Tracking COVID–19 Variants Act

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 fol- lowing 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Tracking COVID–19 4 Variants Act’’. 5 SEC. 2. FINDINGS. 6 Congress finds that— 7 VerDate Sep 11 2014 22:40 Feb 23, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S236.IS S236 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 236 IS (1) new variants of SARS–CoV–2 are being 1 identified around the world and in the United 2 States; 3 (2) identifying new variants of SARS–CoV–2 4 and analyzing the epidemiology of variants are crit- 5 ical to the continued response to the COVID–19 6 pandemic and efforts to prepare for future 7 pandemics; 8 (3) national sequence-based surveillance will en- 9 able the United States to best identify new variants; 10 and 11 (4) the United States is conducting sequence- 12 based surveillance of approximately 0.3 percent of 13 COVID–19 cases, lagging far behind other nations. 14 SEC. 3. GUIDANCE. 15 The Secretary of Health and Human Services (re- 16 ferred to in this Act as the ‘‘Secretary’’), acting through 17 the Director of the Centers for Disease Control and Pre- 18 vention, shall issue national guidance to support scientific 19 collaboration relating to viral sequencing as a key strategy 20 to the COVID–19 response activities of the United States, 21 including guidance related to the sharing of specimens ob- 22 tained from patients, the secure sharing of information 23 about such specimens necessary for an effective public 24 VerDate Sep 11 2014 22:40 Feb 23, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S236.IS S236 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 236 IS health response to COVID–19, and the appropriate use 1 of viral sequence data derived from such specimens. 2 SEC. 4. FUNDING FOR GENOMIC SEQUENCING, ANALYTICS, 3 AND DISEASE SURVEILLANCE. 4 (a) IN GENERAL.—The Secretary, acting through the 5 Director of the Centers for Disease Control and Preven- 6 tion, shall establish and implement a program to strength- 7 en and expand activities related to genomic sequencing, 8 analytics, and disease surveillance. 9 (b) USE OF FUNDS.—In implementing the program 10 under subsection (a), the Secretary, acting through the 11 Director of the Centers for Disease Control and Preven- 12 tion, shall— 13 (1) conduct and expand activities, including 14 supporting the Advanced Molecular Detection Pro- 15 gram, to sequence the genome of circulating strains 16 of the SARS–CoV–2 virus, to identify mutations in 17 the SARS–CoV–2 virus, and to survey the circula- 18 tion and transmission of variant strains of the 19 SARS–CoV–2 virus; 20 (2) provide technical assistance and guidance 21 and award grants or cooperative agreements to 22 State, local, Tribal, or territorial public health de- 23 partments to increase the capacity of such depart- 24 ments to sequence the genome of circulating strains 25 VerDate Sep 11 2014 22:40 Feb 23, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S236.IS S236 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 236 IS of the SARS–CoV–2 virus, to identify mutations in 1 the SARS–CoV–2 virus, to use genomic sequencing 2 to identify outbreaks and clusters of COVID–19 in- 3 fections caused by specific variants of SARS–CoV– 4 2, and to develop effective COVID–19 response 5 strategies based on genetic sequencing and surveil- 6 lance data; and 7 (3) carry out activities to both enhance the 8 informatics capabilities of the public health work- 9 force and expand the numbers of qualified public 10 health informaticians available to analyze and inter- 11 pret data produced through advanced molecular de- 12 tection and genomic sequencing to establish, expand, 13 or enhance capacity for conducting statistical public 14 health research. 15 (c) IMPLEMENTATION.— 16 (1) COOPERATIVE AGREEMENTS FOR TECH- 17 NICAL ASSISTANCE.—Cooperative agreements de- 18 scribed in subsection (b)(2) may include partner- 19 ships with academic research institutions. 20 (2) CAPACITY FOR SHARING AND LINKING.— 21 The capacity referred to in subsection (b)(3) may in- 22 clude sharing and linking information and accessing 23 and utilizing linked health data files in accordance 24 with established data use agreements with data hold- 25 VerDate Sep 11 2014 22:40 Feb 23, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S236.IS S236 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 236 IS ers (including electronic case reporting, electronic 1 health records, and electronic test orders and re- 2 sults) with public health agencies and related sys- 3 tems, including the National Death Index, immuni- 4 zation information systems, syndromic surveillance 5 systems, laboratory information management sys- 6 tems, electronic case reporting systems, medical ex- 7 aminer case management systems, and Patient Uni- 8 fied Look-up Systems for Emergencies. 9 (d) FACILITIES.—Funds appropriated under sub- 10 section (f) may be used for grants for the construction, 11 alteration, or renovation of non-federally owned facilities 12 to improve genetic sequencing and surveillance capabilities 13 at the State and local level. 14 (e) EXPANSION OF ONGOING ACTIVITIES.—Funds 15 appropriated under subsection (f) may be used for grants 16 for the maintenance and expansion of current and ongoing 17 activities to analyze and interpret data produced through 18 advanced molecular detection and genomic sequencing, in- 19 cluding for emerging public health threats. 20 (f) AUTHORIZATION OF APPROPRIATIONS.—There is 21 authorized to be appropriated, $2,000,000,000 for fiscal 22 year 2021 to carry out this section, to remain available 23 until expended. 24 VerDate Sep 11 2014 22:40 Feb 23, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S236.IS S236 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 236 IS SEC. 5. EVIDENCE-BUILDING DEMONSTRATION PROGRAM. 1 (a) IN GENERAL.—The Secretary, acting through the 2 Director of the National Center for Health Statistics, shall 3 carry out a demonstration program to expand the data 4 linkage program of the Department of Health and Human 5 Services, consisting of Federal statistical and pro- 6 grammatic datasets from specified Federal entities, as au- 7 thorized by subchapter III of chapter 35 of title 44, 8 United States Code, for the purpose of facilitating statis- 9 tical public health research on trends and patterns across 10 specifically defined, statistically relevant populations, with 11 a particular focus on linking social determinants of health 12 data, including with respect to— 13 (1) food insecurity; 14 (2) housing instability; 15 (3) transportation access; 16 (4) safety; 17 (5) social connection and isolation; 18 (6) financial resource strain; 19 (7) stress; 20 (8) race and ethnicity; and 21 (9) sexual orientation and gender identity. 22 (b) ACTIVITIES.—Activities carried out under the 23 demonstration program under this section shall include— 24 (1) assessing the availability of identified and 25 deidentified data sets held by Federal, State, local, 26 VerDate Sep 11 2014 22:40 Feb 23, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S236.IS S236 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 236 IS and non-Federal entities that may be useful for re- 1 search described in subsection (a); and 2 (2) using existing authorities and linkages of 3 data in accordance with subchapter III of chapter 35 4 of title 44, United States Code, when relevant to re- 5 quest the submission of datasets to the National 6 Center for Health Statistics for linking. 7 (c) LIMITATION.—The Secretary shall limit access to 8 data under the demonstration program under this sec- 9 tion— 10 (1) to Federal statistical agencies and qualified 11 public and private researchers, as determined by the 12 Director of the National Center for Health Statis- 13 tics; 14 (2) for a period to be specified by the Sec- 15 retary; and 16 (3) exclusively for the purpose described in sub- 17 section (a). 18 (d) PROCESS FOR MAKING DATA AVAILABLE.— 19 (1) IN GENERAL.—Consistent with paragraph 20 (2), the Secretary shall establish a rigorous process 21 for making data available and usable under the dem- 22 onstration program under this section. 23 (2) REQUIREMENTS.—Prior to making any 24 data available under the demonstration program 25 VerDate Sep 11 2014 22:40 Feb 23, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S236.IS S236 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 236 IS under this section, by an entity described in sub- 1 section (b)(1) to another entity described in sub- 2 section (b)(1)— 3 (A) the receiving entity shall submit to the 4 Director of the National Center for Health Sta- 5 tistics an application for data for the purpose 6 described in subsection (a); and 7 (B) the Director shall approve or deny 8 such request in writing, including in the case of 9 a denial an explanation of the reasons for the 10 denial. 11 (e) RULEMAKING.— 12 (1) NO DELAY ON IMPLEMENTATION.—The 13 Secretary— 14 (A) shall begin the implementation of the 15 demonstration program under this section upon 16 the date of enactment of this Act; and 17 (B) shall not delay such implementation 18 for purposes of promulgating the regulations re- 19 quired by paragraph (2). 20 (2) PROMULGATION.—The Secretary shall— 21 (A) promulgate regulations for carrying 22 out this section; and 23 (B) specify in such regulations the allowed 24 and disallowed purposes for sharing and linking 25 VerDate Sep 11 2014 22:40 Feb 23, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S236.IS S236 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 236 IS data through the program, including areas of 1 potential research. 2 (f) WEBSITE.—The Secretary shall maintain a pub- 3 licly accessible website— 4 (1) providing information about the demonstra- 5 tion program under this section; 6 (2) facilitating stakeholder participation in such 7 demonstration program; 8 (3) facilitating oversight of such demonstration 9 program; 10 (4) providing lists of datasets from Federal and 11 non-Federal entities; 12 (5) providing lists of identified and deidentified 13 datasets; 14 (6) identifying linked datasets; 15 (7) delineating a process to protect privacy and 16 confidentiality; 17 (8) identifying sources of the datasets; and 18 (9) delineating categories of personal data. 19 (g) PROGRAM REQUIREMENTS.—The demonstration 20 program under this section shall be designed to— 21 (1) support data matching services for agencies 22 and researchers using the National Death Index; 23 and 24 VerDate Sep 11 2014 22:40 Feb 23, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S236.IS S236 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 236 IS (2) facilitate collaboration with States and pri- 1 vate entities to examine, update, and modernize the 2 fee structure of the National Death Index to support 3 a broad range of data queries. 4 (h) CONTRACTED ENTITIES.— 5 (1) IN GENERAL.—Subject to the availability of 6 appropriations, the Secretary may enter into con- 7 tracts with eligible entities, as appropriate, for infra- 8 structure and support services in carrying out the 9 demonstration program under this section. 10 (2) ELIGIBILITY.—To be eligible for a contract 11 under paragraph (1), an entity shall— 12 (A) demonstrate core capabilities for data 13 sharing, data linkage, and compliance with sub- 14 chapter III of chapter 35 of title 44, United 15 States Code; and 16 (B) adhere to security standards in accord- 17 ance with the Federal Risk and Authorization 18 Management Program (or any successor pro- 19 gram). 20 (i) RULE OF CONSTRUCTION.—Nothing in this sec- 21 tion shall be construed to authorize the availability or use 22 of data for— 23 (1) law enforcement; or 24 VerDate Sep 11 2014 22:40 Feb 23, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S236.IS S236 pamtmann on DSKBC07HB2PROD with BILLS 11 •S 236 IS (2) any determination of the eligibility of an in- 1 dividual for any direct or indirect payment, benefit, 2 or service. 3 (j) REPORT TO CONGRESS.—Not later than 1 year 4 after the date of enactment of this Act, and annually 5 thereafter, the Secretary shall submit a report to the Con- 6 gress on the implementation of this section, including— 7 (1) identification of best State practices for— 8 (A) sharing data with, and reporting data 9 to, the National Death Index; and 10 (B) ensuring the quality of such data; and 11 (2) recommendations to improve— 12 (A) such sharing and reporting; and 13 (B) access to the National Death Index by 14 researchers. 15 (k) AUTHORIZATION OF APPROPRIATIONS.—There is 16 authorized to be appropriated to carry out this section, 17 $10,000,000 for fiscal year 2021, to remain available until 18 expended. 19 Æ VerDate Sep 11 2014 22:40 Feb 23, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6301 E:\BILLS\S236.IS S236 pamtmann on DSKBC07HB2PROD with BILLS