[Federal Register Volume 85, Number 159 (Monday, August 17, 2020)]
[Notices]
[Pages 50035-50040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18005]
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DEPARTMENT OF HOMELAND SECURITY
Federal Emergency Management Agency
[Docket ID FEMA-2020-0016]
Voluntary Agreement Under Section 708 of the Defense Production
Act; Manufacture and Distribution of Critical Healthcare Resources
Necessary To Respond to a Pandemic
AGENCY: Federal Emergency Management Agency, Homeland Security (DHS).
ACTION: Notice.
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SUMMARY: The Federal Emergency Management Agency (FEMA) announces the
formation of a voluntary agreement under Section 708 of the Defense
Production Act for the Manufacture and Distribution of Critical
Healthcare Resources Necessary to Respond to a Pandemic. This Notice
contains the text of the Voluntary Agreement.
FOR FURTHER INFORMATION CONTACT: Harold Lucie, Joint DPA Office,
Federal Emergency Management Agency, 500 C Street SW, Washington, DC
20472-3184, telephone (202) 212-2900, and email FEMA-DPA@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 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 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 Defense Production Act,
the Department of Justice is separately publishing this finding in this
issue of the Federal Register as a notice. The FEMA Administrator, as
the Sponsor of the agreement, has certified in writing that the
agreement is necessary to help provide for the national defense.
Text of the Voluntary Agreement, 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. Committee 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 Committee
VII. Application and Agreement
VIII. Assignment
Voluntary Agreement, 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
Chairman of the Federal Trade Commission (FTC), has developed this
Voluntary Agreement (Agreement). This Agreement is intended to maximize
the effectiveness of the manufacture and distribution of Critical
Healthcare Resources nationwide to respond to a pandemic by
establishing unity of effort between the Participants and the Federal
Government for integrated coordination, planning, information sharing
with FEMA, and allocation and distribution of Critical Healthcare
Resources. The activities contemplated by this Agreement are limited to
those necessary to respond to a Pandemic, at the sole determination of
FEMA. This Agreement affords Participants defenses
[[Page 50036]]
to civil and criminal actions brought for violations of antitrust laws
when carrying out this Agreement and an appropriate Plan of Action.
This Agreement is intended to foster a close working relationship among
FEMA, HHS, and the Participants to address national defense needs
through cooperative action under the direction and supervision of FEMA.
This Agreement, when implemented through a Plan of Action, affords
Participants a safe harbor to exchange information, collaborate and
adjust commercial operations as to particular products and services,
when FEMA determines it necessary for the national defense, and only to
the extent necessary for the national defense.
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 personal protective equipment (PPE), Pharmaceuticals and other
Critical Healthcare Resources is necessary for the national defense.
This Agreement will maximize the effectiveness of the manufacture and
distribution of Critical Healthcare Resources nationwide to respond to
a pandemic by establishing unity of effort between the Participants and
the Federal Government for integrated coordination, planning,
information sharing with FEMA, allocation and distribution of Critical
Healthcare Resources. The activities included in this Agreement are
limited to those necessary to respond to a Pandemic, at the sole
determination, direction, and supervision of FEMA and implemented
through Plans of Action.
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
(Mar. 27, 2020); Prioritization and Allocation of Certain Scarce or
Threatened Health and Medical Resources for Domestic Use, 85 FR 20195
(Apr. 10, 2020). Pursuant to DPA section 708(f)(1)(A), the
Administrator certifies that this Agreement is necessary for the
national defense.
III. General Provisions
A. Definitions
Administrator
The FEMA Administrator who, as a Presidentially appointed and
Senate confirmed official, is the Sponsor of this 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 this Agreement. 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 any Sub-
Committee formed to carry out this Agreement.
Agreement
The Voluntary Agreement. Participants who have been invited to join
and agreed to the terms of this Agreement as described in Section VII
below may join the ``Committee for the Distribution of Healthcare
Resources Necessary to Respond to a Pandemic.''
Attendees
Subject matter experts, invited by the Chairperson to attend
meetings authorized under this Agreement, to provide technical advice
or to represent other Government agencies or interested parties.
Attendees are not Members of the Committee.
Chairperson
FEMA senior executive, appointed by the Administrator, to chair the
``Committee for the Distribution of Healthcare Resources Necessary to
Respond to a Pandemic.'' The Chairperson shall be responsible for the
overall management and administration of the Committee, this Agreement,
and Plans of Action developed under this Agreement while remaining
under the supervision of the Administrator; may create one or more Sub-
Committees, as approved by 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
this Agreement; and otherwise shall carry out all duties and
responsibilities assigned to him. The Administrator may appoint one or
more co-Chairpersons to chair the Committee and Sub-Committees, as
appropriate.
Committee
Committee for the Distribution of Healthcare Resources Necessary to
Respond to a Pandemic established under this Agreement. Provides
Committee Members a forum to maximize the effectiveness of the
manufacture and distribution of Critical Healthcare Resources
nationwide to respond to a Pandemic through integrated coordination,
planning, and identification and development of Plans of Action needed
to respond to a pandemic, including making recommendations on the
creation of a Plan of Action.
Critical Healthcare Resources
All categories of health and medical resources for which production
and distribution capacity is necessary to respond to a pandemic,
including, but not limited to, PPE, Pharmaceuticals, respiratory
devices, vaccines, raw materials, supplies, and medical devices.
Documents
Any information, on paper or in electronic format, including
written, recorded, and graphic materials of every kind, in the
possession, custody, or control of the Participant.
Members
Collectively the Chairperson, Representatives, and Participants of
the Committee. Jointly responsible for developing all decisions
necessary to carry out this Agreement and to develop and execute Plans
of Action under this Agreement.
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 this
Agreement, that has been specifically invited to participate in this
Agreement by the Chairperson, and that has applied and agreed to the
[[Page 50037]]
terms of this Agreement in Section VII below. ``Participant'' includes
a corporate or non-corporate entity entering into this 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 this
Agreement at any time during its effective period.
Personal Protective Equipment
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.
Pharmaceuticals
All drugs defined under the Food, Drug, and Cosmetic Act, 21 U.S.C.
321(g), including biological products defined under the Public Health
Service Act, 42 U.S.C. 262(i).
Plan of Action
A documented method, pursuant to 50 U.S.C. 4558(b)(2), proposed by
FEMA and adopted by invited Participants, to implement this 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. Completing the Plan of
Action Agreement confers responsibilities on the Participant consistent
with those articulated in the Plan of Action and affords Participants
antitrust protections for actions taken consistent with that Plan of
Action as described in Section IV below.
Point of Care
All categories of medical service providers necessary to respond to
a pandemic, as determined by the Chairperson after consultation with
the Members of the Committee. This may include, but is not limited to,
Acute Care, First Responders, Nursing Homes, Private Hospitals, Public
Hospitals, Veterans Administration Hospitals, Physician Offices, Dental
Offices, Ambulatory Clinics, Pharmacies, Community Health Clinics,
Laboratories, and other acute and non-acute care facilities responsible
for healthcare.
Representatives
The representatives the Administrator identifies and invites to the
Committee from FEMA, HHS, and other Federal agencies with equities in
this Agreement, 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.
B. Committee Participation
The Committee established under this Agreement will consist of the
(1) Chairperson, (2) Representatives from FEMA, HHS, DOJ, and other
Federal agencies with equities in this Agreement, and (3) Participants
that have substantive capabilities, resources or expertise to carry out
the purpose of this Agreement. Other Attendees--invited by the
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 Committee meetings. Collectively, the
Chairperson, Representatives and Participants will serve as the Members
of the Committee. Public notice will be provided as each Participant
joins or withdraws from this Agreement. The list of Participants will
be published annually in the Federal Register.
C. Effective Date and Duration of Participation
This Agreement is effective immediately upon the signature of the
Participant or their authorized designees. This Agreement shall remain
in effect until terminated in accordance with 44 CFR 332.4, or in any
case, it shall be effective no more than five (5) years from the date
the requirements of DPA section 708(f)(1) are satisfied as to the
initial Voluntary Agreement regarding the manufacture and distribution
of critical healthcare resources necessary to respond to a Pandemic,
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 Agreement until it is activated, as described
in Section III(E.), below.
D. Withdrawal
Participants may withdraw from this Agreement at any point, subject
to the fulfillment of obligations incurred under this Agreement prior
to the date this agreement is terminated with regard to such
Participant, by giving written notice to the Administrator at least
fifteen (15) calendar days prior to the effective date of that
Participant's withdrawal. Following receipt of such notice, the
Administrator will inform the other Participants of the date of the
withdrawal.
Upon the effective date of the withdrawal, the Participant must
cease all activities under this Agreement.
E. Plan of Action Activation and Deactivation
Upon occurrence of a Pandemic, the Administrator may authorize a
Plan of Action and Sub-Committee for one or more specific Pandemic
response workstreams, functional areas, or Critical Healthcare Resource
national defense needs, e.g., a pharmaceuticals plan of action, or a
PPE distribution plan of action, or a vaccine plan of action. The
Administrator will invite a select group of Participants who are
representative of the segment of the industry for which the Plan of
Action is intended to participate on the Sub-Committee. The Plan of
Action will be activated for each invited Participant when the
Participant executes a Plan of Action Agreement. Actions taken by
Participants to develop a Plan of Action and actions taken after
executing a Plan of Action Agreement to collectively coordinate, plan
and collaborate, pursuant to that Plan of Action and as directed and
supervised by FEMA, will constitute action taken to develop and carry
out this Agreement pursuant to 50 U.S.C. 4558(j).
Sub-Committees will meet only for the purposes specified in this
Agreement and as provided for in writing by the Chairperson. They will
report directly to the Committee regarding all actions taken by them,
and any Plan of Action adopted by a Sub-Committee must be approved
first by the Chairperson. A Plan of Action may not become effective
unless and until the Attorney General (after consultation with the
Chairman of the Federal Trade Commission) finds, in writing, that such
purpose(s) of the Plan of Action may not reasonably be achieved through
a Plan of Action having less anticompetitive effects or without any
Plan of Action and publishes such finding in the Federal Register. The
Chairperson may appoint a Sub-Committee Chairperson to preside over
each Sub-Committee as
[[Page 50038]]
a delegate of the Chairperson; however, the Chairperson retains
responsibility for all Sub-Committees and for administerial and record
keeping requirements of any meetings held by such Sub-Committees,
including providing public notice as required of any meetings.
When recommended by the Sub-Committee Chairperson, the
Administrator will provide notice of a Plan of Action Deactivation. Any
actions taken by Participants after the Deactivation date are outside
the scope of Plan of Action Agreement and the Section IV antitrust
defense is not available.
F. Rules and Regulations
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
Agreement or a Plan of Action at any time, and may remove Participants
from this Agreement or a Plan of Action at any time. Participants may
propose modifications or amendments to this Agreement at any time. The
Administrator shall inform Participants of modifications or amendments
to this Agreement as they are issued. If a Participant indicates an
intent to withdraw from the Agreement due to a modification or
amendment of the Agreement, the Participant will not be required to
perform actions directed by that modification or amendment.
The Attorney General, after consultation with the Chairman of the
FTC and the Administrator, may terminate or modify, in writing, this
Agreement or a Plan of Action at any time, and may remove Participants
from this Agreement or a Plan of Action at any time. If the Attorney
General decides to use this authority, the Attorney General will notify
the Chairperson as soon as possible, who will in turn notify
Participants.
H. Expenses
Participation in this Agreement does not confer funds to
Participants, nor does it limit or prohibit any pre-existing source of
funds. Unless otherwise specified, all expenses, administrative or
otherwise, incurred by Participants associated with participation in
this Agreement shall be borne exclusively by the Participants.
I. Record Keeping
The 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 Agreement. Each
Participant shall maintain for 5 years all minutes of meetings,
transcripts, records, documents, and other data, including any
communications with other Participants or with any other member of the
Committee, including drafts, related to the carrying out of this
Agreement or any Plan of Action or incorporating data or information
received in the course of carrying out this Agreement or any Plan of
Action. Each 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 Participant in
this Agreement 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 Agreement or a Plan of Action, that such action was
taken by the Participant in the course of developing or carrying out
this Agreement or a Plan of Action, that the Participant complied with
the provisions of DPA section 708 and the rules promulgated thereunder,
and that the Participant acted in accordance with the terms of this
Agreement and any relevant Plan of Action. Except in the case of
actions taken to develop this Agreement or a Plan of Action, this
defense shall be available only to the extent the Participant asserting
the defense demonstrates that the action was specified in, or was
within the scope of, this Agreement or a Plan of Action.
This defense shall not apply to any action occurring after the
termination of this Agreement or a Plan of Action. Immediately upon
modification of this Agreement or a Plan of Action, no antitrust
immunity shall apply to any subsequent action that is beyond the scope
of the modified Agreement or Plan of Action. The 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
Each Participant agrees to voluntarily collaborate with all
Committee Members to recommend Plans of Action and Sub-Committees that
will, at the direction of and under the supervision of FEMA, maximize
the effectiveness of the manufacture and distribution of Critical
Healthcare Resources nationwide to respond to a pandemic by
establishing unity of effort between the Participants and the Federal
Government for integrated coordination, planning, information sharing
with FEMA, and allocation and distribution of Critical Healthcare
Resources. These efforts aim to promote efficiency and timeliness to
mitigate shortages of Critical Healthcare Resources to respond to a
Pandemic and to meet the overall demands of the healthcare and other
selected critical infrastructure sectors, along with those demands
necessary to continue all-level-of-government mission-essential
functions.
As the sponsoring agency, FEMA will maintain oversight over
Committee and Sub-Committee activities and direct and supervise actions
taken to carry out this Agreement and subsequent Plans of Action,
including by retaining decision-making authority over actions taken
pursuant to this Agreement and subsequent Plans of Action to ensure
such actions are necessary to address a direct threat to the national
defense. The Department of Justice (DOJ) and the Chairman of the FTC
will monitor activities of the Committee and Sub-Committees to ensure
they execute their responsibilities in a manner consistent with this
Agreement having the least anticompetitive effects possible.
A. Plan of Action Execution
Specific Member obligations and actions to be undertaken will only
be provided for in individual Plans of Action, not in the Agreement.
Activities taken to develop a Plan of Action or to implement a Plan of
Action that has been activated pursuant to section III.E. above will
provide Participants the antitrust defense described in section
[[Page 50039]]
IV. Each Plan of Action will endeavor to clearly identify the conduct
that Participants will undertake in carrying out the Plan of Action and
that would be subject to the defense described in Section IV.
Each Plan of Action will describe what information Members will
share, as directed by FEMA and under FEMA's supervision. Information
will be used to create a common operating picture in furtherance of the
Plan of Action's purpose and/or to promote overall situational
awareness of Critical Healthcare Resource manufacturing and
distribution activities.
Each Plan of Action, and information gathered pursuant to that
plan, will be used to support one or more of the following objectives:
(1) Facilitate maximum availability of Critical Healthcare
Resources to end-users by deconflicting overlapping requirements for
the collective Participant customer base;
(2) Facilitate maximum availability of Critical Healthcare
Resources to Members by deconflicting overlapping supply chain demands
of Members;
(3) Facilitate efficient distribution of Critical Healthcare
Resources by deconflicting overlapping distribution chain activities of
Members;
(4) Inform where expansion of the manufacture of Critical
Healthcare resources is necessary;
(5) Identify and prioritize Critical Healthcare Resource
requirements;
(6) Validate Critical Healthcare Resource requirements;
(7) Project future demand for Critical Healthcare Resource
requirements.
(8) Execute a collaborative manufacturing strategy to more
efficiently make use of limited resources for key manufacturing lines
of effort for Critical Healthcare Resources;
(9) Collaborate in the voluntary Participant allocation of Critical
Healthcare Resources nationwide;
(10) Cooperate to the fullest extent possible to distribute
Critical Healthcare Resources to locations most in need, as identified
by FEMA;
(11) Explore strategies for increased manufacturing of Critical
Health Resources in or near the United States;
(12) Carry out any other activities as determined and directed by
FEMA necessary to address the Pandemic's direct threat to the national
defense.
B. Information Management and Responsibilities
FEMA will request only that data and information from Participants
that is necessary to meet the objectives of a Plan of Action. Upon
signing a Plan of Action Agreement, participants should endeavor to
cooperate to the greatest extent possible to share data and information
necessary to meet the objectives of the Plan of Action.
The specific data requested, procedures for sharing that data, and
data management and disposition will be tailored for each specific Plan
of Action. Where feasible and to the greatest extent possible, FEMA
will incorporate the following principles regarding data sharing into
each Plan of Action:
In general, Participants will not be asked to share
competitively sensitive information directly with other Participants.
Direct sharing of information among Participants will be requested only
when necessary and will be closely supervised by FEMA, including
requiring appropriate safeguards regarding participant use and
dissemination of other participants' data.
If FEMA needs to share information with parties outside
the Sub-Committee, FEMA will limit the amount and type of information
shared to the greatest extent feasible and permitted by law, while
still furthering the objectives of the Plan of Action.
Prior to distribution within or outside the Sub-Committee,
FEMA will aggregate and anonymize data in such a way that will maximize
the effectiveness of the Plan of Action without compromising
competitively sensitive information.
Pursuant to 5 U.S.C. 552(b)(4) and 44 CFR 332.5, FEMA will
withhold from disclosure under the Freedom of Information Act
Participant trade secrets and commercial or financial information and
will restrict Sub-Committee meeting attendance where necessary to
protect trade secrets and commercial or financial information.
Any party receiving competitively sensitive information
through a Plan of Action shall use such information solely for the
purposes outlined in the Plan of Action and take steps, such as
imposing firewalls or tracking usage, to ensure such information is not
used for any other purpose. Disclosure and use of competitively
sensitive information will be limited to the greatest extent possible.
At the conclusion of a Participant's involvement in a Plan
of Action--due to the deactivation of the Plan of Action 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 of Action. This sequestration will
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
The Chairperson is responsible for ensuring the Attorney General,
or suitable delegate(s) from DOJ, and the FTC Chairman, or suitable
delegate(s) from the FTC, have awareness of activities under this
Agreement, including Plan of Action activation, deactivation, and
scheduling of meetings. The Attorney General, the FTC Chairman, or
their delegates may attend Committee and Sub-Committee meetings and
request to be apprised of any activities taken in accordance with
activities under this Agreement or a Plan of Action. DOJ or FTC
Representatives may request and review any proposed action by the
Committee, Sub-Committee or Participants undertaken pursuant to this
Agreement or Plan of Action, 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 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 Committee
There is established a Committee for the Manufacture and
Distribution of Healthcare Resources Necessary to Respond to a Pandemic
(Committee) to provide the Federal Government and the Participants a
forum to maximize the effectiveness of the manufacture and distribution
of Critical Healthcare Resources nationwide to respond to a Pandemic
through integrated coordination, planning, and information sharing with
FEMA. A Chairperson designated by the FEMA Administrator will convene
and preside over the Committee. The Committee will not be used for
widespread or collective exchange of information among members. These
activities, if required, shall be done within individual Sub-
Committees, and in accordance with an established Plan of Action. The
Committee 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
[[Page 50040]]
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 Agreement and a Plan of
Action.
The Committee will consist of designated Representatives from FEMA,
HHS, other Federal agencies with equities in this Agreement, and each
Participant. The Attorney General and Chairman of the FTC, or their
delegates, may also join the Committee and attend meetings at their
discretion. Attendees may also be invited at the discretion of the
Chairperson as subject matter experts, to provide technical advice, or
to represent other Government agencies, but will not be considered part
of the Committee.
To the extent necessary to respond to the Pandemic and at the
explicit direction of the Chairperson, the Committee Members will
provide technical advice to each other as needed, share information
collectively, identify and validate places and resources of the
greatest need, project future manufacturing and distribution demands,
collectively identify and resolve the allocation of scarce resources
amongst all necessary public and private sector domestic needs, and as
necessary, share vendor, manufacturer and distribution information, and
take any other necessary actions to maximize the timely manufacture and
distribution of Critical Healthcare Resources as determined necessary
by FEMA to respond to the Pandemic. The Chairperson or his or her
designee, at the Chairperson's sole discretion, will make decisions on
these issues in order to ensure the maximum coordination, efficiency,
and effectiveness in the use of Member's resources and will create and
execute Plans of Action as needed. All Participants will be invited to
open Committee meetings. For selected Committee meetings, attendance
may be limited to designated Participants to meet specific operational
requirements.
The 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 Agreement. Additionally, the
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. The 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 10 days of
the meeting and will include the reasons why the meeting is closed
pursuant to 44 CFR 332.3(c)(2).
The 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 Participants. The Chair shall take
necessary actions to protect from public disclosure any data discussed
with or obtained from Participants which a 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.
The Administrator, in his or her sole discretion and after
consultation with the Committee Members, will create Plans of Action
and Sub-Committees for specific workstreams or functional areas
requiring collective coordination, planning, and collaboration. These
Sub-Committees shall be subject to the same rules, regulations and
requirements of the Committee and any other rules or requirements
deemed necessary by the Chairperson, the Administrator, or the Attorney
General, after consultation with the Chairman of the FTC.
VII. Application and Agreement
The Participant identified below hereby agrees to join in the
Federal Emergency Management Agency sponsored Voluntary Agreement
entitled Committee for the Manufacture and Distribution of Healthcare
Resources Necessary to Respond to a Pandemic (Agreement) and to become
a Participant in this Committee. This Agreement will be published in
the Federal Register. This Agreement is authorized under section 708 of
the Defense Production Act of 1950, as amended. Regulations governing
this Agreement appear at 44 CFR part 332. The applicant, as
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 Agreement.
VIII. Assignment
No Participant may assign or transfer this Agreement, in whole or
in part, or any protections, rights or obligations hereunder without
the prior written consent of the Chairperson. When requested, the
Chairperson will respond to written requests for consent within 10
business days of receipt.
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(Company name)
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(Name of authorized representative)
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(Signature of authorized representative)
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(Date)
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Administrator (Sponsor)
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(Date)
Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-18005 Filed 8-14-20; 8:45 am]
BILLING CODE 9111-19-P