FDA Notice of Intent to Award a Sole Source and related RFQ: Human induced pluripotent stem cell-derived Macrophages (hiPSC-MACs)

NOTICE OF INTENT TO AWARD A SOLE SOURCE (and associated RFQ/Sol for the sole source procurement): The U.S. Food and Drug Administration (FDA)/National Center for Toxicological Research (NCTR) intends to award a sole source, firm fixed price purchase order to Fujifilm Cellular Dynamics, Inc., 465 Science Dr, Madison, WI 53711-1000, under the authority of FAR 13.106-1(b)(1).

The FDA/NCTR, Division of Systems Biology (DSB) has an approved scientific study (S00913) requiring the use of Human induced pluripotent stem cell-derived macrophages (hiPSC-MACs). The macrophages must be from the lot number previously used for this study (lot# 106775). Background Human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) are an important tool used in drug development for the evaluation of cardiotoxicity.

These cells, however, lack the ability to mimic in vivo cellular changes in response to inflammation or infection, which is important in the study of infection-/inflammation-induced myocyte injury. Recently, a co-culture model of hiPSC-CMs and hiPSC-MACs was employed to mimic Covid-19-induced myocyte injury. To further characterize the model for immune-cardiotoxicity assessment, the Division of Systems Biology at NCTR aims to setup and refine the model at NCTR.

The work and information gathered under this study will be critical in determining the feasibility of using the model in the future in the context of regulatory use, such as predictive toxicology studies for assessing the potential immune-cardiotoxicity of candidate drugs. product ingredients, impurities, homogenates/extracts of foods, etc., particularly human-specific biological products for which animals are not good model systems.

In order to move forward with this study and maintain consistency in the study, the Division of Systems Biology requires the purchase of macrophages from the same lot (Lot # 106775) as were used for the initial study. This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(1) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole source contract and is not a request for competitive proposals.

The statutory authority for this sole-source procurement is FAR 13.106-1(b)(1). This notice of intent is not a request for competitive proposals. Responsible sources who believe they may submit a capability statement to Suzanne Martella at suzanne.martella@fda.hhs.gov on or before March 25, 2024 at 10:00 am Central Time (CT). A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.

Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No phone calls will be accepted. See attached solicitation for this procurement for the sole source items. J&A will be posted separately.