Notice of Intent to Sole Source
ID: FDA-1284766Type: Special Notice
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFWashington, DC, 20201, US

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

PSC

GENERAL SCIENCE AND TECHNOLOGY R&D SERVICES; GENERAL SCIENCE AND TECHNOLOGY; APPLIED RESEARCH (AJ12)

Set Aside

No Set aside used (NONE)

Original Source

https://sam.gov/opp/2d472891df0849d8a95445c03c94ee7d/view
Timeline
    Description

    The Department of Health and Human Services, specifically the FDA, intends to award a Sole Source Firm Fixed Price contract to Fujifilm Irvine Scientific, Inc. for the procurement of Human Induced Pluripotent Stem Cell-Derived (hiPSC) cells. The objective of this contract is to acquire specific types of hiPSC cells, including cardiomyocytes, neurons, astrocytes, and hepatocytes, which are essential for supporting research on microphysiological systems (MPS) crucial for drug safety and efficacy evaluations. This procurement underscores the FDA's commitment to enhancing drug evaluation processes through innovative biological models, with a contract period of one year from the award date. Interested parties who believe they can meet the requirements are invited to submit capability statements by June 16, 2025, to the primary contact, Rodney D. Aytch, at rodney.aytch@fda.hhs.gov.

    Point(s) of Contact
    Rodney D. Aytch
    (240) 402-7514
    rodney.aytch@fda.hhs.gov
    Files
    Title
    Posted
    Solicitation - Notice of Intent to SS.pdf
    The FDA plans to award a Sole Source Firm Fixed Price contract to Fujifilm Irvine Scientific, Inc. for the purchase of human induced pluripotent stem (hiPSC) cells, as outlined in the notice dated June 5, 2025. The contract is justified under FAR Part 6.302-1, indicating that only one supplier can fulfill the agency's requirements. The notice serves to inform the public of the intended award while outlining minimum requirements, which can be found in the attached Statement of Work. Although this notice is not a call for competitive proposals, parties believing they can meet the requirements are invited to submit capability statements by June 16, 2025. The government retains the discretion to award the contract to another organization if capable proposals are submitted. The expected decision will occur roughly ten days after the notice. Interested parties should direct their submissions to the designated contract specialist, Rodney D. Aytch, via the provided email.
    SOW_042825.doc
    The U.S. Food and Drug Administration (FDA) seeks to procure Human Induced Pluripotent Stem Cell-Derived (hiPSC) cells to support research on microphysiological systems (MPS), which are crucial for evaluating drug safety and efficacy. The contract outlines the need for specific types of hiPSC cells, including cardiomyocytes, neurons, astrocytes, and hepatocytes, with stringent quality control measures required from the vendor. Each cell type must meet minimum viability and purity standards, and the products must come with adequate handling guidelines and enough culture medium for maintenance. Deliverables include a variety of kits and supplements, all to be shipped frozen to the FDA in Silver Spring, MD, with coordination required for delivery. The contract period spans one year from the award date, emphasizing comprehensive inspection and acceptance criteria to ensure quality and compliance with FDA standards. This procurement reflects the FDA's commitment to advancing drug evaluation processes using innovative biological models.
    Lifecycle
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    Notice of Intent to Sole Source
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