ODIG-FDA Enterprise Data Support Operations Support

The ODIG-FDA Enterprise Data Support Operations Support contract is a forecast opportunity with the Food and Drug Administration designed to provide agencywide data quality operations. The primary objective is to implement human-in-the-loop validation to ensure regulatory-grade accuracy, consistency, and compliance across the agency's AI-enabled systems. By integrating human expertise, the program aims to mitigate automation bias, address complex edge cases, and maintain the scientific integrity necessary for critical regulatory decisions. This initiative directly supports CDER user fee commitments by enhancing review efficiency and accelerating decision timelines. The framework ensures that AI tools serve to augment rather than replace expert judgment, thereby preserving accountability and transparency. Ultimately, the contract focuses on establishing reliable AI analytics to maintain public trust in the FDA's regulatory processes.