FDA BIMO Inspections and Compliance Support
ID: SS-75F40123Q00029Type: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA OFFICE OF ACQ GRANT SVCSBeltsville, MD, 20705, USA

Original Source

https://sam.gov/workspace/contract/opp/80475e97bc504be0b99366ffb597a2fd/view
Timeline
    Description

    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.

    Point(s) of Contact
    Michelle Dacanay
    michelle.dacanay@fda.hhs.gov
    Files
    Title
    Posted
    SS-75F40126Q00027 FDA BIMO Support Sources Sought.pdf
    The U.S. Food and Drug Administration (FDA) is seeking small businesses to support its Bio-Research Monitoring (BIMO) program through a Blanket Purchase Agreement (BPA). This Sources Sought Notice is for market research only and does not guarantee a contract award. The FDA aims to modernize and consolidate IT systems supporting BIMO inspections and compliance across all centers. The selected contractor will provide technical and administrative expertise for developing, operating, and maintaining a unified suite of tools and systems. Key areas include workflow management, data integration, inspection support tools, and a centralized BIMO database and analytics platform. The initiative also requires expertise in AI, E2E testing, data architecture, project management, legacy system support, training, and SharePoint/Power BI support. The deadline for responses is January 5, 2026.
    Lifecycle
    Title
    Type
    FDA BIMO Inspections and Compliance Support
    Currently viewing
    Sources Sought
    Similar Opportunities
    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.
    RFI PHARMACY TEMPERATURE MONITORING
    Homeland Security, Department Of
    The Department of Homeland Security, specifically the U.S. Immigration and Customs Enforcement (ICE), is seeking information from vendors regarding a Request for Information (RFI) for a modernized temperature monitoring system. This system is intended for use in medical refrigerators, freezers, and storage areas across 17 detention facilities, with a focus on functionality such as data monitoring, alerts, and compliance with CDC, VFC, and FDA standards. Vendors are required to provide detailed proposals that include system capabilities, implementation timelines, customer support, and a comprehensive cost breakdown for the setup and ongoing fees. Interested parties must submit their responses by December 4, 2025, at 5 PM EST, and can reach out to Vladimir Jockovic or Michelle Taylor for further inquiries.
    American National Standards Institute (ANSI) Standards Membership
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking to procure a Brand Name American National Standards Institute (ANSI) Standards Membership through a Request for Quotation (RFQ) identified as 75F40126Q00014. The objective of this acquisition is to secure unlimited FDA user access to ANSI standards for a base year and four option years, which is critical for the FDA's regulatory functions, particularly in the area of medical devices. This membership will enable the FDA to maintain access to essential medical device standards and participate in various standards development committees, ensuring compliance with regulatory responsibilities. Interested contractors must submit their fixed-price quotes to Brian Wodzisz via email by 3:00 PM ET on December 30, 2025, with quotes evaluated based on the lowest price technically acceptable criteria.
    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.
    Facilities Technology Management (FTM)
    Justice, Department Of
    The Federal Bureau of Investigation (FBI) is seeking industry feedback through a Request for Information (RFI) related to its Facilities Technology Management (FTM) initiative. The primary objectives include providing operations and maintenance support for the TRIRIGA system until its end of life in September 2027, as well as conducting a comprehensive systems assessment to optimize the FBI's facilities technology portfolio. This assessment will involve evaluating existing systems and market-available options, focusing on requirements alignment, cost analysis, and risk assessment. Interested vendors are encouraged to submit capabilities statements by December 23, 2025, and may have the opportunity to participate in a Reverse Industry Day based on their submissions. For further inquiries, contact Tammy Clark at tjclark2@fbi.gov or 304-476-3678, or Marie Agrinzoni at meagrinzoni@fbi.gov.
    DH10--Drug Decision Support Database Subscription
    Veterans Affairs, Department Of
    The Department of Veterans Affairs (VA) is soliciting quotes for a Drug Decision Support Database Subscription under RFQ 36C25926Q0059, specifically set aside for small business concerns. The procurement requires a web-based database that can support up to 110 simultaneous users, providing extensive searchable capabilities for both US domestic and foreign medications, determining FDA approval status, and listing both approved and off-label indications with supporting studies. This subscription is crucial for the Foreign Medical Program, which processes pharmacy claims for US Veterans residing or traveling abroad, and the contract will be awarded as a firm-fixed price with a base year and four option years starting March 31, 2026. Interested vendors must submit their quotes, including technical capability, pricing, and an authorized distributor letter, by 12:00 PM MST on January 5, 2026, to Stephanie Cahill at Stephanie.Cahill@va.gov.
    Request for Information - Software Licenses for Digital Evaluation and Analysis
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), is seeking responses to a Request for Information (RFI) for software licenses related to a digital evaluation and analysis platform. The objective is to procure license subscription access that enables rapid, remote user testing on both desktop and mobile platforms, incorporating various testing methodologies, including unmoderated and moderated tests with participants from a Contributor Network of public health professionals. This platform is crucial for enhancing the usability of CDC digital content and must comply with IT security, PII, and Section 508 accessibility standards. Interested vendors should submit their responses, including company information and comments on the draft Statement of Work, by January 7, 2026, and can direct inquiries to Jennifer Gartzke at xuy7@cdc.gov or by phone at 404-498-0020.
    Protect Premium Service Agreement on ZEISS LSM 880 and Axio Observer 7 Microscopes
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA), is seeking qualified small businesses to provide a Protect Premium Service Agreement for ZEISS LSM 880 and Axio Observer 7 microscopes. The required services include preventative maintenance, on-demand repairs, software updates, technical telephone consultations, unlimited on-site visits, and access to proprietary parts and OEM-certified technicians. This procurement is crucial for maintaining the functionality of laboratory equipment used in research related to substance use disorders. Interested businesses must submit electronic capability statements by January 5, 2026, at 1:00 p.m. EST to Andrew Varley at andrew.varley@nih.gov, as this notice serves to gather information for determining the appropriate acquisition method and potential set-asides.
    Microbial Identification System (MIS)
    Dept Of Defense
    The Department of Defense, through the United States Army Health Contracting Activity, is seeking information regarding a commercial solution for a Microbial Identification System (MIS) to enhance its MicroScan autoSCAN-4 System. The objective is to procure a system that meets the Critical Operational Device Specifications (CODS), which include operational characteristics, support for specific testing panels, and compatibility with a LabPro computer running Windows 11. This procurement is crucial for ensuring reliable laboratory systems in medical environments, particularly in austere settings. Interested vendors must submit their responses by 4:00 PM Central Time on April 3, 2025, to Linda McGhee at linda.a.mcghee.civ@health.mil, and are encouraged to provide detailed information about their capabilities and products as outlined in the RFI documents.