Rapid Assessment Machine Learning Software for PMTA and SE regulatory revie

Past New Requirement Updated

Agency
Solicitation expected
Estimated value
$25,000 to $250,000
Set-aside
No set-aside

Forecast facts

Anticipated award
NAICS code
511210 Software Publishers
Points of contact

Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.

About this forecast

The Food and Drug Administration is forecasting a new requirement for Rapid Assessment Machine Learning Software designed to support PMTA (Premarket Tobacco Application) and SE (Substantial Equivalence) regulatory reviews. This software procurement is intended to streamline and enhance the agency's ability to process and evaluate regulatory submissions through advanced machine learning capabilities. The estimated solicitation release date is December 1, 2025, with an anticipated award date of February 1, 2026.

The contract award value is estimated between $25,000 and $250,000, with no set-aside restrictions applied to this opportunity. This requirement falls under NAICS code 511210 (Software Publishers) and is being administered by the FDA's Center for Tobacco Products Acquisitions office. For further information regarding this forecasted opportunity, interested parties should direct inquiries to ctpacquisitions@fda.hhs.gov.

Forecast text

Rapid Assessment Machine Learning Software for PMTA and SE regulatory reviews

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