[Federal Register Volume 86, Number 102 (Friday, May 28, 2021)]
[Notices]
[Pages 28851-28884]
[FR Doc No: 2021-11278]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2020-0016]

Pandemic Response Voluntary Agreement Under Section 708 of the
Defense Production Act; Plans of Action To Respond to COVID-19

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

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency (FEMA) announces the
formation of four Plans 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 Manufacture, Allocation, and Distribution of
Diagnostic Test Kits and other Testing Components to Respond to COVID-
19; 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; Plan
of Action to Establish a National Strategy for the Manufacture,
Allocation, and Distribution of Medical Devices to Respond to COVID-19;
and Plan of Action to Establish a National Strategy for the
Manufacture, Allocation, and Distribution of Medical Gases to Respond
to COVID-19. This notice contains the text of all four Plans of Action.

FOR FURTHER INFORMATION CONTACT: Robert Glenn, Office of Business,
Industry, Infrastructure Integration, via email at<EMAIL_ADDRESS>or
via phone at<PHONE_NUMBER>.

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 and
after requesting and considering public comments, FEMA completed and
published in the Federal Register a ``Voluntary Agreement, Manufacture
and Distribution of Critical Healthcare Resources Necessary to Respond
to a

Pandemic'' (Voluntary Agreement).\4\ Unless terminated earlier, 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\ Voluntary Agreement Under Section 708 of the Defense
Production Act; Manufacture and Distribution of Critical Healthcare
Resources Necessary to Respond to a Pandemic, 85 FR 50035, 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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    FEMA is now activating four Plans of Action under the Voluntary
Agreement:
    (1) 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. The primary goal of
the Plan is to create a mechanism to immediately meet exigent requests
for Diagnostic Test Kits and other Testing Components anywhere in the
Nation and to ensure that actions to support stockpiling of Diagnostic
Test Kits and other Testing Components do not interfere with immediate
requirements.
    (2) 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. The
primary goal of the Plan is to create a mechanism to immediately meet
exigent requests for Drug Products, Drug Substances, and Associated
Medical Devices anywhere in the Nation and to ensure that actions to
support Drug Products, Drug Substances, and Associated Medical Devices
stockpiling and reserves do not interfere with immediate requirements
that would result in an unacceptable risk to healthcare providers or
other potential recipients of Drug Products, Drug Substances, and
Associated Medical Devices.
    (3) Plan of Action to Establish a National Strategy for the
Manufacture, Allocation, and Distribution of Medical Devices to Respond
to COVID-19. The primary goal of the Plan is to create a mechanism to
immediately meet exigent Medical Device requests anywhere in the Nation
and to ensure that actions to support Medical Device stockpiling and
reserves do not interfere with immediate requirements that would result
in an unacceptable risk to healthcare providers or other potential
Medical Device recipients.
    (4) Plan of Action to Establish a National Strategy for the
Manufacture, Allocation, and Distribution of Medical Gases to Respond
to COVID-19. The primary purpose of this Plan is to create a mechanism
to immediately meet exigent Medical Gas requests anywhere in the Nation
and to ensure that actions to support Medical Gas stockpiling and
reserves do not interfere with immediate requirements that would result
in an unacceptable risk to healthcare providers or other potential
Medical Gas recipients.
    Appropriate members of the private sector will be invited to join
each Plan of Action as Sub-Committee Participants. Provided that a Sub-
Committee Participant acts in accordance with the terms of a Plan, the
DPA affords the Participant a defense to civil and criminal action
brought under the antitrust laws (or any similar law of any state) for
actions taken to carry out the Plan. The Plans are 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.
    The Attorney General, in consultation with the Chairman of the
Federal Trade Commission, has made the required finding for each Plan
of Action that the purposes of section 708(c)(1) of the DPA cannot
reasonably be achieved without each Plan of Action, or by Plans of
Action having less anticompetitive effects than the proposed Plans of
Action. Pursuant to section 708(f)(1)(B) of the DPA, the Department of
Justice separately published the findings for these Plans of Action in
the Federal Register. The FEMA Administrator has certified in writing
that each 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 Diagnostic Test Kits and
Other Testing Components 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 Manufacture,
Allocation and Distribution of Diagnostic Test Kits and Other Testing
Components 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 allocation and
distribution of Critical Healthcare Resources.
    This document establishes a Plan of Action (Plan) to Establish a
National Strategy for the Manufacture, Allocation and Distribution of
Diagnostic Test Kits and other Testing Components to Respond to COVID-
19. This Plan will be implemented under the Voluntary Agreement by
several Sub-Committees.
    (1) Sub-Committee to Define Requirements for COVID-19 Diagnostic
Test Kits and other Testing Components,
    (2) Sub-Committee for Lab-Based Testing,
    (3) Sub-Committee for Point-of-Care Testing,
    (4) Sub-Committee for At-Home Testing,

    (5) Sub-Committee for Swabs (Nasal & Throat), and
    (6) Sub-Committee for Transfer Media and Pipette Tips.
    The Sub-Committee to Define Requirements for COVID-19 Diagnostic
Test Kits and other Testing Components will be formed first. FEMA may
establish additional Sub-Committees under this Plan, so long as:
    (1) The Sub-Committee addresses one specific and well-defined
category of item needed for COVID-19 testing; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define
Requirements for COVID-19 Diagnostic Test Kits and other Testing
Components.
    The purpose of the Plan is to maximize the manufacture and
efficient distribution of Diagnostic Test Kits and other Testing
Components 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 requests for Diagnostic Test Kits
and other Testing Components anywhere in the Nation and to ensure that
actions to support stockpiling of Diagnostic Test Kits and other
Testing Components do not interfere with immediate 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.....................................................      421
II. Authorities................................................      421
III. General Provisions........................................      421
    A. Definitions.............................................      421
    B. Plan of Action Participation............................      425
    C. Effective Date and Duration of Participation............      426
    D. Withdrawal..............................................      426
    E. Plan of Action Activation and Deactivation..............      427
    F. Rules and Regulations...................................      427
    G. Modification and Amendment..............................      428
    H. Expenses................................................      428
    I. Record Keeping..........................................      428
IV. Antitrust Defense..........................................      429
V. Terms and Conditions........................................      429
    A. Plan of Action Execution................................      429
    B. Information Management and Responsibilities.............      431
    C. Oversight...............................................      435
VI. Establishment of the Sub-Committees........................      436
VII. Application and Agreement.................................      437
VIII. Assignment...............................................      438

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 Diagnostic Test Kits and other Testing Components is necessary for
the national defense. This 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 is
established under the Voluntary Agreement and establishes six 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 Diagnostic Test Kits and other Testing Components
and create a prioritization protocol for End-Users based upon their
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); Prioritization and Allocation of Certain Scarce or
Threatened Health and Medical Resources for Domestic Use, 85 FR 20195
(April 10, 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).
Allocation
    The process of determining and directing the relative distribution
among one or more competing requests from End-Users for the same
Diagnostic Test Kits and other Testing Components. 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 Diagnostic Test
Kits and other Testing Components to minimize impacts to life, safety,
and economic disruption associated with shortages of Diagnostic Test
Kits and other Testing Components. 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, 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 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.
Diagnostic Test Kit
    Defined as any ``drug'' or ``device'' under the United States Food,
Drug, and Cosmetic Act, 21 U.S.C. 321(g) or (h), respectively, used for
detection or identification of the novel coronavirus in any individual.
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, independent physician offices,
first responders, alternate care facilities 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 a particular type of Diagnostic Test Kit or other Testing Component
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.
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.
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 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 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 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.
Testing Components
    Defined as any article needed to support the transportation,
storage, distribution, or administration of a Diagnostic Test Kit or
subsequent result. Common Testing Components include collection swabs,
transport media and pipette tips, but other associated materials may be
included, if and as appropriate.

B. Plan of Action Participation

    This Plan will be implemented under the Voluntary Agreement by one
or more Sub-Committees.
    (1) Sub-Committee to Define Requirements for COVID-19 Diagnostic
Test Kits and other Testing Components,
    (2) Sub-Committee for Lab-Based Testing,
    (3) Sub-Committee for Point-of-Care Testing,
    (4) Sub-Committee for At-Home Testing,
    (5) Sub-Committee for Swabs (Nasal & Throat), and
    (6) Sub-Committee for Transfer Media and Pipette Tips.
    The Sub-Committee to Define Requirements for COVID-19 Diagnostic
Test Kits and other Testing Components will be formed first. FEMA may
establish additional Sub-Committees under this Plan, so long as:
    (1) The Sub-Committee addresses one specific and well-defined
category of item needed for COVID-19 testing; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define
Requirements for COVID-19 Diagnostic Test Kits and other Testing
Components.
    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 the following Sub-Committees, beginning
with the Sub-Committee to Define Requirements for COVID-19 Diagnostic
Test Kits and other Testing Components, which will be responsible for
implementing this Plan.
    (1) Sub-Committee to Define Requirements for COVID-19 Diagnostic
Test Kits and other Testing Components,
    (2) Sub-Committee for Lab-Based Testing,
    (3) Sub-Committee for Point-of-Care Testing,
    (4) Sub-Committee for At-Home Testing,
    (5) Sub-Committee for Swabs (Nasal & Throat), and
    (6) Sub-Committee for Transfer Media and Pipette Tips.
    The Sub-Committee to Define Requirements for COVID-19 Diagnostic
Test Kits and other Testing Components will be formed first. FEMA may
establish additional Sub-Committees under this Plan, so long as:
    (1) The Sub-Committee addresses one specific and well-defined
category of item needed for COVID-19 testing; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define
Requirements for COVID-19 Diagnostic Test Kits and other Testing
Components.
    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 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 the following objectives to
respond to a Pandemic by maximizing the manufacture and efficient
distribution of selected types of Diagnostic Test Kits and other
Testing Components and creating a prioritization protocol for End-Users
based upon their demonstrated or projected requirements. Each Sub-
Committee will undertake the following Objectives for the Diagnostic
Test Kits and other Testing Components within its area of jurisdiction.
1. Objectives
    (1) Optimize the timely production of sufficient quantities of
Diagnostic Test Kits and other Testing Components, as part of the
overall national strategy, to reduce transmission of COVID-19 and
mitigate the impacts caused by it.
    (2) Identify and encourage the development of Diagnostic Test Kits
and Testing Components that can identify more than one illness (e.g.,
flu, strep throat or other bacterial infections, common cold, seasonal
allergies, and COVID-19).
    (3) Identify and encourage the development of Diagnostic Test Kits
and Testing Components that can mitigate supply chain constraints, by
leveraging new technologies and different components.
    (4) Ensure Diagnostic Test Kits and other Testing Components are
distributed effectively and equitably across the whole community
nationally based on necessity and risk.
    (5) Balance restoration and maintenance of the nation's stockpile
of Diagnostic Test Kits and other Testing Components with near-term
requirements.
    (6) Establish a process for FEMA Allocation of Diagnostic Test Kits
and other Testing Components nationwide.
    (7) Evaluate supply chain components to determine national
vulnerabilities and propose corrective actions to improve resiliency in
the manufacture and distribution of Diagnostic Test Kits and other
Testing Components.
    (8) Ensure ongoing competition in the manufacture and distribution
of Diagnostic Test Kits and other Testing Components 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 Diagnostic
Test Kits and other Testing Components 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 the current and
projected supply measured against current and projected demand may not
adequately meet the requirements of all identified End-Users or
regional or geographic areas of the country.
    (2) Provide input to the Chairperson in creating a prioritized list
of End Users of Diagnostic Test Kits and other Testing Components, by
category of End User, for each type of Diagnostic Test Kits and other
Testing Components identified by each Sub-Committee, and ascertaining
the relative demand and supply of Diagnostic Test Kits and other
Testing Components 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 in
responding to the COVID-19 pandemic. This list may be updated
throughout the life of the Plan 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 Diagnostic Test Kits and other
Testing Components and identify when the expansion of the domestic
manufacture of Diagnostic Test Kits and other Testing Components 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 Diagnostic Test Kits
and other Testing Components.
    (5) Create a process for and collaborate in the evaluation of
competing claims for Diagnostic Test Kits and/or other Testing
Components 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:
     Facilitate maximum availability of Diagnostic Test Kits
and other Testing Components to the nation by deconflicting overlapping
demands from the collective Participants' customer base, as directed
and decided by the Chairperson.
     Facilitate maximum availability of Diagnostic Test Kits
and other Testing Components to the nation by deconflicting overlapping
supply chain demands placed upon Members, as directed and decided by
the Chairperson.
     Facilitate the efficient distribution of Diagnostic Test
Kits and other Testing Components by deconflicting overlapping
distribution chain activities of Members, as directed and decided by
the Chairperson.
     Create a process for and collaborate in the Allocation of
Diagnostic Test Kits and other Testing Components nationwide consistent
with the decisions made by the Chairperson.
    (8) Provide data and information necessary to validate the efforts
of the Sub-Committee including the actual and planned amounts of
Diagnostic Test Kits and other Testing Components 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 and Sub-Committee.
    (11) Carry out other activities regarding Diagnostic Test Kits and
other Testing Components 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-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
confidential or privileged 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 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 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 Diagnostic Test Kits and other Testing Components 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 Diagnostic Test Kits and other
Testing Components and to create a prioritization protocol based upon
identified types of Diagnostic Test Kits and other Testing Components
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 Diagnostic
Test Kits and other Testing Components needs in Exigent Circumstances
anywhere in the Nation, and to ensure that actions to support the
stockpiling of Diagnostic Test Kits and other Testing Components do not
interfere with immediate requirements that would result in an
unacceptable risk to healthcare providers or other potential Diagnostic
Test Kits and other Testing Components 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 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.
    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 allocation and distribution of Diagnostic Test Kits and other
Testing Components 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-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 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 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 Manufacture, Allocation
and Distribution of Diagnostic Test Kits and other Testing Components
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 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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Text of the 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
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 Manufacture,
Allocation, and Distribution of Drug Products, Drug Substances, and
Associated Medical Devices 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 allocation and
distribution of Critical Healthcare Resources.
    This document establishes a Plan of Action (Plan) 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. This Plan will be implemented under the Voluntary
Agreement by several Sub-Committees, beginning with a Sub-Committee to
Define Requirements for COVID-19 Drug Products, Drug Substances, and
Associated Medical Devices:
    (1) Sub-Committee to Define Requirements for COVID-19 Drug
Products, Drug Substances, and Associated Medical Devices

    (2) Sub-Committee for Monoclonal Antibodies,
    (3) Sub-Committee for Drug Products, Drug Substances, and
Associated Medical Devices Related to the Treatment of Respiratory
Illness,
    (4) Sub-Committee for Drug Products, Drug Substances, and
Associated Medical Devices Related to Acute and Intensive Care,
    (5) Sub-Committee to Accelerate Coronavirus Treatment,
    (6) Sub-Committee for Strategic Investment Towards On-Shoring of
Pharmaceutical Manufacturing and Fill-Finish, and
    (7) Sub-Committee for Emergency Use Authorizations.
    FEMA may establish additional Sub-Committees under this Plan, so
long as:
    (1) The Sub-Committee addresses one specific and well-defined
category of Drug Products, Drug Substances, or Associated Medical
Devices; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define
Requirements for COVID-19 Drug Products, Drug Substances, and
Associated Medical Devices.
    The purpose of the Plan and the Sub-Committees is to maximize the
manufacture and efficient distribution of selected types of Drug
Products, Drug Substances, and Associated Medical Devices, 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 requests for Drug Products, Drug Substances, and
Associated Medical Devices anywhere in the Nation and to ensure that
actions to support Drug Products, Drug Substances, and Associated
Medical Devices stockpiling and reserves do not interfere with
immediate requirements that would result in an unacceptable risk to
healthcare providers or other potential recipients of Drug Products,
Drug Substances, and Associated Medical Devices. 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.....................................................      380
II. Authorities................................................      380
III. General Provisions........................................      381
    A. Definitions.............................................      381
    B. Plan of Action Participation............................      385
    C. Effective Date and Duration of Participation............      386
    D. Withdrawal..............................................      386
    E. Plan of Action Activation and Deactivation..............      387
    F. Rules and Regulations...................................      387
    G. Modification and Amendment..............................      387
    H. Expenses................................................      388
    I. Record Keeping..........................................      388
IV. Antitrust Defense..........................................      389
V. Terms and Conditions........................................      389
    A. Plan of Action Execution................................      389
    B. Information Management and Responsibilities.............      392
    C. Oversight...............................................      396
VI. Establishment of the Sub-Committees........................      396
VII. Application and Agreement.................................      398
VIII. Assignment...............................................      398

IX. 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, allocation and
distribution of Drug Products, Drug Substances, and Associated Medical
Devices is necessary for the national defense. This 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 is established under the Voluntary
Agreement and establishes seven 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 Drug Products, Drug
Substances, and Associated Medical Devices and create a prioritization
protocol for End-Users based upon their demonstrated or projected
requirements.

X. 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 section 708(f)(1)(A), the
Administrator certifies that this Plan is necessary for the national
defense.

XI. General Provisions

J. 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 Drug
Products, Drug Substances, or Associated Medical Devices. 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 Drug Products, Drug
Substances, and Associated Medical Devices to minimize impacts to life,
safety, and economic disruption associated with shortages of Drug
Products, Drug Substances, and Associated Medical Devices. Allocation
will take place only under Exigent Circumstances. Although FEMA retains
decision making authority for all Allocation under this Plan, other
federal agency partners retain decision-making authority for all assets
under their control.
Associated Medical Devices
    A device, as defined under the United States Food, Drug, and
Cosmetic Act, 21 U.S.C. 321(h), that is used to manufacture, transport,
distribute, deliver, sanitize, dispose of, or in any other way
facilitate the use of, any drug product or drug substance needed to
cure, mitigate or treat COVID-19.
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 them. 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 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.
Drug Product
    Is a finished dosage form, e.g., tablet, capsule, or solution, that
contains a drug substance, generally, but not necessarily, in
association with one or more other ingredients.
Drug Substance
    Is an active ingredient that is intended to furnish pharmacological
activity or other direct effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease or to affect the structure or any
function of the human body, but does not include intermediates used in
the synthesis of such ingredient.
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
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 Drug Products, Drug Substances, and
Associated Medical Devices 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.
Fill-Finish
    Fill-finish is the final manufacturing step in the overall drug
manufacturing process. This process transfers a sterile drug from a
filling needle to a sterile container.
On-Shoring
    Building domestic capacity that is otherwise available in other
Countries.
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.
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 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 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.
Strategic Investment
    Targeted investments for on-shoring of drug product and drug
substance manufacturing, including fill-finish capacities.
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 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.

K. 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 Requirements for COVID-19 Drug
Products, Drug Substances, and Associated Medical Devices,
    (2) Sub-Committee for Monoclonal Antibodies,
    (3) Sub-Committee for Drug Products, Drug Substances, and
Associated Medical Devices Related to the Treatment of Respiratory
Illness,
    (4) Sub-Committee for Drug Products, Drug Substances, and
Associated Medical Devices Related to Acute and Intensive Care,
    (5) Sub-Committee to Accelerate Coronavirus Treatment,
    (6) Sub-Committee for Strategic Investment Towards On-Shoring of
Pharmaceutical Manufacturing and Fill-Finish, and
    (7) Sub-Committee for Emergency Use Authorizations.
    FEMA may establish additional Sub-Committees under this Plan, so
long as:
    (1) The Sub-Committee addresses one specific and well-defined
category of Drug Products, Drug Substances, and Associated Medical
Devices; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define
Requirements for COVID-19 Drug Products, Drug Substances, and
Associated Medical Devices.
    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.

L. 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.

M. 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).

N. 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, beginning
with the Sub-Committee to Define Requirements for COVID-19 Drug
Products, Drug Substances, and Associated Medical Devices, which will
be responsible for implementing this Plan.
    (1) Sub-Committee to Define Requirements for COVID-19 Drug
Products, Drug Substances, and Associated Medical Devices,
    (2) Sub-Committee for Monoclonal Antibodies,
    (3) Sub-Committee for Drug Products, Drug Substances, and
Associated Medical Devices Related to the Treatment of Respiratory
Illness,
    (4) Sub-Committee for Drug Products, Drug Substances, and
Associated Medical Devices Related to Acute and Intensive Care,
    (5) Sub-Committee to Accelerate Coronavirus Treatment,
    (6) Sub-Committee for Strategic Investment Towards On-Shoring of
Pharmaceutical Manufacturing and Fill-Finish, and
    (7) Sub-Committee for Emergency Use Authorizations.
    FEMA may establish additional Sub-Committees under this Plan, so
long as:
    (1) The Sub-Committee addresses one specific and well-defined
category of Drug Products, Drug Substances, and Associated Medical
Devices; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define
Requirements for COVID-19 Drug Products, Drug Substances, and
Associated Medical Devices.
    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.

O. 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.

P. 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.

Q. 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.

R. 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.

XII. 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.

XIII. 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 the following objectives to
respond to a Pandemic by maximizing the manufacture and efficient
distribution of selected types of Drug Products, Drug Substances, and
Associated Medical Devices 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 Drug
Products, Drug Substances, and Associated Medical Devices within its
area of jurisdiction.
1. Objectives
    (1) Optimize the timely production of sufficient quantities of Drug
Products, Drug Substances, and Associated Medical Devices to reduce
loss of life and transmission of the COVID-19 virus.
    (2) Expand domestic manufacturing of Drug Products, Drug
Substances, and Associated Medical Devices, including fill-finish
capacities.
    (3) Ensure Drug Products, Drug Substances, and Associated Medical
Devices are distributed effectively across the whole community
nationally based on risk.
    (4) Balance restoration and maintenance of the nation's stockpile
of Drug Products, Drug Substances, and Associated Medical Devices with
near-term requirements.
    (5) Establish a process for FEMA Allocation of Drug Products, Drug
Substances, and Associated Medical Devices nationwide.
    (6) Ensure ongoing competition in the manufacture and distribution
of Drug Products, Drug Substances, and Associated Medical Devices 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 Drug
Products, Drug Substances, and Associated Medical Devices 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 the current and projected supply measured against current and
projected demand may not adequately meet the Drug Product, Drug
Substance, and Associated Medical Device 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 Drug Product, Drug Substance, and Associated Medical Device End-
Users by categories for each type of Drug Product, Drug Substance, and
Associated Medical Device identified by each Sub-Committee, and
ascertaining the relative demand and supply of Drug Products, Drug
Substances, and Associated Medical Devices 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 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 Drug Products, Drug Substances,
and Associated Medical Devices and identify when the expansion of the
domestic manufacture of Drug Products, Drug Substances, and Associated
Medical Devices 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 Drug Products, Drug
Substances, and Associated Medical Devices.

    (5) Create a process for and collaborate in the evaluation of
competing claims for Drug Products, Drug Substances, and Associated
Medical Devices 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:
     Facilitate maximum availability of Drug Products, Drug
Substances, and Associated Medical Devices to the nation or particular
geographies by deconflicting overlapping demands from the collective
Participants' customer base, as directed and decided by the
Chairperson.
     Facilitate maximum availability of Drug Products, Drug
Substances, and Associated Medical Devices to the nation or particular
geographies by deconflicting overlapping supply chain demands placed
upon Members, as directed and decided by the Chairperson.
     Facilitate the efficient distribution of Drug Products,
Drug Substances, and Associated Medical Devices by deconflicting
overlapping distribution chain activities of Members, as directed and
decided by the Chairperson.
     Create a process for and collaborate in the Allocation of
Drug Products, Drug Substances, and Associated Medical Devices
nationwide or in particular geographies consistent with the decisions
made by the Chairperson.
     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.
     Create a process for and collaborate in establishing
expanded domestic Drug Product, Drug Substance, and Associated Medical
Device manufacturing and fill-finish capacities.
    (8) Provide data and information necessary to validate the efforts
of the Sub-Committee including the actual and planned amounts of Drug
Products, Drug Substances, and Associated Medical Devices 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 and Sub-Committee.
    (11) Carry out other activities regarding Drug Products, Drug
Substances, and Associated Medical Devices 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.

D. 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-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
confidential or privileged 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 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.

E. 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 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.

XIV. 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 Drug Products, Drug Substances, and Associated Medical
Devices 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 Drug Products, Drug Substances, and
Associated Medical Devices and to create a prioritization protocol
based upon identified types of Drug Product, Drug Substance, and
Associated Medical Device 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 Drug Product, Drug Substance, and Associated Medical Device
needs in Exigent Circumstances anywhere in the Nation, and to ensure
that actions to support Drug Product, Drug Substance, and Associated
Medical Device stockpiling and reserves do not interfere with immediate
requirements that would result in an unacceptable risk to healthcare
providers or other potential Drug Product, Drug Substance, and
Associated Medical Device 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 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.
    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 Drug Products, Drug Substances, and Associated
Medical Devices 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-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 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 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.

XV. 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 Drug Products, Drug Substances, and
Associated Medical Devices 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.

XVI. 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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Text of the Plan of Action To Establish a National Strategy for the
Manufacture, Allocation, and Distribution of Medical Devices 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 Manufacture,
Allocation, and Distribution of Medical Devices 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 allocation and
distribution of Critical Healthcare Resources.
    This document establishes a Plan of Action (Plan) to Establish a
National Strategy for the Manufacture, Allocation, and Distribution of
Medical Devices 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 Medical Device Requirements,
    (2) Sub-Committee for General Hospital Devices,
    (3) Sub-Committee for Immunology Devices,
    (4) Sub-Committee for Microbiology Devices,
    (5) Sub-Committee for Pathology Devices, and
    (6) Sub-Committee for Toxicology Devices.
    The Sub-Committee to Define COVID-19 Medical Device Requirements
will be formed first.
    FEMA may establish additional Sub-Committees under this Plan, so
long as:
    (1) The Sub-Committee addresses one specific and well-defined
category of Medical Device; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define
COVID-19 Medical Device Requirements.
    The purpose of the Plan and the Sub-Committees is to maximize the
manufacture and efficient distribution of selected types of Medical
Devices 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 Medical Device requests anywhere
in the Nation and to ensure that actions to support Medical Device
stockpiling and reserves do not interfere with immediate requirements
that would result in an unacceptable risk to healthcare providers or
other potential Medical Device 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.

Table of Contents

I. Purpose.....................................................      421
II. Authorities................................................      421
III. General Provisions........................................      421
    A. Definitions.............................................      421
    B. Plan of Action Participation............................      425
    C. Effective Date and Duration of Participation............      426
    D. Withdrawal..............................................      426
    E. Plan of Action Activation and Deactivation..............      427
    F. Rules and Regulations...................................      427
    G. Modification and Amendment..............................      428
    H. Expenses................................................      428
    I. Record Keeping..........................................      428
IV. Antitrust Defense..........................................      429
V. Terms and Conditions........................................      429
    A. Plan of Action Execution................................      429
    B. Information Management and Responsibilities.............      431
    C. Oversight...............................................      435
VI. Establishment of the Sub-Committees........................      436
VII. Application and Agreement.................................      437
VIII. Assignment...............................................      438

XVII. 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 Medical Devices is necessary for the national defense. This Plan of
Action to Establish a National Strategy for the Manufacture,
Allocation, and Distribution of Medical Devices to Respond to COVID-19
is established under the Voluntary Agreement and establishes six 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 Medical Devices and create a prioritization
protocol for End-Users based upon their demonstrated or projected
requirements.

XVIII. 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.)