The purpose of the workshop is to exchange information with industry on the regulatory challenges to developing and licensing a Cytomegalocirus (CMV) vaccine.The workshop will encourage the identification of issues and the exchange of ideas that relate to the development of a safe and effective vaccine for the significant health problem.On January 10 and January 11, 2012, CBER with other agency partners, including NIH, CDC and the National Vaccine Program Office, co-sponsored a workshop focused on the development of cytomegalovirus vaccines. Meeting participants from academia, professional organizations, patient advocacy groups, and the U.S. government reached general consensus of the importance of CMV as a pathogen and the significant potential public health value of a CMV vaccine. Additionally, meeting participants identified clinically relevant endpoints for Phase 3 vaccine trials to address congenital, stem cell transplant, and solid organ transplant CMV indications and developed a framework for a case definition of congenital CMV. Finally, stakeholders identified priorities for further vaccine-related research on CMV, including the development improved immunological assays and epidemiological data.COMPLETEDON TRACKA. Form workshop planning committee and appoint chairperson3/31/2011Completed3/31/2011B. Complete workshop planning12/31/2011Completed12/31/2011C. Publish Federal Register Notice12/16/2011Completed12/16/2011D. Conduct workshop1/10-11/2012Completed1/11/2012E. Complete workshop report4/30/2012Completed4/27/2012Molecular 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/ucm206349.htmFDA-TRACK CBER Research and Review Offices Dashboard