[House Report 118-523]
[From the U.S. Government Publishing Office]


118th Congress }                                             { Report
                        HOUSE OF REPRESENTATIVES
 2d Session    }                                             { 118-523

======================================================================



 
            SECURING AMERICA'S VACCINES FOR EMERGENCIES ACT 
                                 OF 2023

                                _______
                                

  May 23, 2024.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

        Mr. McHenry, from the Committee on Financial Services, 
                       submitted the following

                              R E P O R T

                        [To accompany H.R. 555]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Financial Services, to whom was referred 
the bill (H.R. 555) to amend the Defense Production Act of 1950 
to ensure the supply of certain medical materials essential to 
national defense, and for other purposes, having considered the 
same, reports favorably thereon with an amendment and 
recommends that the bill as amended do pass.
    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Securing America's Vaccines for 
Emergencies Act of 2023'' or the ``SAVE Act of 2023''.

SEC. 2. SECURING ESSENTIAL MEDICAL MATERIALS.

  (a) Statement of Policy.--Section 2(b) of the Defense Production Act 
of 1950 (50 U.S.C. 4502) is amended--
          (1) by redesignating paragraphs (3) through (8) as paragraphs 
        (4) through (9), respectively; and
          (2) by inserting after paragraph (2) the following:
          ``(3) authorities under this Act should be used when 
        appropriate to ensure the availability of medical materials 
        essential to national defense, including through measures 
        designed to secure the drug supply chain, and taking into 
        consideration the importance of United States competitiveness, 
        scientific leadership and cooperation, and innovative 
        capacity;''.
  (b) Strengthening Domestic Capability.--Section 107 of the Defense 
Production Act of 1950 (50 U.S.C. 4517) is amended--
          (1) in subsection (a), by inserting ``(including medical 
        materials)'' after ``materials''; and
          (2) in subsection (b)(1), by inserting ``(including medical 
        materials such as drugs (as defined under the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)), devices, and 
        biological products (as that term is defined in section 351 of 
        the Public Health Service Act (42 U.S.C. 262)) to diagnose, 
        cure, mitigate, treat, or prevent disease that are essential to 
        national defense)'' after ``essential materials''.
  (c) Strategy on Securing Supply Chains for Medical Materials.--Title 
I of the Defense Production Act of 1950 (50 U.S.C. 4511 et seq.) is 
amended by adding at the end the following:

``SEC. 109. STRATEGY ON SECURING SUPPLY CHAINS FOR MEDICAL MATERIALS.

  ``(a) In General.--Not later than 180 days after the date of the 
enactment of this section, the President, in consultation with the 
Secretary of Health and Human Services, the Secretary of Commerce, the 
Secretary of Homeland Security, and the Secretary of Defense, shall 
transmit a strategy to the appropriate Members of Congress that 
includes the following:
          ``(1) A detailed plan to use the authorities under this title 
        and title III, or any other provision of law, to ensure the 
        supply of medical materials (including drugs (as defined under 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
        seq.)), devices, and biological products (as that term is 
        defined in section 351 of the Public Health Service Act (42 
        U.S.C. 262)) to diagnose, cure, mitigate, treat, or prevent 
        disease) essential to national defense, to the extent necessary 
        for the purposes of this Act.
          ``(2) An analysis of vulnerabilities to existing supply 
        chains for such medical materials, and recommendations to 
        address the vulnerabilities.
          ``(3) Measures to be undertaken by the President to diversify 
        such supply chains, as appropriate and as required for national 
        defense.
          ``(4) A discussion of--
                  ``(A) any significant effects resulting from the plan 
                and measures described in this subsection on the 
                production, cost, or distribution of biological 
                products or any other devices or drugs;
                  ``(B) a timeline to ensure that essential components 
                of the supply chain for medical materials are not under 
                the exclusive control of a foreign government in a 
                manner that the President determines could threaten the 
                national defense of the United States; and
                  ``(C) efforts to mitigate any risks resulting from 
                the plan and measures described in this subsection to 
                United States competitiveness, scientific leadership, 
                and innovative capacity, including efforts to cooperate 
                and proactively engage with United States allies.
  ``(b) Progress Report.--Following submission of the strategy under 
subsection (a), the President shall submit to the appropriate Members 
of Congress an annual progress report until September 30, 2027, 
evaluating the implementation of the strategy, and may include updates 
to the strategy as appropriate. The strategy and progress reports shall 
be submitted in unclassified form but may contain a classified annex.
  ``(c) Appropriate Members of Congress.--In this section, the term 
`appropriate Members of Congress' means the Speaker, majority leader, 
and minority leader of the House of Representatives, the majority 
leader and minority leader of the Senate, the Chairman and Ranking 
Member of the Committee on Financial Services of the House of 
Representatives, and the Chairman and Ranking Member of the Committee 
on Banking, Housing, and Urban Affairs of the Senate.''.

SEC. 3. INVESTMENT IN SUPPLY CHAIN SECURITY.

  (a) In General.--Section 303 of the Defense Production Act of 1950 
(50 U.S.C. 4533) is amended by adding at the end the following:
  ``(h) Investment in Supply Chain Security.--
          ``(1) In general.--In addition to other authorities in this 
        title, the President may make available to an eligible entity 
        described in paragraph (2) payments to increase the security of 
        supply chains and supply chain activities, if the President 
        certifies to Congress not less than 30 days before making such 
        a payment that the payment is critical to meet national defense 
        requirements of the United States.
          ``(2) Eligible entity.--An eligible entity described in this 
        paragraph is an entity that--
                  ``(A) is organized under the laws of the United 
                States or any jurisdiction within the United States; 
                and
                  ``(B) produces--
                          ``(i) one or more critical components;
                          ``(ii) critical technology; or
                          ``(iii) one or more products or raw materials 
                        for the security of supply chains or supply 
                        chain activities.
          ``(3) Definitions.--In this subsection, the terms `supply 
        chain' and `supply chain activities' have the meanings given 
        those terms by the President by regulation.''.
  (b) Regulations.--
          (1) In general.--Not later than 90 days after the date of the 
        enactment of this Act, the President shall prescribe 
        regulations setting forth definitions for the terms ``supply 
        chain'' and ``supply chain activities'' for the purposes of 
        section 303(h) of the Defense Production Act of 1950 (50 U.S.C. 
        4533(h)), as added by subsection (a).
          (2) Scope of definitions.--The definitions required by 
        paragraph (1)--
                  (A) shall encompass--
                          (i) the organizations, people, activities, 
                        information, and resources involved in the 
                        delivery and operation of a product or service 
                        used by the Government; or
                          (ii) critical infrastructure as defined in 
                        Presidential Policy Directive 21 (February 12, 
                        2013; relating to critical infrastructure 
                        security and resilience); and
                  (B) may include variations as determined necessary 
                and appropriate by the President for purposes of 
                national defense.

                          PURPOSE AND SUMMARY

    Introduced on January 26, 2023, by Representative French 
Hill, H.R. 555, the Securing America's Vaccines for Emergencies 
Act of 2023 (SAVE Act), would amend sections of the Defense 
Production Act (DPA) (50 U.S.C. Sec. 4501-4568) to authorize 
the President to make payments to manufacturers to ensure the 
availability of medical materials important to the national 
defense. It would also require the President to submit a 
strategy to Congress that includes (1) a plan to use 
authorities under the Defense Production Act of 1950 to ensure 
the supply of medical materials essential to the national 
defense; and (2) plans to diversify, and address 
vulnerabilities in, supply chains for essential medical 
materials. Finally, it requires the President to submit to 
Congress annual progress reports through FY2025 evaluating the 
implementation of the strategy. By limiting the strategy to 
national defense, the SAVE Act would also help prevent the DPA 
from being abused for unrelated purposes. Further, the SAVE Act 
would require any strategy to consider potential tradeoffs 
between DPA and risks to U.S. competitiveness and innovation. 
These considerations will help the U.S. be better prepared for 
future emergencies that undermine national security.

                  BACKGROUND AND NEED FOR LEGISLATION

    The DPA allows the President to require companies to 
prioritize and accept contracts to meet national defense 
requirements. The DPA also allows for the President to 
incentivize production through loans, loan guarantees, and 
purchase commitments. The COVID-19 pandemic underscored the 
potential for infectious disease to undermine U.S. national 
security interests. Together with Operation Warp Speed, the 
previous Administration used the DPA 18 times to accelerate the 
delivery of COVID-19 therapeutics and related equipment. The 
DPA allowed the Administration to prioritize contracts with 
medical suppliers. While the previous Administration's 
invocation of the DPA was welcomed during the pandemic, there 
is no broader government strategy on the appropriate use of the 
DPA to address critical health emergencies, including its use 
to diversify medical supply chains away from China. This lack 
of clarity was the impetus for the SAVE Act.

                                HEARING

    Pursuant to clause 3(c)(6) of rule XIII, the following 
hearing was used to develop H.R. 555: The Committee on 
Financial Services held a hearing on February 7, 2023, titled: 
``Combatting the Economic Threat from China.''

                        COMMITTEE CONSIDERATION

    The Committee on Financial Services met in open session on 
February 28, 2023, and ordered H.R. 555 to be reported 
favorably to the House as amended by a recorded vote of 33 ayes 
to 1 nay (Record vote no. FC-22), a quorum being present. 
Before the question was called to order the bill favorably 
reported, the Committee adopted an amendment in the nature of a 
substitute offered by Mr. Hill by voice vote.

                            COMMITTEE VOTES

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the order to report legislation and amendments thereto. H.R. 
555 was ordered favorably reported to the House as amendment by 
a recorded vote of 33 ayes to 1 nay (Record vote no. FC-22), a 
quorum being present. 

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                      COMMITTEE OVERSIGHT FINDINGS

    Pursuant to clause 3(c) of rule XIII of the Rules of the 
House of Representatives, the findings and recommendations of 
the Committee based on oversight activities under clause 
2(b)(1) of rule X of the Rules of the House of Representatives, 
are incorporated in the descriptive portions of this report.

                    PERFORMANCE GOALS AND OBJECTIVES

    Pursuant to clause 3(c)(4) of rule XIII of the Rules of the 
House of Representatives, the goal of H.R. 555 is to help the 
U.S. be better prepared for future emergencies that undermine 
national security.

                 CONGRESSIONAL BUDGET OFFICE ESTIMATES

    Pursuant to clause 3(d)(1) of House rule XIII, the 
Committee adopts as its own the cost estimate prepared by the 
Director of the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


       NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX  
                            EXPENDITURES 

    Pursuant to clause 3(c)(2) of rule XIII of the Rules of the 
House of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1973.

                       FEDERAL MANDATES STATEMENT

    Pursuant to section 423 of the Unfunded Mandates Reform 
Act, the Committee adopts as its own the estimate of the 
Federal mandates prepared by the Director of the Congressional 
Budget Office.

                      ADVISORY COMMITTEE STATEMENT

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  APPLICABILITY TO LEGISLATIVE BRANCH

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

                         EARMARK IDENTIFICATION

    Pursuant to clause 9 of rule XXI of the Rules of the House 
of Representatives, the Committee has carefully reviewed the 
provisions of the bill and states that the provisions of the 
bill do not contain any congressional earmarks, limited tax 
benefits, or limited tariff benefits within the meaning of the 
rule.

                    DUPLICATION OF FEDERAL PROGRAMS

    Pursuant to clause 3(c)(5) of rule XIII of the Rules of the 
House of Representatives, the Committee states that no 
provision of the bill establishes or reauthorizes a program of 
the Federal Government known to be duplicative of another 
Federal program, including any program that was included in a 
report to Congress pursuant to section 21 of the Public Law 
111-139 or the most recent Catalog of Federal Domestic 
Assistance.

             SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Sec. 1: Short title

    This Act may be cited as the ``Securing America's Vaccines 
for Emergencies Act of 2023'' or the ``SAVE Act of 2023''.

Sec. 2: Securing essential medical materials

    This Section amends the DPA's statement of policy to 
specify the availability of medical materials is essential to 
national defense.

Sec. 3: Investment in supply chain security

    This Section requires the President to submit a strategy to 
employ the DPA to secure medical supplies essential for 
national defense, identify vulnerabilities to the medical 
supply chain, and work to diversify the supply chain so that 
key elements are not under the exclusive control of adversarial 
governments. Finally, the bill requires progress updates to 
Congress on implementation of the strategy.

                                  [all]