H.R. 1108

119 HR 1108 IH: Diagnostics Testing Preparedness Plan Act of 2025
 U.S. House of Representatives
 2025-02-07
 text/xml
 EN
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 I  119th CONGRESS  1st Session  H. R. 1108  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.
1.
Short title
This Act may be cited as the   Diagnostics Testing Preparedness Plan Act of 2025  .
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:
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.
 .