42 U.S.C. § 300hh–34: Genomic sequencing…

Summary

The Secretary must strengthen and expand work on sequencing germs, analyzing those sequences, and using them for public health tracking. The Secretary will do this through the CDC Director and with advice from the NIH and other agencies. The work must keep and grow existing sequencing programs, explore new technologies and computing tools, help detect and respond to new infectious threats, give technical help to State, Tribal, local, and territorial health departments (including those already getting related funding), train the public health workforce in genomics and bioinformatics, and work with public and private partners. The Secretary may give grants, contracts, or cooperative agreements to labs, academic groups, and others with genomics expertise. The Secretary must also fund centers of excellence that research and test new genomics tools, improve ways to combine and analyze genetic and outbreak data, support genomic surveillance and response, do applied research, and create training materials. Applicants for these centers must explain how they will partner with academic experts.

Title 42, §300hh–34

The Public Health and Welfare, Source: USLM XML via OLRC

(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 through 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 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 300hh–31 of this title;

(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 entities, including 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 shall, as appropriate, award grants, contracts, or cooperative agreements to public health agencies 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; and

(E)develop and provide training materials for experts in the fields of genomics, microbiology, bioinformatics, epidemiology, and other fields, as appropriate.

(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.

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Guidance Supporting Genomic Sequencing of Pathogens Collaboration Pub. L. 117–328, div. FF, title II, § 2212(a), Dec. 29, 2022, 136 Stat. 5732, provided that: “The Secretary of Health and Human Services (referred to in this section as the ‘Secretary’), in consultation with the heads of other Federal departments or agencies, 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 [42 U.S.C. 300hh–34], as added by subsection (b). Such guidance shall address the secure sharing, for public health surveillance purposes, of specimens of such pathogens, between appropriate entities and public health authorities, consistent with the

Regulations

promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 [Pub. L. 104–191] (42 U.S.C. 1320d–2 note), as applicable, and in a manner that protects personal privacy to the extent required by applicable privacy law, at a minimum, and the appropriate use of sequence data derived from such specimens.”

§300hh–34 Genomic Sequencing, Analytics, and Public Health Surveillance of Pathogens Program

Summary

Title 42, §300hh–34

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Regulations

Citations & Metadata