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.

Closed Special Notice Posted

Solicitation number
FDARFI10282022
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
54171 Research and Development in the Physical, Engineering, and Life Sciences
PSC
B537 Special Studies/Analysis- Medical/Health
Place of performance
Silver Spring, Maryland 20903, United States

Notice details come from SAM.gov. Updated .

Notice text

2 versions

Update #2 · Latest ·

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.

Update #1 ·

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 Attachment for RFI.

Files

File Type Posted
Copy of Appendix A - Supplemental Data Resource Table Final_.xlsx XLSX spreadsheet
RFI number FDARFI10282022.pdf PDF

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