Preparing for the Next Pandemic Act

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 Na- tional Stockpile. 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 ‘‘Preparing for the Next 4 Pandemic Act’’. 5 SEC. 2. SUSTAINED ON-SHORE MANUFACTURING CAPACITY 6 FOR PUBLIC HEALTH EMERGENCIES. 7 (a) IN GENERAL.—Section 319L of the Public 8 Health Service Act (42 U.S.C. 247d–7e) is amended— 9 (1) in subsection (a)(6)(B)— 10 VerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 4231 IS (A) by redesignating clauses (iv) and (v) as 1 clauses (v) and (vi), respectively; 2 (B) by inserting after clause (iii), the fol- 3 lowing: 4 ‘‘(iv) activities to support domestic 5 manufacturing surge capacity of products 6 or platform technologies, including manu- 7 facturing capacity and capabilities to uti- 8 lize platform technologies to provide for 9 flexible manufacturing initiatives;’’; and 10 (C) in clause (vi) (as so redesginated), by 11 inserting ‘‘manufacture,’’ after ‘‘improvement,’’; 12 (2) in subsection (b)— 13 (A) in the first sentence of paragraph (1), 14 by inserting ‘‘support for domestic manufac- 15 turing surge capacity,’’ after ‘‘initiatives for in- 16 novation,’’; and 17 (B) in paragraph (2)— 18 (i) in subparagraph (B), by striking 19 ‘‘and’’ at the end; 20 (ii) by redesignating subparagraph 21 (C) as subparagraph (D); and 22 (iii) by inserting after subparagraph 23 (B), the following: 24 VerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 4231 IS ‘‘(C) activities to support manufacturing 1 surge capacities and capabilities to increase the 2 availability of existing medical countermeasures 3 and utilize existing novel platforms to manufac- 4 ture new medical countermeasures to meet 5 manufacturing demands to address threats that 6 pose a significant level of risk to national secu- 7 rity; and’’; 8 (3) in subsection (c)— 9 (A) in paragraph (2)— 10 (i) in subparagraph (C), by striking 11 ‘‘and’’ at the end; 12 (ii) in subparagraph (D), by striking 13 the period and inserting ‘‘; and’’; and 14 (iii) by adding at the end the fol- 15 lowing: 16 ‘‘(E) promoting domestic manufacturing 17 surge capacity and capabilities for counter- 18 measure advanced research and development, 19 including facilitating contracts to support flexi- 20 ble or surge manufacturing.’’; 21 (B) in paragraph (4)— 22 (i) in subparagraph (B)— 23 (I) in clause (iii), by striking 24 ‘‘and’’ at the end; 25 VerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231 pbinns on DSKJLVW7X2PROD with BILLS 4 •S 4231 IS (II) in clause (iv), by striking the 1 period and inserting ‘‘; and’’; and 2 (III) by adding at the end the 3 following: 4 ‘‘(v) support and maintain domestic 5 manufacturing surge capacity and capabili- 6 ties, including through contracts to sup- 7 port flexible or surge manufacturing, to en- 8 sure that additional production of counter- 9 measures is available in the event that the 10 Secretary determines there is such a need 11 for additional production.’’; 12 (ii) in subparagraph (D)— 13 (I) in clause (ii), by striking 14 ‘‘and’’ at the end; 15 (II) by redesignating clause (iii) 16 as clause (iv); and 17 (III) by inserting after clause (ii) 18 the following: 19 ‘‘(iii) research to advance manufac- 20 turing capacities and capabilities for med- 21 ical countermeasures and platform tech- 22 nologies that may be utilized for medical 23 countermeasures; and’’; and 24 VerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231 pbinns on DSKJLVW7X2PROD with BILLS 5 •S 4231 IS (iii) in subparagraph (E), by striking 1 clause (ix); and 2 (C) in paragraph (7)(C)(i), by striking ‘‘up 3 to 100 highly qualified individuals, or up to 50 4 percent of the total number of employees, 5 whichever is less,’’ and inserting ‘‘75 percent of 6 the total number of employees’’; 7 (4) in subsection (d), by adding at the end the 8 following: 9 ‘‘(3) ADDITIONAL FUNDING.—For necessary ex- 10 penses to improve and expand manufacturing surge 11 capacity and capabilities, there is authorized to be 12 appropriated to the Fund $5,000,000,000, to remain 13 available until September 30, 2030. 14 ‘‘(4) ADVANCE APPROPRIATION.— 15 ‘‘(A) IN GENERAL.—There is appropriated, 16 out of amounts in the Treasury not otherwise 17 appropriated for the fiscal year ending Sep- 18 tember 30, 2021, for necessary expenses to im- 19 prove and expand manufacturing surge capacity 20 and capabilities pursuant to subsection 21 (c)(4)(B)(v), $5,000,000,000, to remain avail- 22 able until September 30, 2030. 23 ‘‘(B) EMERGENCY DESIGNATION.— 24 VerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231 pbinns on DSKJLVW7X2PROD with BILLS 6 •S 4231 IS ‘‘(i) IN GENERAL.—The amounts pro- 1 vided by this paragraph are designated as 2 an emergency requirement pursuant to sec- 3 tion 4(g) of the Statutory Pay-As-You-Go 4 Act of 2010 (2 U.S.C. 933(g)). 5 ‘‘(ii) DESIGNATION IN SENATE.—In 6 the Senate, this paragraph is designated as 7 an emergency requirement pursuant to sec- 8 tion 4112(a) of H. Con. Res. 71 (115th 9 Congress), the concurrent resolution on the 10 budget for fiscal year 2018. 11 ‘‘(C) APPLICATION OF PROVISIONS.— 12 Amounts appropriated pursuant to this para- 13 graph for fiscal year 2021 shall be subject to 14 the requirements contained in Public Law 116– 15 94 for funds for programs authorized under 16 section 319L of this Act.’’; 17 (5) in subsection (e)(1)— 18 (A) by redesignating subparagraphs (B) 19 through (D) as subparagraphs (C) through (E), 20 respectively; and 21 (B) by inserting after subparagraph (A), 22 the following: 23 ‘‘(B) TEMPORARY FLEXIBILITY.—During a 24 public health emergency under section 319, the 25 VerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231 pbinns on DSKJLVW7X2PROD with BILLS 7 •S 4231 IS Secretary shall be provided with an additional 1 60 business days to comply with information re- 2 quests for the disclosure of information under 3 section 552 of title 5, United States Code, re- 4 lated to the activities under this section (unless 5 such activities are otherwise exempt under sub- 6 paragraph (A)).’’; and 7 (6) in subsection (f)— 8 (A) in paragraph (1), by striking ‘‘Not 9 later than 180 days after the date of enactment 10 of this subsection’’ and inserting ‘‘Not later 11 than 180 days after the date of enactment of 12 the Preparing for the Next Pandemic Act’’; and 13 (B) in paragraph (2), by striking ‘‘Not 14 later than 1 year after the date of enactment of 15 this subsection’’ and inserting ‘‘Not later than 16 1 year after the date of enactment of the Pre- 17 paring for the Next Pandemic Act’’. 18 (b) MEDICAL COUNTERMEASURE INNOVATION PART- 19 NER.—The restrictions under section 202 of division A of 20 the Further Consolidated Appropriations Act, 2020 (Pub- 21 lic Law 116–94), or any other provision of law imposing 22 a restriction on salaries of individuals related to a previous 23 appropriation to the Department of Health and Human 24 Services, shall not apply with respect to salaries paid pur- 25 VerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231 pbinns on DSKJLVW7X2PROD with BILLS 8 •S 4231 IS suant to an agreement under the medical countermeasure 1 innovation partner program under section 319L(c)(4)(E) 2 of the Public Health Service Act (42 U.S.C. 247d– 3 7e(c)(4)(E)). 4 SEC. 3. IMPROVING AND SUSTAINING STATE MEDICAL 5 STOCKPILES. 6 Section 319F–2 of the Public Health Service Act (42 7 U.S.C. 247d–6b) is amended by adding at the end the fol- 8 lowing: 9 ‘‘(i) IMPROVING AND MAINTAINING STATE MEDICAL 10 STOCKPILES.— 11 ‘‘(1) IN GENERAL.—The Secretary, acting 12 through the Assistant Secretary for Preparedness 13 and Response, shall award grants, contracts, or co- 14 operative agreements to eligible entities to maintain 15 a stockpile of appropriate drugs, vaccines and other 16 biological products, medical devices, and other med- 17 ical supplies (including personal protective equip- 18 ment, ancillary medical supplies, and other applica- 19 ble supplies required for the administration of drugs, 20 vaccines and other biological products, medical de- 21 vices, and diagnostic tests) to be used during a pub- 22 lic health emergency declared by the Governor of a 23 State or by the Secretary under section 319, or a 24 major disaster or emergency declared by the Presi- 25 VerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231 pbinns on DSKJLVW7X2PROD with BILLS 9 •S 4231 IS dent under section 401 or 501, respectively, of the 1 Robert T. Stafford Disaster Relief and Emergency 2 Assistance Act, in order to support the preparedness 3 goals described in paragraphs (2), (3), and (8) of 4 section 2802(b). 5 ‘‘(2) ELIGIBLE ENTITIES.— 6 ‘‘(A) IN GENERAL.—To be eligible to re- 7 ceive an award under paragraph (1), an entity 8 shall— 9 ‘‘(i) be a State or consortium of 10 States that is a recipient of an award 11 under section 319C–1(b); and 12 ‘‘(ii) prepare, in consultation with ap- 13 propriate health care providers and health 14 officials within the State or consortium of 15 States, and submit to the Secretary an ap- 16 plication that contains such information as 17 the Secretary may require, including a 18 plan for the State stockpile and a descrip- 19 tion of the activities such entity will carry 20 out under the agreement, consistent with 21 the requirements of paragraph (3). 22 ‘‘(B) LIMITATION.—The Secretary may 23 make an award under this subsection to not 24 more than one eligible entity in each State. 25 VerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231 pbinns on DSKJLVW7X2PROD with BILLS 10 •S 4231 IS ‘‘(C) SUPPLEMENT NOT SUPPLANT.— 1 Awards, contracts, or grants awarded under 2 this subsection shall supplement, not supplant, 3 the reserve amounts of medical supplies pro- 4 cured by and for the Strategic National Stock- 5 pile under subsection (a). 6 ‘‘(D) ADMINISTRATIVE EXPENSES.—Not 7 more than 5 percent of amounts received by an 8 entity pursuant to an award under this sub- 9 section may be used for administrative ex- 10 penses. 11 ‘‘(E) CLARIFICATION.—An eligible entity 12 receiving an award under this subsection may 13 assign a lead entity to manage the State stock- 14 pile, which may be a recipient of an award 15 under section 319C–2(b). 16 ‘‘(F) REQUIREMENT OF MATCHING 17 FUNDS.— 18 ‘‘(i) IN GENERAL.—Subject to clause 19 (ii), the Secretary may not make an award 20 under this subsection unless the applicant 21 agrees, with respect to the costs to be in- 22 curred by the applicant in carrying out the 23 purpose described in this subsection, to 24 VerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231 pbinns on DSKJLVW7X2PROD with BILLS 11 •S 4231 IS make available non-Federal contributions 1 toward such costs in an amount equal to— 2 ‘‘(I) for each of fiscal years 2023 3 and 2024, not less than $1 for each 4 $10 of Federal funds provided in the 5 award; 6 ‘‘(II) for each of fiscal years 7 2025 and 2026, not less than $1 for 8 each $5 of Federal funds provided in 9 the award; and 10 ‘‘(III) for fiscal year 2027 and 11 each fiscal year thereafter, not less 12 than $1 for each $3 of Federal funds 13 provided in the award. 14 ‘‘(ii) WAIVER.— 15 ‘‘(I) IN GENERAL.—The Sec- 16 retary may, upon the request of a 17 State, waive the requirement under 18 clause (i) in whole or in part if the 19 Secretary determines that extraor- 20 dinary economic conditions in the 21 State in the fiscal year involved or in 22 the previous fiscal year justify the 23 waiver. 24 VerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231 pbinns on DSKJLVW7X2PROD with BILLS 12 •S 4231 IS ‘‘(II) APPLICABILITY OF WAIV- 1 ER.—A waiver provided by the Sec- 2 retary under this subparagraph shall 3 apply only to the fiscal year involved. 4 ‘‘(3) STOCKPILING ACTIVITIES AND REQUIRE- 5 MENTS.—A recipient of a grant, contract, or cooper- 6 ative agreement under this subsection shall use such 7 funds to carry out the following: 8 ‘‘(A) Maintaining a stockpile of appro- 9 priate drugs, vaccines and other biological prod- 10 ucts, medical devices, and other supplies (in- 11 cluding personal protective equipment, ancillary 12 medical supplies, and other applicable supplies 13 required for the administration of drugs, vac- 14 cines and other biological products, medical de- 15 vices, and diagnostic tests) to be used during a 16 public health emergency in such numbers, 17 types, and amounts as the State determines 18 necessary, consistent with such State’s stockpile 19 plan. Such a recipient may not use funds to 20 support the stockpiling of countermeasures as 21 defined under subsection (c), unless the eligible 22 entity provides justification for maintaining 23 such products and the Secretary determines 24 such appropriate and applicable. 25 VerDate Sep 11 2014 01:20 Jul 26, 2020 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S4231.IS S4231 pbinns on DSKJLVW7X2PROD with BILLS 13 •S 4231 IS ‘‘(B) Deploying the stockpile as required 1 by the State to respond to an actual or poten- 2 tial public health emergency. 3 ‘‘(C) Replenishing and making necessary 4 additions or modifications to the contents of 5 such stockpile or stockpiles, including to ad- 6 dress potential depletion. 7 ‘‘(D) In consultation with Federal, State, 8 and local officials, take into consideration the 9 availability, deployment, dispensing, and admin- 10 istration requirements of medical products with- 11 in the stockpile. 12 ‘‘(E) Ensuring that procedures are fol- 13 lowed for inventory management and account- 14 ing, and for the physical security of the stock- 15 [Text truncated for display. 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