118 S2329 IS: Emerging Pathogen Preparedness Program Authorization Act U.S. Senate 2023-07-13 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. 2329IN THE SENATE OF THE UNITED STATESJuly 13, 2023Mr. Hickenlooper (for himself and Mr. Budd) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo establish an emerging pathogen preparedness program within the Food and Drug Administration to improve regulatory oversight of medical countermeasures for future pandemics.

1.

Short title

This Act may be cited as the Emerging Pathogen Preparedness Program Authorization Act.

2.

Emerging pathogens preparedness program

(a)

In general

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4) is amended by adding at the end the following:(j)

Emerging pathogens preparedness program

(1)

In general

The Secretary shall establish a program to facilitate the development, review, licensure, approval, and clearance of countermeasures, and products that could potentially be countermeasures, under the jurisdiction of the Center for Biologics Evaluation and Research.(2)

Activities

The activities of the program established under paragraph (1) may include, either directly or by grant, contract, or cooperative agreement, the following:(A)Any activities described in subsection (b).(B)Activities to advance scientific research related to the development of tools, standards, and approaches to assess the safety, efficacy, quality, and performance of countermeasures.(C)Activities to maintain or enhance surveillance programs that monitor countermeasures.(D)Activities to help ensure blood safety and availability.(E)Prioritizing the research and development of platform vaccine technologies to support an emergency use authorization request under section 564 or an application under 351(a) of the Public Health Service Act.(F)Such other activities as the Secretary determines necessary or appropriate.(3)

Rule of construction

Nothing in this subsection shall be construed to alter the authority of the Secretary to license, approve, clear, or authorize countermeasures, including biological products, pursuant to section 351 of the Public Health Service Act or section 505 or 564 of this Act, including standards of evidence and applicable conditions for licensure, approval, clearance, or authorization..(b)

Authorization of appropriations

To carry out subsection (j) of section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4), as added by subsection (a), there is authorized to be appropriated $60,000,000 for each of fiscal years 2024 through 2028.