[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Notices]
[Pages 6880-6889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02549]


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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2020-0016]


Plan of Action To Establish a National Strategy for the 
Coordination of National Multimodal Healthcare Supply Chains To Respond 
to COVID-19; Implemented Under the Voluntary Agreement for the 
Manufacture and Distribution of Critical Healthcare Resources Necessary 
To Respond to a Pandemic Under Section 708 of the Defense Production 
Act

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

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency (FEMA) is publishing 
the text of one additional Plan of Action under the Voluntary Agreement 
for the Manufacture and Distribution of Critical Healthcare Resources 
Necessary to Respond to a Pandemic: Plan of Action to Establish a 
National Strategy for the Coordination of National Multimodal 
Healthcare Supply Chains to Respond to COVID-19.

FOR FURTHER INFORMATION CONTACT: Robert Glenn, Office of Business,

[[Page 6881]]

Industry, Infrastructure Integration, [email protected], or (202) 212-
1666.

SUPPLEMENTARY INFORMATION:

Background and Legal Authority

    The Defense Production Act (DPA), 50 U.S.C. 4501 et seq., 
authorizes the making of ``voluntary agreements and plans of action'' 
with, among others, representatives of industry and business to help 
provide for the national defense.\1\ The President's authority to 
facilitate voluntary agreements was delegated to the Secretary of 
Homeland Security with respect to responding to the spread of COVID-19 
within the United States in Executive Order 13911.\2\ The Secretary of 
Homeland Security has further delegated this authority to the FEMA 
Administrator.\3\
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    \1\ 50 U.S.C. 4558(c)(1).
    \2\ 85 FR 18403 (Apr. 1, 2020).
    \3\ DHS Delegation 09052, Rev. 00.1 (Apr. 1, 2020); DHS 
Delegation Number 09052 Rev. 00 (Jan. 3, 2017).
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    On August 17, 2020, after the appropriate consultations with the 
Attorney General and the Chairman of the Federal Trade Commission, FEMA 
completed and published in the Federal Register a ``Voluntary Agreement 
for the Manufacture and Distribution of Critical Healthcare Resources 
Necessary to Respond to a Pandemic'' (Voluntary Agreement).\4\ Unless 
terminated prior to that date, the Voluntary Agreement is effective 
until August 17, 2025, and may be extended subject to additional 
approval by the Attorney General after consultation with the Chairman 
of the Federal Trade Commission. The Voluntary Agreement may be used to 
prepare for or respond to any pandemic, including COVID-19, during that 
time.
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    \4\ 85 FR 50035 (Aug. 17, 2020). The Attorney General, in 
consultation with the Chairman of the Federal Trade Commission, made 
the required finding that the purpose of the voluntary agreement may 
not reasonably be achieved through an agreement having less 
anticompetitive effects or without any voluntary agreement and 
published the finding in the Federal Register on the same day. 85 FR 
50049 (Aug. 17, 2020).
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    Previously, FEMA has announced the activation of five Plans of 
Action under the Voluntary Agreement:
    (1) Plan of Action to Establish a National Strategy for the 
Manufacture, Allocation, and Distribution of Personal Protective 
Equipment (PPE) to Respond to COVID-19.
    (2) Plan of Action to Establish a National Strategy for the 
Manufacture, Allocation, and Distribution of Diagnostic Test Kits and 
other Testing Components to Respond to COVID-19.
    (3) Plan of Action to Establish a National Strategy for the 
Manufacture, Allocation, and Distribution of Drug Products, Drug 
Substances, and Associated Medical Devices to Respond to COVID-19.
    (4) Plan of Action to Establish a National Strategy for the 
Manufacture, Allocation, and Distribution of Medical Devices to Respond 
to COVID-19.
    (5) Plan of Action to Establish a National Strategy for the 
Manufacture, Allocation, and Distribution of Medical Gases to Respond 
to COVID-19.
    FEMA has now activated a sixth Plan of Action under the Voluntary 
Agreement:
    (6) Plan of Action to Establish a National Strategy for the 
Coordination of National Multimodal Healthcare Supply Chains to Respond 
to COVID-19.
    This Plan is necessitated by continued transportation-related 
concerns and shortfalls that interfere with the movement of critical 
resources for our nation's COVID-19 response. Appropriate members of 
the private sector have been invited to join the Plan of Action as Sub-
Committee Participants. Provided that a Sub-Committee Participant acts 
in accordance with the terms of the Plan, the DPA affords the 
Participant an affirmative defense to certain civil and criminal 
actions brought under the antitrust laws (or any similar law of any 
state) for appropriate actions taken to carry out the Plan. The Plan is 
designed to foster a close working relationship among FEMA, Department 
of Health and Human Services, and Sub-Committee Participants to address 
national defense needs through cooperative action under the direction 
and active supervision of FEMA.
    The Attorney General, in consultation with the Chairman of the 
Federal Trade Commission, has made the required finding for the Plan of 
Action that the purposes of section 708(c)(1) of the DPA cannot 
reasonably be achieved without the Plan of Action, or by a Plan of 
Action having less anticompetitive effects than the proposed Plan of 
Action. Pursuant to section 708(f)(1)(B) of the DPA, the Department of 
Justice separately published the finding for this Plan of Action in the 
Federal Register.\5\ The FEMA Administrator has certified in writing 
that the Plan of Action is necessary to help provide for the national 
defense.
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    \5\ 86 FR 57444 (Oct. 15, 2021).
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Text of the Plan of Action To Establish a National Strategy for the 
Coordination of National Multimodal Healthcare Supply Chains To Respond 
to COVID-19 Implemented Under the Voluntary Agreement for the 
Manufacture and Distribution of Critical Healthcare Resources Necessary 
To Respond to a Pandemic

Plan of Action To Establish a National Strategy for the Coordination of 
National Multimodal Healthcare Supply Chains To Respond to COVID-19 
Implemented Under the Voluntary Agreement for the Manufacture and 
Distribution of Critical Healthcare Resources Necessary To Respond to a 
Pandemic

Preface

    Pursuant to section 708 of the Defense Production Act of 1950 
(DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management 
Agency (FEMA) Administrator (Administrator), after consultation with 
the Secretary of the Department of Health and Human Services (HHS), the 
Attorney General of the United States (Attorney General), and the Chair 
of the Federal Trade Commission (FTC), developed a Voluntary Agreement 
for the Manufacture and Distribution of Critical Healthcare Resources 
Necessary to Respond to a Pandemic (Voluntary Agreement), 85 FR 50035 
(August 17, 2020). The Voluntary Agreement, which operates through a 
series of Plans of Action, maximizes the manufacture and efficient 
distribution of Critical Healthcare Resources nationwide to respond to 
a pandemic by establishing unity of effort between Participants and the 
Federal Government for integrated coordination, planning, information 
sharing with FEMA, as authorized by FEMA, and distribution of Critical 
Healthcare Resources.
    This document establishes a Plan of Action (Plan) to Establish a 
National Strategy for the Coordination of National Multimodal 
Healthcare Supply Chains to Respond to COVID-19. This Plan will be 
implemented under the Voluntary Agreement by one or more Sub-
Committees, beginning with a Sub-Committee to Define Requirements for 
COVID-19 National Multimodal Healthcare Supply Chains and may also 
include:
    (1) Sub-Committee to Define Requirements for COVID-19 National 
Multimodal Healthcare Supply Chains,
    (2) Sub-Committee for Aviation,
    (3) Sub-Committee for Surface Transportation (including Highway, 
Motor Carriers, and Freight Rail), and
    (4) Sub-Committee for Maritime Transportation.

[[Page 6882]]

    FEMA may combine these Sub-Committees or establish additional Sub-
Committees under this Plan, so long as:
    (1) The Sub-Committee addresses one specific and well-defined 
component of the National Multimodal Healthcare Supply Chains System; 
and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
Requirements for COVID-19 National Multimodal Healthcare Supply Chains.
    The purpose of the Plan and Sub-Committees is to evaluate and 
optimize coordination of National Multimodal Healthcare Supply Chains 
System resources related to the COVID-19 response. The primary goal of 
the Plan is to create a mechanism to immediately address exigent needs 
within the National Multimodal Healthcare Supply Chains System and to 
ensure actions to address such needs do not come with unacceptable 
risks or interfere with other efforts to meet critical End-User 
requirements. When the requirements of the Plan are met, it affords 
Sub-Committee Participants defenses to civil and criminal actions 
brought under the antitrust laws (or any similar law of any state) for 
actions taken within the scope of the Plan. The Plan is designed to 
foster a close working relationship among FEMA, HHS, and Sub-Committee 
Participants to address national defense needs through cooperative 
action under the direction and active supervision of FEMA.

Table of Contents

I. Purpose
II. Authorities
III. General Provisions
    A. Definitions
    B. Plan of Action Participation
    C. Effective Date and Duration of Participation
    D. Withdrawal
    E. Plan of Action Activation and Deactivation
    F. Rules and Regulations
    G. Modification and Amendment
    H. Expenses
    I. Record Keeping
IV. Antitrust Defense
V. Terms and Conditions
    A. Plan of Action Execution
    B. Information Management and Responsibilities
    C. Oversight
VI. Establishment of the Sub-Committees
VII. Application and Agreement
VIII. Assignment

I. Purpose

    A pandemic may present conditions that pose a direct threat to the 
national defense of the United States or its preparedness programs such 
that, pursuant to DPA section 708(c)(1), it becomes necessary to 
establish an agreement and plan to collaboratively evaluate and 
coordinate resources within the National Multimodal Healthcare Supply 
Chains System. This Plan of Action to Establish a National Strategy for 
the Coordination of National Multimodal Healthcare Supply Chains to 
Respond to COVID-19 is established under the Voluntary Agreement and 
initially establishes up to four Sub-Committees responsible for the 
Plan's oversight and implementation. The Plan and Sub-Committees will 
optimize the coordination of National Multimodal Healthcare Supply 
Chains and create a prioritization protocol based upon End-Users' 
demonstrated or projected requirements.

II. Authorities

    Section 708, Defense Production Act (50 U.S.C. 4558); sections 
402(2) & 501(b), Robert T. Stafford Disaster Relief and Emergency 
Assistance Act (42 U.S.C. 5121-5207); sections 503(b)(2)(B) & 
504(a)(10) & (16) of the Homeland Security Act of 2002 (6 U.S.C. 
313(b)(2)(B), 314(a)(10) & (16)); sections 201, 301, National 
Emergencies Act (50 U.S.C. 1601 et seq.); section 319, Public Health 
Service Act (42 U.S.C. 247d); Executive Order (E.O.) 13911, 85 FR 18403 
(March 27, 2020). Pursuant to DPA section 708(f)(1)(A), the 
Administrator certifies that this Plan is necessary for the national 
defense.

III. General Provisions

A. Definitions

Administrator
    The FEMA Administrator is the Sponsor of the Voluntary Agreement. 
Pursuant to a delegation or redelegation of the functions given to the 
President by DPA section 708, the Administrator proposes and provides 
for the development and carrying out of the Voluntary Agreement, 
including through the development and implementation of Plans of 
Action. The Administrator is responsible for carrying out all duties 
and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and 
for appointing one or more Chairpersons to manage and administer the 
Committee and all Sub-Committees formed to carry out the Voluntary 
Agreement.
Agreement
The Voluntary Agreement for the Manufacture and Distribution of 
Critical Healthcare Resources Necessary to Respond to a Pandemic 
(Voluntary Agreement).
Allotment
    The process of analyzing and determining the relative distribution 
among one or more competing requests from End-Users utilizing the same 
National Multimodal Healthcare Supply Chains. Through the allotment 
process, FEMA--with participation from Sub-Committee Participants--will 
assess the actual needs of End-Users and determine how to divide the 
available and projected capabilities of National Multimodal Healthcare 
Supply Chains to minimize impacts to life, safety, and economic 
disruption associated with shortages. Allotment will take place only 
under Exigent Circumstances. With the exception of all forms of civil 
transportation resources under the jurisdiction of the Department of 
Transportation, which are excluded from this Plan, FEMA retains 
decision-making authority for allotment under this Plan.
Attendees
    Subject matter experts, invited by the Chairperson or a Sub-
Committee Chairperson to attend meetings authorized under the Voluntary 
Agreement or this Plan, to provide technical advice or to represent 
other government agencies or interested parties. Invitations to 
attendees will be extended as required for Committee or Sub-Committee 
meetings and deliberations.
Chairperson
    FEMA senior executive(s), appointed by the Administrator, to chair 
the Committee for the Distribution of Healthcare Resources Necessary to 
Respond to a Pandemic (Committee). The Chairperson shall be responsible 
for the overall management and administration of the Committee, the 
Voluntary Agreement, and Plans of Action developed under the Voluntary 
Agreement while remaining under the supervision of the Administrator; 
shall initiate, or approve in advance, each meeting held to discuss 
problems, determine policies, recommend actions, and make decisions 
necessary to carry out the Voluntary Agreement; appoint one or more co-
Chairpersons to chair the Committee, and otherwise shall carry out all 
duties and responsibilities assigned to him. With the approval of the 
Administrator, the Chairperson may create one or more Sub-Committees, 
and

[[Page 6883]]

may appoint one or more Sub-Committee Chairpersons to chair the Sub-
Committees, as appropriate.
Committee
    Committee for the Distribution of Healthcare Resources Necessary to 
Respond to a Pandemic established under the Voluntary Agreement.
Competitively Sensitive Information
    Competitively Sensitive Information that is shared pursuant to this 
Plan may include any Document or other tangible thing or oral 
transmission that contains financial, business, commercial, scientific, 
technical, economic, or engineering information or data, including, but 
not limited to

 financial statements and data,
 customer and supplier lists,
 price and other terms of sale to customers,
 sales records, projections and forecasts,
 inventory levels,
 capacity and capacity utilization,
 cost information,
 sourcing and procurement information,
 manufacturing and production information,
 delivery and shipping information,
 systems and data designs, and
 methods, techniques, processes, procedures, programs, codes, 
or similar information,

whether tangible or intangible, and regardless of the method of 
storage, compilation, or recordation, if the owner thereof has taken 
reasonable measures to protect the information from disclosure to the 
public or competitors. These measures may be evidenced by marking or 
labeling the items as ``competitively sensitive information'' during 
submission to FEMA or in the Participant's customary and existing 
treatment of such information (regardless of labeling).
    All Competitively Sensitive Information provided by a Sub-Committee 
Participant as described herein is deemed Competitively Sensitive 
Information, except for Information that:
    a. Is published or has been made publicly available at the time of 
disclosure by the Sub-Committee Participant;
    b. was in the possession of, or was lawfully and readily available 
to, FEMA from another source at the time of disclosure without 
breaching any obligation of confidentiality applicable to the other 
source; or
    c. was independently developed or acquired without reference to or 
reliance upon the Sub-Committee Participant's Competitively Sensitive 
Information;
    Where information deemed Competitively Sensitive Information is 
required to be disclosed by law, regulation, or court order, the 
``Competitively Sensitive'' (or substantially similar) label will 
continue to attach to all information and portion(s) of documents that 
are not made public through the required disclosure.
Document
    Any information, on paper or in electronic/audio/visual format, 
including written, recorded, and graphic materials of every kind, in 
the possession, custody, or control of the Participant and used or 
shared in the course of participation in the Voluntary Agreement or a 
subsequent Plan of Action.
End-User
    This includes all direct and ancillary medical support including, 
but not limited to, hospitals, independent healthcare providers, 
nursing homes, medical laboratories, dental care providers, independent 
physician offices, first responders, alternate care facilities, 
distributors, wholesalers, and the general public that reasonably 
represents the totality of the nation's response to COVID-19.
Exigent Circumstances
    As determined by the Chairperson, the actual or forecasted shortage 
of resources and their impact on the National Multimodal Healthcare 
Supply Chains which likely cannot be fulfilled via usual market 
mechanisms for an acute, critical time period, and where immediate and 
substantial harm is projected to occur from lack of intervention.
National Multimodal Healthcare Supply Chains System
    Any or all of the necessary resources and processes contributing to 
the supply, production, and distribution of critical healthcare 
resources necessary to respond to COVID-19.
    This Plan focuses on resources, entities, and processes within the 
Transportation Systems Sector, identified under Presidential Policy 
Directive (PPD)-21, Critical Infrastructure Security and Resilience, 
that support National Multimodal Healthcare Supply Chains.
Pandemic
    A Pandemic is defined as an epidemic that has spread to human 
populations across a large geographic area that is subject to one or 
more declarations under the National Emergencies Act, the Public Health 
Service Act, or the Robert T. Stafford Disaster Relief and Emergency 
Assistance Act, or if the Administrator determines that one or more 
declarations is likely to occur and the epidemic poses a direct threat 
to the national defense or its preparedness programs. For example, 
Coronavirus Disease 2019 (COVID-19) meets the definition of a Pandemic.
Participant
    An individual, partnership, corporation, association, or private 
organization, other than a federal agency, that has substantive 
capabilities, resources or expertise to carry out the purpose of the 
Voluntary Agreement, that has been specifically invited to participate 
in the Voluntary Agreement by the Chairperson, and that has applied and 
agreed to the terms of the Voluntary Agreement. ``Participant'' 
includes a corporate or non-corporate entity entering into the 
Voluntary Agreement and all subsidiaries and affiliates of that entity 
in which that entity has 50 percent or more control either by stock 
ownership, board majority, or otherwise. The Administrator may invite 
Participants to join the Voluntary Agreement at any time during its 
effective period.
Plan of Action (Plan)
    This document. A documented method, pursuant to 50 U.S.C. 
4558(b)(2), proposed by FEMA to implement a particular set of 
activities under the Voluntary Agreement, through a Sub-Committee 
focused on a particular Critical Healthcare Resource, or pandemic 
response workstream or functional area necessary for the national 
defense.
Plan of Action Agreement
    A separate commitment made by Participants upon invitation and 
agreement to participate in a Plan of Action as part of one or more 
Sub-Committees. Completing the Plan of Action Agreement confers 
responsibilities on the Participant consistent with those articulated 
in the Plan of Action and affords Participants a defense against 
antitrust claims under section 708 for actions taken to develop or 
carry out the Plan and the appropriate Sub-Committee(s), as described 
in Section IV below.
Representatives
    The representatives the Administrator identifies and invites to the 
Committee from FEMA, HHS, and other federal

[[Page 6884]]

agencies with equities in this Plan, and empowered to speak on behalf 
of their agencies' interests. The Attorney General and the Chair of the 
FTC, or their delegates, may also attend any meeting as a 
Representative.
Sub-Committee
    A body formed by the Administrator from select Participants to 
implement a Plan of Action.
Sub-Committee Chairperson
    FEMA executive, appointed by the Chairperson, to chair a Sub-
Committee to implement a Plan of Action. The Sub-Committee Chairperson 
shall be responsible for the overall management and administration of 
the Sub-Committee in furtherance of this Plan while remaining under the 
supervision of the Administrator and the Chairperson.
Sub-Committee Members
    Collectively the Sub-Committee Chairperson(s), Representatives, and 
Sub-Committee Participants. Jointly responsible for developing and 
executing this Plan.
Sub-Committee Participant
    A subset of Participants of the Committee, that have been 
specifically invited to participate in a Sub-Committee by the Sub-
Committee Chairperson, and that have applied and agreed to the terms of 
this Plan and signed the Plan of Action Agreement. The Sub-Committee 
Chairperson may invite Participants in the Committee to join a Sub-
Committee as a Sub-Committee Participant at any time during the Plan's 
effective period.

B. Plan of Action Participation

    This Plan will be carried out by a subset of the Participants in 
the Voluntary Agreement through several Sub-Committees, which may 
include:
    (1) Sub-Committee to Define Requirements for COVID-19 National 
Multimodal Healthcare Supply Chains,
    (2) Sub-Committee for Aviation,
    (3) Sub-Committee for Surface Transportation (including Highway, 
Motor Carriers, and Freight Rail), and
    (4) Sub-Committee for Maritime Transportation.
    FEMA may combine these Sub-Committees or establish additional Sub-
Committees under this Plan, so long as:
    (1) The Sub-Committee addresses one specific and well-defined 
component of the National Multimodal Healthcare Supply Chains System; 
and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
Requirements for COVID-19 National Multimodal Healthcare Supply Chains.
    Each Sub-Committee will consist of the (1) Sub-Committee 
Chairperson(s), (2) Representatives from FEMA, HHS, the Department of 
Justice (DOJ), and other federal agencies with equities in this Plan, 
and (3) Sub-Committee Participants that have substantive capabilities, 
resources or expertise to carry out the purpose of this Plan and have 
signed the Plan of Action Agreement. The Chairperson shall invite Sub-
Committee Participants who, in his or her determination, are reasonably 
representative of the appropriate industry or segment of such industry. 
Other Attendees--invited by the Sub-Committee Chairperson as subject 
matter experts to provide technical advice or to represent the 
interests of other government agencies or interested parties--may also 
participate in Sub-Committee meetings. The naming of these Sub-
Committees does not commit the Administrator to creating them unless 
and until circumstances dictate.

C. Effective Date and Duration of Participation

    This Plan is effective immediately upon satisfaction of the 
requirements of DPA section 708(f)(1). This Plan shall remain in effect 
until terminated in accordance with 44 CFR 332.4. It shall be effective 
for no more than five (5) years from August 17, 2020, when the 
requirements of DPA section 708(f)(1) were satisfied for the Voluntary 
Agreement, unless otherwise terminated pursuant to DPA section 
708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section 
708(f)(2). No action may take place under this Plan until it is 
activated, as described in Section III(E), below.

D. Withdrawal

    Participation in the Plan is voluntary, as is the acceptance of 
most obligations under the Plan. Sub-Committee Participants may 
withdraw from this Plan or from an individual Sub-Committee at any 
point, subject to the fulfillment of obligations previously agreed upon 
by the Participant prior to the date of withdrawal. Note that the 
obligations outlined in V.B regarding information management and 
associated responsibilities apply once a party has shared or received 
information through a Sub-Committee and remain in place after the 
party's withdrawal from the Sub-Committee or Plan. If a Sub-Committee 
Participant indicates an intent to withdraw from the Plan due to a 
modification or amendment of the Plan (described below), the Sub-
Committee Participant will not be required to perform actions directed 
by that modification or amendment. Withdrawal from the Plan will 
automatically trigger withdrawal from all Sub-Committees; however, a 
Participant may withdraw from a Sub-Committee without also withdrawing 
from the Plan or other Sub-Committees. To withdraw from the Plan or 
from an individual Sub-Committee, a Participant must provide written 
notice to the Administrator at least fifteen (15) calendar days prior 
to the effective date of that Sub-Committee Participant's withdrawal 
specifying the scope of withdrawal. Following receipt of such notice, 
the Administrator will inform the other Sub-Committee Participants of 
the date and the scope of the withdrawal.
    Upon the effective date of the withdrawal from the Plan, the Sub-
Committee Participant must cease all activities under the Plan. Upon 
the effective date of the withdrawal from one or more Sub-Committee(s), 
the Sub-Committee Participant must cease all activities under the Plan 
that pertain to the withdrawn Sub-Committee(s).

E. Plan of Action Activation and Deactivation

    The Administrator, in consultation with the Chairperson and Sub-
Committee Chairperson, will invite a select group of Participants in 
the Voluntary Agreement to form at least one of the following Sub-
Committees, beginning with the Sub-Committee to Define Requirements for 
COVID-19 National Multimodal Healthcare Supply Chains, which will be 
responsible for implementing this Plan.
    (1) Sub-Committee to Define Requirements for COVID-19 National 
Multimodal Healthcare Supply Chains,
    (2) Sub-Committee for Aviation,
    (3) Sub-Committee for Surface Transportation (including Highway, 
Motor Carriers, and Freight Rail), and
    (4) Sub-Committee for Maritime Transportation.

FEMA may combine these Sub-Committees or establish additional Sub-
Committees under this Plan, so long as:
    (1) The Sub-Committee addresses one specific and well-defined 
component of the National Multimodal Healthcare Supply Chains System; 
and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
Requirements for COVID-19 National Multimodal Healthcare Supply Chains.
    This Plan will be activated for each invited Participant when the 
Participant executes a Plan of Action Agreement, and a Participant may 
not participate in a Sub-Committee until the Plan of

[[Page 6885]]

Action Agreement is executed. Participants will be invited to join this 
Plan at the discretion of the Chairperson or the Sponsor to the 
Voluntary Agreement. Participants will be further invited to attend 
specific meetings of one or more Sub-Committees at the discretion of 
the Chairperson.

F. Rules and Regulations

    Sub-Committee Participants acknowledge and agree to comply with all 
provisions of DPA section 708, as amended, and regulations related 
thereto which are promulgated by FEMA, the Department of Homeland 
Security, HHS, the Attorney General, and the FTC. FEMA has promulgated 
standards and procedures pertaining to voluntary agreements in 44 CFR 
part 332. The Administrator shall inform Participants of new rules and 
regulations as they are issued.

G. Modification and Amendment

    The Administrator, after consultation with the Attorney General and 
the Chair of the FTC, may terminate or modify, in writing, this Plan at 
any time. The Attorney General, after consultation with the Chair of 
the FTC and the Administrator, may terminate or modify, in writing, 
this Plan at any time. Sub-Committee Participants may propose 
modifications or amendments to the Plan or to the Sub-Committees at any 
time.
    Where possible, material modifications to the Plan or a Sub-
Committee will be subject to a 30-calendar day delayed implementation 
and opportunity for notice and comment by Sub-Committee Participants to 
the Chairperson. This delayed implementation period may be shortened or 
eliminated if the Administrator deems it necessary. The Administrator 
shall inform Sub-Committee Participants of modifications or amendments 
to the Plan or to the Sub-Committees as they are proposed and issued.
    The Administrator, after consultation with the Attorney General and 
the Chair of the FTC, may remove Sub-Committee Participants from the 
Plan or from a Sub-Committee at any time. The Attorney General, after 
consultation with the Chair of the FTC and the Administrator, may 
remove Sub-Committee Participants from this Plan or from a Sub-
Committee at any time. If a Participant is removed from the Plan or 
from a Sub-Committee, the Participant may request written notice of the 
reasons for removal from the Chairperson, who shall provide such notice 
in a reasonable time period.

H. Expenses

    Participation in this Plan or in a Sub-Committee does not confer 
funds to Sub-Committee Participants, nor does it limit or prohibit any 
pre-existing source of funds. Unless otherwise specified, all expenses, 
administrative or otherwise, incurred by Sub-Committee Participants 
associated with participation in this Plan or a Sub-Committee shall be 
borne exclusively by the Sub-Committee Participants.

I. Record Keeping

    Each Sub-Committee Chairperson shall have primary responsibility 
for maintaining records in accordance with 44 CFR part 332 and shall be 
the official custodian of records related to carrying out this Plan. 
Each Sub-Committee Participant shall maintain for five years all 
minutes of meetings, transcripts, records, documents, and other data, 
including any communications with other Sub-Committee Participants or 
with any other member of the Sub-Committee, including drafts, related 
to the carrying out of this Plan or incorporating data or information 
received in the course of carrying out this Plan. Each Sub-Committee 
Participant agrees to produce to the Administrator, the Attorney 
General, and the Chair of the FTC upon request any item that this 
section requires the Participant to maintain. Any record maintained in 
accordance with 44 CFR part 332 shall be available for public 
inspection and copying, unless exempted on the grounds specified in 5 
U.S.C. 552(b)(1), (3) or (4) or identified as privileged and 
confidential information in accordance with DPA section 705(d), and 44 
CFR 332.5.

IV. Antitrust Defense

    Under the provisions of DPA subsection 708(j), each Sub-Committee 
Participant in this Plan shall have available as a defense to any civil 
or criminal action brought for violation of the antitrust laws (or any 
similar law of any State) with respect to any action to develop or 
carry out this Plan, that such action was taken by the Sub-Committee 
Participant in the course of developing or carrying out this Plan, that 
the Sub-Committee Participant complied with the provisions of DPA 
section 708 and the rules promulgated thereunder, and that the Sub-
Committee Participant acted in accordance with the terms of the 
Voluntary Agreement and this Plan. Except in the case of actions taken 
to develop this Plan, this defense shall be available only to the 
extent the Sub-Committee Participant asserting the defense demonstrates 
that the action was specified in, or was within the scope of, this Plan 
and within the scope of the appropriate Sub-Committee(s), including 
being taken at the direction and under the active supervision of FEMA.
    This defense shall not apply to any actions taken after the 
termination of this Plan. Immediately upon modification of this Plan, 
no defense to antitrust claims under Section 708 shall be available to 
any subsequent action that is beyond the scope of the modified Plan. 
The Sub-Committee Participant asserting the defense bears the burden of 
proof to establish the elements of the defense. The defense shall not 
be available if the person against whom the defense is asserted shows 
that the action was taken for the purpose of violating the antitrust 
laws.

V. Terms and Conditions

    As the sponsoring agency, FEMA will maintain oversight over Sub-
Committee activities and direct and supervise actions taken to carry 
out this Plan, including by retaining decision-making authority over 
actions taken pursuant to the Plan to ensure such actions are necessary 
to address a direct threat to the national defense. The Attorney 
General and the Chair of the FTC will monitor activities of the Sub-
Committees to ensure they execute their responsibilities in a manner 
consistent with this Plan and their actions have the least 
anticompetitive effects possible.

A. Plan of Action Execution

    This Plan will be used to support Pandemic response by maximizing 
the coordination for selected National Multimodal Healthcare Supply 
Chains and creating a prioritization protocol for End-Users. Each Sub-
Committee will support the following objectives to mitigate the loss of 
life and public health threats associated with COVID-19.
1. Objectives
    (1) Identify capabilities to effectively support National 
Multimodal Healthcare Supply Chains.
    (2) Ensure effective coordination of National Multimodal Healthcare 
Supply Chains System resources that may be required for the Response to 
COVID-19.
    (3) Ensure ongoing competition continues within the National 
Multimodal Healthcare Supply Chains System to the greatest extent 
possible under the DPA.
2. Actions
    Sub-Committee Participants may be asked to support these objectives 
by taking the following specific actions:

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    (1) Assist the Chairperson in identifying priorities and challenges 
within the National Multimodal Healthcare Supply Chains System that 
should be addressed within the Plan's Sub-Committees because of their 
importance to the national response to COVID-19. Using the best 
evidence available, Participants should consider whether current and 
projected National Multimodal Healthcare Supply Chains System resources 
are sufficient to meet essential needs of End-Users and geographic 
areas, and if there are any critical shortfalls of such resources that 
may be of concern for the response to COVID-19.
    (2) Create a collaborative process for evaluating and addressing 
competing National Multimodal Healthcare Supply Chains System claims, 
as directed and decided by the Chairperson.
    (3) Develop a mechanism to inform prioritization of the 
distribution of healthcare products through National Multimodal 
Healthcare Supply Chains, as directed and decided by the Chairperson.
    (4) Prepare a general strategy to accomplish the activities listed 
in V(A)(2) and V(A)(5) regarding activities in Exigent Circumstances 
consistent with the decisions made by the Chairperson.
    (5) In Exigent Circumstances, with review and concurrence in all 
possible instances by DOJ in consultation with FTC:
     Facilitate maximum use of the National Multimodal 
Healthcare Supply Chains System to meet requirements of the nation or 
particular geographic areas by deconflicting overlapping demands from 
the collective Participants' End-Users, as directed and decided by the 
Chairperson.
     Facilitate maximum availability of resources provided 
within the National Multimodal Healthcare Supply Chains System to meet 
requirements of the nation or particular geographic areas, as directed 
and decided by the Chairperson.
     Facilitate the efficient distribution of resources through 
the National Multimodal Healthcare Supply Chains System by 
deconflicting overlapping distribution chain activities of Sub-
Committee Members, as directed and decided by the Chairperson.
     Establish a process and means of collaboration to address 
exigent End-User requirements in a manner aligned with the objectives 
of this Plan, as directed and decided by the Chairperson.
    (6) Provide data and information necessary to validate the efforts 
of the Sub-Committee including the actual and planned COVID-19 response 
activities that may foreseeably impact National Multimodal Healthcare 
Supply Chains throughout the nation, as determined by the Chairperson.
    (7) Provide feedback to the Chairperson and Sub-Committee Members 
on outcomes, accomplishments, and impediments of collective efforts to 
accomplish objectives and actions outlined in this Plan.
    (8) Advise the Chairperson whether additional Participants or 
Attendees should be invited to join this Plan and its Sub-Committees.
    (9) Carry out other activities that the Sub-Committees under this 
Plan determine to be necessary for the coordination of National 
Multimodal Healthcare Supply Chains System resources to address the 
COVID-19 Pandemic's direct threat to the national defense, as 
determined and directed by the Chairperson, where such activities have 
been reviewed and approved by DOJ and FTC and received concurrence from 
Sub-Committee members.

B. Information Management and Responsibilities

    FEMA will request only the data and information from Sub-Committee 
Participants that is necessary to meet the objectives of the Plan and 
consistent with the scope of the relevant Sub-Committees. Upon signing 
a Plan of Action Agreement for this Plan, FEMA requests that 
Participants endeavor to cooperate with diligence and speed, and to the 
extent permissible under this Plan, and to share with FEMA any data and 
information necessary to meet the objectives of this Plan.
    Sub-Committee Participants agree to share with FEMA the following 
data with diligence and speed to the extent permissible under this 
Plan, and to abide by the following guidelines where feasible and 
consistent with the data that is owned by each Sub-Committee 
Participant:
    (1) In general, Participants will not be asked to share 
Competitively Sensitive Information directly with other Participants.
    (2) FEMA will only request direct sharing of Competitively 
Sensitive Information among Participants during Exigent Circumstances 
where there is a mission critical need or timeline such that sharing 
only through FEMA is impractical or threatens the outcome of the Plan 
or Sub-Committee action. Such requests, if made, will be only among 
Participants whose participation is necessary to meet the objectives of 
the Plan, will be limited in scope to the greatest extent possible, and 
will be shared only pursuant to safeguards subject to prior review and 
audit by DOJ and FTC. Direct sharing of Competitively Sensitive 
Information with other Participants will be limited in scope and 
circumstances to the greatest extent possible. Participants may not 
share Competitively Sensitive Information directly with other 
Participants unless specifically requested by FEMA, in consultation 
with DOJ and FTC. All Competitively Sensitive Information delivered to 
FEMA or to another Sub-Committee Participant shall be delivered by 
secure means, for example, password-protected or encrypted electronic 
files or drives with the password/key delivered by separate 
communication or method or via upload to an appropriately secure web 
portal as directed by FEMA. All data delivered to the web portal 
designated by FEMA is deemed to be Competitively Sensitive Information.
    (3) To allow FEMA to identify and appropriately protect documents 
containing Competitively Sensitive Information by the Sub-Committee 
Participant providing the documents, the Sub-Committee Participant will 
make good faith efforts to designate any Competitively Sensitive 
Information by placing restrictive markings on documents and things 
considered to be competitively sensitive, the restrictive markings 
being sufficiently clear in wording and visibility to indicate the 
restricted nature of the data. The Sub-Committee Participant will 
identify Competitively Sensitive Information that is disclosed verbally 
by oral warning. Information designated as competitively sensitive 
will, to the extent allowed by law, be presumed to constitute trade 
secrets, or commercial or financial information, and be provided by the 
Sub-Committee Participant to FEMA with the expectation that it will be 
kept confidential by both parties, as such terms are understood in 
accordance with 5 U.S.C. 552(b)(4) of the Freedom of Information Act 
and federal judicial interpretations of this statute. FEMA agrees that 
to the extent any information designated as competitively sensitive by 
a Sub-Committee Participant is responsive to a request for disclosure 
under the Freedom of Information Act, FEMA will consult with the Sub-
Committee Participant and afford the Participant ten (10) working days 
to object to any disclosure by FEMA.
    (4) FEMA will make good faith efforts to appropriately recognize 
unmarked Documents containing Competitively Sensitive Information as 
Competitively Sensitive Information. However, FEMA cannot guarantee 
that all unmarked

[[Page 6887]]

Documents will be recognized as being Competitively Sensitive 
Information and protected from disclosure to third parties. If the 
unmarked Documents have not been disclosed without restriction outside 
of FEMA, the Sub-Committee Participant may retroactively request to 
have appropriate designations placed on the Documents. If the unmarked 
Documents have been disclosed without restriction outside of FEMA, FEMA 
will, to the extent practicable, remove any requested information from 
public forums controlled by FEMA and will work promptly to request that 
a receiving party return or destroy disclosed unmarked Documents if 
requested by the Sub-Committee Participant.
    (5) Competitively Sensitive Information may be used by FEMA, alone 
or in combination with additional information, including Documents and 
Competitively Sensitive Information received from third parties, to 
support FEMA's implementation of this Plan as determined by the 
Chairperson. In all situations, FEMA will aggregate and anonymize 
Competitively Sensitive Information to the greatest extent possible to 
protect the interests retained by the owners of the data while still 
allowing the objectives of the Plan and Sub-Committee to be achieved. 
To the greatest extent possible, such aggregation will render the 
competitively sensitive nature of the Competitively Sensitive 
Information of the Sub-Committee Participant no longer recognizable in 
a commercially sensitive manner, and without sufficient information to 
enable, by inference or otherwise, attribution to Sub-Committee 
Participant or its affiliates (as clearly identified and disclosed to 
FEMA). Any disclosure of Competitively Sensitive Information by FEMA, 
within or outside a Sub-Committee, will be subject to review and 
approval by DOJ and FTC.
    (6) Except as otherwise expressly permitted by applicable federal 
law, FEMA shall not disclose any Competitively Sensitive Information or 
use any Competitively Sensitive Information for any purpose other than 
in connection with the purposes of this Plan, and FEMA will not sell 
any Competitively Sensitive Information of any Sub-Committee 
Participant.
    (7) Except as described below, FEMA may disclose Competitively 
Sensitive Information only to its employees, officers, directors, 
contractors, agents, and advisors (including attorneys, accountants, 
consultants, and financial advisors). Any individual with access to 
Competitively Sensitive Information will be expected to comply with the 
terms of this Plan.
    a. Information Sharing within the Sub-Committee: FEMA may share 
Competitively Sensitive Information with Sub-Committee Participants and 
Federal Representatives of the Plan, and their respective employees, 
officers, directors, contractors, agents, and advisors (including 
attorneys, accountants, consultants, and financial advisors) where 
there is a need to know and where disclosure is reasonably necessary in 
furtherance of implementing the Plan. FEMA will aggregate and anonymize 
data prior to sharing with the Sub-Committee Participants to the 
greatest extent possible while still allowing the objectives of the 
Plan to be achieved, and will not share data--particularly to 
competitors of the submitter--prior to consultation with and approval 
by the DOJ and FTC.
    i. Sub-Committee Participants, when providing Competitively 
Sensitive Information to FEMA, may request that this Information not be 
shared with other Sub-Committee Participants. Where these requests are 
made in good faith and are reasonable in nature, FEMA will respect 
these requests to the greatest extent possible and will consult the 
owner of the data prior to any release made to Sub-Committee 
Participants.
    b. Restricted Reports. FEMA may communicate Competitively Sensitive 
Information to appropriate government officials through Restricted 
Reports. The information contained in Restricted Reports shall be 
aggregated and anonymized to the greatest extent possible, while 
recognizing that these officials may need a certain amount of 
granularity and specificity of information to appropriately respond to 
COVID-19. FEMA will aim to aggregate data to the County level, and will 
not share Restricted Reports prior to consultation and approval from 
the DOJ and FTC. FEMA may disclose Restricted Reports to relevant White 
House and Administration officials and State Governors, and their 
respective employees, officers, directors, contractors, agents, and 
advisors (including attorneys, accountants, consultants, and financial 
advisors) who have a need to know and to whom such disclosure is 
reasonably necessary solely in furtherance of the implementation of 
this Plan. FEMA shall take appropriate action (by instructions, 
agreement, or otherwise) to ensure that receiving parties comply with 
all data-sharing confidentiality and obligations under this Plan as if 
such persons or entities had been parties to this Plan.
    c. Public Reports. FEMA may share information with the public 
through Public Reports. Data contained in Public Reports shall be fully 
aggregated and anonymized. Public Reports shall be aggregated to at 
least a state level and may be publicly disclosed after consultation 
and approval from the DOJ and FTC.
    (8) Where possible and not obviated by Exigent Circumstances, FEMA 
will notify Sub-Committee Participants prior to the release of any 
Competitively Sensitive Information that has not been fully aggregated 
and anonymized. In consultation with DOJ and FTC, FEMA will consider 
any good-faith requests made by Sub-Committee members to hold the 
release of data or requests for further aggregation or anonymization. 
In general, FEMA will not provide notification prior to the release of 
Public Reports, under the presumption that the data in these reports 
has already been fully anonymized and de-identified.
    (9) Any party receiving Competitively Sensitive Information through 
this Plan shall use such information solely for the purposes outlined 
in the Plan and take steps, such as imposing previously approved 
firewalls or tracking usage, to prevent misuse of the information. 
Disclosure and use of Competitively Sensitive Information will be 
limited to the greatest extent possible, and any party receiving 
Competitively Sensitive Information shall follow the procedures 
outlined in paragraph 7 above.
    (10) At the conclusion of a Participant's involvement in a Plan--
due to the deactivation of the Plan or due to the Participant's 
withdrawal or removal--each Participant will be requested to sequester 
any and all Competitively Sensitive Information received through 
participation in the Plan. This sequestration shall include the 
deletion of all Competitively Sensitive Information unless required to 
be kept pursuant to the Record Keeping requirements as described supra, 
Section I, 44 CFR part 332, or any other provision of law.

C. Oversight

    Each Sub-Committee Chairperson is responsible for ensuring that the 
Attorney General, or suitable delegate(s) from the DOJ, and the FTC 
Chair, or suitable delegate(s) from the FTC, have awareness of 
activities under this Plan, including activation, deactivation, and 
scheduling of meetings. The Attorney General, the FTC Chair, or their 
delegates may attend Sub-Committee meetings and request to be apprised 
of any activities taken in accordance with activities under this Plan. 
DOJ or FTC Representatives may request and review

[[Page 6888]]

any proposed action by the Sub-Committee or Sub-Committee Participants 
undertaken pursuant to this Plan, including the provision of data. If 
any DOJ or FTC Representative believes any actions proposed or taken 
are not consistent with relevant antitrust protections provided by the 
DPA, he or she shall provide warning and guidance to the Sub-Committee 
as soon as the potential issue is identified. If questions arise about 
the antitrust protections applicable to any particular action, FEMA may 
request DOJ, in consultation with the FTC, provide an opinion on the 
legality of the action under relevant DPA antitrust protections.

VI. Establishment of the Sub-Committees

    This Plan establishes Sub-Committees to implement the Plan of 
Action to Establish a National Strategy for the Coordination of 
National Multimodal Healthcare Supply Chains to Respond to COVID-19 to 
provide the Federal Government and the Participants a forum to maximize 
the coordination of selected National Multimodal Healthcare Supply 
Chain resources and to create a prioritization protocol based upon 
existing or projected needs of End-Users and geographic areas within 
the National Multimodal Healthcare Supply Chains System. The outcome 
should include a framework to expeditiously meet critical needs within 
the National Multimodal Healthcare Supply Chains System that may arise 
in Exigent Circumstances, and to ensure actions to address such needs 
do not come with unacceptable risks to End-Users or interfere with 
other efforts to meet critical End-User requirements. A Sub-Committee 
Chairperson designated by the Chairperson will convene and preside over 
each Sub-Committee. Sub-Committees will not be used for contract 
negotiations or contract discussions between the Participants and the 
Federal Government; such negotiations or discussions will be in 
accordance with applicable federal contracting policies and procedures. 
However, this shall not limit any discussion within a Sub-Committee 
about the operational utilization of existing and potential contracts 
between the Participants and Representatives when seeking to align 
their use with overall manufacturing and distribution efforts 
consistent with this Plan.
    Each Sub-Committee will consist of designated Representatives from 
FEMA, HHS, other federal agencies with equities in this Plan, and each 
Sub-Committee Participant. The Attorney General and Chair of the FTC, 
or their delegates, may also join each Sub-Committee and attend 
meetings at their discretion. Attendees may also be invited at the 
discretion of a Sub-Committee Chairperson as subject matter experts, to 
provide technical advice, or to represent other government agencies, 
but will not be considered part of the Sub-Committee.
    Only to the extent necessary to respond to COVID-19 as explicitly 
directed by the Sub-Committee Chairperson, and subject to the 
provisions of Section V(B), Sub-Committee Members may be asked to 
provide technical advice, share information, help identify and validate 
places and resources of the greatest need, help project future 
manufacturing and distribution demands, assist in identifying and 
resolving the allotment of scarce resources under Exigent 
Circumstances, and take other actions necessary to maximize the timely 
coordination of National Multimodal Healthcare Supply Chains System 
resources for the COVID-19. A Sub-Committee Chairperson or his or her 
designee, at the Sub-Committee Chairperson's sole discretion, will make 
decisions on these issues in order to ensure the maximum efficiency and 
effectiveness in the use of Sub-Committee Member's resources. All Sub-
Committee Participants will be invited to open Sub-Committee meetings. 
For selected Sub-Committee meetings, attendance may be limited to 
designated Sub-Committee Participants to meet specific operational 
requirements, as determined by FEMA.
    Each Sub-Committee Chairperson shall notify the Attorney General, 
the Chair of the FTC, Representatives, and Participants of the time, 
place, and nature of each meeting and of the proposed agenda of each 
meeting to be held to carry out this Plan. Additionally, each Sub-
Committee Chairperson shall provide for publication in the Federal 
Register of a notice of the time, place, and nature of each meeting. If 
a meeting is open, a Federal Register notice will be published 
reasonably in advance of the meeting. A Sub-Committee Chair may 
restrict attendance at meetings only on the grounds outlined by 44 CFR 
332.5(c)(1)-(3). If a meeting is closed, a Federal Register notice will 
be published within ten (10) days of the meeting and will include the 
reasons why the meeting is closed pursuant to 44 CFR 332.3(c)(2).
    The Sub-Committee Chairperson shall establish the agenda for each 
meeting, be responsible for adherence to the agenda, and provide for a 
written summary or other record of each meeting and provide copies of 
transcripts or other records to FEMA, the Attorney General, the Chair 
of the FTC, and all Sub-Committee Participants. The Chairperson shall 
take necessary actions to protect from public disclosure any data 
discussed with or obtained from Sub-Committee Participants which a Sub-
Committee Participant has identified as a trade secret or as privileged 
and confidential in accordance with DPA sections 708(h)(3) and 705(d), 
or which qualifies for withholding under 44 CFR 332.5.

VII. Application and Agreement

    The Sub-Committee Participant identified below hereby agrees to 
join in the Federal Emergency Management Agency sponsored Plan of 
Action to Establish a National Strategy for the Coordination of 
National Multimodal Healthcare Supply Chains to Respond to COVID-19 
under the Voluntary Agreement for the Manufacture and Distribution of 
Healthcare Resources Necessary to Respond to a Pandemic and to become a 
Participant in one or more Sub-Committees established by this Plan. 
This Plan will be published in the Federal Register. This Plan is 
authorized under section 708 of the Defense Production Act of 1950, as 
amended. Regulations governing the Voluntary Agreement for the 
Manufacture and Distribution of Healthcare Resources Necessary to 
Respond to a Pandemic and all subsequent Plans of Action at 44 CFR part 
332. The applicant, as a Sub-Committee Participant, agrees to comply 
with the provisions of section 708 of the Defense Production Act of 
1950, as amended, the regulations at 44 CFR part 332, and the terms of 
this Plan.

VIII. Assignment

    No Sub-Committee Participant may assign or transfer this Plan, in 
whole or in part, or any protections, rights or obligations hereunder 
without the prior written consent of the Sub-Committee Chairperson. 
When requested, the Sub-Committee Chairperson will respond to written 
requests for consent within 10 (ten) business days of receipt.

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Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-02549 Filed 2-3-22; 11:15 am]
BILLING CODE 9111-19-P