Tracking COVID–19 Variants Act
Bill: S.236 | Sponsor: Sen. Baldwin, Tammy (D-WI)
Policy area: Health

Summary:
Tracking COVID-19 Variants Act
This bill expands viral genomic sequencing, disease surveillance, and other public health research activities.
Specifically, the Centers for Disease Control and Prevention (CDC) must issue guidance on the sequencing of the virus that causes COVID-19 (i.e., coronavirus disease 2019). Additionally, the CDC must establish a program to strengthen genomic sequencing, analytics, and disease surveillance activities. As part of this program, the CDC must provide grants and technical assistance to health departments to build their capacity to carry out such activities.
Furthermore, the National Center for Health Statistics (NCHS) must carry out a demonstration program to expand an existing program that links different federal data sets for statistical public health research, including research on food insecurity, housing instability, and other social determinants of health. In particular, the program must support linkages with the National Death Index, a database of death records maintained by the NCHS.

To improve activities for the gathering of data on, and the tracking 
                     of, new variants of COVID-19.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Tracking COVID-19 Variants Act''.

SEC. 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.

SEC. 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.

SEC. 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.

SEC. 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.
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