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This bill would require the Secretary of Health and Human Services to create and publish a plan for how the federal government will quickly develop, approve, make, buy, and distribute diagnostic tests during a public health emergency. The goal is to make sure testing can be expanded fast when there is a dangerous outbreak or other major threat, such as a chemical, biological, radiological, or nuclear event. The plan would also help the government work better with drug and test makers, labs, distributors, states, local governments, and Tribal governments. It would look at how to build stronger testing capacity in the United States, use newer testing tools, and fix supply problems so tests can reach people more quickly.
- The plan must cover the full process for diagnostic tests, from early development and validation to manufacturing, buying, and distribution.
- It must consider new testing options, including high-volume lab tests, tests done at the point of care, and rapid tests people can use at home.
- The Secretary may contract with public and private groups to increase U.S. capacity and help state, local, and Tribal health departments respond quickly to disease outbreaks.
- The plan must be made public within one year after the bill becomes law and updated at least every three years after that.
Official Summaries
Diagnostics Testing Preparedness Plan Act of 2025
This bill requires the Department of Health and Human Services (HHS) to develop and publish a plan for the rapid development and distribution of diagnostic tests in response to a chemical, biological, radiological, or nuclear threat, including an emerging infectious disease, that causes or has significant potential to cause a declared public health emergency.
Specifically, HHS must coordinate with any relevant public and private entities, such as government entities and device manufacturers, in creating the plan and facilitating its collaborative implementation. The plan must take into consideration certain factors specified in the bill, including domestic testing capacity, novel technologies, and medical supply needs. HHS must publish the plan within one year after enactment of the bill and then update the plan every three years.
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1108 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 1108
To amend the Public Health Service Act to direct the Secretary of
Health and Human Services to develop a plan to improve the development
and distribution of diagnostic tests during a public health emergency,
and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 7, 2025
Mrs. Miller-Meeks (for herself, Ms. Schrier, Mr. Crenshaw, and Mr.
Carson) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to direct the Secretary of
Health and Human Services to develop a plan to improve the development
and distribution of diagnostic tests during a public health emergency,
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.
This Act may be cited as the ``Diagnostics Testing Preparedness
Plan Act of 2025''.
SEC. 2. IMPROVING DEVELOPMENT AND DISTRIBUTION OF DIAGNOSTIC TESTS.
Section 319B of the Public Health Service Act (42 U.S.C. 247d-2) is
amended to read as follows:
``SEC. 319B. IMPROVING DEVELOPMENT AND DISTRIBUTION OF DIAGNOSTIC
TESTS.
``(a) Diagnostic Testing Preparedness Plan.--The Secretary shall
develop, make publicly available, and update a plan for the rapid
development, validation, authorization, manufacture, procurement, and
distribution of diagnostic tests, and for rapid scaling of testing
capacity, in response to chemical, biological, radiological, or nuclear
threats, including emerging infectious diseases, for which a public
health emergency is declared under section 319, or that has significant
potential to cause such a public health emergency.
``(b) Purposes.--The purpose of the plan under subsection (a) shall
be to--
``(1) facilitate the development and utilization of
diagnostic tests;
``(2) describe the processes for the rapid development,
validation, authorization, manufacture, procurement, and
distribution of diagnostic tests, and for rapid scaling of
testing capacity; and
``(3) facilitate coordination and collaboration among
public and private entities to improve the rapid development
and utilization of diagnostic testing during a public health
emergency.
``(c) Considerations.--The plan under subsection (a) shall take
into consideration--
``(1) domestic capacity, including any such capacity
established through partnerships with public and private
entities pursuant to subsection (e), to support the
development, validation, manufacture, procurement, and
distribution of tests, and the rapid scaling of testing
capacity;
``(2) novel technologies and platforms that--
``(A) may be used to improve testing capabilities,
including--
``(i) high-throughput laboratory
diagnostics;
``(ii) point-of-care diagnostics; and
``(iii) rapid at-home diagnostics;
``(B) improve the accessibility of diagnostic
tests; and
``(C) facilitate the development and manufacture of
diagnostic tests;
``(3) medical supply needs related to testing, including
diagnostic testing, equipment, supplies, and component parts,
and any potential vulnerabilities related to the availability
of such medical supplies and related planning needs, consistent
with section 2811(b)(4)(J);
``(4) strategies for the rapid and efficient distribution
of tests locally, regionally, or nationwide and appropriate
scaling of laboratory testing capacity; and
``(5) assessment of such strategies through drills and
operational exercises carried out under section 2811(b)(4)(G),
as appropriate.
``(d) Coordination.--To inform the development and update of the
plan under subsection (a), and in carrying out activities to implement
such plan, the Secretary shall coordinate with industry, such as device
manufacturers, clinical and reference laboratories, and medical product
distributors, States, local governmental entities, Indian Tribes and
Tribal organizations, and other relevant public and private entities.
``(e) Capacity Building.--The Secretary may contract with public
and private entities, as appropriate, to increase domestic capacity in
the rapid development, validation, authorization, manufacture,
procurement, and distribution of diagnostic tests, as appropriate, to
State, local, and Tribal health departments and other appropriate
entities for immediate public health response activities to address an
infectious disease with respect to which a public health emergency is
declared under section 319, or that has significant potential to cause
such a public health emergency.
``(f) Deadlines for Plan.--
``(1) Public release.--Not later than one year after the
date of enactment of the Diagnostics Testing Preparedness Plan
Act of 2025, the Secretary shall publicly release the plan
developed under subsection (a).
``(2) Updates.--The Secretary shall update such plan not
less frequently than once every 3 years after the date of the
initial public release of the plan.''.
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