[Federal Register Volume 85, Number 236 (Tuesday, December 8, 2020)]
[Notices]
[Pages 79020-79028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26986]
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DEPARTMENT OF HOMELAND SECURITY
Federal Emergency Management Agency
[Docket ID FEMA-2020-0016]
Plan of Action To Establish a National Strategy for the
Manufacture, Allocation, and Distribution of Personal Protective
Equipment (PPE) To Respond to COVID-19; Implemented Under the Voluntary
Agreement for the Manufacture and Distribution of Critical Healthcare
Resources Necessary To Respond to a Pandemic
AGENCY: Federal Emergency Management Agency, DHS.
ACTION: Notice.
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SUMMARY: The Federal Emergency Management Agency (FEMA) announces the
activation of a Plan of Action to establish a National Strategy for the
manufacture, allocation, and distribution of Personal Protective
Equipment (PPE) to respond to COVID-19 implemented under the Voluntary
Agreement for the manufacture and distribution of critical healthcare
resources necessary to respond to a pandemic. This Notice contains the
text of the Plan of Action.
FOR FURTHER INFORMATION CONTACT: Robert Glenn, Office of Business,
Industry, Infrastructure Integration, Federal Emergency Management
Agency, (202) 212-1666, and email OB3I@fema.dhs.gov.
SUPPLEMENTARY INFORMATION:
Authority
Section 708 of the Defense Production Act (DPA), 50 U.S.C. 4558,
allows the President to provide for the formation of voluntary
agreements and plans of action by the private sector to help provide
for the national defense. This authority was delegated to the Secretary
of Homeland Security generally in section 401 of Executive Order
13603,\1\ ``National Defense Resources Preparedness,'' and specifically
for response to COVID-19 in section 3 of Executive Order 13911,\2\
``Delegating Additional Authority Under the Defense Production Act With
Respect to Health and Medical Resources To Respond to the Spread of
COVID-19.'' The Secretary of Homeland Security has delegated these
authorities to the FEMA Administrator in Department of Homeland
Security (DHS) Delegation 09052 Rev. 00, ``Delegation of Defense
Production Act Authority to the Administrator of the Federal Emergency
Management Agency,'' (Jan. 3, 2017), and DHS Delegation 09052 Rev.
00.1, ``Delegation of Defense Production Act Authority to the
Administrator of the Federal Emergency Management Agency'' (Apr. 1,
2020), respectively.
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\1\ 77 FR 16651 (Mar. 22, 2012).
\2\ 85 FR 18403 (Apr. 1, 2020).
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Background
FEMA sought and received approval from the Attorney General, after
consultation with the Federal Trade Commission (FTC), to begin
consultation with the private sector, as required by Section 708(c)(2).
Pursuant to that approval, on May 12, 2020, FEMA posted an announcement
of a public meeting and request for comments to develop a Voluntary
Agreement in the Federal Register (85 FR 28031). FEMA held a public
meeting on May 21, 2020, and accepted public comments until June 5,
2020.\3\ FEMA received 34 public comments and considered these comments
when preparing the Voluntary Agreement.\4\
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\3\ The original comment period was extended to allow
commentators additional time to respond. FEMA posted notices of
extension to www.regulations.gov under the Docket ID for this
notice, FEMA-2020-0016.
\4\ Available on www.regulations.gov under the Docket ID for
this notice.
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The Attorney General, in consultation with the Chairman of the
Federal Trade Commission, made the required finding that the purpose of
the Voluntary Agreement may not reasonably be achieved through an
agreement having less anticompetitive effect or without any Voluntary
Agreement. Pursuant to Sec. 708(f)(1)(B) of the DPA, the Department of
Justice separately published this finding in the Federal Register on
August 17, 2020 as a notice (85 FR 50049). The FEMA Administrator, as
the Sponsor of the agreement, certified in writing that the agreement
was necessary to help provide for the national defense. FEMA provided
notice of the formation and the
[[Page 79021]]
text of the Voluntary Agreement in the Federal Register on August 17,
2020 (85 FR 50035).
On October 13, 2020, FEMA held a virtual meeting to implement the
Voluntary Agreement for the Manufacture and Distribution of Critical
Healthcare Resources Necessary to Respond to a Pandemic (see 85 FR
63567). A portion of the meeting was open to the public. One objective
of this meeting was to discuss the activation of the first Plan of
Action under the Voluntary Agreement to identify more efficient methods
of allocating and distributing Personal Protective Equipment to meet
national demand and ways of expanding the production of critical
healthcare resources, with an initial focus on the manufacture of N95
masks. From this meeting, FEMA incorporated public comments and
feedback from the U.S. Department of Justice and the Federal Trade
Commission to develop the Plan of Action.
The Attorney General, in consultation with the Chairman of the
Federal Trade Commission, made the required finding that the purposes
of section 708(c)(1) of the DPA cannot reasonably be achieved without
any Plan of Action, or by a plan of action having less anticompetitive
effects than the proposed Plan of Action. Pursuant to section
708(f)(1)(B) of the DPA, the Department of Justice is separately
publishing this finding in the Federal Register as a notice. The FEMA
Administrator has certified in writing that this Plan of Action is
necessary to help provide for the national defense.
Text of the Plan of Action to Establish a National Strategy for the
manufacture, allocation, and distribution of Personal Protective
Equipment (PPE) to respond to COVID-19 implemented under the voluntary
agreement for the MANUFACTURE AND DISTRIBUTION OF CRITICAL HEALTHCARE
RESOURCES NECESSARY TO RESPOND TO A PANDEMIC
Table of Contents
Preface
I. Purpose
II. Authorities
III. General Provisions
A. Definitions
B. Plan of Action Participation
C. Effective Date and Duration of Participation
D. Withdrawal
E. Plan of Action Activation and Deactivation
F. Rules and Regulations
G. Modification and Amendment
H. Expenses
I. Record Keeping
IV. Antitrust Defense
V. Terms and Conditions
A. Plan of Action Execution
B. Information Management and Responsibilities
C. Oversight
VI. Establishment of the Sub-Committees
VII. Application and Agreement
VIII. Assignment
Preface
Pursuant to section 708 of the Defense Production Act of 1950
(DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management
Agency (FEMA) Administrator (Administrator), after consultation with
the Secretary of the Department of Health and Human Services (HHS), the
Attorney General of the United States (Attorney General), and the
Chairman of the Federal Trade Commission (FTC), developed a Voluntary
Agreement for the Manufacture and Distribution of Critical Healthcare
Resources Necessary to Respond to a Pandemic (Voluntary Agreement), 85
FR 50035 (August 17, 2020). The Voluntary Agreement, which operates
through a series of Plans of Action, maximizes the manufacture and
efficient distribution of Critical Healthcare Resources nationwide to
respond to a pandemic by establishing unity of effort between
Participants and the Federal Government for integrated coordination,
planning, information sharing with FEMA, as authorized by FEMA, and
allocation and distribution of Critical Healthcare Resources.
This document establishes a Plan of Action (Plan) for the
Manufacture, Allocation, and Distribution of Personal Protective
Equipment (PPE) to Respond to COVID-19. This Plan will be implemented
under the Voluntary Agreement by several Sub-Committees:
(1) Sub-Committee to Define COVID-19 PPE Requirements,
(2) Sub-Committee for N-95 and other Medical Respirators,
(3) Sub-Committee for Gloves,
(4) Sub-Committee for Gowns, and
(5) Sub-Committee for Eye and Facial Coverings.
FEMA may establish additional Sub-Committees under this Plan of
Action, so long as:
(1) The Sub-Committee addresses one specific and well-defined
category of PPE; and
(2) The Sub-Committee is recommended by the Sub-Committee to Define
COVID-19 PPE Requirements.
The purpose of the Plan and the Sub-Committees is to maximize the
manufacture and efficient distribution of selected types of critical
PPE and create a prioritization protocol for End-Users based upon their
demonstrated or projected requirements including geographic and
regional circumstances. The primary goal of the Plan is to create a
mechanism to immediately meet exigent PPE requests anywhere in the
Nation and to ensure that actions to support PPE stockpiling and
reserves do not interfere with immediate requirements that would result
in an unacceptable risk to healthcare providers or other potential PPE
recipients. When the requirements of the Plan are met, it affords Sub-
Committee Participants defenses to civil and criminal actions brought
under the antitrust laws (or any similar law of any state) for actions
taken within the scope of the Plan. The Plan is designed to foster a
close working relationship among FEMA, HHS, and Sub-Committee
Participants to address national defense needs through cooperative
action under the direction and active supervision of FEMA.
I. Purpose
A pandemic may present conditions that pose a direct threat to the
national defense of the United States or its preparedness programs such
that, pursuant to DPA section 708(c)(1), an agreement to collectively
coordinate, plan, and collaborate for the manufacture and distribution
of PPE is necessary for the national defense. This Plan of Action to
Establish a National Strategy for the Manufacture, Allocation, and
Distribution of Personal Protective Equipment (PPE) to Respond to
COVID-19 is established under the Voluntary Agreement and establishes
five Sub-Committees to oversee and implement the Plan. The Plan and
Sub-Committees will optimize the manufacture and the efficient
distribution of selected types of critical PPE and create a
prioritization protocol for End-Users based upon their demonstrated or
projected requirements and taking into account geographic and regional
circumstances for stabilization and reduction of COVID-19 exposure.
II. Authorities
Section 708, Defense Production Act (50 U.S.C. 4558); sections
402(2) & 501(b), Robert T. Stafford Disaster Relief and Emergency
Assistance Act (42 U.S.C. 5121-5207); sections 503(b)(2)(B) &
504(a)(10) & (16) of the Homeland Security Act of 2002 (6 U.S.C.
313(b)(2)(B), 314(a)(10) & (16)); sections 201, 301, National
Emergencies Act (50 U.S.C. 1601 et seq.); section 319, Public Health
Service Act (42 U.S.C. 247d); Executive Order (E.O.) 13911, 85 FR 18403
(March 27, 2020); Prioritization and Allocation of Certain Scarce or
Threatened Health and Medical Resources for Domestic Use, 85 FR 20195
(April 10, 2020). Pursuant to DPA
[[Page 79022]]
section 708(f)(1)(A), the Administrator certifies that this Plan is
necessary for the national defense.
III. General Provisions
A. Definitions
Administrator
The FEMA Administrator is the Sponsor of the Voluntary Agreement.
Pursuant to a delegation or redelegation of the functions given to the
President by DPA section 708, the Administrator proposes and provides
for the development and carrying out of the Voluntary Agreement,
including through the development and implementation of Plans of
Action. The Administrator is responsible for carrying out all duties
and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and
for appointing one or more Chairpersons to manage and administer the
Committee and all Sub-Committees formed to carry out the Voluntary
Agreement.
Agreement
The Voluntary Agreement for the Manufacture and Distribution of
Critical Healthcare Resources Necessary to Respond to a Pandemic
(Voluntary Agreement).
Allocation
The process of determining and directing the relative distribution
among one or more competing requests from End-Users for the same PPE.
Through the Allocation process, FEMA--with participation from Sub-
Committee Participants--will assess the actual needs of End-Users and
determine how to divide the available and projected supply of PPE to
minimize impacts to life, safety, and economic disruption associated
with shortages of critical PPE. Allocation will take place only under
Exigent Circumstances. FEMA retains decision-making authority for all
Allocation under this Plan.
Attendees
Subject matter experts, invited by the Chairperson or a Sub-
Committee Chairperson to attend meetings authorized under the Voluntary
Agreement or this Plan of Action, to provide technical advice or to
represent other government agencies or interested parties. Invitations
to attendees will be extended as required for Committee or Sub-
Committee meetings and deliberations.
Chairperson
FEMA senior executive(s), appointed by the Administrator, to chair
the Committee for the Distribution of Healthcare Resources Necessary to
Respond to a Pandemic (Committee). The Chairperson shall be responsible
for the overall management and administration of the Committee, the
Voluntary Agreement, and Plans of Action developed under the Voluntary
Agreement while remaining under the supervision of the Administrator;
shall initiate, or approve in advance, each meeting held to discuss
problems, determine policies, recommend actions, and make decisions
necessary to carry out the Voluntary Agreement; appoint one or more co-
Chairpersons to chair the Committee, and otherwise shall carry out all
duties and responsibilities assigned to him. With the approval of the
Administrator, the Chairperson may create one or more Sub-Committees,
and may appoint one or more Sub-Committee Chairpersons to chair the
Sub-Committees, as appropriate.
Committee
Committee for the Distribution of Healthcare Resources Necessary to
Respond to a Pandemic established under the Voluntary Agreement.
Competitively Sensitive Information
Competitively Sensitive Information that is shared pursuant to this
Plan of Action may include any Document or other tangible thing or oral
transmission that contains financial, business, commercial, scientific,
technical, economic, or engineering information or data, including, but
not limited to
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 and the
general public that reasonably represents the totality of the nation's
professional or medical response to COVID-19. ``End-User'' may also
include essential workers necessary to maintain or restore critical
infrastructure operations, including but not limited to law
enforcement, education, food and agriculture, energy, water and
wastewater, and public works personnel.
Exigent Circumstances
As determined by the Chairperson, the actual or forecasted shortage
of a particular type or types of PPE which
[[Page 79023]]
likely cannot be fulfilled via usual market mechanisms for an acute,
critical time period, and where immediate and substantial harm is
projected to occur from lack of intervention.
Pandemic
A Pandemic is defined as an epidemic that has spread to human
populations across a large geographic area that is subject to one or
more declarations under the National Emergencies Act, the Public Health
Service Act, or the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, or if the Administrator determines that one or more
declarations is likely to occur and the epidemic poses a direct threat
to the national defense or its preparedness programs. For example,
Coronavirus Disease 2019 (COVID-19).
Participant
An individual, partnership, corporation, association, or private
organization, other than a federal agency, that has substantive
capabilities, resources or expertise to carry out the purpose of the
Voluntary Agreement, that has been specifically invited to participate
in the Voluntary Agreement by the Chairperson, and that has applied and
agreed to the terms of the Voluntary Agreement. ``Participant''
includes a corporate or non-corporate entity entering into the
Voluntary Agreement and all subsidiaries and affiliates of that entity
in which that entity has 50 percent or more control either by stock
ownership, board majority, or otherwise. The Administrator may invite
Participants to join the Voluntary Agreement at any time during its
effective period.
Personal Protective Equipment (PPE)
Objects that provide measures of safety protection for healthcare
workers, first responders, critical infrastructure personnel and/or the
general public for the response to the Pandemic. These PPE items may
include, but are not limited to, face coverings, filtering facepiece
respirators, face shields, isolation and surgical gowns, examination
and surgical gloves, suits, and foot coverings.
Plan of Action (Plan)
This document. A documented method, pursuant to 50 U.S.C.
4558(b)(2), proposed by FEMA to implement a particular set of
activities under the Voluntary Agreement, through a Sub-Committee
focused on a particular Critical Healthcare Resource, or pandemic
response workstream or functional area necessary for the national
defense.
Plan of Action Agreement
A separate commitment made by Participants upon invitation and
agreement to participate in a Plan of Action as part of one or more
Sub-Committees. Completing the Plan of Action Agreement confers
responsibilities on the Participant consistent with those articulated
in the Plan of Action and affords Participants a defense against
antitrust claims under section 708 for actions taken to develop or
carry out the Plan of Action and the appropriate Sub-Committee(s), as
described in Section IV below.
Representatives
The representatives the Administrator identifies and invites to the
Committee from FEMA, HHS, and other federal agencies with equities in
this Plan, and empowered to speak on behalf of their agencies'
interests. The Attorney General and the Chairman of the FTC, or their
delegates, may also attend any meeting as a Representative.
Sub-Committee
A body formed by the Administrator from select Participants to
implement a Plan of Action.
Sub-Committee Chairperson
FEMA official, appointed by the Chairperson, to chair a Sub-
Committee to implement a Plan of Action. The Sub-Committee Chairperson
shall be responsible for the overall management and administration of
the Sub-Committee in furtherance of this Plan of Action while remaining
under the supervision of the Administrator and the Chairperson.
Sub-Committee Members
Collectively the Sub-Committee Chairperson(s), Representatives, and
Sub-Committee Participants. Jointly responsible developing and
executing this Plan.
Sub-Committee Participant
A subset of Participants of the Committee, that have been
specifically invited to participate in a Sub-Committee by the Sub-
Committee Chairperson, and that have applied and agreed to the terms of
this Plan and signed the Plan of Action Agreement. The Sub-Committee
Chairperson may invite Participants in the Committee to join a Sub-
Committee as a Sub-Committee Participant at any time during the Plan's
effective period.
B. Plan of Action Participation
This Plan will be carried out by a subset of the Participants in
the Voluntary Agreement through several Sub-Committees:
(1) Sub-Committee to Define COVID-19 PPE Requirements,
(2) Sub-Committee for N-95 and other Medical Respirators,
(3) Sub-Committee for Gloves,
(4) Sub-Committee for Gowns, and
(5) Sub-Committee for Eye and Facial Coverings.
FEMA may establish additional Sub-Committees under this Plan of
Action, so long as:
(1) The Sub-Committee addresses one specific and well-defined
category of PPE; and
(2) The Sub-Committee is recommended by the Sub-Committee to Define
COVID-19 PPE Requirements.
Each Sub-Committee will consist of the (1) Sub-Committee
Chairperson(s), (2) Representatives from FEMA, HHS, the Department of
Justice (DOJ), and other federal agencies with equities in this Plan,
and (3) Sub-Committee Participants that have substantive capabilities,
resources or expertise to carry out the purpose of this Plan and have
signed the Plan of Action Agreement. The Chairperson shall invite Sub-
Committee Participants who, in his or her determination, are reasonably
representative of the appropriate industry or segment of such industry.
Other Attendees--invited by the Sub-Committee Chairperson as subject
matter experts to provide technical advice or to represent the
interests of other government agencies or interested parties--may also
participate in Sub-Committee meetings. The naming of these Sub-
Committees does not commit the Administrator to creating them unless
and until circumstances dictate.
C. Effective Date and Duration of Participation
This Plan is effective immediately upon satisfaction of the
requirements of DPA section 708(f)(1). This Plan shall remain in effect
until terminated in accordance with 44 CFR 332.4. It shall be effective
for no more than five (5) years from August 17, 2020, when the
requirements of DPA section 708(f)(1) were satisfied for the Voluntary
Agreement, unless otherwise terminated pursuant to DPA section
708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section
708(f)(2). No action may take place under this Plan until it is
activated, as described in Section III(E), below.
D. Withdrawal
Participation in the Plan is voluntary, as is the acceptance of
most obligations under the Plan. Sub-Committee Participants may
withdraw from this
[[Page 79024]]
Plan or from an individual Sub-Committee at any point, subject to the
fulfillment of obligations previously agreed upon by the Participant
prior to the date of withdrawal. Note that the obligations outlined in
V.B regarding information management and associated responsibilities
apply once a party has shared or received information through a Sub-
Committee, and remain in place after the party's withdrawal from the
Sub-Committee or Plan. If a Sub-Committee Participant indicates an
intent to withdraw from the Plan due to a modification or amendment of
the Plan (described below), the Sub-Committee Participant will not be
required to perform actions directed by that modification or amendment.
Withdrawal from the Plan will automatically trigger withdrawal from all
Sub-Committees; however, a Participant may withdraw from a Sub-
Committee without also withdrawing from the Plan or other Sub-
Committees. To withdraw from the Plan or from an individual Sub-
Committee, a Participant must provide written notice to the
Administrator at least fifteen (15) calendar days prior to the
effective date of that Sub-Committee Participant's withdrawal
specifying the scope of withdrawal. Following receipt of such notice,
the Administrator will inform the other Sub-Committee Participants of
the date and the scope of the withdrawal.
Upon the effective date of the withdrawal from the Plan, the Sub-
Committee Participant must cease all activities under the Plan. Upon
the effective date of the withdrawal from one or more Sub-Committee(s),
the Sub-Committee Participant must cease all activities under the Plan
that pertain to the withdrawn Sub-Committee(s).
E. Plan of Action Activation and Deactivation
The Administrator, in consultation with the Chairperson and Sub-
Committee Chairperson, will invite a select group of Participants in
the Voluntary Agreement to form the following Sub-Committees, which
will be responsible for implementing this Plan:
(1) Sub-Committee to Define COVID-19 PPE Requirements,
(2) Sub-Committee for N-95 and other Medical Respirators,
(3) Sub-Committee for Gloves,
(4) Sub-Committee for Gowns, and
(5) Sub-Committee for Eye and Facial Coverings.
FEMA may establish additional Sub-Committees under this Plan of
Action, so long as:
(1) The Sub-Committee addresses one specific and well-defined
category of PPE; and
(2) The Sub-Committee is recommended by the Sub-Committee to Define
COVID-19 PPE Requirements.
This Plan will be activated for each invited Participant when the
Participant executes a Plan of Action Agreement, and a Participant may
not participate in a Sub-Committee until the Plan of Action Agreement
is executed. Participants will be invited to join this Plan at the
discretion of the Chairperson or the Sponsor to the Voluntary
Agreement. Participants will be further invited to attend specific
meetings of one or more Sub-Committees at the discretion of the
Chairperson.
F. Rules and Regulations
Sub-Committee Participants acknowledge and agree to comply with all
provisions of DPA section 708, as amended, and regulations related
thereto which are promulgated by FEMA, the Department of Homeland
Security, HHS, the Attorney General, and the FTC. FEMA has promulgated
standards and procedures pertaining to voluntary agreements in 44 CFR
part 332. The Administrator shall inform Participants of new rules and
regulations as they are issued.
G. Modification and Amendment
The Administrator, after consultation with the Attorney General and
the Chairman of the FTC, may terminate or modify, in writing, this Plan
at any time. The Attorney General, after consultation with the Chairman
of the FTC and the Administrator, may terminate or modify, in writing,
this Plan at any time. Sub-Committee Participants may propose
modifications or amendments to the Plan or to the Sub-Committees at any
time.
Where possible, material modifications to the Plan or a Sub-
Committee will be subject to a 30 calendar day delayed implementation
and opportunity for notice and comment by Sub-Committee Participants to
the Chairperson. This delayed implementation period may be shortened or
eliminated if the Administrator deems it necessary. The Administrator
shall inform Sub-Committee Participants of modifications or amendments
to the Plan or to the Sub-Committees as they are proposed and issued.
The Administrator, after consultation with the Attorney General and
the Chairman of the FTC, may remove Sub-Committee Participants from the
Plan or from a Sub-Committee at any time. The Attorney General, after
consultation with the Chairman of the FTC and the Administrator, may
remove Sub-Committee Participants from this Plan or from a Sub-
Committee at any time. If a Participant is removed from the Plan or
from a Sub-Committee, the Participant may request written notice of the
reasons for removal from the Chairperson, who shall provide such notice
in a reasonable time period.
H. Expenses
Participation in this Plan or in a Sub-Committee does not confer
funds to Sub-Committee Participants, nor does it limit or prohibit any
pre-existing source of funds. Unless otherwise specified, all expenses,
administrative or otherwise, incurred by Sub-Committee Participants
associated with participation in this Plan or a Sub-Committee shall be
borne exclusively by the Sub-Committee Participants.
I. Record Keeping
Each Sub-Committee Chairperson shall have primary responsibility
for maintaining records in accordance with 44 CFR part 332 and shall be
the official custodian of records related to carrying out this Plan.
Each Sub-Committee Participant shall maintain for five years all
minutes of meetings, transcripts, records, documents, and other data,
including any communications with other Sub-Committee Participants or
with any other member of the Sub-Committee, including drafts, related
to the carrying out of this Plan or incorporating data or information
received in the course of carrying out this Plan. Each Sub-Committee
Participant agrees to produce to the Administrator, the Attorney
General, and the Chairman of the FTC upon request any item that this
section requires the Participant to maintain. Any record maintained in
accordance with 44 CFR part 332 shall be available for public
inspection and copying, unless exempted on the grounds specified in 5
U.S.C. 552(b)(1), (3) or (4) or identified as privileged and
confidential information in accordance with DPA section 705(d), and 44
CFR 332.5.
IV. Antitrust Defense
Under the provisions of DPA subsection 708(j), each Sub-Committee
Participant in this Plan shall have available as a defense to any civil
or criminal action brought for violation of the antitrust laws (or any
similar law of any State) with respect to any action to develop or
carry out this Plan, that such action was taken by the Sub-Committee
Participant in the course of developing or carrying out this Plan, that
the Sub-
[[Page 79025]]
Committee Participant complied with the provisions of DPA section 708
and the rules promulgated thereunder, and that the Sub-Committee
Participant acted in accordance with the terms of the Voluntary
Agreement and this Plan. Except in the case of actions taken to develop
this Plan, this defense shall be available only to the extent the Sub-
Committee Participant asserting the defense demonstrates that the
action was specified in, or was within the scope of, this Plan and
within the scope of the appropriate Sub-Committee(s), including being
taken at the direction and under the active supervision of FEMA.
This defense shall not apply to any actions taken after the
termination of this Plan. Immediately upon modification of this Plan,
no defense to antitrust claims under Section 708 shall be available to
any subsequent action that is beyond the scope of the modified Plan.
The Sub-Committee Participant asserting the defense bears the burden of
proof to establish the elements of the defense. The defense shall not
be available if the person against whom the defense is asserted shows
that the action was taken for the purpose of violating the antitrust
laws.
V. Terms and Conditions
As the sponsoring agency, FEMA will maintain oversight over Sub-
Committee activities and direct and supervise actions taken to carry
out this Plan, including by retaining decision-making authority over
actions taken pursuant to the Plan to ensure such actions are necessary
to address a direct threat to the national defense. The Attorney
General and the Chairman of the FTC will monitor activities of the Sub-
Committees to ensure they execute their responsibilities in a manner
consistent with this Plan and their actions have the least
anticompetitive effects possible.
A. Plan of Action Execution
This Plan will be used to support the following objectives to
respond to a Pandemic by maximizing the manufacture and efficient
distribution of selected types of critical PPE and creating a
prioritization protocol for End-Users based upon their demonstrated or
projected requirements and taking into account geographic and regional
circumstances. Each Sub-Committee will undertake the following
Objectives for the PPE item(s) within its area of jurisdiction.
1. Objectives
(1) Optimize the timely production of sufficient quantities of PPE
to reduce loss of life and transmission of the COVID-19 virus.
(2) Ensure PPE is distributed effectively across the whole
community nationally based on risk.
(3) Balance restoration and maintenance of the nation's stockpile
of PPE with near-term requirements.
(4) Establish a process for FEMA Allocation of PPE nationwide.
(5) Ensure ongoing competition in the manufacture and distribution
of PPE to the greatest extent possible under the DPA.
2. Actions
Sub-Committee Participants may be asked to support these objectives
by taking the following specific actions:
(1) Assist the Chairperson in identifying which types of critical
PPE should be included within each Sub-Committee. Identification will
be based upon each item's importance to the national response to COVID-
19 and whether it can be reasonably inferred, based upon the best
evidence available, that that current and projected supply measured
against current and projected demand may not adequately meet the PPE
requirements to all identified End-Users or regional or geographic
areas of the country as result of measures taken to respond to COVID-
19.
(2) Provide input to the Chairperson in creating a prioritized list
of PPE End-Users by categories for each type of critical PPE identified
by each Sub-Committee, and ascertaining the relative demand and supply
of PPE among and within those End User categories. Prioritization shall
be decided by the Chairperson, based upon each item's importance,
reflecting the consensus views of the Sub-Committee Members that it
represents the most effective way to save lives and prevent the
transmission of the COVID-19 virus. This list may be updated throughout
the life of the Plan of Action based upon either short term or long-
term demands. These categories should be considered holistically in
terms of the Whole-of-Nation response to COVID-19.
(3) Evaluate the domestic supply of PPE and identify when the
expansion of the domestic manufacture of PPE may be necessary, as
directed and decided by the Chairperson.
(4) Provide information, assist, and validate, as necessary as
decided by the Chairperson, demand projections for PPE.
(5) Create a process for and collaborate in the evaluation of
competing claims for PPE from End-Users.
(6) Prepare a general strategy to accomplish the activities listed
in V(A)(2)(7) below regarding activities in Exigent Circumstances
consistent with the decisions made by the Chairperson.
(7) In Exigent Circumstances, with review and concurrence in all
possible instances by DOJ in consultation with FTC:
Facilitate maximum availability of PPE to the nation or
particular geographies by deconflicting overlapping demands from the
collective Participants' customer base, as directed and decided by the
Chairperson.
Facilitate maximum availability of PPE to the nation or
particular geographies by deconflicting overlapping supply chain
demands placed upon Members, as directed and decided by the
Chairperson.
Facilitate the efficient distribution of PPE 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
PPE 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.
(8) Provide data and information necessary to validate the efforts
of the Sub-Committee including the actual and planned amounts of PPE to
be distributed throughout the Nation, as determined by the Chairperson.
(9) Provide feedback to the Sub-Committee on the outcomes of the
collective efforts of the Sub-Committee Members and any impediments or
bottlenecks.
(10) Advise the Chairperson whether additional Participants or
Attendees should be invited to join this Plan of Action and Sub-
Committee.
(11) Carry out other activities regarding critical PPE as
identified by Sub-Committees under this Plan as determined and directed
by the Chairperson necessary to address the COVID-19 virus' direct
threat to the national defense, where such activities have been
reviewed and approved by DOJ and FTC and received concurrence from Sub-
Committee members.
B. Information Management and Responsibilities
FEMA will request only that data and information from Sub-Committee
Participants that is necessary to meet the objectives of the Plan and
consistent with the scope of the relevant Sub-
[[Page 79026]]
Committees. Upon signing a Plan of Action Agreement for this Plan, FEMA
requests that Participants endeavor to cooperate with diligence and
speed, and to the extent permissible under this Plan, and share with
FEMA data and information necessary to meet the objectives of this
Plan.
Sub-Committee Participants agree to share with FEMA the following
data with diligence and speed, to the extent permissible under this
Plan, and abide by the following guidelines, where feasible and
consistent with the data that is owned by each Sub-Committee
Participant:
(1) In general, Participants will not be asked to share
Competitively Sensitive Information directly with other Participants.
(2) FEMA will only request direct sharing of Competitively
Sensitive Information among Participants during Exigent Circumstances
where there is a mission critical need or timeline such that sharing
only through FEMA is impractical or threatens the outcome of the Plan
or Sub-Committee action. Such requests, if made, will be only among
Participants whose participation is necessary to meet the objectives of
the Plan, will be limited in scope to the greatest extent possible, and
will be shared only pursuant to safeguards subject to prior review and
audit by DOJ and FTC. Direct sharing of Competitively Sensitive
Information with other Participants will be limited in scope and
circumstances to the greatest extent possible. Participants may not
share Competitively Sensitive Information directly with other
Participants unless specifically requested by FEMA, in consultation
with DOJ and FTC. All Competitively Sensitive Information delivered to
FEMA or to another Sub-Committee Participant shall be delivered by
secure means, for example, password-protected or encrypted electronic
files or drives with the password/key delivered by separate
communication or method or via upload to an appropriately secure web
portal as directed by FEMA. All data delivered to the web portal
designated by FEMA is deemed to be Competitively Sensitive Information.
(3) To allow FEMA to identify and appropriately protect documents
containing Competitively Sensitive Information by the Sub-Committee
Participant providing the documents, the Sub-Committee Participant will
make good faith efforts to designate any Competitively Sensitive
Information by placing restrictive markings on documents and things
considered to be competitively sensitive, the restrictive markings
being sufficiently clear in wording and visibility to indicate the
restricted nature of the data. The Sub-Committee Participant will
identify Competitively Sensitive Information that is disclosed verbally
by oral warning. Information designated as competitively sensitive
will, to the extent allowed by law, be presumed to constitute trade
secrets, or commercial or financial information, and be provided by the
Sub-Committee Participant to FEMA with the expectation that it will be
kept confidential by both parties, as such terms are understood in
accordance with 5 U.S.C. 552(b)(4) of the Freedom of Information Act
and federal judicial interpretations of this statute. FEMA agrees that
to the extent any information designated as competitively sensitive by
a Sub-Committee Participant is responsive to a request for disclosure
under the Freedom of Information Act, FEMA will consult with the Sub-
Committee Participant and afford the Participant ten (10) working days
to object to any disclosure by FEMA.
(4) FEMA will make good faith efforts to appropriately recognize
unmarked Documents containing Competitively Sensitive Information as
Competitively Sensitive Information. However, FEMA cannot guarantee
that all unmarked Documents will be recognized as being Competitively
Sensitive Information and protected from disclosure to third parties.
If the unmarked Documents have not been disclosed without restriction
outside of FEMA, the Sub-Committee Participant may retroactively
request to have appropriate designations placed on the Documents. If
the unmarked Documents have been disclosed without restriction outside
of FEMA, FEMA will, to the extent practicable, remove any requested
information from public forums controlled by FEMA and will work
promptly to request that a receiving party return or destroy disclosed
unmarked Documents if requested by the Sub-Committee Participant.
(5) Competitively Sensitive Information may be used by FEMA, alone
or in combination with additional information, including Documents and
Competitively Sensitive Information received from third parties, to
support FEMA's implementation of this Plan of Action as determined by
the Chairperson. In all situations, FEMA will aggregate and anonymize
Competitively Sensitive Information to the greatest extent possible to
protect the interests retained by the owners of the data while still
allowing the objectives of the Plan of Action and Sub-Committee to be
achieved. To the greatest extent possible, such aggregation will render
the competitively sensitive nature of the Competitively Sensitive
Information of the Sub-Committee Participant no longer recognizable in
a commercially sensitive manner, and without sufficient information to
enable, by inference or otherwise, attribution to Sub-Committee
Participant or its affiliates (as clearly identified and disclosed to
FEMA). Any disclosure of Competitively Sensitive Information by FEMA,
within or outside a Sub-Committee, will be subject to review and
approval by DOJ and FTC.
(6) Except as otherwise expressly permitted by applicable federal
law, FEMA shall not disclose any Competitively Sensitive Information or
use any Competitively Sensitive Information for any purpose other than
in connection with the purposes of this Plan of Action, and FEMA will
not sell any Competitively Sensitive Information of any Sub-Committee
Participant.
(7) Except as described below, FEMA may disclose Competitively
Sensitive Information only to its employees, officers, directors,
contractors, agents, and advisors (including attorneys, accountants,
consultants, and financial advisors). Any individual with access to
Competitively Sensitive Information will be expected to comply with the
terms of this Plan of Action.
a. Information Sharing within the Sub-Committee: FEMA may share
Competitively Sensitive Information with Sub-Committee Participants and
Federal Representatives of the Plan of Action, and their respective
employees, officers, directors, contractors, agents, and advisors
(including attorneys, accountants, consultants, and financial advisors)
where there is a need to know and where disclosure is reasonably
necessary in furtherance of implementing the Plan of Action. FEMA will
aggregate and anonymize data prior to sharing with the Sub-Committee
Participants to the greatest extent possible while still allowing the
objectives of the Plan of Action to be achieved, and will not share
data--particularly to competitors of the submitter--prior to
consultation with and approval by the DOJ and FTC.
i. Sub-Committee Participants, when providing Competitively
Sensitive Information to FEMA, may request that this Information not be
shared with other Sub-Committee Participants. Where these requests are
made in good faith and are reasonable in nature, FEMA will respect
these requests to the greatest extent possible and will consult the
owner of the data prior to any release made to Sub-Committee
Participants.
[[Page 79027]]
b. Restricted Reports. FEMA may communicate Competitively Sensitive
Information to appropriate government officials through Restricted
Reports. The information contained in Restricted Reports shall be
aggregated and anonymized to the greatest extent possible, while
recognizing that these officials may need a certain amount of
granularity and specificity of information to appropriately respond to
COVID-19. FEMA will aim to aggregate data to the County level, and will
not share Restricted Reports prior to consultation and approval from
the DOJ and FTC. FEMA may disclose Restricted Reports to relevant White
House and Administration officials and State Governors, and their
respective employees, officers, directors, contractors, agents, and
advisors (including attorneys, accountants, consultants, and financial
advisors) who have a need to know and to whom such disclosure is
reasonably necessary solely in furtherance of the implementation of
this Plan of Action. FEMA shall take appropriate action (by
instructions, agreement, or otherwise) to ensure that receiving parties
comply with all data-sharing confidentiality and obligations under this
Plan of Action as if such persons or entities had been parties to this
Plan of Action.
c. Public Reports. FEMA may share information with the public
through Public Reports. Data contained in Public Reports shall be fully
aggregated and anonymized. Public Reports shall be aggregated to at
least a state level and may be publicly disclosed after consultation
and approval from the DOJ and FTC.
(8) Where possible and not obviated by Exigent Circumstances, FEMA
will notify Sub-Committee Participants prior to the release of any
Competitively Sensitive Information that has not been fully aggregated
and anonymized. In consultation with DOJ and FTC, FEMA will consider
any good-faith requests made by Sub-Committee members to hold the
release of data or requests for further aggregation or anonymization.
In general, FEMA will not provide notification prior to the release of
Public Reports, under the presumption that the data in these reports
has already been fully anonymized and de-identified.
(9) Any party receiving Competitively Sensitive Information through
this Plan shall use such information solely for the purposes outlined
in the Plan and take steps, such as imposing previously approved
firewalls or tracking usage, to prevent misuse of the information.
Disclosure and use of Competitively Sensitive Information will be
limited to the greatest extent possible, and any party receiving
Competitively Sensitive Information shall follow the procedures
outlined in paragraph 7 above.
(10) At the conclusion of a Participant's involvement in a Plan--
due to the deactivation of the Plan or due to the Participant's
withdrawal or removal--each Participant will be requested to sequester
any and all Competitively Sensitive Information received through
participation in the Plan. This sequestration shall include the
deletion of all Competitively Sensitive Information unless required to
be kept pursuant to the Record Keeping requirements as described supra,
Section I, 44 CFR part 332, or any other provision of law.
C. Oversight
Each Sub-Committee Chairperson is responsible for ensuring that the
Attorney General, or suitable delegate(s) from the DOJ, and the FTC
Chairman, or suitable delegate(s) from the FTC, have awareness of
activities under this Plan, including activation, deactivation, and
scheduling of meetings. The Attorney General, the FTC Chairman, or
their delegates may attend Sub-Committee meetings and request to be
apprised of any activities taken in accordance with activities under
this Plan. DOJ or FTC Representatives may request and review any
proposed action by the Sub-Committee or Sub-Committee Participants
undertaken pursuant to this Plan, including the provision of data. If
any DOJ or FTC Representative believes any actions proposed or taken
are not consistent with relevant antitrust protections provided by the
DPA, he or she shall provide warning and guidance to the Sub-Committee
as soon as the potential issue is identified. If questions arise about
the antitrust protections applicable to any particular action, FEMA may
request DOJ, in consultation with the FTC, provide an opinion on the
legality of the action under relevant DPA antitrust protections.
VI. Establishment of the Sub-Committees
This Plan establishes Sub-Committees to implement the Plan to
Establish a National Strategy for the Manufacture, Allocation, and
Distribution of Personal Protective Equipment (PPE) to Respond to
COVID-19 to provide the Federal Government and the Participants a forum
to maximize the manufacture and efficient distribution of selected
types of critical PPE and to create a prioritization protocol based
upon identified types of PPE End-Users and their demonstrated or
projected requirements, and demonstrated or projected geographic and
regional areas of need. The outcome should include a framework to
expeditiously meet any PPE needs in Exigent Circumstances anywhere in
the Nation, and to ensure that actions to support PPE stockpiling and
reserves do not interfere with immediate requirements that would result
in an unacceptable risk to healthcare providers or other potential PPE
recipients. A Sub-Committee Chairperson designated by the Chairperson
will convene and preside over each Sub-Committee. Sub-Committees will
not be used for contract negotiations or contract discussions between
the Participants and the Federal Government; such negotiations or
discussions will be in accordance with applicable federal contracting
policies and procedures. However, this shall not limit any discussion
within a Sub-Committee about the operational utilization of existing
and potential contracts between the Participants and Representatives
when seeking to align their use with overall manufacturing and
distribution efforts consistent with this Plan.
Each Sub-Committee will consist of designated Representatives from
FEMA, HHS, other federal agencies with equities in this Plan, and each
Sub-Committee Participant. The Attorney General and Chairman of the
FTC, or their delegates, may also join each Sub-Committee and attend
meetings at their discretion. Attendees may also be invited at the
discretion of a Sub-Committee Chairperson as subject matter experts, to
provide technical advice, or to represent other government agencies,
but will not be considered part of the Sub-Committee.
To the extent necessary to respond to the Pandemic, only at the
explicit direction of a Sub-Committee Chairperson, and subject to the
provisions of Section V(B), Sub-Committee Members may be asked to
provide technical advice, share information, help identify and validate
places and resources of the greatest need, help project future
manufacturing and distribution demands, assist in identifying and
resolving the allocation of scarce resources amongst all necessary
public and private sector domestic needs under Exigent Circumstances,
and take any other necessary actions to maximize the timely manufacture
and distribution of PPE as determined necessary by FEMA to respond to
the Pandemic. A Sub-Committee Chairperson or his or her designee, at
the Sub-Committee Chairperson's sole discretion, will make decisions on
these issues in order to ensure the maximum efficiency and
effectiveness in the use of Sub-
[[Page 79028]]
Committee Member's resources. All Sub-Committee Participants will be
invited to open Sub-Committee meetings. For selected Sub-Committee
meetings, attendance may be limited to designated Sub-Committee
Participants to meet specific operational requirements, as determined
by FEMA.
Each Sub-Committee Chairperson shall notify the Attorney General,
the Chairman of the FTC, Representatives, and Participants of the time,
place, and nature of each meeting and of the proposed agenda of each
meeting to be held to carry out this Plan of Action. Additionally, each
Sub-Committee Chairperson shall provide for publication in the Federal
Register of a notice of the time, place, and nature of each meeting. If
a meeting is open, a Federal Register notice will be published
reasonably in advance of the meeting. A Sub-Committee Chairman may
restrict attendance at meetings only on the grounds outlined by 44 CFR
332.5(c)(1)-(3). If a meeting is closed, a Federal Register notice will
be published within ten (10) days of the meeting and will include the
reasons why the meeting is closed pursuant to 44 CFR 332.3(c)(2).
The Sub-Committee Chairperson shall establish the agenda for each
meeting, be responsible for adherence to the agenda, and provide for a
written summary or other record of each meeting and provide copies of
transcripts or other records to FEMA, the Attorney General, the
Chairman of the FTC, and all Sub-Committee Participants. The
Chairperson shall take necessary actions to protect from public
disclosure any data discussed with or obtained from Sub-Committee
Participants which a Sub-Committee Participant has identified as a
trade secret or as privileged and confidential in accordance with DPA
sections 708(h)(3) and 705(d), or which qualifies for withholding under
44 CFR 332.5.
VII. Application and Agreement
The Sub-Committee Participant identified below hereby agrees to
join in the Federal Emergency Management Agency sponsored Plan of
Action to Establish a National Strategy for the Manufacture,
Allocation, and Distribution of Personal Protective Equipment (PPE)
under the Voluntary Agreement for the Manufacture and Distribution of
Healthcare Resources Necessary to Respond to a Pandemic and to become a
Participant in one or more Sub-Committees established by this Plan.
This Plan will be published in the Federal Register. This Plan is
authorized under section 708 of the Defense Production Act of 1950, as
amended. Regulations governing the Voluntary Agreement for the
Manufacture and Distribution for the Manufacture and Distribution of
Healthcare Resources Necessary to Respond to a Pandemic and all
subsequent Plans of Action appear at 44 CFR part 332. The applicant, as
a Sub-Committee Participant, agrees to comply with the provisions of
section 708 of the Defense Production Act of 1950, as amended, the
regulations at 44 CFR part 332, and the terms of this Plan.
VIII. Assignment
No Sub-Committee Participant may assign or transfer this Plan, in
whole or in part, or any protections, rights or obligations hereunder
without the prior written consent of the Sub-Committee Chairperson.
When requested, the Sub-Committee Chairperson will respond to written
requests for consent within 10 (ten) business days of receipt.
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(Name of authorized representative)
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(Signature of authorized representative)
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Sub-Committee Chairperson
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(Date)
Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-26986 Filed 12-7-20; 8:45 am]
BILLING CODE 9111-19-P