Conduct Blood Risk Assessment Workshop with stakeholders. The workshop conveys information to stakeholders on important statistical, epidemiological, and risk assessment considerations for the regulation of blood and blood products. The workshop advances the FDA Transparency Initiative by enhancing stakeholders' understanding of risk assessment and its role in the regulatory decision-making process.On May 13 and 14, 2010, CBER held a workshop on quantitative risk assessment on blood safety and availability for CBER stakeholders. The purpose of the workshop was to discuss the structure of risk assessment, to present a case-study (Malaria exposure and blood donor deferral) demonstrating risk assessment principles, and to solicit stakeholder input on how to better involve stakeholders in complex risk assessments. Stakeholders from the patient advocacy groups and from the regulated industry provided feedback in presentations and during panel discussions. Stakeholder input from the workshop has enabled OBE to consider new strategies for addressing questions regarding risk management and communications. For example, complex risk assessments may require special consideration. Public meetings might be needed either within or outside of the advisory committees meetings to present and discuss the critical assumptions of a risk assessment early in the process. OBE is planning on web posting workshop presentations along with edited transcripts by February 2011.A. Finalize statement of work8/20/2009Completed8/20/2009B. Select contractor for workshop9/10/2009Completed9/10/2009C. Develop summary and goals2/12/2010Completed3/1/2010D. Draft workshop agenda2/12/2010Completed3/31/2010E. Identify workshop speakers2/26/2010Completed4/7/2010F. Select/invite speakers3/15/2010Completed4/11/2010G. Finalize workshop agenda5/3/2010Completed5/3/2010H. Announce workshop in Federal Register and FDA website4/13/2010Completed4/1/2010I. Pre-meeting review5/5/2010Completed5/5/2010J. Hold Joint Public Workshop5/13-14/2010Completed5/14/2010K. Evaluate workshop to determine next steps for OBE6/14/2010Completed6/14/2010Molecular EpidemiologyMolecular epidemiology is a branch of medical science that focuses on the contribution of potential genetic and environmental risk factors, identified at the molecular level, to the etiology, distribution and prevention of disease within families and across populations.http://www.fda.gov/AboutFDA/Transparency/track/ucm206350.htmFDA-TRACK CBER Cross Program Support Offices Dashboard