Sec. 3209. Animal testing alternatives
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/bill/117/hr/2617/unknown/section-3209A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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 by inserting after subsection
(y)the following: 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: Cell-based assays. Organ chips and microphysiological systems. Computer modeling. Other nonhuman or human biology-based test methods, such as bioprinting. Animal tests. . 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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