Managing American Knowledge and Equipment to Prevent Pandemic Emergencies Act or the MAKE PPE Act
This bill addresses federal planning and coordination related to production and distribution of personal protective equipment and other critical nonpharmaceutical supplies during public health emergencies. It also supports efforts to expand domestic manufacturing and production of the materials and incorporates inventory management of the materials in existing grants for community and hospital preparedness.
The bill specifically directs the Federal Emergency Management Agency (FEMA) to develop the capacity to coordinate these activities. In addition, FEMA, the Executive Office of the President, and the Department of Health and Human Services must jointly develop, in consultation with relevant federal partners, a protocol for federal procurement and distribution of equipment and supplies during emergencies. They must report to Congress on this protocol.
FEMA must also establish the Office of Pandemic Preparedness and Response to coordinate, and develop a strategy related to, the procurement and distribution of critical materials. Among other tasks, the office must set up a data repository to track the demand for these materials.
With respect to expanding domestic production, the Department of Defense and the Department of Veterans Affairs must, subject to some exceptions and waivers, purchase critical nonpharmaceutical materials that are produced domestically. Additionally, the National Institutes of Standards and Technology must award grants for U.S. manufacturers to expand domestic production capacity of critical materials and for entities to develop educational materials to aid the public in making temporary masks and other equipment.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8553 Introduced in House (IH)]
<DOC>
116th CONGRESS
2d Session
H. R. 8553
To provide for expanded capacity to respond to pandemic disaster, and
for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 9, 2020
Mr. Cartwright (for himself, Mr. Morelle, Mr. Peterson, and Mr. Pappas)
introduced the following bill; which was referred to the Committee on
Transportation and Infrastructure, and in addition to the Committees on
Energy and Commerce, Science, Space, and Technology, Armed Services,
and Veterans' Affairs, for a period to be subsequently determined by
the Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To provide for expanded capacity to respond to pandemic disaster, and
for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Managing American Knowledge and
Equipment to Prevent Pandemic Emergencies Act'' or the ``MAKE PPE
Act''.
SEC. 2. CAPACITY TO RESPOND TO PANDEMIC DISASTER.
(a) In General.--Section 102 of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act (42 U.S.C. 5122) is amended by
inserting ``any public health emergency (including any pandemic or
virus threat),'' after ``drought),''.
(b) Whole of Society Reiliency.--Section 2802(b) of the Public
Health Service Act (42 U.S.C. 300hh-1(b)) is amended--
(1) by redesignating paragraphs (7), (8), (9), and (10) as
paragraphs (8), (9), (10), and (11), respectively; and
(2) by inserting after paragraph (6) the following:
``(7) Whole of society resiliency.--Developing a capacity
for long-term response to a major pandemic or other infectious
disease outbreak, including the manufacture and distribution of
critical pharmaceutical and nonpharmaceutical supplies,
including personal protective equipment, needed to slow the
spread of a pandemic or other infectious disease while
preserving essential functions of society.''.
(c) Development of Capacity.--Title II of the Robert T. Stafford
Disaster Relief and Emergency Assistance Act (42 U.S.C. 5131 et seq.)
is amended by adding at the end the following:
``SEC. 205. CAPACITY FOR MATERIALS NEEDED.
``(a) In General.--The Administrator shall develop the capacity to
coordinate the procurement, distribution, and tracking of critical
nonpharmaceutical materials needs of the United States during a major
pandemic or other infectious disease outbreak of regional, national, or
global scale.
``(b) Collection and Dissemination of Data.--The Administrator
shall develop the capacity to coordinate the collection and
dissemination of data to track national demand for critical
nonpharmaceutical materials during a major pandemic or other infectious
disease outbreak of regional, national, or global scale.''.
SEC. 3. COORDINATING PROCUREMENT AND DISTRIBUTION DURING A PANDEMIC
EMERGENCY.
(a) In General.--The Executive Office of the President, the
Administrator of the Federal Emergency Management Agency, and the
Assistant Secretary of Health and Human Services for Preparedness and
Response shall jointly develop a protocol under which the Federal
Emergency Management Agency shall--
(1) assume responsibility for coordinating Federal
procurement of critical nonpharmaceutical supplies during a
national public health emergency based on the severity and
extent of such an emergency; and
(2) implement the companion strategy developed under
section 5.
(b) Coordination.--In developing the protocol under subsection (a),
the Executive Office of the President, the Administrator of the Federal
Emergency Management Agency, and the Assistant Secretary of Health and
Human Services for Preparedness and Response shall consult with the
Director of the Centers for Disease Control and Prevention, the
Commanding General of the Corps of Engineers, and other heads of
Federal agencies determined necessary by the Administrator of the
Federal Emergency Management Agency and the Assistant Secretary of
Health and Human Services for Preparedness and Response.
(c) Contents.--The protocol developed under subsection (a) shall--
(1) specify the categories of personal protective equipment
and related items to be coordinated by the Federal Emergency
Management Agency, in line with the strategy for critical
materials described in section 206 of the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, added by this
Act; and
(2) consider the scale and severity of an emergency in
determining when and how the Federal Emergency Management
Agency shall exercise authorities under the protocol, as well
as the process by which the Assistant Secretary of Health and
Human Services for Preparedness and Response, including the
Director of the Strategic National Stockpile, shall work in
coordination with the Federal Emergency Management Agency.
(d) Report.--Not later than 1 year after the date of enactment of
this Act, the Executive Office of the President, the Administrator of
the Federal Emergency Management Agency, and the Assistant Secretary of
Health and Human Services for Preparedness and Response shall jointly
submit to the relevant committees of jurisdiction of the House of
Representatives and the Senate, including the Committee on
Appropriations of the House of Representatives and the Senate, a report
detailing the protocol developed under subsection (a), including any
minority or dissenting views of such officers.
(e) Regulations.--Not later than 1 year after the submission of the
report under subsection (d), the Administrator of the Federal Emergency
Management Agency shall issue such regulations as are necessary to
implement the protocol developed under subsection (a).
SEC. 4. CAPACITY TO MANAGE CRITICAL SUPPLIES.
Title II of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act (42 U.S.C. 5131 et seq.) is further amended by adding at
the end the following:
``SEC. 206. OFFICE OF PANDEMIC PREPAREDNESS AND RESPONSE.
``(a) In General.--The Administrator shall establish an Office of
Pandemic Preparedness and Response within the Federal Emergency
Management Agency to coordinate the procurement, distribution, and
tracking of the critical nonpharmaceutical materials needs of the
United States, when necessary, during a public health emergency.
``(b) Associate Administrator.--The Administrator shall appoint an
Associate Administrator to run the Office of Pandemic Preparedness and
Response.
``(c) Duties.--
``(1) Office.--
``(A) In general.--The Office of Pandemic
Preparedness and Response shall--
``(i) develop and maintain a data
repository that tracks demand for critical
nonpharmaceutical materials in the event of a
national pandemic emergency, including 30-, 60-
, and 90-day demand projections;
``(ii) require the data repository
described in clause (i) to track inventory and
productive capacity to meet national critical
nonpharmaceutical material needs, including 30-
, 60-, and 90-day inventory and productive
capacity forecasts; and
``(iii) develop, publish, implement, and
maintain a stakeholder engagement plan,
including ensuring that the Federal Emergency
Management Agency shall consult with private-
sector representatives and regional and local
public health and emergency management
organizations to coordinate data collection, in
accordance with applicable privacy or other
data collection and storage regulations or
statutes.
``(B) Nonpublic information.--The data repository
developed under subparagraph (A) shall not be public.
``(C) Public information.--The Office shall make
available summary information of the data repository in
a public format.
``(D) Consultation.--In developing the data
repository and stakeholder engagement plan under
subparagraph (A), the Associate Administrator shall
consult with ASPR to avoid duplication and to encourage
coordinated data collection and use.
``(E) Report to congress.--Annually, the Associate
Administrator shall submit to Congress, and make
public, a report that includes a list of agencies or
entities in compliance and noncompliance with data
collection efforts necessary for the data repository
developed under subparagraph (A).
``(2) Associate administrator.--The Associate Administrator
of the Office of Pandemic Preparedness and Response shall
convene exercises not less than biennially with stakeholders
(including senior representatives of the Food and Drug
Administration, the Department of Homeland Security, the
Centers for Disease Control and Prevention, the Department of
Health and Human Services (except the Assistant Secretary of
Health and Human Services for Preparedness and Response), the
National Institute of Health, the Veterans Affairs
Administration, the Department of Defense, the Indian Health
Service, and the United States intelligence community)
determined by the Associate Administrator to be essential to
the pandemic response to ensure the agency's readiness to
procure, distribute, and track critical nonpharmaceutical
materials during a public health emergency.''.
SEC. 5. PLANNING TO MEET CRITICAL SUPPLY NEEDS.
(a) In General.--The Associate Administrator of the Office of
Pandemic Preparedness and Response of the Federal Emergency Management
Agency, in coordination with the Assistant Secretary of Health and
Human Services for Preparedness and Response, shall develop a companion
strategy to accompany the National Health Security Strategy under
section 2802 of the Public Health Service Act (42 U.S.C. 300hh-1) in
order to ensure the availability of critical nonpharmaceutical supplies
and the ability to distribute such supplies during a public health
emergency that triggers the protocols under section 3 of this Act.
(b) Contents.--The companion strategy under subsection (a) shall--
(1) include an assessment of critical nonpharmaceutical
materials, particularly personal protective equipment and other
ancillary medical supplies, needed during a pandemic;
(2) take into account the best available science;
(3) consider different responses to differing levels of
severity of a public health emergency, based on input from
stakeholders, as well as from external sources, including the
National Academies, academic sources, State, Tribal,
territorial, and local governments, and the private sector;
(4) evaluate the reliability and security of suppliers
necessary to ensure the production, procurement, and
distribution of critical nonpharmaceutical materials, including
considering--
(A) supplier diversity, country of origin, supply
chain stability, and cybersecurity risk to distribution
and to production facilities;
(B) priority to domestic sources of supply; and
(C) how to maximize the use of materials produced
in the United States in accordance with section 3 of
this Act; and
(5) include strategies for last mile distribution to ensure
supplies get into the possession of end users.
(c) Publication.--Not later than 1 year after the date of enactment
of this Act, the Associate Administrator shall submit to the relevant
committees of jurisdiction of the House of Representatives and the
Senate and publish publicly in unclassified and classified (if
necessary) versions.
(d) Update.--The Associate Administrator, in consultation with
stakeholders shall update the companion strategy under subsection (a)
not less often than every 5 years.
(e) Stakeholders Defined.--In this section, the term
``stakeholders'' means senior representatives of the Food and Drug
Administration, the Department of Homeland Security, the Centers for
Disease Control and Prevention, the Department of Health and Human
Services (except the Assistant Secretary of Health and Human Services
for Preparedness and Response), the National Institute of Health, the
Veterans Affairs Administration, the Department of Defense, the Indian
Health Service, and the United States intelligence community.
SEC. 6. PLANNING FOR PRODUCTION.
Section 319C-2(b)(1) of the Public Health Service Act (42 U.S.C.
247d-3b) is amended--
(1) in subparagraph (A)(iv) by striking ``; and'' and
inserting a semicolon;
(2) in subparagraph (B) by striking ``; or'' and inserting
``; and''; and
(3) by inserting after subparagraph (B) the following:
``(C) prepare a plan and be capable of coordinating
inventory management activities during a national
public health emergency with State and Federal
officials; or''.
SEC. 7. PRESERVING PRODUCTIVE CAPACITY.
(a) In General.--Section 2533a(b) of title 10, United States Code,
is amended by adding at the end the following:
``(5) Critical nonpharmaceutical materials identified under
section 206 of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act.''.
(b) Veterans Administration.--
(1) Covered purchases.--
(A) In general.--Subject to subparagraph (B), any
covered item purchased by the Secretary of the
Department of Veterans Affairs shall be from the United
States. For purposes of this subsection, ``from the
United States'' means that 100 percent of a product is
grown, reprocessed, reused, or produced in the United
States.
(B) Exceptions.--Notwithstanding subparagraph (A),
the Secretary may waive the requirements of such
subparagraph if the Secretary determines that
satisfactory quality and sufficient quantity of any
such covered item from the United States cannot be
procured as and when needed at United States market
prices. This subsection shall not apply to covered
items that are or that include materials determined to
be non-available in accordance with section 25.104 of
title 48 of the Federal Acquisition Regulation.
(2) Exception for small purchases.--Paragraph (1) shall not
apply to purchases for amounts not greater than $150,000. A
proposed purchase or contract for an amount greater than
$150,000 may not be divided into several purchases or contracts
for lesser amounts in order to qualify for this exception.
(3) Applicability.--The requirements of this subsection
shall apply with respect to a purchase of a covered item made
pursuant to paragraph (1) on or after the date of the enactment
of this Act.
(4) Definition of covered item.--In this subsection, the
term ``covered item'' means a critical nonpharmaceutical
material identified under section 206 of the Robert T. Stafford
Disaster Relief and Emergency Assistance Act.
(c) Waiver of Certain Requirements.--
(1) In general.--Notwithstanding any other provision of
law, the Assistant Secretary of Health and Human Services for
Preparedness and Response may waive the requirements of section
2533a(b)(5).
(2) Regulations.--The Assistant Secretary of Health and
Human Services for Preparedness and Response shall issue such
regulations as are necessary to implement paragraph (1).
(3) Contents.--In issuing regulations under paragraph (2),
the Assistant Secretary of Health and Human Services for
Preparedness and Response shall take into account--
(A) that American-made products shall be
prioritized in purchasing;
(B) that the prices to be paid should not be
generally within historic norms or in line with current
market prices;
(C) that when sourcing from foreign countries is
necessary, priority should be given to countries with
reliable supply chains and longstanding relationships
with the United States; and
(D) that waivers to purchase foreign-produced goods
may be authorized when American-produced goods are not
available in sufficient quantities, at reasonable
prices, and at satisfactory quality.
SEC. 8. EXPANDING PRODUCTIVE CAPACITY AND RESILIENCE.
(a) Productive Capacity Grants and Technical Assistance.--
(1) In general.--The Director of the National Institute of
Standards and Technology, in consultation with the
Manufacturing Extension Partnership, shall establish a program
to provide grants and technical assistance to qualified United
States manufacturers that can demonstrate current capacity or
future capacity to produce critical nonpharmaceutical materials
identified under section 206 of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act that are designated by the
Assistant Secretary of Health and Human Services for
Preparedness and Response as unable to be sourced in sufficient
and reasonably available commercial quantities and of a
satisfactory quality in the United States.
(2) Application.--To be eligible to receive a grant or
technical assistance under this subsection, qualified United
States manufacturers shall submit to the Director an
application at such time, in such manner, and containing such
information as the Director may require.
(3) Awareness campaigns.--In carrying out this subsection,
Manufacturing Extension Partnership programs shall conduct
awareness campaigns in economically distressed areas, including
qualified opportunity zones (as such term is defined in section
1400Z-1 of the Internal Revenue Code of 1986).
(4) Requirement.--In selecting grant recipients and
providing technical assistance under this subsection, the
Director shall provide not less than 40 percent of funds made
available to carry out this section to economically distressed
areas, including qualified opportunity zones (as such term is
defined in section 1400Z-1 of the Internal Revenue Code of
1986).
(5) Prioritization.--In selecting grant recipients and
providing technical assistance under this subsection, the
Director shall prioritize recipients based on such recipient's
ability to address shortfalls in the strategy developed under
section 5.
(6) Eligible uses.--A grant provided under this subsection
may be used for capital investments and labor.
(7) Authorization of appropriations.--There is authorized
to carry out this subsection $100,000,000 for each of fiscal
years 2021 through 2026.
(b) At-Home Equipment Grants.--
(1) In general.--The Director of the National Institute of
Standards and Technology shall establish a program to provide
grants to support the development of plans and educational
materials to assist the United States public in making
temporary masks or other equipment as determined appropriate by
the Director, at home.
(2) Application.--To be eligible to receive a grant under
this subsection, an entity shall submit an application to the
Director at such time, in such manner, and containing such
information as the Director may require.
(3) Authorization of appropriations.--There is authorized
to carry out this subsection $25,000,000 for each of fiscal
years 2021 through 2026.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Transportation and Infrastructure, and in addition to the Committees on Energy and Commerce, Science, Space, and Technology, Armed Services, and Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Transportation and Infrastructure, and in addition to the Committees on Energy and Commerce, Science, Space, and Technology, Armed Services, and Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Transportation and Infrastructure, and in addition to the Committees on Energy and Commerce, Science, Space, and Technology, Armed Services, and Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Transportation and Infrastructure, and in addition to the Committees on Energy and Commerce, Science, Space, and Technology, Armed Services, and Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Transportation and Infrastructure, and in addition to the Committees on Energy and Commerce, Science, Space, and Technology, Armed Services, and Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
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Referred to the Subcommittee on Economic Development, Public Buildings, and Emergency Management.