1. Short title This Act may be cited as the Patient Safety and Toxicology Modernization Act of 2017 . 2. Findings Congress finds the following: (1) Preclinical testing serves a fundamental role in characterizing the potential risks and benefits associated with regulated medicines and products. (2) Critical gaps remain in the understanding of the relationship between patient response and preclinical findings. (3) Serious, rare, and unexpected adverse events may be observed in clinical trials or postapproval, particularly toxicology effects not identified in animals that may harm human organs. (4) Patient efficacy, safety, dosage information, and speedier access to new medicines will benefit from models that are more predictive than animals and that mimic key elements of human organs. (5) A 2011 report by the Food and Drug Administration, entitled Advancing Regulatory Science at FDA , prioritized toxicology testing and the development of models of human adverse response as one of the areas of regulatory science where new or enhanced engagement by the agency is essential to the continued success of the public health and regulatory mission of the Food and Drug Administration. (6) The Food and Drug Administration’s 2016 draft commitment letter concerning the reauthorization of fees relating to drugs under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379g et seq.) proposes a process to add new preclinical models that will not be finalized until at least 2021. (7) Peer-reviewed data is readily available to illustrate the benefits of commercially available human tissue models to improve the drug discovery process by replicating key elements of living human tissue. (8) The Food and Drug Administration should take immediate steps to validate new models, including three-dimensional human tissue models, that improve regulatory decisionmaking in preclinical, clinical, labeling, and postmarket safety and efficacy testing, or other uses by product sponsors. 3. Guidance with