Abstract # A-65

CDRH Regulatory Response to Public Health Issues of BSE. Center for Devices and Radiological Health (CDRH) BSE Working Group: K.B. Hellman (Chair), D. Berkowitz, S.A. Brown, C. Durfor, C. Gaffey, W.D. Galloway, A.L. Gonzalez, K.R. Johnson, R.G. Kammula, L.M. Kennell, K. Krell, J. Less, P. Soprey, K. Richter, M.E. Torrence, K. Warburton, J. Welch, Center for Devices and Radiological Health, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852

In March 1996, a number of cases of a variant form of Creutzfeldt-Jakob Disease (CJD), a fatal transmissible spongiform encephalopathy (TSE) in humans, were reported in Great Britain (GB). A possible association with bovine spongiform encephalopathy (BSE), of high incidence in the cattle of GB, has been suggested, although transmission of the BSE causative agent to humans has not been shown. At present, there is no diagnostic test for the BSE agent. These developments raised concern throughout the FDA, especially at the CDRH, regarding products containing or manufactured from bovine-derived materials. In response, a CDRH BSE Working Group was formed to gather data on bovine- and other animal-derived products, to evaluate the associated public health risks, and to develop guidance for reviewers. An ongoing CDRH project to develop a biomaterials database afforded a system for storing, organizing, and analyzing the data collected.