Develop research techniques to produce new biomarkers and evaluate existing biomarkers. This research has widespread interest and is a collaborative FDA effort involving CDER, CFSAN, CVM, and CDRH.NCTR promotes personalized nutrition and medicine by developing a broad range of studies involving systems toxicology assessments to characterize biomarkers of health, disease risk and disease status. These biomarkers will aid the FDA in establishing risk measures for FDA-regulated products and assessing the benefits and potential risk of treatments in a personalized nutrition and medicine paradigm.Developing and validating genetic biomarkers will better enable the FDA to identify persons most likely to benefit from, or experience adverse reactions to, particular drugs, devices, biologics, cosmetics and nutrients. This will reduce the rate of adverse events in patients.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.<b>Phase 1:</b> National Center for Toxicological Research (NCTR) scientists have authored an invited book chapter for an upcoming volume of <i>Molecular Toxicology Protocols</i> (Methods in Molecular Biology series). The chapter details methods for conducting the Pig-a gene mutation assay in mice and rats. The Pig-a assay is a flow-cytometer-based assay that can be used to assess the <i>in vivo</i> mutagenic potential of suspected toxicants. The assay is rapid, relatively inexpensive, and is functional across species (mice-to-human), making it a potentially valuable tool for regulatory safety assessments.main1. Present and discuss genetic biomarker research to support personalized nutrition and health (to date) with the scientific community at the Society for Toxicology Meeting3/31/2010Completed3/31/2010main2. Present and discuss genetic biomarker research to establish risk measures (to date) with the scientific community at the Society for Toxicology Meeting3/31/2010Completed3/31/2010main3. Approve protocol for a new study to evaluate a new mutation biomarker for its utility in detecting chemically induced mutations at low levels of exposure5/31/2010Completed5/31/2010main4. Complete discussions with collaborators in CDER, CFSAN, CVM, and CDRH to gain input into the development of a research program for new mutational and cancer biomarkers5/31/2010Completed5/31/2010main5. Complete the evaluation of a new mutational biomarker using an initial set of chemicals in a multi-laboratory collaborative trial6/30/2010Completed6/30/2010main6. Complete training of a postdoctoral fellow in specialized molecular techniques involved in cancer biomarker research6/30/2010Completed6/30/2010main7. Complete and submit a manuscript for an overview of cancer biomarkers research7/30/2010Completed7/30/2010main8. Complete and submit a manuscript to provide an overview of the current methodology for a new biomarker assay using the Pig-A gene; this gene mutation assay will detect the ability of chemicals/pharmaceuticals to induce genetic damage7/30/2010Completed7/30/2010ON TRACKON TRACKmain1. Complete a second set of experiments investigating the utility and capabilities of the new gene mutation assay using the Pig-A gene9/30/2011Completed9/30/2011main2. Complete a third set of experiments9/30/2012Completed9/30/2012main3. Complete the assessment of research findings for this project1/1/2013On Trackmain4. Develop draft technical report/manuscript/publicationTBDNot Yet Startedmain5. Complete the peer review (NCTR and other researchers) of draft technical report, manuscript, and/or publicationTBDNot Yet Startedmain6. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking systemTBDNot Yet Startedmain7. Submit final technical report, manuscript and/or publication to a scientific journalTBDNot Yet Startedbiomarkersmeasurable endpoints that are either precursors for or surrogate indicators for diseaseCDERCenter for Drug Evaluation and ResearchCFSANCenter for Food Safety and Applied NutritionCVMCenter for Veterinary MedicineCDRHCenter for Devices and Radiological Healthhttp://www.fda.gov/AboutFDA/Transparency/track/ucm203296.htmFDA-TRACK NCTR Dashboardhttp://www.fda.gov/AboutFDA/Transparency/track/ucm252974.htmFDA-TRACK Research Glossary਍††਍਍਍਍਍਍਍