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Last progress March 6, 2025 (11 months ago)
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Last progress March 3, 2025 (11 months ago)
Referred to the House Committee on Energy and Commerce.
Requires the HHS Secretary to create, publish within one year, and regularly update a national plan for rapidly developing, validating, authorizing, manufacturing/procuring, and distributing diagnostic tests during public-health emergencies (including chemical, biological, radiological, nuclear threats and emerging infectious diseases). The plan must describe end-to-end processes, address domestic capacity and technologies, include distribution strategies, be developed with public/private coordination, and be refreshed at least every three years; the Secretary may use contracts to build domestic testing capacity.
Amends Section 319B of the Public Health Service Act (42 U.S.C. 247d–2) to add a new titled section, “Improving development and distribution of diagnostic tests.”
The Secretary shall develop, make publicly available, and update a diagnostic testing preparedness plan for rapid development, validation, authorization, manufacture, procurement, distribution, and scaling of diagnostic tests in response to chemical, biological, radiological, or nuclear threats or emerging infectious diseases that cause or could cause a public health emergency under section 319.
Purpose of the plan: (1) facilitate development and use of diagnostic tests; (2) describe processes for rapid development, validation, authorization, manufacture, procurement, distribution, and scaling of testing capacity; (3) facilitate coordination and collaboration among public and private entities to improve rapid development and use of diagnostic testing during a public health emergency.
The plan must consider domestic capacity (including capacity from public–private partnerships) to support development, validation, manufacture, procurement, distribution, and rapid scaling of tests.
The plan must consider novel technologies and platforms that may improve testing capabilities — specifically high-throughput laboratory diagnostics, point-of-care diagnostics, and rapid at-home diagnostics — and how those technologies can improve accessibility and facilitate development and manufacture of tests.
Who is affected and how:
Federal agencies (HHS, CDC, FDA, BARDA and procurement offices): will need to lead plan development, coordinate interagency and external stakeholders, establish procedures for rapid test review/authorization, and potentially manage contracts to increase domestic capacity. This adds planning and coordination responsibilities and may require allocation of staff/time and future contracting/funding.
Diagnostic test developers and medical/device manufacturers: will be engaged in planning, may receive predictable pathways and timelines for validation and authorization during emergencies, and could benefit from government contracting to expand domestic manufacturing capacity.
Clinical diagnostic laboratories (hospital labs, independent labs, public health labs): stand to gain clearer channels for receiving tests quickly, predictable distribution plans, and guidance on validation and use; they may also be asked to participate in validation networks and data-sharing arrangements.
State, local, Tribal, and territorial public health agencies and health-care providers: the plan must account for distribution to these users; they will be recipients of guidance and tests and may be asked to coordinate on implementation and equity-focused distribution strategies.
Patients and the general public: benefit from faster availability of validated tests and more consistent access during emergencies, improving detection, treatment, and outbreak control—but benefits depend on timely implementation and adequate funding.
Domestic supply chain and workforce (manufacturing, logistics, distribution): potential growth in demand and contracting opportunities to expand capacity; requires workforce development and investment in facilities/equipment.
Potential costs and implementation challenges:
The requirement to create and update an operational plan imposes administrative work and coordination costs on HHS and partners; building domestic capacity through contracts will require appropriations or use of existing authorities and could be resource-intensive.
Effectiveness depends on follow-through: publishing a plan is a necessary step but will only improve emergency response if paired with adequate contracting, appropriations, regulatory agility, and operational execution at state/local levels.
Regulatory coordination (e.g., with FDA for authorizations) and supply-chain constraints (raw materials, trained workforce) could limit speed without parallel investments.
Overall impact: strengthens federal preparedness and aims to shorten the time between emerging threats and widespread availability of validated diagnostics, while requiring interagency coordination and potential investment to realize those gains.
Last progress February 7, 2025 (12 months ago)
Introduced on February 7, 2025 by Mariannette Miller-Meeks