117 S2952 IS: FDA Modernization Act of 2021 U.S. Senate 2021-10-07 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.

II117th CONGRESS1st SessionS. 2952IN THE SENATE OF THE UNITED STATESOctober 7, 2021Mr. Paul (for himself, Mr. Booker, Mr. Braun, Mr. Kennedy, and Mr. Luján) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo amend the Federal Food, Drug, and Cosmetic Act to allow manufacturers and sponsors of a drug to use alternative testing methods to animal testing to investigate the safety and effectiveness of a drug, and for other purposes.

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Short title

This Act may be cited as the FDA Modernization Act of 2021.

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New approach methodologies

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended—(1)in subsection (b)(5)(B)(i)(II), by striking animal and inserting nonclinical tests or studies;(2)in subsection (i)—(A)in paragraph (1)(A), by striking preclinical tests (including tests on animals) and inserting nonclinical tests; and(B)in paragraph (2)(B), by striking animal and inserting nonclinical tests or studies; and(3)after subsection (y), by inserting the following:(z)

Nonclinical test or study defined

For purposes of this section, the term nonclinical test or study means a test or study conducted in vitro, in silico, in chemico, or in vivo that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug, and may include the following: (1)Cell-based assays.(2)Organ chips and microphysiological systems.(3)Computer models.(4)Other non-animal or human biology-based test methods.(5)Animal tests..