Nfusion Subscription Service (or equal)
ID: FDA-RFI-126534Type: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA OFFICE OF OPERATIONSSilver Spring, MD, 20993, USA

NAICS

Other Computer Related Services (541519)

PSC

IT AND TELECOM - SECURITY AND COMPLIANCE PRODUCTS (HARDWARE AND PERPETUAL LICENSE SOFTWARE) (7J20)
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking sources for the Nfusion Annual Subscription Service, which includes geo site access, either as a brand name or an equivalent product. The primary objective is to procure 25 concurrent licenses for Nfusion to enable up to 175 investigators to conduct secure and anonymous online research, which is critical for the FDA's Office of Criminal Investigations in enforcing laws related to FDA-regulated products. The service must meet specific cybersecurity requirements, including malware immunity and compatibility with FDA IT systems, while also providing maintenance and technical support throughout the contract duration. Interested parties are encouraged to submit capability statements by April 25, 2025, and should direct any inquiries to Robert Waite at robert.waite@fda.hhs.gov.

    Point(s) of Contact
    Files
    Title
    Posted
    The document outlines a Statement of Work for the procurement of Nfusion Annual Subscription Service by the FDA's Office of Criminal Investigations (OCI). The OCI, responsible for enforcing laws related to FDA-regulated products, is emphasizing the need for a secure online research tool to support its cyber operations. The objective is to acquire 25 concurrent licenses for Nfusion, allowing up to 175 investigators to conduct anonymous online research without detection via sophisticated tracking methods. Requirements include malware immunity, secure desktop functionality, oversight analytics, and compatibility with the FDA’s IT systems. The Contractor must provide maintenance and technical support throughout the contract, detailing past performance information and firm qualifications. This market research seeks responses from small businesses but is open to any interested parties, with a focus on identifying contractors capable of delivering these specific cybersecurity capabilities to enhance the OCI's operational effectiveness. The submission deadline for capability statements is April 25, 2025.
    Lifecycle
    Title
    Type
    Sources Sought
    Similar Opportunities
    FDA BIMO Inspections and Compliance Support
    Health And Human Services, Department Of
    The U.S. Food and Drug Administration (FDA) is conducting a Sources Sought notice to identify small businesses capable of providing professional services for its Bio-Research Monitoring (BIMO) program. The FDA aims to modernize and consolidate its IT systems to enhance inspections and compliance support, requiring expertise in areas such as workflow management, data integration, and the development of a centralized BIMO database and analytics platform. This initiative is critical for improving the efficiency and effectiveness of BIMO inspections across all centers, and interested parties must submit their responses by January 5, 2026, to Michelle Dacanay at michelle.dacanay@fda.hhs.gov.
    FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is soliciting proposals through the FY26 Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science. This opportunity aims to acquire basic and applied research and development proposals that support regulatory science and innovation, focusing on modernizing the evaluation of FDA-regulated products, enhancing post-market surveillance, and improving public health preparedness. The FDA emphasizes the importance of advancing scientific knowledge in various research areas, including new methodologies and advanced manufacturing techniques, to ensure product safety and efficacy across diverse populations. Interested parties must submit a checklist, concept paper, and full proposal by February 24, 2026, with early submissions encouraged. For further inquiries, contact Ian Weiss at Ian.Weiss@fda.hhs.gov or call 301-796-5728.
    FDA Data Dashboard Bridge Order
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is issuing a sole source bridge order to Salient CRGT, Inc. for the FDA Data Dashboard project. This procurement aims to support the FDA’s Division of Enforcement Systems Solutions through a limited source justification in accordance with FAR 8.405-6 requirements, utilizing the GSA MAS Schedule 54151S for Information Technology Professional Services. The services provided are critical for maintaining and enhancing the FDA's data management capabilities, ensuring effective enforcement and regulatory compliance. Interested parties can reach out to Michelle Dacanay at michelle.dacanay@fda.hhs.gov for further details regarding this opportunity.
    GraphPad Prism Subscription Renewal
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to renew a contract for 500 subscriptions of GraphPad Prism software, which is critical for biostatistical analysis and scientific graphing. This non-competitive procurement is justified under the Federal Acquisition Regulation (FAR) due to GraphPad Software, LLC being the sole provider of the software, with the renewal period set from April 8, 2025, to April 7, 2026. GraphPad Prism is widely utilized by research institutions and pharmaceutical companies, ensuring the accuracy and efficiency of scientific data analysis within the NIH. Interested vendors may express their capabilities, but the government retains discretion over competitive offers, with the total contract value not exceeding $250,000. For inquiries, contact Verne L. Griffin at verne.griffin@nih.gov or 301-594-7730, or Michael L. Falzone at michael.falzone@nih.gov or 301-827-1873.
    Digital Slide Scanner System
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking to acquire a Digital Slide Scanner System for the National Center for Toxicological Research (NCTR) to replace outdated equipment in its Pathology Lab. The new scanner must be capable of scanning at 20X and 40X magnifications, support brightfield and fluorescent imaging, and include features such as barcode scanning, z-stack capability, and image analysis software, while ensuring compliance with FedRAMP and FISMA standards. This system is crucial for creating digital copies of glass slides for research sharing and publications, as well as for providing quantitative data analysis. Interested vendors should note that responses are due by December 18, 2025, and can contact David Kramer at david.kramer@fda.hhs.gov or Nick Sartain at nick.sartain@fda.hhs.gov for further information.
    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.
    Data Access Program
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified contractors for the Data Access Program, aimed at enhancing access to linked datasets for research on aging. The primary objectives include reviewing requests for CMS-linked datasets, conducting data linkage, maintaining data documentation, and providing technical assistance to researchers, all while ensuring compliance with security standards. This initiative is crucial for facilitating high-quality research on health care utilization and outcomes among older adults. Interested parties can contact Shaun Rostad at shaun.rostad@nih.gov or Linda Smith at linda.smith2@nih.gov for further information. The Request for Proposals (RFP No. 75N95023R00003) is expected to be released on or about January 26, 2026, with proposals due 45 days after the release date.
    NCI OA Special Notice of Subcontract Opportunity at the Frederick National Laboratory for Cancer Research
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), has issued a Special Notice regarding subcontracting opportunities at the Frederick National Laboratory for Cancer Research (FNLCR). This opportunity focuses on the need for laboratory assays and services to assess cytokines in nasal mucosa samples for up to nine phase 1 trials and two phase 2 trials related to the NextGen COVID-19 vaccine program, which is critical for advancing the National Institute of Allergy and Infectious Diseases (NIAID) mission. The FNLCR, operated by Leidos Biomedical Research, Inc., plays a vital role in cancer and AIDS research, and this notice aims to inform potential subcontractors of the requirements without constituting a formal solicitation. Interested parties can reach out to Tara Phillips at tara.phillips@nih.gov for further details regarding Solicitation/RFP No. S26-111, with a response date set for January 14, 2026.
    Medical Equipment and Furnishings, Fixtures, and Equipment (FF&E) Planning Software as a Services (SaaS)
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Indian Health Service, is seeking proposals for a software license for Medical Equipment and Furnishings, Fixtures, and Equipment (FF&E) Planning Software as a Service (SaaS) to support the construction of new healthcare facilities. The objective is to replace outdated spreadsheet-based methods that have resulted in cost overruns and project delays, with a web-based solution that includes features such as real-time updates, API connectivity, and compliance with federal regulations. Proposals are due by December 26, 2025, at 3:00 pm EST, and must be submitted via email to Colleen Henry at colleen.henry@ihs.gov, with evaluations based on price and compliance with specified terms and conditions.
    Irradiated Rodent Feed
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking proposals for the procurement of Certified and Irradiated Rodent Diet Feed NIH-07 and NTP-2000, along with Assay Analysis, under the combined synopsis/solicitation 76F40125Q132188. This opportunity is set aside for small businesses and requires adherence to specific technical standards regarding feed irradiation, contaminant analysis, nutritional content, and facility sanitation, as outlined in the solicitation documents. The goods are essential for research purposes at the National Center for Toxicological Research (NCTR) and will be procured through a Single Award Indefinite Delivery, Indefinite Quantity (ID/IQ) contract with a guaranteed minimum of $5,000 and an estimated maximum of $350,000 over a five-year ordering period. Proposals are due by December 22, 2025, at 1:00 PM Central Time, and interested parties can contact Howard Nesmith at howard.nesmith@fda.hhs.gov or by phone at 870-543-7459 for further information.