Real-World Application for Innovation and Development
The U.S. Food and Drug Administration (FDA) is seeking small businesses to support the Real-World Application for Innovation and Development (RAPID) platform, a cloud-based environment designed to enhance regulatory review processes through advanced data analytics and artificial intelligence technologies. The procurement aims to improve the FDA's Office of Computational Science capabilities by developing innovative analytical solutions, supporting data science research, and evaluating cutting-edge technologies across multiple cloud service providers including AWS, Azure, and Google GCP. Potential vendors must demonstrate expertise in AI development, cloud computing architecture, DevSecOps, and AI Risk Management, with a focus on creating customized Large Language Models and multi-modal AI solutions. Interested parties are required to submit a 10-page capability statement addressing technical experience and specific qualifications by February 11, 2025, at 12:00 PM ET to Noah.Padilla@fda.hhs.gov. The procurement will specifically target vendors on GSA MAS Schedules 54151S and 54151HEAL who can support the platform's complex data integration, analytical tool development, and regulatory decision-making needs.
The opportunity is designated as a Total Small Business set-aside under the Computer Systems Design Services NAICS category, with a contract structure anticipated to be a Blanket Purchase Agreement. The contract will have a one-year base period with four potential option years, running from September 28, 2025, to September 28, 2030. While specific award values were not explicitly detailed, the scope suggests a significant investment in technological innovation and platform enhancement. Work will predominantly be performed off-site, with occasional meetings at the FDA's White Oak campus in Silver Spring, Maryland. Contractors must meet stringent security requirements, including personnel background investigations and compliance with HSPD-12 residency standards. The platform will require supporting various data analytics tools like R-Studio Connect, Jupyter Analytics, Qlik Sense, and Tableau, with an emphasis on developing and implementing advanced AI and machine learning solutions that can scale to meet FDA's complex regulatory and scientific analysis needs.
FDA-SSN-75F40125Q00029 Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services
1/21/25, 2:06 PM Request for Information (RFI): OII-Extended Reality/Reality Simulation Training & Development Capability
The Food and Drug Administration (FDA) is conducting a Request for Information (RFI) to explore market capabilities for Artificial Intelligence-powered Extended Reality (XR) simulation tools specifically designed for training regulatory inspection and investigation personnel. The agency seeks advanced Augmented Reality (AR) or Virtual Reality (VR) platforms that can provide immersive, experiential, and microlearning opportunities for its workforce. Interested companies must submit a 10-page capability statement addressing specific requirements by January 17, 2025, with responses sent via email to Vivianna Diaz. The RFI is structured as market research under Federal Acquisition Regulations Part 10 and is not a formal solicitation or binding commitment. Potential respondents are advised to avoid submitting non-disclosure agreements or sensitive business information, and telephone inquiries will not be accepted.
This pre-solicitation notice does not indicate a specific set-aside designation and does not reveal potential award values or precise budget ranges. The FDA currently manages an extensive training infrastructure, including over 225 instructor-led courses and 490 online courses through their LearnED Training System, which serves more than 13,284 users across various governmental and academic partners. The RFI targets XR training platforms that can simulate real-world inspection environments, with a particular focus on complex scenarios like sample collection in warehouse settings. While no incumbent contractors are mentioned, the agency is seeking comprehensive solutions that offer multi-user collaboration capabilities, integration with existing learning management systems, and AI-powered adaptive learning features. The procurement process appears focused on gathering market intelligence to inform future training technology acquisitions for the Office of Inspections and Investigations.
RFQ1736621 Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services
12/23/24, 11:58 AM FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
The United States Food and Drug Administration (FDA), an agency within the Department of Health and Human Services, has issued a Fiscal Year 2025 Broad Agency Announcement (BAA) soliciting basic and applied research and development proposals to support regulatory science and innovation. This Special Notice, published on October 3, 2024, invites research proposals that advance scientific knowledge in specific areas aligned with the FDA's mission to protect and promote national health. The BAA is not limited to a single procurement service code and represents an agency-wide mechanism for funding extramural research. The announcement seeks proposals that can contribute to the FDA's scientific and regulatory objectives across various research domains. The BAA will be accompanied by a virtual informational event on November 17th, 2024, to provide detailed guidance about the application process and research priorities.
Eligible contractors include private sector organizations, Federally Funded Research and Development Centers (FFRDCs), and academic institutions interested in supporting regulatory science. The BAA focuses on three primary research charges: modernizing the development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and enhancing public health preparedness and response. Proposals must be submitted by February 24, 2025, at 11:59 PM EST, with an optional early concept paper submission window from October 4 to November 8, 2024. The FDA anticipates making multiple procurement contract awards, with a preference for cost reimbursement contracts over firm fixed-price models. Research priorities include alternative testing methods, advanced manufacturing approaches, analytical techniques, biomarkers, clinical trial designs, and approaches addressing diverse populations such as racial and ethnic minorities, women, rare diseases, and pediatric groups. The agency will conduct a two-tiered review process, reserving the right to select all, some, or none of the submitted proposals based on quality and alignment with FDA priorities.
FDABAA-25-00123 Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services
10/3/24, 11:24 AM Computerized Labeling Assessment Tool (CLAT) Services
The Food and Drug Administration (FDA) intends to award a single award IDIQ to a small business as follows:
Objective:
FDA requires a comprehensive solution to best accomplish FDA specific mission objectives to ensure the safe use of drug products by minimizing medication errors related to drug product labeling. These objectives include the following:
• Automate drug product labeling reviews
• Implement and promote operational and cost efficiencies
Scope of the Requirement
The Government requires drug product labeling review support services for prescription and nonprescription drug products, that includes:
• Develop a Computerized Labeling Assessment Tool (CLAT) that meets FDA standards (e.g., security, usability, cloud infrastructure) and can be used to perform automated labeling review activities
• Implement CLAT in FDA’s environment that meets FDA’s infrastructure and security standards
• Access and organize submitted labeling files
• Apply automated capabilities to perform labeling assessments
• Report review findings (includes analytics and data visualization tools)
• Workload and performance metrics
• Use of open source software, artificial intelligence and other novel or emerging technologies to develop CLAT
• Test, and validate CLAT
• Evaluate new or additional labeling review activities for possible automation
• Enhance or expand functionality and capabilities for automated labeling review assessments by additional FDA offices and the public
• Quality assurance, quality control, and quality improvement
• User experience and user interface design
• Integrate CLAT with other internal or external data sources
FDA-20-SOL-1223486 Department of Health and Human Services Food and Drug Administration
7/1/20, 6:04 PM Safety Engineering and Occupational Safety Support Services
This solicitation seeks safety engineering and occupational safety support services through an Indefinite-Delivery, Indefinite-Quantity contract for the Department of Health and Human Services Food and Drug Administration. Services include laboratory design and safety reviews, maintenance of primary barrier equipment, industrial hygiene, and supporting laboratory quality, safety, and security. Offerors must demonstrate the necessary qualifications and security clearances, and proposals will be evaluated based on technical approach and price. The response deadline is June 1, 2020.
The solicitation carries no set-aside designations. The primary NAICS code is 541715 and PSC code R425. The IDIQ has a maximum total value of $49.5 million over a one-year base period and four one-year options to be performed at FDA sites nationwide. Contractor personnel must undergo background checks and obtain security credentials corresponding to the risk levels of their positions. The solicitation was amended to extend the response deadline and respond to questions.
75F40120R00001 Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services
4/9/20, 7:33 PM