SEC. 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.”.