CNS Organoid Neuropharmacological Analysis

Form / Attachment / Pricing Sheet

This document is the Contractor's Commitment to Protect Non-Public Information (NPI) Agreement. It is required for individuals who will access Non-Public Information (NPI) from the Food and Drug Administration (FDA) files in performance of their duties under Solicitation Number 75F40126Q134171.

• Requires the contractor's employee to agree not to release, publish, or disclose NPI.
• Mandates protection of NPI in accordance with specific U.S. Code and other applicable provisions.
• Outlines specific agreements for handling NPI, including secure storage, access control, return of NPI upon contract completion or request, and reporting of unauthorized access incidents.
• Acknowledges understanding of legal provisions and potential criminal penalties for violations.
• Includes signature, printed name, and witness fields for completion.

Bidders must ensure their personnel understand and agree to this NPI agreement if they are to be involved in work requiring access to FDA's non-public information. This form is a mandatory requirement for personnel handling sensitive data under the contract.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial products or services, issued as a Request for Quote (RFQ) for CNS Organoid Neuropharmacological Analysis. The U.S. Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR) requires functional examination of neuromodulatory effects of a drug and related transcriptomic changes in human Central Nervous System (CNS)-3D brain organoids. This acquisition is not set-aside for small business concerns. The FDA intends to award a sole-source, firm-fixed-price purchase order to 28Bio.

• Characterize acute and chronic neuromodulatory effects of a marketed small molecule drug (cost up to $1,000) in human CNS-3D brain organoids, including spontaneous Ca2+ burst and induced variability.

• Characterize the role of the 5-HT5A receptor in drug-induced effects using co-treatment with the 5-HT5A receptor inhibitor SB-699551.

• Evaluate transcriptional changes induced by chronic exposure to the drug.

• Deliverables include study design, experimental conditions, raw data, analyzed results, statistical analyses, and final study reports in electronic format.

• The contractor will buy the test article (drug) as specified by the government.

• Contract Type: Commercial Item-Firm Fixed Price.

• Period of Performance: Estimated from 8/1/2026 - 4/30/2027.

• Place of Performance: Contractor's facility.

• FOB Point: Destination.

• Offers are due by email to nick.sartain@fda.hhs.gov on or before July 6, 2026, by 1:00 P.M. (Central Time).

• Evaluation will be based on Technical Capability/Risk, Past Performance, and Price. Technical Capability/Risk and Past Performance are considered more important than price.

• Offerors must submit a written Accessibility Conformance Report (ACR) for each item not in compliance with 508 standards.

• This acquisition is not set-aside for small business concerns.

• NAICS Code: 541380 - Testing Laboratories and Services; Small Business Size Standard: $19 million.

• The solicitation number is 75F40126Q134171.

• The full text of provisions and clauses may be accessed electronically.

• Contractor must submit signed FDA form 3398 with quote submission.

• No advance payments will be made. Payment terms are Net 30 days after government acceptance.

• All electronic documents must be submitted without the use of macros.