[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3635 Engrossed in House (EH)]

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117th CONGRESS
  1st Session
                                H. R. 3635

_______________________________________________________________________

                                 AN ACT


 
 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. Reimbursable transfers.
Sec. 3. Equipment maintenance.
Sec. 4. Supply chain flexibility manufacturing pilot.
Sec. 5. GAO study on the feasibility and benefits of a user fee 
                            agreement.
Sec. 6. Grants for State strategic stockpiles.
Sec. 7. Action reporting.
Sec. 8. Improved, transparent processes.
Sec. 9. Authorization of appropriations.

SEC. 2. REIMBURSABLE TRANSFERS.

    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) Transfers and reimbursements.--
                    ``(A) In general.--Without regard to chapter 5 of 
                title 40, United States Code, the Secretary may 
                transfer to any Federal department or agency, on a 
                reimbursable basis, any drugs, vaccines and other 
                biological products, medical devices, and other 
                supplies in the stockpile if--
                            ``(i) the transferred supplies are less 
                        than one year from expiry;
                            ``(ii) the stockpile is able to replenish 
                        the supplies, as appropriate; and
                            ``(iii) the Secretary decides the transfer 
                        is in the best interest of the United States 
                        Government.
                    ``(B) Use of reimbursement.--Reimbursement derived 
                from the transfer of supplies pursuant to subparagraph 
                (A) may, to the extent and in the amounts made 
                available in advance in appropriations Acts, be used by 
                the Secretary to carry out this section. Funds made 
                available pursuant to the preceding sentence are in 
                addition to any other funds that may be made available 
                for such purpose.
                    ``(C) Rule of construction.--This paragraph shall 
                not be construed to preclude transfers of products in 
                the stockpile under other authorities.
                    ``(D) Report.--Not later than September 30, 2023, 
                the Secretary shall submit to the Committee on Energy 
                and Commerce of the House of Representatives and the 
                Committee on Health, Education, Labor, and Pensions of 
                the Senate a report on each transfer made under this 
                paragraph and the amount received by the Secretary in 
                exchange for that transfer.
                    ``(E) Sunset.--The authority to make transfers 
                under this paragraph shall cease to be effective on 
                September 30, 2024.''.

SEC. 3. 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''; 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. 4. 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 3, 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 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)) 
                by--
                            ``(i) increasing emergency stock of 
                        critical medical supplies;
                            ``(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)), as amended by section 2, is further 
amended by adding at the end the following:
            ``(7) Reporting.--Not later than September 30, 2023, the 
        Secretary shall submit to the Committee on Energy and Commerce 
        of the House of Representatives and the Committee on Health, 
        Education, Labor and Pensions of the Senate 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.
            ``(8) 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. 5. 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; and
            (4) 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 the Congress a report on 
the findings and conclusions of the study under subsection (a).

SEC. 6. 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 deemed 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 2022.
    ``(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 two 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) 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.
    ``(g) 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.
    ``(h) Sunset.--The authority vested by this section terminates at 
the end of fiscal year 2024.''.

SEC. 7. 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 Energy and 
        Commerce of the House of Representatives and the Committee on 
        Health, Education, Labor, and Pensions of the Senate 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, 2022; 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 for such outcome.

SEC. 8. 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, 
        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, Tribes, or territories;
            (4) clear plans for future, urgent communication between 
        the Secretary and States, localities, 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 Energy and Commerce 
        of the House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate 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, 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. 9. 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''.

            Passed the House of Representatives October 20, 2021.

            Attest:

                                                                 Clerk.
117th CONGRESS

  1st Session

                               H. R. 3635

_______________________________________________________________________

                                 AN ACT

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