II 116th CONGRESS 2d Session S. 4231 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. Short title This Act may be cited as the Preparing for the Next Pandemic Act . 2. Sustained on-shore manufacturing capacity for public health emergencies (a) In general Section 319L of the Public Health Service Act ( 42 U.S.C. 247d–7e ) is amended— (1) in subsection (a)(6)(B)— (A) by redesignating clauses (iv) and (v) as clauses (v) and (vi), respectively; (B) by inserting after clause (iii), the following: (iv) activities to support domestic manufacturing surge capacity of products or platform technologies, including manufacturing capacity and capabilities to utilize platform technologies to provide for flexible manufacturing initiatives; ; and (C) in clause (vi) (as so redesginated), by inserting manufacture, after improvement, ; (2) in subsection (b)— (A) in the first sentence of paragraph (1), by inserting support for domestic manufacturing surge capacity, after initiatives for innovation, ; and (B) in paragraph (2)— (i) in subparagraph (B), by striking and at the end; (ii) by redesignating subparagraph (C) as subparagraph (D); and (iii) by inserting after subparagraph (B), the following: (C) activities to support manufacturing surge capacities and capabilities to increase the availability of existing medical countermeasures and utilize existing novel platforms to manufacture new medical countermeasures to meet manufacturing demands to address threats that pose a significant level of risk to national security; and ; (3) in subsection (c)— (A) in paragraph (2)— (i) in subparagraph (C), by striking and at the end; (ii) in subparagraph (D), by striking the period and inserting ; and ; and (iii) by adding at the end the following: (E) promoting domestic manufacturing surge capacity and capabilities for countermeasure advanced research and development, including facilitating contracts to support flexible or surge manufacturing. ; (B) in paragraph (4)— (i) in subparagraph (B)— (I) in clause (iii), by striking and at the end; (II) in clause (iv), by striking the period and inserting ; and ; and (III) by adding at the end the following: (v) support and maintain domestic manufacturing surge capacity and capabilities, including through contracts to support flexible or surge manufacturing, to ensure that additional production of countermeasures is available in the event that the Secretary determines there is such a need for additional production. ; (ii) in subparagraph (D)— (I) in clause (ii), by striking and at the end; (II) by redesignating clause (iii) as clause (iv); and (III) by inserting after clause (ii) the following: (iii) research to advance manufacturing capacities and capabilities for medical countermeasures and platform technologies that may be utilized for medical countermeasures; and ; and (iii) in subparagraph (E), by striking clause (ix); and (C) in paragraph (7)(C)(i), by striking up to 100 highly qualified individuals, or up to 50 percent of the total number of employees, whichever is less, and inserting 75 percent of the total number of employees ; (4) in subsection (d), by adding at the end the following: (3) Additional funding For necessary expenses to improve and expand manufacturing surge capacity and capabilities, there is authorized to be appropriated to the Fund $5,000,000,000, to remain available until September 30, 2030. (4) Advance appropriation (A) In general There is appropriated, out of amounts in the Treasury not otherwise appropriated for the fiscal year ending September 30, 2021, for necessary expenses to improve and expand manufacturing surge capacity and capabilities pursuant to subsection (c)(4)(B)(v), $5,000,000,000, to remain available until September 30, 2030. (B) Emergency designation (i) In general The amounts provided by this paragraph are designated as an emergency requirement pursuant to section 4(g) of the Statutory Pay-As-You-Go Act of 2010 ( 2 U.S.C. 933(g) ). (ii) Designation in senate In the Senate, this paragraph is designated as an emergency requirement pursuant to section 4112(a) of H. Con. Res. 71 (115th Congress), the concurrent resolution on the budget for fiscal year 2018. (C) Application of provisions Amounts appropriated pursuant to this paragraph for fiscal year 2021 shall be subject to the requirements contained in Public Law 116–94 for funds for programs authorized under section 319L of this Act. ; (5) in subsection (e)(1)— (A) by redesignating subparagraphs (B) through (D) as subparagraphs (C) through (E), respectively; and (B) by inserting after subparagraph (A), the following: (B) Temporary flexibility During a public health emergency under section 319, the Secretary shall be provided with an additional 60 business days to comply with information requests for the disclosure of information under section 552 of title 5, United States Code, related to the activities under this section (unless such activities are otherwise exempt under subparagraph (A)). ; and (6) in subsection (f)— (A) in paragraph (1), by striking Not later than 180 days after the date of enactment of this subsection and inserting Not later than 180 days after the date of enactment of the Preparing for the Next Pandemic Act ; and (B) in paragraph (2), by striking Not later than 1 year after the date of enactment of this subsection and inserting Not later than 1 year after the date of enactment of the Preparing for the Next Pandemic Act . (b) Medical Countermeasure Innovation Partner The restrictions under section 202 of division A of the Further Consolidated Appropriations Act, 2020 ( Public Law 116–94 ), or any other provision of law imposing a restriction on salaries of individuals related to a previous appropriation to the Department of Health and Human Services, shall not apply with respect to salaries paid pursuant to an agreement under the medical countermeasure innovation partner program under section 319L(c)(4)(E) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(4)(E)). 3. Improving and sustaining State medical stockpiles Section 319F–2 of the Public Health Service Act ( 42 U.S.C. 247d–6b ) is amended by adding at the end the following: (i) Improving and maintaining State medical stockpiles (1) In general The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall award grants, contracts, or cooperative agreements to eligible entities to maintain a stockpile of appropriate drugs, vaccines and other biological products, medical devices, and other medical supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests) to be used during a public health emergency declared by the Governor of a State or by the Secretary under section 319, or a major disaster or emergency declared by the President under section 401 or 501, respectively, of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, in order to support the preparedness goals described in paragraphs (2), (3), and (8) of section 2802(b). (2) Eligible entities (A) In general To be eligible to receive an award under paragraph (1), an entity shall— (i) be a State or consortium of States that is a recipient of an award under section 319C–1(b); and (ii) prepare, in consultation with appropriate health care providers and health officials within the State or consortium of States, and submit to the Secretary an application that contains such information as the Secretary may require, including a plan for the State stockpile and a description of the activities such entity will carry out under the agreement, consistent with the requirements of paragraph (3). (B) Limitation The Secretary may make an award under this subsection to not more than one eligible entity in each State. (C) Supplement not supplant Awards, contracts, or grants awarded under this subsection shall supplement, not supplant, the reserve amounts of medical supplies procured by and for the Strategic National Stockpile under subsection (a). (D) Administrative expenses Not more than 5 percent of amounts received by an entity pursuant to an award under this subsection may be used for administrative expenses. (E) Clarification An eligible entity receiving an award under this subsection may assign a lead entity to manage the State stockpile, which may be a recipient of an award under section 319C–2(b). (F) Requirement of matching funds (i) In general Subject to clause (ii), the Secretary may not make an award under this subsection unless the applicant agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in this subsection, to make available non-Federal contributions toward such costs in an amount equal to— (I) for each of fiscal years 2023 and 2024, not less than $1 for each $10 of Federal funds provided in the award; (II) for each of fiscal years 2025 and 2026, not less than $1 for each $5 of Federal funds provided in the award; and (III) for fiscal year 2027 and each fiscal year thereafter, not less than $1 for each $3 of Federal funds provided in the award. (ii) Waiver (I) In general The Secretary may, upon the request of a State, waive the requirement under clause (i) in whole or in part if the Secretary determines that extraordinary economic conditions in the State in the fiscal year involved or in the previous fiscal year justify the waiver. (II) Applicability of waiver A waiver provided by the Secretary under this subparagraph shall apply only to the fiscal year involved. (3) Stockpiling activities and requirements A recipient of a grant, contract, or cooperative agreement under this subsection shall use such funds to carry out the following: (A) Maintaining a stockpile of appropriate drugs, vaccines and other biological products, medical devices, and other supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests) to be used during a public health emergency in such numbers, types, and amounts as the State determines necessary, consistent with such State’s stockpile plan. Such a recipient may not use funds to support the stockpiling of countermeasures as defined under subsection (c), unless the eligible entity provides justification for maintaining such products and the Secretary determines such appropriate and applicable. (B) Deploying the stockpile as required by the State to respond to an actual or potential public health emergency. (C) Replenishing and making necessary additions or modifications to the contents of such stockpile or stockpiles, including to address potential depletion. (D) In consultation with Federal, State, and local officials, take into consideration the availability, deployment, dispensing, and administration requirements of medical products within the stockpile. (E) Ensuring that procedures are followed for inventory management and accounting, and for the physical security of the stockpile, as appropriate. (F) Reviewing and revising, as appropriate, the contents of the stockpile on a regular basis to ensure that to the extent practicable, advanced technologies and medical products are considered. (G) Carrying out exercises, drills, and other training for purposes of stockpile deployment, dispensing, and administration of medical products, and for purposes of assessing the capability of such stockpile to address the medical supply needs of public health emergencies of varying types and scales, which may be conducted in accordance with requirements related to exercises, drills, and other training for recipients of awards under section 319C–1 or 319C–2, as applicable. (H) Carrying out other activities as the State determines appropriate, to support State efforts to prepare for, and respond to, public health threats. (4) State plan coordination The eligible entity under this subsection shall ensure appropriate coordination of the State stockpile plan developed pursuant to paragraph (2)(A)(ii) and the plans required pursuant to section 319C–1. (5) Guidance for States Not later than 180 days after the date of enactment of this subsection, the Secretary, acting through the Assistant Secretary for Preparedness and Response, shall issue guidance for States related to maintaining and replenishing a stockpile of medical products. The Secretary shall update such guidance as appropriate. (6) Assistance to States The Secretary shall provide assistance to States, including technical assistance, as appropriate, to maintain and improve State and local public health preparedness capabilities to distribute and dispense medical products from a State stockpile. (7) Coordination with the Strategic National Stockpile Each recipient of an award under this subsection shall ensure that the State stockpile plan developed pursuant to paragraph (2)(A)(ii) contains such information as the Secretary may require related to current inventory of supplies maintained pursuant to paragraph (3), and any plans to replenish such supplies, or procure new or alternative supplies. The Secretary shall use information obtained from State stockpile plans to inform the maintenance and management of the Strategic National Stockpile pursuant to subsection (a). (8) Performance and accountability (A) In general The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall develop and implement a process to review and audit entities in receipt of an award under this subsection, including by establishing metrics to ensure that each entity receiving such an award is carrying out activities in accordance with the applicable State stockpile plan. The Secretary may require entities to— (i) measure progress toward achieving the outcome goals; and (ii) at least annually, test, exercise, and rigorously evaluate the stockpile capacity and response capabilities of the entity, and report to the Secretary on the results of such test, exercise, and evaluation, and on progress toward achieving outcome goals, based on criteria established by the Secretary. (B) Notification of failure The Secretary shall develop and implement a process to notify entities that are determined by the Secretary to have failed to meet the requirements of the terms of an award under this subsection. Such process shall provide such entities with the opportunity to correct such noncompliance. An entity that fails to correct such noncompliance shall be subject to subparagraph (C). (C) Withholding of certain amounts from entities that fail to achieve benchmarks or submit State stockpile plan Beginning with fiscal year 2022, and in each succeeding fiscal year, the Secretary shall withhold from each entity that has failed substantially to meet the terms of an award under this subsection for at least 1 of the 2 immediately preceding fiscal years (beginning with fiscal year 2022), the amount allowed for administrative expenses described in described in paragraph (2)(D). (9) Authorization of appropriations For the purpose of carrying out this subsection, there are authorized to be appropriated $1,000,000,000 for each of fiscal years 2021 through 2030, to remain available until expended. (10) Advance appropriation (A) In general There is appropriated, out of amounts in the Treasury not otherwise appropriated, for fiscal year 2021, for necessary expenses to establish and maintain State medical stockpiles pursuant to this subsection, $10,000,000,000, to remain available until September 30, 2030. (B) Emergency designation (i) In general The amounts provided by this paragraph are designated as an emergency requirement pursuant to section 4(g) of the Statutory Pay-As-You-Go Act of 2010 ( 2 U.S.C. 933(g) ). (ii) Designation in Senate In the Senate, this paragraph is designated as an emergency requirement pursuant to section 4112(a) of H. Con. Res. 71 (115th Congress), the concurrent resolution on the budget for fiscal year 2018. (C) Application of provisions Amounts appropriated pursuant to this paragraph for fiscal year 2021 shall be subject to the requirements contained in Public Law 116–94 for funds for programs authorized under section 319F–2 of this Act. . 4. Strengthening the Strategic National Stockpile Section 319F–2 of the Public Health Service Act ( 42 U.S.C. 247d–6b ) is amended— (1) in subsection (a)— (A) in paragraph (2)(A), by adding and the contracts issued under paragraph (5) after paragraph (1) ; (B) in paragraph (3)(F), by striking Secretary of Homeland Security and inserting Secretary of Health and Human Services, in coordination with or at the request of, the Secretary of Homeland Security, ; (C) by redesignating paragraph (5) as paragraph (6); (D) by inserting after paragraph (4) the following: (5) Surge capacity The Secretary, in maintaining the stockpile under paragraph (1) and carrying out procedures under paragraph (3), may— (A) enter into contracts or cooperative agreements with vendors for procurement, maintenance, and storage of reserve amounts of drugs, vaccines and other biological products, medical devices, and other medical supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests in the stockpile), under such terms and conditions (including quantity, production schedule, maintenance costs, and price of product) as the Secretary may specify, including for purposes of— (i) maintenance and storage of reserve amounts of products intended to be delivered to the ownership of the Federal Government under the contract, which may consider costs of shipping, or otherwise transporting, handling, storage, and related costs for such product or products; and (ii) maintaining domestic manufacturing capacity of such products to ensure additional reserved production capacity of such products is available, and that such products are provided in a timely manner, to be delivered to the ownership of the Federal Government under the contract and deployed in the event that the Secretary determines that there is a need to quickly purchase additional quantities of such product; and (B) promulgate such regulations as the Secretary determines necessary to implement this paragraph. ; and (E) in subparagraph (A) of paragraph (6), as so redesignated— (i) in clause (viii), by striking ; and and inserting a semicolon; (ii) in clause (ix), by striking the period and inserting ; and ; and (iii) by adding at the end the following: (x) an assessment of the contracts or cooperative agreements entered into pursuant to paragraph (5). ; and (2) in subsection (c)(2)(C), by striking on an annual basis and inserting not later than March 15 of each year .