Title: Managing American Knowledge and Equipment to Prevent Pandemic Emergencies Act
Policy area: Health

Summary:
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>