Title: Expanding COVID–19 Testing Capacity Act of 2020
Policy area: Health

Summary:
Expanding COVID-19 Testing Capacity Act of 2020
This bill expands access to COVID-19 (i.e., coronavirus disease 2019) diagnostic testing by establishing various programs and grants to facilitate the manufacture and provision of tests.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 5082 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  2d Session
                                S. 5082

    To provide Federal support for COVID-19 testing, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           December 21, 2020

  Ms. Warren introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
    To provide Federal support for COVID-19 testing, and for other 
                               purposes.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Expanding COVID-19 
Testing Capacity Act of 2020''.
    (b) Table of Contents.--The table of contents for the Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Definitions.
Sec. 3. Federal manufacturing of COVID-19 diagnostic tests.
Sec. 4. COVID-19 testing for covered Federal employees.
Sec. 5. Federal distribution of COVID-19 tests to qualified entities.
Sec. 6. Supplemental grants for COVID-19 testing.
Sec. 7. Reports and guidance on COVID-19 diagnostic testing.
Sec. 8. Demographic and geographic data collection.

SEC. 2. DEFINITIONS.

    In this Act:
            (1) Associated medical supplies.--The term ``associated 
        medical supplies'' means any product necessary for the 
        development and administration of COVID-19 diagnostic tests, 
        including chemical reagents, test swabs, and personal 
        protective equipment (including surgical masks, surgical gowns, 
        face shields, gloves, and N95 masks).
            (2) COVID-19 diagnostic test.--The term ``COVID-19 
        diagnostic test'' means a test--
                    (A) that is an in vitro diagnostic product (as 
                defined in section 809.3 of title 21, Code of Federal 
                Regulations, or any successor thereto) for the 
                detection of SARS-CoV-2 or the diagnosis of COVID-19; 
                and
                    (B) the administration of which--
                            (i) is approved, cleared, or authorized 
                        under section 510(k), 513, 515, or 564 of the 
                        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                        360(k), 360c, 360e, 360bbb-3); or
                            (ii) the developer has received an 
                        emergency use authorization under section 564 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 360bbb-3), unless and until the 
                        emergency use authorization request under such 
                        section 564.
            (3) COVID-19 pandemic.--The term ``COVID-19 pandemic'' 
        means the period beginning on the date that the public health 
        emergency with respect to COVID-19 took effect, and ending on 
        the date that is 6 months after the date on which the public 
        health emergency declaration with respect to COVID-19 
        terminates.
            (4) Indian tribe.--Except as otherwise provided, the term 
        ``Indian Tribe'' has the meaning given the term ``Indian 
        tribe'' in section 4 of the Indian Self-Determination and 
        Education Assistance Act (25 U.S.C. 5304).
            (5) Public health emergency with respect to covid-19.--The 
        term ``public health emergency with respect to COVID-19'' means 
        the public health emergency declared by the Secretary under 
        section 319 of the Public Health Service Act (21 U.S.C. 247d) 
        on January 31, 2020, with respect to COVID-19.
            (6) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (7) Tribal organization.--Except as otherwise provided, the 
        term ``Tribal organization'' has the meaning given the term 
        ``tribal organization'' in section 4 of the Indian Self-
        Determination and Education Assistance Act (25 U.S.C. 5304).
            (8) Urban indian organization.--The term ``urban Indian 
        organization'' has the meaning given the term in section 4 of 
        the Indian Health Care Improvement Act (25 U.S.C. 1603).

SEC. 3. FEDERAL MANUFACTURING OF COVID-19 DIAGNOSTIC TESTS.

    (a) In General.--As soon as practicable after the date of enactment 
of this Act, but no later than 15 days after such date of enactment, 
the Secretary shall begin the process of manufacturing, or contracting 
with entities for the manufacture of, COVID-19 diagnostic tests and 
associated medical supplies, with a particular focus on extraction-free 
highly sensitive molecular tests, pooled highly sensitive molecular 
tests, low-cost rapid antigen test, low-cost highly sensitive molecular 
tests, assays that can use a variety of reagents, and other products as 
determined by the Secretary. The Secretary shall continue such process 
until the end of the COVID-19 pandemic.
    (b) Submission of Applications.--For each COVID-19 diagnostic test 
and associated drug or device that the Secretary intends to market, or 
contract with another entity for the marketing of, the Secretary 
shall--
            (1) submit an application under subsection (b) or (j) of 
        section 505 or section 515 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355, 360e) or subsection (a) or (j) of 
        section 351 of the Public Health Service Act (42 U.S.C. 262), 
        submit a notification under section 510(k) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360(k)), or submit a request 
        for classification under section 513(f)(2) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360c(f)(2)) (or enter into a 
        contract with another entity to submit such an application, 
        notification, or request);
            (2) request an emergency use authorization of the product 
        under section 564 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360bbb-3) (or enter into a contract with another 
        entity to submit an application for such use); or
            (3) obtain from the holder of an application approved under 
        subsection (c) or (j) of section 505 or section 515 of the 
        Federal Food, Drug, and Cosmetic Act or subsection (a) or (k) 
        of section 351 of the Public Health Service Act, or cleared 
        under section 510(k) of the Federal Food, Drug, and Cosmetic 
        Act, rights to manufacture such product.
    (c) Provision of Products.--With respect to COVID-19 diagnostic 
tests and associated drugs and devices manufactured pursuant to 
subsection (a), the Secretary shall--
            (1) provide such COVID-19 diagnostic tests and associated 
        medical supplies at no cost to Federal, State, local, 
        territorial, and Native health programs, and other domestic 
        health care providers, including domestic commercial health 
        care providers, as determined by the Secretary; and
            (2) sell additional tests and associated drugs and devices, 
        at-cost, to other commercial entities and international 
        entities not described in paragraph (1).
    (d) Obtaining Rights To Manufacture and Market.--
            (1) In general.--When necessary to fulfill the Secretary's 
        duties under this section, the Secretary shall acquire the 
        rights to manufacture and market COVID-19 diagnostic tests and 
        associated drugs and devices as authorized under this section.
            (2) Licensing authority.--
                    (A) In general.--Notwithstanding any other 
                provision of law, the Secretary may issue licenses, as 
                useful for fulfilling the duties under this Act, 
                allowing the Department of Health and Human Services to 
                practice or have practiced (which may include licensure 
                of retroactive practice) any invention in the United 
                States or territories of the United States, including 
                making, using, offering to sell or selling, importing, 
                or exporting such invention, to reference or rely upon 
                clinical trial data submitted to a regulatory authority 
                or the grant of marketing approval, and to access and 
                use otherwise confidential information, including know-
                how, related to the manufacture of COVID-19 diagnostic 
                tests and associated medical supplies.
                    (B) Non-voluntary licensing.--For any license that 
                involves a non-voluntary authorization to use patented 
                inventions, regulatory test data, data, know-how or 
                other intellectual property rights, the license shall 
                provide for reasonable remuneration to rights holders 
                such as a reasonable royalty on the sales of product, a 
                1-time payment, or some combination, 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 sector, North American 
                Industry Classification System code 325410, provided 
                that when products are distributed for free, the 
                royalty shall be based upon the cost of goods. When 
                there are multiple rights holders, the allocation of 
                the total royalty payments shall be determined by--
                            (i) agreement among the rights holders;
                            (ii) allocation by arbitration among the 
                        rights holders; or
                            (iii) if neither clause (i) nor (ii) 
                        applies, by the Secretary.
            (3) Transparency.--Subject to paragraph (4), the Secretary 
        shall post any contract agreement under subsection (a) or 
        license issued under paragraph (2)(A) on the public internet 
        website of the Department of Health and Human Services, on the 
        date on which such agreement or license takes effect.
            (4) Protected information.--In carrying out this section, 
        the Secretary shall enforce applicable law concerning the 
        protection of confidential commercial information and trade 
        secrets.
    (e) Pricing Determinations.--
            (1) At-cost price.--In determining an at-cost price for 
        COVID-19 diagnostic tests and associated medical supplies for 
        purposes of subsection (c)(2), the Secretary shall consider--
                    (A) the cost to the Federal Government of 
                manufacturing the applicable COVID-19 diagnostic test 
                or associated drug or device; and
                    (B) the cost to acquire or manufacture under 
                subparagraph (A) the applicable COVID-19 diagnostic 
                test or associated drug or device.
            (2) Transparency.--All prices charged for COVID-19 
        diagnostic tests and associated medical supplies shall be made 
        publicly available by the Secretary.
    (f) Awarding Contracts.--
            (1) Priority.--In awarding contracts under this section, 
        the Secretary shall prioritize entities manufacturing COVID-19 
        diagnostic tests or associated medical supplies using 
        components originating from, and manufactured in, the United 
        States.
            (2) Contract requirements.--All contracts issued under this 
        section shall include a requirement that the contract 
        recipients reasonably price products produced under the 
        contract.
    (g) Report to the President and Congress.--The Secretary shall 
prepare and submit to the President, the Committee on Health, 
Education, Labor, and Pensions of the Senate, and the Committee on 
Energy and Commerce of the House of Representatives, a monthly report 
during the COVID-19 pandemic, and a final report 3 months after such 
pandemic has concluded, that includes--
            (1) an assessment of the major supply chain challenges 
        facing health care facilities, medical providers, the Federal 
        Government, State, local, territorial, and Tribal governments, 
        and the private sector in COVID-19 diagnostic tests and 
        associated medical supplies; and
            (2) a description of the authorization or approval status 
        and available supply of all COVID-19 diagnostic tests and 
        associated medical supplies for which manufacturing has been 
        authorized under this section, including products for which the 
        Secretary has submitted an application for approval, a 
        notification for clearance, or a request for classification to 
        the Food and Drug Administration but has not yet received 
        approval, clearance, or classification, and products for which 
        the Secretary has received approval, clearance, or 
        classification, from the Food and Drug Administration but are 
        not being manufactured.
    (h) Proceeds From Sales.--There are authorized to be appropriated 
to the Secretary for each fiscal year, for purposes of carrying out 
this section, an amount equal to the proceeds from the sale of COVID-19 
diagnostic tests and associated medical supplies described in 
subsection (c)(2) in the previous fiscal year.

SEC. 4. COVID-19 TESTING FOR COVERED FEDERAL EMPLOYEES.

    (a) Definitions.--In this section:
            (1) Agency.--The term ``agency''--
                    (A) means--
                            (i) each agency, office, or other 
                        establishment in the executive, legislative, or 
                        judicial branch of the Federal Government, 
                        including--
                                    (I) an Executive agency, as that 
                                term is defined in section 105 of title 
                                5, United States Code;
                                    (II) a military department, as that 
                                term is defined in section 102 of title 
                                5, United States Code;
                                    (III) the Federal Aviation 
                                Administration;
                                    (IV) the Transportation Security 
                                Administration;
                                    (V) the Department of Veterans 
                                Affairs;
                                    (VI) the Government Accountability 
                                Office;
                                    (VII) the Library of Congress;
                                    (VIII) the Postal Service;
                                    (IX) the House of Representatives;
                                    (X) the Senate; and
                                    (XI) the Architect of the Capitol;
                            (ii) the District of Columbia courts and 
                        the District of Columbia Public Defender 
                        Service; or
                            (iii) an--
                                    (I) Indian Tribe or Tribal 
                                organization carrying out a contract or 
                                compact under the Indian Self-
                                Determination and Education Assistance 
                                Act (25 U.S.C. 5301 et seq.);
                                    (II) Indian Tribe or Tribal 
                                organization that receives a grant 
                                under the Tribally Controlled Schools 
                                Act of 1988 (25 U.S.C. 2501 et seq.); 
                                or
                                    (III) Indian Tribe or Tribal 
                                organization (as defined in section 
                                5212 of the Tribally Controlled Schools 
                                Act of 1988 (25 U.S.C. 2511)) that 
                                receives a grant under that Act (25 
                                U.S.C. 2501 et seq.); and
                    (B) does not include a nonappropriated fund 
                instrumentality under the jurisdiction of the Armed 
                Forces.
            (2) Covered duty.--The term ``covered duty'' means all work 
        performed by a Federal employee, except duties that a Federal 
        employee performs while teleworking from a residence.
            (3) Federal employee.--The term ``Federal employee'' 
        means--
                    (A) an individual who engages in covered duties on 
                behalf of an agency at any time during the COVID-19 
                pandemic, or an individual classified as an independent 
                contractor by the agency who engages in covered duties 
                during such period;
                    (B) includes--
                            (i) any person performing work for an 
                        agency who engages in covered duties during the 
                        COVID-19 pandemic, regardless of whether such 
                        person is classified as an independent 
                        contractor by the agency; and
                            (ii) any paid or unpaid intern, fellow, 
                        trainee, or other person performing work for an 
                        agency who engages in covered duties during the 
                        COVID-19 pandemic; and
                    (C) does not include any employee of a Federal 
                contractor.
            (4) Timely manner.--The term ``timely manner'', with 
        respect to the administration of a COVID-19 diagnostic test, 
        means within 24 hours of the administration of such test.
    (b) Federal Employee COVID-19 Testing.--
            (1) In general.--Not later than 30 days after the date of 
        enactment of this Act, each agency shall begin to--
                    (A) conduct or contract with entities to conduct 
                COVID-19 diagnostic tests for Federal employees 
                employed by the agency at no cost to the employee, 
                regardless of whether such employees exhibit symptoms 
                of COVID-19, provided at locations accessible to the 
                Federal employees;
                    (B) provide each Federal employee employed by the 
                agency with the results of the diagnostic tests, 
                regardless of the results, including an interpretation 
                of what the test means in the employee's preferred 
                language, in a timely manner;
                    (C) submit the results of such tests to relevant 
                Federal, State, local, territorial, and Tribal public 
                health officials; and
                    (D) publish the aggregate results of such 
                diagnostic tests in accordance with section 8.
            (2) Time period.--Each agency shall continue the activities 
        described in subparagraphs (A), (B), and (C) of paragraph (1) 
        throughout the duration of the COVID-19 pandemic.
            (3) Minimum wage and overtime.--Notwithstanding any other 
        provision of law, for any individual employed by a contractor 
        or subcontractor, and who performs work assisted in whole or in 
        part by funding under this section, with respect to such 
        employment, such individual shall--
                    (A) be paid a wage of not less than $15 per hour; 
                and
                    (B) if such individual is paid at a rate that is 
                the full-time equivalent of less than $51,000 per year, 
                receive overtime pay of one-and-one-half times the 
                individual's regular rate of pay for all hours worked 
                in excess of 40 hours per workweek.
    (c) Frequency and Location of COVID-19 Diagnostic Testing.--In 
administering COVID-19 tests pursuant to subsection (b), each agency 
shall provide COVID-19 diagnostic tests at frequencies and locations 
recommended by the State, local, territorial or Tribal public health 
officials with jurisdiction over the geographic areas in which the 
applicable Federal employees work, or, if a national testing strategy 
is developed by Federal officials, in compliance with the national 
testing strategy.
    (d) 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-19 diagnostic tests required under 
this section.

SEC. 5. FEDERAL DISTRIBUTION OF COVID-19 TESTS TO QUALIFIED ENTITIES.

    (a) Definitions.--In this section:
            (1) COVID-19 testing.--The term ``COVID-19 testing'' has 
        the meaning given such term in interim final rules promulgated 
        by the Secretary within 15 days of the date of enactment of 
        this Act.
            (2) Essential work.--The term ``essential work'' means any 
        work that--
                    (A) is performed during the period of the COVID-19 
                pandemic;
                    (B) cannot be performed while teleworking from a 
                residence; and
                    (C)(i) involves--
                            (I) regular in-person interactions with 
                        patients, the public, or coworkers of the 
                        individual performing the work; or
                            (II) regular physical handling of items 
                        that were handled by, or are to be handled by 
                        patients, the public, or coworkers of the 
                        individual performing the work; and
                    (ii) is in the area of--
                            (I) first responder work, in the public 
                        sector or private sector, including services in 
                        response to emergencies that have the potential 
                        to cause death or serious bodily injury, such 
                        as police, fire, emergency medical, protective, 
                        child maltreatment, domestic violence, and 
                        correctional services (including activities 
                        carried out by employees in fire protection 
                        activities, as defined in section 3(y) of the 
                        Fair Labor Standards Act of 1938 (29 U.S.C. 
                        203(y)) and activities of law enforcement 
                        officers, as defined in section 1204(6) of the 
                        Omnibus Crime Control and Safe Streets Act of 
                        1968 (34 U.S.C. 10284(6)));
                            (II) health care work physically provided 
                        in inpatient settings (including hospitals and 
                        other inpatient post-acute care settings such 
                        as nursing homes, inpatient rehabilitation 
                        facilities, and other related settings) and 
                        other work physically performed in such 
                        inpatient settings that supports or is in 
                        furtherance of such health care work physically 
                        provided in inpatient settings;
                            (III) health care work physically provided 
                        in outpatient settings (including at physician 
                        offices, community health centers, Tribal 
                        clinics, rural health clinics and other 
                        clinics, hospital outpatient departments, 
                        freestanding emergency departments, health 
                        centers, ambulatory surgical centers, dialysis 
                        centers, dental offices, and other related 
                        settings), and other work physically performed 
                        in such outpatient settings that supports or is 
                        in furtherance of such health care work 
                        physically provided in outpatient settings;
                            (IV) pharmacy work, physically performed in 
                        pharmacies, drug stores, or other retail 
                        facilities specializing in medical goods and 
                        supplies;
                            (V) any work physically performed in a 
                        facility that performs medical testing and 
                        diagnostic services, including laboratory 
                        processing, medical testing services, imaging 
                        services, or related activities;
                            (VI) home- and community-based health care 
                        work, including home health care, residential 
                        care, assistance with activities of daily 
                        living, and any services provided by direct 
                        care workers (as defined in section 799B of the 
                        Public Health Service Act (42 U.S.C. 295p)), 
                        personal care aides, 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 (25 U.S.C. 1601 et 
                        seq.), job coaches, or supported employment 
                        providers, and any other provision of care to 
                        individuals in their homes by direct service 
                        providers, personal care attendants, and home 
                        health aides;
                            (VII) biomedical research;
                            (VIII) behavioral health work requiring 
                        physical interaction with individuals, 
                        including mental health services and substance 
                        use disorder prevention, treatment, and 
                        recovery services;
                            (IX) nursing care and residential work 
                        physically provided in a facility;
                            (X) family care, including child care 
                        services, in-home child care services such as 
                        nanny services, and care services provided by 
                        family members to other family members;
                            (XI) social services work, including social 
                        work, case management, social and human 
                        services, child welfare, family services, 
                        shelter and services for people who have 
                        experienced intimate partner violence or sexual 
                        assault, services for individuals who are 
                        homeless, child services, community food and 
                        housing services, and other emergency social 
                        services;
                            (XII) public health work conducted at a 
                        State, local, territorial, or Tribal government 
                        public health agency, including epidemiological 
                        activities, surveillance, contact tracing, data 
                        analysis, statistical research, health 
                        education, and other disease detection, 
                        prevention, and response methods;
                            (XIII) work conducted at a hospital, 
                        clinic, triage center, or other permanent or 
                        temporary health facility operated by the 
                        Indian Health Service, an Indian Tribe, Tribal 
                        organization, or urban Indian organization;
                            (XIV) grocery work physically performed at 
                        grocery stores, supermarkets, convenience 
                        stores, corner stores, drug stores, retail 
                        facilities specializing in medical goods and 
                        supplies, bodegas, or another location where 
                        individuals purchase non-prepared food items;
                            (XV) restaurant work, including carry-out, 
                        drive-thru, or food delivery work, requiring 
                        physical interaction with individuals or food 
                        products;
                            (XVI) food production work involving the 
                        physical interaction with food products, 
                        including all agricultural work, farming, 
                        harvesting, fishing, forestry, ranching, 
                        processing, canning, slaughtering, packaging, 
                        baking, butchering, and other food production 
                        work, such as any service or activity described 
                        in section 3(f) of the Fair Labor Standards Act 
                        of 1938 (29 U.S.C. 203(f)) or section 3121(g) 
                        of the Internal Revenue Code of 1986, and the 
                        handling, planting, drying, packing, packaging, 
                        processing, freezing, or grading prior to 
                        delivery for storage of any agricultural or 
                        horticultural commodity in its unmanufactured 
                        state;
                            (XVII) transportation work, including--
                                    (aa) any services in public 
                                transportation, as defined in section 
                                5302(14) of title 49, United States 
                                Code;
                                    (bb) any private transportation of 
                                people, such as transportation provided 
                                by air, rail, bus, taxicab, personal 
                                car or truck, non-motorized vehicle, or 
                                otherwise, including all services 
                                performed by individuals working in or 
                                on such vehicles, vehicle depots, or 
                                transit facilities;
                                    (cc) any services in passenger rail 
                                transportation, including commuter 
                                rail, intercity passenger rail, or 
                                Amtrak, including services performed by 
                                employees of contractors of such 
                                entities;
                                    (dd) any services in the 
                                transportation of persons, property, or 
                                mail by an aircraft of an air carrier 
                                conducting operations under part 121 of 
                                title 14, Code of Federal Regulations 
                                (or successor regulations), or a 
                                foreign air carrier within, to, or from 
                                the United States, either on board an 
                                aircraft or on the ground at an 
                                airport, including services performed 
                                by employees of contractors of air 
                                carriers, or foreign air carriers, as 
                                described in section 4111(3) of the 
                                CARES Act (15 U.S.C. 9071(3));
                                    (ee) any services as an aircraft 
                                mechanic or technician who performs 
                                maintenance, repair, or overhaul work 
                                on an aircraft of an air carrier 
                                conducting operations under such part 
                                121 or foreign air carrier within the 
                                United States;
                                    (ff) services as maritime workers 
                                who qualify as seamen under section 
                                10101(3) of title 46, United States 
                                Code, and other maritime employees 
                                including--
                                            (AA) longshoremen, harbor 
                                        workers and shipbuilders 
                                        covered under section 2(3) of 
                                        the Longshore and Harbor 
                                        Workers' Compensation Act (33 
                                        U.S.C. 902(3)) involved in the 
                                        transportation of merchandise 
                                        or passengers by water; and
                                            (BB) shipbuilders and ship 
                                        repairers who are working for 
                                        an employer performing 
                                        shipbuilding or ship repair 
                                        work under contract or 
                                        subcontract to the Departments 
                                        of Defense, Energy or Homeland 
                                        Security for military or other 
                                        national security purposes;
                                    (gg) services as maritime 
                                transportation workers supporting or 
                                enabling transportation functions, 
                                including such services as--
                                            (AA) barge workers, tug 
                                        operators, and port and 
                                        facility security personnel;
                                            (BB) marine dispatchers; 
                                        and
                                            (CC) workers who repair and 
                                        maintain marine vessels 
                                        (including the equipment and 
                                        infrastructure that enables 
                                        operations that encompass 
                                        movement of cargo and 
                                        passengers); and
                                    (hh) work physically performed in a 
                                warehouse or other facility in 
                                warehousing (including all services 
                                performed by individuals picking, 
                                sorting, packing, and shipping in 
                                warehouses), storage, distribution, or 
                                call center support facilities, and 
                                other essential operational support 
                                functions that are necessary to accept, 
                                store, and process goods, and that 
                                facilitate the goods' transportation 
                                and delivery;
                            (XVIII) cleaning work and building 
                        maintenance work physically performed on the 
                        grounds of a facility, including all custodial 
                        or janitorial services, security services, and 
                        repair and maintenance services;
                            (XIX) work in the collection, removal, 
                        transport, storage, or disposal of residential, 
                        industrial, or commercial solid waste and 
                        recycling, including services provided by 
                        individuals who drive waste or recycling 
                        trucks, who pick up waste or recycling from 
                        residential or commercial locations, or who 
                        work at waste or recycling centers or 
                        landfills;
                            (XX) work in the gathering, processing, 
                        disseminating, and delivery of news and 
                        information that serves the public interest to 
                        the public through mass media, including 
                        television, radio, and newspapers;
                            (XXI) any work performed by an employee of 
                        a State, locality, or Tribal government, that 
                        is determined to be essential work by the 
                        highest authority of such State, locality, or 
                        Tribal government;
                            (XXII) educational work, school nutrition 
                        work, and other work required to operate a 
                        school facility, including early childhood and 
                        after-school enrichment programs, preschool 
                        programs, elementary and secondary education, 
                        and higher education;
                            (XXIII) laundry work, including work in 
                        laundromats, laundry service companies, and dry 
                        cleaners;
                            (XXIV) elections work physically performed 
                        at polling places or otherwise amongst the 
                        public, including public-sector elections 
                        personnel and private-sector elections 
                        personnel;
                            (XXV) hazardous materials management, 
                        response, and cleanup work associated with any 
                        other essential work covered under this 
                        paragraph, including health care waste 
                        (including medical, pharmaceuticals, and 
                        medical material production), and testing 
                        operations (including laboratories processing 
                        test kits);
                            (XXVI) disinfection work for all facilities 
                        and modes of transportation involved in other 
                        essential work covered under this paragraph;
                            (XXVII) work in critical clinical research, 
                        development, and testing necessary for COVID-19 
                        response that involves physical interaction 
                        with hazardous materials, such as samples of 
                        COVID-19;
                            (XXVIII) work in mortuary, funeral, 
                        cremation, burial, cemetery, and related 
                        services;
                            (XXIX) work requiring physical interactions 
                        with patients in physical therapy, occupational 
                        therapy, speech-language pathology, and 
                        respiratory therapy and other therapy services;
                            (XXX) dental care work requiring physical 
                        interaction with patients;
                            (XXXI) work performed by employees of the 
                        United States Postal Service;
                            (XXXII) work at hotel and commercial 
                        lodging facilities that are used for COVID-19 
                        mitigation and containment measures; and
                            (XXXIII) work installing or repairing a 
                        telecommunications line or equipment.
            (3) Essential worker.--The term ``essential worker'' means 
        an individual whose work and duties include essential work, 
        including individuals that are employees of employers and 
        individuals performing any services or labor for remuneration, 
        regardless of whether such individual is classified as an 
        independent contractor by the employer.
            (4) Qualified entity.--The term ``qualified entity'' 
        means--
                    (A) a congregate care setting, including any 
                skilled nursing facilities, assisted living facilities, 
                prisons and jails, residential behavioral health care 
                and psychiatric facilities, and facilities providing 
                services for aging adults and people with disabilities;
                    (B) an education center, including any childcare 
                facilities, elementary and secondary schools that have 
                resumed (or plan to resume within 30 days of receipt of 
                items under subsection (b)) any form of in-person 
                instruction, and colleges and universities that have 
                resumed (or plan to resume within 30 days of receipt of 
                items under subsection (b)) any form of in-person 
                instruction or on-campus housing;
                    (C) a community center, such as State and local 
                government buildings, religious centers, and nonprofit 
                service organizations;
                    (D) a prison, jail, or youth detention facility;
                    (E) a hospital, community health center, Tribal or 
                Indian Health Service clinic or hospital, or other 
                medical facility;
                    (F) a small business;
                    (G) a business that employs essential workers;
                    (H) a homeless shelter or entity supporting 
                individuals living in housing funded with support from 
                the Department of Housing and Urban Development, 
                including housing provided under the supportive housing 
                for the elderly program under section 202 of the 
                Housing Act of 1959 (12 U.S.C. 1701q); or
                    (I) another entity, as determined by the Secretary, 
                that could serve as a COVID-19 diagnostic testing site.
            (5) Timely manner.--The term ``timely manner'', with 
        respect to the administration of a COVID-19 diagnostic test, 
        means within 24 hours of the administration of such test.
    (b) Distribution of COVID-19 Diagnostic Tests.--
            (1) In general.--Within 40 days of the date of enactment of 
        this Act, the Secretary shall--
                    (A) begin distributing COVID-19 diagnostic tests 
                and associated medical supplies, including tests and 
                medical supplies manufactured under section 3, to 
                qualified entities via State, local, territorial, and 
                Tribal governments for the purpose of--
                            (i) providing COVID-19 diagnostic testing 
                        to essential workers and individuals served by 
                        qualified entities, at no cost to the essential 
                        workers and individuals, regardless of whether 
                        such workers and individuals exhibit symptoms 
                        of COVID-19, at locations accessible to the 
                        essential workers and individuals in the course 
                        of their work;
                            (ii) providing essential workers and 
                        individuals served by qualified entities with 
                        the results of the diagnostic tests, regardless 
                        of the results, including an interpretation of 
                        what the test means in the employee's preferred 
                        language, in a timely manner;
                            (iii) submitting the results of such tests 
                        to relevant Federal, State, local, territorial, 
                        and Tribal public health officials; and
                            (iv) publishing the aggregate results of 
                        such diagnostic tests in accordance with 
                        section 8; and
                    (B) hire and deploy employees, or contract with 
                outside entities to hire and deploy employees, as 
                necessary to assist in the distribution, provision, 
                administration of, and data collection regarding COVID-
                19 diagnostic tests as described in subparagraph (A).
            (2) Employees.--In hiring employees, or contracting with 
        outside entities to hire employees, to carry out this 
        subsection, the Secretary shall prioritize, or require 
        contractors to prioritize, hiring individuals from within the 
        communities served by the applicable qualified entity.
            (3) Minimum wage and overtime.--Notwithstanding any other 
        provision of law, for any individual employed by a contractor 
        or subcontractor, and who performs work assisted in whole or in 
        part by funding under this section, with respect to such 
        employment, such individual shall--
                    (A) be paid a wage of not less than $15 per hour; 
                and
                    (B) if such individual is paid at a rate that is 
                the full-time equivalent of less than $51,000 per year, 
                receive overtime pay of one-and-one-half times the 
                individual's regular rate of pay for all hours worked 
                in excess of 40 hours per workweek.
    (c) Coordination With State, Local, Territorial, and Tribal 
Governments.--Within 30 days of the date of enactment of this Act, a 
representative of each State, local, territorial, and Tribal government 
shall submit to the Secretary a list of qualified entities in their 
jurisdiction and a description of employee, resource, and other 
infrastructure needs necessary for the distribution of COVID-19 
diagnostic tests and associated drugs and devices under subsection (b).
    (d) Frequency and Location of COVID-19 Diagnostic Testing.--In 
distributing COVID-19 tests under (b), the Secretary shall provide 
COVID-19 diagnostic tests at frequencies and locations recommended by 
the State, local, territorial, or Tribal public health officials with 
jurisdiction over the geographic areas in which qualified entities are 
located, or, if a national testing strategy is developed by Federal 
officials, in compliance with the national testing strategy.
    (e) Public Reporting.--Beginning 30 days after the date of 
enactment of this Act and for the duration of the COVID-19 pandemic, 
the Secretary shall publish weekly, in a machine readable format, the 
total number of tests distributed to, and the total number of tests 
administered in, each State, county, territory, and Tribe under 
subsection (b).
    (f) Authorization of Appropriations.--There is authorized to be 
appropriated such sums as may be necessary to carry out this section.

SEC. 6. SUPPLEMENTAL GRANTS FOR COVID-19 TESTING.

    (a) In General.--No later than 30 days after the date of enactment 
of this Act, the Secretary, acting through the Director of the Centers 
for Disease Control and Prevention shall--
            (1) issue competitive grants to State, local, and 
        territorial governments for the purpose of increasing access to 
        COVID-19 diagnostic testing; and
            (2) issue noncompetitive and formula-based awards to Indian 
        Tribes and Tribal organizations.
    (b) Priority Areas and Populations.--In issuing grants under 
subsection (a), the Secretary shall--
            (1) prioritize areas and populations that have been 
        disproportionately affected by COVID-19, and areas where 
        operationalizing testing programs is not possible with existing 
        resources; and
            (2) consider the capacity that States, localities, 
        territories, and Tribes already have at the time of application 
        to conduct widespread COVID-19 diagnostic testing.
    (c) Use of Funds.--Grants awarded under subsection (a) may be used 
to--
            (1) establish new COVID-19 diagnostic testing sites at 
        community centers, such as State, local, territorial, and 
        Tribal government buildings, churches, health centers, clinics, 
        and public parks, subject to Federal quality control standards 
        for laboratory testing;
            (2) hire State, local, territorial, and Tribal government 
        employees, or contract with outside entities, to assist in the 
        development, distribution, and provision of COVID-19 diagnostic 
        tests within the State, locality, territory, or Tribe;
            (3) purchase COVID-19 diagnostic tests and the medical 
        supplies necessary to conduct such tests;
            (4) increase the number of COVID-19 diagnostic tests 
        provided at congregate settings, such as--
                    (A) skilled nursing facilities;
                    (B) assisted living facilities;
                    (C) childcare facilities;
                    (D) elementary and secondary schools that have 
                resumed, or plan to resume within 30 days, in-person 
                instruction;
                    (E) colleges and universities that have resumed, or 
                plan to resume within 30 days, in-person instruction or 
                on-campus housing;
                    (F) prisons, jails, and youth detention facilities;
                    (G) residential behavioral health care and 
                psychiatric facilities;
                    (H) institutions providing services for aging 
                adults and people with intellectual and developmental 
                disabilities, rehabilitation facilities, and group 
                homes; and
                    (I) homeless shelters;
            (5) educate the public about the availability of COVID-19 
        diagnostic tests in their communities and what to do if a 
        positive result is received;
            (6) issue subgrants, cooperative agreements, or contracts 
        to labs, hospitals, and other test providers to reduce test 
        processing time; submit the results to State, local, 
        territorial, and Tribal public health officials; and prevent 
        delays in the distribution of testing results, such as through 
        transferring research lab capacity to COVID-19 testing capacity 
        and building new labs to reduce test processing turnaround 
        time;
            (7) enable the State, locality, territory, or Tribe to 
        detect and identify trends in COVID-19 and develop guidance for 
        communities on how to develop testing programs and expand test 
        capacity;
            (8) reduce disparities in access to COVID-19 diagnostic 
        testing among the communities hardest hit by COVID-19; and
            (9) additional uses, as determined by the Secretary, in 
        accordance with subsection (e).
    (d) Requirement.--Any COVID-19 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 status. The 
results shall be submitted to relevant State, local, territorial, and 
Tribal public health officials.
    (e) Minimum Wage and Overtime.--Notwithstanding any other provision 
of law, for any individual employed by a contractor or subcontractor, 
and who performs work assisted in whole or in part by funding under 
this section, with respect to such employment, such individual shall--
            (1) be paid a wage of not less than $15 per hour; and
            (2) if such individual is paid at a rate that is the full-
        time equivalent of less than $51,000 per year, receive overtime 
        pay of one-and-one-half times the individual's regular rate of 
        pay for all hours worked in excess of 40 hours per workweek.
    (f) Additional Uses of Funds.--In determining appropriate uses of 
funds under subsection (c)(9), the Secretary shall consider the 
incidence of COVID-19 in States, localities, territories, and Tribes, 
the availability and uptake of vaccines for COVID-19 in States, 
localities, territories, and Tribes, and advancements in COVID-19 
diagnostic test technologies.
    (g) Authorization of Appropriations.--
            (1) In general.--There is authorized to be appropriated 
        $25,000,000,000 for fiscal year 2021 for purposes of awarding 
        grants under this section.
            (2) Tribal set-aside.--Not less than 10 percent of the 
        total amount appropriated under paragraph (1) for a fiscal year 
        shall be reserved for noncompetitive awards to--
                    (A) Indian Tribes or Tribal organizations carrying 
                out a contract or compact under the Indian Self-
                Determination and Education Assistance Act (25 U.S.C. 
                5301 et seq.);
                    (B) Indian Tribes or Tribal organizations receiving 
                a grant under the Tribally Controlled Schools Act of 
                1988 (25 U.S.C. 2501 et seq.); and
                    (C) Indian Tribes or tribal organizations (as 
                defined in section 5212 of the Tribally Controlled 
                Schools Act of 1988 (25 U.S.C. 2511)) receiving grants 
                under that Act (25 U.S.C. 2501 et seq.).
            (3) Local government set aside.--Not less than 30 percent 
        of the total amount appropriated under paragraph (1) for a 
        fiscal year shall be reserved for grants awarded directly to 
        local governments.

SEC. 7. REPORTS AND GUIDANCE ON COVID-19 DIAGNOSTIC TESTING.

    (a) Updated Guidance on COVID-19 Rapid Diagnostic Tests.--
            (1) In general.--Not later than 30 days after the date of 
        enactment of this Act, the Secretary, acting through the 
        Commissioner of Food and Drugs, shall issue updated guidance on 
        the development of rapid COVID-19 diagnostic tests, the 
        provision of such tests, including in nonclinical environments, 
        and the appropriate collection and electronic reporting of 
        results (including geographic and demographic data, including 
        with respect to race and ethnicity) and data regarding such 
        tests to Federal, State, local, and Tribal public health 
        officials.
            (2) Rapid covid-19 diagnostic test.--For purposes of 
        paragraph (1), the term ``rapid COVID-19 diagnostic test'' 
        means a COVID-19 diagnostic test that can be performed by a 
        user, with or without the need of a medical professional or 
        medical supervisor, and that can produce results within 1 hour 
        of application.
    (b) Updated Surveillance Testing Guidance.--
            (1) In general.--Not later than 30 days after the date of 
        enactment of this Act, the Secretary, acting through the 
        Commissioner of Food and Drugs and in consultation with the 
        Director of the Centers for Disease Control and Prevention, 
        shall issue guidance on COVID-19 surveillance testing best 
        practices. Such guidance shall address how COVID-19 
        surveillance testing can be used to keep qualified entities, as 
        defined in section 5(a), open to the public, and how tests with 
        differing accuracy standards, including rapid point of care 
        antigen tests and pooled molecular tests, can each be used in 
        COVID-19 surveillance testing at qualified entities among 
        children and adult.
            (2) COVID-19 surveillance testing.--For purposes of 
        paragraph (1), the term ``COVID-19 surveillance testing'' means 
        the ongoing, systematic collection, analysis, and 
        interpretation of COVID-19 diagnostic test results for the 
        purpose of monitoring for a community- or population-level 
        infection and disease, or to characterize the incidence and 
        prevalence of disease.
    (c) Report on National Daily Testing Benchmark.--Not later than 30 
days after the date of enactment of this Act, the Secretary, acting 
through the Commissioner of Food and Drugs and in consultation with the 
Director of the Centers for Disease Control and Prevention, shall issue 
recommendations on the total number of COVID-19 diagnostic tests that 
should be conducted in the United States per day to control the spread 
of COVID-19, with a focus on the number of tests necessary to protect 
essential workers, as defined in section 5(a), from COVID-19 infection.
    (d) Comparison of COVID-19 Diagnostic Test Performance.--Not later 
than 30 days after the date of enactment of this Act, the Secretary, 
acting through the Commissioner of Food and Drugs, shall issue a report 
comparing the performance of COVID-19 diagnostic tests on the market, 
including a comparison of the differing sensitivity and accuracy of 
such tests in asymptomatic and symptomatic populations and children and 
adults.
    (e) Review of COVID-19 Diagnostic Test Approval Pathways.--Not 
later than 30 days after the date of enactment of this Act, the 
Secretary, acting through the Commissioner of Food and Drugs, shall 
review the process for approving COVID-19 diagnostic tests for market, 
with a particular focus on extraction-free highly sensitive molecular 
tests, pooled highly sensitive molecular tests, low-cost rapid antigen 
test, low-cost highly sensitive molecular tests, assays that can use a 
variety of reagents, and other products as determined by the Secretary, 
and take steps as necessary to expedite such process, as appropriate.

SEC. 8. DEMOGRAPHIC AND GEOGRAPHIC DATA COLLECTION.

    (a) COVID-19 Data Collection.--The Secretary, 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 Service, shall 
make publicly available on the website of the Centers for Disease 
Control and Prevention data collected relating to COVID-19 testing from 
entities receiving Federal funding under this Act, including data 
disaggregated by race, ethnicity, sex (including sexual orientation and 
gender identity), age, primary language, socioeconomic status, 
disability status, pregnancy status, occupation, county, and zip code.
    (b) Application of Standards.--To the extent practicable, 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 Prevention, and shall 
be collected, analyzed, and reported in accordance with the standards 
promulgated under section 3101 of the Public Health Service Act (42 
U.S.C. 300kk).
    (c) Timeline.--The data made available under this section shall be 
updated on a weekly basis throughout the COVID-19 pandemic.
    (d) Privacy.--In publishing data under this section, the Secretary 
shall take all necessary steps to protect the privacy of individuals 
whose information is included in such data, including--
            (1) complying with privacy protections provided under the 
        regulations promulgated under section 264(c) of the Health 
        Insurance Portability and Accountability Act of 1996 (42 U.S.C. 
        1320d-2 note) and State law; and
            (2) protections from all inappropriate internal use by an 
        entity that collects, stores, or receives the data, including 
        use of such data in determinations of eligibility (or continued 
        eligibility) in health plans, and from inappropriate uses.
    (e) Data Use.--Neither the Secretary, nor any other officer or 
employee of the Federal Government, or local government liaison, may 
use the information furnished under this legislation for any purpose 
other than the statistical and public health purposes for which such 
information is supplied, or make any publication whereby the data 
furnished by any particular establishment or individual under this Act 
can be identified, or permit anyone other than the sworn officers and 
employees of the Department of Health and Human Services to examine the 
individual reports.
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