II 

117TH CONGRESS 

1ST SESSION S. 236 

To improve activities for the gathering of data on, and the tracking of, 

new variants of COVID–19. 

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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Tracking COVID–19 

5 Variants Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds that— 


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1 (1) new variants of SARS–CoV–2 are being 

2 identified around the world and in the United 

3 States; 

4 (2) identifying new variants of SARS–CoV–2 

5 and analyzing the epidemiology of variants are crit6 ical to the continued response to the COVID–19 

7 pandemic and efforts to prepare for future 

8 pandemics; 

9 (3) national sequence-based surveillance will en10 able the United States to best identify new variants; 

11 and 

12 (4) the United States is conducting sequence13 based surveillance of approximately 0.3 percent of 

14 COVID–19 cases, lagging far behind other nations. 

15 SEC. 3. GUIDANCE. 

16 The Secretary of Health and Human Services (re17 ferred to in this Act as the ‘‘Secretary’’), acting through 

18 the Director of the Centers for Disease Control and Pre19 vention, shall issue national guidance to support scientific 

20 collaboration relating to viral sequencing as a key strategy 

21 to the COVID–19 response activities of the United States, 

22 including guidance related to the sharing of specimens ob23 tained from patients, the secure sharing of information 

24 about such specimens necessary for an effective public 


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1 health response to COVID–19, and the appropriate use 

2 of viral sequence data derived from such specimens. 

3 SEC. 4. FUNDING FOR GENOMIC SEQUENCING, ANALYTICS, 

4 AND DISEASE SURVEILLANCE. 

5 (a) IN GENERAL.—The Secretary, acting through the 

6 Director of the Centers for Disease Control and Preven7 tion, shall establish and implement a program to strength8 en and expand activities related to genomic sequencing, 

9 analytics, and disease surveillance. 

10 (b) USE OF FUNDS.—In implementing the program 

11 under subsection (a), the Secretary, acting through the 

12 Director of the Centers for Disease Control and Preven13 tion, shall— 

14 (1) conduct and expand activities, including 

15 supporting the Advanced Molecular Detection Pro16 gram, to sequence the genome of circulating strains 

17 of the SARS–CoV–2 virus, to identify mutations in 

18 the SARS–CoV–2 virus, and to survey the circula19 tion and transmission of variant strains of the 

20 SARS–CoV–2 virus; 

21 (2) provide technical assistance and guidance 

22 and award grants or cooperative agreements to 

23 State, local, Tribal, or territorial public health de24 partments to increase the capacity of such depart25 ments to sequence the genome of circulating strains 


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1 of the SARS–CoV–2 virus, to identify mutations in 

2 the SARS–CoV–2 virus, to use genomic sequencing 

3 to identify outbreaks and clusters of COVID–19 in4 fections caused by specific variants of SARS–CoV– 

5 2, and to develop effective COVID–19 response 

6 strategies based on genetic sequencing and surveil7 lance data; and 

8 (3) carry out activities to both enhance the 

9 informatics capabilities of the public health work10 force and expand the numbers of qualified public 

11 health informaticians available to analyze and inter12 pret data produced through advanced molecular de13 tection and genomic sequencing to establish, expand, 

14 or enhance capacity for conducting statistical public 

15 health research. 

16 (c) IMPLEMENTATION.— 

17 (1) COOPERATIVE AGREEMENTS FOR TECH18 NICAL ASSISTANCE.—Cooperative agreements de19 scribed in subsection (b)(2) may include partner20 ships with academic research institutions. 

21 (2) CAPACITY FOR SHARING AND LINKING.— 

22 The capacity referred to in subsection (b)(3) may in23 clude sharing and linking information and accessing 

24 and utilizing linked health data files in accordance 

25 with established data use agreements with data holdVerDate Sep 11 2014 22:40 Feb 23, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S236.IS S236

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1 ers (including electronic case reporting, electronic 

2 health records, and electronic test orders and re3 sults) with public health agencies and related sys4 tems, including the National Death Index, immuni5 zation information systems, syndromic surveillance 

6 systems, laboratory information management sys7 tems, electronic case reporting systems, medical ex8 aminer case management systems, and Patient Uni9 fied Look-up Systems for Emergencies. 

10 (d) FACILITIES.—Funds appropriated under sub11 section (f) may be used for grants for the construction, 

12 alteration, or renovation of non-federally owned facilities 

13 to improve genetic sequencing and surveillance capabilities 

14 at the State and local level. 

15 (e) EXPANSION OF ONGOING ACTIVITIES.—Funds 

16 appropriated under subsection (f) may be used for grants 

17 for the maintenance and expansion of current and ongoing 

18 activities to analyze and interpret data produced through 

19 advanced molecular detection and genomic sequencing, in20 cluding for emerging public health threats. 

21 (f) AUTHORIZATION OF APPROPRIATIONS.—There is 

22 authorized to be appropriated, $2,000,000,000 for fiscal 

23 year 2021 to carry out this section, to remain available 

24 until expended. 


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1 SEC. 5. EVIDENCE-BUILDING DEMONSTRATION PROGRAM. 

2 (a) IN GENERAL.—The Secretary, acting through the 

3 Director of the National Center for Health Statistics, shall 

4 carry out a demonstration program to expand the data 

5 linkage program of the Department of Health and Human 

6 Services, consisting of Federal statistical and pro7 grammatic datasets from specified Federal entities, as au8 thorized by subchapter III of chapter 35 of title 44, 

9 United States Code, for the purpose of facilitating statis10 tical public health research on trends and patterns across 

11 specifically defined, statistically relevant populations, with 

12 a particular focus on linking social determinants of health 

13 data, including with respect to— 

14 (1) food insecurity; 

15 (2) housing instability; 

16 (3) transportation access; 

17 (4) safety; 

18 (5) social connection and isolation; 

19 (6) financial resource strain; 

20 (7) stress; 

21 (8) race and ethnicity; and 

22 (9) sexual orientation and gender identity. 

23 (b) ACTIVITIES.—Activities carried out under the 

24 demonstration program under this section shall include— 

25 (1) assessing the availability of identified and 

26 deidentified data sets held by Federal, State, local, 


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1 and non-Federal entities that may be useful for re2 search described in subsection (a); and 

3 (2) using existing authorities and linkages of 

4 data in accordance with subchapter III of chapter 35 

5 of title 44, United States Code, when relevant to re6 quest the submission of datasets to the National 

7 Center for Health Statistics for linking. 

8 (c) LIMITATION.—The Secretary shall limit access to 

9 data under the demonstration program under this sec10 tion— 

11 (1) to Federal statistical agencies and qualified 

12 public and private researchers, as determined by the 

13 Director of the National Center for Health Statis14 tics; 

15 (2) for a period to be specified by the Sec16 retary; and 

17 (3) exclusively for the purpose described in sub18 section (a). 

19 (d) PROCESS FOR MAKING DATA AVAILABLE.— 

20 (1) IN GENERAL.—Consistent with paragraph 

21 (2), the Secretary shall establish a rigorous process 

22 for making data available and usable under the dem23 onstration program under this section. 

24 (2) REQUIREMENTS.—Prior to making any 

25 data available under the demonstration program 


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1 under this section, by an entity described in sub2 section (b)(1) to another entity described in sub3 section (b)(1)— 

4 (A) the receiving entity shall submit to the 

5 Director of the National Center for Health Sta6 tistics an application for data for the purpose 

7 described in subsection (a); and 

8 (B) the Director shall approve or deny 

9 such request in writing, including in the case of 

10 a denial an explanation of the reasons for the 

11 denial. 

12 (e) RULEMAKING.— 

13 (1) NO DELAY ON IMPLEMENTATION.—The 

14 Secretary— 

15 (A) shall begin the implementation of the 

16 demonstration program under this section upon 

17 the date of enactment of this Act; and 

18 (B) shall not delay such implementation 

19 for purposes of promulgating the regulations re20 quired by paragraph (2). 

21 (2) PROMULGATION.—The Secretary shall— 

22 (A) promulgate regulations for carrying 

23 out this section; and 

24 (B) specify in such regulations the allowed 

25 and disallowed purposes for sharing and linking 


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1 data through the program, including areas of 

2 potential research. 

3 (f) WEBSITE.—The Secretary shall maintain a pub4 licly accessible website— 

5 (1) providing information about the demonstra6 tion program under this section; 

7 (2) facilitating stakeholder participation in such 

8 demonstration program; 

9 (3) facilitating oversight of such demonstration 

10 program; 

11 (4) providing lists of datasets from Federal and 

12 non-Federal entities; 

13 (5) providing lists of identified and deidentified 

14 datasets; 

15 (6) identifying linked datasets; 

16 (7) delineating a process to protect privacy and 

17 confidentiality; 

18 (8) identifying sources of the datasets; and 

19 (9) delineating categories of personal data. 

20 (g) PROGRAM REQUIREMENTS.—The demonstration 

21 program under this section shall be designed to— 

22 (1) support data matching services for agencies 

23 and researchers using the National Death Index; 

24 and 


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1 (2) facilitate collaboration with States and pri2 vate entities to examine, update, and modernize the 

3 fee structure of the National Death Index to support 

4 a broad range of data queries. 

5 (h) CONTRACTED ENTITIES.— 

6 (1) IN GENERAL.—Subject to the availability of 

7 appropriations, the Secretary may enter into con8 tracts with eligible entities, as appropriate, for infra9 structure and support services in carrying out the 

10 demonstration program under this section. 

11 (2) ELIGIBILITY.—To be eligible for a contract 

12 under paragraph (1), an entity shall— 

13 (A) demonstrate core capabilities for data 

14 sharing, data linkage, and compliance with sub15 chapter III of chapter 35 of title 44, United 

16 States Code; and 

17 (B) adhere to security standards in accord18 ance with the Federal Risk and Authorization 

19 Management Program (or any successor pro20 gram). 

21 (i) RULE OF CONSTRUCTION.—Nothing in this sec22 tion shall be construed to authorize the availability or use 

23 of data for— 

24 (1) law enforcement; or 


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1 (2) any determination of the eligibility of an in2 dividual for any direct or indirect payment, benefit, 

3 or service. 

4 (j) REPORT TO CONGRESS.—Not later than 1 year 

5 after the date of enactment of this Act, and annually 

6 thereafter, the Secretary shall submit a report to the Con7 gress on the implementation of this section, including— 

8 (1) identification of best State practices for— 

9 (A) sharing data with, and reporting data 

10 to, the National Death Index; and 

11 (B) ensuring the quality of such data; and 

12 (2) recommendations to improve— 

13 (A) such sharing and reporting; and 

14 (B) access to the National Death Index by 

15 researchers. 

16 (k) AUTHORIZATION OF APPROPRIATIONS.—There is 

17 authorized to be appropriated to carry out this section, 

18 $10,000,000 for fiscal year 2021, to remain available until 

19 expended. 

Æ 


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