[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2672 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                S. 2672

  To require the Secretary of Health and Human Services to develop a 
  strategic framework to improve the development and distribution of 
diagnostic tests in response to chemical, biological, radiological, or 
                            nuclear threats.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 27, 2023

Ms. Smith (for herself and Ms. Collins) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To require the Secretary of Health and Human Services to develop a 
  strategic framework to improve the development and distribution of 
diagnostic tests in response to chemical, biological, radiological, or 
                            nuclear threats.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Improving Development and 
Distribution of Diagnostic Tests Act''.

SEC. 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:

``SEC. 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.''.
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