Utilize new genomics and other molecular technologies and approaches for evaluating FDA-regulated products for adverse genetic effects. This is a collaborative effort with CDRH and CFSAN.DGMT focuses on the development and validation of new methods to assess genetic risk. New molecular technologies are being developed and can be used to evaluate structural and functional changes to the genetic material of both rodents and humans.An increased understanding of mutational mechanisms and test systems that have an increased ability to detect genetic damage, etc. will provide FDA with better information for decision-making. In the future, these new approaches to evaluate toxicity will allow for the integration of information across the various types of adverse health outcomes. For instance, when these technologies are fully developed, it will be possible to concurrently evaluate chemicals for their ability to cause cancer, to impact the nervous system, to cause birth defects, and to modify the immune function.When developed and validated, this new assay which helps to distinguish between chemicals that can cause genetic damage/cancer and those that are safe will provide a better method for use in FDA product safety evaluations such as preclinical safety evaluation for pharmaceuticals.ON TRACKON TRACKmain1. Present and discuss new technologies for safety assessments with the scientific community at the Society for Toxicology Meeting3/31/2010Completed3/31/2010main2. Complete and accept review article describing the potential for microRNA analysis to be useful in evaluating whether a new drug or other chemical is a carcinogen5/31/2010Completed5/31/2010main3. Approve protocol to develop a new project to assess the utility of gene expression analysis to evaluate whether a new drug or chemical is a carcinogen6/30/2010Completed6/30/2010main4. Complete the hiring process for a new support research scientist to assist in developing new molecular technologies7/30/2010Completed7/30/2010main5. Complete training for support scientist for the microRNA/gene expression project8/30/2010Completed8/30/2010main6. Present and discuss research from gene expression studies at the Environmental Mutagen Society Meeting10/31/2010Completed10/31/2010main7. Present and discuss research at ILSI/HESI Workgroup Meeting10/20/2011Completed10/20/2011main8. Complete research12/31/2012On Trackmain9. Complete the assessment of research findingsTBDNot Yet Startedmain10. Develop draft technical report/manuscript/publicationTBDNot Yet Startedmain11. Complete the peer review (NCTR and other researchers) of draft technical report, manuscript, and/or publicationTBDNot Yet Startedmain12. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking systemTBDNot Yet Startedmain13. Submit final technical report, manuscript and/or publication to a scientific journalTBDNot Yet Startedgenomicshigh throughput technologies used to analyze the products made by all of the genes or a subset of the genes in a cellCDRHCenter for Devices and Radiological HealthCFSANCenter for Food Safety and Applied NutritionmicroRNAmicro Ribonucleic acidgene expression analysisan analysis of the products made by geneshttp://www.fda.gov/AboutFDA/Transparency/track/ucm203296.htmFDA-TRACK NCTR Dashboardhttp://www.fda.gov/AboutFDA/Transparency/track/ucm252974.htmFDA-TRACK Research Glossary਍††਍਍਍਍਍਍਍