[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2329 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                S. 2329

To establish an emerging pathogen preparedness program within the Food 
  and Drug Administration to improve regulatory oversight of medical 
                 countermeasures for future pandemics.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 13, 2023

 Mr. Hickenlooper (for himself and Mr. Budd) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To establish an emerging pathogen preparedness program within the Food 
  and Drug Administration to improve regulatory oversight of medical 
                 countermeasures for future pandemics.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

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

SEC. 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.
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