ODIG-FDA Enterprise Data Support Operations Support
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $13,000,000 to $20,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- Not on record
- Points of contact
-
- OC Acquisition Liaison oacquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is procuring enterprise data support operations and validation services to support an agencywide data quality operations program with human-in-the-loop validation across FDA's AI-enabled systems, with estimated solicitation release on 2026-05-01 and estimated award on 2026-11-01. The contract will ensure regulatory-grade data accuracy, consistency, and compliance by preventing automation bias, identifying edge cases that AI may miss, and maintaining scientific integrity required for regulatory decisions; this work directly supports CDER user fee commitments by improving review efficiency, accelerating time-to-decision, and preserving expert judgment alongside AI tools.
The estimated award value ranges from $13 million to $20 million. Inquiries should be directed to oacquisitions@fda.hhs.gov.
Forecast text
Contract is provide support for agencywide data quality operations program with humans in the loop, this is essential to ensure regulatory-grade data accuracy, consistency, and compliance across FDA's AI-enabled systems. Human-in-the-loop validation prevents automation bias, catches edge cases AI may miss, and maintains scientific integrity required for regulatory decisions. This directly supports CDER user fee commitments by improving review efficiency, accelerating time-to-decision, and ensuring AI tools augment-not replace-expert judgment. Quality data enables reliable AI analytics while preserving accountability, transparency, and public trust in FDA's regulatory processes.
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