RFI 4 Vendors Questions.pdf
PDF 83 KB Posted
- Attached to
- RFI SENTINEL 3. 0
- Solicitation number
- FDARFI5302025
About this file
This document is a Request for Information (RFI) #4 containing vendors' questions and FDA responses for the Sentinel 3.0 Data Hub and Scientific Support Services contract. The RFI reveals key details about the FDA's planned procurement, including that they intend to award a five-year Sentinel System contract by December 2025, with a FedRAMP cloud-based, multi-tenant data platform. The FDA specified that the FedRAMP Accreditation Level should be Moderate at minimum, and they will only award one vendor contract for Tier 6.
The document shows Optum Serve as the sole vendor asking questions, which covered topics such as contract timeline, FedRAMP environment readiness, and data requirements. Notably, the FDA is interested in both open and closed claims systems for Tier 2, seeking commercial healthcare insurance claims data from third-party aggregators with a large number of claims available to conduct safety studies. The FDA was clear in its responses, declining to extend the RFI response date and confirming specific technical and contractual expectations for potential vendors.
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| File | Type | Posted |
|---|---|---|
| RFI_SENTINEL 3.0 5 30 2025.pdf |
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Sentinel 3.0 Data Hub and Scientific Support Services: RFI #4
Vendors’ Questions and FDA Responses
Question No.
Vendor’s Name
RFI
Page
RFI Language Vendor’s Question or Recommendation
FDA Response
1 Optum Serve
- - Is it possible to extend the response time to this RFI?
No, FDA cannot extend the RFI response data.
2 Optum Serve
2 The Data Platform is a contractor-operated, FedRAMP cloudbased, multi-tenant environment
What FedRAMP Accreditation Level (low, moderate, or high) is being requested?
The level of FedRAMP Accreditation should be Moderate, at a minimum.
3 Optum Serve
2 N/A Will FDA consider awarding more than one data platform (Tier 6) contract?
No, only one vendor will be awarded in Tier 6.
4 Optum Serve
2 FDA plans to award a five-year Sentinel System contract by December 2025
Is FDA expecting that the FedRAMP environment be ready by the contract award or by the contract start date?
Yes. FDA is expecting the contractor will have access to a FedRAMP environment by the beginning of the period of performance (i.e., Contract award – December 2025, Contract start date – December 2025).
5 Optum Serve
2 Tier 2: Commercial Healthcare Insurance Claims Data from Third- Party Aggregator(s) (access to medical records is not required)
Is FDA interested in open claims systems, aggregated across multiple payers, in Tier 2? Or are only closed claims databases of interest?
Both, with a large number of claims available to conduct safety studies.
File details come from the government source that posted it. Updated .