117 HR 2565 IH: FDA Modernization Act of 2021 U.S. House of Representatives 2021-04-15 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 CONGRESS1st SessionH. R. 2565IN THE HOUSE OF REPRESENTATIVESApril 15, 2021Mr. Buchanan (for himself, Mrs. Luria, Ms. Mace, Ms. Sherrill, and Mr. Brendan F. Boyle of Pennsylvania) introduced the following bill; which was referred to the Committee on Energy and CommerceA 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.

1.

Short title

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

2.

Animal testing alternatives

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 (including tests on animals); and(B)in paragraph (2)(B), by striking animal or human studies 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 that is most likely to predict human response based on scientific evidence and occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug. Such test or study may include the following: (1)Cell-based assays.(2)Organ chips and microphysiological systems.(3)Sophisticated computer modeling.(4)Other human biology-based test methods.(5)Animal tests..