Biopharmaceutics Classification System (BCS) / Automated Solubility Apparatus

The FDA's Center for Drug Evaluation and Research (CDER) is conducting market research to identify providers of a Biopharmaceutics Classification System (BCS) / Automated Solubility Apparatus, with capability statements due by July 16, 2026. This is a three-tiered sources-sought effort structured to evaluate domestic and small-business capacity independently.

Delivery location is the FDA/CDER facility at 10903 New Hampshire Avenue, Silver Spring, Maryland. The apparatus must maintain sample container temperature at 37°C, support adjustable stirring speed for thick samples, enable simultaneous multi-sample operation with time-point sample withdrawal capability, and include filtering or centrifuge capability. Desired features include automated dilution, pH monitoring, and direct HPLC connection. Part One seeks any provider offering Made in America products; Part Two targets small businesses under NAICS 334516 (Analytical Laboratory Instrument Manufacturing) with a size standard of 1,000 employees manufacturing in America; Part Three welcomes all providers with products made outside America.

The system must be newly manufactured, latest model, with one-year warranty covering parts and labor. Delivery includes installation, on-site training for at least six scientists, performance testing, network computer support, and all shipping and crating costs covered by the provider. Respondents must submit proposed product information, capability statement indicating Made in America status, business name, SAM Unique Entity ID, NAICS small business program representations, and country of origin if applicable. Responses are due by email to Howard.Nesmith@fda.hhs.gov by 1:00 PM Central Time. This market research does not obligate the Government to award a contract, and responses will not constitute adequate responses to any subsequent solicitation.