Hold Joint Public Workshop with OCBQ on Placental/Umbilical Cord Blood Products with American Association of Blood Banks (AABB). CBER and AABB are collaborating to present: Cord Blood Licensure - A Workshop. The purpose of the workshop is to provide an educational opportunity for potential stakeholders such as cord blood banks, registries, individual physicians, and other stakeholders to learn about the pathway to licensure or investigational new drug (IND) submission for minimally manipulated allogeneic unrelated cord blood for specified indications.On March 8 and 9, 2010, CBER conducted a workshop to provide an educational opportunity for cord blood banks, registries, and other stakeholders to learn about the pathway to licensure or Investigational New Drug (IND) submission for minimally manipulated allogeneic cord blood for specified indications. As a result of stakeholder input that occurred during the meeting, OCTGT/OCBQ are currently working toward finalizing the draft guidance <a href=http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM187146.pdf target=”_blank”>“Investigational New Drug Application for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for specified Indications”</a>. Additionally, stakeholder input assisted OCTGT/OCBQ in addressing items in a CBER-sponsored 2-day Cord Blood training course for CBER and Office of Regulatory Affairs (ORA) staff, as well as updating the Compliance Program Guidance Manual (7345.848) to include Cord Blood Products.A. Identify FDA planning committee and select OCTGT members1/13/2010Completed11/24/2009B. Finalize contract for workshop2/12/2010Completed12/3/2009C. Draft workshop agenda2/12/2010Completed12/4/2009D. Establish schedule and process for joint FDA-AABB planning meetings2/12/2010Completed12/4/2009E. Confirm workshop speakers2/3/2010Completed12/2/2010F. Finalize workshop agenda2/6/2010Completed2/1/2010G. Announce workshop on FDA website as a web notice2/15/2010Completed1/27/2010H. Draft OCTGT presentations2/26/2010Completed2/26/2010I. Finalize OCTGT presentations3/5/2010Completed3/5/2010J. Hold Joint Public Workshop3/8-9/2010Completed3/8-9/2010K. Evaluate workshop to determine next steps for OCTGT6/14/2010Completed6/4/2010Molecular 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