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 countermeasures 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 domestic supply chain for countermeasures in the stockpile, 

and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protecting American 

5 Heroes Act of 2020’’. 


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1 SEC. 2. STRATEGIC NATIONAL STOCKPILE. 

2 (a) ADDITIONAL PROVISIONS TO PREPARE THE

3 STRATEGIC NATIONAL STOCKPILE FOR PUBLIC HEALTH

4 EMERGENCIES.— 

5 (1) IN GENERAL.—Section 319F–2 of the Pub6 lic Health Service Act (42 U.S.C. 247d–6b) is 

7 amended— 

8 (A) by redesignating subsection (h) as sub9 section (i); and 

10 (B) by inserting after subsection (g) the 

11 following: 

12 ‘‘(h) ADDITIONAL PROVISIONS TO PREPARE THE

13 STRATEGIC NATIONAL STOCKPILE FOR PUBLIC HEALTH

14 EMERGENCIES.— 

15 ‘‘(1) PREPARING FOR EMERGENCIES AFFECT16 ING ALL STATES.— 

17 ‘‘(A) IN GENERAL.—The Public Health 

18 Emergency Medical Countermeasures Enter19 prise established under section 2811–1 shall de20 velop a model to enable the stockpile under sub21 section (a)(1) to be prepared to effectively re22 spond to a public health emergency, including 

23 one that simultaneously affects all States. 

24 ‘‘(B) MODEL.—The model under subpara25 graph (A) shall include— 


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1 ‘‘(i)(I) requirements with respect to 

2 the number, types, and amounts of coun3 termeasures that are necessary to prepare 

4 the stockpile under subsection (a)(1) to re5 spond to a public health emergency de6 scribed in subparagraph (A); and 

7 ‘‘(II) the cost necessary to meet such 

8 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 


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1 only has one source, domestic or for2 eign, for procurement; and 

3 ‘‘(V) steps needed to diversify 

4 sources for any countermeasure in the 

5 stockpile that has only one source, do6 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 Counter11 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 TO IDENTIFY AND MAIN16 TAIN DOMESTIC SUPPLY CHAIN.— 

17 ‘‘(A) IN GENERAL.—The Executive Deputy 

18 Assistant Secretary of the Strategic National 

19 Stockpile appointed under paragraph (3) (re20 ferred to in this paragraph as the ‘Executive 

21 Deputy Assistant Secretary’) shall, in accord22 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). 


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1 ‘‘(B) REQUIREMENT FOR ITEMS IN STOCK2 PILE.— 

3 ‘‘(i) IN GENERAL.—Except as pro4 vided under clause (ii), the Executive Dep5 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, re9 processed, reused, or produced in the 

10 United States. 

11 ‘‘(ii) WAIVERS.—The Executive Dep12 uty Assistant Secretary may, on a case-by13 case basis, waive the requirement under 

14 clause (i) in the case of a contract for a 

15 countermeasure in the stockpile under sub16 section (a)(1)— 

17 ‘‘(I) for which the Executive 

18 Deputy Assistant Secretary deter19 mines that a satisfactory quality and 

20 sufficient quantity of such counter21 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 


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1 ‘‘(II) that is, or includes, any 

2 material determined to be a nonavail3 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 procure9 ment of a countermeasure in the stockpile 

10 under subsection (a)(1), if the Executive 

11 Deputy Assistant Secretary applies a waiv12 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 described in subsection 

17 (a)(2)(A) a notification that the waiver has 

18 been applied. 

19 ‘‘(C) NOTICE OF DISCONTINUANCE OR

20 INTERRUPTION IN DOMESTIC SUPPLY CHAIN.— 

21 ‘‘(i) TIMING.—The Executive Deputy 

22 Assistant Secretary shall require any man23 ufacturer of a countermeasure in the 

24 stockpile under subsection (a)(1) (other 

25 than a countermeasure to which a waiver 


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1 has been applied under subparagraph 

2 (B)(ii)) to provide notice to the Executive 

3 Deputy Assistant Secretary of any dis4 continuance or interruption in the manu5 facture of such countermeasure. Such no6 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 sub12 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 discontinu18 ation or interruption of the counter19 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 


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1 ingredient, and any alternative 

2 sources for the active pharmaceutical 

3 ingredient known by the manufac4 turer; 

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 DEPUTY ASSISTANT SEC17 RETARY OF THE STRATEGIC NATIONAL STOCK18 PILE.— 

19 ‘‘(A) IN GENERAL.—The Assistant Sec20 retary for Preparedness and Response shall ap21 point an Executive Deputy Assistant Secretary 

22 of the Strategic National Stockpile (referred to 

23 in this paragraph as the ‘Executive Deputy As24 sistant Secretary’), who shall report directly to 

25 the Assistant Secretary for Preparedness and 


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1 Response and serve in a career reserved posi2 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 se7 lected from individuals who, on the day before 

8 the date of enactment of the Protecting Amer9 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 ap14 pointees and are eligible for reinstatement 

15 as such career appointees. 

16 ‘‘(C) FUNCTIONS.—The Executive Deputy 

17 Assistant Secretary appointed under subpara18 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 domes25 tic supply chain for countermeasures in 


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1 such stockpile to the greatest extent pos2 sible; 

3 ‘‘(iii) consult with States and relevant 

4 stakeholders, including public health orga5 nizations, about the procurement and dis6 tribution of countermeasures in the stock7 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 Amer12 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 Exec17 utive Deputy Assistant Secretary shall submit 

18 to the Assistant Secretary for Preparedness and 

19 Response and each Committee described in sub20 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 


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1 health emergency that simultaneously af2 fects all States; 

3 ‘‘(iii) whether any countermeasures in 

4 the stockpile have expired or failed to re5 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 domes12 tic supply chain, for such counter13 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 


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1 ‘‘(II) whether any steps should be 

2 taken to diversify sourcing of such counter3 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 Pre9 paredness and Response shall appoint such in10 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 de15 vice, or other supplies (including personal protective 

16 equipment, ancillary medical supplies, and other ap17 plicable supplies required for the administration of 

18 drugs, vaccines and other biological products, med19 ical devices, and diagnostic tests in the stockpile) de20 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 (A) in the subsection heading, by striking 

25 ‘‘AUTHORIZATION OF APPROPRIATIONS’’ and 


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1 inserting ‘‘APPROPRIATIONS; AUTHORIZATION

2 OF APPROPRIATIONS’’; and 

3 (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 sub9 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 ap17 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 Service Act (42 U.S.C. 300hh– 

22 10(d)(2)(G)) is amended by striking ‘‘as de23 fined in section 319F–2(h)’’ and inserting ‘‘as 

24 defined in section 319F–2(i)’’. 


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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 insert10 ing ‘‘, including domestic manufacturing capac11 ity,’’ after ‘‘appropriate manufacturing capac12 ity’’; 

13 (2) in paragraph (3)— 

14 (A) by redesignating subparagraphs (E) 

15 through (J) as subparagraphs (F) through (K), 

16 respectively; 

17 (B) by inserting after subparagraph (D) 

18 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 sup24 ply chain based in the United States for counVerDate Sep 11 2014 20:07 Aug 13, 2020 Jkt 099200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S4368.IS S4368

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1 termeasures (as defined in subsection (h)(4)) in 

2 the stockpile;’’; and 

3 (C) in subparagraph (F), as so redesig4 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 (B) by inserting after clause (ii) the fol13 lowing: 

14 ‘‘(iii) an assessment of the plans de15 veloped by the Executive Deputy Assistant 

16 Secretary of the Strategic National Stock17 pile appointed under subsection (h)(3) to, 

18 in accordance with subsection (h)(2), es19 tablish, maintain, and (when necessary) ex20 pand a supply chain based in the United 

21 States for countermeasures (as defined in 

22 subsection (h)(4)) procured for the stock23 pile;’’. 


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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 insert6 ing ‘‘based on any review conducted under para7 graph (2)’’; and 

8 (2) in paragraph (2), by adding at the end the 

9 following: 

10 ‘‘(C) IN-PERSON OR VIRTUAL BRIEF11 INGS.— 

12 ‘‘(i) IN GENERAL.—Not later than 30 

13 days after submitting each annual threat14 based review under subparagraph (A) to 

15 the Committees described in such subpara16 graph, the Executive Deputy Assistant 

17 Secretary of the Strategic National Stock18 pile, appointed under subsection (h)(3), 

19 shall provide an in-person, or virtual, brief20 ing on such review to the members of such 

21 Committees. 

22 ‘‘(ii) PUBLIC HEALTH EMER23 GENCIES.— 

24 ‘‘(I) MONTHLY REVIEWS.—Dur25 ing the period of any public health 


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1 emergency, the Executive Deputy As2 sistant Secretary of the Strategic Na3 tional Stockpile, appointed under sub4 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 sup13 ply chain, including the domestic 

14 supply chain, for such counter15 measures; 

16 ‘‘(cc) how such counter17 measures are being distributed; 

18 and 

19 ‘‘(dd) communication with 

20 State and local governments on 

21 their needs with respect to ac22 quiring such countermeasures in 

23 the stockpile and on the status of 

24 countermeasures that are avail25 able in the stockpile. 


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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, brief8 ing to all members of Congress on 

9 each issue described in items (aa) 

10 through (dd) of subclause (I). 

11 ‘‘(D) SUPPLEMENTAL REVIEWS.—In the 

12 event that the Executive Deputy Assistant Sec13 retary of the Strategic National Stockpile, ap14 pointed under subsection (h)(3), determines 

15 there is a significant depletion of any counter16 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 threat22 based review on each issue described in 

23 items (aa) through (dd) of subparagraph 

24 (C)(I); and 


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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 ACT OF 1950. 

6 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 re10 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.’’. 

Æ 


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