117 HR 747 IH: Access to Technology and Equipment for Same-day Tests Act U.S. House of Representatives 2021-02-03 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I117th CONGRESS1st SessionH. R. 747IN THE HOUSE OF REPRESENTATIVESFebruary 3, 2021Ms. DeGette (for herself and Mr. Bucshon) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo amend the Public Health Service Act to authorize grants for acquiring equipment and supplies capable of performing same-day clinical laboratory testing in a point-of-care setting, and to assist laboratories in meeting the cost of acquiring high-throughput equipment, and for other purposes.

1.

Short title

This Act may be cited as the Access to Technology and Equipment for Same-day Tests Act or the Access to TESTs Act.

2.

Grants for same-day point-of-care testing in communities

Section 2821 of the Public Health Service Act (42 U.S.C. 300hh–31) is amended—(1)by redesignating subsection (b) as subsection (d); and(2)after making such redesignation, by inserting after subsection (a) the following new subsection:(b)

Grants for same-Day point-of-Care testing in communities

(1)

Grants

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants to eligible entities to assist such entities in acquiring legally-marketed equipment and supplies capable of performing, storing, and processing same-day clinical laboratory testing, including molecular, serological, and antigen tests, in a point-of-care setting.(2)

Eligibility

To be eligible for a grant under paragraph (1), an entity shall—(A)be—(i)a hospital;(ii)a primary care facility;(iii)a clinic;(iv)a pharmacy;(v)a physician; or(vi)such other type of health care provider as the Secretary may determine for purposes of this section;(B)be in compliance with section 353 (commonly referred to as the Clinical Laboratory Improvement Amendments of 1988); and(C)submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may reasonably require.(3)

Amount of grant

The amount of a grant under paragraph (1) may not exceed $20,000.(4)

Priority

In awarding grants under paragraph (1), the Secretary shall give highest priority to eligible entities providing services to—(A)underserved populations in rural areas; and(B)medically underserved populations (as defined in section 330(b)(3))..

3.

Grants for laboratories To acquire high-throughput diagnostic equipment

Section 2821 of the Public Health Service Act (42 U.S.C. 300hh–31) is amended by inserting after subsection (b) (as added by section 2) the following new subsection:(c)

Grants for laboratories To acquire high-Throughput diagnostic equipment

(1)

Grants

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants to eligible entities to assist such entities in purchasing high-throughput diagnostic equipment and related supplies to administer, store, and process molecular, serological, and antigen tests.(2)

Eligibility

To be eligible for a grant under paragraph (1), an entity shall—(A)be—(i)a State, local, or Tribal public health laboratory;(ii)a laboratory within a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention;(iii)a laboratory not described in clause (i) or (ii) that the Secretary determines (at the Secretary’s discretion) provides population-based testing for the prevention and control of infectious, communicable, genetic, or chronic diseases; or(iv)a consortium of 2 or more entities described in any of clauses (i) through (iii); and(B)submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may reasonably require.(3)

Amount of grant

The amount of a grant under paragraph (1) may not exceed $2,000,000, except in the case of eligible entity described in paragraph (2)(A)(iv).(4)

High-throughput diagnostic equipment defined

In this subsection, the term high-throughput diagnostic equipment means legally-marketed equipment capable of performing multichannel analysis for use in clinical laboratory testing, including molecular, serological, and antigen tests..

4.

Authorization of appropriations

Section 2821(d) of the Public Health Service Act (42 U.S.C. 300hh–31(d)) (as redesignated by section 2) is amended to read as follows:(1)by striking There are authorized to be appropriated to carry out this section and inserting the following:(1)

In general

There is authorized to be appropriated to carry out subsection (a); and(2)by adding at the end, the following:(2)

Authorization of appropriations

(A)

Testing grants

For carrying out subsection (b), there is authorized to be appropriated $500,000,000 for fiscal year 2021, to remain available until expended.(B)

Equipment grants

For carrying out subsection (c), there is authorized to be appropriated $250,000,000 for fiscal year 2021, to remain available until expended.(C)

Administrative expenses

Of the total amount made available to carry out subsections (b) and (c) for any fiscal year, the Secretary may not use more than 5 percent of such amount for the expenses of administering such subsections..