Sources Sought 134171 cns organoid analysis.docx

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA) is conducting market research to support the National Center for Toxicological Research (NCTR), requirement for CNS Organoid Neuropharmacological Analysis.

The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required supplies. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The associated North American Industry Classification System (NAICS) Code is- 541380 - Testing Laboratories and Services; the applicable Small Business Size Standard is $19 million.

Statement of Work: CNS Organoid Neuropharmacological Analysis

Background The U.S. Food and Drug Administration’s (FDA) National Center for Toxicological Research (NCTR), Jefferson, AR requires functional examination of neuromodulatory effects of a drug and related transcriptomic changes in human Central Nervous System (CNS)-3D brain organoids. Specifically, the CNS-3D human brain organoid testing includes (1) characterizing acute and chronic neuromodulatory effects of a marketed small molecule drug in human CNS-3D brain organoids, including spontaneous Ca2+ burst and induced variability in Ca2+ burst timing; (2) characterizing the role of the 5-HT5A receptor in drug-induced effects in human CNS-3D brain organoids using co-treatment with the 5-HT5A receptor inhibitor SB-699551; and (3) evaluating transcriptional changes induced by chronic exposure to the drug in human CNS-3D brain organoids. This work is in coordination with FDA review teams and directly supports patient safety, regulatory product center review work, and the Food, Drug and Cosmetics Act.

Objectives The objectives of the lab analysis service are:

Characterizing acute and chronic neuromodulatory effects of a marketed small molecule drug (drug cost up to $1000) in human CNS-3D brain organoids, including spontaneous Ca2+ burst and induced variability in Ca2+ burst timing.

Characterizing the role of the 5-HT5A receptor in drug-induced effects in human CNS-3D brain organoids using co-treatment with the 5-HT5A receptor inhibitor SB-699551.

Evaluating transcriptional changes induced by chronic exposure to the drug in human CNS-3D brain organoids.

Scope Reports will be delivered for the functional examination of neuromodulatory effects of a marketed small molecule drug and related transcriptomic changes in human CNS-3D brain organoids. Data shall be provided electronically, including study design, experimental conditions, and results analyzed. This analysis will be conducted at the contractor lab, no installation/training is needed. This is also a one-time analysis; there are no option periods.

Tasks CNS-3D human brain organoid testing includes (1) characterizing acute and chronic neuromodulatory effects of a marketed small molecule drug in human CNS-3D brain organoids, including spontaneous Ca2+ burst and induced variability in Ca2+ burst timing; (2) characterizing the role of the 5-HT5A receptor in drug-induced effects in human CNS-3D brain organoids using co-treatment with the 5-HT5A receptor inhibitor SB-699551; and (3) evaluating transcriptional changes induced by chronic exposure to the drug in human CNS-3D brain organoids.

· Human iPSC-derived CNS-3D organoids at 10 weeks of differentiation will be treated with a drug (25 µM and 100 µM), serotonin (positive control) (25 µM and 100 µM), and DMSO (negative control) with or without a SB-699551 for 2 weeks. A total of 10 treatment groups shall be tested.

· Each treatment group shall have 32 organoids (n=32/group).

· The CNS-3D brain organoids shall be characterized and consistent with the organoids previously used in related FDA research. Use of 28Bio organoids is required in order to maintain continuity and comparability with prior research data. The organoids shall be comprised of serotonergic neurons and astrocytes and confirmed expression of 5-HT5A receptor. Expression profile of serotonin receptors and other GPCRs shall be available. The organoids shall exhibit spontaneous and coordinated neuronal network activity such as spontaneous Ca2+ bursts, which can be captured in real-time with FLIPR analysis.

· Ca2+ flux shall be measured longitudinally on Day 1 (pre-exposure, 30, 60, and 240 minutes post-exposure), Day 3 and Day 14, using the FLIPR Tetra® High-Throughput Cellular Screening System.

· Waveform analysis of Ca2+ flux data shall be performed for the features that describe the number (peak frequency), size (peak height), and shape (peak skew) of spontaneous calcium oscillations in each organoid, along with variability of the burst strength, burst timing, and the calcium influx rate.

· Viability shall be assessed by quantifying the amount of released lactate dehydrogenase (LDH) using the LDH-GloTM cytotoxicity assay at each media change on Day 1 (prior to exposure) and during chronic exposure on Days 3, 5, 7, 12 and 14.

· Transcriptomic analysis shall be conducted to evaluate differences between the treatment groups after chronic exposure for 2 weeks. The analysis can be done for pooled organoids (8 organoids/pool, n = 4 pools/group).

· Transcriptomic analysis shall be performed using RNA sequencing techniques (RNAseq). Data analysis shall be performed to find differential expression of genes (DEG), and gene ontology (GO) analysis shall be conducted to find pathways associate with chronic drug treatment.

· Statistical analyses shall be performed for each treatment time point and dose group.

· Results shall be comparable with our preliminary data.

· Data provided shall include study design, experimental conditions, and results.

· All data shall be provided to NCTR via email or an internet site for downloading. The service company does not own the data (i.e., intellectual property). NCTR/FDA is the owner of the data.

Delivery Delivery address: to be completed at time of award.

Deliverable Schedule

Government review

One week

Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) No government-furnished property, material, equipment, or information will be provided in the scope of this acquisition.

Security Security requirements are not applicable to this contract.

Travel Travel is not applicable to this contract.

Special Material Requirements The contract shall buy the test article (drug) as specified by the government.

Other Unique Requirements Data Deliverables and Use of Information The Contractor shall provide all deliverable data generated under this contract in electronic format, including study design, experimental conditions, raw data, analyzed results, statistical analyses, and final study reports, as required by the contract.

Data and information provided by the Government to the Contractor, or generated by the Contractor in performance of this contract, shall be used only for purposes of performing this contract and shall not be released, disclosed, or used for any other purpose except as authorized in writing by the Contracting Officer or as otherwise required by law.

The Government’s rights in delivered data shall be governed by the contract clause or clauses included in the contract.

Publication and Disclosure Restriction The Contractor shall not publish, present, or otherwise publicly disclose nonpublic information, data, or results generated under or provided in connection with this contract without prior written approval from the Contracting Officer, except as otherwise required by law.

Place of Performance Performance will be at the Contractor’s facility.

Period of Performance The period of performance will be from 8/1/2026-3/31/2027.

Anticipated Contract Type: Firm Fixed Price

Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements.

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:

· Business name, SAM Unique Entity ID number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm);

· Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, ISO certifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.

· Three (3) years of past performance information, where the respondent has provided same or substantially similar product/service solutions on the same or near-same requirements. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include SAM Unique Entity ID number and size status) if not the respondent.

· If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.

· If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

· Identification of AbilityOne Contracts available that can meet the requirement.

· Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC).

· Provide information if any of these specifications are too restrictive. Failure to provide information indicating that the listed specifications are too restrictive will be interpreted as confirmation that the specifications are adequate for a competitive environment.

· If a large business, identify the subcontracting opportunities that would exist for small business concerns;

· Standard commercial warranty and payment terms;

· Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the place of performance. Provide (1) the place of performance for the services that process Americans’ organoid data samples, genome or exome data, RNA/DNA (stored or transmitted electronically), to include a specification of whether that processing will occur through or in any foreign country or entity, (2) whether the samples, genome or exome, DNA/RNA will be provided to any other country or entity, or (3) whether any information technology capabilities used to receive, process, or respond to this contract, to include but not limited to servers, data storage, cloud storage, or analytics tools, are located in any foreign country or entity; and

· Though this is not a request for quote, informational pricing is required

The government is not responsible for locating or securing any information, not identified in the response.

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before May 4, 2026 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference NCTR-2026-134171.

Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Responses with weblinks will not be opened or viewed.

Responses must demonstrate capability, not merely affirm the respondent's capability (i.e. the response must go beyond the statement that, "XYZ company can provide the instrument, technical support etc.").

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).