,,ii #aafth ,,congress #b;d ,session ,s4 #ejhb ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #ba1 #bjbj ,ms4 ,warren introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to provide ,federal support for ,,covid-#ai testing1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,expanding ,,covid-#ai ,testing ,capacity ,act of #bjbj4 7b7 ,table of contents ,the table of contents for the ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,definitions4 ,sec4 #c4 ,federal manufacturing of ,,covid-#ai diagnostic tests4 ,sec4 #d4 ,,covid-#ai testing for covered ,federal employees4 ,sec4 #e4 ,federal distribution of ,,covid-#ai tests to qualified entities4 ,sec4 #f4 ,supplemental grants for ,,covid-#ai testing4 ,sec4 #g4 ,reports and guidance on ,,covid-#ai diagnostic testing4 ,sec4 #h4 ,demographic and geographic data collection4 #b4 ,definitions ,in this ,act3 7#a7 ,associated medical supplies ,the term associated medical supplies means any product necessary for the development and administration of ,,covid-#ai diagnostic tests1 including chemical reagents1 test swabs1 and personal protective equipment 7including surgical masks1 surgical gowns1 face shields1 gloves1 and ,n#ie masks74 7#b7 ,,covid-#ai diagnostic test ,the term ,,covid-#ai diagnostic test means a test-- 7,a7 that is an in vitro diagnostic product 7as defined in section #hji4c of title #ba1 ,code of ,federal ,regulations1 or any successor thereto7 for the detection of ,,sars-,co,v-#b or the diagnosis of ,,covid-#ai2 and 7,b7 the administration of which-- 7i7 is approved1 cleared1 or authorized under section #eaj7k71 #eac1 #eae1 or #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k71 #cfj;c1 #cfj;e1 #cfj;bbb-#c72 or 7ii7 the developer has received an emergency use authorization under section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c71 unless and until the emergency use authorization request under such section #efd4 7#c7 ,,covid-#ai pandemic ,the term ,,covid-#ai pandemic means the period beginning on the date that the public health emergency with respect to ,,covid-#ai took effect1 and ending on the date that is #f months after the date on which the public health emergency declaration with respect to ,,covid-#ai terminates4 7#d7 ,indian ,tribe ,except as otherwise provided1 the term ,indian ,tribe has the meaning given the term ,indian tribe in section #d of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd74 7#e7 ,public health emergency with respect to ,,covid-#ai ,the term public health emergency with respect to ,,covid-#ai means the public health emergency declared by the ,secretary under section #cai of the ,public ,health ,service ,act 7#ba ,u4,s4,c4 #bdg;d7 on ,january #ca1 #bjbj1 with respect to ,,covid-#ai4 7#f7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4 7#g7 ,tribal organization ,except as otherwise provided1 the term ,tribal organization has the meaning given the term tribal organization in section #d of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd74 7#h7 ,urban ,indian organization ,the term urban ,indian organization has the meaning given the term in section #d of the ,indian ,health ,care ,improvement ,act 7#be ,u4,s4,c4 #afjc74 #c4 ,federal manufacturing of ,,covid-#ai diagnostic tests 7a7 ,in general ,as soon as practicable after the date of enactment of this ,act1 but no later than #ae days after such date of enactment1 the ,secretary shall begin the process of manufacturing1 or contracting with entities for the manufacture of1 ,,covid-#ai diagnostic tests and associated medical supplies1 with a particular focus on extraction-free highly sensitive molecular tests1 pooled highly sensitive molecular tests1 low-cost rapid antigen test1 low-cost highly sensitive molecular tests1 assays that can use a variety of reagents1 and other products as determined by the ,secretary4 ,the ,secretary shall continue such process until the end of the ,,covid-#ai pandemic4 7b7 ,submission of applications ,for each ,,covid-#ai diagnostic test and associated drug or device that the ,secretary intends to market1 or contract with another entity for the marketing of1 the ,secretary shall-- 7#a7 submit an application under subsection 7b7 or 7j7 of section #eje or section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj;e7 or subsection 7a7 or 7j7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 submit a notification under section #eaj7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k771 or submit a request for classification under section #eac7;f77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7f77#b77 7or enter into a contract with another entity to submit such an application1 notification1 or request72 7#b7 request an emergency use authorization of the product under section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 7or enter into a contract with another entity to submit an application for such use72 or 7#c7 obtain from the holder of an application approved under subsection 7c7 or 7j7 of section #eje or section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act or subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act1 or cleared under section #eaj7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 rights to manufacture such product4 7c7 ,provision of products ,with respect to ,,covid-#ai diagnostic tests and associated drugs and devices manufactured pursuant to subsection 7a71 the ,secretary shall-- 7#a7 provide such ,,covid-#ai diagnostic tests and associated medical supplies at no cost to ,federal1 ,state1 local1 territorial1 and ,native health programs1 and other domestic health care providers1 including domestic commercial health care providers1 as determined by the ,secretary2 and 7#b7 sell additional tests and associated drugs and devices1 at-cost1 to other commercial entities and international entities not described in paragraph 7#a74 7d7 ,obtaining rights ,to manufacture and market 7#a7 ,in general ,when necessary to fulfill the ,secretary's duties under this section1 the ,secretary shall acquire the rights to manufacture and market ,,covid-#ai diagnostic tests and associated drugs and devices as authorized under this section4 7#b7 ,licensing authority 7,a7 ,in general ,notwithstanding any other provision of law1 the ,secretary may issue licenses1 as useful for fulfilling the duties under this ,act1 allowing the ,department of ,health and ,human ,services to practice or have practiced 7which may include licensure of retroactive practice7 any invention in the ,united ,states or territories of the ,united ,states1 including making1 using1 offering to sell or selling1 importing1 or exporting such invention1 to reference or rely upon clinical trial data submitted to a regulatory authority or the grant of marketing approval1 and to access and use otherwise confidential information1 including know-how1 related to the manufacture of ,,covid-#ai diagnostic tests and associated medical supplies4 7,b7 ,non-voluntary licensing ,for any license that involves a non-voluntary authorization to use patented inventions1 regulatory test data1 data1 know-how or other intellectual property rights1 the license shall provide for reasonable remuneration to rights holders such as a reasonable royalty on the sales of product1 a #a-time payment1 or some combination1 provided that the combined royalty payments to all rights holders shall not exceed the percentage of sales that is the average percent of all royalty payments reported to the ,internal ,revenue ,service by companies in the pharmaceutical and medicines sector1 ,north ,american ,industry ,classification ,system code #cbedaj1 provided that when products are distributed for free1 the royalty shall be based upon the cost of goods4 ,when there are multiple rights holders1 the allocation of the total royalty payments shall be determined by-- 7i7 agreement among the rights holders2 7ii7 allocation by arbitration among the rights holders2 or 7iii7 if neither clause 7i7 nor 7ii7 applies1 by the ,secretary4 7#c7 ,transparency ,subject to paragraph 7#d71 the ,secretary shall post any contract agreement under subsection 7a7 or license issued under paragraph 7#b77;,a7 on the public internet website of the ,department of ,health and ,human ,services1 on the date on which such agreement or license takes effect4 7#d7 ,protected information ,in carrying out this section1 the ,secretary shall enforce applicable law concerning the protection of confidential commercial information and trade secrets4 7e7 ,pricing determinations 7#a7 ,at-cost price ,in determining an at-cost price for ,,covid-#ai diagnostic tests and associated medical supplies for purposes of subsection 7c77#b71 the ,secretary shall consider-- 7,a7 the cost to the ,federal ,government of manufacturing the applicable ,,covid-#ai diagnostic test or associated drug or device2 and 7,b7 the cost to acquire or manufacture under subparagraph 7,a7 the applicable ,,covid-#ai diagnostic test or associated drug or device4 7#b7 ,transparency ,all prices charged for ,,covid-#ai diagnostic tests and associated medical supplies shall be made publicly available by the ,secretary4 7f7 ,awarding contracts 7#a7 ,priority ,in awarding contracts under this section1 the ,secretary shall prioritize entities manufacturing ,,covid-#ai diagnostic tests or associated medical supplies using components originating from1 and manufactured in1 the ,united ,states4 7#b7 ,contract requirements ,all contracts issued under this section shall include a requirement that the contract recipients reasonably price products produced under the contract4 7g7 ,report to the ,president and ,congress ,the ,secretary shall prepare and submit to the ,president1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a monthly report during the ,,covid-#ai pandemic1 and a final report #c months after such pandemic has concluded1 that includes-- 7#a7 an assessment of the major supply chain challenges facing health care facilities1 medical providers1 the ,federal ,government1 ,state1 local1 territorial1 and ,tribal governments1 and the private sector in ,,covid-#ai diagnostic tests and associated medical supplies2 and 7#b7 a description of the authorization or approval status and available supply of all ,,covid-#ai diagnostic tests and associated medical supplies for which manufacturing has been authorized under this section1 including products for which the ,secretary has submitted an application for approval1 a notification for clearance1 or a request for classification to the ,food and ,drug ,administration but has not yet received approval1 clearance1 or classification1 and products for which the ,secretary has received approval1 clearance1 or classification1 from the ,food and ,drug ,administration but are not being manufactured4 7h7 ,proceeds from sales ,there are authorized to be appropriated to the ,secretary for each fiscal year1 for purposes of carrying out this section1 an amount equal to the proceeds from the sale of ,,covid-#ai diagnostic tests and associated medical supplies described in subsection 7c77#b7 in the previous fiscal year4 #d4 ,,covid-#ai testing for covered ,federal employees 7a7 ,definitions ,in this section3 7#a7 ,agency ,the term agency-- 7,a7 means-- 7i7 each agency1 office1 or other establishment in the executive1 legislative1 or judicial branch of the ,federal ,government1 including-- 7,i7 an ,executive agency1 as that term is defined in section #aje of title #e1 ,united ,states ,code2 7,,ii7 a military department1 as that term is defined in section #ajb of title #e1 ,united ,states ,code2 7,,iii7 the ,federal ,aviation ,administration2 7,,iv7 the ,transportation ,security ,administration2 7,v7 the ,department of ,veterans ,affairs2 7,,vi7 the ,government ,accountability ,office2 7,,vii7 the ,library of ,congress2 7,,viii7 the ,postal ,service2 7,,ix7 the ,house of ,representatives2 7,x7 the ,senate2 and 7,,xi7 the ,architect of the ,capitol2 7ii7 the ,district of ,columbia courts and the ,district of ,columbia ,public ,defender ,service2 or 7iii7 an-- 7,i7 ,indian ,tribe or ,tribal organization carrying out a contract or compact under the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecja et seq472 7,,ii7 ,indian ,tribe or ,tribal organization that receives a grant under the ,tribally ,controlled ,schools ,act of #aihh 7#be ,u4,s4,c4 #beja et seq472 or 7,,iii7 ,indian ,tribe or ,tribal organization 7as defined in section #ebab of the ,tribally ,controlled ,schools ,act of #aihh 7#be ,u4,s4,c4 #beaa77 that receives a grant under that ,act 7#be ,u4,s4,c4 #beja et seq472 and 7,b7 does not include a nonappropriated fund instrumentality under the jurisdiction of the ,armed ,forces4 7#b7 ,covered duty ,the term covered duty means all work performed by a ,federal employee1 except duties that a ,federal employee performs while teleworking from a residence4 7#c7 ,federal employee ,the term ,federal employee means-- 7,a7 an individual who engages in covered duties on behalf of an agency at any time during the ,,covid-#ai pandemic1 or an individual classified as an independent contractor by the agency who engages in covered duties during such period2 7,b7 includes-- 7i7 any person performing work for an agency who engages in covered duties during the ,,covid-#ai pandemic1 regardless of whether such person is classified as an independent contractor by the agency2 and 7ii7 any paid or unpaid intern1 fellow1 trainee1 or other person performing work for an agency who engages in covered duties during the ,,covid-#ai pandemic2 and 7,c7 does not include any employee of a ,federal contractor4 7#d7 ,timely manner ,the term timely manner1 with respect to the administration of a ,,covid-#ai diagnostic test1 means within #bd hours of the administration of such test4 7b7 ,federal employee ,,covid-#ai testing 7#a7 ,in general ,not later than #cj days after the date of enactment of this ,act1 each agency shall begin to-- 7,a7 conduct or contract with entities to conduct ,,covid-#ai diagnostic tests for ,federal employees employed by the agency at no cost to the employee1 regardless of whether such employees exhibit symptoms of ,,covid-#ai1 provided at locations accessible to the ,federal employees2 7,b7 provide each ,federal employee employed by the agency with the results of the diagnostic tests1 regardless of the results1 including an interpretation of what the test means in the employee's preferred language1 in a timely manner2 7,c7 submit the results of such tests to relevant ,federal1 ,state1 local1 territorial1 and ,tribal public health officials2 and 7,d7 publish the aggregate results of such diagnostic tests in accordance with section #h4 7#b7 ,time period ,each agency shall continue the activities described in subparagraphs 7,a71 7,b71 and 7,c7 of paragraph 7#a7 throughout the duration of the ,,covid-#ai pandemic4 7#c7 ,minimum wage and overtime ,notwithstanding any other provision of law1 for any individual employed by a contractor or subcontractor1 and who performs work assisted in whole or in part by funding under this section1 with respect to such employment1 such individual shall-- 7,a7 be paid a wage of not less than #ae per hour2 and 7,b7 if such individual is paid at a rate that is the full-time equivalent of less than #ea1jjj per year1 receive overtime pay of one-and-one-half times the individual's regular rate of pay for all hours worked in excess of #dj hours per workweek4 7c7 ,frequency and location of ,,covid-#ai diagnostic testing ,in administering ,,covid-#ai tests pursuant to subsection 7b71 each agency shall provide ,,covid-#ai diagnostic tests at frequencies and locations recommended by the ,state1 local1 territorial or ,tribal public health officials with jurisdiction over the geographic areas in which the applicable ,federal employees work1 or1 if a national testing strategy is developed by ,federal officials1 in compliance with the national testing strategy4 7d7 ,authorization of ,appropriations ,there is authorized to be appropriated to each ,federal agency such sums as may be necessary to procure and administer the ,,covid-#ai diagnostic tests required under this section4 #e4 ,federal distribution of ,,covid-#ai tests to qualified entities 7a7 ,definitions ,in this section3 7#a7 ,,covid-#ai testing ,the term ,,covid-#ai testing has the meaning given such term in interim final rules promulgated by the ,secretary within #ae days of the date of enactment of this ,act4 7#b7 ,essential work ,the term essential work means any work that-- 7,a7 is performed during the period of the ,,covid-#ai pandemic2 7,b7 cannot be performed while teleworking from a residence2 and 7,c7 7i7 involves-- 7,i7 regular in-person interactions with patients1 the public1 or coworkers of the individual performing the work2 or 7,,ii7 regular physical handling of items that were handled by1 or are to be handled by patients1 the public1 or coworkers of the individual performing the work2 and 7ii7 is in the area of-- 7,i7 first responder work1 in the public sector or private sector1 including services in response to emergencies that have the potential to cause death or serious bodily injury1 such as police1 fire1 emergency medical1 protective1 child maltreatment1 domestic violence1 and correctional services 7including activities carried out by employees in fire protection activities1 as defined in section #c7y7 of the ,fair ,labor ,standards ,act of #aich 7#bi ,u4,s4,c4 #bjc7y77 and activities of law enforcement officers1 as defined in section #abjd7f7 of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#cd ,u4,s4,c4 #ajbhd7f7772 7,,ii7 health care work physically provided in inpatient settings 7including hospitals and other inpatient post-acute care settings such as nursing homes1 inpatient rehabilitation facilities1 and other related settings7 and other work physically performed in such inpatient settings that supports or is in furtherance of such health care work physically provided in inpatient settings2 7,,iii7 health care work physically provided in outpatient settings 7including at physician offices1 community health centers1 ,tribal clinics1 rural health clinics and other clinics1 hospital outpatient departments1 freestanding emergency departments1 health centers1 ambulatory surgical centers1 dialysis centers1 dental offices1 and other related settings71 and other work physically performed in such outpatient settings that supports or is in furtherance of such health care work physically provided in outpatient settings2 7,,iv7 pharmacy work1 physically performed in pharmacies1 drug stores1 or other retail facilities specializing in medical goods and supplies2 7,v7 any work physically performed in a facility that performs medical testing and diagnostic services1 including laboratory processing1 medical testing services1 imaging services1 or related activities2 7,,vi7 home- and community-based health care work1 including home health care1 residential care1 assistance with activities of daily living1 and any services provided by direct care workers 7as defined in section #gii;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #biep771 personal care aides1 community health aides and community health aides participating in the ,community ,health ,representative ,program or the ,community ,health ,aide ,program under the ,indian ,health ,care ,improvement ,act 7#be ,u4,s4,c4 #afja et seq471 job coaches1 or supported employment providers1 and any other provision of care to individuals in their homes by direct service providers1 personal care attendants1 and home health aides2 7,,vii7 biomedical research2 7,,viii7 behavioral health work requiring physical interaction with individuals1 including mental health services and substance use disorder prevention1 treatment1 and recovery services2 7,,ix7 nursing care and residential work physically provided in a facility2 7,x7 family care1 including child care services1 in-home child care services such as nanny services1 and care services provided by family members to other family members2 7,,xi7 social services work1 including social work1 case management1 social and human services1 child welfare1 family services1 shelter and services for people who have experienced intimate partner violence or sexual assault1 services for individuals who are homeless1 child services1 community food and housing services1 and other emergency social services2 7,,xii7 public health work conducted at a ,state1 local1 territorial1 or ,tribal government public health agency1 including epidemiological activities1 surveillance1 contact tracing1 data analysis1 statistical research1 health education1 and other disease detection1 prevention1 and response methods2 7,,xiii7 work conducted at a hospital1 clinic1 triage center1 or other permanent or temporary health facility operated by the ,indian ,health ,service1 an ,indian ,tribe1 ,tribal organization1 or urban ,indian organization2 7,,xiv7 grocery work physically performed at grocery stores1 supermarkets1 convenience stores1 corner stores1 drug stores1 retail facilities specializing in medical goods and supplies1 bodegas1 or another location where individuals purchase non-prepared food items2 7,,xv7 restaurant work1 including carry-out1 drive-thru1 or food delivery work1 requiring physical interaction with individuals or food products2 7,,xvi7 food production work involving the physical interaction with food products1 including all agricultural work1 farming1 harvesting1 fishing1 forestry1 ranching1 processing1 canning1 slaughtering1 packaging1 baking1 butchering1 and other food production work1 such as any service or activity described in section #c7;f7 of the ,fair ,labor ,standards ,act of #aich 7#bi ,u4,s4,c4 #bjc7;f77 or section #caba7;g7 of the ,internal ,revenue ,code of #aihf1 and the handling1 planting1 drying1 packing1 packaging1 processing1 freezing1 or grading prior to delivery for storage of any agricultural or horticultural commodity in its unmanufactured state2 7,,xvii7 transportation work1 including-- 7aa7 any services in public transportation1 as defined in section #ecjb7ad7 of title #di1 ,united ,states ,code2 7bb7 any private transportation of people1 such as transportation provided by air1 rail1 bus1 taxicab1 personal car or truck1 non-motorized vehicle1 or otherwise1 including all services performed by individuals working in or on such vehicles1 vehicle depots1 or transit facilities2 7cc7 any services in passenger rail transportation1 including commuter rail1 intercity passenger rail1 or ,amtrak1 including services performed by employees of contractors of such entities2 7dd7 any services in the transportation of persons1 property1 or mail by an aircraft of an air carrier conducting operations under part #aba of title #ad1 ,code of ,federal ,regulations 7or successor regulations71 or a foreign air carrier within1 to1 or from the ,united ,states1 either on board an aircraft or on the ground at an airport1 including services performed by employees of contractors of air carriers1 or foreign air carriers1 as described in section #daaa7c7 of the ,,cares ,act 7#ae ,u4,s4,c4 #ijga7c772 7ee7 any services as an aircraft mechanic or technician who performs maintenance1 repair1 or overhaul work on an aircraft of an air carrier conducting operations under such part #aba or foreign air carrier within the ,united ,states2 7ff7 services as maritime workers who qualify as seamen under section #ajaja7c7 of title #df1 ,united ,states ,code1 and other maritime employees including-- 7,,aa7 longshoremen1 harbor workers and shipbuilders covered under section #b7c7 of the ,longshore and ,harbor ,workers' ,compensation ,act 7#cc ,u4,s4,c4 #ijb7c77 involved in the transportation of merchandise or passengers by water2 and 7,,bb7 shipbuilders and ship repairers who are working for an employer performing shipbuilding or ship repair work under contract or subcontract to the ,departments of ,defense1 ,energy or ,homeland ,security for military or other national security purposes2 7gg7 services as maritime transportation workers supporting or enabling transportation functions1 including such services as-- 7,,aa7 barge workers1 tug operators1 and port and facility security personnel2 7,,bb7 marine dispatchers2 and 7,,cc7 workers who repair and maintain marine vessels 7including the equipment and infrastructure that enables operations that encompass movement of cargo and passengers72 and 7hh7 work physically performed in a warehouse or other facility in warehousing 7including all services performed by individuals picking1 sorting1 packing1 and shipping in warehouses71 storage1 distribution1 or call center support facilities1 and other essential operational support functions that are necessary to accept1 store1 and process goods1 and that facilitate the goods' transportation and delivery2 7,,xviii7 cleaning work and building maintenance work physically performed on the grounds of a facility1 including all custodial or janitorial services1 security services1 and repair and maintenance services2 7,,xix7 work in the collection1 removal1 transport1 storage1 or disposal of residential1 industrial1 or commercial solid waste and recycling1 including services provided by individuals who drive waste or recycling trucks1 who pick up waste or recycling from residential or commercial locations1 or who work at waste or recycling centers or landfills2 7,,xx7 work in the gathering1 processing1 disseminating1 and delivery of news and information that serves the public interest to the public through mass media1 including television1 radio1 and newspapers2 7,,xxi7 any work performed by an employee of a ,state1 locality1 or ,tribal government1 that is determined to be essential work by the highest authority of such ,state1 locality1 or ,tribal government2 7,,xxii7 educational work1 school nutrition work1 and other work required to operate a school facility1 including early childhood and after-school enrichment programs1 preschool programs1 elementary and secondary education1 and higher education2 7,,xxiii7 laundry work1 including work in laundromats1 laundry service companies1 and dry cleaners2 7,,xxiv7 elections work physically performed at polling places or otherwise amongst the public1 including public-sector elections personnel and private-sector elections personnel2 7,,xxv7 hazardous materials management1 response1 and cleanup work associated with any other essential work covered under this paragraph1 including health care waste 7including medical1 pharmaceuticals1 and medical material production71 and testing operations 7including laboratories processing test kits72 7,,xxvi7 disinfection work for all facilities and modes of transportation involved in other essential work covered under this paragraph2 7,,xxvii7 work in critical clinical research1 development1 and testing necessary for ,,covid-#ai response that involves physical interaction with hazardous materials1 such as samples of ,,covid-#ai2 7,,xxviii7 work in mortuary1 funeral1 cremation1 burial1 cemetery1 and related services2 7,,xxix7 work requiring physical interactions with patients in physical therapy1 occupational therapy1 speech-language pathology1 and respiratory therapy and other therapy services2 7,,xxx7 dental care work requiring physical interaction with patients2 7,,xxxi7 work performed by employees of the ,united ,states ,postal ,service2 7,,xxxii7 work at hotel and commercial lodging facilities that are used for ,,covid-#ai mitigation and containment measures2 and 7,,xxxiii7 work installing or repairing a telecommunications line or equipment4 7#c7 ,essential worker ,the term essential worker means an individual whose work and duties include essential work1 including individuals that are employees of employers and individuals performing any services or labor for remuneration1 regardless of whether such individual is classified as an independent contractor by the employer4 7#d7 ,qualified entity ,the term qualified entity means-- 7,a7 a congregate care setting1 including any skilled nursing facilities1 assisted living facilities1 prisons and jails1 residential behavioral health care and psychiatric facilities1 and facilities providing services for aging adults and people with disabilities2 7,b7 an education center1 including any childcare facilities1 elementary and secondary schools that have resumed 7or plan to resume within #cj days of receipt of items under subsection 7b77 any form of in-person instruction1 and colleges and universities that have resumed 7or plan to resume within #cj days of receipt of items under subsection 7b77 any form of in-person instruction or on-campus housing2 7,c7 a community center1 such as ,state and local government buildings1 religious centers1 and nonprofit service organizations2 7,d7 a prison1 jail1 or youth detention facility2 7,e7 a hospital1 community health center1 ,tribal or ,indian ,health ,service clinic or hospital1 or other medical facility2 7,f7 a small business2 7,g7 a business that employs essential workers2 7,h7 a homeless shelter or entity supporting individuals living in housing funded with support from the ,department of ,housing and ,urban ,development1 including housing provided under the supportive housing for the elderly program under section #bjb of the ,housing ,act of #aiei 7#ab ,u4,s4,c4 #agjaq72 or 7,i7 another entity1 as determined by the ,secretary1 that could serve as a ,,covid-#ai diagnostic testing site4 7#e7 ,timely manner ,the term timely manner1 with respect to the administration of a ,,covid-#ai diagnostic test1 means within #bd hours of the administration of such test4 7b7 ,distribution of ,,covid-#ai diagnostic tests 7#a7 ,in general ,within #dj days of the date of enactment of this ,act1 the ,secretary shall-- 7,a7 begin distributing ,,covid-#ai diagnostic tests and associated medical supplies1 including tests and medical supplies manufactured under section #c1 to qualified entities via ,state1 local1 territorial1 and ,tribal governments for the purpose of-- 7i7 providing ,,covid-#ai diagnostic testing to essential workers and individuals served by qualified entities1 at no cost to the essential workers and individuals1 regardless of whether such workers and individuals exhibit symptoms of ,,covid-#ai1 at locations accessible to the essential workers and individuals in the course of their work2 7ii7 providing essential workers and individuals served by qualified entities with the results of the diagnostic tests1 regardless of the results1 including an interpretation of what the test means in the employee's preferred language1 in a timely manner2 7iii7 submitting the results of such tests to relevant ,federal1 ,state1 local1 territorial1 and ,tribal public health officials2 and 7iv7 publishing the aggregate results of such diagnostic tests in accordance with section #h2 and 7,b7 hire and deploy employees1 or contract with outside entities to hire and deploy employees1 as necessary to assist in the distribution1 provision1 administration of1 and data collection regarding ,,covid-#ai diagnostic tests as described in subparagraph 7,a74 7#b7 ,employees ,in hiring employees1 or contracting with outside entities to hire employees1 to carry out this subsection1 the ,secretary shall prioritize1 or require contractors to prioritize1 hiring individuals from within the communities served by the applicable qualified entity4 7#c7 ,minimum wage and overtime ,notwithstanding any other provision of law1 for any individual employed by a contractor or subcontractor1 and who performs work assisted in whole or in part by funding under this section1 with respect to such employment1 such individual shall-- 7,a7 be paid a wage of not less than #ae per hour2 and 7,b7 if such individual is paid at a rate that is the full-time equivalent of less than #ea1jjj per year1 receive overtime pay of one-and-one-half times the individual's regular rate of pay for all hours worked in excess of #dj hours per workweek4 7c7 ,coordination with ,state1 local1 territorial1 and ,tribal governments ,within #cj days of the date of enactment of this ,act1 a representative of each ,state1 local1 territorial1 and ,tribal government shall submit to the ,secretary a list of qualified entities in their jurisdiction and a description of employee1 resource1 and other infrastructure needs necessary for the distribution of ,,covid-#ai diagnostic tests and associated drugs and devices under subsection 7b74 7d7 ,frequency and location of ,,covid-#ai diagnostic testing ,in distributing ,,covid-#ai tests under 7b71 the ,secretary shall provide ,,covid-#ai diagnostic tests at frequencies and locations recommended by the ,state1 local1 territorial1 or ,tribal public health officials with jurisdiction over the geographic areas in which qualified entities are located1 or1 if a national testing strategy is developed by ,federal officials1 in compliance with the national testing strategy4 7e7 ,public reporting ,beginning #cj days after the date of enactment of this ,act and for the duration of the ,,covid-#ai pandemic1 the ,secretary shall publish weekly1 in a machine readable format1 the total number of tests distributed to1 and the total number of tests administered in1 each ,state1 county1 territory1 and ,tribe under subsection 7b74 7f7 ,authorization of appropriations ,there is authorized to be appropriated such sums as may be necessary to carry out this section4 #f4 ,supplemental grants for ,,covid-#ai testing 7a7 ,in general ,no later than #cj days after the date of enactment of this ,act1 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention shall-- 7#a7 issue competitive grants to ,state1 local1 and territorial governments for the purpose of increasing access to ,,covid-#ai diagnostic testing2 and 7#b7 issue noncompetitive and formula-based awards to ,indian ,tribes and ,tribal organizations4 7b7 ,priority areas and populations ,in issuing grants under subsection 7a71 the ,secretary shall-- 7#a7 prioritize areas and populations that have been disproportionately affected by ,,covid-#ai1 and areas where operationalizing testing programs is not possible with existing resources2 and 7#b7 consider the capacity that ,states1 localities1 territories1 and ,tribes already have at the time of application to conduct widespread ,,covid-#ai diagnostic testing4 7c7 ,use of funds ,grants awarded under subsection 7a7 may be used to-- 7#a7 establish new ,,covid-#ai diagnostic testing sites at community centers1 such as ,state1 local1 territorial1 and ,tribal government buildings1 churches1 health centers1 clinics1 and public parks1 subject to ,federal quality control standards for laboratory testing2 7#b7 hire ,state1 local1 territorial1 and ,tribal government employees1 or contract with outside entities1 to assist in the development1 distribution1 and provision of ,,covid-#ai diagnostic tests within the ,state1 locality1 territory1 or ,tribe2 7#c7 purchase ,,covid-#ai diagnostic tests and the medical supplies necessary to conduct such tests2 7#d7 increase the number of ,,covid-#ai diagnostic tests provided at congregate settings1 such as-- 7,a7 skilled nursing facilities2 7,b7 assisted living facilities2 7,c7 childcare facilities2 7,d7 elementary and secondary schools that have resumed1 or plan to resume within #cj days1 in-person instruction2 7,e7 colleges and universities that have resumed1 or plan to resume within #cj days1 in-person instruction or on-campus housing2 7,f7 prisons1 jails1 and youth detention facilities2 7,g7 residential behavioral health care and psychiatric facilities2 7,h7 institutions providing services for aging adults and people with intellectual and developmental disabilities1 rehabilitation facilities1 and group homes2 and 7,i7 homeless shelters2 7#e7 educate the public about the availability of ,,covid-#ai diagnostic tests in their communities and what to do if a positive result is received2 7#f7 issue subgrants1 cooperative agreements1 or contracts to labs1 hospitals1 and other test providers to reduce test processing time2 submit the results to ,state1 local1 territorial1 and ,tribal public health officials2 and prevent delays in the distribution of testing results1 such as through transferring research lab capacity to ,,covid-#ai testing capacity and building new labs to reduce test processing turnaround time2 7#g7 enable the ,state1 locality1 territory1 or ,tribe to detect and identify trends in ,,covid-#ai and develop guidance for communities on how to develop testing programs and expand test capacity2 7#h7 reduce disparities in access to ,,covid-#ai diagnostic testing among the communities hardest hit by ,,covid-#ai2 and 7#i7 additional uses1 as determined by the ,secretary1 in accordance with subsection 7e74 7d7 ,requirement ,any ,,covid-#ai diagnostic test conducted with the support of a grant awarded under this section shall be provided to patients free of charge and without regard for immigration status4 ,the results shall be submitted to relevant ,state1 local1 territorial1 and ,tribal public health officials4 7e7 ,minimum wage and overtime ,notwithstanding any other provision of law1 for any individual employed by a contractor or subcontractor1 and who performs work assisted in whole or in part by funding under this section1 with respect to such employment1 such individual shall-- 7#a7 be paid a wage of not less than #ae per hour2 and 7#b7 if such individual is paid at a rate that is the full-time equivalent of less than #ea1jjj per year1 receive overtime pay of one-and-one-half times the individual's regular rate of pay for all hours worked in excess of #dj hours per workweek4 7f7 ,additional uses of funds ,in determining appropriate uses of funds under subsection 7c77#i71 the ,secretary shall consider the incidence of ,,covid-#ai in ,states1 localities1 territories1 and ,tribes1 the availability and uptake of vaccines for ,,covid-#ai in ,states1 localities1 territories1 and ,tribes1 and advancements in ,,covid-#ai diagnostic test technologies4 7g7 ,authorization of appropriations 7#a7 ,in general ,there is authorized to be appropriated #be1jjj1jjj1jjj for fiscal year #bjba for purposes of awarding grants under this section4 7#b7 ,tribal set-aside ,not less than #aj percent of the total amount appropriated under paragraph 7#a7 for a fiscal year shall be reserved for noncompetitive awards to-- 7,a7 ,indian ,tribes or ,tribal organizations carrying out a contract or compact under the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecja et seq472 7,b7 ,indian ,tribes or ,tribal organizations receiving a grant under the ,tribally ,controlled ,schools ,act of #aihh 7#be ,u4,s4,c4 #beja et seq472 and 7,c7 ,indian ,tribes or tribal organizations 7as defined in section #ebab of the ,tribally ,controlled ,schools ,act of #aihh 7#be ,u4,s4,c4 #beaa77 receiving grants under that ,act 7#be ,u4,s4,c4 #beja et seq474 7#c7 ,local government set aside ,not less than #cj percent of the total amount appropriated under paragraph 7#a7 for a fiscal year shall be reserved for grants awarded directly to local governments4 #g4 ,reports and guidance on ,,covid-#ai diagnostic testing 7a7 ,updated guidance on ,,covid-#ai rapid diagnostic tests 7#a7 ,in general ,not later than #cj days after the date of enactment of this ,act1 the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall issue updated guidance on the development of rapid ,,covid-#ai diagnostic tests1 the provision of such tests1 including in nonclinical environments1 and the appropriate collection and electronic reporting of results 7including geographic and demographic data1 including with respect to race and ethnicity7 and data regarding such tests to ,federal1 ,state1 local1 and ,tribal public health officials4 7#b7 ,rapid ,,covid-#ai diagnostic test ,for purposes of paragraph 7#a71 the term rapid ,,covid-#ai diagnostic test means a ,,covid-#ai diagnostic test that can be performed by a user1 with or without the need of a medical professional or medical supervisor1 and that can produce results within #a hour of application4 7b7 ,updated surveillance testing guidance 7#a7 ,in general ,not later than #cj days after the date of enactment of this ,act1 the ,secretary1 acting through the ,commissioner of ,food and ,drugs and in consultation with the ,director of the ,centers for ,disease ,control and ,prevention1 shall issue guidance on ,,covid-#ai surveillance testing best practices4 ,such guidance shall address how ,,covid-#ai surveillance testing can be used to keep qualified entities1 as defined in section #e7;a71 open to the public1 and how tests with differing accuracy standards1 including rapid point of care antigen tests and pooled molecular tests1 can each be used in ,,covid-#ai surveillance testing at qualified entities among children and adult4 7#b7 ,,covid-#ai surveillance testing ,for purposes of paragraph 7#a71 the term ,,covid-#ai surveillance testing means the ongoing1 systematic collection1 analysis1 and interpretation of ,,covid-#ai diagnostic test results for the purpose of monitoring for a community- or population-level infection and disease1 or to characterize the incidence and prevalence of disease4 7c7 ,report on national daily testing benchmark ,not later than #cj days after the date of enactment of this ,act1 the ,secretary1 acting through the ,commissioner of ,food and ,drugs and in consultation with the ,director of the ,centers for ,disease ,control and ,prevention1 shall issue recommendations on the total number of ,,covid-#ai diagnostic tests that should be conducted in the ,united ,states per day to control the spread of ,,covid-#ai1 with a focus on the number of tests necessary to protect essential workers1 as defined in section #e7;a71 from ,,covid-#ai infection4 7d7 ,comparison of ,,covid-#ai diagnostic test performance ,not later than #cj days after the date of enactment of this ,act1 the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall issue a report comparing the performance of ,,covid-#ai diagnostic tests on the market1 including a comparison of the differing sensitivity and accuracy of such tests in asymptomatic and symptomatic populations and children and adults4 7e7 ,review of ,,covid-#ai diagnostic test approval pathways ,not later than #cj days after the date of enactment of this ,act1 the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall review the process for approving ,,covid-#ai diagnostic tests for market1 with a particular focus on extraction-free highly sensitive molecular tests1 pooled highly sensitive molecular tests1 low-cost rapid antigen test1 low-cost highly sensitive molecular tests1 assays that can use a variety of reagents1 and other products as determined by the ,secretary1 and take steps as necessary to expedite such process1 as appropriate4 #h4 ,demographic and geographic data collection 7a7 ,,covid-#ai data collection ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in consultation with the ,administrator of the ,centers for ,medicare ,medicaid ,services and the ,director of the ,indian ,health ,service1 shall make publicly available on the website of the ,centers for ,disease ,control and ,prevention data collected relating to ,,covid-#ai testing from entities receiving ,federal funding under this ,act1 including data disaggregated by race1 ethnicity1 sex 7including sexual orientation and gender identity71 age1 primary language1 socioeconomic status1 disability status1 pregnancy status1 occupation1 county1 and zip code4 7b7 ,application of standards ,to the extent practicable1 data collection under this section shall follow standards developed by the ,office of ,minority ,health of the ,department of ,health and ,human ,services and the ,centers for ,disease ,control and ,prevention1 and shall be collected1 analyzed1 and reported in accordance with the standards promulgated under section #caja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjkk74 7c7 ,timeline ,the data made available under this section shall be updated on a weekly basis throughout the ,,covid-#ai pandemic4 7d7 ,privacy ,in publishing data under this section1 the ,secretary shall take all necessary steps to protect the privacy of individuals whose information is included in such data1 including-- 7#a7 complying with privacy protections provided under the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note7 and ,state law2 and 7#b7 protections from all inappropriate internal use by an entity that collects1 stores1 or receives the data1 including use of such data in determinations of eligibility 7or continued eligibility7 in health plans1 and from inappropriate uses4 7e7 ,data use ,neither the ,secretary1 nor any other officer or employee of the ,federal ,government1 or local government liaison1 may use the information furnished under this legislation for any purpose other than the statistical and public health purposes for which such information is supplied1 or make any publication whereby the data furnished by any particular establishment or individual under this ,act can be identified1 or permit anyone other than the sworn officers and employees of the ,department of ,health and ,human ,services to examine the individual reports4