[Federal Register Volume 85, Number 236 (Tuesday, December 8, 2020)]
[Notices]
[Pages 79020-79028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26986]


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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 
Manufacture, Allocation, and Distribution of Personal Protective 
Equipment (PPE) 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

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency (FEMA) announces the 
activation of a Plan of Action to establish a National Strategy for the 
manufacture, allocation, and distribution of Personal Protective 
Equipment (PPE) 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. This Notice contains the 
text of the Plan of Action.

FOR FURTHER INFORMATION CONTACT: Robert Glenn, Office of Business, 
Industry, Infrastructure Integration, Federal Emergency Management 
Agency, (202) 212-1666, and email <a href="/cdn-cgi/l/email-protection#feb1bccdb7be989b939fd09a968dd0999188"><span class="__cf_email__" data-cfemail="165954255f5670737b7738727e6538717960">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Authority

    Section 708 of the Defense Production Act (DPA), 50 U.S.C. 4558, 
allows the President to provide for the formation of voluntary 
agreements and plans of action by the private sector to help provide 
for the national defense. This authority was delegated to the Secretary 
of Homeland Security generally in section 401 of Executive Order 
13603,\1\ ``National Defense Resources Preparedness,'' and specifically 
for response to COVID-19 in section 3 of Executive Order 13911,\2\ 
``Delegating Additional Authority Under the Defense Production Act With 
Respect to Health and Medical Resources To Respond to the Spread of 
COVID-19.'' The Secretary of Homeland Security has delegated these 
authorities to the FEMA Administrator in Department of Homeland 
Security (DHS) Delegation 09052 Rev. 00, ``Delegation of Defense 
Production Act Authority to the Administrator of the Federal Emergency 
Management Agency,'' (Jan. 3, 2017), and DHS Delegation 09052 Rev. 
00.1, ``Delegation of Defense Production Act Authority to the 
Administrator of the Federal Emergency Management Agency'' (Apr. 1, 
2020), respectively.
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    \1\ 77 FR 16651 (Mar. 22, 2012).
    \2\ 85 FR 18403 (Apr. 1, 2020).
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Background

    FEMA sought and received approval from the Attorney General, after 
consultation with the Federal Trade Commission (FTC), to begin 
consultation with the private sector, as required by Section 708(c)(2). 
Pursuant to that approval, on May 12, 2020, FEMA posted an announcement 
of a public meeting and request for comments to develop a Voluntary 
Agreement in the Federal Register (85 FR 28031). FEMA held a public 
meeting on May 21, 2020, and accepted public comments until June 5, 
2020.\3\ FEMA received 34 public comments and considered these comments 
when preparing the Voluntary Agreement.\4\
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    \3\ The original comment period was extended to allow 
commentators additional time to respond. FEMA posted notices of 
extension to www.regulations.gov under the Docket ID for this 
notice, FEMA-2020-0016.
    \4\ Available on www.regulations.gov under the Docket ID for 
this notice.
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    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 effect or without any Voluntary 
Agreement. Pursuant to Sec. 708(f)(1)(B) of the DPA, the Department of 
Justice separately published this finding in the Federal Register on 
August 17, 2020 as a notice (85 FR 50049). The FEMA Administrator, as 
the Sponsor of the agreement, certified in writing that the agreement 
was necessary to help provide for the national defense. FEMA provided 
notice of the formation and the

[[Page 79021]]

text of the Voluntary Agreement in the Federal Register on August 17, 
2020 (85 FR 50035).
    On October 13, 2020, FEMA held a virtual meeting to implement the 
Voluntary Agreement for the Manufacture and Distribution of Critical 
Healthcare Resources Necessary to Respond to a Pandemic (see 85 FR 
63567). A portion of the meeting was open to the public. One objective 
of this meeting was to discuss the activation of the first Plan of 
Action under the Voluntary Agreement to identify more efficient methods 
of allocating and distributing Personal Protective Equipment to meet 
national demand and ways of expanding the production of critical 
healthcare resources, with an initial focus on the manufacture of N95 
masks. From this meeting, FEMA incorporated public comments and 
feedback from the U.S. Department of Justice and the Federal Trade 
Commission to develop the Plan of Action.
    The Attorney General, in consultation with the Chairman of the 
Federal Trade Commission, made the required finding that the purposes 
of section 708(c)(1) of the DPA cannot reasonably be achieved without 
any 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 is separately 
publishing this finding in the Federal Register as a notice. The FEMA 
Administrator has certified in writing that this Plan of Action is 
necessary to help provide for the national defense.
    Text of the Plan of Action to Establish a National Strategy for the 
manufacture, allocation, and distribution of Personal Protective 
Equipment (PPE) 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

Table of Contents

Preface
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

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 
Chairman 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 
allocation and distribution of Critical Healthcare Resources.
    This document establishes a Plan of Action (Plan) for the 
Manufacture, Allocation, and Distribution of Personal Protective 
Equipment (PPE) to Respond to COVID-19. This Plan will be implemented 
under the Voluntary Agreement by several Sub-Committees:
    (1) Sub-Committee to Define COVID-19 PPE Requirements,
    (2) Sub-Committee for N-95 and other Medical Respirators,
    (3) Sub-Committee for Gloves,
    (4) Sub-Committee for Gowns, and
    (5) Sub-Committee for Eye and Facial Coverings.
    FEMA may establish additional Sub-Committees under this Plan of 
Action, so long as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of PPE; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
COVID-19 PPE Requirements.
    The purpose of the Plan and the Sub-Committees is to maximize the 
manufacture and efficient distribution of selected types of critical 
PPE and create a prioritization protocol for End-Users based upon their 
demonstrated or projected requirements including geographic and 
regional circumstances. The primary goal of the Plan is to create a 
mechanism to immediately meet exigent PPE requests anywhere in the 
Nation and to ensure that actions to support PPE stockpiling and 
reserves do not interfere with immediate requirements that would result 
in an unacceptable risk to healthcare providers or other potential PPE 
recipients. 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.

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), an agreement to collectively 
coordinate, plan, and collaborate for the manufacture and distribution 
of PPE is necessary for the national defense. This Plan of Action to 
Establish a National Strategy for the Manufacture, Allocation, and 
Distribution of Personal Protective Equipment (PPE) to Respond to 
COVID-19 is established under the Voluntary Agreement and establishes 
five Sub-Committees to oversee and implement the Plan. The Plan and 
Sub-Committees will optimize the manufacture and the efficient 
distribution of selected types of critical PPE and create a 
prioritization protocol for End-Users based upon their demonstrated or 
projected requirements and taking into account geographic and regional 
circumstances for stabilization and reduction of COVID-19 exposure.

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); Prioritization and Allocation of Certain Scarce or 
Threatened Health and Medical Resources for Domestic Use, 85 FR 20195 
(April 10, 2020). Pursuant to DPA

[[Page 79022]]

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).
Allocation
    The process of determining and directing the relative distribution 
among one or more competing requests from End-Users for the same PPE. 
Through the Allocation 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 supply of PPE to 
minimize impacts to life, safety, and economic disruption associated 
with shortages of critical PPE. Allocation will take place only under 
Exigent Circumstances. FEMA retains decision-making authority for all 
Allocation 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 of Action, 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 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 of Action 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

<bullet> Financial statements and data,
<bullet> customer and supplier lists,
<bullet> price and other terms of sale to customers,
<bullet> sales records, projections and forecasts,
<bullet> inventory levels,
<bullet> capacity and capacity utilization,
<bullet> cost information,
<bullet> sourcing and procurement information,
<bullet> manufacturing and production information,
<bullet> delivery and shipping information,
<bullet> systems and data designs, and
<bullet> 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 and the 
general public that reasonably represents the totality of the nation's 
professional or medical response to COVID-19. ``End-User'' may also 
include essential workers necessary to maintain or restore critical 
infrastructure operations, including but not limited to law 
enforcement, education, food and agriculture, energy, water and 
wastewater, and public works personnel.
Exigent Circumstances
    As determined by the Chairperson, the actual or forecasted shortage 
of a particular type or types of PPE which

[[Page 79023]]

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.
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).
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.
Personal Protective Equipment (PPE)
    Objects that provide measures of safety protection for healthcare 
workers, first responders, critical infrastructure personnel and/or the 
general public for the response to the Pandemic. These PPE items may 
include, but are not limited to, face coverings, filtering facepiece 
respirators, face shields, isolation and surgical gowns, examination 
and surgical gloves, suits, and foot coverings.
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 of Action 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 agencies with equities in 
this Plan, and empowered to speak on behalf of their agencies' 
interests. The Attorney General and the Chairman 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 official, 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 of Action 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 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:
    (1) Sub-Committee to Define COVID-19 PPE Requirements,
    (2) Sub-Committee for N-95 and other Medical Respirators,
    (3) Sub-Committee for Gloves,
    (4) Sub-Committee for Gowns, and
    (5) Sub-Committee for Eye and Facial Coverings.
    FEMA may establish additional Sub-Committees under this Plan of 
Action, so long as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of PPE; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
COVID-19 PPE Requirements.
    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

[[Page 79024]]

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 the following Sub-Committees, which 
will be responsible for implementing this Plan:
    (1) Sub-Committee to Define COVID-19 PPE Requirements,
    (2) Sub-Committee for N-95 and other Medical Respirators,
    (3) Sub-Committee for Gloves,
    (4) Sub-Committee for Gowns, and
    (5) Sub-Committee for Eye and Facial Coverings.
    FEMA may establish additional Sub-Committees under this Plan of 
Action, so long as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of PPE; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
COVID-19 PPE Requirements.
    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 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 Chairman of the FTC, may terminate or modify, in writing, this Plan 
at any time. The Attorney General, after consultation with the Chairman 
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 Chairman 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 Chairman 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 Chairman 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-

[[Page 79025]]

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 Chairman 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 the following objectives to 
respond to a Pandemic by maximizing the manufacture and efficient 
distribution of selected types of critical PPE and creating a 
prioritization protocol for End-Users based upon their demonstrated or 
projected requirements and taking into account geographic and regional 
circumstances. Each Sub-Committee will undertake the following 
Objectives for the PPE item(s) within its area of jurisdiction.
1. Objectives
    (1) Optimize the timely production of sufficient quantities of PPE 
to reduce loss of life and transmission of the COVID-19 virus.
    (2) Ensure PPE is distributed effectively across the whole 
community nationally based on risk.
    (3) Balance restoration and maintenance of the nation's stockpile 
of PPE with near-term requirements.
    (4) Establish a process for FEMA Allocation of PPE nationwide.
    (5) Ensure ongoing competition in the manufacture and distribution 
of PPE 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:
    (1) Assist the Chairperson in identifying which types of critical 
PPE should be included within each Sub-Committee. Identification will 
be based upon each item's importance to the national response to COVID-
19 and whether it can be reasonably inferred, based upon the best 
evidence available, that that current and projected supply measured 
against current and projected demand may not adequately meet the PPE 
requirements to all identified End-Users or regional or geographic 
areas of the country as result of measures taken to respond to COVID-
19.
    (2) Provide input to the Chairperson in creating a prioritized list 
of PPE End-Users by categories for each type of critical PPE identified 
by each Sub-Committee, and ascertaining the relative demand and supply 
of PPE among and within those End User categories. Prioritization shall 
be decided by the Chairperson, based upon each item's importance, 
reflecting the consensus views of the Sub-Committee Members that it 
represents the most effective way to save lives and prevent the 
transmission of the COVID-19 virus. This list may be updated throughout 
the life of the Plan of Action based upon either short term or long-
term demands. These categories should be considered holistically in 
terms of the Whole-of-Nation response to COVID-19.
    (3) Evaluate the domestic supply of PPE and identify when the 
expansion of the domestic manufacture of PPE may be necessary, as 
directed and decided by the Chairperson.
    (4) Provide information, assist, and validate, as necessary as 
decided by the Chairperson, demand projections for PPE.
    (5) Create a process for and collaborate in the evaluation of 
competing claims for PPE from End-Users.
    (6) Prepare a general strategy to accomplish the activities listed 
in V(A)(2)(7) below regarding activities in Exigent Circumstances 
consistent with the decisions made by the Chairperson.
    (7) In Exigent Circumstances, with review and concurrence in all 
possible instances by DOJ in consultation with FTC:
    <bullet> Facilitate maximum availability of PPE to the nation or 
particular geographies by deconflicting overlapping demands from the 
collective Participants' customer base, as directed and decided by the 
Chairperson.
    <bullet> Facilitate maximum availability of PPE to the nation or 
particular geographies by deconflicting overlapping supply chain 
demands placed upon Members, as directed and decided by the 
Chairperson.
    <bullet> Facilitate the efficient distribution of PPE by 
deconflicting overlapping distribution chain activities of Members, as 
directed and decided by the Chairperson.
    <bullet> Create a process for and collaborate in the Allocation of 
PPE nationwide or in particular geographies consistent with the 
decisions made by the Chairperson.
    <bullet> Create a process for and collaborate in meeting any other 
exigent requirements throughout the nation or particular geographies 
consistent with the overall strategy prepared by this Sub-Committee.
    (8) Provide data and information necessary to validate the efforts 
of the Sub-Committee including the actual and planned amounts of PPE to 
be distributed throughout the Nation, as determined by the Chairperson.
    (9) Provide feedback to the Sub-Committee on the outcomes of the 
collective efforts of the Sub-Committee Members and any impediments or 
bottlenecks.
    (10) Advise the Chairperson whether additional Participants or 
Attendees should be invited to join this Plan of Action and Sub-
Committee.
    (11) Carry out other activities regarding critical PPE as 
identified by Sub-Committees under this Plan as determined and directed 
by the Chairperson necessary to address the COVID-19 virus' direct 
threat to the national defense, 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 that 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-

[[Page 79026]]

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 share with 
FEMA 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 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 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 of Action 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 of Action 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 of Action, 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 of Action.
    a. Information Sharing within the Sub-Committee: FEMA may share 
Competitively Sensitive Information with Sub-Committee Participants and 
Federal Representatives of the Plan of Action, 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 of Action. 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 of Action 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.

[[Page 79027]]

    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 of Action. 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 of Action as if such persons or entities had been parties to this 
Plan of Action.
    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 
Chairman, 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 Chairman, 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 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 to 
Establish a National Strategy for the Manufacture, Allocation, and 
Distribution of Personal Protective Equipment (PPE) to Respond to 
COVID-19 to provide the Federal Government and the Participants a forum 
to maximize the manufacture and efficient distribution of selected 
types of critical PPE and to create a prioritization protocol based 
upon identified types of PPE End-Users and their demonstrated or 
projected requirements, and demonstrated or projected geographic and 
regional areas of need. The outcome should include a framework to 
expeditiously meet any PPE needs in Exigent Circumstances anywhere in 
the Nation, and to ensure that actions to support PPE stockpiling and 
reserves do not interfere with immediate requirements that would result 
in an unacceptable risk to healthcare providers or other potential PPE 
recipients. 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 Chairman 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.
    To the extent necessary to respond to the Pandemic, only at the 
explicit direction of a 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 allocation of scarce resources amongst all necessary 
public and private sector domestic needs under Exigent Circumstances, 
and take any other necessary actions to maximize the timely manufacture 
and distribution of PPE as determined necessary by FEMA to respond to 
the Pandemic. 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-

[[Page 79028]]

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 Chairman 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 of Action. 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 Chairman 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 
Chairman 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 Manufacture, 
Allocation, and Distribution of Personal Protective Equipment (PPE) 
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 for the Manufacture and Distribution of 
Healthcare Resources Necessary to Respond to a Pandemic and all 
subsequent Plans of Action appear 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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(Company name)

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(Name of authorized representative)

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(Signature of authorized representative)

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(Date)

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Sub-Committee Chairperson

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(Date)

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-26986 Filed 12-7-20; 8:45 am]
BILLING CODE 9111-19-P


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