At the same time, by reducing the
potential for the ``umbrella'' effect of the resubmission exclusion,
the proposed amendment could result in the inclusion of multiple
proposals submitted by differing proponents offering different
objectives or means to address the same issue.\142\
---------------------------------------------------------------------------

    \140\ See supra note 120.
    \141\ See supra note 139.
    \142\ See supra note 54 and the accompanying text.
---------------------------------------------------------------------------

    The proposed amendment to the resubmission exclusion could result
in benefits to shareholder-proponents to the extent that that there is
an increase in the number of proposals included in companies' proxy
statements and shareholder-proponents submit only those proposals that
are net beneficial to them. The increase in the number of submitted
proposals could also result in benefits to companies and their non-
proponent shareholders if these additional proposals lead to value-
enhancing changes. To the extent that the proposed amendment would
facilitate proponents experimenting and making adjustments to
previously submitted proposals to build broader support, the amendment
could also lead to proposals that align more closely with the
objectives of shareholders to be put to a shareholder vote. Voting
outcome data for these additional proposals could further inform
management about shareholder views, allowing it to consider actions
that are of greater importance across larger swaths of the shareholder
base and potentially leading to improved efficiency in the management-
shareholder engagement process. On the other hand, the potential
increase in the number of submitted shareholder proposals could
translate to increased costs to companies associated with the
consideration of proposals, engagement with shareholder-proponents, or
proposal inclusion in the proxy statement and increased costs to non-
proponent shareholders associated with their own consideration of
shareholder proposals.\143\ Further, the potential increase in the
number of submitted proposals could result in additional costs to
companies and their non-proponent shareholders if these additional
proposals lead to changes that reduce companies' future performance.
---------------------------------------------------------------------------

    \143\ See supra note 126.
---------------------------------------------------------------------------

    Lastly, because voting outcomes and shareholder-proponents'
propensity to resubmit previously voted-on proposals varies across
proposal topics and proponent types, this amendment may impact certain
proposal categories and certain proponent types more than others. In
particular, subject to specific facts and circumstances, the proposed
amendment may have a greater effect on environmental proposals and
proposals submitted by institutional proponents because these types of
proposals are less likely to be eligible for resubmission following the
2020 amendments to the voting thresholds in Rule 14a-8(i)(12) than
governance and social proposals and proposals submitted by individual
proponents, respectively.\144\
---------------------------------------------------------------------------

    \144\ See supra notes 100 and 101 for a description of how we
grouped proposals into governance, social, and environmental
categories, and proponent types.
---------------------------------------------------------------------------

D. Anticipated Effects on Efficiency, Competition, and Capital
Formation

    By making exclusion determinations more certain and predictable and
enabling companies and shareholder-proponents to make more informed
decisions around the submission of a no-action request and submission
of a proposal, respectively, we expect the proposed amendments to
improve efficiency. Specifically, the proposed amendments could allow
companies to avoid inefficiently using time and resources to attempt to
exclude a shareholder proposal from proxy statements in instances in
which the proposed amendments would not permit exclusion. Similarly,
the proposed amendments could allow shareholder-proponents to avoid
inefficiently using time and resources to prepare a proposal submission
that

likely will be excluded from a company's proxy statement.
    The proposed amendments could lead to additional effects on
efficiency and capital formation as a result of the potential changes
in companies' and shareholder-proponents' behavior leading to a change
in the number and characteristics of proposals included in companies'
proxy statements. For example, the proposed amendments could further
improve efficiency and increase capital formation if additional
included shareholder proposals result in value-enhancing policy changes
or provide additional information to management about shareholder
views.\145\ On the other hand, companies may bear costs associated with
considering and addressing additional proposals, leading to a potential
reduction in efficiency and capital formation.\146\
---------------------------------------------------------------------------

    \145\ See supra notes 122-124 and the accompanying text.
    \146\ See supra note 126.
---------------------------------------------------------------------------

    Because the potential costs and benefits of the proposed amendments
may be greater for certain companies, the proposed amendments could
result in competitive effects. For example, the proposed amendment
could have a greater effect on U.S. public companies relative to those
that are not subject to the federal proxy rules, namely foreign
companies and U.S. private companies. Further, the proposed amendments
could have a greater effect on larger public companies relative to
smaller public companies because larger public companies are more
likely to receive shareholder proposals. These competition effects
could, for instance, arise through the capital formation channel
described above. However, because the proposed amendments could result
in greater benefits but also greater costs to certain companies, we
cannot reliably predict whether and how the competitive position of
these companies may change as a result of the proposed amendments.

E. Reasonable Alternatives

1. Rule 14a-8(i)(10)--Substantial Implementation
    We considered a number of alternative approaches to amending Rule
14a-8(i)(10). First, we considered proposing a change to the rule that
would require a proposal to be fully implemented in exactly the way a
proponent describes it in the proposal for it to be excludable from a
company's proxy statement. The benefit of this approach is that it
would be a standard that is more predictable in application because it
would not require a determination of which elements of the proposal are
essential. We expect that this alternative could lead to greater
consistency and predictability of determinations under Rule 14a-
8(i)(10). Further, because a full implementation standard would be more
straightforward for companies and proponents to understand and apply,
it may be more likely to result in a lower number of no-action requests
than under the proposed amendments. However, this alternative could
result in more shareholder proposals appearing in a company's proxy
statement relative to the proposed amendment even if the differences
between a shareholder-proponent's preferred policies and the policies
that the company has already implemented are only minimal. The full
implementation alternative would be likely to result in relatively
greater costs associated with companies' addressing and non-proponent
shareholders' consideration of these additional proposals.
    We also considered various other formulations of what would be
considered ``substantially implemented,'' such as if the company has
already:
    (1) Effected substantially all of what the proposal requests;
    (2) Addressed substantially all of the underlying concerns of the
proposal; or
    (3) Implemented the essential objectives of the proposal.
    All three of these alternatives may require a more fact-intensive
analysis (e.g., delineating ``what the proposal requests'' or its
``underlying concerns'' or ``essential objectives'' and determining
whether the company has ``substantially'' addressed them) compared to
the proposed amendment. Further, in the second and third alternatives,
the analysis may not be sufficiently focused on the specific elements
of the proposal, which may not serve the purpose of the exclusion to
avoid the consideration of proposals on which a company has already
``favorably acted.'' We expect that all three alternative standards
would be difficult to apply in a consistent and predictable manner. As
a result, companies and shareholders would potentially experience
greater uncertainty with respect to the application of the substantial
implementation exclusion under such alternatives relative to the
proposed amendment.
2. Rule 14a-8(i)(11)--Duplication
    As an additional change to the proposed amendment to Rule 14a-
8(i)(11), we considered changing the existing first-in-time standard to
instead provide for the exclusion of the duplicative proposal that has
fewer co-proponents. As with the first-in-time standard, this
alternative would provide an objective criterion for exclusion of a
proposal. By focusing on the number of co-proponents, this alternative
would place an emphasis on the potential breadth of shareholder support
a proposal might receive. However, we find little evidence in the data
that the number of co-proponents is positively associated with the
level of support for a proposal.\147\ Further, this alternative
approach would not provide a methodology for determining which proposal
should be excluded in cases in which duplicative proposals have the
same number of co-filers. We also considered changing the existing
first-in-time standard to instead provide for the exclusion of the
duplicative proposal that has fewer number of shares held by a
proponent or co-proponents. However, a proponent's ownership or the
aggregate ownership of co-proponents may not be correlated with the
eventual level of shareholder support a proposal may receive.\148\
Lastly, we expect that the potential benefits associated with changing
the first-in-time standard to one of the alternatives described above,
beyond those of the proposed amendment, would be minimal because the
proposed amendment alone may reduce the incentives for proponents to
submit a proposal quickly or reduce the incentives for proponents to
attempt to preempt other proposals those proponents do not agree with
and in turn, address the concerns associated with the first-in-time
standard of the duplication exclusion.
---------------------------------------------------------------------------

    \147\ Using shareholder proposals that were voted on in meetings
held in 2017-2021 and controlling for proposal topic, we find a
positive but not statistically significant correlation between the
numbers of co-proponents and the voting support a proposal received.
    \148\ See 2019 Proposing Release, supra note 3, at 66488 n. 188.
---------------------------------------------------------------------------

3. Rule 14a-8(i)(12)--Resubmissions
    As an alternative to the proposed amendment to Rule 14a-8(i)(12),
we considered returning to the pre-1983 standard defining a
resubmission as ``substantially the same proposal'' and interpreting
that to mean a proposal that is virtually identical (in form as well as
substance) to a proposal previously included in the company's proxy
materials. This alternative may be easier to apply relative to the
proposed amendments because it would not involve a determination about
the objectives and means of a proposal. We would expect that such an
alternative

could to lead to a greater consistency and predictability of
determinations under Rule 14a-8(i)(12) and potentially result in fewer
no-action requests. However, as discussed in Section II.C, reverting to
the pre-1983 standard would re-introduce the concern previously
acknowledged by the Commission that a shareholder-proponent could make
some minor changes to a previously submitted proposal so as to not have
the proposal excluded. In turn, this alternative could result in the
inclusion of proposals in companies' proxy statements that have little
potential for obtaining broader or majority support in the near term,
which could result in greater costs for companies and their
shareholders.

F. Request for Comment

    We request comment on all aspects of our economic analysis,
including the potential costs and benefits of the proposed amendments
and alternatives thereto, and whether the amendments, if adopted, would
promote efficiency, competition, and capital formation. Commenters are
requested to provide empirical data, estimation methodologies, and
other factual support for their views, in particular, on costs and
benefits estimates. In addition, we request comments on our selection
of data sources, empirical methodology, and the assumptions we have
made throughout the analysis. In addition, we request comment on the
following:
    1. Are there any entities that would be affected by the proposed
amendments that are not discussed in the economic analysis? In which
ways are those entities affected by the proposed amendments? Please
provide an estimate of the number of any additional affected entities.
    2. Are there any costs or benefits of the proposed amendments that
are not discussed in the economic analysis? If so, please describe the
types of costs and benefits and provide a dollar estimate of these
costs and benefits.
    3. We have provided a qualitative analysis of the costs and
benefits of the proposed amendments. What would be the quantitative
impact of the proposed amendments? Please provide data about or dollar
estimates of the costs and benefits as they relate to proponents,
companies, and non-proponent shareholders.
    4. What would be the effects of the proposed amendments, including
any effects on efficiency, competition, and capital formation? Would
the proposed amendments be beneficial or detrimental to proponents,
companies, and the companies' non-proponent shareholders, and why in
each case?
    5. Could the proposed amendments to Rule 14a-8(i)(10), Rule 14a-
8(i)(11), or Rule 14a-8(i)(12) allow companies to make more informed
decisions around inclusion or exclusion of proposals and the submission
of no-action requests? Would companies submit fewer no-action requests
to the Commission's staff as a result of the proposed amendments? Could
there be a cost savings to companies associated with companies no
longer attempting to exclude proposals that are unlikely to be
excludable under Rule 14a-8(i)(10), Rule 14a-8(i)(11), or Rule 14a-
8(i)(12)?
    6. Could the proposed amendments to Rule 14a-8(i)(10), Rule 14a-
8(i)(11), or Rule 14a-8(i)(12) allow shareholder-proponents to make
more informed decisions around submitting proposals? Would shareholder-
proponents submit different proposals in terms of subject matter and/or
quantity as a result? Could the proposed amendments benefit
shareholder-proponents by allowing them to avoid submitting proposals
that are likely to be excludable under Rule 14a-8(i)(10), Rule 14a-
8(i)(11), or Rule 14a-8(i)(12)?
    7. How might companies and shareholder-proponents change their
behavior in response to the proposed amendments to Rule 14a-8(i)(10),
Rule 14a-8(i)(11), or Rule 14a-8(i)(12)? How might these changes in
behavior affect the number and characteristics of proposals submitted
and included in companies' proxy statements? How might these changes in
behavior impact the distribution of proposal topics submitted and
included in companies' proxy statements? Would these changes result in
benefits or costs to companies, proponents, and non-proponent
shareholders?
    8. We described in Section III.E above a number of alternative
approaches or additional changes to the proposed amendments that we
considered. Are there any costs or benefits to these alternatives that
are not discussed in the economic analysis? If so, please describe the
types of costs and benefits and provide a dollar estimate of these
costs and benefits.
    9. Are there additional alternatives to the proposed amendments
that we should consider? If so, please describe the types of costs and
benefits of these additional alternatives and provide a dollar estimate
of these costs and benefits.

IV. Paperwork Reduction Act

A. Summary of the Collection of Information

    Certain provisions of our rules and schedules that would be
affected by the proposed amendments contain ``collection of
information'' requirements within the meaning of the Paperwork
Reduction Act of 1995 (``PRA'').\149\ We are submitting the proposed
amendments to the Office of Management and Budget (``OMB'') for review
in accordance with the PRA.\150\ The hours and costs associated with
preparing, filing, and sending the schedules, including preparing
documentation required by the shareholder-proposal process, constitute
paperwork burdens imposed by the collection of information. An agency
may not conduct or sponsor, and a person is not required to comply
with, a collection of information requirement unless it displays a
currently valid OMB control number. Compliance with the information
collection is mandatory. Responses to the information collection are
not kept confidential, and there is no mandatory retention period for
the information disclosed. The title for the affected collection of
information is:
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    \149\ 44 U.S.C. 3501 et seq.
    \150\ 44 U.S.C. 3507(d) and 5 CFR 1320.11.
---------------------------------------------------------------------------

    ``Regulation 14A (Commission Rules 14a-1 through 14a-21 and
Schedule 14A)'' (OMB Control No. 3235-0059).
    We adopted the existing regulations and schedule pursuant to the
Exchange Act. The regulations and schedule set forth the disclosure and
other requirements for proxy statements filed by issuers and other
soliciting parties. A detailed description of the proposed amendments,
including the need for the information and its proposed use, as well as
a description of the likely respondents, can be found in Section II
above, and a discussion of the expected economic effects of the
proposed amendments can be found in Section III above.

B. Summary of the Proposed Amendments' Effects on the Collection of
Information

    As discussed in Section II above, the proposed amendments are
intended to provide a clearer framework for the application of three of
the substantive bases for the exclusion of shareholder proposals under
Rule 14a-8. The proposed amendments to Rule 14a-8(i)(10), 14a-8(i)(11),
and 14a-8(i)(12) would provide greater certainty and transparency to
shareholders and companies as they evaluate whether these bases would
apply to particular proposals.

C. Incremental and Aggregate Burden and Cost Estimates for the Proposed
Amendments

    The paperwork burden estimate for Regulation 14A includes the
burdens imposed by our rules that may be incurred by all parties
involved in the proxy process leading up to and associated with the
filing of a Schedule 14A. The current number of estimated responses for
the collection of information for Regulation 14A is 6,369 annual
responses, reflecting 777,590 internal burden hours and a professional
cost burden of $103,678,712.\151\ The total burden estimate for
Regulation 14A reflects, among other things, the collection-of-
information burden associated with Rule 14a-8, which includes both the
time that a shareholder-proponent spends to prepare its proposals for
inclusion in a company's proxy statement, as well as the time that the
company spends to prepare its proxy statement to include and respond to
such proposals. We recognize that the burdens on a particular proponent
or company would likely vary based on a number of factors, including
the propensity of a particular shareholder-proponent to submit
proposals, or the number of shareholder proposals received by a
particular company, which may be related to its line of business or
industry or other factors.
---------------------------------------------------------------------------

    \151\ These numbers reflect the Commission's current OMB PRA
filing inventory. The OMB PRA filing inventory represents a three-
year average. Averages may not align with the actual number of
filings in any given year.
---------------------------------------------------------------------------

    The proposed amendments to Rule 14a-8 would revise the text of Rule
14a-8 to provide clearer standards for exclusion, and promote more
consistent and predictable determinations regarding the exclusion of
proposals under the rule. The proposed amendments are not expected to
affect the number of annual responses under the Regulation 14A
information collection, as the obligation to prepare and file proxy
statements would remain irrespective of the proposed amendments. The
proposed amendments could either increase the burden associated with
particular filings (for example, by leading to the inclusion of more
shareholder proposals in companies' proxy statements) or reduce the
burden (for example, by providing a clearer basis for exclusion of a
shareholder proposal). While the effects of the proposed amendments on
the burden hours and professional costs are difficult to predict, as
they would depend on a number of interrelated and potentially
offsetting factors, we expect that the overall burdens associated with
Regulation 14A would not change significantly. Thus we are estimating
no change in paperwork burden in connection with the proposed
amendments, although we solicit comment on this and other aspects of
our PRA analysis below.
Request for Comment
    Pursuant to 44 U.S.C. 3506(c)(2)(B), we request comment in order
to:
     Evaluate whether the proposed collections of information
are necessary for the proper performance of the functions of the
Commission, including whether the information would have practical
utility;
     Evaluate the accuracy and assumptions and estimates of the
burden of the proposed collection of information;
     Determine whether there are ways to enhance the quality,
utility, and clarity of the information to be collected;
     Evaluate whether there are ways to minimize the burden of
the collection of information on those who respond, including through
the use of automated collection techniques or other forms of
information technology; and
     Evaluate whether the proposed amendments would have any
effects on any other collection of information not previously
identified in this section.
    Any member of the public may direct to us any comments concerning
the accuracy of these burden estimates and any suggestions for reducing
these burdens. Persons submitting comments on the collection of
information requirements should direct their comments to the Office of
Management and Budget, Attention: Desk Officer for the U.S. Securities
and Exchange Commission, Office of Information and Regulatory Affairs,
Washington, DC 20503, and send a copy to, Vanessa A. Countryman,
Secretary, U.S. Securities and Exchange Commission, 100 F Street NE,
Washington, DC 20549-1090, with reference to File No. S7-20-22.
Requests for materials submitted to OMB by the Commission with regard
to the collection of information should be in writing, refer to File
No. S7-20-22 and be submitted to the U.S. Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736. OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this proposed rule. Consequently, a comment to OMB is best assured of
having its full effect if the OMB receives it within 30 days of
publication.

V. Small Business Regulatory Enforcement Fairness Act

    For purposes of the Small Business Regulatory Enforcement Fairness
Act of 1996 (``SBREFA''),\152\ the Commission must advise OMB as to
whether the proposed amendments constitute a ``major'' rule. Under
SBREFA, a rule is considered ``major'' where, if adopted, it results or
is likely to result in:
---------------------------------------------------------------------------

    \152\ 5 U.S.C. 801 et seq.
---------------------------------------------------------------------------

     An annual effect on the U.S. economy of $100 million or
more (either in the form of an increase or a decrease);
     A major increase in costs or prices for consumers or
individual industries; or
     Significant adverse effects on competition, investment, or
innovation.
    We request comment on whether the proposed amendments would be a
``major rule'' for purposes of SBREFA. In particular, we request
comment on the potential effect of the proposed amendments on the U.S.
economy on an annual basis; any potential increase in costs or prices
for consumers or individual industries; and any potential effect on
competition, investment, or innovation. Commenters are requested to
provide empirical data and other factual support for their views to the
extent possible.

VI. Initial Regulatory Flexibility Act Analysis

    The Regulatory Flexibility Act (``RFA'') \153\ requires an agency,
when issuing a rulemaking proposal, to prepare and make available for
public comment an Initial Regulatory Flexibility Analysis (``IRFA'')
that describes the impact of the proposed rule on small entities.\154\
This IRFA has been prepared in accordance with the RFA and relates to
the proposed amendments to Rule 14a-8(i)(10), Rule 14a-8(i)(11), and
Rule 14a-8(i)(12) under the Exchange Act described in Section II above.
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    \153\ 5 U.S.C. 601 et seq.
    \154\ 5 U.S.C. 603(a).
---------------------------------------------------------------------------

A. Reasons for, and Objectives of, the Proposed Action

    Rule 14a-8 provides an important mechanism for shareholders to
express their views, provide feedback to companies, and raise important
issues for the consideration of their fellow shareholders by the
inclusion of shareholder proposals in the company's proxy statement.
The proposed amendments are intended to facilitate shareholder suffrage
and communication between shareholders and the companies in which they
invest, as well as among a company's

shareholders, through the shareholder proposal process. In particular,
they are intended to enhance the ability of shareholders to express
diverse objectives, consider various ways to address issues, and
provide greater certainty and transparency to shareholders and
companies as to the application of certain of the substantive standards
for the exclusion of proposals under Rule 14a-8. The reasons for, and
objectives of, the proposed amendments are discussed in more detail in
Section II above. We discuss the economic impact and potential
alternatives to the proposed amendments in Section III, and the
estimated compliance costs and burdens of the amendments under the PRA
in Section IV above.

B. Legal Basis

    We are proposing amendments to the rules under the authority set
forth in Sections 3(b), 14, and 23(a) of the Exchange Act, as amended,
and Sections 20(a), 30, and 38 of the Investment Company Act, as
amended.

C. Small Entities Subject to the Proposed Rules

    The proposed amendments would affect some small entities that are
either: (i) shareholder-proponents that submit Rule 14a-8 proposals, or
(ii) issuers subject to the federal proxy rules that receive Rule 14a-8
proposals. The RFA defines ``small entity'' to mean ``small business,''
``small organization'' or ``small governmental jurisdiction.'' \155\
The definition of ``small entity'' does not include individuals. For
purposes of the RFA, under our rules, an issuer of securities or a
person, other than an investment company, is a ``small business'' or
``small organization'' if it had total assets of $5 million or less on
the last day of its most recent fiscal year.\156\ We estimate that
there are approximately 772 issuers that are subject to the federal
proxy rules, other than investment companies, that may be considered
small entities.\157\ An investment company, including a business
development company, is considered to be a ``small business'' if it,
together with other investment companies in the same group of related
investment companies, has net assets of $50 million or less as of the
end of its most recent fiscal year.\158\ We estimate that, as of
December 2021, there were approximately 80 investment companies that
are subject to the federal proxy rules that may be considered small
entities.\159\ We are unable to estimate the number of potential
shareholder-proponents that may be considered small entities; \160\
therefore, we request comment on the number of these small entities.
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    \155\ 5 U.S.C. 601(6).
    \156\ 17 CFR 240.0-10(a).
    \157\ This estimate is based on staff analysis of issuers
potentially subject to the final amendments, excluding co-
registrants, BDCs, and issuers of asset-backed securities, with
EDGAR filings on Form 10-K, or amendments thereto, or any proxy
filing as described in note 73, supra, filed during the calendar
year of Jan. 1, 2021 to Dec. 31, 2021. This analysis is based on
data from XBRL filings, S&P Compustat, Ives Group Audit Analytics,
and manual review of filings submitted to the Commission.
    \158\ 17 CFR 270.0-10.
    \159\ This estimate is derived from an analysis of data obtained
from Morningstar Direct as well as data filed with the Commission
(Forms N-Q and N-CSR) for or during the last quarter of 2021.
    \160\ For the purposes of our Economic Analysis, we have
estimated that there were approximately 176 proponents that
submitted a proposal to be included in a company's proxy statement
as a lead proponent during calendar year 2021. See supra Section
III.A. Out of these 176 proponents, 66 were individuals, and 110
were non-individuals. Thus, no more than 110 of these unique
proponents would be considered small entities. However, this data
allows for the identification of a sole lead proponent of each
proposal, but not all of a proposal's proponents, and, as a result,
it should be interpreted as a lower bound on the total number of
unique proponents.
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D. Projected Reporting, Recordkeeping, and Other Compliance
Requirements

    If adopted, the proposed amendments would apply to small entities
to the same extent as other entities, irrespective of size. Therefore,
we generally expect the nature of any benefits and costs associated
with the proposed amendments to be similar for large and small
entities. However, as noted in Section III.C above, the proposed
amendments could have a greater effect on larger entities because
larger entities are more likely to receive shareholder proposals and
submit no-action requests than smaller entities. Accordingly, we refer
to the discussion of the proposed amendments' economic impact,
including the estimated costs and benefits, on all affected parties,
including small entities, in Section III.C above. Consistent with that
discussion, we anticipate that the economic benefits and costs likely
could vary among small entities based on a number of factors, such as
the propensity of a particular shareholder-proponent to submit
proposals, or the number of shareholder proposals received by a
particular issuer, which may be related to its line of business or
industry or other factors, which makes it difficult to project the
economic impact on small entities with precision. While the proposals
themselves do not impose any new reporting, recordkeeping or compliance
requirements, they could affect the costs associated with preparing a
proxy statement or a shareholder proposal depending on the particular
facts and circumstances. As explained in Section III, in many cases we
are unable to quantify these costs because we lack information
necessary to make reasonable estimates. As a general matter, however,
we recognize that the costs of the proposed amendments borne by the
affected entities could have a proportionally greater effect on small
entities, as these costs may be a relatively greater percentage of the
total cost of operations for smaller entities than larger entities, and
thus small entities may be less able to bear such costs relative to
larger entities. The proposed amendments could create varying
competitive effects for companies based on company size. As noted in
Section III.D above, the proposed amendments could have a greater
competitive effect on larger public companies relative to smaller
public companies because larger public companies are more likely to
receive shareholder proposals. However, because the proposed amendments
could result in both greater benefits and greater costs to certain
companies, we cannot reliably predict whether and how the competitive
position of smaller public companies may change as a result of the
proposed amendments.
    Compliance with the proposed amendments may require the use of
professional skills, including legal skills. We request comment on how
the proposed disclosure amendments would affect small entities,
including the type of professional skills necessary for compliance with
the proposed amendments.

E. Duplicative, Overlapping, or Conflicting Federal Rules

    We believe that the proposed amendments would not duplicate,
overlap, or conflict with other federal rules.

F. Significant Alternatives

    The RFA directs us to consider significant alternatives that would
accomplish our stated objectives, while minimizing any significant
adverse impact on small entities. In connection with the proposed
amendments, we considered the following alternatives:
     Establishing different compliance or reporting
requirements that take into account the resources available to small
entities;
     Clarifying, consolidating, or simplifying compliance and
reporting requirements under the rules for small entities;
     Using performance rather than design standards; and

     Exempting small entities from all or part of the
requirements.
    The Rule 14a-8 shareholder proposal process is used regularly by
issuers and shareholder-proponents of all sizes, and the rule generally
does not impose different standards or requirements based on the size
of the issuer or shareholder-proponent. We do not believe that
establishing different compliance or reporting obligations in
conjunction with the proposed amendments or exempting small entities
from all or part of the requirements is necessary. We believe the
proposed amendments are equally appropriate for issuers and
shareholder-proponents of all sizes seeking to engage with one another
through the Rule 14a-8 process, and we see no reason why a shareholder-
proponent of a company that is a small entity should be required to
comply with differing standards regarding submission of a shareholder
proposal to the company than a shareholder-proponent of a company that
is a larger entity. In this regard, we anticipate that the proposed
amendments would result in more predictable and consistent
determinations regarding the application of Rule 14a-8(i)(10), Rule
14a-8(i)(11), and Rule 14a-8(i)(12) across proposals and over time,
which would benefit both issuers and shareholder-proponents of all
sizes. We do not believe that imposing different standards or
requirements based on the size of the issuer or shareholder-proponent
is necessary, and may result in additional costs associated with
ascertaining whether a particular issuer or shareholder-proponent may
avail itself of such different standards. For these reasons, we are not
proposing differing compliance or reporting requirements or timetables,
or an exception, for small entities. However, we seek comment on
whether and how the proposed amendments could be modified to provide
differing compliance or reporting requirements or timetables for small
entities and whether such separate requirements would be appropriate.
    The proposed amendments are intended to provide a clearer framework
for the application of certain of the rule's substantive bases for the
exclusion of proposals that is applicable to, and equally appropriate
for, issuers and shareholder-proponents of all sizes. We believe that
the proposed amendments are clear and that further clarification,
consolidation, or simplification of the compliance requirements for
small entities is not necessary, although we solicit comment on how the
proposed amendments could be revised to reduce the burden on small
entities.
    Rule 14a-8 historically, and the proposed amendments generally, use
design standards rather than performance standards in order to promote
uniform requirements for all issuers and shareholder-proponents in
connection with the submission of shareholder proposals. We solicit
comment as to whether there are aspects of the proposed amendments for
which performance standards would be appropriate.

G. Request for Comment

    We encourage the submission of comments with respect to any aspect
of this IRFA. In particular, we request comments regarding:
     How the proposed amendments can achieve their objective
while lowering the burden on small entities;
     The number of small entities, including shareholder-
proponents, that may be affected by the proposed amendments;
     The existence or nature of the potential impact of the
proposed amendments on small entities and whether the proposed
amendments would have any effects that have not been discussed in the
analysis;
     How to quantify the impact of the proposed amendments; and
     Whether there are any federal rules that duplicate,
overlap, or conflict with the proposed amendments.
    Commenters are asked to describe the nature of any impact and
provide empirical data supporting the extent of the impact. Comments
will be considered in the preparation of the Final Regulatory
Flexibility Analysis, if the proposed amendments are adopted, and will
be placed in the same public file as comments on the proposed
amendments themselves.

Statutory Authority and Text of Proposed Rule Amendments

    We are proposing the rule amendments contained in this document
under the authority set forth in Sections 3(b), 14, and 23(a) of the
Exchange Act, as amended, and Sections 20(a), 30, and 38 of the
Investment Company Act, as amended.

List of Subjects in 17 CFR Part 240

    Reporting and recordkeeping requirements; Securities.

    In accordance with the foregoing, we are proposing to amend title
17, chapter II of the Code of Federal Regulations as follows:

PART 240--GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF
1934

0
1. The general authority citation for part 240 continues to read as
follows:

    Authority:  15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z-2, 77z-3,
77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78c-3, 78c-5, 78d, 78e, 78f,
78g, 78i, 78j, 78j-1, 78k, 78k-1, 78l, 78m, 78n, 78n-1, 78o, 78o-4,
78o-10, 78p, 78q, 78q-1, 78s, 78u-5, 78w, 78x, 78dd, 78ll, 78mm,
80a-20, 80a-23, 80a-29, 80a-37, 80b-3, 80b-4, 80b-11, and 7201 et
seq., and 8302; 7 U.S.C. 2(c)(2)(E); 12 U.S.C. 5221(e)(3); 18 U.S.C.
1350; Pub. L. 111-203, 939A, 124 Stat. 1376 (2010); and Pub. L. 112-
106, sec. 503 and 602, 126 Stat. 326 (2012), unless otherwise noted.
* * * * *
0
2. Amend Sec.  240.14a-8 by revising the text of paragraphs (i)(10)
through (12) to read as follows:

Sec.  240.14a-8  Shareholder proposals.

* * * * *
    (i) * * *
    (10) Substantially implemented: If the company has already
implemented the essential elements of the proposal;
* * * * *
    (11) Duplication: If the proposal substantially duplicates (i.e.,
addresses the same subject matter and seeks the same objective by the
same means as) another proposal previously submitted to the company by
another proponent that will be included in the company's proxy
materials for the same meeting;
    (12) Resubmissions: If the proposal substantially duplicates (i.e.,
addresses the same subject matter and seeks the same objective by the
same means as) a proposal, or proposals, previously included in the
company's proxy materials within the preceding five calendar years if
the most recent vote occurred within the preceding three calendar years
and the most recent vote was:
    (i) Less than 5 percent of the votes cast if previously voted on
once;
    (ii) Less than 15 percent of the votes cast if previously voted on
twice; or
    (iii) Less than 25 percent of the votes cast if previously voted on
three or more times.
* * * * *

    By the Commission.

    Dated: July 13, 2022.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2022-15348 Filed 7-26-22; 8:45 am]
BILLING CODE 8011-01-P