To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes.

Subjects: Health


<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3795 Introduced in House (IH)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                H. R. 3795

To amend the Public Health Service Act to require the development of a 
 diagnostic testing preparedness plan to be used during public health 
                  emergencies, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 5, 2023

   Mr. Pence (for himself, Mr. Carson, Mr. Bucshon, and Ms. Schrier) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act to require the development of a 
 diagnostic testing preparedness plan to be used during public health 
                  emergencies, 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. DIAGNOSTIC TESTING PREPAREDNESS PLAN.

    The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by 
inserting after section 319F-5 of such Act (42 U.S.C. 247d-6f) the 
following:

``SECTION 319F-6. DIAGNOSTIC TESTING PREPAREDNESS PLAN.

    ``(a) In General.--The Secretary, acting through the Assistant 
Secretary for Preparedness and Response, and in consultation with the 
heads of relevant Federal agencies, shall develop not later than 1 year 
after the date of enactment of this section and update not less than 
every 3 years thereafter a plan for rapid development, authorization, 
scaling, procurement, and distribution of diagnostics and clinical and 
diagnostic laboratory testing capacity during a public health emergency 
declared under section 319.
    ``(b) Purposes.--The purposes of the plan under subsection (a) 
shall be--
            ``(1) to facilitate the development of diagnostics for use 
        with respect to a novel chemical, biological, radiological, or 
        nuclear threat or an emerging infectious disease, including any 
        such high-throughput laboratory diagnostic, point-of-care 
        diagnostic, or rapid at-home or point-of-use diagnostic; and
            ``(2) to describe the processes for rapid development, 
        authorization, scaling, procurement, and distribution of 
        diagnostics and clinical and diagnostic laboratory testing 
        capacity.
    ``(c) Public-Private Coordination.--
            ``(1) In general.--The Secretary, acting through the 
        Assistant Secretary for Preparedness and Response, shall 
        include within the plan under subsection (a) a plan for public-
        private coordination on national diagnostic testing during a 
        public health emergency.
            ``(2) Contents.--The plan under paragraph (1) shall be 
        designed to facilitate coordination and collaboration among--
                    ``(A) government agencies; and
                    ``(B) critical private-sector diagnostic testing 
                stakeholders, including private-sector clinical and 
                diagnostic laboratories, diagnostic manufacturers, 
                health care product distributors, and research 
                laboratories.
    ``(d) Public Availability.--The Secretary, acting through the 
Assistant Secretary for Preparedness and Response, shall make the plan 
under subsection (a) publicly available.
    ``(e) Reports to Congress.--Not later than 1 year after commencing 
implementation of the plan under subsection (a) for a public health 
emergency, the Secretary, acting through the Assistant Secretary for 
Preparedness and Response, shall submit to the Congress a report 
evaluating the effectiveness of activities implemented under the 
plan.''.
                                 &lt;all&gt;
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