Biopharmaceutics Classification System (BCS) / Automated Solubility Apparatus

The FDA’s Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality is issuing a sources‑sought notice (Solicitation 75F40126SS131706) to identify vendors capable of supplying a new, commercially available Biopharmaceutics Classification System (BCS) automated solubility apparatus. The system must be a latest‑model, never‑used electro‑mechanical dynamic load frame that supports high‑throughput solubility testing—including 37 °C sample bath, programmable stirring, multiple simultaneous sample containers, inline filtration or centrifuge sampling, dilution, pH monitoring, and direct HPLC integration—for BCS‑based biowaiver determinations. Required deliverables include cradle‑to‑site delivery, installation, on‑site performance testing, and training for at least six FDA scientists, all supported by a minimum one‑year parts‑and‑labor warranty and full coverage of crating, shipping, and delivery costs. The apparatus must comply with Made‑in‑America requirements under Executive Order 14005, and respondents must provide a capability statement, detailed product description, descriptive literature, and complete business information (DUNS, UEI, NAICS 334516, size status, etc.). Responses are due by 16 July 2026, 13:00 EST, via email to Howard.Nesmith@fda.hhs.gov. Required sections include Proposed Product Information, Made‑in‑America Capability Statement, Business and Contact Information, and supporting literature; optional sections cover GSA contract details, subcontracting opportunities for small businesses, and informational pricing. The place of performance is the FDA facility in Silver Spring, MD (20993). This notice does not obligate a contract but will be used to shape a future solicitation.

Notice ID

ee77d70a51e1433289e458799397318d

Solicitation Number

75F40126SS131706

NAICS Code

334516

Classification Code

6640