Federal Register #FDA-2026-N-4390

HHS Seeks Input on FDA AI Clinical Trials Pilot and Extends ACF Employment Research

The U.S. Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA) and the Administration for Children and Families (ACF), is seeking stakeholder input and extending research initiatives: - FDA is requesting information for a pilot program to evaluate artificial intelligence (AI)-enabled technologies in early-phase clinical trials - Focus areas: improving trial efficiency, safety monitoring, dose selection, and decision-making quality - Program will align with the National Institute of Standards and Technology (NIST) AI Risk Management Framework (AI RMF) - No specific OEMs, vendors, or products are being procured at this stage - Stakeholder feedback is sought on pilot design, participant selection, collaboration models, operational structure, evaluation metrics, and criteria for success - Emphasis on trustworthy AI systems and industry alignment - ACF's Office of Planning, Research, and Evaluation is extending data collection for the Next Generation of Enhanced Employment Strategies Project - One-year extension for follow-up survey data collection on employment outcomes for individuals with disabilities - 160 data collection activities planned - Key government buyers: - Food and Drug Administration (FDA) - Administration for Children and Families (ACF), Office of Planning, Research, and Evaluation - No product or service procurement is currently planned for the FDA pilot; ACF is extending a research data collection effort - Notable requirements: - For FDA: Input on AI pilot program structure, metrics, and collaboration models - For ACF: Continued data collection for impact study on employment and well-being outcomes

Description

The Food and Drug Administration (FDA) is requesting information on a proposed pilot program to evaluate how artificial intelligence (AI)-enabled technologies can enhance efficiency, speed, and decision-making quality in early-phase clinical trials. These trials often face challenges such as high uncertainty, limited patient populations, and inefficient decision processes. The pilot aims to explore AI's potential to improve trial efficiency, safety monitoring, dose selection, and early regulatory decisions while adhering to FDA's scientific and regulatory standards and promoting trustworthy AI systems. The program will be guided by principles aligned with the National Institute of Standards and Technology (NIST) AI Risk Management Framework.

View original listing