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Congressional Research Service
Version 00 · Introduced in House · Feb 7, 2025
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.
People & committees
Rep. Miller-Meeks, Mariannette [R-IA-1] · R–IA
Legislative record
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Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We also preserved the text version used in the PlainBill explanation below.
Source last updated: Jun 16, 2025. Consult Congress.gov for the current record.
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PlainBill explanation
Based on the full Introduced in House · 2025-02-07 text. This explanation has not received human editorial review. This overview describes the proposal’s major provisions; it does not establish what its real-world effects would be.
The bill would require the Secretary to publish and regularly update a plan to develop, validate, authorize, manufacture, purchase, and distribute diagnostic tests quickly in response to certain public health threats. The plan would also address expanding testing capacity. The Secretary would have to coordinate with manufacturers, laboratories, distributors, and State, local, and Tribal entities, among others. The bill would allow contracts to expand domestic testing capacity for infectious diseases covered by a declared public health emergency or with significant potential to cause one.
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.
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.
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.
Section 1 would name the legislation the Diagnostics Testing Preparedness Plan Act of 2025. Section 2 would replace section 319B of the Public Health Service Act with the proposed diagnostic-testing provisions.
This Act may be cited as the Diagnostics Testing Preparedness Plan Act of 2025.
Section 319B of the Public Health Service Act (42 U.S.C. 247d–2) is amended to read as follows:
The required plan would cover chemical, biological, radiological, and nuclear threats, including emerging infectious diseases. It would apply when a public health emergency has been declared under section 319 or a threat has significant potential to cause such an emergency. Its stated purposes include facilitating test development and use, explaining how testing can expand quickly, and improving cooperation between public and private entities; these are objectives, not demonstrated results.
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.
Planning would have to consider domestic testing capacity, including capacity built through partnerships with public and private entities. It would also have to consider new technologies for processing many laboratory tests, testing where patients receive care, and rapid testing at home, along with accessibility and test development and manufacturing.
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;
The plan would have to consider testing equipment, supplies, component parts, and potential weaknesses in their availability. Related planning would have to be consistent with the referenced section 2811(b)(4)(J).
(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);
The plan would have to consider strategies for distributing tests quickly and efficiently at local, regional, or national levels and expanding laboratory testing capacity appropriately. It would also consider evaluating those strategies through drills and operational exercises under section 2811(b)(4)(G), as appropriate.
(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.
The Secretary would have to coordinate with industry, States, local governments, Indian Tribes, Tribal organizations, and other relevant public and private entities when developing, updating, and implementing the plan. The industry examples include device manufacturers, clinical and reference laboratories, and medical-product distributors.
(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.
The Secretary could, but would not be required to, contract with public and private entities to expand domestic capacity across the testing process. This authority would support immediate responses by State, local, and Tribal health departments and other appropriate entities to infectious diseases covered by a declared public health emergency or with significant potential to cause one.
(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.
If enacted, the bill would require public release of the plan within one year after enactment. Updates would be required at least once every three years after the initial public release.
(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.
The supplied actions snapshot, updated June 16, 2025, records introduction in the House and referral to the House Committee on Energy and Commerce on February 7, 2025.
Source snapshot updated 2025-06-16T11:33:14Z. 2025-02-07: Referred to the House Committee on Energy and Commerce. 2025-02-07: Introduced in House
A closer look
Reviewed version: Introduced in House · 2025-02-07. These findings describe provisions and who may benefit; they are not judgments of waste, corruption, or motive.
This review covers the supplied bill text. “None identified” does not rule out provisions in later versions or accompanying reports and disclosures.
Provisions outside the bill’s main subject, or policy changes attached to appropriations.
None identified in the reviewed text
No unrelated rider was identified in the complete supplied introduced-text version. This conclusion does not establish absence in other versions or accompanying materials.
Spending directed to particular recipients or places outside ordinary competitive or formula-based allocation.
None identified in the reviewed text
No congressionally directed spending for particular recipients or places was identified in the complete supplied introduced-text version. This conclusion is limited to that text and does not establish absence in other versions or accompanying materials.
Narrow exceptions, exemptions, or preferential treatment that warrant a closer look.
None identified in the reviewed text
No materially narrow carve-out, special exemption, or preferential treatment was identified in the complete supplied introduced-text version. This conclusion does not establish absence in other versions or accompanying materials.
Full text preserved for this analysis. Legislative record snapshot: Jun 16, 2025. How PlainBill uses AI