Engineering and Application Support Services
ID: FDA-SSN-125075Type: Sources Sought
Overview

Buyer

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

NAICS

Custom Computer Programming Services (541511)

PSC

IT AND TELECOM - IT MANAGEMENT SUPPORT SERVICES (LABOR) (DF01)

Original Source

https://sam.gov/opp/d32a29de3520445aa4caac46a037ccd7/view
Timeline
    Description

    The Food and Drug Administration (FDA) is seeking qualified small businesses to provide Engineering and Application Support Services aimed at modernizing its IT infrastructure and application environments. The procurement focuses on DevSecCXOps, Innovation, Modernization, and Engineering Services, with an emphasis on IT project management, infrastructure modernization, and operational support. This initiative is critical for enhancing the FDA's technological capabilities to ensure public health safety and streamline service delivery. Interested contractors must submit their responses by September 30, 2024, detailing their corporate profiles and relevant experience, with a projected contract value of up to $80 million. For further inquiries, potential bidders can contact Roosevelt Walker at roosevelt.walker@fda.hhs.gov.

    Point(s) of Contact
    Roosevelt Walker
    roosevelt.walker@fda.hhs.gov
    Files
    Title
    Posted
    Attachment 1_SOW_updated_Amend_0001.pdf
    The Food and Drug Administration (FDA) seeks a contractor to provide DevSecCXOps, Innovation, Modernization, and Engineering Services aimed at modernizing its IT infrastructure and application systems. The initiative aligns with the FDA's mission to ensure public health safety through advanced technological capabilities. The responsibilities include transitioning current operations with minimal disruption, project management, and delivering innovative solutions. Key objectives focus on infrastructure modernization, mobility strategy implementation, cloud adoption, application modernization, and business continuity planning. Task areas outlined for the contractor encompass transition support, project management, cloud computing, application design, prototyping, infrastructure modernization, and microservices development. The contractor will need to collaborate directly with FDA personnel, ensure compliance with federal standards, and enhance data governance. This comprehensive effort aims to solidify the FDA’s technology strategy, streamline service delivery, and foster an agile, secure IT environment that meets evolving regulatory demands and improves public health outcomes. The document acts as a blueprint for prospective contractors responding to this RFP, detailing expectations and requirements necessary for effective modernization of FDA's operations.
    Attachment 1_Statement of Work (SOW).pdf
    The FDA seeks to modernize its IT infrastructure and application environments through the CTO Engineering and Application Support BPA, aimed at enhancing public health services. This contract covers DevSecCXOps, innovation, modernization, and engineering services, enabling agile methodologies like cloud computing and microservices. Key objectives include improving network reliability, developing a comprehensive mobility strategy, and enhancing cloud strategies for efficiency. The contractor is required to manage transition activities, project oversight, and apply innovative technologies to optimize systems, ensuring alignment with FDA guidelines. The scope includes enterprise architecture support, application design, and prototyping, which enhances FDA operations while advancing cybersecurity measures. Performance metrics and customer experience objectives will drive the modernization efforts. The BPA will last five years with a budget of up to $100 million, demonstrating the government’s commitment to leveraging technology for improved regulatory capabilities. The overall success hinges on a collaborative, efficient approach to IT service delivery that meets evolving public health challenges.
    SSNT_125075_Amendment_0001.pdf
    The U.S. Food and Drug Administration (FDA) is conducting market research for a Single Award Blanket Purchase Agreement (BPA) to procure Chief Technology Officer (CTO) Engineering and Application Support Services, specifically targeting small businesses. The FDA aims to identify small business capabilities in IT project management, infrastructure modernization, and operational support, with a projected value of up to $80 million. Interested companies are directed to provide comprehensive responses not exceeding 12 pages, outlining their corporate profiles, relevant experience with similar contracts, use of Agile methodologies, mobile application development, and ability to manage complex staffing needs. Responses due by September 30, 2024, will assist the government in deciding the competitive landscape for the potential solicitation, which remains non-binding. The FDA encourages no inclusion of proprietary or sensitive information in submissions and has outlined a series of specific questions for potential contractors to address, thereby ensuring a robust evaluation of capabilities. This process reflects the FDA’s effort to enhance its IT infrastructure while exploring avenues for small business participation in federal contracting.
    SSNT_125075.pdf
    The U.S. Food and Drug Administration (FDA) is conducting market research to identify capable small business sources for a Single Award Blanket Purchase Agreement (BPA) pertaining to Chief Technology Officer (CTO) Engineering and Application Support Services. The focus is on IT project management and support for FDA's web infrastructure. The associated NAICS code is 541511, with a small business size standard of $34 million. Responses to the Sources Sought Notice (SSNT) must detail corporate profiles, relevant contract experience, Agile methodology application, experience with data processing, mobile application development, staffing capabilities, and applicable GSA schedule contracts. Interested parties need to demonstrate their qualifications and adhere to restrictions on proprietary information in their submissions, which are due by September 30, 2024. The government may use the information provided to determine future solicitation approaches, potentially setting aside the requirement for small businesses or opening it to full competition. This notice emphasizes that it is not a solicitation for proposals but rather a method for the FDA to assess potential contractor capabilities and facilitate future procurement processes.
    Lifecycle
    Title
    Type
    Engineering and Application Support Services
    Currently viewing
    Sources Sought
    Similar Opportunities
    Facility Management System (FMS) Administration and Data Management
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking qualified vendors for the administration and data management of its Facility Management System (FMS), utilizing the ARCHIBUS software. The contractor will be responsible for providing ongoing FMS support, ensuring compliance with federal reporting requirements, maintaining data integrity, and offering user training and technical assistance. This initiative is crucial for managing the FDA's facilities efficiently in response to increasing service demands and regulatory requirements, with the contract anticipated to span from March 24, 2025, to March 23, 2030. Interested parties must submit their responses, including a Vendor Feedback Form, to Nicholas Bisher and Kimberly Pennix by September 23, 2024, at 2:00 PM EST, as this is a Sources Sought Notice and not a solicitation for proposals.
    Software Component Package Risk & Vulnerability Periodic Database
    Active
    Health And Human Services, Department Of
    The U.S. Food and Drug Administration (FDA) is seeking to award a firm fixed price purchase order for a Software Component Package Risk and Vulnerability Periodic Database to Dark Sky Technology, Inc. This procurement aims to enhance the cybersecurity of medical devices by acquiring a subscription service that reports known software vulnerabilities, which is critical for the FDA's Center for Devices and Radiological Health (CDRH) to effectively assess and mitigate risks associated with medical device software. The initiative is part of the FDA's response to the Food and Drug Omnibus Reform Act of 2022, emphasizing the importance of safeguarding public health in an evolving technological landscape. Interested parties can contact Brian Wodzisz at Brian.Wodzisz@fda.hhs.gov for further information, with the contract performance period extending up to five years.
    PRIMO Software Licensing
    Active
    Health And Human Services, Department Of
    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.
    FDA Library Digital Subscription Services and Support
    Active
    Health And Human Services, Department Of
    The Food and Drug Administration (FDA) is seeking qualified vendors to provide digital subscription services and support for its library resources, aimed at enhancing access to credible scientific information for its staff. The procurement involves establishing a Blanket Purchase Agreement that consolidates subscription management, covering renewals and purchases of journals, databases, and training materials, while ensuring these resources are accessible through a secure online tracking system. This initiative is crucial for maintaining an extensive and well-managed library that supports the FDA's public health mission, ensuring reliable access to critical information for its employees. Interested vendors should submit their capabilities statements by September 23, 2024, to Vivianna Diaz at Vivianna.Diaz@fda.hhs.gov, with a total funding allowance of $450,000 for unforeseen subscription changes over the contract period from January 1, 2025, to January 31, 2030.
    Contractor Laboratory Support Services and Disposal of Packaging Materials
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is soliciting contractor support for laboratory support services and the disposal of packaging materials under RFQ 75F40124Q00549. The contractor will be responsible for tasks including the disposal of refrigerated sample boxes, handling dry ice, and maintaining a clean laboratory environment, while ensuring compliance with OSHA regulations and supporting laboratory safety checks. This contract is crucial for maintaining operational efficiency and safety within the FDA's Office of Compliance and Biologics Quality (OCBQ) and is expected to span a three-year period from September 30, 2024, to September 29, 2027, with a firm-fixed price structure. Interested contractors should submit their quotes electronically, adhering to specified guidelines, and can contact Matthew Tran at matthew.tran@fda.hhs.gov for further information.
    DM: Prediction Model Software
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking advanced prediction model software to enhance product quality and efficiency within its Division of Product Quality and Research (DPQR). The software must be capable of mining large and complex datasets to identify critical quality parameters and optimize product performance at a molecular level, particularly in a high-performance computing (HPC) environment. This procurement is vital for addressing product quality issues in pharmaceutical manufacturing and ensuring compliance with FDA standards. Interested vendors should contact Allison Meads at allison.meads@fda.hhs.gov or Steven Gagnon at steven.gagnon@fda.hhs.gov for further details, as the contract will follow a firm fixed price model with specific deliverables and a performance period extending until installation and warranty completion.
    Software Bill of Materials (SBOM) Validation Comparison Set
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration's Center for Devices and Radiological Health (CDRH), is seeking to award a firm fixed price purchase order to MedCrypt, Inc. for the development of a Software Bill of Materials (SBOM) Validation Comparison Dataset. The primary objective of this procurement is to enhance cybersecurity for medical devices by providing a continuously updated dataset of known vulnerabilities, which will aid in the analysis of risks and potential exploits associated with software components used in these devices. This initiative is crucial for ensuring the safety and efficacy of healthcare technologies, particularly in light of recent legislative mandates under the Food and Drug Omnibus Reform Act of 2022. Interested parties can contact Brian Wodzisz at Brian.Wodzisz@fda.hhs.gov for further information regarding this opportunity.
    CFSAN Security Radio Upgrade & Security Communications Support Services
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Food and Drug Administration (FDA), is seeking proposals for the CFSAN Security Radio Upgrade & Security Communications Support Services contract. The primary objective is to enhance communication and emergency response capabilities at the College Park, Maryland campus by providing telecommunication devices, including 30 handheld radios with advanced features, and associated support services. This initiative is crucial for ensuring effective coordination, safety, and security during emergencies, while adhering to federal security requirements. Proposals are due by September 23, 2024, and interested parties can contact Matthew Tran at matthew.tran@fda.hhs.gov for further information.
    Software License and Device Warranty for Two Nanopore GridION Instruments
    Active
    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 Software License and Device Warranty for two Nanopore GridION instruments, which are critical for the FDA's Next Generation Sequencing (NGS) initiatives focused on genomic data collection and analysis. The procurement aims to ensure optimal performance of these instruments through software and hardware updates, remote troubleshooting, and a return and replace policy for faulty devices, with a total cost of $25,000 for a one-year warranty and license renewal. This acquisition underscores the FDA's commitment to enhancing pathogen identification capabilities through advanced genomic technology, with the performance period set from September 28, 2024, to September 27, 2025, and the possibility of extending for three additional years, subject to funding. Interested vendors should submit their quotes electronically to Raphael Hall at raphael.hall@fda.hhs.gov by September 19, 2024, at 11:59 PM Eastern Standard Time.
    Subscription to news, schedules, federal budget and appropriations
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking to procure subscriptions to Budget Tracker for six individuals, aimed at enhancing legislative tracking and budget monitoring capabilities. The procurement includes a base year subscription with options for four additional years, providing essential documents related to appropriation bills, detailed bill status charts, and legislative analysis. These subscriptions are critical for the FDA's Office of Regulatory Affairs to maintain continuous access to vital financial and legislative information, particularly during periods of congressional delays in finalizing appropriations. Interested vendors should contact Valrica Manns at valrica.manns@fda.hhs.gov or call 301-837-7507 for further details, with the anticipated period of performance extending from August 2024 to August 2029.