117 HR 6377 IH: Free At-Home Tests for All Act U.S. House of Representatives 2022-01-12 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 CONGRESS2d SessionH. R. 6377IN THE HOUSE OF REPRESENTATIVESJanuary 12, 2022Mr. Beyer (for himself, Ms. Titus, Mr. Morelle, and Mr. Kahele) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Financial Services, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concernedA BILLTo direct the Secretary of Health and Human Services to purchase and make available for free rapid tests for SARS–CoV–2, and for other purposes.

1.

Short title

This Act may be cited as the Free At-Home Tests for All Act.

2.

Free rapid test program

(a)

Bulk purchases

The Secretary of Health and Human Services (in this Act referred to as the Secretary) shall purchase in bulk a sufficient quantity of rapid tests for SARS–CoV–2 to provide two such tests per week to every resident of the United States over the 12-month period beginning on the date of enactment of this Act.(b)

Free availability

The Secretary shall make the tests purchased pursuant to subsection (a) available for free—(1)at pharmacies, including online pharmacies participating in a pharmacy partnership program;(2)at public schools; and(3)by online order or phone call directly from the Department of Health and Human Services.(c)

Proctoring; return envelopes

The tests purchased pursuant to subsection (a) shall—(1)each be proctored without charge; and(2)be made available together with a free postage-paid envelope for delivering completed tests to the Centers for Disease Control and Prevention or a relevant public health laboratory for genomic sequencing.(d)

Materials for individuals who test positive

The Secretary shall—(1)distribute to proctors of tests purchased pursuant to subsection (a) informational materials about social distancing, treatment, and further testing for individuals who test positive; and(2)require such proctors to provide such materials to such individuals.(e)

Relation to Defense Production Act

In making purchases authorized under this section, the President may utilize the authorities provided under title I of the Defense Production Act of 1950 (50 U.S.C. 4511 et seq.).(f)

Definition

In this section, the term rapid test means an antigen diagnostic test.(g)

Authorization of appropriations

To carry out this section, there are authorized to be appropriated such sums as may be necessary. The amounts authorized to be appropriated by the preceding sentence are in addition to amounts otherwise available to carry out this section.

3.

Coordination with Medicare and Medicaid programs

The Secretary shall—(1)conduct outreach to individuals entitled to benefits under the Medicare or Medicaid programs regarding the availability of rapid tests (as defined in section 2); and(2)make such tests available through the Medicare and Medicaid programs at no cost to such individuals, including by mail.

4.

Food and Drug Administration

(a)

Automatic EUA

(1)

In general

Subject to paragraph (2), during the period of the public health emergency for COVID–19 in effect under section 319 of the Public Health Service Act (42 U.S.C. 247d), including any extensions thereof, an antigen diagnostic test for SARS–CoV–2 is deemed to have in effect an emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) if the test is listed for emergency use by—(A)the World Health Organization; or(B)a stringent regulatory authority (as defined by the World Health Organization for purposes of medicine procurement decisions).(2)

Continued authority

Upon the deeming of an emergency use authorization by paragraph (1) for a test, the Secretary of Health and Human Services and the Commissioner of Food and Drugs shall continue to have all authorities vested in such officials by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and other applicable law to rescind such emergency use authorization or otherwise regulate such test.(b)

Advisory committee on diagnostic and serological testing

The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall establish and maintain a permanent advisory committee to advise the Department of Health and Human Services regarding the development, manufacture, distribution, and use of diagnostic and serological testing for public health needs.