BON20363 08M 116TH CONGRESS 2D SESSION S.L.C. S. ll To prepare the Strategic National Stockpile for a public health emergency and require the maintenance of a domestic supply chain for countermeasures in the stockpile, and for other purposes. IN THE SENATE OF THE UNITED STATES Mr. BROWN llllllllll introduced the following bill; which was read twice and referred to the Committee on llllllllll A BILL To prepare the Strategic National Stockpile for a public health emergency and require the maintenance of a domestic supply chain for countermeasures in the stockpile, and for other purposes. 1 Be it enacted by the Senate and House of Representa- 2 tives of the United States of America in Congress assembled, 3 4 SECTION 1. SHORT TITLE. This Act may be cited as the ‘‘Protecting American 5 Heroes Act of 2020’’. BON20363 08M S.L.C. 2 1 SEC. 2. STRATEGIC NATIONAL STOCKPILE. 2 (a) ADDITIONAL PROVISIONS 3 STRATEGIC NATIONAL STOCKPILE PREPARE TO FOR THE PUBLIC HEALTH 4 EMERGENCIES.— 5 (1) IN GENERAL.—Section 319F–2 of the Pub- 6 lic Health Service Act (42 U.S.C. 247d–6b) is 7 amended— 8 9 10 11 12 (A) by redesignating subsection (h) as subsection (i); and (B) by inserting after subsection (g) the following: ‘‘(h) ADDITIONAL PROVISIONS 13 STRATEGIC NATIONAL STOCKPILE TO FOR PREPARE THE PUBLIC HEALTH 14 EMERGENCIES.— 15 16 17 ‘‘(1) PREPARING FOR EMERGENCIES AFFECT- ING ALL STATES.— ‘‘(A) IN GENERAL.—The Public Health 18 Emergency Medical Countermeasures Enter- 19 prise established under section 2811–1 shall de- 20 velop a model to enable the stockpile under sub- 21 section (a)(1) to be prepared to effectively re- 22 spond to a public health emergency, including 23 one that simultaneously affects all States. 24 25 ‘‘(B) MODEL.—The model under subparagraph (A) shall include— BON20363 08M S.L.C. 3 1 ‘‘(i)(I) requirements with respect to 2 the number, types, and amounts of coun- 3 termeasures that are necessary to prepare 4 the stockpile under subsection (a)(1) to re- 5 spond to a public health emergency de- 6 scribed in subparagraph (A); and 7 8 ‘‘(II) the cost necessary to meet such requirements; 9 ‘‘(ii) an assessment of the domestic 10 supply chain for all countermeasures that 11 are needed for the stockpile to be prepared 12 for a public health emergency described in 13 subparagraph (A), including— 14 ‘‘(I) an identification of any 15 known domestic suppliers of such 16 countermeasures; 17 ‘‘(II) an identification of any 18 gaps in the domestic supply chain for 19 such countermeasures; 20 ‘‘(III) steps needed to address 21 the gaps in the domestic supply chain 22 for such countermeasures; 23 ‘‘(IV) an identification of any 24 countermeasure in the stockpile that BON20363 08M S.L.C. 4 1 only has one source, domestic or for- 2 eign, for procurement; and 3 ‘‘(V) steps needed to diversify 4 sources for any countermeasure in the 5 stockpile that has only one source, do- 6 mestic or foreign, for procurement. 7 ‘‘(C) SUBMISSION TO CONGRESS.—Not 8 later than 120 days after the date of enactment 9 of the Protecting American Heroes Act of 2020, 10 the Public Health Emergency Medical Counter- 11 measures Enterprise established under section 12 2811–1 shall submit the assessment required 13 under subparagraph (B)(ii) to each Committee 14 described in subsection (a)(2)(A). 15 ‘‘(2) REQUIREMENT 16 17 TO IDENTIFY AND MAIN- TAIN DOMESTIC SUPPLY CHAIN.— ‘‘(A) IN GENERAL.—The Executive Deputy 18 Assistant Secretary of the Strategic National 19 Stockpile appointed under paragraph (3) (re- 20 ferred to in this paragraph as the ‘Executive 21 Deputy Assistant Secretary’) shall, in accord- 22 ance with this paragraph, identify and maintain 23 a domestic source (which may be multiple 24 sources) for all countermeasures in the stockpile 25 under subsection (a)(1). BON20363 08M S.L.C. 5 1 2 3 ‘‘(B) REQUIREMENT FOR ITEMS IN STOCK- PILE.— ‘‘(i) IN GENERAL.—Except as pro- 4 vided under clause (ii), the Executive Dep- 5 uty Assistant Secretary shall require all 6 countermeasures in the stockpile under 7 subsection (a)(1), and any component part 8 of such countermeasures, to be grown, re- 9 processed, reused, or produced in the 10 United States. 11 ‘‘(ii) WAIVERS.—The Executive Dep- 12 uty Assistant Secretary may, on a case-by- 13 case basis, waive the requirement under 14 clause (i) in the case of a contract for a 15 countermeasure in the stockpile under sub- 16 section (a)(1)— 17 ‘‘(I) for which the Executive 18 Deputy Assistant Secretary deter- 19 mines that a satisfactory quality and 20 sufficient quantity of such counter- 21 measure that is grown, reprocessed, 22 reused, or produced in the United 23 States cannot be procured as and 24 when needed at United States market 25 prices; or BON20363 08M S.L.C. 6 1 ‘‘(II) that is, or includes, any 2 material determined to be a nonavail- 3 able article under section 25.104 of 4 the Federal Acquisition Regulation for 5 purposes of subpart I of part 25 of 6 the Federal Acquisition Regulation. 7 ‘‘(iii) NOTIFICATION OF WAIVERS.—In 8 the case of any contract for the procure- 9 ment of a countermeasure in the stockpile 10 under subsection (a)(1), if the Executive 11 Deputy Assistant Secretary applies a waiv- 12 er under clause (ii) with respect to that 13 contract, the Executive Deputy Assistant 14 Secretary shall, not later than 7 days after 15 the award of the contract, submit to each 16 Committee 17 (a)(2)(A) a notification that the waiver has 18 been applied. 19 ‘‘(C) NOTICE described OF in subsection DISCONTINUANCE OR 20 INTERRUPTION IN DOMESTIC SUPPLY CHAIN.— 21 ‘‘(i) TIMING.—The Executive Deputy 22 Assistant Secretary shall require any man- 23 ufacturer of a countermeasure in the 24 stockpile under subsection (a)(1) (other 25 than a countermeasure to which a waiver BON20363 08M S.L.C. 7 1 has been applied under subparagraph 2 (B)(ii)) to provide notice to the Executive 3 Deputy Assistant Secretary of any dis- 4 continuance or interruption in the manu- 5 facture of such countermeasure. Such no- 6 tice shall be submitted to the Executive 7 Deputy Assistant Secretary— 8 ‘‘(I) at least 6 months prior to 9 the date of the discontinuance or 10 interruption; or 11 ‘‘(II) if compliance with sub- 12 clause (I) is not possible, as soon as 13 practicable. 14 ‘‘(ii) CONTENTS.—The notice required 15 under clause (i) shall include disclosure 16 of— 17 ‘‘(I) reasons for the discontinu- 18 ation or interruption of the counter- 19 measure; 20 ‘‘(II) if applicable, and without 21 disclosing proprietary information, if 22 an active pharmaceutical ingredient is 23 a reason for, or risk factor in, such 24 discontinuation or interruption, the 25 source of the active pharmaceutical BON20363 08M S.L.C. 8 1 ingredient, 2 sources for the active pharmaceutical 3 ingredient known by the manufac- 4 turer; and any alternative 5 ‘‘(III) if applicable, whether any 6 associated device used for preparation 7 or administration included in the 8 countermeasure is a reason for, or a 9 risk factor in, such discontinuation or 10 interruption; 11 ‘‘(IV) if applicable, the expected 12 duration of the interruption; and 13 ‘‘(V) any such other information 14 as the Executive Deputy Assistant 15 Secretary may require. 16 ‘‘(3) EXECUTIVE 17 RETARY 18 PILE.— 19 OF THE ‘‘(A) IN DEPUTY STRATEGIC ASSISTANT NATIONAL GENERAL.—The SEC- STOCK- Assistant Sec- 20 retary for Preparedness and Response shall ap- 21 point an Executive Deputy Assistant Secretary 22 of the Strategic National Stockpile (referred to 23 in this paragraph as the ‘Executive Deputy As- 24 sistant Secretary’), who shall report directly to 25 the Assistant Secretary for Preparedness and BON20363 08M S.L.C. 9 1 Response and serve in a career reserved posi- 2 tion, as defined in section 3132(a) of title 5, 3 United States Code. 4 ‘‘(B) QUALIFICATIONS.—Any individual 5 appointed as the Executive Deputy Assistant 6 Secretary under subparagraph (A) shall be se- 7 lected from individuals who, on the day before 8 the date of enactment of the Protecting Amer- 9 ican Heroes Act of 2020— 10 ‘‘(i) are career appointees, as defined 11 in section 3132(a) of title 5, United States 12 Code; or 13 ‘‘(ii) are former such career ap- 14 pointees and are eligible for reinstatement 15 as such career appointees. 16 ‘‘(C) FUNCTIONS.—The Executive Deputy 17 Assistant Secretary appointed under subpara- 18 graph (A) shall— 19 ‘‘(i) notwithstanding the functions of 20 the Assistant Secretary for Preparedness 21 and Response under section 2811–1, have 22 authority to make decisions with respect to 23 the stockpile under subsection (a)(1); 24 ‘‘(ii) establish and maintain a domes- 25 tic supply chain for countermeasures in BON20363 08M S.L.C. 10 1 such stockpile to the greatest extent pos- 2 sible; 3 ‘‘(iii) consult with States and relevant 4 stakeholders, including public health orga- 5 nizations, about the procurement and dis- 6 tribution of countermeasures in the stock- 7 pile; and 8 ‘‘(iv) carry out all other duties of any 9 individual serving as the Director of the 10 Strategic National Stockpile prior to the 11 date of enactment of the Protecting Amer- 12 ican Heroes Act of 2020. 13 ‘‘(D) QUARTERLY REPORT.—Not later 14 than 180 days after the date of enactment of 15 the Protecting American Heroes Act of 2020, 16 and each calendar quarter thereafter, the Exec- 17 utive Deputy Assistant Secretary shall submit 18 to the Assistant Secretary for Preparedness and 19 Response and each Committee described in sub- 20 section (a)(2)(A) a report that includes— 21 ‘‘(i) the number, types, and amounts 22 of countermeasures in the stockpile under 23 subsection (a)(1); 24 ‘‘(ii) whether such number, types, and 25 amounts are sufficient to meet a public BON20363 08M S.L.C. 11 1 health emergency that simultaneously af- 2 fects all States; 3 ‘‘(iii) whether any countermeasures in 4 the stockpile have expired or failed to re- 5 ceive necessary maintenance in a timely 6 fashion; 7 ‘‘(iv) the status of the domestic supply 8 chain with respect to countermeasures in 9 such stockpile, including— 10 ‘‘(I) whether there are gaps in 11 the supply chain, including the domes- 12 tic supply chain, for such counter- 13 measures; and 14 ‘‘(II) any instance in which the 15 Executive Deputy Assistant Secretary 16 applies a waiver under paragraph 17 (2)(B)(ii) to a countermeasure; 18 ‘‘(v) recommended steps necessary to 19 address any gap described in clause (iv)(I); 20 and 21 ‘‘(vi)(I) whether any countermeasures 22 in such stockpile are obtained from a sole 23 source; and BON20363 08M S.L.C. 12 1 ‘‘(II) whether any steps should be 2 taken to diversify sourcing of such counter- 3 measures. 4 ‘‘(E) FIRST APPOINTMENT.—With respect 5 to the first individual to serve as the Executive 6 Deputy Assistant Secretary after the date of 7 enactment of the Protecting American Heroes 8 Act of 2020, the Assistant Secretary for Pre- 9 paredness and Response shall appoint such in- 10 dividual under subparagraph (A) not later than 11 90 days after such date of enactment 12 ‘‘(4) DEFINITION OF COUNTERMEASURE.—In 13 this subsection, the term ‘countermeasure’ includes a 14 drug, vaccine or other biological product, medical de- 15 vice, or other supplies (including personal protective 16 equipment, ancillary medical supplies, and other ap- 17 plicable supplies required for the administration of 18 drugs, vaccines and other biological products, med- 19 ical devices, and diagnostic tests in the stockpile) de- 20 scribed in subsection (a)(1).’’. 21 (2) APPROPRIATIONS.—Section 319F–2(f) of 22 the Public Health Service Act (42 U.S.C. 247d– 23 6b(f)) is amended— 24 25 (A) in the subsection heading, by striking ‘‘AUTHORIZATION OF APPROPRIATIONS’’ and BON20363 08M S.L.C. 13 1 inserting ‘‘APPROPRIATIONS; AUTHORIZATION 2 OF 3 APPROPRIATIONS’’; and (B) by amending paragraph (1) to read as 4 follows: 5 ‘‘(1) STRATEGIC NATIONAL STOCKPILE.—There 6 are appropriated, out of any money in the Treasury 7 not otherwise appropriated, such sums as necessary, 8 to remain available until expended, to carry out sub- 9 sections (a) and (h). Such amounts are in addition 10 to any amounts in the special reserve fund under 11 subsection (g).’’. 12 (3) CONFORMING AMENDMENTS.— 13 (A) Section 319F–2 of the Public Health 14 Service Act (42 U.S.C. 247d–6b) is amended— 15 (i) in subsection (c), by striking ‘‘as 16 defined in subsection (h)’’ each place it ap- 17 pears; and 18 (ii) in subsection (f), by striking as 19 ‘‘referred to in subsection (h)’’. 20 (B) Section 2811(d)(2)(G) of the Public 21 Health 22 10(d)(2)(G)) is amended by striking ‘‘as de- 23 fined in section 319F–2(h)’’ and inserting ‘‘as 24 defined in section 319F–2(i)’’. Service Act (42 U.S.C. 300hh– BON20363 08M S.L.C. 14 1 (b) DOMESTIC SUPPLY CHAIN EVALUATIONS IN 2 THREAT ASSESSMENT AND GAO REPORT; FUNCTIONS OF 3 SECRETARY.—Section 319F–2(a) of the Public Health 4 Service Act (42 U.S.C. 247d–6b(a)) is amended— 5 (1) in paragraph (2)— 6 (A) in subparagraph (A), by inserting ‘‘, 7 including the domestic supply chain for such 8 contents,’’ after ‘‘within the stockpile’’; and 9 (B) in subparagraph (B)(i)(II), by insert- 10 ing ‘‘, including domestic manufacturing capac- 11 ity,’’ after ‘‘appropriate manufacturing capac- 12 ity’’; 13 (2) in paragraph (3)— 14 (A) by redesignating subparagraphs (E) 15 through (J) as subparagraphs (F) through (K), 16 respectively; 17 18 (B) by inserting after subparagraph (D) the following: 19 ‘‘(E) acting through the Executive Deputy 20 Assistant Secretary of the Strategic National 21 Stockpile appointed under subsection (h)(3), in 22 accordance with subsection (h)(2), establish, 23 maintain, and (when necessary) expand a sup- 24 ply chain based in the United States for coun- BON20363 08M S.L.C. 15 1 termeasures (as defined in subsection (h)(4)) in 2 the stockpile;’’; and 3 (C) in subparagraph (F), as so redesig- 4 nated, by inserting ‘‘to ensure a robust supply 5 chain for the production in the United States of 6 countermeasures (as defined in subsection 7 (h)(4)),’’ before ‘‘in consultation with’’; and 8 (3) in paragraph (5)(A)— 9 (A) by redesignating clauses (iii) through 10 (ix) as clauses (iv) through (x), respectively; 11 and 12 13 (B) by inserting after clause (ii) the following: 14 ‘‘(iii) an assessment of the plans de- 15 veloped by the Executive Deputy Assistant 16 Secretary of the Strategic National Stock- 17 pile appointed under subsection (h)(3) to, 18 in accordance with subsection (h)(2), es- 19 tablish, maintain, and (when necessary) ex- 20 pand a supply chain based in the United 21 States for countermeasures (as defined in 22 subsection (h)(4)) procured for the stock- 23 pile;’’. BON20363 08M S.L.C. 16 1 (c) ENHANCING THREAT-BASED REVIEWS.—Section 2 319F–2(a) of the Public Health Service Act (42 U.S.C. 3 247d–6b(a)) is amended— 4 (1) in paragraph (1), by striking ‘‘based on the 5 review conducted under paragraph (2)’’ and insert- 6 ing ‘‘based on any review conducted under para- 7 graph (2)’’; and 8 9 10 11 12 (2) in paragraph (2), by adding at the end the following: ‘‘(C) IN-PERSON OR VIRTUAL BRIEF- INGS.— ‘‘(i) IN GENERAL.—Not later than 30 13 days after submitting each annual threat- 14 based review under subparagraph (A) to 15 the Committees described in such subpara- 16 graph, the Executive Deputy Assistant 17 Secretary of the Strategic National Stock- 18 pile, appointed under subsection (h)(3), 19 shall provide an in-person, or virtual, brief- 20 ing on such review to the members of such 21 Committees. 22 23 24 25 ‘‘(ii) PUBLIC HEALTH EMER- GENCIES.— ‘‘(I) MONTHLY REVIEWS.—Dur- ing the period of any public health BON20363 08M S.L.C. 17 1 emergency, the Executive Deputy As- 2 sistant Secretary of the Strategic Na- 3 tional Stockpile, appointed under sub- 4 section (h)(3), shall, on a monthly 5 basis, provide an in-person, or virtual, 6 briefing to all members of Congress 7 on— 8 ‘‘(aa) the countermeasures 9 (as defined in subsection (h)4)) 10 in the stockpile under paragraph 11 (1); 12 ‘‘(bb) the status of the sup- 13 ply chain, including the domestic 14 supply chain, for such counter- 15 measures; 16 ‘‘(cc) how such counter- 17 measures are being distributed; 18 and 19 ‘‘(dd) communication with 20 State and local governments on 21 their needs with respect to ac- 22 quiring such countermeasures in 23 the stockpile and on the status of 24 countermeasures that are avail- 25 able in the stockpile. BON20363 08M S.L.C. 18 1 ‘‘(II) BASELINE REVIEW.—Not 2 later than 15 days after the date of 3 enactment of the Protecting American 4 Heroes Act of 2020, the Secretary 5 shall conduct a baseline review of the 6 stockpile under paragraph (1) and 7 provide an in-person, or virtual, brief- 8 ing to all members of Congress on 9 each issue described in items (aa) 10 11 through (dd) of subclause (I). ‘‘(D) SUPPLEMENTAL REVIEWS.—In the 12 event that the Executive Deputy Assistant Sec- 13 retary of the Strategic National Stockpile, ap- 14 pointed under subsection (h)(3), determines 15 there is a significant depletion of any counter- 16 measure (as defined in subsection (h)(4)) in the 17 stockpile under paragraph (1), the Executive 18 Deputy Assistant Secretary of the Strategic 19 National Stockpile shall, not later than 30 days 20 after making such determination— 21 ‘‘(i) conduct a supplemental threat- 22 based review on each issue described in 23 items (aa) through (dd) of subparagraph 24 (C)(I); and BON20363 08M S.L.C. 19 1 ‘‘(ii) provide such review in writing to 2 the Committees described in subparagraph 3 (A).’’. 4 SEC. 3. ENHANCEMENTS TO THE DEFENSE PRODUCTION 5 6 ACT OF 1950. Section 107 of the Defense Production Act of 1950 7 (50 U.S.C. 4517) is amended by adding at the end the 8 following: 9 ‘‘(c) HEALTH EMERGENCY AUTHORITY.—With re- 10 spect to a public health emergency declared under section 11 319 of the Public Health Service Act (42 U.S.C. 247d), 12 or preparations for such a public health emergency, the 13 Secretary of Health and Human Services and the Admin14 istrator of the Federal Emergency Management Agency 15 may carry out the authorities provided under this section 16 to the same extent as the President.’’.