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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. DIAGNOSTIC TESTING PREPAREDNESS PLAN. 3 The Public Health Service Act (42 U.S.C. 201 et 4 seq.) is amended by inserting after section 319F–5 of such 5 Act (42 U.S.C. 247d–6f) the following: 6 VerDate Sep 11 2014 05:18 Jun 07, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3795.IH H3795 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 3795 IH ‘‘SECTION 319F–6. DIAGNOSTIC TESTING PREPAREDNESS 1 PLAN. 2 ‘‘(a) IN GENERAL.—The Secretary, acting through 3 the Assistant Secretary for Preparedness and Response, 4 and in consultation with the heads of relevant Federal 5 agencies, shall develop not later than 1 year after the date 6 of enactment of this section and update not less than every 7 3 years thereafter a plan for rapid development, authoriza- 8 tion, scaling, procurement, and distribution of diagnostics 9 and clinical and diagnostic laboratory testing capacity dur- 10 ing a public health emergency declared under section 319. 11 ‘‘(b) PURPOSES.—The purposes of the plan under 12 subsection (a) shall be— 13 ‘‘(1) to facilitate the development of diagnostics 14 for use with respect to a novel chemical, biological, 15 radiological, or nuclear threat or an emerging infec- 16 tious disease, including any such high-throughput 17 laboratory diagnostic, point-of-care diagnostic, or 18 rapid at-home or point-of-use diagnostic; and 19 ‘‘(2) to describe the processes for rapid develop- 20 ment, authorization, scaling, procurement, and dis- 21 tribution of diagnostics and clinical and diagnostic 22 laboratory testing capacity. 23 ‘‘(c) PUBLIC-PRIVATE COORDINATION.— 24 ‘‘(1) IN GENERAL.—The Secretary, acting 25 through the Assistant Secretary for Preparedness 26 VerDate Sep 11 2014 05:18 Jun 07, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3795.IH H3795 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 3795 IH and Response, shall include within the plan under 1 subsection (a) a plan for public-private coordination 2 on national diagnostic testing during a public health 3 emergency. 4 ‘‘(2) CONTENTS.—The plan under paragraph 5 (1) shall be designed to facilitate coordination and 6 collaboration among— 7 ‘‘(A) government agencies; and 8 ‘‘(B) critical private-sector diagnostic test- 9 ing stakeholders, including private-sector clin- 10 ical and diagnostic laboratories, diagnostic man- 11 ufacturers, health care product distributors, 12 and research laboratories. 13 ‘‘(d) PUBLIC AVAILABILITY.—The Secretary, acting 14 through the Assistant Secretary for Preparedness and Re- 15 sponse, shall make the plan under subsection (a) publicly 16 available. 17 ‘‘(e) REPORTS TO CONGRESS.—Not later than 1 year 18 after commencing implementation of the plan under sub- 19 section (a) for a public health emergency, the Secretary, 20 acting through the Assistant Secretary for Preparedness 21 and Response, shall submit to the Congress a report evalu- 22 ating the effectiveness of activities implemented under the 23 plan.’’. 24 Æ VerDate Sep 11 2014 05:18 Jun 07, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\H3795.IH H3795 kjohnson on DSK79L0C42PROD with BILLS