Protecting American Heroes Act of 2020

II 116TH CONGRESS 2D SESSION S. 4368 To prepare the Strategic National Stockpile for a public health emergency and require the maintenance of a domestic supply chain for counter- measures in the stockpile, and for other purposes. IN THE SENATE OF THE UNITED STATES JULY 29, 2020 Mr. BROWN introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To prepare the Strategic National Stockpile for a public health emergency and require the maintenance of a do- mestic supply chain for countermeasures in the stockpile, 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 ‘‘Protecting American 4 Heroes Act of 2020’’. 5 VerDate Sep 11 2014 20:07 Aug 13, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4368.IS S4368 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 4368 IS SEC. 2. STRATEGIC NATIONAL STOCKPILE. 1 (a) ADDITIONAL PROVISIONS TO PREPARE THE 2 STRATEGIC NATIONAL STOCKPILE FOR PUBLIC HEALTH 3 EMERGENCIES.— 4 (1) IN GENERAL.—Section 319F–2 of the Pub- 5 lic Health Service Act (42 U.S.C. 247d–6b) is 6 amended— 7 (A) by redesignating subsection (h) as sub- 8 section (i); and 9 (B) by inserting after subsection (g) the 10 following: 11 ‘‘(h) ADDITIONAL PROVISIONS TO PREPARE THE 12 STRATEGIC NATIONAL STOCKPILE FOR PUBLIC HEALTH 13 EMERGENCIES.— 14 ‘‘(1) PREPARING FOR EMERGENCIES AFFECT- 15 ING ALL STATES.— 16 ‘‘(A) IN GENERAL.—The Public Health 17 Emergency Medical Countermeasures Enter- 18 prise established under section 2811–1 shall de- 19 velop a model to enable the stockpile under sub- 20 section (a)(1) to be prepared to effectively re- 21 spond to a public health emergency, including 22 one that simultaneously affects all States. 23 ‘‘(B) MODEL.—The model under subpara- 24 graph (A) shall include— 25 VerDate Sep 11 2014 20:07 Aug 13, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4368.IS S4368 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 4368 IS ‘‘(i)(I) requirements with respect to 1 the number, types, and amounts of coun- 2 termeasures that are necessary to prepare 3 the stockpile under subsection (a)(1) to re- 4 spond to a public health emergency de- 5 scribed in subparagraph (A); and 6 ‘‘(II) the cost necessary to meet such 7 requirements; 8 ‘‘(ii) an assessment of the domestic 9 supply chain for all countermeasures that 10 are needed for the stockpile to be prepared 11 for a public health emergency described in 12 subparagraph (A), including— 13 ‘‘(I) an identification of any 14 known domestic suppliers of such 15 countermeasures; 16 ‘‘(II) an identification of any 17 gaps in the domestic supply chain for 18 such countermeasures; 19 ‘‘(III) steps needed to address 20 the gaps in the domestic supply chain 21 for such countermeasures; 22 ‘‘(IV) an identification of any 23 countermeasure in the stockpile that 24 VerDate Sep 11 2014 20:07 Aug 13, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4368.IS S4368 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 4368 IS only has one source, domestic or for- 1 eign, for procurement; and 2 ‘‘(V) steps needed to diversify 3 sources for any countermeasure in the 4 stockpile that has only one source, do- 5 mestic or foreign, for procurement. 6 ‘‘(C) SUBMISSION TO CONGRESS.—Not 7 later than 120 days after the date of enactment 8 of the Protecting American Heroes Act of 2020, 9 the Public Health Emergency Medical Counter- 10 measures Enterprise established under section 11 2811–1 shall submit the assessment required 12 under subparagraph (B)(ii) to each Committee 13 described in subsection (a)(2)(A). 14 ‘‘(2) REQUIREMENT TO IDENTIFY AND MAIN- 15 TAIN DOMESTIC SUPPLY CHAIN.— 16 ‘‘(A) IN GENERAL.—The Executive Deputy 17 Assistant Secretary of the Strategic National 18 Stockpile appointed under paragraph (3) (re- 19 ferred to in this paragraph as the ‘Executive 20 Deputy Assistant Secretary’) shall, in accord- 21 ance with this paragraph, identify and maintain 22 a domestic source (which may be multiple 23 sources) for all countermeasures in the stockpile 24 under subsection (a)(1). 25 VerDate Sep 11 2014 20:07 Aug 13, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4368.IS S4368 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 4368 IS ‘‘(B) REQUIREMENT FOR ITEMS IN STOCK- 1 PILE.— 2 ‘‘(i) IN GENERAL.—Except as pro- 3 vided under clause (ii), the Executive Dep- 4 uty Assistant Secretary shall require all 5 countermeasures in the stockpile under 6 subsection (a)(1), and any component part 7 of such countermeasures, to be grown, re- 8 processed, reused, or produced in the 9 United States. 10 ‘‘(ii) WAIVERS.—The Executive Dep- 11 uty Assistant Secretary may, on a case-by- 12 case basis, waive the requirement under 13 clause (i) in the case of a contract for a 14 countermeasure in the stockpile under sub- 15 section (a)(1)— 16 ‘‘(I) for which the Executive 17 Deputy Assistant Secretary deter- 18 mines that a satisfactory quality and 19 sufficient quantity of such counter- 20 measure that is grown, reprocessed, 21 reused, or produced in the United 22 States cannot be procured as and 23 when needed at United States market 24 prices; or 25 VerDate Sep 11 2014 20:07 Aug 13, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4368.IS S4368 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 4368 IS ‘‘(II) that is, or includes, any 1 material determined to be a nonavail- 2 able article under section 25.104 of 3 the Federal Acquisition Regulation for 4 purposes of subpart I of part 25 of 5 the Federal Acquisition Regulation. 6 ‘‘(iii) NOTIFICATION OF WAIVERS.—In 7 the case of any contract for the procure- 8 ment of a countermeasure in the stockpile 9 under subsection (a)(1), if the Executive 10 Deputy Assistant Secretary applies a waiv- 11 er under clause (ii) with respect to that 12 contract, the Executive Deputy Assistant 13 Secretary shall, not later than 7 days after 14 the award of the contract, submit to each 15 Committee described in subsection 16 (a)(2)(A) a notification that the waiver has 17 been applied. 18 ‘‘(C) NOTICE OF DISCONTINUANCE OR 19 INTERRUPTION IN DOMESTIC SUPPLY CHAIN.— 20 ‘‘(i) TIMING.—The Executive Deputy 21 Assistant Secretary shall require any man- 22 ufacturer of a countermeasure in the 23 stockpile under subsection (a)(1) (other 24 than a countermeasure to which a waiver 25 VerDate Sep 11 2014 20:07 Aug 13, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S4368.IS S4368 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 4368 IS has been applied under subparagraph 1 (B)(ii)) to provide notice to the Executive 2 Deputy Assistant Secretary of any dis- 3 continuance or interruption in the manu- 4 facture of such countermeasure. Such no- 5 tice shall be submitted to the Executive 6 Deputy Assistant Secretary— 7 ‘‘(I) at least 6 months prior to 8 the date of the discontinuance or 9 interruption; or 10 ‘‘(II) if compliance with sub- 11 clause (I) is not possible, as soon as 12 practicable. 13 ‘‘(ii) CONTENTS.—The notice required 14 under clause (i) shall include disclosure 15 of— 16 ‘‘(I) reasons for the discontinu- 17 ation or interruption of the counter- 18 measure; 19 ‘‘(II) if applicable, and without 20 disclosing proprietary information, if 21 an active pharmaceutical ingredient is 22 a reason for, or risk factor in, such 23 discontinuation or interruption, the 24 source of the active pharmaceutical 25 VerDate Sep 11 2014 20:07 Aug 13, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S4368.IS S4368 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 4368 IS ingredient, and any alternative 1 sources for the active pharmaceutical 2 ingredient known by the manufac- 3 turer; 4 ‘‘(III) if applicable, whether any 5 associated device used for preparation 6 or administration included in the 7 countermeasure is a reason for, or a 8 risk factor in, such discontinuation or 9 interruption; 10 ‘‘(IV) if applicable, the expected 11 duration of the interruption; and 12 ‘‘(V) any such other information 13 as the Executive Deputy Assistant 14 Secretary may require. 15 ‘‘(3) EXECUTIVE DEPUTY ASSISTANT SEC- 16 RETARY OF THE STRATEGIC NATIONAL STOCK- 17 PILE.— 18 ‘‘(A) IN GENERAL.—The Assistant Sec- 19 retary for Preparedness and Response shall ap- 20 point an Executive Deputy Assistant Secretary 21 of the Strategic National Stockpile (referred to 22 in this paragraph as the ‘Executive Deputy As- 23 sistant Secretary’), who shall report directly to 24 the Assistant Secretary for Preparedness and 25 VerDate Sep 11 2014 20:07 Aug 13, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4368.IS S4368 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 4368 IS Response and serve in a career reserved posi- 1 tion, as defined in section 3132(a) of title 5, 2 United States Code. 3 ‘‘(B) QUALIFICATIONS.—Any individual 4 appointed as the Executive Deputy Assistant 5 Secretary under subparagraph (A) shall be se- 6 lected from individuals who, on the day before 7 the date of enactment of the Protecting Amer- 8 ican Heroes Act of 2020— 9 ‘‘(i) are career appointees, as defined 10 in section 3132(a) of title 5, United States 11 Code; or 12 ‘‘(ii) are former such career ap- 13 pointees and are eligible for reinstatement 14 as such career appointees. 15 ‘‘(C) FUNCTIONS.—The Executive Deputy 16 Assistant Secretary appointed under subpara- 17 graph (A) shall— 18 ‘‘(i) notwithstanding the functions of 19 the Assistant Secretary for Preparedness 20 and Response under section 2811–1, have 21 authority to make decisions with respect to 22 the stockpile under subsection (a)(1); 23 ‘‘(ii) establish and maintain a domes- 24 tic supply chain for countermeasures in 25 VerDate Sep 11 2014 20:07 Aug 13, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S4368.IS S4368 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 4368 IS such stockpile to the greatest extent pos- 1 sible; 2 ‘‘(iii) consult with States and relevant 3 stakeholders, including public health orga- 4 nizations, about the procurement and dis- 5 tribution of countermeasures in the stock- 6 pile; and 7 ‘‘(iv) carry out all other duties of any 8 individual serving as the Director of the 9 Strategic National Stockpile prior to the 10 date of enactment of the Protecting Amer- 11 ican Heroes Act of 2020. 12 ‘‘(D) QUARTERLY REPORT.—Not later 13 than 180 days after the date of enactment of 14 the Protecting American Heroes Act of 2020, 15 and each calendar quarter thereafter, the Exec- 16 utive Deputy Assistant Secretary shall submit 17 to the Assistant Secretary for Preparedness and 18 Response and each Committee described in sub- 19 section (a)(2)(A) a report that includes— 20 ‘‘(i) the number, types, and amounts 21 of countermeasures in the stockpile under 22 subsection (a)(1); 23 ‘‘(ii) whether such number, types, and 24 amounts are sufficient to meet a public 25 VerDate Sep 11 2014 20:07 Aug 13, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S4368.IS S4368 pamtmann on DSKBC07HB2PROD with BILLS 11 •S 4368 IS health emergency that simultaneously af- 1 fects all States; 2 ‘‘(iii) whether any countermeasures in 3 the stockpile have expired or failed to re- 4 ceive necessary maintenance in a timely 5 fashion; 6 ‘‘(iv) the status of the domestic supply 7 chain with respect to countermeasures in 8 such stockpile, including— 9 ‘‘(I) whether there are gaps in 10 the supply chain, including the domes- 11 tic supply chain, for such counter- 12 measures; and 13 ‘‘(II) any instance in which the 14 Executive Deputy Assistant Secretary 15 applies a waiver under paragraph 16 (2)(B)(ii) to a countermeasure; 17 ‘‘(v) recommended steps necessary to 18 address any gap described in clause (iv)(I); 19 and 20 ‘‘(vi)(I) whether any countermeasures 21 in such stockpile are obtained from a sole 22 source; and 23 VerDate Sep 11 2014 20:07 Aug 13, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S4368.IS S4368 pamtmann on DSKBC07HB2PROD with BILLS 12 •S 4368 IS ‘‘(II) whether any steps should be 1 taken to diversify sourcing of such counter- 2 measures. 3 ‘‘(E) FIRST APPOINTMENT.—With respect 4 to the first individual to serve as the Executive 5 Deputy Assistant Secretary after the date of 6 enactment of the Protecting American Heroes 7 Act of 2020, the Assistant Secretary for Pre- 8 paredness and Response shall appoint such in- 9 dividual under subparagraph (A) not later than 10 90 days after such date of enactment. 11 ‘‘(4) DEFINITION OF COUNTERMEASURE.—In 12 this subsection, the term ‘countermeasure’ includes a 13 drug, vaccine or other biological product, medical de- 14 vice, or other supplies (including personal protective 15 equipment, ancillary medical supplies, and other ap- 16 plicable supplies required for the administration of 17 drugs, vaccines and other biological products, med- 18 ical devices, and diagnostic tests in the stockpile) de- 19 scribed in subsection (a)(1).’’. 20 (2) APPROPRIATIONS.—Section 319F–2(f) of 21 the Public Health Service Act (42 U.S.C. 247d– 22 6b(f)) is amended— 23 (A) in the subsection heading, by striking 24 ‘‘AUTHORIZATION OF APPROPRIATIONS’’ and 25 VerDate Sep 11 2014 20:07 Aug 13, 2020 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S4368.IS S4368 pamtmann on DSKBC07HB2PROD with BILLS 13 •S 4368 IS inserting ‘‘APPROPRIATIONS; AUTHORIZATION 1 OF APPROPRIATIONS’’; and 2 (B) by amending paragraph (1) to read as 3 follows: 4 ‘‘(1) STRATEGIC NATIONAL STOCKPILE.—There 5 are appropriated, out of any money in the Treasury 6 not otherwise appropriated, such sums as necessary, 7 to remain available until expended, to carry out sub- 8 sections (a) and (h). Such amounts are in addition 9 to any amounts in the special reserve fund under 10 subsection (g).’’. 11 (3) CONFORMING AMENDMENTS.— 12 (A) Section 319F–2 of the Public Health 13 Service Act (42 U.S.C. 247d–6b) is amended— 14 (i) in subsection (c), by striking ‘‘as 15 defined in subsection (h)’’ each place it ap- 16 pears; and 17 (ii) in subsection (f), by striking as 18 ‘‘referred to in subsection (h)’’. 19 (B) Section 2811(d)(2)(G) of the Public 20 Health Service Act (42 U.S.C. 300hh– 21 10(d)(2)(G)) is amended by striking ‘‘as de- 22 fined in section 319F–2(h)’’ and inserting ‘‘as 23 defined in section 319F–2(i)’’. 24 VerDate Sep 11 2014 20:07 Aug 13, 2020 Jkt 099200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S4368.IS S4368 pamtmann on DSKBC07HB2PROD with BILLS 14 •S 4368 IS (b) DOMESTIC SUPPLY CHAIN EVALUATIONS IN 1 THREAT ASSESSMENT AND GAO REPORT; FUNCTIONS OF 2 SECRETARY.—Section 319F [Text truncated for display. Full text available on Congress.gov.]