Rapid Assessment Machine Learning Software for PMTA and SE regulatory revie

The Food and Drug Administration is forecasting a procurement for machine learning software designed to accelerate the assessment of Premarket Tobacco Product Applications and Substantial Equivalence submissions. The initiative aims to leverage advanced artificial intelligence to improve the efficiency and consistency of regulatory reviews, reducing manual analysis time while maintaining rigorous scientific standards. The project will focus on developing or procuring a software system capable of processing complex regulatory data, identifying patterns, and generating actionable insights for FDA reviewers, with the ultimate goal of streamlining pathways for tobacco product evaluation. The contract opportunity is categorized under NAICS code 511210, indicating it pertains to software publishing and related services. The point of contact for program inquiries is the CTP Acquisition Liaison, reachable via ctpacquisitions@fda.hhs.gov, while the contracting officer position is currently undetermined. The anticipated work will be performed without specified geographic constraints, and the opportunity is open to all potential vendors regardless of set-aside status. Interested parties are encouraged to monitor the official HHS OSDBU portal for future solicitation updates, as no formal request for proposal has yet been issued and the posting remains a forecast of future intent.