Title: Preparing for the Next Pandemic Act
Policy area: Health

Summary:
Preparing for the Next Pandemic Act
This bill provides funding to the Biomedical Advanced Research and Development Authority (BARDA) for activities to expand domestic manufacturing of medical countermeasures and to the Office of the Assistant Secretary for Preparedness and Response for grants to establish state stockpiles of medical supplies for use during public health emergencies. These funds are designated as an emergency requirement, which exempts them from discretionary spending limits and other budget enforcement rules.
The bill also makes other changes to BARDA's authorities and duties with respect to countermeasures and the administration of the Strategic National Stockpile.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4231 Introduced in Senate (IS)]

<DOC>






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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Preparing for the Next Pandemic 
Act''.

SEC. 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)).

SEC. 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.''.

SEC. 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''.
                                 <all>