II 117th CONGRESS 1st Session S. 236 IN THE SENATE OF THE UNITED STATES February 4, 2021 Ms. Baldwin (for herself, Mr. Brown , Mrs. Feinstein , Mr. Blumenthal , Mr. Markey , Mr. Peters , and Ms. Klobuchar ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To improve activities for the gathering of data on, and the tracking of, new variants of COVID–19.

1. Short title This Act may be cited as the Tracking COVID–19 Variants Act . 2. Findings Congress finds that— (1) new variants of SARS–CoV–2 are being identified around the world and in the United States; (2) identifying new variants of SARS–CoV–2 and analyzing the epidemiology of variants are critical to the continued response to the COVID–19 pandemic and efforts to prepare for future pandemics; (3) national sequence-based surveillance will enable the United States to best identify new variants; and (4) the United States is conducting sequence-based surveillance of approximately 0.3 percent of COVID–19 cases, lagging far behind other nations. 3. Guidance The Secretary of Health and Human Services (referred to in this Act as the Secretary ), acting through the Director of the Centers for Disease Control and Prevention, shall issue national guidance to support scientific collaboration relating to viral sequencing as a key strategy to the COVID–19 response activities of the United States, including guidance related to the sharing of specimens obtained from patients, the secure sharing of information about such specimens necessary for an effective public health response to COVID–19, and the appropriate use of viral sequence data derived from such specimens. 4. Funding for genomic sequencing, analytics, and disease surveillance (a) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish and implement a program to strengthen and expand activities related to genomic sequencing, analytics, and disease surveillance. (b) Use of funds In implementing the program under subsection (a), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall— (1) conduct and expand activities, including supporting the Advanced Molecular Detection Program, to sequence the genome of circulating strains of the SARS–CoV–2 virus, to identify mutations in the SARS–CoV–2 virus, and to survey the circulation and transmission of variant strains of the SARS–CoV–2 virus; (2) provide technical assistance and guidance and award grants or cooperative agreements to State, local, Tribal, or territorial public health departments to increase the capacity of such departments to sequence the genome of circulating strains of the SARS–CoV–2 virus, to identify mutations in the SARS–CoV–2 virus, to use genomic sequencing to identify outbreaks and clusters of COVID–19 infections caused by specific variants of SARS–CoV–2, and to develop effective COVID–19 response strategies based on genetic sequencing and surveillance data; and (3) carry out activities to both enhance the informatics capabilities of the public health workforce and expand the numbers of qualified public health informaticians available to analyze and interpret data produced through advanced molecular detection and genomic sequencing to establish, expand, or enhance capacity for conducting statistical public health research. (c) Implementation (1) Cooperative agreements for technical assistance Cooperative agreements described in subsection (b)(2) may include partnerships with academic research institutions. (2) Capacity for sharing and linking The capacity referred to in subsection (b)(3) may include sharing and linking information and accessing and utilizing linked health data files in accordance with established data use agreements with data holders (including electronic case reporting, electronic health records, and electronic test orders and results) with public health agencies and related systems, including the National Death Index, immunization information systems, syndromic surveillance systems, laboratory information management systems, electronic case reporting systems, medical examiner case management systems, and Patient Unified Look-up Systems for Emergencies. (d) Facilities Funds appropriated under subsection (f) may be used for grants for the construction, alteration, or renovation of non-federally owned facilities to improve genetic sequencing and surveillance capabilities at the State and local level. (e) Expansion of ongoing activities Funds appropriated under subsection (f) may be used for grants for the maintenance and expansion of current and ongoing activities to analyze and interpret data produced through advanced molecular detection and genomic sequencing, including for emerging public health threats. (f) Authorization of appropriations There is authorized to be appropriated, $2,000,000,000 for fiscal year 2021 to carry out this section, to remain available until expended. 5. Evidence-building demonstration program (a) In general The Secretary, acting through the Director of the National Center for Health Statistics, shall carry out a demonstration program to expand the data linkage program of the Department of Health and Human Services, consisting of Federal statistical and programmatic datasets from specified Federal entities, as authorized by subchapter III of chapter 35 of title 44, United States Code, for the purpose of facilitating statistical public health research on trends and patterns across specifically defined, statistically relevant populations, with a particular focus on linking social determinants of health data, including with respect to— (1) food insecurity; (2) housing instability; (3) transportation access; (4) safety; (5) social connection and isolation; (6) financial resource strain; (7) stress; (8) race and ethnicity; and (9) sexual orientation and gender identity. (b) Activities Activities carried out under the demonstration program under this section shall include— (1) assessing the availability of identified and deidentified data sets held by Federal, State, local, and non-Federal entities that may be useful for research described in subsection (a); and (2) using existing authorities and linkages of data in accordance with subchapter III of chapter 35 of title 44, United States Code, when relevant to request the submission of datasets to the National Center for Health Statistics for linking. (c) Limitation The Secretary shall limit access to data under the demonstration program under this section— (1) to Federal statistical agencies and qualified public and private researchers, as determined by the Director of the National Center for Health Statistics; (2) for a period to be specified by the Secretary; and (3) exclusively for the purpose described in subsection (a). (d) Process for making data available (1) In general Consistent with paragraph (2), the Secretary shall establish a rigorous process for making data available and usable under the demonstration program under this section. (2) Requirements Prior to making any data available under the demonstration program under this section, by an entity described in subsection (b)(1) to another entity described in subsection (b)(1)— (A) the receiving entity shall submit to the Director of the National Center for Health Statistics an application for data for the purpose described in subsection (a); and (B) the Director shall approve or deny such request in writing, including in the case of a denial an explanation of the reasons for the denial. (e) Rulemaking (1) No delay on implementation The Secretary— (A) shall begin the implementation of the demonstration program under this section upon the date of enactment of this Act; and (B) shall not delay such implementation for purposes of promulgating the regulations required by paragraph (2). (2) Promulgation The Secretary shall— (A) promulgate regulations for carrying out this section; and (B) specify in such regulations the allowed and disallowed purposes for sharing and linking data through the program, including areas of potential research. (f) Website The Secretary shall maintain a publicly accessible website— (1) providing information about the demonstration program under this section; (2) facilitating stakeholder participation in such demonstration program; (3) facilitating oversight of such demonstration program; (4) providing lists of datasets from Federal and non-Federal entities; (5) providing lists of identified and deidentified datasets; (6) identifying linked datasets; (7) delineating a process to protect privacy and confidentiality; (8) identifying sources of the datasets; and (9) delineating categories of personal data. (g) Program requirements The demonstration program under this section shall be designed to— (1) support data matching services for agencies and researchers using the National Death Index; and (2) facilitate collaboration with States and private entities to examine, update, and modernize the fee structure of the National Death Index to support a broad range of data queries. (h) Contracted entities (1) In general Subject to the availability of appropriations, the Secretary may enter into contracts with eligible entities, as appropriate, for infrastructure and support services in carrying out the demonstration program under this section. (2) Eligibility To be eligible for a contract under paragraph (1), an entity shall— (A) demonstrate core capabilities for data sharing, data linkage, and compliance with subchapter III of chapter 35 of title 44, United States Code; and (B) adhere to security standards in accordance with the Federal Risk and Authorization Management Program (or any successor program). (i) Rule of construction Nothing in this section shall be construed to authorize the availability or use of data for— (1) law enforcement; or (2) any determination of the eligibility of an individual for any direct or indirect payment, benefit, or service. (j) Report to Congress Not later than 1 year after the date of enactment of this Act, and annually thereafter, the Secretary shall submit a report to the Congress on the implementation of this section, including— (1) identification of best State practices for— (A) sharing data with, and reporting data to, the National Death Index; and (B) ensuring the quality of such data; and (2) recommendations to improve— (A) such sharing and reporting; and (B) access to the National Death Index by researchers. (k) Authorization of appropriations There is authorized to be appropriated to carry out this section, $10,000,000 for fiscal year 2021, to remain available until expended.