Notice of Intent to Sole Source_CDRH-2024-122548.pdf

Notice of Intent to Sole Source

The U.S. Food & Drug Administration (FDA) intends to issue a sole-source commercial product purchase order to FUJIFILM CELLULAR DYNAMICS, INC located at 465 SCIENCE DR, MADISON, WI 53711-1000.

An award is anticipated to be made using Simplified Acquisition Procedures and under the authority of Federal Acquisition Regulation (FAR) Part 13.106-1(b)(1)(i) wherein the circumstances of the proposed contract action deem only one source reasonably available.

The FDA Office of Science and Engineering Laboratories (OSEL), Division of Biomedical Physics (DBP) has an active and important research program in Induced Pluripotent Stem Cell and Electrophysiology (iPSC&EP) that utilizes large quantities of human induced pluripotent stem cell-derived cardiomyocytes, neurons, astrocytes and hepatocytes. The cells are used across multiple program areas and linked to key program deliverables that OSEL is currently pursuing in its efforts to advance regulatory science. The experiments conducted support regulatory research projects on the development of in vitro nonclinical tools for medical device safety and efficacy assessment.

FUJIFILM CELLULAR DYNAMICS, INC has been determined to be the only reasonable available source due to providing a proprietary iPSC line that has been verified and validated by FDA. Moreover, the intended awardee has a proprietary cardiac, neuronal, and glial (i.e., astrocyte) differentiation process/methodology. Switching to a different iPSC line, would make all previous FDA research data obsolete and would result in significantly delayed project timelines; additionally, investments and research with iPSCs delivered under previous contracts would become unusable.

This notice is not a request for competitive quotations. However, any party that believes it can meet this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement.

Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed award based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to FUJIFILM CELLULAR DYNAMICS, INC within approximately fifteen

(15) days after the response date of this notice unless the Government determines that any other organization has the capability to meet this requirement.

Response Date: 03/28/2024 at 10:00 a.m. ET. Please email responses to Contracting Officer Benjamin Dorgan at benjamin.dorgan@fda.hhs.gov. No phone calls will be accepted.

mailto:benjamin.dorgan@fda.hhs.gov