Title: Strengthening America’s Strategic National Stockpile Act of 2021
Policy area: Health

Summary:
Strengthening America's Strategic National Stockpile Act of 2021
This bill makes changes to the administration and management of the Strategic National Stockpile.
Among these changes, the bill requires the Department of Health and Human Services (HHS) to ensure the contents of the stockpile remain in working order. HHS may enter into maintenance service contracts to carry out this requirement.
Furthermore, as part of its management of the stockpile, HHS must establish and maintain domestic reserves of certain supplies, including by entering into cooperative agreements or partnerships to access facilities and equipment to produce these supplies. The authority for such agreements and partnerships terminates on September 30, 2024.
Additionally, the bill temporarily authorizes HHS to award grants to states for maintaining stockpiles of certain equipment and supplies for use during public health emergencies.
HHS must also develop transparent processes for the use and distribution of supplies from the stockpile that address, for example, the prioritization of requests. Additionally, during the COVID-19 emergency, the Office of the Assistant Secretary for Preparedness and Response must report monthly on requests for supplies from states, tribes, and other jurisdictions. These reports must include the rationale for any partially fulfilled or denied requests.
Lastly, the Government Accountability Office must study the feasibility of establishing user fees to offset costs for procuring single-source materials for, and distributing such materials from, the stockpile.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 1974 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 1974

 To amend the Public Health Service Act with respect to the Strategic 
              National Stockpile, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              June 8, 2021

Ms. Hassan (for herself and Mr. Cassidy) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act with respect to the Strategic 
              National Stockpile, and for other purposes.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Strengthening 
America's Strategic National Stockpile Act of 2021''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Equipment maintenance.
Sec. 3. Supply chain flexibility manufacturing pilot.
Sec. 4. GAO study on the feasibility and benefits of a user fee 
                            agreement.
Sec. 5. Grants for State strategic stockpiles.
Sec. 6. Action reporting.
Sec. 7. Improved, transparent processes.
Sec. 8. Authorization of appropriations.

SEC. 2. EQUIPMENT MAINTENANCE.

    Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) 
is amended--
            (1) in subsection (a)(3)--
                    (A) in subparagraph (I), by striking ``; and'' and 
                inserting a semicolon;
                    (B) in subparagraph (J), by striking the period at 
                the end and inserting a semicolon; and
                    (C) by inserting the following new subparagraph at 
                the end:
                    ``(K) ensure contents of the stockpile remain in 
                good working order and, as appropriate, conduct 
                maintenance services on contents of the stockpile and 
                dispose of contents that are no longer in working 
                order; and''; and
            (2) in subsection (c)(7)(B), by adding at the end the 
        following new clause:
                            ``(ix) Equipment maintenance service.--In 
                        carrying out this section, the Secretary may 
                        enter into contracts for the procurement of 
                        equipment maintenance services.''.

SEC. 3. SUPPLY CHAIN FLEXIBILITY MANUFACTURING PILOT.

    (a) In General.--Section 319F-2(a)(3) of the Public Health Service 
Act (42 U.S.C. 247d-6b(a)(3)), as amended by section 2, is further 
amended by adding at the end the following new subparagraph:
                    ``(L) enhance medical supply chain elasticity and 
                establish and maintain domestic reserves of critical 
                medical supplies (including such personal protective 
                equipment, ancillary medical supplies, and other 
                applicable supplies required for the administration of 
                drugs, vaccines and other biological products, and 
                other medical devices (including diagnostic tests) as 
                the Secretary, in consultation with the Public Health 
                Emergency Medical Countermeasures Enterprise, 
                determines appropriate) by--
                            ``(i) increasing or contracting emergency 
                        stock of critical medical supplies, as 
                        appropriate;
                            ``(ii) geographically diversifying domestic 
                        production of such medical supplies, as 
                        appropriate;
                            ``(iii) entering into cooperative 
                        agreements or partnerships with respect to 
                        manufacturing lines, facilities, and equipment 
                        for the domestic production of such medical 
                        supplies; and
                            ``(iv) managing, either directly or through 
                        cooperative agreements with manufacturers and 
                        distributors, domestic reserves established 
                        under this subparagraph by refreshing and 
                        replenishing stock of such medical supplies.''.
    (b) Reporting; Sunset.--Section 319F-2(a) of the Public Health 
Service Act (42 U.S.C. 247d-6b(a)) is amended by adding at the end the 
following:
            ``(6) Reporting.--Not later than September 30, 2023, the 
        Secretary shall submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives a report on the 
        details of each cooperative agreement or partnership entered 
        into under paragraph (3)(L), including the amount expended by 
        the Secretary on each such cooperative agreement or 
        partnership.
            ``(7) Sunset.--The authority to enter into cooperative 
        agreements or partnerships pursuant to paragraph (3)(L) shall 
        cease to be effective on September 30, 2024.''.
    (c) Funding.--Section 319F-2(f) of the Public Health Service Act 
(42 U.S.C. 247d-6b(f)) is amended by adding at the end the following:
            ``(3) Supply chain elasticity.--
                    ``(A) In general.--For the purpose of carrying out 
                subsection (a)(3)(L), there is authorized to be 
                appropriated $500,000,000 for each of fiscal years 2022 
                through 2024, to remain available until expended.
                    ``(B) Relation to other amounts.--The amount 
                authorized to be appropriated by subparagraph (A) for 
                the purpose of carrying out subsection (a)(3)(L) is in 
                addition to any other amounts available for such 
                purpose.''.

SEC. 4. GAO STUDY ON THE FEASIBILITY AND BENEFITS OF A USER FEE 
              AGREEMENT.

    (a) In General.--The Comptroller General of the United States shall 
conduct a study to investigate the feasibility of establishing user 
fees to offset certain Federal costs attributable to the procurement of 
single-source materials for the Strategic National Stockpile under 
section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) and 
distributions of such materials from the Stockpile. In conducting this 
study, the Comptroller General shall consider, to the extent 
information is available--
            (1) whether entities receiving such distributions generate 
        profits from those distributions;
            (2) any Federal costs attributable to such distributions;
            (3) whether such user fees would provide the Secretary with 
        funding to potentially offset procurement costs of such 
        materials for the Strategic National Stockpile, including an 
        analysis of an overall estimate of such annual procurement 
        costs;
            (4) whether funding certainty through regular 
        appropriations would facilitate more appropriate long term 
        investments and contracts related to the Strategic National 
        Stockpile; and
            (5) any other issues the Comptroller General identifies as 
        relevant.
    (b) Report.--Not later than February 1, 2024, the Comptroller 
General of the United States shall submit to Congress a report on the 
findings and conclusions of the study under subsection (a).

SEC. 5. GRANTS FOR STATE STRATEGIC STOCKPILES.

    Title III of the Public Health Service Act is amended by inserting 
after section 319F-4 of such Act (42 U.S.C. 247d-6e) the following new 
section:

``SEC. 319F-5. GRANTS FOR STATE STRATEGIC STOCKPILES.

    ``(a) In General.--The Secretary may establish a pilot program 
consisting of awarding grants to States to expand or maintain a 
strategic stockpile of commercially available drugs, devices, personal 
protective equipment, and other products determined by the State to be 
essential in the event of a public health emergency.
    ``(b) Allowable Use of Funds.--
            ``(1) Uses.--A State receiving a grant under this section 
        may use the grant funds to--
                    ``(A) acquire commercially available products 
                listed pursuant to paragraph (2) for inclusion in the 
                State's strategic stockpile;
                    ``(B) store, maintain, and distribute products in 
                such stockpile; and
                    ``(C) conduct planning in connection with such 
                activities.
            ``(2) List.--The Secretary shall develop and publish a list 
        of the products that are eligible, as described in subsection 
        (a), for inclusion in a State's strategic stockpile using funds 
        received under this section.
            ``(3) Consultation.--In developing the list under paragraph 
        (2) and otherwise determining the allowable uses of grant funds 
        under this section, the Secretary shall consult with States and 
        relevant stakeholders, including public health organizations.
    ``(c) Funding Requirement.--The Secretary may not obligate or 
expend any funds to award grants or fund any previously awarded grants 
under this section for a fiscal year unless the total amount made 
available to carry out section 319F-2 for such fiscal year is equal to 
or greater than the total amount of funds made available to carry out 
section 319F-2 for fiscal year 2021.
    ``(d) Matching Funds.--
            ``(1) In general.--With respect to the costs of expanding 
        and maintaining a strategic stockpile through a grant under 
        this section, as a condition on receipt of the grant, a State 
        shall make available (directly) non-Federal contributions in 
        cash toward such costs in an amount that is equal to not less 
        than the amount of Federal funds provided through the grant.
            ``(2) Waiver.--The Secretary may waive the requirement of 
        paragraph (1) with respect to a State for the first 2 years of 
        the State receiving a grant under this section if the Secretary 
        determines that such waiver is needed for the State to 
        establish a strategic stockpile described in subsection (a).
    ``(e) Technical Assistance.--The Secretary shall provide technical 
assistance to States in establishing, expanding, and maintaining a 
stockpile described in subsection (a).
    ``(f) Annual Reports.--Each State receiving a grant under this 
section shall submit to the Secretary an annual report on the contents 
of its State stockpile, including any expansions or contractions in 
such contents over the past year.
    ``(g) Definition.--In this section, the term `drug' has the meaning 
given to that term in section 201 of the Federal Food, Drug, and 
Cosmetic Act.
    ``(h) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $3,500,000,000 for each of 
fiscal years 2022 through 2024, to remain available until expended.
    ``(i) Sunset.--The authority vested by this section terminates at 
the end of fiscal year 2024.''.

SEC. 6. ACTION REPORTING.

    (a) In General.--The Secretary of Health and Human Services or the 
Assistant Secretary for Preparedness and Response, in consultation with 
the Administrator of the Federal Emergency Management Agency, shall--
            (1) not later than 30 days after the date of enactment of 
        this Act, issue a report to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives regarding all 
        State, local, Tribal, and territorial requests for supplies 
        from the Strategic National Stockpile related to COVID-19; and
            (2) not less than every 30 days thereafter through the end 
        of the emergency period (as such term is defined in section 
        1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b-
        5(g)(1)(B))), submit to such committees an updated version of 
        such report.
    (b) Reporting Period.--
            (1) Initial report.--The initial report under subsection 
        (a) shall address all requests described in such subsection 
        made during the period--
                    (A) beginning on January 31, 2020; and
                    (B) ending on the date that is 30 days before the 
                date of submission of the report.
            (2) Updates.--Each update to the report under subsection 
        (a) shall address all requests described in such subsection 
        made during the period--
                    (A) beginning at the end of the previous reporting 
                period under this section; and
                    (B) ending on the date that is 30 days before the 
                date of submission of the updated report.
    (c) Contents of Report.--The report under subsection (a) (and 
updates thereto) shall include--
            (1) the details of each request described in such 
        subsection, including--
                    (A) the specific medical countermeasures, devices, 
                personal protective equipment, and other materials 
                requested; and
                    (B) the amount of such materials requested; and
            (2) the outcomes of each request described in subsection 
        (a), including--
                    (A) whether the request was wholly fulfilled, 
                partially fulfilled, or denied;
                    (B) if the request was wholly or partially 
                fulfilled, the fulfillment amount; and
                    (C) if the request was partially fulfilled or 
                denied, a rationale and public health assessment for 
                such outcome.

SEC. 7. IMPROVED, TRANSPARENT PROCESSES.

    (a) In General.--Not later than January 1, 2022, the Secretary of 
Health and Human Services shall develop and implement improved, 
transparent processes for the use and distribution of 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) in the Strategic National Stockpile under section 319F-2 of the 
Public Health Service Act (42 U.S.C. 247d-6b) (in this section referred 
to as the ``Stockpile'').
    (b) Processes.--The processes developed under subsection (a) shall 
include--
            (1) the form and manner in which States, localities, Indian 
        Tribes, and territories are required to submit requests for 
        supplies from the Stockpile;
            (2) the criteria used by the Secretary of Health and Human 
        Services in responding to such requests, including the reasons 
        for fulfilling or denying such requests;
            (3) what circumstances result in prioritization of 
        distribution of supplies from the Stockpile to States, 
        localities, Indian Tribes, or territories;
            (4) clear plans for future, urgent communication between 
        the Secretary and States, localities, Indian Tribes, and 
        territories regarding the outcome of such requests; and
            (5) any differences in the processes developed under 
        subsection (a) for geographically related emergencies, such as 
        weather events, and national emergencies, such as pandemics.
    (c) Classification.--The processes developed under subsection (a) 
shall be unclassified to the greatest extent possible consistent with 
national security. The Secretary of Health and Human Services may 
classify portions of such processes as necessary to protect national 
security.
    (d) Report to Congress.--Not later than January 1, 2022, the 
Secretary of Health and Human Services shall--
            (1) submit a report to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives regarding the 
        improved, transparent processes developed under this section;
            (2) include in such report recommendations for 
        opportunities for communication (by telebriefing, phone calls, 
        or in-person meetings) between the Secretary and States, 
        localities, Indian Tribes, and territories regarding such 
        improved, transparent processes; and
            (3) submit such report in unclassified form to the greatest 
        extent possible, except that the Secretary may include a 
        classified appendix if necessary to protect national security.

SEC. 8. AUTHORIZATION OF APPROPRIATIONS.

    Section 319F-2(f)(1) of the Public Health Service Act (42 U.S.C. 
247d-6b(f)(1)) is amended by striking ``$610,000,000 for each of fiscal 
years 2019 through 2023'' and inserting ``$705,000,000 for each of 
fiscal years 2022 through 2024''.
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