II 

116TH CONGRESS 

2D SESSION S. 4231 

To strengthen and sustain on-shore manufacturing capacity and State 

stockpiles, and to improve the Strategic National Stockpile. 

IN THE SENATE OF THE UNITED STATES 

JULY 20, 2020 

Mr. ALEXANDER introduced the following bill; which was read twice and 

referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To strengthen and sustain on-shore manufacturing capacity 

and State stockpiles, and to improve the Strategic National Stockpile. 

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 ‘‘Preparing for the Next 

5 Pandemic Act’’. 

6 SEC. 2. SUSTAINED ON-SHORE MANUFACTURING CAPACITY 

7 FOR PUBLIC HEALTH EMERGENCIES. 

8 (a) IN GENERAL.—Section 319L of the Public 

9 Health Service Act (42 U.S.C. 247d–7e) is amended— 

10 (1) in subsection (a)(6)(B)— 


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1 (A) by redesignating clauses (iv) and (v) as 

2 clauses (v) and (vi), respectively; 

3 (B) by inserting after clause (iii), the fol4 lowing: 

5 ‘‘(iv) activities to support domestic 

6 manufacturing surge capacity of products 

7 or platform technologies, including manu8 facturing capacity and capabilities to uti9 lize platform technologies to provide for 

10 flexible manufacturing initiatives;’’; and 

11 (C) in clause (vi) (as so redesginated), by 

12 inserting ‘‘manufacture,’’ after ‘‘improvement,’’; 

13 (2) in subsection (b)— 

14 (A) in the first sentence of paragraph (1), 

15 by inserting ‘‘support for domestic manufac16 turing surge capacity,’’ after ‘‘initiatives for in17 novation,’’; and 

18 (B) in paragraph (2)— 

19 (i) in subparagraph (B), by striking 

20 ‘‘and’’ at the end; 

21 (ii) by redesignating subparagraph 

22 (C) as subparagraph (D); and 

23 (iii) by inserting after subparagraph 

24 (B), the following: 


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1 ‘‘(C) activities to support manufacturing 

2 surge capacities and capabilities to increase the 

3 availability of existing medical countermeasures 

4 and utilize existing novel platforms to manufac5 ture new medical countermeasures to meet 

6 manufacturing demands to address threats that 

7 pose a significant level of risk to national secu8 rity; and’’; 

9 (3) in subsection (c)— 

10 (A) in paragraph (2)— 

11 (i) in subparagraph (C), by striking 

12 ‘‘and’’ at the end; 

13 (ii) in subparagraph (D), by striking 

14 the period and inserting ‘‘; and’’; and 

15 (iii) by adding at the end the fol16 lowing: 

17 ‘‘(E) promoting domestic manufacturing 

18 surge capacity and capabilities for counter19 measure advanced research and development, 

20 including facilitating contracts to support flexi21 ble or surge manufacturing.’’; 

22 (B) in paragraph (4)— 

23 (i) in subparagraph (B)— 

24 (I) in clause (iii), by striking 

25 ‘‘and’’ at the end; 


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1 (II) in clause (iv), by striking the 

2 period and inserting ‘‘; and’’; and 

3 (III) by adding at the end the 

4 following: 

5 ‘‘(v) support and maintain domestic 

6 manufacturing surge capacity and capabili7 ties, including through contracts to sup8 port flexible or surge manufacturing, to en9 sure that additional production of counter10 measures is available in the event that the 

11 Secretary determines there is such a need 

12 for additional production.’’; 

13 (ii) in subparagraph (D)— 

14 (I) in clause (ii), by striking 

15 ‘‘and’’ at the end; 

16 (II) by redesignating clause (iii) 

17 as clause (iv); and 

18 (III) by inserting after clause (ii) 

19 the following: 

20 ‘‘(iii) research to advance manufac21 turing capacities and capabilities for med22 ical countermeasures and platform tech23 nologies that may be utilized for medical 

24 countermeasures; and’’; and 


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1 (iii) in subparagraph (E), by striking 

2 clause (ix); and 

3 (C) in paragraph (7)(C)(i), by striking ‘‘up 

4 to 100 highly qualified individuals, or up to 50 

5 percent of the total number of employees, 

6 whichever is less,’’ and inserting ‘‘75 percent of 

7 the total number of employees’’; 

8 (4) in subsection (d), by adding at the end the 

9 following: 

10 ‘‘(3) ADDITIONAL FUNDING.—For necessary ex11 penses to improve and expand manufacturing surge 

12 capacity and capabilities, there is authorized to be 

13 appropriated to the Fund $5,000,000,000, to remain 

14 available until September 30, 2030. 

15 ‘‘(4) ADVANCE APPROPRIATION.— 

16 ‘‘(A) IN GENERAL.—There is appropriated, 

17 out of amounts in the Treasury not otherwise 

18 appropriated for the fiscal year ending Sep19 tember 30, 2021, for necessary expenses to im20 prove and expand manufacturing surge capacity 

21 and capabilities pursuant to subsection 

22 (c)(4)(B)(v), $5,000,000,000, to remain avail23 able until September 30, 2030. 

24 ‘‘(B) EMERGENCY DESIGNATION.— 


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1 ‘‘(i) IN GENERAL.—The amounts pro2 vided by this paragraph are designated as 

3 an emergency requirement pursuant to sec4 tion 4(g) of the Statutory Pay-As-You-Go 

5 Act of 2010 (2 U.S.C. 933(g)). 

6 ‘‘(ii) DESIGNATION IN SENATE.—In 

7 the Senate, this paragraph is designated as 

8 an emergency requirement pursuant to sec9 tion 4112(a) of H. Con. Res. 71 (115th 

10 Congress), the concurrent resolution on the 

11 budget for fiscal year 2018. 

12 ‘‘(C) APPLICATION OF PROVISIONS.— 

13 Amounts appropriated pursuant to this para14 graph for fiscal year 2021 shall be subject to 

15 the requirements contained in Public Law 116– 

16 94 for funds for programs authorized under 

17 section 319L of this Act.’’; 

18 (5) in subsection (e)(1)— 

19 (A) by redesignating subparagraphs (B) 

20 through (D) as subparagraphs (C) through (E), 

21 respectively; and 

22 (B) by inserting after subparagraph (A), 

23 the following: 

24 ‘‘(B) TEMPORARY FLEXIBILITY.—During a 

25 public health emergency under section 319, the 


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1 Secretary shall be provided with an additional 

2 60 business days to comply with information re3 quests for the disclosure of information under 

4 section 552 of title 5, United States Code, re5 lated to the activities under this section (unless 

6 such activities are otherwise exempt under sub7 paragraph (A)).’’; and 

8 (6) in subsection (f)— 

9 (A) in paragraph (1), by striking ‘‘Not 

10 later than 180 days after the date of enactment 

11 of this subsection’’ and inserting ‘‘Not later 

12 than 180 days after the date of enactment of 

13 the Preparing for the Next Pandemic Act’’; and 

14 (B) in paragraph (2), by striking ‘‘Not 

15 later than 1 year after the date of enactment of 

16 this subsection’’ and inserting ‘‘Not later than 

17 1 year after the date of enactment of the Pre18 paring for the Next Pandemic Act’’. 

19 (b) MEDICAL COUNTERMEASURE INNOVATION PART20 NER.—The restrictions under section 202 of division A of 

21 the Further Consolidated Appropriations Act, 2020 (Pub22 lic Law 116–94), or any other provision of law imposing 

23 a restriction on salaries of individuals related to a previous 

24 appropriation to the Department of Health and Human 

25 Services, shall not apply with respect to salaries paid purVerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231

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1 suant to an agreement under the medical countermeasure 

2 innovation partner program under section 319L(c)(4)(E) 

3 of the Public Health Service Act (42 U.S.C. 247d– 

4 7e(c)(4)(E)). 

5 SEC. 3. IMPROVING AND SUSTAINING STATE MEDICAL 

6 STOCKPILES. 

7 Section 319F–2 of the Public Health Service Act (42 

8 U.S.C. 247d–6b) is amended by adding at the end the fol9 lowing: 

10 ‘‘(i) IMPROVING AND MAINTAINING STATE MEDICAL

11 STOCKPILES.— 

12 ‘‘(1) IN GENERAL.—The Secretary, acting 

13 through the Assistant Secretary for Preparedness 

14 and Response, shall award grants, contracts, or co15 operative agreements to eligible entities to maintain 

16 a stockpile of appropriate drugs, vaccines and other 

17 biological products, medical devices, and other med18 ical supplies (including personal protective equip19 ment, ancillary medical supplies, and other applica20 ble supplies required for the administration of drugs, 

21 vaccines and other biological products, medical de22 vices, and diagnostic tests) to be used during a pub23 lic health emergency declared by the Governor of a 

24 State or by the Secretary under section 319, or a 

25 major disaster or emergency declared by the PresiVerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231

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1 dent under section 401 or 501, respectively, of the 

2 Robert T. Stafford Disaster Relief and Emergency 

3 Assistance Act, in order to support the preparedness 

4 goals described in paragraphs (2), (3), and (8) of 

5 section 2802(b). 

6 ‘‘(2) ELIGIBLE ENTITIES.— 

7 ‘‘(A) IN GENERAL.—To be eligible to re8 ceive an award under paragraph (1), an entity 

9 shall— 

10 ‘‘(i) be a State or consortium of 

11 States that is a recipient of an award 

12 under section 319C–1(b); and 

13 ‘‘(ii) prepare, in consultation with ap14 propriate health care providers and health 

15 officials within the State or consortium of 

16 States, and submit to the Secretary an ap17 plication that contains such information as 

18 the Secretary may require, including a 

19 plan for the State stockpile and a descrip20 tion of the activities such entity will carry 

21 out under the agreement, consistent with 

22 the requirements of paragraph (3). 

23 ‘‘(B) LIMITATION.—The Secretary may 

24 make an award under this subsection to not 

25 more than one eligible entity in each State. 


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1 ‘‘(C) SUPPLEMENT NOT SUPPLANT.— 

2 Awards, contracts, or grants awarded under 

3 this subsection shall supplement, not supplant, 

4 the reserve amounts of medical supplies pro5 cured by and for the Strategic National Stock6 pile under subsection (a). 

7 ‘‘(D) ADMINISTRATIVE EXPENSES.—Not 

8 more than 5 percent of amounts received by an 

9 entity pursuant to an award under this sub10 section may be used for administrative ex11 penses. 

12 ‘‘(E) CLARIFICATION.—An eligible entity 

13 receiving an award under this subsection may 

14 assign a lead entity to manage the State stock15 pile, which may be a recipient of an award 

16 under section 319C–2(b). 

17 ‘‘(F) REQUIREMENT OF MATCHING

18 FUNDS.— 

19 ‘‘(i) IN GENERAL.—Subject to clause 

20 (ii), the Secretary may not make an award 

21 under this subsection unless the applicant 

22 agrees, with respect to the costs to be in23 curred by the applicant in carrying out the 

24 purpose described in this subsection, to 


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1 make available non-Federal contributions 

2 toward such costs in an amount equal to— 

3 ‘‘(I) for each of fiscal years 2023 

4 and 2024, not less than $1 for each 

5 $10 of Federal funds provided in the 

6 award; 

7 ‘‘(II) for each of fiscal years 

8 2025 and 2026, not less than $1 for 

9 each $5 of Federal funds provided in 

10 the award; and 

11 ‘‘(III) for fiscal year 2027 and 

12 each fiscal year thereafter, not less 

13 than $1 for each $3 of Federal funds 

14 provided in the award. 

15 ‘‘(ii) WAIVER.— 

16 ‘‘(I) IN GENERAL.—The Sec17 retary may, upon the request of a 

18 State, waive the requirement under 

19 clause (i) in whole or in part if the 

20 Secretary determines that extraor21 dinary economic conditions in the 

22 State in the fiscal year involved or in 

23 the previous fiscal year justify the 

24 waiver. 


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1 ‘‘(II) APPLICABILITY OF WAIV2 ER.—A waiver provided by the Sec3 retary under this subparagraph shall 

4 apply only to the fiscal year involved. 

5 ‘‘(3) STOCKPILING ACTIVITIES AND REQUIRE6 MENTS.—A recipient of a grant, contract, or cooper7 ative agreement under this subsection shall use such 

8 funds to carry out the following: 

9 ‘‘(A) Maintaining a stockpile of appro10 priate drugs, vaccines and other biological prod11 ucts, medical devices, and other supplies (in12 cluding personal protective equipment, ancillary 

13 medical supplies, and other applicable supplies 

14 required for the administration of drugs, vac15 cines and other biological products, medical de16 vices, and diagnostic tests) to be used during a 

17 public health emergency in such numbers, 

18 types, and amounts as the State determines 

19 necessary, consistent with such State’s stockpile 

20 plan. Such a recipient may not use funds to 

21 support the stockpiling of countermeasures as 

22 defined under subsection (c), unless the eligible 

23 entity provides justification for maintaining 

24 such products and the Secretary determines 

25 such appropriate and applicable. 


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1 ‘‘(B) Deploying the stockpile as required 

2 by the State to respond to an actual or poten3 tial public health emergency. 

4 ‘‘(C) Replenishing and making necessary 

5 additions or modifications to the contents of 

6 such stockpile or stockpiles, including to ad7 dress potential depletion. 

8 ‘‘(D) In consultation with Federal, State, 

9 and local officials, take into consideration the 

10 availability, deployment, dispensing, and admin11 istration requirements of medical products with12 in the stockpile. 

13 ‘‘(E) Ensuring that procedures are fol14 lowed for inventory management and account15 ing, and for the physical security of the stock16 pile, as appropriate. 

17 ‘‘(F) Reviewing and revising, as appro18 priate, the contents of the stockpile on a reg19 ular basis to ensure that to the extent prac20 ticable, advanced technologies and medical 

21 products are considered. 

22 ‘‘(G) Carrying out exercises, drills, and 

23 other training for purposes of stockpile deploy24 ment, dispensing, and administration of medical 

25 products, and for purposes of assessing the caVerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231

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1 pability of such stockpile to address the medical 

2 supply needs of public health emergencies of 

3 varying types and scales, which may be con4 ducted in accordance with requirements related 

5 to exercises, drills, and other training for recipi6 ents of awards under section 319C–1 or 319C– 

7 2, as applicable. 

8 ‘‘(H) Carrying out other activities as the 

9 State determines appropriate, to support State 

10 efforts to prepare for, and respond to, public 

11 health threats. 

12 ‘‘(4) STATE PLAN COORDINATION.—The eligible 

13 entity under this subsection shall ensure appropriate 

14 coordination of the State stockpile plan developed 

15 pursuant to paragraph (2)(A)(ii) and the plans re16 quired pursuant to section 319C–1. 

17 ‘‘(5) GUIDANCE FOR STATES.—Not later than 

18 180 days after the date of enactment of this sub19 section, the Secretary, acting through the Assistant 

20 Secretary for Preparedness and Response, shall 

21 issue guidance for States related to maintaining and 

22 replenishing a stockpile of medical products. The 

23 Secretary shall update such guidance as appropriate. 

24 ‘‘(6) ASSISTANCE TO STATES.—The Secretary 

25 shall provide assistance to States, including technical 


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1 assistance, as appropriate, to maintain and improve 

2 State and local public health preparedness capabili3 ties to distribute and dispense medical products 

4 from a State stockpile. 

5 ‘‘(7) COORDINATION WITH THE STRATEGIC NA6 TIONAL STOCKPILE.—Each recipient of an award 

7 under this subsection shall ensure that the State 

8 stockpile plan developed pursuant to paragraph 

9 (2)(A)(ii) contains such information as the Secretary 

10 may require related to current inventory of supplies 

11 maintained pursuant to paragraph (3), and any 

12 plans to replenish such supplies, or procure new or 

13 alternative supplies. The Secretary shall use infor14 mation obtained from State stockpile plans to inform 

15 the maintenance and management of the Strategic 

16 National Stockpile pursuant to subsection (a). 

17 ‘‘(8) PERFORMANCE AND ACCOUNTABILITY.— 

18 ‘‘(A) IN GENERAL.—The Secretary, acting 

19 through the Assistant Secretary for Prepared20 ness and Response, shall develop and implement 

21 a process to review and audit entities in receipt 

22 of an award under this subsection, including by 

23 establishing metrics to ensure that each entity 

24 receiving such an award is carrying out activi25 ties in accordance with the applicable State 


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1 stockpile plan. The Secretary may require enti2 ties to— 

3 ‘‘(i) measure progress toward achiev4 ing the outcome goals; and 

5 ‘‘(ii) at least annually, test, exercise, 

6 and rigorously evaluate the stockpile ca7 pacity and response capabilities of the enti8 ty, and report to the Secretary on the re9 sults of such test, exercise, and evaluation, 

10 and on progress toward achieving outcome 

11 goals, based on criteria established by the 

12 Secretary. 

13 ‘‘(B) NOTIFICATION OF FAILURE.—The 

14 Secretary shall develop and implement a proc15 ess to notify entities that are determined by the 

16 Secretary to have failed to meet the require17 ments of the terms of an award under this sub18 section. Such process shall provide such entities 

19 with the opportunity to correct such noncompli20 ance. An entity that fails to correct such non21 compliance shall be subject to subparagraph 

22 (C). 

23 ‘‘(C) WITHHOLDING OF CERTAIN AMOUNTS

24 FROM ENTITIES THAT FAIL TO ACHIEVE

25 BENCHMARKS OR SUBMIT STATE STOCKPILE


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1 PLAN.—Beginning with fiscal year 2022, and in 

2 each succeeding fiscal year, the Secretary shall 

3 withhold from each entity that has failed sub4 stantially to meet the terms of an award under 

5 this subsection for at least 1 of the 2 imme6 diately preceding fiscal years (beginning with 

7 fiscal year 2022), the amount allowed for ad8 ministrative expenses described in described in 

9 paragraph (2)(D). 

10 ‘‘(9) AUTHORIZATION OF APPROPRIATIONS.— 

11 For the purpose of carrying out this subsection, 

12 there are authorized to be appropriated 

13 $1,000,000,000 for each of fiscal years 2021 

14 through 2030, to remain available until expended. 

15 ‘‘(10) ADVANCE APPROPRIATION.— 

16 ‘‘(A) IN GENERAL.—There is appropriated, 

17 out of amounts in the Treasury not otherwise 

18 appropriated, for fiscal year 2021, for necessary 

19 expenses to establish and maintain State med20 ical stockpiles pursuant to this subsection, 

21 $10,000,000,000, to remain available until Sep22 tember 30, 2030. 

23 ‘‘(B) EMERGENCY DESIGNATION.— 

24 ‘‘(i) IN GENERAL.—The amounts pro25 vided by this paragraph are designated as 


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1 an emergency requirement pursuant to sec2 tion 4(g) of the Statutory Pay-As-You-Go 

3 Act of 2010 (2 U.S.C. 933(g)). 

4 ‘‘(ii) DESIGNATION IN SENATE.—In 

5 the Senate, this paragraph is designated as 

6 an emergency requirement pursuant to sec7 tion 4112(a) of H. Con. Res. 71 (115th 

8 Congress), the concurrent resolution on the 

9 budget for fiscal year 2018. 

10 ‘‘(C) APPLICATION OF PROVISIONS.— 

11 Amounts appropriated pursuant to this para12 graph for fiscal year 2021 shall be subject to 

13 the requirements contained in Public Law 116– 

14 94 for funds for programs authorized under 

15 section 319F–2 of this Act.’’. 

16 SEC. 4. STRENGTHENING THE STRATEGIC NATIONAL 

17 STOCKPILE. 

18 Section 319F–2 of the Public Health Service Act (42 

19 U.S.C. 247d–6b) is amended— 

20 (1) in subsection (a)— 

21 (A) in paragraph (2)(A), by adding ‘‘and 

22 the contracts issued under paragraph (5)’’ after 

23 ‘‘paragraph (1)’’; 

24 (B) in paragraph (3)(F), by striking ‘‘Sec25 retary of Homeland Security’’ and inserting 


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1 ‘‘Secretary of Health and Human Services, in 

2 coordination with or at the request of, the Sec3 retary of Homeland Security,’’; 

4 (C) by redesignating paragraph (5) as 

5 paragraph (6); 

6 (D) by inserting after paragraph (4) the 

7 following: 

8 ‘‘(5) SURGE CAPACITY.—The Secretary, in 

9 maintaining the stockpile under paragraph (1) and 

10 carrying out procedures under paragraph (3), may— 

11 ‘‘(A) enter into contracts or cooperative 

12 agreements with vendors for procurement, 

13 maintenance, and storage of reserve amounts of 

14 drugs, vaccines and other biological products, 

15 medical devices, and other medical supplies (in16 cluding personal protective equipment, ancillary 

17 medical supplies, and other applicable supplies 

18 required for the administration of drugs, vac19 cines and other biological products, medical de20 vices, and diagnostic tests in the stockpile), 

21 under such terms and conditions (including 

22 quantity, production schedule, maintenance 

23 costs, and price of product) as the Secretary 

24 may specify, including for purposes of— 


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1 ‘‘(i) maintenance and storage of re2 serve amounts of products intended to be 

3 delivered to the ownership of the Federal 

4 Government under the contract, which may 

5 consider costs of shipping, or otherwise 

6 transporting, handling, storage, and re7 lated costs for such product or products; 

8 and 

9 ‘‘(ii) maintaining domestic manufac10 turing capacity of such products to ensure 

11 additional reserved production capacity of 

12 such products is available, and that such 

13 products are provided in a timely manner, 

14 to be delivered to the ownership of the 

15 Federal Government under the contract 

16 and deployed in the event that the Sec17 retary determines that there is a need to 

18 quickly purchase additional quantities of 

19 such product; and 

20 ‘‘(B) promulgate such regulations as the 

21 Secretary determines necessary to implement 

22 this paragraph.’’; and 

23 (E) in subparagraph (A) of paragraph (6), 

24 as so redesignated— 


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1 (i) in clause (viii), by striking ‘‘; and’’ 

2 and inserting a semicolon; 

3 (ii) in clause (ix), by striking the pe4 riod and inserting ‘‘; and’’; and 

5 (iii) by adding at the end the fol6 lowing: 

7 ‘‘(x) an assessment of the contracts or 

8 cooperative agreements entered into pursu9 ant to paragraph (5).’’; and 

10 (2) in subsection (c)(2)(C), by striking ‘‘on an 

11 annual basis’’ and inserting ‘‘not later than March 

12 15 of each year’’. 

Æ 


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