119-hr1108

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1108 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 1108

 To amend the Public Health Service Act to direct the Secretary of 
Health and Human Services to develop a plan to improve the development 
and distribution of diagnostic tests during a public health emergency, 
 and for other purposes.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 February 7, 2025

 Mrs. Miller-Meeks (for herself, Ms. Schrier, Mr. Crenshaw, and Mr. 
 Carson) introduced the following bill; which was referred to the 
 Committee on Energy and Commerce

_______________________________________________________________________

 A BILL

 To amend the Public Health Service Act to direct the Secretary of 
Health and Human Services to develop a plan to improve the development 
and distribution of diagnostic tests during a public health emergency, 
 and for other purposes.

 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 ``Diagnostics Testing Preparedness 
Plan Act of 2025''.

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) Diagnostic Testing Preparedness Plan.--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.
 ``

    (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.
 ``
            (c) Considerations.--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;
 ``

    (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) ;
 ``

    (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.
 ``
            (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.
 ``

    (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.
 ``

    (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.''.
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