HR3795-118

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: 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. The purposes of the plan under subsection (a) shall be— 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 to describe the processes for rapid development, authorization, scaling, procurement, and distribution of diagnostics and clinical and diagnostic laboratory testing capacity. 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. The plan under paragraph (1) shall be designed to facilitate coordination and collaboration among— government agencies; and critical private-sector diagnostic testing stakeholders, including private-sector clinical and diagnostic laboratories, diagnostic manufacturers, health care product distributors, and research laboratories. The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall make the plan under subsection (a) publicly available. 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. 319F–6.Diagnostic testing preparedness plan(a)In generalThe 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)PurposesThe 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 generalThe 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)ContentsThe 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 availabilityThe Secretary, acting through the Assistant Secretary for Preparedness and Response, shall make the plan under subsection (a) publicly available.(e)Reports to CongressNot 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..

319F–6. Diagnostic testing preparedness plan 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. The purposes of the plan under subsection (a) shall be— 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 to describe the processes for rapid development, authorization, scaling, procurement, and distribution of diagnostics and clinical and diagnostic laboratory testing capacity. 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. The plan under paragraph (1) shall be designed to facilitate coordination and collaboration among— government agencies; and critical private-sector diagnostic testing stakeholders, including private-sector clinical and diagnostic laboratories, diagnostic manufacturers, health care product distributors, and research laboratories. The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall make the plan under subsection (a) publicly available. 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.