The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) requests public comments to inform the future organization of the Sentinel System. FDA seeks information that will assist in the exploration of alternative approaches to meet FDA’s legal requirements and fulfill its public health mission by adding value to the Sentinel System. Specifically, FDA is interested in organizational capabilities that will support the development of an efficient and economical product safety surveillance system that is not limited to the use of a common data model and a distributed data partners network and instead leverages multiple technical approaches.

See Attachments for RFI.and Appendix A.