Managing American Knowledge and Equipment to Prevent Pandemic Emergencies Act

I 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 Com- mittee on Transportation and Infrastructure, and in addition to the Com- mittees 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 provi- sions 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Managing American 4 Knowledge and Equipment to Prevent Pandemic Emer- 5 gencies Act’’ or the ‘‘MAKE PPE Act’’. 6 VerDate Sep 11 2014 04:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H8553.IH H8553 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 8553 IH SEC. 2. CAPACITY TO RESPOND TO PANDEMIC DISASTER. 1 (a) IN GENERAL.—Section 102 of the Robert T. 2 Stafford Disaster Relief and Emergency Assistance Act 3 (42 U.S.C. 5122) is amended by inserting ‘‘any public 4 health emergency (including any pandemic or virus 5 threat),’’ after ‘‘drought),’’. 6 (b) WHOLE OF SOCIETY REILIENCY.—Section 7 2802(b) of the Public Health Service Act (42 U.S.C. 8 300hh–1(b)) is amended— 9 (1) by redesignating paragraphs (7), (8), (9), 10 and (10) as paragraphs (8), (9), (10), and (11), re- 11 spectively; and 12 (2) by inserting after paragraph (6) the fol- 13 lowing: 14 ‘‘(7) WHOLE OF SOCIETY RESILIENCY.—Devel- 15 oping a capacity for long-term response to a major 16 pandemic or other infectious disease outbreak, in- 17 cluding the manufacture and distribution of critical 18 pharmaceutical and nonpharmaceutical supplies, in- 19 cluding personal protective equipment, needed to 20 slow the spread of a pandemic or other infectious 21 disease while preserving essential functions of soci- 22 ety.’’. 23 (c) DEVELOPMENT OF CAPACITY.—Title II of the 24 Robert T. Stafford Disaster Relief and Emergency Assist- 25 VerDate Sep 11 2014 04:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8553.IH H8553 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 8553 IH ance Act (42 U.S.C. 5131 et seq.) is amended by adding 1 at the end the following: 2 ‘‘SEC. 205. CAPACITY FOR MATERIALS NEEDED. 3 ‘‘(a) IN GENERAL.—The Administrator shall develop 4 the capacity to coordinate the procurement, distribution, 5 and tracking of critical nonpharmaceutical materials needs 6 of the United States during a major pandemic or other 7 infectious disease outbreak of regional, national, or global 8 scale. 9 ‘‘(b) COLLECTION AND DISSEMINATION OF DATA.— 10 The Administrator shall develop the capacity to coordinate 11 the collection and dissemination of data to track national 12 demand for critical nonpharmaceutical materials during a 13 major pandemic or other infectious disease outbreak of re- 14 gional, national, or global scale.’’. 15 SEC. 3. COORDINATING PROCUREMENT AND DISTRIBU- 16 TION DURING A PANDEMIC EMERGENCY. 17 (a) IN GENERAL.—The Executive Office of the Presi- 18 dent, the Administrator of the Federal Emergency Man- 19 agement Agency, and the Assistant Secretary of Health 20 and Human Services for Preparedness and Response shall 21 jointly develop a protocol under which the Federal Emer- 22 gency Management Agency shall— 23 (1) assume responsibility for coordinating Fed- 24 eral procurement of critical nonpharmaceutical sup- 25 VerDate Sep 11 2014 04:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8553.IH H8553 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 8553 IH plies during a national public health emergency 1 based on the severity and extent of such an emer- 2 gency; and 3 (2) implement the companion strategy devel- 4 oped under section 5. 5 (b) COORDINATION.—In developing the protocol 6 under subsection (a), the Executive Office of the Presi- 7 dent, the Administrator of the Federal Emergency Man- 8 agement Agency, and the Assistant Secretary of Health 9 and Human Services for Preparedness and Response shall 10 consult with the Director of the Centers for Disease Con- 11 trol and Prevention, the Commanding General of the 12 Corps of Engineers, and other heads of Federal agencies 13 determined necessary by the Administrator of the Federal 14 Emergency Management Agency and the Assistant Sec- 15 retary of Health and Human Services for Preparedness 16 and Response. 17 (c) CONTENTS.—The protocol developed under sub- 18 section (a) shall— 19 (1) specify the categories of personal protective 20 equipment and related items to be coordinated by 21 the Federal Emergency Management Agency, in line 22 with the strategy for critical materials described in 23 section 206 of the Robert T. Stafford Disaster Relief 24 VerDate Sep 11 2014 04:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H8553.IH H8553 pbinns on DSKJLVW7X2PROD with BILLS 5 •HR 8553 IH and Emergency Assistance Act, added by this Act; 1 and 2 (2) consider the scale and severity of an emer- 3 gency in determining when and how the Federal 4 Emergency Management Agency shall exercise au- 5 thorities under the protocol, as well as the process 6 by which the Assistant Secretary of Health and 7 Human Services for Preparedness and Response, in- 8 cluding the Director of the Strategic National Stock- 9 pile, shall work in coordination with the Federal 10 Emergency Management Agency. 11 (d) REPORT.—Not later than 1 year after the date 12 of enactment of this Act, the Executive Office of the Presi- 13 dent, the Administrator of the Federal Emergency Man- 14 agement Agency, and the Assistant Secretary of Health 15 and Human Services for Preparedness and Response shall 16 jointly submit to the relevant committees of jurisdiction 17 of the House of Representatives and the Senate, including 18 the Committee on Appropriations of the House of Rep- 19 resentatives and the Senate, a report detailing the protocol 20 developed under subsection (a), including any minority or 21 dissenting views of such officers. 22 (e) REGULATIONS.—Not later than 1 year after the 23 submission of the report under subsection (d), the Admin- 24 istrator of the Federal Emergency Management Agency 25 VerDate Sep 11 2014 04:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H8553.IH H8553 pbinns on DSKJLVW7X2PROD with BILLS 6 •HR 8553 IH shall issue such regulations as are necessary to implement 1 the protocol developed under subsection (a). 2 SEC. 4. CAPACITY TO MANAGE CRITICAL SUPPLIES. 3 Title II of the Robert T. Stafford Disaster Relief and 4 Emergency Assistance Act (42 U.S.C. 5131 et seq.) is fur- 5 ther amended by adding at the end the following: 6 ‘‘SEC. 206. OFFICE OF PANDEMIC PREPAREDNESS AND RE- 7 SPONSE. 8 ‘‘(a) IN GENERAL.—The Administrator shall estab- 9 lish an Office of Pandemic Preparedness and Response 10 within the Federal Emergency Management Agency to co- 11 ordinate the procurement, distribution, and tracking of 12 the critical nonpharmaceutical materials needs of the 13 United States, when necessary, during a public health 14 emergency. 15 ‘‘(b) ASSOCIATE ADMINISTRATOR.—The Adminis- 16 trator shall appoint an Associate Administrator to run the 17 Office of Pandemic Preparedness and Response. 18 ‘‘(c) DUTIES.— 19 ‘‘(1) OFFICE.— 20 ‘‘(A) IN GENERAL.—The Office of Pan- 21 demic Preparedness and Response shall— 22 ‘‘(i) develop and maintain a data re- 23 pository that tracks demand for critical 24 nonpharmaceutical materials in the event 25 VerDate Sep 11 2014 04:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H8553.IH H8553 pbinns on DSKJLVW7X2PROD with BILLS 7 •HR 8553 IH of a national pandemic emergency, includ- 1 ing 30-, 60-, and 90-day demand projec- 2 tions; 3 ‘‘(ii) require the data repository de- 4 scribed in clause (i) to track inventory and 5 productive capacity to meet national crit- 6 ical nonpharmaceutical material needs, in- 7 cluding 30-, 60-, and 90-day inventory and 8 productive capacity forecasts; and 9 ‘‘(iii) develop, publish, implement, and 10 maintain a stakeholder engagement plan, 11 including ensuring that the Federal Emer- 12 gency Management Agency shall consult 13 with private-sector representatives and re- 14 gional and local public health and emer- 15 gency management organizations to coordi- 16 nate data collection, in accordance with ap- 17 plicable privacy or other data collection 18 and storage regulations or statutes. 19 ‘‘(B) NONPUBLIC INFORMATION.—The 20 data repository developed under subparagraph 21 (A) shall not be public. 22 ‘‘(C) PUBLIC INFORMATION.—The Office 23 shall make available summary information of 24 the data repository in a public format. 25 VerDate Sep 11 2014 04:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H8553.IH H8553 pbinns on DSKJLVW7X2PROD with BILLS 8 •HR 8553 IH ‘‘(D) CONSULTATION.—In developing the 1 data repository and stakeholder engagement 2 plan under subparagraph (A), the Associate Ad- 3 ministrator shall consult with ASPR to avoid 4 duplication and to encourage coordinated data 5 collection and use. 6 ‘‘(E) REPORT TO CONGRESS.—Annually, 7 the Associate Administrator shall submit to 8 Congress, and make public, a report that in- 9 cludes a list of agencies or entities in compli- 10 ance and noncompliance with data collection ef- 11 forts necessary for the data repository devel- 12 oped under subparagraph (A). 13 ‘‘(2) ASSOCIATE ADMINISTRATOR.—The Asso- 14 ciate Administrator of the Office of Pandemic Pre- 15 paredness and Response shall convene exercises not 16 less than biennially with stakeholders (including sen- 17 ior representatives of the Food and Drug Adminis- 18 tration, the Department of Homeland Security, the 19 Centers for Disease Control and Prevention, the De- 20 partment of Health and Human Services (except the 21 Assistant Secretary of Health and Human Services 22 for Preparedness and Response), the National Insti- 23 tute of Health, the Veterans Affairs Administration, 24 the Department of Defense, the Indian Health Serv- 25 VerDate Sep 11 2014 04:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H8553.IH H8553 pbinns on DSKJLVW7X2PROD with BILLS 9 •HR 8553 IH ice, and the United States intelligence community) 1 determined by the Associate Administrator to be es- 2 sential to the pandemic response to ensure the agen- 3 cy’s readiness to procure, distribute, and track crit- 4 ical nonpharmaceutical materials during a public 5 health emergency.’’. 6 SEC. 5. PLANNING TO MEET CRITICAL SUPPLY NEEDS. 7 (a) IN GENERAL.—The Associate Administrator of 8 the Office of Pandemic Preparedness and Response of the 9 Federal Emergency Management Agency, in coordination 10 with the Assistant Secretary of Health and Human Serv- 11 ices for Preparedness and Response, shall develop a com- 12 panion strategy to accompany the National Health Secu- 13 rity Strategy under section 2802 of the Public Health 14 Service Act (42 U.S.C. 300hh–1) in order to ensure the 15 availability of critical nonpharmaceutical supplies and the 16 ability to distribute such supplies during a public health 17 emergency that triggers the protocols under section 3 of 18 this Act. 19 (b) CONTENTS.—The companion strategy under sub- 20 section (a) shall— 21 (1) include an assessment of critical non- 22 pharmaceutical materials, particularly personal pro- 23 tective equipment and other ancillary medical sup- 24 plies, needed during a pandemic; 25 VerDate Sep 11 2014 04:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H8553.IH H8553 pbinns on DSKJLVW7X2PROD with BILLS 10 •HR 8553 IH (2) take into account the best available science; 1 (3) consider different responses to differing lev- 2 els of severity of a public health emergency, based 3 on input from stakeholders, as well as from external 4 sources, including the National Academies, academic 5 sources, State, Tribal, territorial, and local govern- 6 ments, and the private sector; 7 (4) evaluate the reliability and security of sup- 8 pliers necessary to ensure the production, procure- 9 ment, and distribution of critical nonpharmaceutical 10 materials, including considering— 11 (A) supplier diversity, country of origin, 12 supply chain stability, and cybersecurity risk to 13 distribution and to production facilities; 14 (B) priority to domestic sources of supply; 15 and 16 (C) how to maximize the use of materials 17 produced in the United States in accordance 18 with section 3 of this Act; and 19 (5) include strategies for last mile distribution 20 to ensure supplies get into the possession of end 21 users. 22 (c) PUBLICATION.—Not later than 1 year after the 23 date of enactment of this Act, the Associate Administrator 24 shall submit to the relevant committees of jurisdiction of 25 VerDate Sep 11 2014 04:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H8553.IH H8553 pbinns on DSKJLVW7X2PROD with BILLS 11 •HR 8553 IH the House of Representatives and the Senate and publish 1 publicly in unclassified and classified (if necessary) 2 versions. 3 (d) UPDATE.—The Associate Administrator, in con- 4 sultation with stakeholders shall update the companion 5 strategy under subsection (a) not less often than every 5 6 years. 7 (e) STAKEHOLDERS DEFINED.—In this section, the 8 term ‘‘stakeholders’’ means senior representatives of the 9 Food and Drug Administration, the Department of Home- 10 land Security, the Centers for Disease Control and Pre- 11 vention, the Department of Health and Human Services 12 (except the Assistant Secretary of Health and Human 13 Services for Preparedness and Response), the National In- 14 stitute of Health, the Veterans Affairs Administration, the 15 Department of Defense, the Indian Health Service, and 16 the United States intelligence community. 17 SEC. 6. PLANNING FOR PRODUCTION. 18 Section 319C–2(b)(1) of the Public Health Service 19 Act (42 U.S.C. 247d–3b) is amended— 20 (1) in subparagraph (A)(iv) by striking ‘‘; and’’ 21 and inserting a semicolon; 22 (2) in subparagraph (B) by striking ‘‘; or’’ and 23 inserting ‘‘; and’’; and 24 VerDate Sep 11 2014 04:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H8553.IH H8553 pbinns on DSKJLVW7X2PROD with BILLS 12 •HR 8553 IH (3) by inserting after subparagraph (B) the fol- 1 lowing: 2 ‘‘(C) prepare a plan and [Text truncated for display. Full text available on Congress.gov.]