II 117th CONGRESS 2d Session S. 3534 IN THE SENATE OF THE UNITED STATES January 31, 2022 Ms. Baldwin (for herself and Mr. Cassidy ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To strengthen and expand activities related to genomic sequencing of pathogens, and for other purposes.

1. Short title This Act may be cited as the Tracking Pathogens Act . 2. Genomic sequencing (a) Guidance supporting genomic sequencing of pathogens collaboration The Secretary of Health and Human Services (referred to in this section as the Secretary ), acting through the Director of the Centers for Disease Control and Prevention and in consultation with the heads of other agencies and departments, as appropriate, shall issue guidance to support collaboration relating to genomic sequencing of pathogens, including the use of new and innovative approaches and technology for the detection, characterization, and sequencing of pathogens, to improve public health surveillance and preparedness and response activities, consistent with section 2824 of the Public Health Service Act, as added by subsection (b). Such guidance shall address the sharing, for public health surveillance purposes, of specimens of such pathogens, between appropriate entities and public health authorities pursuant to the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note), in a manner that protects personal privacy to the extent required by applicable Federal and State privacy law, at a minimum, and the appropriate use of sequence data derived from such specimens. (b) Genomic sequencing program Title XXVIII of the Public Health Service Act ( 42 U.S.C. 300hh et seq. ) is amended by adding at the end the following: 2824. Genomic sequencing, analytics, and public health surveillance of pathogens program (a) Genomic sequencing, analytics, and public health surveillance of pathogens program The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Director of the National Institutes of Health and heads of other departments and agencies, as appropriate, shall strengthen and expand activities related to genomic sequencing of pathogens, including new and innovative approaches and technology for the detection, characterization, and sequencing of pathogens, analytics, and public health surveillance, including— (1) continuing and expanding activities, which may include existing genomic sequencing activities related to advanced molecular detection, to— (A) identify and respond to emerging infectious disease threats; and (B) identify the potential use of genomic sequencing technologies, advanced computing, and other advanced technology, including strategies for environmental sampling, to inform surveillance activities and incorporate the use of such technologies, as appropriate, into related activities; (2) providing technical assistance and guidance to State, Tribal, local, and territorial public health departments to increase the capacity of such departments to perform genomic sequencing of pathogens, including recipients of funding under section 2821; (3) carrying out activities to enhance the capabilities of the public health workforce with respect to pathogen genomics, epidemiology, and bioinformatics, including through training; and (4) continuing and expanding activities, as applicable, with public and private entities, including relevant departments and agencies, laboratories, academic institutions, and industry. (b) Partnerships For the purposes of carrying out the activities described in subsection (a), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants, contracts, or cooperative agreements to academic and other laboratories with expertise in genomic sequencing for public health purposes, including new and innovative approaches to, and related technology for, the detection, characterization, and sequencing of pathogens. (c) Centers of excellence (1) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, as appropriate, award grants, contracts, or cooperative agreements to public health agencies or public health agency partnerships for the establishment or operation of centers of excellence to promote innovation in pathogen genomics and molecular epidemiology to improve the control of and response to pathogens that may cause a public health emergency. Such centers shall, as appropriate— (A) identify and evaluate the use of genomics, or other related technologies that may advance public health preparedness and response; (B) improve the identification, development, and use of tools for integrating and analyzing genomic and epidemiologic data; (C) assist with genomic surveillance of, and response to, infectious diseases, including analysis of pathogen genomic data; (D) conduct applied research to improve public health surveillance of, and response to, infectious diseases through innovation in pathogen genomics and molecular epidemiology; (E) develop and provide training materials for experts in the fields of genomics, microbiology, bioinformatics, epidemiology, and other fields, as appropriate; and (F) conduct workforce development through advanced training in academic laboratories. (2) Requirements To be eligible for an award under paragraph (1), an entity shall submit to the Secretary an application containing such information as the Secretary may require, including a description of how the entity will partner, as applicable, with academic institutions or a consortium of academic partners that have relevant expertise, such as microbial genomics, molecular epidemiology, or the application of bioinformatics or statistics. (d) Authorization For purposes of carrying out this section, there are authorized to be appropriated $175,000,000 for each of fiscal years 2023 through 2027. .