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H.R. 1108House119th Congress (2025-2027)In Committee

Diagnostics Testing Preparedness Plan Act of 2025

Sponsored by Mariannette Miller-MeeksRep. Mariannette Miller-Meeks (R-IA)
Introduced February 7, 2025

AI-Generated Summary

Updated November 24, 2025 at 2:51 AM UTC

The Diagnostics Testing Preparedness Plan Act of 2025 amends the Public Health Service Act to require the Secretary of Health and Human Services to develop a comprehensive plan for rapid creation and distribution of diagnostic tests during public‑health emergencies, such as chemical, biological, radiological, nuclear threats or emerging infectious diseases. The plan is intended to improve testing capacity, coordinate public‑private efforts, and address supply and distribution challenges. It applies to federal agencies, state and local governments, tribal entities, and private industry involved in test development and distribution.

Key Provisions

  • The HHS Secretary must create a publicly‑available plan that outlines how to quickly develop, validate, authorize, manufacture, procure, and distribute diagnostic tests during a declared public‑health emergency or a threat with high potential for one.
  • The plan must describe how to scale testing capacity and detail coordination among federal, state, local, tribal, industry, and other public‑private partners.
  • It must consider domestic production capacity, new testing technologies (high‑throughput labs, point‑of‑care, at‑home tests), medical‑supply needs, distribution strategies, and include regular drills or exercises to assess readiness.
  • The Secretary may contract with public or private entities to build domestic capacity for rapid test development and distribution to health departments and other responders.
  • The completed plan must be released within one year of the law’s enactment and updated at least every three years.

Legislative Activity

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HouseIntro Referral Latest Action

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

February 7, 2025

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HouseIntro Referral

Introduced in House

February 7, 2025

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

February 7, 2025

Bill Text

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Introduced in HouseIssued February 7, 2025

I

119th CONGRESS

1st Session

H. R. 1108

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.

1.

Short title

This Act may be cited as the Diagnostics Testing Preparedness Plan Act of 2025.

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:

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.

.