Nitrosamines Forum to Advance Critical Translational Science (NA FACTS)

Title: Nitrosamines Forum for Advancing Critical Translational Science (NA FACTS)FOA Title & Number: Identification and Evaluation of Possible Approaches to Addressing NitrosamineImpurities in Drugs (U01) RFA-FD-24-020Project Summary 1 The Health and Environmental Sciences Institute (HESI) will address the need to implement feasible and 2 sustainable safety assessment methods that protect public health from nitrosamine (NA) risks while ensuring 3 uninterrupted access to essential medications by establishing the Nitrosamines Forum for Advancing Critical 4 Translational Science (NA FACTS). NA FACTS will form two multi-stakeholder advisory teams each with 5 distinct tasks. One advisory team will be tasked with identifying prioritizing and preparing a report with 6 recommendations on in vivo and in vitro research priorities for assessment of NA impurities in drugs (Specific 7 Aim 1). This advisory team may identify and initiate a select number of new projects within the existing HESI 8 Genetic Toxicology Testing Committee (GTTC) Nitrosamines Research Program (NRP) and establish a 9 competitive seed funding mechanism to catalyze a limited number of additional new programs (Specific Aim10 3). A second advisory team will be tasked with designing and convening a workshop to assess the feasibility of11 establishing a public-facing (Q)SAR database that builds on NA classification (Specific Aim 2). The NA FACTS12 Principal Investigator (PI) and Key/Senior Persons will provide FDA with a report synthesizing the13 recommendations from the prioritization exercise and the outcomes of this workshop. The summary reports14 for Aims 1 and 2 will be publicly posted with FDA approval. Specific Aim 4 (assessment of opportunities to15 ensure that research and practices identified in Aims 1-3 can continue following closure of the cooperative16 agreement) will be fulfilled as a component of Aims 1-3 above. Specifically HESI personnel will utilize the17 networks and topical areas developed in Aims 1-3 to focus this effort. HESI personnel will also apply their18 decades of expertise to assess and evaluate stakeholders interest in supporting or leading continued work19 related to Aims 1-3 at the close of this cooperative agreement. HESI personnel will work with the NA FACTS20 team and existing GTTC NRP to facilitate discussion of possible resource models and program mechanisms21 that could support sustained activity (e.g. stakeholder contributions of funding or expertise/data/studies22 grants etc.). HESI foresees ongoing success advancing this important work given the organizations 35 years of23 designing innovative scientific resource sharing collaborations which includes the establishment and growth24 the GTTC NRP.