Sec. 501. Alternatives to animal testing
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Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended— in subsection (i)— in paragraph (1)(A), by striking preclinical tests (including tests on animals) and inserting nonclinical tests ; and in paragraph (2)(B), by striking animal and inserting nonclinical tests ; and after subsection (y), by inserting the following: For purposes of this section, the term nonclinical test means a test conducted in vitro, in silico, or in chemico, or a non-human in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug, and may include animal tests, or non-animal or human biology-based test methods, such as cell-based assays, microphysiological systems, or computer models. .
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: an assessment of toxicity (which may rely on, or consist of, a study or studies described in item
(aa)or (cc)); and .
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