Notice of Intent to Sole Source - FDA_2272025
ID: FDA_2272025Type: Special Notice
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONRockville, MD, 20841, US

NAICS

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

PSC

GENERAL SCIENCE AND TECHNOLOGY R&D SERVICES; GENERAL SCIENCE AND TECHNOLOGY; BASIC RESEARCH (AJ11)

Set Aside

Total Small Business Set-Aside (FAR 19.5) (SBA)

Original Source

https://sam.gov/opp/59c5885c2cc446e780122994d6ad781b/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), intends to issue a Sole Source Firm Fixed Price contract for the procurement of two Emulate Zoe CM1 Organ-On-A-Chip culture modules and one Orb Hub Module-1. This procurement aims to evaluate microphysiological systems (MPS) as alternatives to traditional in-vitro models in pharmacokinetic and toxicology studies, which are crucial for advancing FDA's scientific operations and regulatory practices. The selected modules will support the FDA's Division of Applied Regulatory Science (DARS) and must be delivered and installed within 12 months post-award at the FDA’s White Oak Campus in Silver Spring, Maryland. Interested suppliers who believe they can meet the requirements outlined in the Statement of Work are invited to submit capability statements by March 7, 2025, to Hilda Aryeh at hilda.aryeh@fda.hhs.gov.

    Point(s) of Contact
    HILDA ARYEH
    hilda.aryeh@fda.hhs.gov
    Files
    Title
    Posted
    INTENT TO SOLE SOURCE .pdf
    The Food and Drug Administration (FDA) plans to issue a Sole Source Firm Fixed Price contract to Emulate Bio, located in Boston, Massachusetts, based on the determination that only one source can meet the agency's requirements as specified in FAR Part 6.302-1(a)(2)(ii). This notice serves to inform the public and invites potential other suppliers to submit capability statements if they believe they can fulfill the requirements identified in the attached Statement of Work. Responses must be submitted by March 7, 2025, to the designated FDA contact. The government will decide whether to proceed with the proposed contract based on these submissions and expects to award the contract to Emulate Bio within ten days of the notice unless another organization demonstrates adequate capabilities. This announcement underscores the FDA's procurement process within the context of government RFPs, emphasizing the need for efficiency and specificity in contracting.
    SOW.pdf
    The document outlines a government request for procurement (RFP) regarding two Emulate Zoe CM1 Organ-On-A-Chip culture modules and one Orb Hub Module-1 for the FDA's Division of Applied Regulatory Science (DARS). The objective is to evaluate microphysiological systems (MPS) as alternatives to traditional in-vitro models in pharmacokinetic and toxicology studies. The Emulate devices are already on loan at FDA labs and are essential for maintaining cell cultures in a controlled environment. Key requirements include the capability to regulate media flow and maintain liquid interfaces within the MPS chips. The modules will support various FDA scientific operations and ensure adherence to the Center for Drug Evaluation and Research’s mission. Deliverables revolve around the purchase and installation of the equipment, with performance expected within 12 months post-award at the FDA’s White Oak Campus. Acceptance of the equipment will follow set specifications and quality assurance protocols to ensure functionality. This procurement emphasizes the FDA's commitment to advancing scientific research while enhancing regulatory practices.
    Lifecycle
    Title
    Type
    Notice of Intent to Sole Source - FDA_2272025
    Currently viewing
    Special Notice
    Similar Opportunities
    Facility Management System (FMS) Systems Administration and Data Management
    Buyer not available
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking qualified contractors to provide systems administration and data management services for its Facility Management System (FMS). The procurement involves a firm-fixed-price contract for the administration and management of the FMS, particularly the ARCHIBUS platform, which is crucial for efficient facility tracking and space management in compliance with federal guidelines. This total small business set-aside solicitation is set to commence on March 24, 2025, and will run for one year, with four optional renewal periods extending through 2030. Interested vendors should direct inquiries to Kimberly Pennix at kimberly.pennix@fda.hhs.gov, and must adhere to various federal regulations, including security clearance standards and confidentiality agreements.
    FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
    Buyer not available
    The Department of Health and Human Services, through the Food and Drug Administration (FDA), is seeking proposals for the FY25 Broad Agency Announcement (BAA) aimed at advancing research and development in regulatory science. This initiative focuses on enhancing the FDA's product regulation processes, with key research areas including alternative methods, advanced manufacturing techniques, and improved post-market surveillance. The opportunity is open to a diverse range of applicants, including small businesses and academic institutions, and emphasizes the importance of addressing public health challenges and engaging underserved populations. Interested parties must submit a concept paper by November 8, 2024, with the final proposal due by March 4, 2025. For further inquiries, contact Ian Weiss at Ian.Weiss@fda.hhs.gov or call 301-796-5728.
    PRIMO Software Licensing
    Buyer not available
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking qualified small businesses to provide PRIMO Software Licensing and Maintenance Support Services. The procurement involves supplying 21 PRIMO software licenses for a base year, with two additional option years, to ensure the continuous operation of the FDA's CFSAN CAEMS system. This software is crucial for pharmacovigilance and regulatory compliance, enhancing the FDA's capabilities in monitoring food safety. Interested parties must submit their quotes by August 26, 2024, and are encouraged to contact Roosevelt Walker at roosevelt.walker@fda.hhs.gov for further details. The contract will be awarded as a firm-fixed-price purchase order, emphasizing compliance with federal acquisition regulations and accessibility standards.
    Notice of Intent BD Rhapsody Single-Cell Analysis Reagent Kits
    Buyer not available
    Notice of Intent BD Rhapsody Single-Cell Analysis Reagent Kits The Department of Health and Human Services, Department of, National Institutes of Health, is planning to procure BD Rhapsody Single-Cell Analysis Reagent Kits. These kits are used for the manufacture of human cells and tissue-based products utilized in phase I/II clinical protocols for transplantation, adoptive immunotherapy, and gene therapy conducted in the Clinical Center at the NIH. The procurement includes a standing order for multi-type sequencing kits and reagents with a short shelf life. The contractor will be responsible for shipping the sufficient reagents and kits following the scheduled delivery dates. The shelf life of the sequencing reagents should be at least 3 months, and the shelf life of library generation kits should be at least 6 months. The contractor is also required to provide technical support for all kits and reagents at no additional cost. The period of performance for this procurement is from 5/1/2024 to 8/30/2024. The delivery schedule is overnight delivery Monday through Thursday to the Center for Cellular Engineering (CCE) at NIH/CC in Bethesda, MD. The vendor will be responsible for ensuring the safe transport of cryopreserved patient cells and maintaining the temperature and other parameters during the shipment of reagents and kits. The contractor will be paid per product delivered and is required to provide hard copies of proofs of each product delivered. Interested parties can submit their capabilities to the Office of Purchasing and Contracts by May 1st, 9:00 AM EST. Please note that this is not a request for proposal.
    NOTICE OF INTENT TO SOLE SOURCE: Stability Testing Services And Drug Master File Maintenance For Antibody Drug Conjugate ADCT-701
    Buyer not available
    The Department of Health and Human Services, specifically the National Institutes of Health, is issuing a notice of intent to sole source a contract for stability testing services and drug master file maintenance for ADCT-701, an antibody drug conjugate targeting neuroendocrine neoplasms. The procurement aims to ensure compliance with FDA regulations through stability studies and maintenance of associated Drug Master Files, with testing to be conducted at -70°C and results reported at specified intervals over a period of up to 60 months. This contract is critical for maintaining the integrity and safety of the drug product, with a firm fixed-price purchase order set to commence on April 17, 2025, and conclude by July 17, 2027. Interested parties may contact Miguel Diaz at miguel.diaz@nih.gov or call 240-276-5439 for further information.
    Ambr 250 High Throughput Bioreactor System
    Buyer not available
    The Department of Defense, through the Defense Health Agency (DHA) and the Army Medical Research Acquisition Activity, is seeking sources for the procurement of an Ambr 250 High Throughput Bioreactor System. This bioreactor is required to support up to 12 simultaneous cultures for both mammalian and microbial cells, with features such as automated aseptic processing, programmable control loops for pH and dissolved oxygen, and compliance with current Good Manufacturing Practices (cGMP) and 21 CFR Part 11 regulations. The system will enhance the capabilities of the Walter Reed Army Institute of Research's Pilot Bioproduction Facility for the production of monoclonal antibodies, aligning with the government's focus on advancing health technologies for military medical readiness. Interested parties should contact Brenda Mena at brenda.i.mena.civ@health.mil or Sharew Hailu at sharew.hailu.civ@health.mil for further details, with the performance period for the contract expected to run from June 2025 to May 2026.
    Preventive Maintenance Service for Thermo Orbitrap Fusion Lumos Mass Spectrometer System
    Buyer not available
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking preventive maintenance services for its Thermo Orbitrap Fusion Lumos mass spectrometer system, which is crucial for the Clinical Cancer Metabolism Facility's research activities. The contractor will be responsible for providing all necessary labor, materials, and equipment to maintain the system's functionality, including annual scheduled visits for cleaning, calibration, and testing, as well as emergency services at no additional cost. This procurement is vital for ensuring the accuracy and reliability of data from clinical trials, directly impacting patient care and safety, and is structured as a firm fixed-price order for one year with four optional extensions. Interested parties, particularly small businesses, are encouraged to submit capability statements by March 3, 2025, and can contact David Romley at David.Romley@nih.gov or 240-276-7822 for further information.
    Therakos Inc. Cellex® Photopheresis System Procedural Kits
    Buyer not available
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking procurement for Cellex® Photopheresis System Procedural Kits. This presolicitation aims to acquire in-vitro diagnostic substances that are crucial for therapeutic procedures involving photopheresis, which is significant in treating certain medical conditions. The performance of this contract will take place in Bethesda, Maryland, and interested vendors can reach out to Shasheshe Goolsby at shasheshe.goolsby@nih.gov or by phone at 301-827-4879 for further details. The timeline for this opportunity and additional funding specifics will be outlined in forthcoming announcements.
    CDC DFWED NARST Sensititre Supplies
    Buyer not available
    The Centers for Disease Control and Prevention (CDC) is seeking to award a sole source contract for antimicrobial resistance testing supplies, specifically Sensititre™ broth microdilution testing products, from ThermoFisher Scientific. This procurement is essential for the National Antimicrobial Resistance Monitoring System (NARMS), which has utilized these proprietary materials since 1996 to ensure a standardized approach to monitoring enteric bacteria resistance. The unique nature of these supplies necessitates this sole source approach, as alternatives would require significant investments in new equipment and validation processes, potentially disrupting critical surveillance efforts. Interested parties may respond within 15 days to express their interest, with proposals directed to contract specialist Ashley Williams at dal3@cdc.gov.
    Biosimilar and Interchangeable Continuing Education
    Buyer not available
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking proposals for a contract to provide accredited continuing education on biosimilar and interchangeable products aimed at healthcare providers, including physicians, pharmacists, and nurses. The objective is to develop various educational formats, such as video courses and written materials, to enhance understanding of biosimilars, focusing on their safety, effectiveness, regulatory processes, and clinical applications. This initiative is crucial for building healthcare providers' confidence in prescribing biosimilars, ultimately improving patient education and public health outcomes. The contract has a funding ceiling of $15 million, with a performance period of one year and options for four additional years. Interested parties should contact Sheila Brown at Sheila.Brown1@fda.hhs.gov for further information.