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S. 5082, Expanding COVID–19 Testing Capacity Act of 2020

Summary

S. 5082, the Expanding COVID–19 Testing Capacity Act of 2020, was introduced in the Senate of the United States December 21, 2020, by Ms. Warren. It was read twice and referred to the Committee on Health, Education, Labor, and Pensions. The bill would provide Federal support for COVID–19 testing. Section 3 provides that, no later than 15 days after enactment, the Secretary shall begin manufacturing, or contracting for the manufacture of, COVID–19 diagnostic tests and associated medical supplies until the end of the COVID–19 pandemic. Other sections cover testing for covered Federal employees, Federal distribution of tests to qualified entities, supplemental grants, reports and guidance, and demographic and geographic data collection.

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Bills Bills 116S5082Is Bills 116S5082Is
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Bills Bills 116S5082Is Bills 116S5082Is

Cite this document

“S. 5082, Expanding COVID–19 Testing Capacity Act of 2020.” Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/bills-bills-116s5082is-bills-116s5082is/, SHA-256 7d9eba5b483184d0762c339faab0cae196dd8a614d08e26c546086dcc8abf4bd.

Full text

                                                                                                                                                                        II




                                                                     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.

                                                                       1              Be it enacted by the Senate and House of Representa-
                                                                       2 tives of the United States of America in Congress assembled,
                                                                       3     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

                                                                       4              (a) SHORT TITLE.—This Act may be cited as the
                                                                       5 ‘‘Expanding COVID–19 Testing Capacity Act of 2020’’.
                                                                       6              (b) TABLE OF CONTENTS.—The table of contents for
                                                                       7 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.




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                                                                             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.



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                                                                       1     SEC. 2. DEFINITIONS.

                                                                       2              In this Act:
                                                                       3                        (1)       ASSOCIATED                 MEDICAL              SUPPLIES.—The

                                                                       4              term ‘‘associated medical supplies’’ means any prod-
                                                                       5              uct necessary for the development and administra-
                                                                       6              tion of COVID–19 diagnostic tests, including chem-
                                                                       7              ical reagents, test swabs, and personal protective
                                                                       8              equipment               (including             surgical            masks,         surgical
                                                                       9              gowns, face shields, gloves, and N95 masks).
                                                                     10                         (2) COVID–19 DIAGNOSTIC TEST.—The term
                                                                     11               ‘‘COVID–19 diagnostic test’’ means a test—
                                                                     12                                  (A) that is an in vitro diagnostic product
                                                                     13                         (as defined in section 809.3 of title 21, Code of
                                                                     14                         Federal Regulations, or any successor thereto)
                                                                     15                         for the detection of SARS–CoV–2 or the diag-
                                                                     16                         nosis of COVID–19; and
                                                                     17                                  (B) the administration of which—
                                                                     18                                          (i) is approved, cleared, or authorized
                                                                     19                                  under section 510(k), 513, 515, or 564 of
                                                                     20                                  the Federal Food, Drug, and Cosmetic Act
                                                                     21                                  (21 U.S.C. 360(k), 360c, 360e, 360bbb–3);
                                                                     22                                  or
                                                                     23                                          (ii) the developer has received an
                                                                     24                                  emergency use authorization under section




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                                                                     25                                  564 of the Federal Food, Drug, and Cos-
                                                                     26                                  metic Act (21 U.S.C. 360bbb–3), unless
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                                                                       1                                 and until the emergency use authorization
                                                                       2                                 request under such section 564.
                                                                       3                        (3)         COVID–19                    PANDEMIC.—The                   term
                                                                       4              ‘‘COVID–19 pandemic’’ means the period beginning
                                                                       5              on the date that the public health emergency with
                                                                       6              respect to COVID–19 took effect, and ending on the
                                                                       7              date that is 6 months after the date on which the
                                                                       8              public health emergency declaration with respect to
                                                                       9              COVID–19 terminates.
                                                                     10                         (4) INDIAN TRIBE.—Except as otherwise pro-
                                                                     11               vided, the term ‘‘Indian Tribe’’ has the meaning
                                                                     12               given the term ‘‘Indian tribe’’ in section 4 of the In-
                                                                     13               dian Self-Determination and Education Assistance
                                                                     14               Act (25 U.S.C. 5304).
                                                                     15                         (5) PUBLIC               HEALTH EMERGENCY WITH RE-

                                                                     16               SPECT           TO      COVID–19.—The                     term ‘‘public health
                                                                     17               emergency with respect to COVID–19’’ means the
                                                                     18               public health emergency declared by the Secretary
                                                                     19               under section 319 of the Public Health Service Act
                                                                     20               (21 U.S.C. 247d) on January 31, 2020, with respect
                                                                     21               to COVID–19.
                                                                     22                         (6) SECRETARY.—The term ‘‘Secretary’’ means
                                                                     23               the Secretary of Health and Human Services.
                                                                     24                         (7) TRIBAL ORGANIZATION.—Except as other-



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                                                                     25               wise provided, the term ‘‘Tribal organization’’ has


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                                                                       1              the meaning given the term ‘‘tribal organization’’ in
                                                                       2              section 4 of the Indian Self-Determination and Edu-
                                                                       3              cation Assistance Act (25 U.S.C. 5304).
                                                                       4                        (8) URBAN INDIAN ORGANIZATION.—The term
                                                                       5              ‘‘urban Indian organization’’ has the meaning given
                                                                       6              the term in section 4 of the Indian Health Care Im-
                                                                       7              provement Act (25 U.S.C. 1603).
                                                                       8     SEC. 3. FEDERAL MANUFACTURING OF COVID–19 DIAG-

                                                                       9                             NOSTIC TESTS.

                                                                     10               (a) IN GENERAL.—As soon as practicable after the
                                                                     11 date of enactment of this Act, but no later than 15 days
                                                                     12 after such date of enactment, the Secretary shall begin
                                                                     13 the process of manufacturing, or contracting with entities
                                                                     14 for the manufacture of, COVID–19 diagnostic tests and
                                                                     15 associated medical supplies, with a particular focus on ex-
                                                                     16 traction-free highly sensitive molecular tests, pooled highly
                                                                     17 sensitive molecular tests, low-cost rapid antigen test, low-
                                                                     18 cost highly sensitive molecular tests, assays that can use
                                                                     19 a variety of reagents, and other products as determined
                                                                     20 by the Secretary. The Secretary shall continue such proc-
                                                                     21 ess until the end of the COVID–19 pandemic.
                                                                     22               (b) SUBMISSION                       OF        APPLICATIONS.—For each
                                                                     23 COVID–19 diagnostic test and associated drug or device
                                                                     24 that the Secretary intends to market, or contract with an-



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                                                                     25 other entity for the marketing of, the Secretary shall—


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                                                                       1                        (1) submit an application under subsection (b)
                                                                       2              or (j) of section 505 or section 515 of the Federal
                                                                       3              Food, Drug, and Cosmetic Act (21 U.S.C. 355,
                                                                       4              360e) or subsection (a) or (j) of section 351 of the
                                                                       5              Public Health Service Act (42 U.S.C. 262), submit
                                                                       6              a notification under section 510(k) of the Federal
                                                                       7              Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)),
                                                                       8              or submit a request for classification under section
                                                                       9              513(f)(2) of the Federal Food, Drug, and Cosmetic
                                                                     10               Act (21 U.S.C. 360c(f)(2)) (or enter into a contract
                                                                     11               with another entity to submit such an application,
                                                                     12               notification, or request);
                                                                     13                         (2) request an emergency use authorization of
                                                                     14               the product under section 564 of the Federal Food,
                                                                     15               Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) (or
                                                                     16               enter into a contract with another entity to submit
                                                                     17               an application for such use); or
                                                                     18                         (3) obtain from the holder of an application ap-
                                                                     19               proved under subsection (c) or (j) of section 505 or
                                                                     20               section 515 of the Federal Food, Drug, and Cos-
                                                                     21               metic Act or subsection (a) or (k) of section 351 of
                                                                     22               the Public Health Service Act, or cleared under sec-
                                                                     23               tion 510(k) of the Federal Food, Drug, and Cos-
                                                                     24               metic Act, rights to manufacture such product.



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                                                                       1              (c) PROVISION                   OF        PRODUCTS.—With respect to
                                                                       2 COVID–19 diagnostic tests and associated drugs and de-
                                                                       3 vices manufactured pursuant to subsection (a), the Sec-
                                                                       4 retary shall—
                                                                       5                        (1) provide such COVID–19 diagnostic tests
                                                                       6              and associated medical supplies at no cost to Fed-
                                                                       7              eral, State, local, territorial, and Native health pro-
                                                                       8              grams, and other domestic health care providers, in-
                                                                       9              cluding domestic commercial health care providers,
                                                                     10               as determined by the Secretary; and
                                                                     11                         (2) sell additional tests and associated drugs
                                                                     12               and devices, at-cost, to other commercial entities and
                                                                     13               international entities not described in paragraph (1).
                                                                     14               (d) OBTAINING RIGHTS TO MANUFACTURE                                               AND

                                                                     15 MARKET.—
                                                                     16                         (1) IN GENERAL.—When necessary to fulfill the
                                                                     17               Secretary’s duties under this section, the Secretary
                                                                     18               shall acquire the rights to manufacture and market
                                                                     19               COVID–19 diagnostic tests and associated drugs
                                                                     20               and devices as authorized under this section.
                                                                     21                         (2) LICENSING AUTHORITY.—
                                                                     22                                  (A) IN          GENERAL.—Notwithstanding                       any
                                                                     23                         other provision of law, the Secretary may issue
                                                                     24                         licenses, as useful for fulfilling the duties under



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                                                                     25                         this Act, allowing the Department of Health


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                                                                       1                        and Human Services to practice or have prac-
                                                                       2                        ticed (which may include licensure of retroactive
                                                                       3                        practice) any invention in the United States or
                                                                       4                        territories of the United States, including mak-
                                                                       5                        ing, using, offering to sell or selling, importing,
                                                                       6                        or exporting such invention, to reference or rely
                                                                       7                        upon clinical trial data submitted to a regu-
                                                                       8                        latory authority or the grant of marketing ap-
                                                                       9                        proval, and to access and use otherwise con-
                                                                     10                         fidential information, including know-how, re-
                                                                     11                         lated to the manufacture of COVID–19 diag-
                                                                     12                         nostic tests and associated medical supplies.
                                                                     13                                  (B)         NON-VOLUNTARY                       LICENSING.—For

                                                                     14                         any license that involves a non-voluntary au-
                                                                     15                         thorization to use patented inventions, regu-
                                                                     16                         latory test data, data, know-how or other intel-
                                                                     17                         lectual property rights, the license shall provide
                                                                     18                         for reasonable remuneration to rights holders
                                                                     19                         such as a reasonable royalty on the sales of
                                                                     20                         product, a 1-time payment, or some combina-
                                                                     21                         tion, provided that the combined royalty pay-
                                                                     22                         ments to all rights holders shall not exceed the
                                                                     23                         percentage of sales that is the average percent
                                                                     24                         of all royalty payments reported to the Internal



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                                                                     25                         Revenue Service by companies in the pharma-


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                                                                       1                        ceutical and medicines sector, North American
                                                                       2                        Industry Classification System code 325410,
                                                                       3                        provided that when products are distributed for
                                                                       4                        free, the royalty shall be based upon the cost of
                                                                       5                        goods. When there are multiple rights holders,
                                                                       6                        the allocation of the total royalty payments
                                                                       7                        shall be determined by—
                                                                       8                                         (i) agreement among the rights hold-
                                                                       9                                 ers;
                                                                     10                                          (ii) allocation by arbitration among
                                                                     11                                  the rights holders; or
                                                                     12                                          (iii) if neither clause (i) nor (ii) ap-
                                                                     13                                  plies, by the Secretary.
                                                                     14                         (3) TRANSPARENCY.—Subject to paragraph (4),
                                                                     15               the Secretary shall post any contract agreement
                                                                     16               under subsection (a) or license issued under para-
                                                                     17               graph (2)(A) on the public internet website of the
                                                                     18               Department of Health and Human Services, on the
                                                                     19               date on which such agreement or license takes ef-
                                                                     20               fect.
                                                                     21                         (4) PROTECTED                       INFORMATION.—In                     carrying
                                                                     22               out this section, the Secretary shall enforce applica-
                                                                     23               ble law concerning the protection of confidential
                                                                     24               commercial information and trade secrets.



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                                                                     25               (e) PRICING DETERMINATIONS.—


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                                                                       1                        (1) AT-COST PRICE.—In determining an at-cost
                                                                       2              price for COVID–19 diagnostic tests and associated
                                                                       3              medical supplies for purposes of subsection (c)(2),
                                                                       4              the Secretary shall consider—
                                                                       5                                 (A) the cost to the Federal Government of
                                                                       6                        manufacturing the applicable COVID–19 diag-
                                                                       7                        nostic test or associated drug or device; and
                                                                       8                                 (B) the cost to acquire or manufacture
                                                                       9                        under subparagraph (A) the applicable COVID–
                                                                     10                         19 diagnostic test or associated drug or device.
                                                                     11                         (2) TRANSPARENCY.—All prices charged for
                                                                     12               COVID–19 diagnostic tests and associated medical
                                                                     13               supplies shall be made publicly available by the Sec-
                                                                     14               retary.
                                                                     15               (f) AWARDING CONTRACTS.—
                                                                     16                         (1) PRIORITY.—In awarding contracts under
                                                                     17               this section, the Secretary shall prioritize entities
                                                                     18               manufacturing COVID–19 diagnostic tests or associ-
                                                                     19               ated medical supplies using components originating
                                                                     20               from, and manufactured in, the United States.
                                                                     21                         (2) CONTRACT REQUIREMENTS.—All contracts
                                                                     22               issued under this section shall include a requirement
                                                                     23               that the contract recipients reasonably price prod-
                                                                     24               ucts produced under the contract.



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                                                                       1              (g) REPORT TO THE PRESIDENT AND CONGRESS.—
                                                                       2 The Secretary shall prepare and submit to the President,
                                                                       3 the Committee on Health, Education, Labor, and Pen-
                                                                       4 sions of the Senate, and the Committee on Energy and
                                                                       5 Commerce of the House of Representatives, a monthly re-
                                                                       6 port during the COVID–19 pandemic, and a final report
                                                                       7 3 months after such pandemic has concluded, that in-
                                                                       8 cludes—
                                                                       9                        (1) an assessment of the major supply chain
                                                                     10               challenges facing health care facilities, medical pro-
                                                                     11               viders, the Federal Government, State, local, terri-
                                                                     12               torial, and Tribal governments, and the private sec-
                                                                     13               tor in COVID–19 diagnostic tests and associated
                                                                     14               medical supplies; and
                                                                     15                         (2) a description of the authorization or ap-
                                                                     16               proval status and available supply of all COVID–19
                                                                     17               diagnostic tests and associated medical supplies for
                                                                     18               which manufacturing has been authorized under this
                                                                     19               section, including products for which the Secretary
                                                                     20               has submitted an application for approval, a notifi-
                                                                     21               cation for clearance, or a request for classification to
                                                                     22               the Food and Drug Administration but has not yet
                                                                     23               received approval, clearance, or classification, and
                                                                     24               products for which the Secretary has received ap-



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                                                                     25               proval, clearance, or classification, from the Food


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                                                                       1              and Drug Administration but are not being manu-
                                                                       2              factured.
                                                                       3              (h) PROCEEDS FROM SALES.—There are authorized
                                                                       4 to be appropriated to the Secretary for each fiscal year,
                                                                       5 for purposes of carrying out this section, an amount equal
                                                                       6 to the proceeds from the sale of COVID–19 diagnostic
                                                                       7 tests and associated medical supplies described in sub-
                                                                       8 section (c)(2) in the previous fiscal year.
                                                                       9     SEC. 4. COVID–19 TESTING FOR COVERED FEDERAL EM-

                                                                     10                              PLOYEES.

                                                                     11               (a) DEFINITIONS.—In this section:
                                                                     12                         (1) AGENCY.—The term ‘‘agency’’—
                                                                     13                                  (A) means—
                                                                     14                                          (i) each agency, office, or other estab-
                                                                     15                                  lishment in the executive, legislative, or ju-
                                                                     16                                  dicial branch of the Federal Government,
                                                                     17                                  including—
                                                                     18                                                   (I) an Executive agency, as that
                                                                     19                                          term is defined in section 105 of title
                                                                     20                                          5, United States Code;
                                                                     21                                                   (II) a military department, as
                                                                     22                                          that term is defined in section 102 of
                                                                     23                                          title 5, United States Code;
                                                                     24                                                   (III) the Federal Aviation Ad-



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                                                                     25                                          ministration;


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                                                                       1                                                  (IV) the Transportation Security
                                                                       2                                         Administration;
                                                                       3                                                  (V) the Department of Veterans
                                                                       4                                         Affairs;
                                                                       5                                                  (VI) the Government Account-
                                                                       6                                         ability Office;
                                                                       7                                                  (VII) the Library of Congress;
                                                                       8                                                  (VIII) the Postal Service;
                                                                       9                                                  (IX) the House of Representa-
                                                                     10                                          tives;
                                                                     11                                                   (X) the Senate; and
                                                                     12                                                   (XI) the Architect of the Capitol;
                                                                     13                                          (ii) the District of Columbia courts
                                                                     14                                  and the District of Columbia Public De-
                                                                     15                                  fender Service; or
                                                                     16                                          (iii) an—
                                                                     17                                                   (I) Indian Tribe or Tribal organi-
                                                                     18                                          zation carrying out a contract or com-
                                                                     19                                          pact under the Indian Self-Determina-
                                                                     20                                          tion and Education Assistance Act
                                                                     21                                          (25 U.S.C. 5301 et seq.);
                                                                     22                                                   (II) Indian Tribe or Tribal orga-
                                                                     23                                          nization that receives a grant under
                                                                     24                                          the Tribally Controlled Schools Act of



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                                                                     25                                          1988 (25 U.S.C. 2501 et seq.); or


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                                                                       1                                                  (III) Indian Tribe or Tribal orga-
                                                                       2                                         nization (as defined in section 5212 of
                                                                       3                                         the Tribally Controlled Schools Act of
                                                                       4                                         1988 (25 U.S.C. 2511)) that receives
                                                                       5                                         a grant under that Act (25 U.S.C.
                                                                       6                                         2501 et seq.); and
                                                                       7                                 (B) does not include a nonappropriated
                                                                       8                        fund instrumentality under the jurisdiction of
                                                                       9                        the Armed Forces.
                                                                     10                         (2) COVERED DUTY.—The term ‘‘covered duty’’
                                                                     11               means all work performed by a Federal employee,
                                                                     12               except duties that a Federal employee performs
                                                                     13               while teleworking from a residence.
                                                                     14                         (3) FEDERAL EMPLOYEE.—The term ‘‘Federal
                                                                     15               employee’’ means—
                                                                     16                                  (A) an individual who engages in covered
                                                                     17                         duties on behalf of an agency at any time dur-
                                                                     18                         ing the COVID–19 pandemic, or an individual
                                                                     19                         classified as an independent contractor by the
                                                                     20                         agency who engages in covered duties during
                                                                     21                         such period;
                                                                     22                                  (B) includes—
                                                                     23                                          (i) any person performing work for an
                                                                     24                                  agency who engages in covered duties dur-



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                                                                     25                                  ing the COVID–19 pandemic, regardless of


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                                                                       1                                 whether such person is classified as an
                                                                       2                                 independent contractor by the agency; and
                                                                       3                                         (ii) any paid or unpaid intern, fellow,
                                                                       4                                 trainee, or other person performing work
                                                                       5                                 for an agency who engages in covered du-
                                                                       6                                 ties during the COVID–19 pandemic; and
                                                                       7                                 (C) does not include any employee of a
                                                                       8                        Federal contractor.
                                                                       9                        (4) TIMELY MANNER.—The term ‘‘timely man-
                                                                     10               ner’’, with respect to the administration of a
                                                                     11               COVID–19 diagnostic test, means within 24 hours
                                                                     12               of the administration of such test.
                                                                     13               (b) FEDERAL EMPLOYEE COVID–19 TESTING.—
                                                                     14                         (1) IN GENERAL.—Not later than 30 days after
                                                                     15               the date of enactment of this Act, each agency shall
                                                                     16               begin to—
                                                                     17                                  (A) conduct or contract with entities to
                                                                     18                         conduct COVID–19 diagnostic tests for Federal
                                                                     19                         employees employed by the agency at no cost to
                                                                     20                         the employee, regardless of whether such em-
                                                                     21                         ployees exhibit symptoms of COVID–19, pro-
                                                                     22                         vided at locations accessible to the Federal em-
                                                                     23                         ployees;
                                                                     24                                  (B) provide each Federal employee em-



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                                                                     25                         ployed by the agency with the results of the di-


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                                                                       1                        agnostic tests, regardless of the results, includ-
                                                                       2                        ing an interpretation of what the test means in
                                                                       3                        the employee’s preferred language, in a timely
                                                                       4                        manner;
                                                                       5                                 (C) submit the results of such tests to rel-
                                                                       6                        evant Federal, State, local, territorial, and
                                                                       7                        Tribal public health officials; and
                                                                       8                                 (D) publish the aggregate results of such
                                                                       9                        diagnostic tests in accordance with section 8.
                                                                     10                         (2) TIME PERIOD.—Each agency shall continue
                                                                     11               the activities described in subparagraphs (A), (B),
                                                                     12               and (C) of paragraph (1) throughout the duration of
                                                                     13               the COVID–19 pandemic.
                                                                     14                         (3) MINIMUM WAGE AND OVERTIME.—Notwith-
                                                                     15               standing any other provision of law, for any indi-
                                                                     16               vidual employed by a contractor or subcontractor,
                                                                     17               and who performs work assisted in whole or in part
                                                                     18               by funding under this section, with respect to such
                                                                     19               employment, such individual shall—
                                                                     20                                  (A) be paid a wage of not less than $15
                                                                     21                         per hour; and
                                                                     22                                  (B) if such individual is paid at a rate that
                                                                     23                         is the full-time equivalent of less than $51,000
                                                                     24                         per year, receive overtime pay of one-and-one-



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                                                                     25                         half times the individual’s regular rate of pay


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                                                                       1                        for all hours worked in excess of 40 hours per
                                                                       2                        workweek.
                                                                       3              (c) FREQUENCY AND LOCATION OF COVID–19 DI-
                                                                       4     AGNOSTIC TESTING.—In administering COVID–19 tests

                                                                       5 pursuant to subsection (b), each agency shall provide
                                                                       6 COVID–19 diagnostic tests at frequencies and locations
                                                                       7 recommended by the State, local, territorial or Tribal pub-
                                                                       8 lic health officials with jurisdiction over the geographic
                                                                       9 areas in which the applicable Federal employees work, or,
                                                                     10 if a national testing strategy is developed by Federal offi-
                                                                     11 cials, in compliance with the national testing strategy.
                                                                     12               (d) AUTHORIZATION OF APPROPRIATIONS.—There is
                                                                     13 authorized to be appropriated to each Federal agency such
                                                                     14 sums as may be necessary to procure and administer the
                                                                     15 COVID–19 diagnostic tests required under this section.
                                                                     16      SEC. 5. FEDERAL DISTRIBUTION OF COVID–19 TESTS TO

                                                                     17                              QUALIFIED ENTITIES.

                                                                     18               (a) DEFINITIONS.—In this section:
                                                                     19                         (1) COVID–19 TESTING.—The term ‘‘COVID–
                                                                     20               19 testing’’ has the meaning given such term in in-
                                                                     21               terim final rules promulgated by the Secretary with-
                                                                     22               in 15 days of the date of enactment of this Act.
                                                                     23                         (2) ESSENTIAL                   WORK.—The                  term ‘‘essential
                                                                     24               work’’ means any work that—



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                                                                       1                                 (A) is performed during the period of the
                                                                       2                        COVID–19 pandemic;
                                                                       3                                 (B) cannot be performed while teleworking
                                                                       4                        from a residence; and
                                                                       5                                 (C)(i) involves—
                                                                       6                                         (I) regular in-person interactions with
                                                                       7                                 patients, the public, or coworkers of the in-
                                                                       8                                 dividual performing the work; or
                                                                       9                                         (II) regular physical handling of items
                                                                     10                                  that were handled by, or are to be handled
                                                                     11                                  by patients, the public, or coworkers of the
                                                                     12                                  individual performing the work; and
                                                                     13                                  (ii) is in the area of—
                                                                     14                                          (I) first responder work, in the public
                                                                     15                                  sector or private sector, including services
                                                                     16                                  in response to emergencies that have the
                                                                     17                                  potential to cause death or serious bodily
                                                                     18                                  injury, such as police, fire, emergency med-
                                                                     19                                  ical, protective, child maltreatment, domes-
                                                                     20                                  tic violence, and correctional services (in-
                                                                     21                                  cluding activities carried out by employees
                                                                     22                                  in fire protection activities, as defined in
                                                                     23                                  section 3(y) of the Fair Labor Standards
                                                                     24                                  Act of 1938 (29 U.S.C. 203(y)) and activi-



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                                                                     25                                  ties of law enforcement officers, as defined


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                                                                       1                                 in section 1204(6) of the Omnibus Crime
                                                                       2                                 Control and Safe Streets Act of 1968 (34
                                                                       3                                 U.S.C. 10284(6)));
                                                                       4                                         (II) health care work physically pro-
                                                                       5                                 vided in inpatient settings (including hos-
                                                                       6                                 pitals and other inpatient post-acute care
                                                                       7                                 settings such as nursing homes, inpatient
                                                                       8                                 rehabilitation facilities, and other related
                                                                       9                                 settings) and other work physically per-
                                                                     10                                  formed in such inpatient settings that sup-
                                                                     11                                  ports or is in furtherance of such health
                                                                     12                                  care work physically provided in inpatient
                                                                     13                                  settings;
                                                                     14                                          (III) health care work physically pro-
                                                                     15                                  vided in outpatient settings (including at
                                                                     16                                  physician offices, community health cen-
                                                                     17                                  ters, Tribal clinics, rural health clinics and
                                                                     18                                  other clinics, hospital outpatient depart-
                                                                     19                                  ments, freestanding emergency depart-
                                                                     20                                  ments, health centers, ambulatory surgical
                                                                     21                                  centers, dialysis centers, dental offices, and
                                                                     22                                  other related settings), and other work
                                                                     23                                  physically performed in such outpatient
                                                                     24                                  settings that supports or is in furtherance



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                                                                       1                                 of such health care work physically pro-
                                                                       2                                 vided in outpatient settings;
                                                                       3                                         (IV) pharmacy work, physically per-
                                                                       4                                 formed in pharmacies, drug stores, or
                                                                       5                                 other retail facilities specializing in medical
                                                                       6                                 goods and supplies;
                                                                       7                                         (V) any work physically performed in
                                                                       8                                 a facility that performs medical testing and
                                                                       9                                 diagnostic services, including laboratory
                                                                     10                                  processing, medical testing services, imag-
                                                                     11                                  ing services, or related activities;
                                                                     12                                          (VI)           home-         and        community-based
                                                                     13                                  health care work, including home health
                                                                     14                                  care, residential care, assistance with ac-
                                                                     15                                  tivities of daily living, and any services
                                                                     16                                  provided by direct care workers (as defined
                                                                     17                                  in section 799B of the Public Health Serv-
                                                                     18                                  ice Act (42 U.S.C. 295p)), personal care
                                                                     19                                  aides, community health aides and commu-
                                                                     20                                  nity health aides participating in the Com-
                                                                     21                                  munity Health Representative Program or
                                                                     22                                  the Community Health Aide Program
                                                                     23                                  under the Indian Health Care Improve-
                                                                     24                                  ment Act (25 U.S.C. 1601 et seq.), job



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                                                                     25                                  coaches, or supported employment pro-


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                                                                       1                                 viders, and any other provision of care to
                                                                       2                                 individuals in their homes by direct service
                                                                       3                                 providers, personal care attendants, and
                                                                       4                                 home health aides;
                                                                       5                                         (VII) biomedical research;
                                                                       6                                         (VIII) behavioral health work requir-
                                                                       7                                 ing physical interaction with individuals,
                                                                       8                                 including mental health services and sub-
                                                                       9                                 stance use disorder prevention, treatment,
                                                                     10                                  and recovery services;
                                                                     11                                          (IX) nursing care and residential
                                                                     12                                  work physically provided in a facility;
                                                                     13                                          (X) family care, including child care
                                                                     14                                  services, in-home child care services such
                                                                     15                                  as nanny services, and care services pro-
                                                                     16                                  vided by family members to other family
                                                                     17                                  members;
                                                                     18                                          (XI) social services work, including
                                                                     19                                  social work, case management, social and
                                                                     20                                  human services, child welfare, family serv-
                                                                     21                                  ices, shelter and services for people who
                                                                     22                                  have experienced intimate partner violence
                                                                     23                                  or sexual assault, services for individuals
                                                                     24                                  who are homeless, child services, commu-



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                                                                       1                                 nity food and housing services, and other
                                                                       2                                 emergency social services;
                                                                       3                                         (XII) public health work conducted at
                                                                       4                                 a State, local, territorial, or Tribal govern-
                                                                       5                                 ment public health agency, including epide-
                                                                       6                                 miological activities, surveillance, contact
                                                                       7                                 tracing, data analysis, statistical research,
                                                                       8                                 health education, and other disease detec-
                                                                       9                                 tion, prevention, and response methods;
                                                                     10                                          (XIII) work conducted at a hospital,
                                                                     11                                  clinic, triage center, or other permanent or
                                                                     12                                  temporary health facility operated by the
                                                                     13                                  Indian Health Service, an Indian Tribe,
                                                                     14                                  Tribal organization, or urban Indian orga-
                                                                     15                                  nization;
                                                                     16                                          (XIV) grocery work physically per-
                                                                     17                                  formed at grocery stores, supermarkets,
                                                                     18                                  convenience stores, corner stores, drug
                                                                     19                                  stores, retail facilities specializing in med-
                                                                     20                                  ical goods and supplies, bodegas, or an-
                                                                     21                                  other location where individuals purchase
                                                                     22                                  non-prepared food items;
                                                                     23                                          (XV)           restaurant               work,          including
                                                                     24                                  carry-out, drive-thru, or food delivery



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                                                                       1                                 work, requiring physical interaction with
                                                                       2                                 individuals or food products;
                                                                       3                                         (XVI) food production work involving
                                                                       4                                 the physical interaction with food products,
                                                                       5                                 including all agricultural work, farming,
                                                                       6                                 harvesting,             fishing,           forestry,           ranching,
                                                                       7                                 processing, canning, slaughtering, pack-
                                                                       8                                 aging, baking, butchering, and other food
                                                                       9                                 production work, such as any service or ac-
                                                                     10                                  tivity described in section 3(f) of the Fair
                                                                     11                                  Labor Standards Act of 1938 (29 U.S.C.
                                                                     12                                  203(f)) or section 3121(g) of the Internal
                                                                     13                                  Revenue Code of 1986, and the handling,
                                                                     14                                  planting, drying, packing, packaging, proc-
                                                                     15                                  essing, freezing, or grading prior to deliv-
                                                                     16                                  ery for storage of any agricultural or horti-
                                                                     17                                  cultural commodity in its unmanufactured
                                                                     18                                  state;
                                                                     19                                          (XVII) transportation work, includ-
                                                                     20                                  ing—
                                                                     21                                                   (aa) any services in public trans-
                                                                     22                                          portation,             as       defined           in     section
                                                                     23                                          5302(14) of title 49, United States
                                                                     24                                          Code;



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                                                                       1                                                  (bb) any private transportation of
                                                                       2                                         people, such as transportation pro-
                                                                       3                                         vided by air, rail, bus, taxicab, per-
                                                                       4                                         sonal car or truck, non-motorized ve-
                                                                       5                                         hicle, or otherwise, including all serv-
                                                                       6                                         ices performed by individuals working
                                                                       7                                         in or on such vehicles, vehicle depots,
                                                                       8                                         or transit facilities;
                                                                       9                                                  (cc) any services in passenger rail
                                                                     10                                          transportation, including commuter
                                                                     11                                          rail, intercity passenger rail, or Am-
                                                                     12                                          trak, including services performed by
                                                                     13                                          employees of contractors of such enti-
                                                                     14                                          ties;
                                                                     15                                                   (dd) any services in the transpor-
                                                                     16                                          tation of persons, property, or mail by
                                                                     17                                          an aircraft of an air carrier con-
                                                                     18                                          ducting operations under part 121 of
                                                                     19                                          title 14, Code of Federal Regulations
                                                                     20                                          (or successor regulations), or a for-
                                                                     21                                          eign air carrier within, to, or from the
                                                                     22                                          United States, either on board an air-
                                                                     23                                          craft or on the ground at an airport,
                                                                     24                                          including services performed by em-



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                                                                     25                                          ployees of contractors of air carriers,


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                                                                       1                                         or foreign air carriers, as described in
                                                                       2                                         section 4111(3) of the CARES Act
                                                                       3                                         (15 U.S.C. 9071(3));
                                                                       4                                                  (ee) any services as an aircraft
                                                                       5                                         mechanic or technician who performs
                                                                       6                                         maintenance, repair, or overhaul work
                                                                       7                                         on an aircraft of an air carrier con-
                                                                       8                                         ducting operations under such part
                                                                       9                                         121 or foreign air carrier within the
                                                                     10                                          United States;
                                                                     11                                                   (ff) services as maritime workers
                                                                     12                                          who qualify as seamen under section
                                                                     13                                          10101(3) of title 46, United States
                                                                     14                                          Code, and other maritime employees
                                                                     15                                          including—
                                                                     16                                                            (AA) longshoremen, harbor
                                                                     17                                                   workers and shipbuilders covered
                                                                     18                                                   under             section         2(3)        of   the
                                                                     19                                                   Longshore and Harbor Workers’
                                                                     20                                                   Compensation Act (33 U.S.C.
                                                                     21                                                   902(3)) involved in the transpor-
                                                                     22                                                   tation of merchandise or pas-
                                                                     23                                                   sengers by water; and
                                                                     24                                                            (BB) shipbuilders and ship



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                                                                     25                                                   repairers who are working for an


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                                                                       1                                                  employer performing shipbuilding
                                                                       2                                                  or ship repair work under con-
                                                                       3                                                  tract or subcontract to the De-
                                                                       4                                                  partments of Defense, Energy or
                                                                       5                                                  Homeland Security for military
                                                                       6                                                  or other national security pur-
                                                                       7                                                  poses;
                                                                       8                                                  (gg) services as maritime trans-
                                                                       9                                         portation workers supporting or ena-
                                                                     10                                          bling transportation functions, includ-
                                                                     11                                          ing such services as—
                                                                     12                                                            (AA) barge workers, tug op-
                                                                     13                                                   erators, and port and facility se-
                                                                     14                                                   curity personnel;
                                                                     15                                                            (BB)           marine           dispatchers;
                                                                     16                                                   and
                                                                     17                                                            (CC) workers who repair
                                                                     18                                                   and maintain marine vessels (in-
                                                                     19                                                   cluding the equipment and infra-
                                                                     20                                                   structure that enables operations
                                                                     21                                                   that        encompass                 movement     of
                                                                     22                                                   cargo and passengers); and
                                                                     23                                                   (hh) work physically performed
                                                                     24                                          in a warehouse or other facility in



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                                                                     25                                          warehousing (including all services


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                                                                       1                                         performed by individuals picking, sort-
                                                                       2                                         ing, packing, and shipping in ware-
                                                                       3                                         houses), storage, distribution, or call
                                                                       4                                         center support facilities, and other es-
                                                                       5                                         sential operational support functions
                                                                       6                                         that are necessary to accept, store,
                                                                       7                                         and process goods, and that facilitate
                                                                       8                                         the goods’ transportation and delivery;
                                                                       9                                         (XVIII) cleaning work and building
                                                                     10                                  maintenance work physically performed on
                                                                     11                                  the grounds of a facility, including all cus-
                                                                     12                                  todial or janitorial services, security serv-
                                                                     13                                  ices, and repair and maintenance services;
                                                                     14                                          (XIX) work in the collection, removal,
                                                                     15                                  transport, storage, or disposal of residen-
                                                                     16                                  tial, industrial, or commercial solid waste
                                                                     17                                  and recycling, including services provided
                                                                     18                                  by individuals who drive waste or recycling
                                                                     19                                  trucks, who pick up waste or recycling
                                                                     20                                  from residential or commercial locations,
                                                                     21                                  or who work at waste or recycling centers
                                                                     22                                  or landfills;
                                                                     23                                          (XX) work in the gathering, proc-
                                                                     24                                  essing, disseminating, and delivery of news



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                                                                     25                                  and information that serves the public in-


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                                                                       1                                 terest to the public through mass media,
                                                                       2                                 including television, radio, and newspapers;
                                                                       3                                         (XXI) any work performed by an em-
                                                                       4                                 ployee of a State, locality, or Tribal gov-
                                                                       5                                 ernment, that is determined to be essential
                                                                       6                                 work by the highest authority of such
                                                                       7                                 State, locality, or Tribal government;
                                                                       8                                         (XXII) educational work, school nutri-
                                                                       9                                 tion work, and other work required to op-
                                                                     10                                  erate a school facility, including early
                                                                     11                                  childhood and after-school enrichment pro-
                                                                     12                                  grams, preschool programs, elementary
                                                                     13                                  and secondary education, and higher edu-
                                                                     14                                  cation;
                                                                     15                                          (XXIII) laundry work, including work
                                                                     16                                  in laundromats, laundry service companies,
                                                                     17                                  and dry cleaners;
                                                                     18                                          (XXIV) elections work physically per-
                                                                     19                                  formed at polling places or otherwise
                                                                     20                                  amongst the public, including public-sector
                                                                     21                                  elections personnel and private-sector elec-
                                                                     22                                  tions personnel;
                                                                     23                                          (XXV) hazardous materials manage-
                                                                     24                                  ment, response, and cleanup work associ-



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                                                                     25                                  ated with any other essential work covered


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                                                                       1                                 under this paragraph, including health
                                                                       2                                 care waste (including medical, pharma-
                                                                       3                                 ceuticals, and medical material produc-
                                                                       4                                 tion), and testing operations (including
                                                                       5                                 laboratories processing test kits);
                                                                       6                                         (XXVI) disinfection work for all facili-
                                                                       7                                 ties and modes of transportation involved
                                                                       8                                 in other essential work covered under this
                                                                       9                                 paragraph;
                                                                     10                                          (XXVII) work in critical clinical re-
                                                                     11                                  search, development, and testing necessary
                                                                     12                                  for COVID–19 response that involves
                                                                     13                                  physical interaction with hazardous mate-
                                                                     14                                  rials, such as samples of COVID–19;
                                                                     15                                          (XXVIII) work in mortuary, funeral,
                                                                     16                                  cremation, burial, cemetery, and related
                                                                     17                                  services;
                                                                     18                                          (XXIX) work requiring physical inter-
                                                                     19                                  actions with patients in physical therapy,
                                                                     20                                  occupational therapy, speech-language pa-
                                                                     21                                  thology, and respiratory therapy and other
                                                                     22                                  therapy services;
                                                                     23                                          (XXX) dental care work requiring
                                                                     24                                  physical interaction with patients;



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                                                                       1                                         (XXXI) work performed by employees
                                                                       2                                 of the United States Postal Service;
                                                                       3                                         (XXXII) work at hotel and commer-
                                                                       4                                 cial lodging facilities that are used for
                                                                       5                                 COVID–19 mitigation and containment
                                                                       6                                 measures; and
                                                                       7                                         (XXXIII) work installing or repairing
                                                                       8                                 a telecommunications line or equipment.
                                                                       9                        (3) ESSENTIAL WORKER.—The term ‘‘essential
                                                                     10               worker’’ means an individual whose work and duties
                                                                     11               include essential work, including individuals that are
                                                                     12               employees of employers and individuals performing
                                                                     13               any services or labor for remuneration, regardless of
                                                                     14               whether such individual is classified as an inde-
                                                                     15               pendent contractor by the employer.
                                                                     16                         (4) QUALIFIED ENTITY.—The term ‘‘qualified
                                                                     17               entity’’ means—
                                                                     18                                  (A) a congregate care setting, including
                                                                     19                         any skilled nursing facilities, assisted living fa-
                                                                     20                         cilities, prisons and jails, residential behavioral
                                                                     21                         health care and psychiatric facilities, and facili-
                                                                     22                         ties providing services for aging adults and peo-
                                                                     23                         ple with disabilities;
                                                                     24                                  (B) an education center, including any



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                                                                     25                         childcare facilities, elementary and secondary


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                                                                       1                        schools that have resumed (or plan to resume
                                                                       2                        within 30 days of receipt of items under sub-
                                                                       3                        section (b)) any form of in-person instruction,
                                                                       4                        and colleges and universities that have resumed
                                                                       5                        (or plan to resume within 30 days of receipt of
                                                                       6                        items under subsection (b)) any form of in-per-
                                                                       7                        son instruction or on-campus housing;
                                                                       8                                 (C) a community center, such as State and
                                                                       9                        local government buildings, religious centers,
                                                                     10                         and nonprofit service organizations;
                                                                     11                                  (D) a prison, jail, or youth detention facil-
                                                                     12                         ity;
                                                                     13                                  (E) a hospital, community health center,
                                                                     14                         Tribal or Indian Health Service clinic or hos-
                                                                     15                         pital, or other medical facility;
                                                                     16                                  (F) a small business;
                                                                     17                                  (G) a business that employs essential
                                                                     18                         workers;
                                                                     19                                  (H) a homeless shelter or entity supporting
                                                                     20                         individuals living in housing funded with sup-
                                                                     21                         port from the Department of Housing and
                                                                     22                         Urban Development, including housing provided
                                                                     23                         under the supportive housing for the elderly
                                                                     24                         program under section 202 of the Housing Act



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                                                                     25                         of 1959 (12 U.S.C. 1701q); or


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                                                                       1                                 (I) another entity, as determined by the
                                                                       2                        Secretary, that could serve as a COVID–19 di-
                                                                       3                        agnostic testing site.
                                                                       4                        (5) TIMELY MANNER.—The term ‘‘timely man-
                                                                       5              ner’’, with respect to the administration of a
                                                                       6              COVID–19 diagnostic test, means within 24 hours
                                                                       7              of the administration of such test.
                                                                       8              (b) DISTRIBUTION                          OF      COVID–19 DIAGNOSTIC
                                                                       9 TESTS.—
                                                                     10                         (1) IN GENERAL.—Within 40 days of the date
                                                                     11               of enactment of this Act, the Secretary shall—
                                                                     12                                  (A) begin distributing COVID–19 diag-
                                                                     13                         nostic tests and associated medical supplies, in-
                                                                     14                         cluding tests and medical supplies manufac-
                                                                     15                         tured under section 3, to qualified entities via
                                                                     16                         State, local, territorial, and Tribal governments
                                                                     17                         for the purpose of—
                                                                     18                                          (i) providing COVID–19 diagnostic
                                                                     19                                  testing to essential workers and individuals
                                                                     20                                  served by qualified entities, at no cost to
                                                                     21                                  the essential workers and individuals, re-
                                                                     22                                  gardless of whether such workers and indi-
                                                                     23                                  viduals exhibit symptoms of COVID–19, at
                                                                     24                                  locations accessible to the essential workers



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                                                                     25                                  and individuals in the course of their work;


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                                                                       1                                         (ii) providing essential workers and
                                                                       2                                 individuals served by qualified entities with
                                                                       3                                 the results of the diagnostic tests, regard-
                                                                       4                                 less of the results, including an interpreta-
                                                                       5                                 tion of what the test means in the employ-
                                                                       6                                 ee’s preferred language, in a timely man-
                                                                       7                                 ner;
                                                                       8                                         (iii) submitting the results of such
                                                                       9                                 tests to relevant Federal, State, local, ter-
                                                                     10                                  ritorial, and Tribal public health officials;
                                                                     11                                  and
                                                                     12                                          (iv) publishing the aggregate results
                                                                     13                                  of such diagnostic tests in accordance with
                                                                     14                                  section 8; and
                                                                     15                                  (B) hire and deploy employees, or contract
                                                                     16                         with outside entities to hire and deploy employ-
                                                                     17                         ees, as necessary to assist in the distribution,
                                                                     18                         provision, administration of, and data collection
                                                                     19                         regarding COVID–19 diagnostic tests as de-
                                                                     20                         scribed in subparagraph (A).
                                                                     21                         (2) EMPLOYEES.—In hiring employees, or con-
                                                                     22               tracting with outside entities to hire employees, to
                                                                     23               carry out this subsection, the Secretary shall
                                                                     24               prioritize, or require contractors to prioritize, hiring



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                                                                       1              individuals from within the communities served by
                                                                       2              the applicable qualified entity.
                                                                       3                        (3) MINIMUM WAGE AND OVERTIME.—Notwith-
                                                                       4              standing any other provision of law, for any indi-
                                                                       5              vidual employed by a contractor or subcontractor,
                                                                       6              and who performs work assisted in whole or in part
                                                                       7              by funding under this section, with respect to such
                                                                       8              employment, such individual shall—
                                                                       9                                 (A) be paid a wage of not less than $15
                                                                     10                         per hour; and
                                                                     11                                  (B) if such individual is paid at a rate that
                                                                     12                         is the full-time equivalent of less than $51,000
                                                                     13                         per year, receive overtime pay of one-and-one-
                                                                     14                         half times the individual’s regular rate of pay
                                                                     15                         for all hours worked in excess of 40 hours per
                                                                     16                         workweek.
                                                                     17               (c) COORDINATION WITH STATE, LOCAL, TERRI-
                                                                     18      TORIAL, AND TRIBAL GOVERNMENTS.—Within 30 days of

                                                                     19 the date of enactment of this Act, a representative of each
                                                                     20 State, local, territorial, and Tribal government shall sub-
                                                                     21 mit to the Secretary a list of qualified entities in their
                                                                     22 jurisdiction and a description of employee, resource, and
                                                                     23 other infrastructure needs necessary for the distribution
                                                                     24 of COVID–19 diagnostic tests and associated drugs and



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                                                                     25 devices under subsection (b).


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                                                                       1              (d) FREQUENCY AND LOCATION OF COVID–19 DI-
                                                                       2     AGNOSTIC              TESTING.—In distributing COVID–19 tests
                                                                       3 under (b), the Secretary shall provide COVID–19 diag-
                                                                       4 nostic tests at frequencies and locations recommended by
                                                                       5 the State, local, territorial, or Tribal public health officials
                                                                       6 with jurisdiction over the geographic areas in which quali-
                                                                       7 fied entities are located, or, if a national testing strategy
                                                                       8 is developed by Federal officials, in compliance with the
                                                                       9 national testing strategy.
                                                                     10               (e) PUBLIC REPORTING.—Beginning 30 days after
                                                                     11 the date of enactment of this Act and for the duration
                                                                     12 of the COVID–19 pandemic, the Secretary shall publish
                                                                     13 weekly, in a machine readable format, the total number
                                                                     14 of tests distributed to, and the total number of tests ad-
                                                                     15 ministered in, each State, county, territory, and Tribe
                                                                     16 under subsection (b).
                                                                     17               (f) AUTHORIZATION OF APPROPRIATIONS.—There is
                                                                     18 authorized to be appropriated such sums as may be nec-
                                                                     19 essary to carry out this section.
                                                                     20      SEC. 6. SUPPLEMENTAL GRANTS FOR COVID–19 TESTING.

                                                                     21               (a) IN GENERAL.—No later than 30 days after the
                                                                     22 date of enactment of this Act, the Secretary, acting
                                                                     23 through the Director of the Centers for Disease Control
                                                                     24 and Prevention shall—



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                                                                       1                        (1) issue competitive grants to State, local, and
                                                                       2              territorial governments for the purpose of increasing
                                                                       3              access to COVID–19 diagnostic testing; and
                                                                       4                        (2) issue noncompetitive and formula-based
                                                                       5              awards to Indian Tribes and Tribal organizations.
                                                                       6              (b) PRIORITY AREAS AND POPULATIONS.—In issuing
                                                                       7 grants under subsection (a), the Secretary shall—
                                                                       8                        (1) prioritize areas and populations that have
                                                                       9              been disproportionately affected by COVID–19, and
                                                                     10               areas where operationalizing testing programs is not
                                                                     11               possible with existing resources; and
                                                                     12                         (2) consider the capacity that States, localities,
                                                                     13               territories, and Tribes already have at the time of
                                                                     14               application to conduct widespread COVID–19 diag-
                                                                     15               nostic testing.
                                                                     16               (c) USE OF FUNDS.—Grants awarded under sub-
                                                                     17 section (a) may be used to—
                                                                     18                         (1) establish new COVID–19 diagnostic testing
                                                                     19               sites at community centers, such as State, local, ter-
                                                                     20               ritorial, and Tribal government buildings, churches,
                                                                     21               health centers, clinics, and public parks, subject to
                                                                     22               Federal quality control standards for laboratory test-
                                                                     23               ing;
                                                                     24                         (2) hire State, local, territorial, and Tribal gov-



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                                                                     25               ernment employees, or contract with outside entities,


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                                                                       1              to assist in the development, distribution, and provi-
                                                                       2              sion of COVID–19 diagnostic tests within the State,
                                                                       3              locality, territory, or Tribe;
                                                                       4                        (3) purchase COVID–19 diagnostic tests and
                                                                       5              the medical supplies necessary to conduct such tests;
                                                                       6                        (4) increase the number of COVID–19 diag-
                                                                       7              nostic tests provided at congregate settings, such
                                                                       8              as—
                                                                       9                                 (A) skilled nursing facilities;
                                                                     10                                  (B) assisted living facilities;
                                                                     11                                  (C) childcare facilities;
                                                                     12                                  (D) elementary and secondary schools that
                                                                     13                         have resumed, or plan to resume within 30
                                                                     14                         days, in-person instruction;
                                                                     15                                  (E) colleges and universities that have re-
                                                                     16                         sumed, or plan to resume within 30 days, in-
                                                                     17                         person instruction or on-campus housing;
                                                                     18                                  (F) prisons, jails, and youth detention fa-
                                                                     19                         cilities;
                                                                     20                                  (G) residential behavioral health care and
                                                                     21                         psychiatric facilities;
                                                                     22                                  (H) institutions providing services for
                                                                     23                         aging adults and people with intellectual and
                                                                     24                         developmental disabilities, rehabilitation facili-



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                                                                     25                         ties, and group homes; and


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                                                                       1                                 (I) homeless shelters;
                                                                       2                        (5) educate the public about the availability of
                                                                       3              COVID–19 diagnostic tests in their communities
                                                                       4              and what to do if a positive result is received;
                                                                       5                        (6) issue subgrants, cooperative agreements, or
                                                                       6              contracts to labs, hospitals, and other test providers
                                                                       7              to reduce test processing time; submit the results to
                                                                       8              State, local, territorial, and Tribal public health offi-
                                                                       9              cials; and prevent delays in the distribution of test-
                                                                     10               ing results, such as through transferring research
                                                                     11               lab capacity to COVID–19 testing capacity and
                                                                     12               building new labs to reduce test processing turn-
                                                                     13               around time;
                                                                     14                         (7) enable the State, locality, territory, or Tribe
                                                                     15               to detect and identify trends in COVID–19 and de-
                                                                     16               velop guidance for communities on how to develop
                                                                     17               testing programs and expand test capacity;
                                                                     18                         (8) reduce disparities in access to COVID–19
                                                                     19               diagnostic testing among the communities hardest
                                                                     20               hit by COVID–19; and
                                                                     21                         (9) additional uses, as determined by the Sec-
                                                                     22               retary, in accordance with subsection (e).
                                                                     23               (d) REQUIREMENT.—Any COVID–19 diagnostic test
                                                                     24 conducted with the support of a grant awarded under this



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                                                                     25 section shall be provided to patients free of charge and


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                                                                       1 without regard for immigration status. The results shall
                                                                       2 be submitted to relevant State, local, territorial, and Trib-
                                                                       3 al public health officials.
                                                                       4              (e) MINIMUM WAGE                              AND         OVERTIME.—Notwith-
                                                                       5 standing any other provision of law, for any individual em-
                                                                       6 ployed by a contractor or subcontractor, and who performs
                                                                       7 work assisted in whole or in part by funding under this
                                                                       8 section, with respect to such employment, such individual
                                                                       9 shall—
                                                                     10                         (1) be paid a wage of not less than $15 per
                                                                     11               hour; and
                                                                     12                         (2) if such individual is paid at a rate that is
                                                                     13               the full-time equivalent of less than $51,000 per
                                                                     14               year, receive overtime pay of one-and-one-half times
                                                                     15               the individual’s regular rate of pay for all hours
                                                                     16               worked in excess of 40 hours per workweek.
                                                                     17               (f) ADDITIONAL USES OF FUNDS.—In determining
                                                                     18 appropriate uses of funds under subsection (c)(9), the Sec-
                                                                     19 retary shall consider the incidence of COVID–19 in
                                                                     20 States, localities, territories, and Tribes, the availability
                                                                     21 and uptake of vaccines for COVID–19 in States, localities,
                                                                     22 territories, and Tribes, and advancements in COVID–19
                                                                     23 diagnostic test technologies.
                                                                     24               (g) AUTHORIZATION OF APPROPRIATIONS.—



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                                                                       1                        (1) IN GENERAL.—There is authorized to be
                                                                       2              appropriated $25,000,000,000 for fiscal year 2021
                                                                       3              for purposes of awarding grants under this section.
                                                                       4                        (2) TRIBAL SET-ASIDE.—Not less than 10 per-
                                                                       5              cent of the total amount appropriated under para-
                                                                       6              graph (1) for a fiscal year shall be reserved for non-
                                                                       7              competitive awards to—
                                                                       8                                 (A) Indian Tribes or Tribal organizations
                                                                       9                        carrying out a contract or compact under the
                                                                     10                         Indian Self-Determination and Education As-
                                                                     11                         sistance Act (25 U.S.C. 5301 et seq.);
                                                                     12                                  (B) Indian Tribes or Tribal organizations
                                                                     13                         receiving a grant under the Tribally Controlled
                                                                     14                         Schools Act of 1988 (25 U.S.C. 2501 et seq.);
                                                                     15                         and
                                                                     16                                  (C) Indian Tribes or tribal organizations
                                                                     17                         (as defined in section 5212 of the Tribally Con-
                                                                     18                         trolled Schools Act of 1988 (25 U.S.C. 2511))
                                                                     19                         receiving grants under that Act (25 U.S.C.
                                                                     20                         2501 et seq.).
                                                                     21                         (3) LOCAL GOVERNMENT SET ASIDE.—Not less
                                                                     22               than 30 percent of the total amount appropriated
                                                                     23               under paragraph (1) for a fiscal year shall be re-
                                                                     24               served for grants awarded directly to local govern-



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                                                                     25               ments.


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                                                                       1     SEC. 7. REPORTS AND GUIDANCE ON COVID–19 DIAG-

                                                                       2                             NOSTIC TESTING.

                                                                       3              (a) UPDATED GUIDANCE ON COVID–19 RAPID DI-
                                                                       4     AGNOSTIC TESTS.—

                                                                       5                        (1) IN GENERAL.—Not later than 30 days after
                                                                       6              the date of enactment of this Act, the Secretary, act-
                                                                       7              ing through the Commissioner of Food and Drugs,
                                                                       8              shall issue updated guidance on the development of
                                                                       9              rapid COVID–19 diagnostic tests, the provision of
                                                                     10               such tests, including in nonclinical environments,
                                                                     11               and the appropriate collection and electronic report-
                                                                     12               ing of results (including geographic and demo-
                                                                     13               graphic data, including with respect to race and eth-
                                                                     14               nicity) and data regarding such tests to Federal,
                                                                     15               State, local, and Tribal public health officials.
                                                                     16                         (2) RAPID COVID–19 DIAGNOSTIC TEST.—For
                                                                     17               purposes of paragraph (1), the term ‘‘rapid COVID–
                                                                     18               19 diagnostic test’’ means a COVID–19 diagnostic
                                                                     19               test that can be performed by a user, with or with-
                                                                     20               out the need of a medical professional or medical su-
                                                                     21               pervisor, and that can produce results within 1 hour
                                                                     22               of application.
                                                                     23               (b)        UPDATED               SURVEILLANCE                     TESTING         GUID-
                                                                     24      ANCE.—




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                                                                     25                         (1) IN GENERAL.—Not later than 30 days after
                                                                     26               the date of enactment of this Act, the Secretary, act-
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                                                                       1              ing through the Commissioner of Food and Drugs
                                                                       2              and in consultation with the Director of the Centers
                                                                       3              for Disease Control and Prevention, shall issue guid-
                                                                       4              ance on COVID–19 surveillance testing best prac-
                                                                       5              tices. Such guidance shall address how COVID–19
                                                                       6              surveillance testing can be used to keep qualified en-
                                                                       7              tities, as defined in section 5(a), open to the public,
                                                                       8              and how tests with differing accuracy standards, in-
                                                                       9              cluding rapid point of care antigen tests and pooled
                                                                     10               molecular tests, can each be used in COVID–19 sur-
                                                                     11               veillance testing at qualified entities among children
                                                                     12               and adult.
                                                                     13                         (2) COVID–19 SURVEILLANCE TESTING.—For
                                                                     14               purposes of paragraph (1), the term ‘‘COVID-19
                                                                     15               surveillance testing’’ means the ongoing, systematic
                                                                     16               collection, analysis, and interpretation of COVID–19
                                                                     17               diagnostic test results for the purpose of monitoring
                                                                     18               for a community- or population-level infection and
                                                                     19               disease, or to characterize the incidence and preva-
                                                                     20               lence of disease.
                                                                     21               (c) REPORT ON NATIONAL DAILY TESTING BENCH-
                                                                     22      MARK.—Not later than 30 days after the date of enact-

                                                                     23 ment of this Act, the Secretary, acting through the Com-
                                                                     24 missioner of Food and Drugs and in consultation with the



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                                                                     25 Director of the Centers for Disease Control and Preven-


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                                                                       1 tion, shall issue recommendations on the total number of
                                                                       2 COVID–19 diagnostic tests that should be conducted in
                                                                       3 the United States per day to control the spread of
                                                                       4 COVID–19, with a focus on the number of tests necessary
                                                                       5 to protect essential workers, as defined in section 5(a),
                                                                       6 from COVID–19 infection.
                                                                       7              (d) COMPARISON OF COVID–19 DIAGNOSTIC TEST
                                                                       8 PERFORMANCE.—Not later than 30 days after the date
                                                                       9 of enactment of this Act, the Secretary, acting through
                                                                     10 the Commissioner of Food and Drugs, shall issue a report
                                                                     11 comparing the performance of COVID–19 diagnostic tests
                                                                     12 on the market, including a comparison of the differing
                                                                     13 sensitivity and accuracy of such tests in asymptomatic and
                                                                     14 symptomatic populations and children and adults.
                                                                     15               (e) REVIEW OF COVID–19 DIAGNOSTIC TEST AP-
                                                                     16      PROVAL PATHWAYS.—Not later than 30 days after the

                                                                     17 date of enactment of this Act, the Secretary, acting
                                                                     18 through the Commissioner of Food and Drugs, shall re-
                                                                     19 view the process for approving COVID–19 diagnostic tests
                                                                     20 for market, with a particular focus on extraction-free high-
                                                                     21 ly sensitive molecular tests, pooled highly sensitive molec-
                                                                     22 ular tests, low-cost rapid antigen test, low-cost highly sen-
                                                                     23 sitive molecular tests, assays that can use a variety of re-
                                                                     24 agents, and other products as determined by the Sec-



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                                                                       1 retary, and take steps as necessary to expedite such proc-
                                                                       2 ess, as appropriate.
                                                                       3     SEC. 8. DEMOGRAPHIC AND GEOGRAPHIC DATA COLLEC-

                                                                       4                             TION.

                                                                       5              (a) COVID–19 DATA COLLECTION.—The Secretary,
                                                                       6 acting through the Director of the Centers for Disease
                                                                       7 Control and Prevention and in consultation with the Ad-
                                                                       8 ministrator of the Centers for Medicare & Medicaid Serv-
                                                                       9 ices and the Director of the Indian Health Service, shall
                                                                     10 make publicly available on the website of the Centers for
                                                                     11 Disease Control and Prevention data collected relating to
                                                                     12 COVID–19 testing from entities receiving Federal funding
                                                                     13 under this Act, including data disaggregated by race, eth-
                                                                     14 nicity, sex (including sexual orientation and gender iden-
                                                                     15 tity), age, primary language, socioeconomic status, dis-
                                                                     16 ability status, pregnancy status, occupation, county, and
                                                                     17 zip code.
                                                                     18               (b) APPLICATION OF STANDARDS.—To the extent
                                                                     19 practicable, data collection under this section shall follow
                                                                     20 standards developed by the Office of Minority Health of
                                                                     21 the Department of Health and Human Services and the
                                                                     22 Centers for Disease Control and Prevention, and shall be
                                                                     23 collected, analyzed, and reported in accordance with the
                                                                     24 standards promulgated under section 3101 of the Public



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                                                                     25 Health Service Act (42 U.S.C. 300kk).


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                                                                       1              (c) TIMELINE.—The data made available under this
                                                                       2 section shall be updated on a weekly basis throughout the
                                                                       3 COVID–19 pandemic.
                                                                       4              (d) PRIVACY.—In publishing data under this section,
                                                                       5 the Secretary shall take all necessary steps to protect the
                                                                       6 privacy of individuals whose information is included in
                                                                       7 such data, including—
                                                                       8                        (1) complying with privacy protections provided
                                                                       9              under the regulations promulgated under section
                                                                     10               264(c) of the Health Insurance Portability and Ac-
                                                                     11               countability Act of 1996 (42 U.S.C. 1320d–2 note)
                                                                     12               and State law; and
                                                                     13                         (2) protections from all inappropriate internal
                                                                     14               use by an entity that collects, stores, or receives the
                                                                     15               data, including use of such data in determinations of
                                                                     16               eligibility (or continued eligibility) in health plans,
                                                                     17               and from inappropriate uses.
                                                                     18               (e) DATA USE.—Neither the Secretary, nor any other
                                                                     19 officer or employee of the Federal Government, or local
                                                                     20 government liaison, may use the information furnished
                                                                     21 under this legislation for any purpose other than the sta-
                                                                     22 tistical and public health purposes for which such informa-
                                                                     23 tion is supplied, or make any publication whereby the data
                                                                     24 furnished by any particular establishment or individual



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                                                                     25 under this Act can be identified, or permit anyone other


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                                                                       1 than the sworn officers and employees of the Department
                                                                       2 of Health and Human Services to examine the individual
                                                                       3 reports.
                                                                                                                                Æ




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