I 
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) in-
troduced the following bill; which was referred to the Committee on En-
ergy 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 Representa-
tives 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: 
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‘‘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, authoriza-
tion, scaling, procurement, and distribution of diagnostics 
and clinical and diagnostic laboratory testing capacity dur-
ing 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 infec-
tious 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 develop-
ment, authorization, scaling, procurement, and dis-
tribution 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 
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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 test-
ing stakeholders, including private-sector clin-
ical and diagnostic laboratories, diagnostic man-
ufacturers, health care product distributors, 
and research laboratories. 
‘‘(d) PUBLIC AVAILABILITY.—The Secretary, acting 
through the Assistant Secretary for Preparedness and Re-
sponse, 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 sub-
section (a) for a public health emergency, the Secretary, 
acting through the Assistant Secretary for Preparedness 
and Response, shall submit to the Congress a report evalu-
ating the effectiveness of activities implemented under the 
plan.’’. 
Æ 
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