RFI_Research Kits.pdf

Request for Information (RFI) Procurement of Chip-S1 Basic Research Kits, Compound Distribution Kits, and MPS Consumables RFI Number: FDA-CDER-OTS-26-RFI-A430 Issue Date: May 29, 2026 Response Due Date: June 12, 2026

1. Purpose

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP), Division of Applied Regulatory Science (DARS), is issuing this Request for Information (RFI) for market research purposes to identify qualified vendors capable of supplying Chip-S1 Basic Research Kits, Compound Distribution Kits, and other Microphysiological Systems (MPS) consumables.

This RFI is issued for planning and market research purposes only and does not constitute a solicitation or a commitment to award a contract.

2. Background DARS is conducting research to evaluate the utility of microphysiological systems (MPS) in assessing:

• Bronchopulmonary disposition of anti-infective drugs, including drug penetration into alveolar epithelial lining fluid (ELF)

• Drug transfer into human milk , using blood–milk barrier models, with comparisons to clinical data including the InfantRisk Human Milk Biorepository (HMB)

MPS barrier models integrate epithelial and endothelial cells with dynamic fluid flow to more accurately replicate the cellular microenvironment than traditional in vitro models. Findings from this research are intended to support model qualification and validation, optimize study design, and facilitate integration of advanced in vitro models into drug development programs.

3. Description of Required Items The FDA is seeking information on the availability, pricing, and delivery capabilities for the following items:

# Item Description Catalog Number Type

1 AVA Emulation System

AVA-ES1 Hardware

2 Basic Research Chip Kit – 12 PK

BRK-WER-12 Consumable

3 Chip-A1 Basic Research Kit – 12

PK

BRK-A1-WER-12 Consumable

4 Chip-Array Basic Research Kit – 96 Emulation Pack

BRK-CA-96 Consumable

5 Chip Cradle Replacement Kit

CHIP-CRD Consumable

6 Chip-R1 Basic Research Kit – 12

PK

BRK-R1-12 Consumable

7 Colon Intestine- Chip Co-Culture Kit – 12 PK

BIO-CH3-12 Consumable

8 Compound Distribution Kit

CDK-001 Consumable

9 Duodenum Intestine-Chip Co- Culture Kit – 12 PK

BIO-DH1-CO12 Consumable

10 ER1, 5mL Bottle ER-105 Consumable

11 ER2, 25mL Bottle ER-225 Consumable

12 Fixed Chip Imaging Adapter Kit

CHIP-IMG Consumable

13 Kidney Proximal Tube-Chip Co- Culture Kit – 12 PK

BIO-KH-CO12 Consumable

14 Liver-Chip Quad- Culture Kit – 12 PK

BIO-LH-QUAD12 Consumable

15 Orb Hub Module 1 ORB-HM1 Hardware

16 Pod Imaging Adapter Kit

POD-IMG Consumable

17 Zoë Culture Module 2

ZOE-CM2 Hardware

Key Technical Requirements

• All MPS chips must be compatible with Emulate's Zoë Culture Module to enable continuous fluidic flow control

• Chip-S1 Basic Research Kits (BRK-S1-WER-24) must include the Chip-S1 Stretchable Chip and accompanying Pod Portable Module

• Each kit must include 8 Steriflip filters and ER-1/ER-2 Chip Activation Reagents

• All consumables must be sterilized prior to final packaging

• A functional QC test must be completed before chip release

• Step-by-step instructions for use must be included

4. Information Requested from Vendors Respondents are asked to provide the following:

1. Company Information

• Company name, address, Unique Entity Identifier (UEI), and CAGE code

• Business size and socioeconomic status (e.g., small business, WOSB, SDVOSB)

• GSA Schedule or other existing contract vehicles, if applicable

2. Capability Statement

• Description of experience manufacturing or distributing MPS chips, organ-on-a-chip systems, or comparable life science consumables

• Summary of quality management systems and relevant certifications (e.g., ISO 13485, ISO 9001)

• Demonstrated track record of quality manufacturing and customer service

3. Product Information

• Confirmation of ability to supply the items listed in Section 3, including catalog numbers

• Availability of equivalent or alternative products, if applicable

• Product datasheets, specifications, or catalog documentation

• Provide manufacturing location

4. Pricing Information(rough order of magnitude only)

• Estimated unit pricing per item

• Volume discount structures, if available

• Pricing under existing contract vehicles (e.g., GSA Schedule)

5. Delivery Capabilities

• Standard lead times per item category

• Ability to coordinate delivery scheduling with the FDA Project Lead prior to shipment

• Capacity to provide shipment tracking notifications via email

• Ability to meet surge or urgent order requirements over a five (5)-year period

5. Delivery Information All items shall be delivered to:

• All deliveries must be coordinated with the Project Lead prior to shipment

• No deliveries will be accepted without prior authorization

• Vendors must provide email notification with tracking information upon shipment

6. Instructions for Response

• Submission Deadline: June 12, 2026, 10:00 AM ET

• Submission Method: Email responses to Cynthia.Martin@fda.hhs.gov with subject line: "RFI

Response – FDA-CDER-OTS-26-RFI-A430 – [Company Name]"

• Page Limit: Responses should not exceed 10 pages

• Format: PDF or Microsoft Word preferred

7. Disclaimers

• This RFI is issued solely for market research and planning purposes.

• The FDA is not obligated to issue a solicitation or award a contract as a result of this RFI.

• Responses will not be returned and will not be considered proposals or quotations.

• No reimbursement will be made for costs incurred in responding to this RFI.

• Proprietary or confidential information should be clearly marked; however, the FDA cannot guarantee confidentiality of submitted information.

8. Questions All questions regarding this RFI should be directed to:

Cynthia Martin, Contracting Officer Cynthia.Martin@fda.hhs.gov