Chip-S1 Basic Research Kits, Compound Distribution Kits, and MPS Consumables

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, through its Office of Translational Sciences and Division of Applied Regulatory Science, is conducting market research via a Request for Information to identify qualified vendors capable of supplying Chip-S1 Basic Research Kits, Compound Distribution Kits, and other Microphysiological Systems consumables. This RFI, identified as FDA-CDER-OTS-26-RFI-A430 and posted on May 29, 2026, is strictly for planning and market research and does not constitute a solicitation or commitment to award a contract. Responses must be submitted electronically to [email hidden] no later than June 12, 2026, at 10:00 AM ET, with the subject line clearly formatted to include the RFI number and company name. The requested supplies are intended to support advanced scientific research, including studies on bronchopulmonary disposition of anti-infective drugs and drug transfer into human milk using blood-milk barrier models, with comparisons to clinical data from the InfantRisk Human Milk Biorepository. All MPS chips must be compatible with Emulate’s Zoë Culture Module to enable continuous fluidic flow, and the Chip-S1 Basic Research Kits must include specific components such as the Chip-S1 Stretchable Chip, Pod Portable Module, eight Steriflip filters, and ER-1/ER-2 activation reagents. All consumables must be sterilized prior to final packaging and undergo a functional quality control test prior to release, with step-by-step usage instructions required for each kit. Vendors are expected to provide detailed information regarding their capacity to meet supply demands over a five-year period, including surge or urgent order capabilities, standard lead times, and coordination procedures with the FDA Project Lead prior to any shipment—deliveries without prior authorization will not be accepted. Companies must submit their company name, address, Unique Entity Identifier, CAGE code, business size, socioeconomic status, and any existing contract vehicles such as GSA Schedules. Quality management systems and certifications, including ISO 13485 or ISO 9001, must be summarized, and manufacturing facility locations must be disclosed. Pricing submissions should reflect rough order of magnitude estimates only, without firm-fixed prices or CLIN structures. Responses are limited to ten pages and must be submitted as PDF or Microsoft Word documents. Respondents should note that the FDA will not reimburse costs incurred in preparing submissions and cannot guarantee the confidentiality of