FDA/OCI FY26 Annual Send Explorer Warehouse and Technical Support, or an equal to solution

The contract engages a contractor to provide a Send Explorer Warehouse license or an equivalent software solution, along with comprehensive technical support, for the Food and Drug Administration’s Office of Computational Sciences. The solution must be deployed and maintained across four distinct environments—development, test, pre-production, and production—to facilitate the nonclinical review of CDISC SEND submissions. The contract is a firm-fixed-price agreement with a one-year performance period from September 15, 2026, to September 14, 2027, and deliverables include the annual software license, deployment documentation, regular updates and patches, system integration support, and user training. All services must adhere to strict compliance requirements including HHS Section 508 accessibility standards, FIPS 140-2 encryption for data at rest and in transit, NIST SP 800-53 and 800-171 security controls, NIST SP 800-88 media sanitization procedures, and FDA-specific policies on incident response, confidentiality, and role-based training. Technical support must include real-time consultation, bug resolution, and technology refreshes for dependencies such as Oracle 19c, .NET v10, and D3v6, with a mandated 24-hour SLA for incident response. The contractor is required to submit detailed personnel rosters, complete FDA Form 3398 non-disclosure agreements for all individuals with access to sensitive information, and undergo security and privacy training before beginning work and annually thereafter. Only FDA-authorized or provided devices may process non-public information, and encryption keys must be handed over upon contract closure. Any security incident, including potential PII breaches, must be reported to HHS CSIRC/FDASMC/IRT within one hour of discovery. Upon contract termination, all system documentation must be delivered per FDA OAGS SMGs, and all media must be sanitized or destroyed in compliance with NIST SP 800-88 and FDA IS2P Appendix T. Deliveries must be made to the Office of Computational Science in Silver Spring, Maryland, via secure electronic transfer or physical media, and the Contracting Officer’s Representative, Jing Kang, is responsible for acceptance. No pricing, CLINs, contract value, or options are specified in the solicitation, and no set-asides apply; however, the government retains strict oversight through reporting obligations, compliance validations, and control over system access and data handling.