118 S2093 IS: Disease X Act of 2023 U.S. Senate 2023-06-21 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.

II118th CONGRESS1st SessionS. 2093IN THE SENATE OF THE UNITED STATESJune 21, 2023Ms. Baldwin (for herself and Mr. Tillis) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo establish a program at BARDA for developing medical countermeasures for viral threats with pandemic potential.

1.

Short title

This Act may be cited as the Disease X Act of 2023.

2.

Medical countermeasures for viral threats with pandemic potential

(a)

In general

Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(4)) is amended—(1)in subparagraph (D)—(A)in clause (ii), by striking ; and and inserting a semicolon;(B)by redesignating clause (iii) as clause (v); and(C)by inserting after clause (ii) the following:(iii)the identification and development of platform manufacturing technologies needed for advanced development and manufacturing of medical countermeasures for viral families which have significant potential to cause a pandemic;(iv)advanced research and development of flexible medical countermeasures against priority respiratory virus families and other respiratory viral pathogens with a significant potential to cause a pandemic, with both pathogen-specific and pathogen-agnostic approaches; and; and(2)in subparagraph (F)—(A)in clause (ii), by striking ; and at the end and inserting a semicolon;(B)in clause (iii), by striking the period and inserting ; and; and(C)by adding at the end the following:(iv)priority virus families and other viral pathogens with a significant potential to cause a pandemic..(b)

Funding

Section 319L(d)(2) of the Public Health Service Act (42 U.S.C. 247d–7e(d)(2)) is amended—(1)by striking To carry out and inserting the following:(i)

In general

To carry out; and(2)by adding at the end the following:(ii)

Additional funding

(I)

In general

In addition to the amounts appropriated under clause (i), there is authorized to be appropriated to the Fund $40,000,000 for each of fiscal years 2024 through 2028, which amounts shall be used solely for purposes of carrying out clauses (iii) and (iv) of subsection (c)(4)(D), such amounts to remain available until expended.(II)

Restriction on use of funds

Any product developed using funding appropriated pursuant to subclause (I) shall be substantially manufactured in the United States. The Secretary may waive the requirements of this subclause with respect to individual entities if the Secretary determines that requiring domestic research and development operations would be inconsistent with the public interest..