Improving Development and Distribution of Diagnostic Tests Act

“319B. Improving development and distribution of diagnostic tests

“(a) Framework—The Secretary shall develop, make publicly available not later than 1 year after the date of enactment of the Improving Development and Distribution of Diagnostic Tests Act, and update not less frequently than every 3 years thereafter, a strategic framework 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 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. Such strategic framework shall take into consideration—

“(1) domestic capacity, including any such capacity established through partnerships with public and private entities pursuant to subsection (c), to support the development, validation, authorization, manufacture, procurement, and distribution of tests;

“(2) novel technologies and platforms that may be used to improve testing capabilities, including high-throughput laboratory diagnostics, and point-of-care diagnostics, and any such technologies to improve the accessibility of such tests, and 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, consistent with section 2811(b)(4)(J);

“(4) strategies for the rapid and efficient distribution of tests locally, regionally, or nationwide and scaling laboratory testing capacity; and

“(5) assessing such strategies through drills and operational exercises carried out under section 2811(b)(4)(G), as appropriate.

“(b) Coordination—To inform the development and update of the framework under subsection (a), and in carrying out activities to implement such framework, the Secretary shall coordinate with industry, States, local governmental entities, Indian Tribes and Tribal organizations, Urban Indian organizations, and other relevant public and private entities.

“(c) 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.”