Hardy Diagnostic Reagents and Supplies
ID: NIH-CC-OPC-25-002025Type: Presolicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH - CCBETHESDA, MD, 20892, USA

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

PSC

DRUGS AND BIOLOGICALS (6505)

Original Source

https://sam.gov/opp/acea65568342451095dd46c287941e8c/view
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to award a sole-source contract to Hardy Diagnostics for the procurement of culture media and organism supplies necessary for cGMP Sterility Testing Services. The primary objective is to ensure compliance with FDA regulations by utilizing cGMP quality materials that have been rigorously validated, as these supplies are critical for the isolation and identification of pathogens affecting critically ill patients. The contract will cover a base period of twelve months with an option for an additional three months, and interested vendors capable of providing similar products are encouraged to submit capability statements by the specified deadline. For further inquiries, potential respondents may contact Kimala Winfield at kimala.winfield@nih.gov or Malinda Dehner at dehnerm@cc.nih.gov.

    Point(s) of Contact
    Kimala Winfield
    (301) 496-7015
    kimala.winfield@nih.gov
    Malinda Dehner
    (301) 594-6320
    dehnerm@cc.nih.gov
    Files
    Title
    Posted
    Supply List 25-002025.pdf
    The document titled "Supply List 25-002025" outlines requirements for a government solicitation concerning supplies needed for various federal and local projects. The list specifies the types of materials and products essential for meeting project objectives, detailing quantities and specifications that comply with government standards. It serves as part of Requests for Proposals (RFPs) aimed at both federal grants and state/local needs, facilitating vendors in preparing their bids to fulfill the supply requirements effectively. The main focus is on ensuring that all procured items adhere to the strict guidelines of quality and performance that are mandated by governmental regulations. This supply list is instrumental in guiding procurement processes and fostering transparency and accountability in government spending. Overall, it plays a vital role in streamlining the bidding process for suppliers participating in governmental contracts, ensuring that all aspects are covered for operational efficiency.
    Lifecycle
    Title
    Type
    Hardy Diagnostic Reagents and Supplies
    Currently viewing
    Presolicitation
    Similar Opportunities
    Notice of Intent to Sole Source 2 sets of QX200 ddPCR Systems
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the Clinical Center (CC), intends to negotiate a sole-source contract for the renewal of maintenance services for two QX200 AutoDG ddPCR Systems from Bio-Rad Laboratories. This five-year service contract, valued at $151,494, is essential for the ongoing maintenance and support of these systems, which are critical for droplet digital PCR (ddPCR) vector copy number detection and gene modification efficiency testing on clinical cellular products. The contract ensures compliance with FDA regulations and is vital for patient care testing, as failure to secure these services could adversely affect patient safety. Interested parties may submit capability statements by December 18, 2025, to valerie.gregorio@nih.gov, referencing NOI-CC-26-000112.
    Notice of Intent to Sole Source – Werfen USA, LLC
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), intends to award a sole source contract to Werfen USA, LLC for the procurement of kits and reagents essential for patient care testing, specifically for use with the ACL TOP 350 and 750 analyzers. This procurement, valued at approximately $570,000 over a base year and two option years (January 1, 2026, to December 31, 2028), is critical as the reagents are uniquely validated for the existing instruments, ensuring continuity in patient care and research protocols. The acquisition will be conducted under the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, allowing for increased procedural flexibility and efficiency. Interested parties may submit comments regarding this notice to Ryssa Nix at ryssa.nix@nih.gov by the close date of December 23, 2025, at 12 PM EST.
    Notice of Intent to Sole Source – Stemcell Technologies
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), intends to award a sole source contract to StemCell Technologies Inc. for the procurement of EasySep cell separator kits for the Department of Laboratory Medicine at the NIH Clinical Center. These kits are essential for use with RoboSep instruments currently utilized in the laboratory, and StemCell Technologies is the sole manufacturer capable of meeting the specific clinical and research requirements of the department. Interested parties may express their interest and capabilities regarding this procurement, but the government retains discretion over the decision not to compete the requirement. Comments and inquiries should be directed to Kristin Nagashima at kristin.nagashima@nih.gov by December 19, 2025, at 12 PM EST.
    MasterControl Software-as-a-Service for Electronic Quality Management System
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to procure MasterControl Software-as-a-Service (SaaS) for its Electronic Quality Management System (eQMS) to support the Clinical Quality Management System (CQMS) at the National Institute of Allergy and Infectious Diseases (NIAID). This procurement is intended to ensure compliance with federal and international regulations by managing controlled documents and quality processes related to clinical trials sponsored by NIAID. The MasterControl software has been utilized since 2019 and is critical for managing documentation, training, and regulatory audits, with a contract period of performance from January 1, 2026, to December 31, 2026. Interested vendors may submit their capabilities statements to Linda Smith at linda.smith2@nih.gov within 10 days of this notice, as the government intends to award a sole source contract based on the unique capabilities of MasterControl Solutions.
    SR-X Biomarker Detectio System Maintenance Services
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking maintenance services for the Quanterix SR-X Biomarker Detection System and Washer, with a presolicitation notice for a sole-source procurement. The contract aims to extend warranty services for the original equipment, ensuring that maintenance and repairs are conducted by the manufacturer to avoid warranty voidance and mitigate risks. This procurement is crucial for maintaining the functionality of laboratory equipment used in biomedical research, with services expected to be performed primarily at the Clinical Research Center in Bethesda, Maryland. Interested vendors must submit their quotations, including required documentation, by December 20, 2025, at 12:00 PM EST to Kelly Robinson at kelly.robinson@nih.gov.
    Service Contract for ThermoFisher FEI Tecnal T20. Transmission Electron Microscope
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Child Health and Human Development (NICHD), is seeking to award a non-competitive service contract for the ThermoFisher FEI Tecnal T20 Transmission Electron Microscope. This contract is essential for providing continuous expert maintenance, repairs, and software updates to ensure optimal performance and minimize downtime of the specialized microscope. The contract, justified under FAR Part 13-Simplified Acquisition Procedures, is not expected to exceed $250,000 and will cover the period from February 1, 2026, to January 31, 2027. Interested parties are invited to submit capabilities statements to Mr. Michael Falzone at falzoneml@nih.gov by December 26, 2025.
    Renewal of Leica Microsystems Maintenace for the Division of Intramural Research (DIR)
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to renew maintenance services for Leica Microsystems equipment utilized by the Division of Intramural Research (DIR). This procurement aims to ensure the continued operational efficiency and reliability of critical laboratory instruments and equipment, which are essential for ongoing research activities. The maintenance services will be performed in Rockville, Maryland, and interested vendors can reach out to Hershea Vance at hershea.vance@nih.gov or 301-761-6404, or Tamara McDermott at tamara.mcdermott@nih.gov or 406-375-7487 for further details. The opportunity is categorized under the PSC code J066, which pertains to maintenance, repair, and rebuilding of laboratory equipment.
    All Sites Primary Barrier Equipment and Decontamination Services
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking proposals for a firm-fixed price contract to provide All Sites Primary Barrier Equipment and Decontamination Services across various NIH locations, including the main campus in Bethesda, MD, and the NIAID Integrated Research Facility in Fort Detrick, MD. The contract aims to support the NIH's comprehensive safety program by ensuring the maintenance and decontamination of equipment used in high-level biosafety laboratories, which is crucial for maintaining a safe environment for research activities. Interested small businesses must submit their proposals by the due date of December 26, 2025, and can direct inquiries to primary contact Evguenia Mathur at jane.mathur@nih.gov or secondary contact Ashley Kinderdine at ashley.kinderdine@nih.gov for further clarification.
    Maintenance and Service Contract for various Government-Owned Becton Dickinson and Company Flow Cytometer Equipment
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking a contractor to provide maintenance and service for various government-owned Becton Dickinson and Company flow cytometer equipment. The procurement aims to ensure the operational efficiency and reliability of these critical laboratory instruments, which are essential for various biomedical research applications. Interested vendors should note that the place of performance is located in Bethesda, Maryland, and they can direct inquiries to John Russell, the Contract Specialist, at John.Russell3@nih.gov for further details. The contract is categorized under the PSC code J066, which pertains to maintenance, repair, and rebuilding of laboratory equipment.
    Renewal of Maintenance Services for Philips Imaging Equipment at the Integrated Research Facility (IRF) at Fort Detrick, Maryland
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to renew maintenance services for Philips imaging equipment located at the Integrated Research Facility (IRF) in Fort Detrick, Maryland. This procurement aims to ensure the continued operational efficiency and reliability of critical imaging equipment used in research and clinical applications. The maintenance services are vital for supporting ongoing research initiatives and ensuring compliance with safety and operational standards. Interested vendors can reach out to Danielle Tines at danielle.tines@nih.gov or by phone at 406-363-9251, or Tamara McDermott at tamara.mcdermott@nih.gov or 406-375-7487 for further details regarding the justification and approval documentation.