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I
116TH CONGRESS
2D SESSION
H. R. 6839
To direct the Comptroller General of the United States to submit a report
describing the response of certain entities to the COVID–19 pandemic
with respect to the development, regulatory evaluation, and deployment
of diagnostic tests.
IN THE HOUSE OF REPRESENTATIVES
MAY 12, 2020
Ms. SPANBERGER (for herself and Mr. GONZALEZ of Ohio) introduced the
following bill; which was referred to the Committee on Energy and Commerce
A BILL
To direct the Comptroller General of the United States to
submit a report describing the response of certain enti-
ties to the COVID–19 pandemic with respect to the
development, regulatory evaluation, and deployment of
diagnostic tests.
Be it enacted by the Senate and House of Representa-
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tives of the United States of America in Congress assembled,
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SECTION 1. GAO REPORT ON DIAGNOSTIC TESTS.
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(a) GAO STUDY.—Not later than 18 months after
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the date of enactment of this Act, the Comptroller General
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of the United States shall submit to the Committee on
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Energy and Commerce of the House of Representatives
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•HR 6839 IH
and the Committee on Health, Education, Labor and Pen-
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sions of the Senate a report describing the response of
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entities described in subsection (b) to the COVID–19 pan-
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demic with respect to the development, regulatory evalua-
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tion, and deployment of diagnostic tests.
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(b) ENTITIES DESCRIBED.—Entities described in
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this subsection include—
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(1) laboratories, including public health, aca-
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demic, clinical, and commercial laboratories;
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(2) diagnostic test manufacturers;
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(3) State, local, Tribal, and territorial govern-
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ments; and
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(4) the Food and Drug Administration, the
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Centers for Disease Control and Prevention, the
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Centers for Medicare & Medicaid Services, the Na-
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tional Institutes of Health, and other relevant Fed-
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eral agencies, as appropriate.
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(c) CONTENTS.—The report under subsection (a)
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shall include—
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(1) a description of actions taken by entities de-
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scribed in subsection (b) to develop, evaluate, and
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deploy diagnostic tests;
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(2) an assessment of the coordination of Fed-
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eral agencies in the development, regulatory evalua-
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tion, and deployment of diagnostic tests;
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•HR 6839 IH
(3) an assessment of the standards used by the
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Food and Drug Administration to evaluate diag-
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nostic tests;
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(4) an assessment of the clarity of Federal
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agency guidance related to testing, including the
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ability for individuals without medical training to
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understand which diagnostic tests had been evalu-
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ated by the Food and Drug Administration;
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(5) a description of—
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(A) actions taken and clinical processes
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employed by States and territories that have
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authorized laboratories to develop and perform
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diagnostic tests not authorized, approved, or
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cleared by the Food and Drug Administration,
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including actions of such States and territories
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to evaluate the accuracy and sensitivity of such
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tests; and
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(B) the standards used by States and ter-
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ritories when deciding when to authorize labora-
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tories to develop or perform diagnostic tests;
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(6) an assessment of the steps taken by labora-
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tories and diagnostic test manufacturers to validate
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diagnostic tests, as well as the evidence collected by
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such entities to support validation; and
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•HR 6839 IH
(7) based on available reports, an assessment of
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the accuracy and sensitivity of a representative sam-
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ple of available diagnostic tests.
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(d) DEFINITION.—In this section, the term ‘‘diag-
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nostic test’’ means an in vitro diagnostic product (as de-
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fined in section 809.3(a) of title 21, Code of Federal Regu-
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lations) for—
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(1) the detection of SARS–CoV–2;
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(2) the diagnosis of the virus that causes
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COVID–19; or
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(3) the detection of antibodies specific to
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SARS–CoV–2, such as a serological test.
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Æ
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