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Food and Drug Administration (FDA)

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Regulatory data modernization · HHS Operating Division (regulated-product oversight) · Updated 2026-10-20

Regulates food, drugs, biologics, devices, and tobacco. Buys post-market surveillance and regulated-product data systems through Sentinel, market-research vehicles, and operating-division IT modernization. Sentinel 3.0 has moved past sources sought: FDA issued a draft RFP for the Data Broker contract (Tiers 1-6, notice 75F40126SSN00101) and awarded the Studies-as-a-Service scientific support task in March 2026. Trade press reported that first task order in August 2026 (VSG LLC with Cognizance Technologies and Nitya LLC, under the Scientific Support Service IDIQ).

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FDA Sentinel is the flagship post-market drug surveillance program. Sentinel 3.0 is being bought in pieces: a draft RFP for the Data Broker contract covering Tiers 1-6 (previously 1-5) is out under notice 75F40126SSN00101, the original market research (75F40126SSN00100) says FDA revised the operational framework, and the Studies-as-a-Service scientific support task went to Vets Synergetic Group as an 8(a) order in March 2026. NAICS 518210. The GOCO platform and scientific support tiers have no final RFP date I can confirm. Sentinel 3.0 scopes eight tiers in all: data broker services (1 to 6), a GOCO platform (Tier 7) and scientific support (Tier 8), reported as a multi-award IDIQ around $304M to $310M. Leadership settled on September 9, 2026: CDER, CBER and CTP have permanent directors, and a new Deputy Commissioner for Technology and Artificial Intelligence is the front door for IT and AI work that used to route through an Acting CIO. The Commissioner is still Acting, and the October 7, 2026 profiles page lists no CIO at all; Sanjay Sahoo is Acting Director of the Office of Mission Information Technology Services on the October 13, 2026 overview org chart.

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