Plan of Action To Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains To Respond to COVID-19; Implemented Under the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a Pandemic Under Section 708 of the Defense Production Act
| Published date | 07 February 2022 |
| Citation | 87 FR 6880 |
| Record Number | 2022-02549 |
| Section | Notices |
| Court | Federal Emergency Management Agency |
Federal Register, Volume 87 Issue 25 (Monday, February 7, 2022)
[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Notices]
[Pages 6880-6889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02549]
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DEPARTMENT OF HOMELAND SECURITY
Federal Emergency Management Agency
[Docket ID FEMA-2020-0016]
Plan of Action To Establish a National Strategy for the
Coordination of National Multimodal Healthcare Supply Chains To Respond
to COVID-19; Implemented Under the Voluntary Agreement for the
Manufacture and Distribution of Critical Healthcare Resources Necessary
To Respond to a Pandemic Under Section 708 of the Defense Production
Act
AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.
ACTION: Notice.
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SUMMARY: The Federal Emergency Management Agency (FEMA) is publishing
the text of one additional Plan of Action under the Voluntary Agreement
for the Manufacture and Distribution of Critical Healthcare Resources
Necessary to Respond to a Pandemic: Plan of Action to Establish a
National Strategy for the Coordination of National Multimodal
Healthcare Supply Chains to Respond to COVID-19.
FOR FURTHER INFORMATION CONTACT: Robert Glenn, Office of Business,
[[Page 6881]]
Industry, Infrastructure Integration, [email protected], or (202) 212-
1666.
SUPPLEMENTARY INFORMATION:
Background and Legal Authority
The Defense Production Act (DPA), 50 U.S.C. 4501 et seq.,
authorizes the making of ``voluntary agreements and plans of action''
with, among others, representatives of industry and business to help
provide for the national defense.\1\ The President's authority to
facilitate voluntary agreements was delegated to the Secretary of
Homeland Security with respect to responding to the spread of COVID-19
within the United States in Executive Order 13911.\2\ The Secretary of
Homeland Security has further delegated this authority to the FEMA
Administrator.\3\
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\1\ 50 U.S.C. 4558(c)(1).
\2\ 85 FR 18403 (Apr. 1, 2020).
\3\ DHS Delegation 09052, Rev. 00.1 (Apr. 1, 2020); DHS
Delegation Number 09052 Rev. 00 (Jan. 3, 2017).
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On August 17, 2020, after the appropriate consultations with the
Attorney General and the Chairman of the Federal Trade Commission, FEMA
completed and published in the Federal Register a ``Voluntary Agreement
for the Manufacture and Distribution of Critical Healthcare Resources
Necessary to Respond to a Pandemic'' (Voluntary Agreement).\4\ Unless
terminated prior to that date, the Voluntary Agreement is effective
until August 17, 2025, and may be extended subject to additional
approval by the Attorney General after consultation with the Chairman
of the Federal Trade Commission. The Voluntary Agreement may be used to
prepare for or respond to any pandemic, including COVID-19, during that
time.
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\4\ 85 FR 50035 (Aug. 17, 2020). The Attorney General, in
consultation with the Chairman of the Federal Trade Commission, made
the required finding that the purpose of the voluntary agreement may
not reasonably be achieved through an agreement having less
anticompetitive effects or without any voluntary agreement and
published the finding in the Federal Register on the same day. 85 FR
50049 (Aug. 17, 2020).
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Previously, FEMA has announced the activation of five Plans of
Action under the Voluntary Agreement:
(1) Plan of Action to Establish a National Strategy for the
Manufacture, Allocation, and Distribution of Personal Protective
Equipment (PPE) to Respond to COVID-19.
(2) Plan of Action to Establish a National Strategy for the
Manufacture, Allocation, and Distribution of Diagnostic Test Kits and
other Testing Components to Respond to COVID-19.
(3) Plan of Action to Establish a National Strategy for the
Manufacture, Allocation, and Distribution of Drug Products, Drug
Substances, and Associated Medical Devices to Respond to COVID-19.
(4) Plan of Action to Establish a National Strategy for the
Manufacture, Allocation, and Distribution of Medical Devices to Respond
to COVID-19.
(5) Plan of Action to Establish a National Strategy for the
Manufacture, Allocation, and Distribution of Medical Gases to Respond
to COVID-19.
FEMA has now activated a sixth Plan of Action under the Voluntary
Agreement:
(6) Plan of Action to Establish a National Strategy for the
Coordination of National Multimodal Healthcare Supply Chains to Respond
to COVID-19.
This Plan is necessitated by continued transportation-related
concerns and shortfalls that interfere with the movement of critical
resources for our nation's COVID-19 response. Appropriate members of
the private sector have been invited to join the Plan of Action as Sub-
Committee Participants. Provided that a Sub-Committee Participant acts
in accordance with the terms of the Plan, the DPA affords the
Participant an affirmative defense to certain civil and criminal
actions brought under the antitrust laws (or any similar law of any
state) for appropriate actions taken to carry out the Plan. The Plan is
designed to foster a close working relationship among FEMA, Department
of Health and Human Services, and Sub-Committee Participants to address
national defense needs through cooperative action under the direction
and active supervision of FEMA.
The Attorney General, in consultation with the Chairman of the
Federal Trade Commission, has made the required finding for the Plan of
Action that the purposes of section 708(c)(1) of the DPA cannot
reasonably be achieved without the Plan of Action, or by a Plan of
Action having less anticompetitive effects than the proposed Plan of
Action. Pursuant to section 708(f)(1)(B) of the DPA, the Department of
Justice separately published the finding for this Plan of Action in the
Federal Register.\5\ The FEMA Administrator has certified in writing
that the Plan of Action is necessary to help provide for the national
defense.
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\5\ 86 FR 57444 (Oct. 15, 2021).
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Text of the Plan of Action To Establish a National Strategy for the
Coordination of National Multimodal Healthcare Supply Chains To Respond
to COVID-19 Implemented Under the Voluntary Agreement for the
Manufacture and Distribution of Critical Healthcare Resources Necessary
To Respond to a Pandemic
Plan of Action To Establish a National Strategy for the Coordination of
National Multimodal Healthcare Supply Chains To Respond to COVID-19
Implemented Under the Voluntary Agreement for the Manufacture and
Distribution of Critical Healthcare Resources Necessary To Respond to a
Pandemic
Preface
Pursuant to section 708 of the Defense Production Act of 1950
(DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management
Agency (FEMA) Administrator (Administrator), after consultation with
the Secretary of the Department of Health and Human Services (HHS), the
Attorney General of the United States (Attorney General), and the Chair
of the Federal Trade Commission (FTC), developed a Voluntary Agreement
for the Manufacture and Distribution of Critical Healthcare Resources
Necessary to Respond to a Pandemic (Voluntary Agreement), 85 FR 50035
(August 17, 2020). The Voluntary Agreement, which operates through a
series of Plans of Action, maximizes the manufacture and efficient
distribution of Critical Healthcare Resources nationwide to respond to
a pandemic by establishing unity of effort between Participants and the
Federal Government for integrated coordination, planning, information
sharing with FEMA, as authorized by FEMA, and distribution of Critical
Healthcare Resources.
This document establishes a Plan of Action (Plan) to Establish a
National Strategy for the Coordination of National Multimodal
Healthcare Supply Chains to Respond to COVID-19. This Plan will be
implemented under the Voluntary Agreement by one or more Sub-
Committees, beginning with a Sub-Committee to Define Requirements for
COVID-19 National Multimodal Healthcare Supply Chains and may also
include:
(1) Sub-Committee to Define Requirements for COVID-19 National
Multimodal Healthcare Supply Chains,
(2) Sub-Committee for Aviation,
(3) Sub-Committee for Surface Transportation (including Highway,
Motor Carriers, and Freight Rail), and
(4) Sub-Committee for Maritime Transportation.
[[Page 6882]]
FEMA may combine these Sub-Committees or establish additional Sub-
Committees under this Plan, so long as:
(1) The Sub-Committee addresses one specific and well-defined
component of the National Multimodal Healthcare Supply Chains System;
and
(2) The Sub-Committee is recommended by the Sub-Committee to Define
Requirements for COVID-19 National Multimodal Healthcare Supply Chains.
The purpose of the Plan and Sub-Committees is to evaluate and
optimize coordination of National Multimodal Healthcare Supply Chains
System resources related to the COVID-19 response. The primary goal of
the Plan is to create a mechanism to immediately address exigent needs
within the National Multimodal Healthcare Supply Chains System and to
ensure actions to address such needs do not come with unacceptable
risks or interfere with other efforts to meet critical End-User
requirements. When the requirements of the Plan are met, it affords
Sub-Committee Participants defenses to civil and criminal actions
brought under the antitrust laws (or any similar law of any state) for
actions taken within the scope of the Plan. The Plan is designed to
foster a close working relationship among FEMA, HHS, and Sub-Committee
Participants to address national defense needs through cooperative
action under the direction and active supervision of FEMA.
Table of Contents
I. Purpose
II. Authorities
III. General Provisions
A. Definitions
B. Plan of Action Participation
C. Effective Date and Duration of Participation
D. Withdrawal
E. Plan of Action Activation and Deactivation
F. Rules and Regulations
G. Modification and Amendment
H. Expenses
I. Record Keeping
IV. Antitrust Defense
V. Terms and Conditions
A. Plan of Action Execution
B. Information Management and Responsibilities
C. Oversight
VI. Establishment of the Sub-Committees
VII. Application and Agreement
VIII. Assignment
I. Purpose
A pandemic may present conditions that pose a direct threat to the
national defense of the United States or its preparedness programs such
that, pursuant to DPA section 708(c)(1), it becomes necessary to
establish an agreement and plan to collaboratively evaluate and
coordinate resources within the National Multimodal Healthcare Supply
Chains System. This Plan of Action to Establish a National Strategy for
the Coordination of National Multimodal Healthcare Supply Chains to
Respond to COVID-19 is established under the Voluntary Agreement and
initially establishes up to four Sub-Committees responsible for the
Plan's oversight and implementation. The Plan and Sub-Committees will
optimize the coordination of National Multimodal Healthcare Supply
Chains and create a prioritization protocol based upon End-Users'
demonstrated or projected requirements.
II. Authorities
Section 708, Defense Production Act (50 U.S.C. 4558); sections
402(2) & 501(b), Robert T. Stafford Disaster Relief and Emergency
Assistance Act (42 U.S.C. 5121-5207); sections 503(b)(2)(B) &
504(a)(10) & (16) of the Homeland Security Act of 2002 (6 U.S.C.
313(b)(2)(B), 314(a)(10) & (16)); sections 201, 301, National
Emergencies Act (50 U.S.C. 1601 et seq.); section 319, Public Health
Service Act (42 U.S.C. 247d); Executive Order (E.O.) 13911, 85 FR 18403
(March 27, 2020). Pursuant to DPA section 708(f)(1)(A), the
Administrator certifies that this Plan is necessary for the national
defense.
III. General Provisions
A. Definitions
Administrator
The FEMA Administrator is the Sponsor of the Voluntary Agreement.
Pursuant to a delegation or redelegation of the functions given to the
President by DPA section 708, the Administrator proposes and provides
for the development and carrying out of the Voluntary Agreement,
including through the development and implementation of Plans of
Action. The Administrator is responsible for carrying out all duties
and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and
for appointing one or more Chairpersons to manage and administer the
Committee and all Sub-Committees formed to carry out the Voluntary
Agreement.
Agreement
The Voluntary Agreement for the Manufacture and Distribution of
Critical Healthcare Resources Necessary to Respond to a Pandemic
(Voluntary Agreement).
Allotment
The process of analyzing and determining the relative distribution
among one or more competing requests from End-Users utilizing the same
National Multimodal Healthcare Supply Chains. Through the allotment
process, FEMA--with participation from Sub-Committee Participants--will
assess the actual needs of End-Users and determine how to divide the
available and projected capabilities of National Multimodal Healthcare
Supply Chains to minimize impacts to life, safety, and economic
disruption associated with shortages. Allotment will take place only
under Exigent Circumstances. With the exception of all forms of civil
transportation resources under the jurisdiction of the Department of
Transportation, which are excluded from this Plan, FEMA retains
decision-making authority for allotment under this Plan.
Attendees
Subject matter experts, invited by the Chairperson or a Sub-
Committee Chairperson to attend meetings authorized under the Voluntary
Agreement or this Plan, to provide technical advice or to represent
other government agencies or interested parties. Invitations to
attendees will be extended as required for Committee or Sub-Committee
meetings and deliberations.
Chairperson
FEMA senior executive(s), appointed by the Administrator, to chair
the Committee for the Distribution of Healthcare Resources Necessary to
Respond to a Pandemic (Committee). The Chairperson shall be responsible
for the overall management and administration of the Committee, the
Voluntary Agreement, and Plans of Action developed under the Voluntary
Agreement while remaining under the supervision of the Administrator;
shall initiate, or approve in advance, each meeting held to discuss
problems, determine policies, recommend actions, and make decisions
necessary to carry out the Voluntary Agreement; appoint one or more co-
Chairpersons to chair the Committee, and otherwise shall carry out all
duties and responsibilities assigned to him. With the approval of the
Administrator, the Chairperson may create one or more Sub-Committees,
and
[[Page 6883]]
may appoint one or more Sub-Committee Chairpersons to chair the Sub-
Committees, as appropriate.
Committee
Committee for the Distribution of Healthcare Resources Necessary to
Respond to a Pandemic established under the Voluntary Agreement.
Competitively Sensitive Information
Competitively Sensitive Information that is shared pursuant to this
Plan may include any Document or other tangible thing or oral
transmission that contains financial, business, commercial, scientific,
technical, economic, or engineering information or data, including, but
not limited to
financial statements and data,
customer and supplier lists,
price and other terms of sale to customers,
sales records, projections and forecasts,
inventory levels,
capacity and capacity utilization,
cost information,
sourcing and procurement information,
manufacturing and production information,
delivery and shipping information,
systems and data designs, and
methods, techniques, processes, procedures, programs, codes,
or similar information,
whether tangible or intangible, and regardless of the method of
storage, compilation, or recordation, if the owner thereof has taken
reasonable measures to protect the information from disclosure to the
public or competitors. These measures may be evidenced by marking or
labeling the items as ``competitively sensitive information'' during
submission to FEMA or in the Participant's customary and existing
treatment of such information (regardless of labeling).
All Competitively Sensitive Information provided by a Sub-Committee
Participant as described herein is deemed Competitively Sensitive
Information, except for Information that:
a. Is published or has been made publicly available at the time of
disclosure by the Sub-Committee Participant;
b. was in the possession of, or was lawfully and readily available
to, FEMA from another source at the time of disclosure without
breaching any obligation of confidentiality applicable to the other
source; or
c. was independently developed or acquired without reference to or
reliance upon the Sub-Committee Participant's Competitively Sensitive
Information;
Where information deemed Competitively Sensitive Information is
required to be disclosed by law, regulation, or court order, the
``Competitively Sensitive'' (or substantially similar) label will
continue to attach to all information and portion(s) of documents that
are not made public through the required disclosure.
Document
Any information, on paper or in electronic/audio/visual format,
including written, recorded, and graphic materials of every kind, in
the possession, custody, or control of the Participant and used or
shared in the course of participation in the Voluntary Agreement or a
subsequent Plan of Action.
End-User
This includes all direct and ancillary medical support including,
but not limited to, hospitals, independent healthcare providers,
nursing homes, medical laboratories, dental care providers, independent
physician offices, first responders, alternate care facilities,
distributors, wholesalers, and the general public that reasonably
represents the totality of the nation's response to COVID-19.
Exigent Circumstances
As determined by the Chairperson, the actual or forecasted shortage
of resources and their impact on the National Multimodal Healthcare
Supply Chains which likely cannot be fulfilled via usual market
mechanisms for an acute, critical time period, and where immediate and
substantial harm is projected to occur from lack of intervention.
National Multimodal Healthcare Supply Chains System
Any or all of the necessary resources and processes contributing to
the supply, production, and distribution of critical healthcare
resources necessary to respond to COVID-19.
This Plan focuses on resources, entities, and processes within the
Transportation Systems Sector, identified under Presidential Policy
Directive (PPD)-21, Critical Infrastructure Security and Resilience,
that support National Multimodal Healthcare Supply Chains.
Pandemic
A Pandemic is defined as an epidemic that has spread to human
populations across a large geographic area that is subject to one or
more declarations under the National Emergencies Act, the Public Health
Service Act, or the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, or if the Administrator determines that one or more
declarations is likely to occur and the epidemic poses a direct threat
to the national defense or its preparedness programs. For example,
Coronavirus Disease 2019 (COVID-19) meets the definition of a Pandemic.
Participant
An individual, partnership, corporation, association, or private
organization, other than a federal agency, that has substantive
capabilities, resources or expertise to carry out the purpose of the
Voluntary Agreement, that has been specifically invited to participate
in the Voluntary Agreement by the Chairperson, and that has applied and
agreed to the terms of the Voluntary Agreement. ``Participant''
includes a corporate or non-corporate entity entering into the
Voluntary Agreement and all subsidiaries and affiliates of that entity
in which that entity has 50 percent or more control either by stock
ownership, board majority, or otherwise. The Administrator may invite
Participants to join the Voluntary Agreement at any time during its
effective period.
Plan of Action (Plan)
This document. A documented method, pursuant to 50 U.S.C.
4558(b)(2), proposed by FEMA to implement a particular set of
activities under the Voluntary Agreement, through a Sub-Committee
focused on a particular Critical Healthcare Resource, or pandemic
response workstream or functional area necessary for the national
defense.
Plan of Action Agreement
A separate commitment made by Participants upon invitation and
agreement to participate in a Plan of Action as part of one or more
Sub-Committees. Completing the Plan of Action Agreement confers
responsibilities on the Participant consistent with those articulated
in the Plan of Action and affords Participants a defense against
antitrust claims under section 708 for actions taken to develop or
carry out the Plan and the appropriate Sub-Committee(s), as described
in Section IV below.
Representatives
The representatives the Administrator identifies and invites to the
Committee from FEMA, HHS, and other federal
[[Page 6884]]
agencies with equities in this Plan, and empowered to speak on behalf
of their agencies' interests. The Attorney General and the Chair of the
FTC, or their delegates, may also attend any meeting as a
Representative.
Sub-Committee
A body formed by the Administrator from select Participants to
implement a Plan of Action.
Sub-Committee Chairperson
FEMA executive, appointed by the Chairperson, to chair a Sub-
Committee to implement a Plan of Action. The Sub-Committee Chairperson
shall be responsible for the overall management and administration of
the Sub-Committee in furtherance of this Plan while remaining under the
supervision of the Administrator and the Chairperson.
Sub-Committee Members
Collectively the Sub-Committee Chairperson(s), Representatives, and
Sub-Committee Participants. Jointly responsible for developing and
executing this Plan.
Sub-Committee Participant
A subset of Participants of the Committee, that have been
specifically invited to participate in a Sub-Committee by the Sub-
Committee Chairperson, and that have applied and agreed to the terms of
this Plan and signed the Plan of Action Agreement. The Sub-Committee
Chairperson may invite Participants in the Committee to join a Sub-
Committee as a Sub-Committee Participant at any time during the Plan's
effective period.
B. Plan of Action Participation
This Plan will be carried out by a subset of the Participants in
the Voluntary Agreement through several Sub-Committees, which may
include:
(1) Sub-Committee to Define Requirements for COVID-19 National
Multimodal Healthcare Supply Chains,
(2) Sub-Committee for Aviation,
(3) Sub-Committee for Surface Transportation (including Highway,
Motor Carriers, and Freight Rail), and
(4) Sub-Committee for Maritime Transportation.
FEMA may combine these Sub-Committees or establish additional Sub-
Committees under this Plan, so long as:
(1) The Sub-Committee addresses one specific and well-defined
component of the National Multimodal Healthcare Supply Chains System;
and
(2) The Sub-Committee is recommended by the Sub-Committee to Define
Requirements for COVID-19 National Multimodal Healthcare Supply Chains.
Each Sub-Committee will consist of the (1) Sub-Committee
Chairperson(s), (2) Representatives from FEMA, HHS, the Department of
Justice (DOJ), and other federal agencies with equities in this Plan,
and (3) Sub-Committee Participants that have substantive capabilities,
resources or expertise to carry out the purpose of this Plan and have
signed the Plan of Action Agreement. The Chairperson shall invite Sub-
Committee Participants who, in his or her determination, are reasonably
representative of the appropriate industry or segment of such industry.
Other Attendees--invited by the Sub-Committee Chairperson as subject
matter experts to provide technical advice or to represent the
interests of other government agencies or interested parties--may also
participate in Sub-Committee meetings. The naming of these Sub-
Committees does not commit the Administrator to creating them unless
and until circumstances dictate.
C. Effective Date and Duration of Participation
This Plan is effective immediately upon satisfaction of the
requirements of DPA section 708(f)(1). This Plan shall remain in effect
until terminated in accordance with 44 CFR 332.4. It shall be effective
for no more than five (5) years from August 17, 2020, when the
requirements of DPA section 708(f)(1) were satisfied for the Voluntary
Agreement, unless otherwise terminated pursuant to DPA section
708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section
708(f)(2). No action may take place under this Plan until it is
activated, as described in Section III(E), below.
D. Withdrawal
Participation in the Plan is voluntary, as is the acceptance of
most obligations under the Plan. Sub-Committee Participants may
withdraw from this Plan or from an individual Sub-Committee at any
point, subject to the fulfillment of obligations previously agreed upon
by the Participant prior to the date of withdrawal. Note that the
obligations outlined in V.B regarding information management and
associated responsibilities apply once a party has shared or received
information through a Sub-Committee and remain in place after the
party's withdrawal from the Sub-Committee or Plan. If a Sub-Committee
Participant indicates an intent to withdraw from the Plan due to a
modification or amendment of the Plan (described below), the Sub-
Committee Participant will not be required to perform actions directed
by that modification or amendment. Withdrawal from the Plan will
automatically trigger withdrawal from all Sub-Committees; however, a
Participant may withdraw from a Sub-Committee without also withdrawing
from the Plan or other Sub-Committees. To withdraw from the Plan or
from an individual Sub-Committee, a Participant must provide written
notice to the Administrator at least fifteen (15) calendar days prior
to the effective date of that Sub-Committee Participant's withdrawal
specifying the scope of withdrawal. Following receipt of such notice,
the Administrator will inform the other Sub-Committee Participants of
the date and the scope of the withdrawal.
Upon the effective date of the withdrawal from the Plan, the Sub-
Committee Participant must cease all activities under the Plan. Upon
the effective date of the withdrawal from one or more Sub-Committee(s),
the Sub-Committee Participant must cease all activities under the Plan
that pertain to the withdrawn Sub-Committee(s).
E. Plan of Action Activation and Deactivation
The Administrator, in consultation with the Chairperson and Sub-
Committee Chairperson, will invite a select group of Participants in
the Voluntary Agreement to form at least one of the following Sub-
Committees, beginning with the Sub-Committee to Define Requirements for
COVID-19 National Multimodal Healthcare Supply Chains, which will be
responsible for implementing this Plan.
(1) Sub-Committee to Define Requirements for COVID-19 National
Multimodal Healthcare Supply Chains,
(2) Sub-Committee for Aviation,
(3) Sub-Committee for Surface Transportation (including Highway,
Motor Carriers, and Freight Rail), and
(4) Sub-Committee for Maritime Transportation.
FEMA may combine these Sub-Committees or establish additional Sub-
Committees under this Plan, so long as:
(1) The Sub-Committee addresses one specific and well-defined
component of the National Multimodal Healthcare Supply Chains System;
and
(2) The Sub-Committee is recommended by the Sub-Committee to Define
Requirements for COVID-19 National Multimodal Healthcare Supply Chains.
This Plan will be activated for each invited Participant when the
Participant executes a Plan of Action Agreement, and a Participant may
not participate in a Sub-Committee until the Plan of
[[Page 6885]]
Action Agreement is executed. Participants will be invited to join this
Plan at the discretion of the Chairperson or the Sponsor to the
Voluntary Agreement. Participants will be further invited to attend
specific meetings of one or more Sub-Committees at the discretion of
the Chairperson.
F. Rules and Regulations
Sub-Committee Participants acknowledge and agree to comply with all
provisions of DPA section 708, as amended, and regulations related
thereto which are promulgated by FEMA, the Department of Homeland
Security, HHS, the Attorney General, and the FTC. FEMA has promulgated
standards and procedures pertaining to voluntary agreements in 44 CFR
part 332. The Administrator shall inform Participants of new rules and
regulations as they are issued.
G. Modification and Amendment
The Administrator, after consultation with the Attorney General and
the Chair of the FTC, may terminate or modify, in writing, this Plan at
any time. The Attorney General, after consultation with the Chair of
the FTC and the Administrator, may terminate or modify, in writing,
this Plan at any time. Sub-Committee Participants may propose
modifications or amendments to the Plan or to the Sub-Committees at any
time.
Where possible, material modifications to the Plan or a Sub-
Committee will be subject to a 30-calendar day delayed implementation
and opportunity for notice and comment by Sub-Committee Participants to
the Chairperson. This delayed implementation period may be shortened or
eliminated if the Administrator deems it necessary. The Administrator
shall inform Sub-Committee Participants of modifications or amendments
to the Plan or to the Sub-Committees as they are proposed and issued.
The Administrator, after consultation with the Attorney General and
the Chair of the FTC, may remove Sub-Committee Participants from the
Plan or from a Sub-Committee at any time. The Attorney General, after
consultation with the Chair of the FTC and the Administrator, may
remove Sub-Committee Participants from this Plan or from a Sub-
Committee at any time. If a Participant is removed from the Plan or
from a Sub-Committee, the Participant may request written notice of the
reasons for removal from the Chairperson, who shall provide such notice
in a reasonable time period.
H. Expenses
Participation in this Plan or in a Sub-Committee does not confer
funds to Sub-Committee Participants, nor does it limit or prohibit any
pre-existing source of funds. Unless otherwise specified, all expenses,
administrative or otherwise, incurred by Sub-Committee Participants
associated with participation in this Plan or a Sub-Committee shall be
borne exclusively by the Sub-Committee Participants.
I. Record Keeping
Each Sub-Committee Chairperson shall have primary responsibility
for maintaining records in accordance with 44 CFR part 332 and shall be
the official custodian of records related to carrying out this Plan.
Each Sub-Committee Participant shall maintain for five years all
minutes of meetings, transcripts, records, documents, and other data,
including any communications with other Sub-Committee Participants or
with any other member of the Sub-Committee, including drafts, related
to the carrying out of this Plan or incorporating data or information
received in the course of carrying out this Plan. Each Sub-Committee
Participant agrees to produce to the Administrator, the Attorney
General, and the Chair of the FTC upon request any item that this
section requires the Participant to maintain. Any record maintained in
accordance with 44 CFR part 332 shall be available for public
inspection and copying, unless exempted on the grounds specified in 5
U.S.C. 552(b)(1), (3) or (4) or identified as privileged and
confidential information in accordance with DPA section 705(d), and 44
CFR 332.5.
IV. Antitrust Defense
Under the provisions of DPA subsection 708(j), each Sub-Committee
Participant in this Plan shall have available as a defense to any civil
or criminal action brought for violation of the antitrust laws (or any
similar law of any State) with respect to any action to develop or
carry out this Plan, that such action was taken by the Sub-Committee
Participant in the course of developing or carrying out this Plan, that
the Sub-Committee Participant complied with the provisions of DPA
section 708 and the rules promulgated thereunder, and that the Sub-
Committee Participant acted in accordance with the terms of the
Voluntary Agreement and this Plan. Except in the case of actions taken
to develop this Plan, this defense shall be available only to the
extent the Sub-Committee Participant asserting the defense demonstrates
that the action was specified in, or was within the scope of, this Plan
and within the scope of the appropriate Sub-Committee(s), including
being taken at the direction and under the active supervision of FEMA.
This defense shall not apply to any actions taken after the
termination of this Plan. Immediately upon modification of this Plan,
no defense to antitrust claims under Section 708 shall be available to
any subsequent action that is beyond the scope of the modified Plan.
The Sub-Committee Participant asserting the defense bears the burden of
proof to establish the elements of the defense. The defense shall not
be available if the person against whom the defense is asserted shows
that the action was taken for the purpose of violating the antitrust
laws.
V. Terms and Conditions
As the sponsoring agency, FEMA will maintain oversight over Sub-
Committee activities and direct and supervise actions taken to carry
out this Plan, including by retaining decision-making authority over
actions taken pursuant to the Plan to ensure such actions are necessary
to address a direct threat to the national defense. The Attorney
General and the Chair of the FTC will monitor activities of the Sub-
Committees to ensure they execute their responsibilities in a manner
consistent with this Plan and their actions have the least
anticompetitive effects possible.
A. Plan of Action Execution
This Plan will be used to support Pandemic response by maximizing
the coordination for selected National Multimodal Healthcare Supply
Chains and creating a prioritization protocol for End-Users. Each Sub-
Committee will support the following objectives to mitigate the loss of
life and public health threats associated with COVID-19.
1. Objectives
(1) Identify capabilities to effectively support National
Multimodal Healthcare Supply Chains.
(2) Ensure effective coordination of National Multimodal Healthcare
Supply Chains System resources that may be required for the Response to
COVID-19.
(3) Ensure ongoing competition continues within the National
Multimodal Healthcare Supply Chains System to the greatest extent
possible under the DPA.
2. Actions
Sub-Committee Participants may be asked to support these objectives
by taking the following specific actions:
[[Page 6886]]
(1) Assist the Chairperson in identifying priorities and challenges
within the National Multimodal Healthcare Supply Chains System that
should be addressed within the Plan's Sub-Committees because of their
importance to the national response to COVID-19. Using the best
evidence available, Participants should consider whether current and
projected National Multimodal Healthcare Supply Chains System resources
are sufficient to meet essential needs of End-Users and geographic
areas, and if there are any critical shortfalls of such resources that
may be of concern for the response to COVID-19.
(2) Create a collaborative process for evaluating and addressing
competing National Multimodal Healthcare Supply Chains System claims,
as directed and decided by the Chairperson.
(3) Develop a mechanism to inform prioritization of the
distribution of healthcare products through National Multimodal
Healthcare Supply Chains, as directed and decided by the Chairperson.
(4) Prepare a general strategy to accomplish the activities listed
in V(A)(2) and V(A)(5) regarding activities in Exigent Circumstances
consistent with the decisions made by the Chairperson.
(5) In Exigent Circumstances, with review and concurrence in all
possible instances by DOJ in consultation with FTC:
Facilitate maximum use of the National Multimodal
Healthcare Supply Chains System to meet requirements of the nation or
particular geographic areas by deconflicting overlapping demands from
the collective Participants' End-Users, as directed and decided by the
Chairperson.
Facilitate maximum availability of resources provided
within the National Multimodal Healthcare Supply Chains System to meet
requirements of the nation or particular geographic areas, as directed
and decided by the Chairperson.
Facilitate the efficient distribution of resources through
the National Multimodal Healthcare Supply Chains System by
deconflicting overlapping distribution chain activities of Sub-
Committee Members, as directed and decided by the Chairperson.
Establish a process and means of collaboration to address
exigent End-User requirements in a manner aligned with the objectives
of this Plan, as directed and decided by the Chairperson.
(6) Provide data and information necessary to validate the efforts
of the Sub-Committee including the actual and planned COVID-19 response
activities that may foreseeably impact National Multimodal Healthcare
Supply Chains throughout the nation, as determined by the Chairperson.
(7) Provide feedback to the Chairperson and Sub-Committee Members
on outcomes, accomplishments, and impediments of collective efforts to
accomplish objectives and actions outlined in this Plan.
(8) Advise the Chairperson whether additional Participants or
Attendees should be invited to join this Plan and its Sub-Committees.
(9) Carry out other activities that the Sub-Committees under this
Plan determine to be necessary for the coordination of National
Multimodal Healthcare Supply Chains System resources to address the
COVID-19 Pandemic's direct threat to the national defense, as
determined and directed by the Chairperson, where such activities have
been reviewed and approved by DOJ and FTC and received concurrence from
Sub-Committee members.
B. Information Management and Responsibilities
FEMA will request only the data and information from Sub-Committee
Participants that is necessary to meet the objectives of the Plan and
consistent with the scope of the relevant Sub-Committees. Upon signing
a Plan of Action Agreement for this Plan, FEMA requests that
Participants endeavor to cooperate with diligence and speed, and to the
extent permissible under this Plan, and to share with FEMA any data and
information necessary to meet the objectives of this Plan.
Sub-Committee Participants agree to share with FEMA the following
data with diligence and speed to the extent permissible under this
Plan, and to abide by the following guidelines where feasible and
consistent with the data that is owned by each Sub-Committee
Participant:
(1) In general, Participants will not be asked to share
Competitively Sensitive Information directly with other Participants.
(2) FEMA will only request direct sharing of Competitively
Sensitive Information among Participants during Exigent Circumstances
where there is a mission critical need or timeline such that sharing
only through FEMA is impractical or threatens the outcome of the Plan
or Sub-Committee action. Such requests, if made, will be only among
Participants whose participation is necessary to meet the objectives of
the Plan, will be limited in scope to the greatest extent possible, and
will be shared only pursuant to safeguards subject to prior review and
audit by DOJ and FTC. Direct sharing of Competitively Sensitive
Information with other Participants will be limited in scope and
circumstances to the greatest extent possible. Participants may not
share Competitively Sensitive Information directly with other
Participants unless specifically requested by FEMA, in consultation
with DOJ and FTC. All Competitively Sensitive Information delivered to
FEMA or to another Sub-Committee Participant shall be delivered by
secure means, for example, password-protected or encrypted electronic
files or drives with the password/key delivered by separate
communication or method or via upload to an appropriately secure web
portal as directed by FEMA. All data delivered to the web portal
designated by FEMA is deemed to be Competitively Sensitive Information.
(3) To allow FEMA to identify and appropriately protect documents
containing Competitively Sensitive Information by the Sub-Committee
Participant providing the documents, the Sub-Committee Participant will
make good faith efforts to designate any Competitively Sensitive
Information by placing restrictive markings on documents and things
considered to be competitively sensitive, the restrictive markings
being sufficiently clear in wording and visibility to indicate the
restricted nature of the data. The Sub-Committee Participant will
identify Competitively Sensitive Information that is disclosed verbally
by oral warning. Information designated as competitively sensitive
will, to the extent allowed by law, be presumed to constitute trade
secrets, or commercial or financial information, and be provided by the
Sub-Committee Participant to FEMA with the expectation that it will be
kept confidential by both parties, as such terms are understood in
accordance with 5 U.S.C. 552(b)(4) of the Freedom of Information Act
and federal judicial interpretations of this statute. FEMA agrees that
to the extent any information designated as competitively sensitive by
a Sub-Committee Participant is responsive to a request for disclosure
under the Freedom of Information Act, FEMA will consult with the Sub-
Committee Participant and afford the Participant ten (10) working days
to object to any disclosure by FEMA.
(4) FEMA will make good faith efforts to appropriately recognize
unmarked Documents containing Competitively Sensitive Information as
Competitively Sensitive Information. However, FEMA cannot guarantee
that all unmarked
[[Page 6887]]
Documents will be recognized as being Competitively Sensitive
Information and protected from disclosure to third parties. If the
unmarked Documents have not been disclosed without restriction outside
of FEMA, the Sub-Committee Participant may retroactively request to
have appropriate designations placed on the Documents. If the unmarked
Documents have been disclosed without restriction outside of FEMA, FEMA
will, to the extent practicable, remove any requested information from
public forums controlled by FEMA and will work promptly to request that
a receiving party return or destroy disclosed unmarked Documents if
requested by the Sub-Committee Participant.
(5) Competitively Sensitive Information may be used by FEMA, alone
or in combination with additional information, including Documents and
Competitively Sensitive Information received from third parties, to
support FEMA's implementation of this Plan as determined by the
Chairperson. In all situations, FEMA will aggregate and anonymize
Competitively Sensitive Information to the greatest extent possible to
protect the interests retained by the owners of the data while still
allowing the objectives of the Plan and Sub-Committee to be achieved.
To the greatest extent possible, such aggregation will render the
competitively sensitive nature of the Competitively Sensitive
Information of the Sub-Committee Participant no longer recognizable in
a commercially sensitive manner, and without sufficient information to
enable, by inference or otherwise, attribution to Sub-Committee
Participant or its affiliates (as clearly identified and disclosed to
FEMA). Any disclosure of Competitively Sensitive Information by FEMA,
within or outside a Sub-Committee, will be subject to review and
approval by DOJ and FTC.
(6) Except as otherwise expressly permitted by applicable federal
law, FEMA shall not disclose any Competitively Sensitive Information or
use any Competitively Sensitive Information for any purpose other than
in connection with the purposes of this Plan, and FEMA will not sell
any Competitively Sensitive Information of any Sub-Committee
Participant.
(7) Except as described below, FEMA may disclose Competitively
Sensitive Information only to its employees, officers, directors,
contractors, agents, and advisors (including attorneys, accountants,
consultants, and financial advisors). Any individual with access to
Competitively Sensitive Information will be expected to comply with the
terms of this Plan.
a. Information Sharing within the Sub-Committee: FEMA may share
Competitively Sensitive Information with Sub-Committee Participants and
Federal Representatives of the Plan, and their respective employees,
officers, directors, contractors, agents, and advisors (including
attorneys, accountants, consultants, and financial advisors) where
there is a need to know and where disclosure is reasonably necessary in
furtherance of implementing the Plan. FEMA will aggregate and anonymize
data prior to sharing with the Sub-Committee Participants to the
greatest extent possible while still allowing the objectives of the
Plan to be achieved, and will not share data--particularly to
competitors of the submitter--prior to consultation with and approval
by the DOJ and FTC.
i. Sub-Committee Participants, when providing Competitively
Sensitive Information to FEMA, may request that this Information not be
shared with other Sub-Committee Participants. Where these requests are
made in good faith and are reasonable in nature, FEMA will respect
these requests to the greatest extent possible and will consult the
owner of the data prior to any release made to Sub-Committee
Participants.
b. Restricted Reports. FEMA may communicate Competitively Sensitive
Information to appropriate government officials through Restricted
Reports. The information contained in Restricted Reports shall be
aggregated and anonymized to the greatest extent possible, while
recognizing that these officials may need a certain amount of
granularity and specificity of information to appropriately respond to
COVID-19. FEMA will aim to aggregate data to the County level, and will
not share Restricted Reports prior to consultation and approval from
the DOJ and FTC. FEMA may disclose Restricted Reports to relevant White
House and Administration officials and State Governors, and their
respective employees, officers, directors, contractors, agents, and
advisors (including attorneys, accountants, consultants, and financial
advisors) who have a need to know and to whom such disclosure is
reasonably necessary solely in furtherance of the implementation of
this Plan. FEMA shall take appropriate action (by instructions,
agreement, or otherwise) to ensure that receiving parties comply with
all data-sharing confidentiality and obligations under this Plan as if
such persons or entities had been parties to this Plan.
c. Public Reports. FEMA may share information with the public
through Public Reports. Data contained in Public Reports shall be fully
aggregated and anonymized. Public Reports shall be aggregated to at
least a state level and may be publicly disclosed after consultation
and approval from the DOJ and FTC.
(8) Where possible and not obviated by Exigent Circumstances, FEMA
will notify Sub-Committee Participants prior to the release of any
Competitively Sensitive Information that has not been fully aggregated
and anonymized. In consultation with DOJ and FTC, FEMA will consider
any good-faith requests made by Sub-Committee members to hold the
release of data or requests for further aggregation or anonymization.
In general, FEMA will not provide notification prior to the release of
Public Reports, under the presumption that the data in these reports
has already been fully anonymized and de-identified.
(9) Any party receiving Competitively Sensitive Information through
this Plan shall use such information solely for the purposes outlined
in the Plan and take steps, such as imposing previously approved
firewalls or tracking usage, to prevent misuse of the information.
Disclosure and use of Competitively Sensitive Information will be
limited to the greatest extent possible, and any party receiving
Competitively Sensitive Information shall follow the procedures
outlined in paragraph 7 above.
(10) At the conclusion of a Participant's involvement in a Plan--
due to the deactivation of the Plan or due to the Participant's
withdrawal or removal--each Participant will be requested to sequester
any and all Competitively Sensitive Information received through
participation in the Plan. This sequestration shall include the
deletion of all Competitively Sensitive Information unless required to
be kept pursuant to the Record Keeping requirements as described supra,
Section I, 44 CFR part 332, or any other provision of law.
C. Oversight
Each Sub-Committee Chairperson is responsible for ensuring that the
Attorney General, or suitable delegate(s) from the DOJ, and the FTC
Chair, or suitable delegate(s) from the FTC, have awareness of
activities under this Plan, including activation, deactivation, and
scheduling of meetings. The Attorney General, the FTC Chair, or their
delegates may attend Sub-Committee meetings and request to be apprised
of any activities taken in accordance with activities under this Plan.
DOJ or FTC Representatives may request and review
[[Page 6888]]
any proposed action by the Sub-Committee or Sub-Committee Participants
undertaken pursuant to this Plan, including the provision of data. If
any DOJ or FTC Representative believes any actions proposed or taken
are not consistent with relevant antitrust protections provided by the
DPA, he or she shall provide warning and guidance to the Sub-Committee
as soon as the potential issue is identified. If questions arise about
the antitrust protections applicable to any particular action, FEMA may
request DOJ, in consultation with the FTC, provide an opinion on the
legality of the action under relevant DPA antitrust protections.
VI. Establishment of the Sub-Committees
This Plan establishes Sub-Committees to implement the Plan of
Action to Establish a National Strategy for the Coordination of
National Multimodal Healthcare Supply Chains to Respond to COVID-19 to
provide the Federal Government and the Participants a forum to maximize
the coordination of selected National Multimodal Healthcare Supply
Chain resources and to create a prioritization protocol based upon
existing or projected needs of End-Users and geographic areas within
the National Multimodal Healthcare Supply Chains System. The outcome
should include a framework to expeditiously meet critical needs within
the National Multimodal Healthcare Supply Chains System that may arise
in Exigent Circumstances, and to ensure actions to address such needs
do not come with unacceptable risks to End-Users or interfere with
other efforts to meet critical End-User requirements. A Sub-Committee
Chairperson designated by the Chairperson will convene and preside over
each Sub-Committee. Sub-Committees will not be used for contract
negotiations or contract discussions between the Participants and the
Federal Government; such negotiations or discussions will be in
accordance with applicable federal contracting policies and procedures.
However, this shall not limit any discussion within a Sub-Committee
about the operational utilization of existing and potential contracts
between the Participants and Representatives when seeking to align
their use with overall manufacturing and distribution efforts
consistent with this Plan.
Each Sub-Committee will consist of designated Representatives from
FEMA, HHS, other federal agencies with equities in this Plan, and each
Sub-Committee Participant. The Attorney General and Chair of the FTC,
or their delegates, may also join each Sub-Committee and attend
meetings at their discretion. Attendees may also be invited at the
discretion of a Sub-Committee Chairperson as subject matter experts, to
provide technical advice, or to represent other government agencies,
but will not be considered part of the Sub-Committee.
Only to the extent necessary to respond to COVID-19 as explicitly
directed by the Sub-Committee Chairperson, and subject to the
provisions of Section V(B), Sub-Committee Members may be asked to
provide technical advice, share information, help identify and validate
places and resources of the greatest need, help project future
manufacturing and distribution demands, assist in identifying and
resolving the allotment of scarce resources under Exigent
Circumstances, and take other actions necessary to maximize the timely
coordination of National Multimodal Healthcare Supply Chains System
resources for the COVID-19. A Sub-Committee Chairperson or his or her
designee, at the Sub-Committee Chairperson's sole discretion, will make
decisions on these issues in order to ensure the maximum efficiency and
effectiveness in the use of Sub-Committee Member's resources. All Sub-
Committee Participants will be invited to open Sub-Committee meetings.
For selected Sub-Committee meetings, attendance may be limited to
designated Sub-Committee Participants to meet specific operational
requirements, as determined by FEMA.
Each Sub-Committee Chairperson shall notify the Attorney General,
the Chair of the FTC, Representatives, and Participants of the time,
place, and nature of each meeting and of the proposed agenda of each
meeting to be held to carry out this Plan. Additionally, each Sub-
Committee Chairperson shall provide for publication in the Federal
Register of a notice of the time, place, and nature of each meeting. If
a meeting is open, a Federal Register notice will be published
reasonably in advance of the meeting. A Sub-Committee Chair may
restrict attendance at meetings only on the grounds outlined by 44 CFR
332.5(c)(1)-(3). If a meeting is closed, a Federal Register notice will
be published within ten (10) days of the meeting and will include the
reasons why the meeting is closed pursuant to 44 CFR 332.3(c)(2).
The Sub-Committee Chairperson shall establish the agenda for each
meeting, be responsible for adherence to the agenda, and provide for a
written summary or other record of each meeting and provide copies of
transcripts or other records to FEMA, the Attorney General, the Chair
of the FTC, and all Sub-Committee Participants. The Chairperson shall
take necessary actions to protect from public disclosure any data
discussed with or obtained from Sub-Committee Participants which a Sub-
Committee Participant has identified as a trade secret or as privileged
and confidential in accordance with DPA sections 708(h)(3) and 705(d),
or which qualifies for withholding under 44 CFR 332.5.
VII. Application and Agreement
The Sub-Committee Participant identified below hereby agrees to
join in the Federal Emergency Management Agency sponsored Plan of
Action to Establish a National Strategy for the Coordination of
National Multimodal Healthcare Supply Chains to Respond to COVID-19
under the Voluntary Agreement for the Manufacture and Distribution of
Healthcare Resources Necessary to Respond to a Pandemic and to become a
Participant in one or more Sub-Committees established by this Plan.
This Plan will be published in the Federal Register. This Plan is
authorized under section 708 of the Defense Production Act of 1950, as
amended. Regulations governing the Voluntary Agreement for the
Manufacture and Distribution of Healthcare Resources Necessary to
Respond to a Pandemic and all subsequent Plans of Action at 44 CFR part
332. The applicant, as a Sub-Committee Participant, agrees to comply
with the provisions of section 708 of the Defense Production Act of
1950, as amended, the regulations at 44 CFR part 332, and the terms of
this Plan.
VIII. Assignment
No Sub-Committee Participant may assign or transfer this Plan, in
whole or in part, or any protections, rights or obligations hereunder
without the prior written consent of the Sub-Committee Chairperson.
When requested, the Sub-Committee Chairperson will respond to written
requests for consent within 10 (ten) business days of receipt.
[[Page 6889]]
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(Name of authorized representative)
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(Signature of authorized representative)
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Administrator (Sponsor)
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(Date)
Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-02549 Filed 2-3-22; 11:15 am]
BILLING CODE 9111-19-P
