Sentinel 3.0_SSN - Data Broker Services 03022026 v1.pdf

FDA Sentinel 3.0 Data Broker Services

The U.S. Food and Drug Administration (FDA) issues this Notice as a means of conducting market research to inform acquisition planning in accordance with the Federal Acquisition Regulation (FAR) Parts 7 and 10. This notice is not a Request for Proposal (RFP), Request for Quotation (RFQ), or Invitation for Bid (IFB), and no award will result from this announcement.

As part of its market research, the FDA previously issued Notice FDARFI5302025. The operational framework described in that notice has since been revised. The FDA now anticipates supporting its Sentinel 3.0 programmatic requirements with the following contract structure:

Contract 1:

Sentinel 3.0 – Data Partners (Tiers 1–6, previously Tiers 1–5) providing access to multiple types of healthcare data. The FDA is considering a Data Broker–led acquisition model in which a prime contractor is responsible for acquiring, licensing, governing, and providing access to healthcare data across Tiers 1–6, including coordination with third-party data providers. Respondents should assume a single prime contractor retains full contractual, legal, and compliance responsibility for all data delivered under this model.

Contract 2:

Sentinel 3.0 – Government-Owned, Contractor-Operated (GOCO) platform (Tier 7) serving as a data repository, enabling interoperability, and delivering informatics tools and capabilities. Uder this model, the Government will not require platform development, platform hosting, platform replacement, alternative architectures, or contractor-operated environments. All pricing responses should assume data is delivered to, accessed through, or integrated with the existing Government platform.

Contract 3:

Sentinel 3.0 – Scientific Support Services (Tier 8). Provide scientific services including data analytics support (e.g., capability to conduct complex pharmacoepidemiology and pharmacovigilance studies, and advanced analytics).

Specifically, under this notice, the Government is seeking information to better understand the commercial market’s capabilities to support Tiers 1–6 under a Data Broker–led acquisition model for Sentinel 3.0. The Government anticipates requiring the expertise of an experienced and qualified provider to acquire, aggregate, de-identify, govern, license, and facilitate access to healthcare data across multiple data types and sources. This may include coordination and management of third-party data providers, as outlined in the draft Performance Work Statement (PWS).

The below attachments are included with this notice to provide context and seek industry’s feedback as to their content and seek opportunities to improve the Government’s requirements :

A. Draft Pricing Structure (Section B) B. Draft Performance Work Statement (PWS) (Section C) C. Draft solicitation Agency Requirements (Section H) D. Draft solicitation terms and conditions (Section I)

The FDA contemplates utilizing North American Industry Classification System (NAICS) code is 518210;

Computing Infrastructure Providers, Data Processing, Web Hosting, And Related Services. Interested organizations are requested to respond to the questions below.

https://sam.gov/workspace/contract/opp/90fea8f087764ce29e6dd551488fd8d6/view

1. Data:

Are you able to provide all or any subsets of the data? If subsets, clearly state which ones. If you do not currently posses the capability for all, is there a future possibility of providing access to all data required, if so, how soon?

2. Tier-Specific Pricing Constructs:

What is your approach to pricing for the data when selling to both commercial and government clients for each tier of data? For each of the data tiers listed below, describe your customary pricing arrangements and approach to developing their construct(s). When serving as data broker, would your organization expect to realize and apply when serving as a prime Data Broker responsible for acquiring, licensing, governing, and providing access to the data.

• Tier 1 – Commercial Claims Data (100M lives)

• Tier 2 – Commercial Claims Aggregator Data (100M lives)

• Tier 3 – Healthcare Insurance Claims–EHR Linked Data (100M lives)

• Tier 4 – Specialty and Registry Data (EHR & HIE, as-needed basis, ~10M lives)

• Tier 5 – CMS Data (subscription with user interface)

• Tier 6 – Outpatient Prescription Data (subscription with user interface)

Please indicate whether pricing is typically based on factors such as:

• Covered lives or population size

• Number of data sources

• Number of authorized users

• Subscription tiers or usage bands

• Fixed annual access fees

• Or recommend other measurable pricing units

3. The Government has preference for licensing data or accessing on a subscription basis:

How is the data delivered or access granted? How are data use agreements (DUA) used and executed in your existing business model (s)?

4. User-Based Subscription Pricing (Tiers 5 and 6):

For tiers that are commonly delivered via a subscription model with a user interface (e.g., CMS data and outpatient prescription data), describe how pricing is scaled based on the number of authorized users.

Are enterprise licenses available? Are refreshes available/accounted for in the pricing model (see PWS to ensure refreshes are included) Please provide illustrative pricing ranges or step ladders (e.g., 1-50 users, 51–80 users, 81–100 users, 101–150 users) and identify what is included in each tier of access.

5. Data Broker Service Resource Model & Fee Structure

Describe the types of resources required to perform Data Broker services (if any would likely be a direct cost) in support of the draft PWS, including the types of personnel, level of effort, and activities involved (e.g., data partner engagement, DUA negotiation, governance, onboarding, coordination, and compliance oversight).

6. Draft Attachments:

The Government seeks recommendations for optimizing requirements as defined in draft attachments. See submission requirements below.

Important Considerations

1. Firm-Fixed-Price Task Order Environment: Respondents should assume that Task Orders issued under the Data Broker IDIQ are anticipated to be Firm-Fixed-Price (FFP), consistent with subscription and data acquisition services. Responses should focus on pricing approaches that support predictability, transparency, and scalability under an FFP construct. If FFP is not the customary commercial practice, respondents submissions should provide clear insight to that effect and explain why the Government should consider alternate pricing arrangements, risk or value proposition based.

2. Data Ownership and Rights: All data delivered under this model is Government-owned or Government-controlled in accordance with applicable data use agreements. Responses should assume unrestricted Government use consistent with Sentinel 3.0 objectives.

SUBMISSION REQUIREMENTS (IN THIS ORDER)

1. Company profile inclusive of complete business name, including UEI number, Tax ID, CAGE code and business size and classification (small, small-disadvantaged, SBA Certified 8(a), HUBZone, service-disabled veteran-owned, women-owned, other than small, etc.).

2. Contact Information (Respondent’s name and title, address, telephone, e-mail).

3. If respondent offers the same or similar items/services as described herein for sale via an existing schedule contract, list current contracts (GSA MAS, GWACs, MACs, etc). If none, respondent should definitively provide statement to that effect.

4. Capability statement that proves technical capability experience relative to draft PWS.

5. Confirmation of your entities interest to responding to any subsequent solicitation (should there be one).

6. Description of the anticipated structure of the respondent’s team – do you anticipate being the prime vendor or a subcontractor? Do you anticipate being able to meet the requirements on your own or as part of a team? What would that potential team look like in terms of participants and their associated functions?

Submission Instructions: Responses (capability statements and answers to questions 1-5) shall be no more than 10 pages total. There is no page limitation to respondents’ recommendations to draft attachments. They can be submitted as tracked changes directly within the documents, or in the form of a register using Excel spreadsheet.

Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this notice by no later than 10:00 pm EST March 23, 2026. Responses shall be submitted to Narissa Charles, Contracting Officer at Narissa.charles@fda.hhs.gov.