The Food and Drug Administration, Office of Cosmetics and Colors, announced a sole-source intent to negotiate exclusively with Simulations Plus Inc. for ADMET Predictor Software and related services, with a capability statement deadline of July 23, 2026 at 5:00 PM EST. This is a Notice of Intent, not a solicitation; the Government will conduct the acquisition under FAR Part 12 (commercial acquisition), and no solicitation package is available. Any responsible source believing it can meet requirements may submit a capability statement to raja.seshadri@hhs.gov, though the determination to proceed without competition remains solely at Government discretion.

The software provides a one-year license with eight integrated modules—HTPK Simulation, ADMET Modeler, Metabolism & Transporter, Physicochemical & Biopharmaceutical, Toxicity, Chemistry, MedChem Studio, and REST API—enabling the FDA to screen cosmetic ingredients, develop in-house structure-activity relationship models, and support safety assessments using artificial intelligence and machine learning to estimate absorption, distribution, metabolism, excretion, and toxicity properties of chemicals. The Government determined Simulations Plus is the sole source capable of providing the software, maintenance, updates, installation assistance, and technical support without substantial cost duplication, operational disruption, or compatibility concerns. The period of performance includes one 12-month base period (July 31, 2026 through July 30, 2027) and four optional 12-month renewal periods extending through July 30, 2031.

Sole Source Announcement - ADMET Software for Cosmetic Chemical Safety Assessment Support Package

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