,,ii #aagth ,,congress #ast ,session ,s4 #bcf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #d1 #bjba,ms4 ,baldwin 7for herself1 ,mr4 ,brown1 ,mrs4 ,feinstein1 ,mr4 ,blumenthal1 ,mr4 ,markey1 ,mr4 ,peters1 and ,ms4 ,klobuchar7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to improve activities for the gathering of data on1 and the tracking of1 new variants of ,,covid-#ai4 #a4 ,short title ,this ,act may be cited as the ,tracking ,,covid-#ai ,variants ,act4 #b4 ,findings ,congress finds that-- 7#a7 new variants of ,,sars-,co,v-#b are being identified around the world and in the ,united ,states2 7#b7 identifying new variants of ,,sars-,co,v-#b and analyzing the epidemiology of variants are critical to the continued response to the ,,covid-#ai pandemic and efforts to prepare for future pandemics2 7#c7 national sequence-based surveillance will enable the ,united ,states to best identify new variants2 and 7#d7 the ,united ,states is conducting sequence-based surveillance of approximately #j4c percent of ,,covid-#ai cases1 lagging far behind other nations4 #c4 ,guidance ,the ,secretary of ,health and ,human ,services 7referred to in this ,act as the ,secretary71 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall issue national guidance to support scientific collaboration relating to viral sequencing as a key strategy to the ,,covid-#ai response activities of the ,united ,states1 including guidance related to the sharing of specimens obtained from patients1 the secure sharing of information about such specimens necessary for an effective public health response to ,,covid-#ai1 and the appropriate use of viral sequence data derived from such specimens4 #d4 ,funding for genomic sequencing1 analytics1 and disease surveillance 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall establish and implement a program to strengthen and expand activities related to genomic sequencing1 analytics1 and disease surveillance4 7b7 ,use of funds ,in implementing the program under subsection 7a71 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall-- 7#a7 conduct and expand activities1 including supporting the ,advanced ,molecular ,detection ,program1 to sequence the genome of circulating strains of the ,,sars-,co,v-#b virus1 to identify mutations in the ,,sars-,co,v-#b virus1 and to survey the circulation and transmission of variant strains of the ,,sars-,co,v-#b virus2 7#b7 provide technical assistance and guidance and award grants or cooperative agreements to ,state1 local1 ,tribal1 or territorial public health departments to increase the capacity of such departments to sequence the genome of circulating strains of the ,,sars-,co,v-#b virus1 to identify mutations in the ,,sars-,co,v-#b virus1 to use genomic sequencing to identify outbreaks and clusters of ,,covid-#ai infections caused by specific variants of ,,sars-,co,v-#b1 and to develop effective ,,covid-#ai response strategies based on genetic sequencing and surveillance data2 and 7#c7 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 establish1 expand1 or enhance capacity for conducting statistical public health research4 7c7 ,implementation 7#a7 ,cooperative agreements for technical assistance ,cooperative agreements described in subsection 7b77#b7 may include partnerships with academic research institutions4 7#b7 ,capacity for sharing and linking ,the capacity referred to in subsection 7b77#c7 may include sharing and linking information and accessing and utilizing linked health data files in accordance with established data use agreements with data holders 7including electronic case reporting1 electronic health records1 and electronic test orders and results7 with public health agencies and related systems1 including the ,national ,death ,index1 immunization information systems1 syndromic surveillance systems1 laboratory information management systems1 electronic case reporting systems1 medical examiner case management systems1 and ,patient ,unified ,look-up ,systems for ,emergencies4 7d7 ,facilities ,funds appropriated under subsection 7f7 may be used for grants for the construction1 alteration1 or renovation of non-federally owned facilities to improve genetic sequencing and surveillance capabilities at the ,state and local level4 7e7 ,expansion of ongoing activities ,funds appropriated under subsection 7f7 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 sequencing1 including for emerging public health threats4 7f7 ,authorization of appropriations ,there is authorized to be appropriated1 #b1jjj1jjj1jjj for fiscal year #bjba to carry out this section1 to remain available until expended4 #e4 ,evidence-building demonstration program 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,national ,center for ,health ,statistics1 shall carry out a demonstration program to expand the data linkage program of the ,department of ,health and ,human ,services1 consisting of ,federal statistical and programmatic datasets from specified ,federal entities1 as authorized by subchapter ,,iii of chapter #ce of title #dd1 ,united ,states ,code1 for the purpose of facilitating statistical public health research on trends and patterns across specifically defined1 statistically relevant populations1 with a particular focus on linking social determinants of health data1 including with respect to-- 7#a7 food insecurity2 7#b7 housing instability2 7#c7 transportation access2 7#d7 safety2 7#e7 social connection and isolation2 7#f7 financial resource strain2 7#g7 stress2 7#h7 race and ethnicity2 and 7#i7 sexual orientation and gender identity4 7b7 ,activities ,activities carried out under the demonstration program under this section shall include-- 7#a7 assessing the availability of identified and deidentified data sets held by ,federal1 ,state1 local1 and non-,federal entities that may be useful for research described in subsection 7a72 and 7#b7 using existing authorities and linkages of data in accordance with subchapter ,,iii of chapter #ce of title #dd1 ,united ,states ,code1 when relevant to request the submission of datasets to the ,national ,center for ,health ,statistics for linking4 7c7 ,limitation ,the ,secretary shall limit access to data under the demonstration program under this section-- 7#a7 to ,federal statistical agencies and qualified public and private researchers1 as determined by the ,director of the ,national ,center for ,health ,statistics2 7#b7 for a period to be specified by the ,secretary2 and 7#c7 exclusively for the purpose described in subsection 7a74 7d7 ,process for making data available 7#a7 ,in general ,consistent with paragraph 7#b71 the ,secretary shall establish a rigorous process for making data available and usable under the demonstration program under this section4 7#b7 ,requirements ,prior to making any data available under the demonstration program under this section1 by an entity described in subsection 7b77#a7 to another entity described in subsection 7b77#a7-- 7,a7 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 7a72 and 7,b7 the ,director shall approve or deny such request in writing1 including in the case of a denial an explanation of the reasons for the denial4 7e7 ,rulemaking 7#a7 ,no delay on implementation ,the ,secretary-- 7,a7 shall begin the implementation of the demonstration program under this section upon the date of enactment of this ,act2 and 7,b7 shall not delay such implementation for purposes of promulgating the regulations required by paragraph 7#b74 7#b7 ,promulgation ,the ,secretary shall-- 7,a7 promulgate regulations for carrying out this section2 and 7,b7 specify in such regulations the allowed and disallowed purposes for sharing and linking data through the program1 including areas of potential research4 7f7 ,website ,the ,secretary shall maintain a publicly accessible website-- 7#a7 providing information about the demonstration program under this section2 7#b7 facilitating stakeholder participation in such demonstration program2 7#c7 facilitating oversight of such demonstration program2 7#d7 providing lists of datasets from ,federal and non-,federal entities2 7#e7 providing lists of identified and deidentified datasets2 7#f7 identifying linked datasets2 7#g7 delineating a process to protect privacy and confidentiality2 7#h7 identifying sources of the datasets2 and 7#i7 delineating categories of personal data4 7g7 ,program requirements ,the demonstration program under this section shall be designed to-- 7#a7 support data matching services for agencies and researchers using the ,national ,death ,index2 and 7#b7 facilitate collaboration with ,states and private entities to examine1 update1 and modernize the fee structure of the ,national ,death ,index to support a broad range of data queries4 7h7 ,contracted entities 7#a7 ,in general ,subject to the availability of appropriations1 the ,secretary may enter into contracts with eligible entities1 as appropriate1 for infrastructure and support services in carrying out the demonstration program under this section4 7#b7 ,eligibility ,to be eligible for a contract under paragraph 7#a71 an entity shall-- 7,a7 demonstrate core capabilities for data sharing1 data linkage1 and compliance with subchapter ,,iii of chapter #ce of title #dd1 ,united ,states ,code2 and 7,b7 adhere to security standards in accordance with the ,federal ,risk and ,authorization ,management ,program 7or any successor program74 7i7 ,rule of construction ,nothing in this section shall be construed to authorize the availability or use of data for-- 7#a7 law enforcement2 or 7#b7 any determination of the eligibility of an individual for any direct or indirect payment1 benefit1 or service4 7j7 ,report to ,congress ,not later than #a year after the date of enactment of this ,act1 and annually thereafter1 the ,secretary shall submit a report to the ,congress on the implementation of this section1 including-- 7#a7 identification of best ,state practices for-- 7,a7 sharing data with1 and reporting data to1 the ,national ,death ,index2 and 7,b7 ensuring the quality of such data2 and 7#b7 recommendations to improve-- 7,a7 such sharing and reporting2 and 7,b7 access to the ,national ,death ,index by researchers4 7k7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section1 #aj1jjj1jjj for fiscal year #bjba1 to remain available until expended4