ANIMAL TESTING ALTERNATIVES.

SEC. 3209. ANIMAL TESTING ALTERNATIVES.(a) In General.—Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended—(1) 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”; and (2) by inserting after subsection (y) the following:136 STAT. 5822 “(z) Nonclinical Test Defined.—For purposes of this section, the term ‘nonclinical test’ means a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test, that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug. Such test may include the following:“(1) Cell-based assays. “(2) Organ chips and microphysiological systems. “(3) Computer modeling. “(4) Other nonhuman or human biology-based test methods, such as bioprinting. “(5) Animal tests.” . (b) Biosimilar Biological Product Applications.—Item (bb) of section 351(k)(2)(A)(i)(I) of the Public Health Service Act (42 U.S.C. 262(k)(2)(A)(i)(I)) is amended to read as follows:“(bb) an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc)); and” .