RFI sentinel 3. 0
Closed Special Notice Posted
- Solicitation number
- FDARFI5302025
- Agency
-
Center for Drug Evaluation and Research
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- Silver Spring, Maryland 20993, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services Food and Drug Administration (FDA) has issued a Special Notice for a Request for Information (RFI) regarding the Sentinel 3.0 Data Hub and Scientific Support Services. This RFI is part of the FDA's ongoing Sentinel Initiative, which is designed to fulfill the Food and Drug Administration Amendments Act requirement for an active postmarket risk identification and analysis system. The proposed Sentinel 3.0 aims to consolidate postmarket safety surveillance activities across multiple FDA centers and will be structured as a multiple-award, tiered Indefinite Delivery Indefinite Quantity (IDIQ) contract. The contract will cover seven tiers of healthcare data, a data platform, and scientific support services. The FDA is seeking comprehensive input from potential contractors to develop an advanced data platform with sophisticated capabilities.
The primary objective of this RFI is to gather detailed information for developing a Data Platform with advanced features including data repository services, AI-enabled informatics tools, and robust security measures. The FDA plans to award the contract by December 2025, with a five-year performance period, and has set a response deadline of June 11, 2025, at 3:00 pm EST. Eligible respondents include commercial and not-for-profit organizations, with the option to form teaming arrangements. The contract requires a FedRAMP cloud-based, multi-tenant data platform at a Moderate accreditation level, and will focus on near real-time data access, flexible data integration, and comprehensive data governance. The FDA is particularly interested in contractors who can provide commercial healthcare insurance claims data and demonstrate capabilities in maintaining patient privacy and regulatory compliance. Only one vendor will be selected for Tier 6, and the platform must support postmarket safety surveillance across multiple FDA centers.
Notice text
3 versions
Update #3 · Latest ·
Amendment 02 - Questions and Answers posted in the attachments.
See Attachment for RFI.
Please note that the response time has been extended to June 13, 2025, 3:00 PM ET.
(The RFI indicated a 20 day response time but that is incorrect.). The response time is 14 days thus June 13, 2025, 3:00 PM ET response time.
Update #2 ·
See Attachment for RFI.
Please note that the response time has been extended to June 13, 2025, 3:00 PM ET.
(The RFI indicated a 20 day response time but that is incorrect.). The response time is 14 days thus June 13, 2025, 3:00 PM ET response time.
Update #1 ·
See Attachment for RFI.
Files
| File | Type | Posted |
|---|---|---|
| RFI 4 Vendors Questions.pdf | ||
| RFI_SENTINEL 3.0 5 30 2025.pdf |
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