Sec. 623. Improving development and distribution of diagnostic tests

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Section 319B of the Public Health Service Act ( 42 U.S.C. 247d–2 ) is amended to read as follows: The Secretary shall develop, make publicly available, not later than 1 year after the date of enactment of the Pandemic and All-Hazards Preparedness and Response Act, and update not less frequently than every 3 years thereafter, 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 purpose of the plan under subsection

(a)shall be to— facilitate the development and utilization of diagnostic tests; describe the processes for the rapid development, validation, authorization, manufacture, procurement, and distribution of diagnostic tests, and for rapid scaling of testing capacity; and facilitate coordination and collaboration among public and private entities to improve the rapid development and utilization of diagnostic testing during a public health emergency. The plan under subsection

(a)shall take into consideration— 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; novel technologies and platforms that— may be used to improve testing capabilities, including— high-throughput laboratory diagnostics; point-of-care diagnostics; and rapid at-home diagnostics; improve the accessibility of diagnostic tests; and facilitate the development and manufacture of diagnostic tests; 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); strategies for the rapid and efficient distribution of tests locally, regionally, or nationwide and appropriate scaling of laboratory testing capacity; and assessment of such strategies through drills and operational exercises carried out under section 2811(b)(4)(G), as appropriate. 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 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. .

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42 USC 247d–2

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Sec. 623

Improving development and distribution of diagnostic tests

Cite42 USC 247d–2

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