Surveillance of severe influenza-associated encephalopathy and related complications in US children

This contract seeks to establish a nationwide active surveillance system for severe influenza-associated encephalopathy (IAE) in hospitalized pediatric patients through a multicenter pediatric surveillance network, focusing specifically on Pediatric Intensive Care Units (PICUs). The contractor will implement standardized case definitions to identify laboratory-confirmed influenza cases complicated by encephalopathy, actively collect clinical data from electronic health records, obtain and test clinical specimens, secure and upload primary neuroimaging, coordinate neuroradiology reviews, and conduct longitudinal neurologic follow-up. The primary objectives are to assess risk factors for severe disease, characterize the clinical spectrum of IAE, and evaluate the impact of interventions such as influenza vaccination and antiviral therapies. The project will require developing and maintaining a CDC-approved protocol, data collection tools, a REDCap database, quality assurance and quality control plans, and data dictionaries, all subject to 100% government review and acceptance. The contractor must ensure full compliance with federal accessibility standards under Section 508, encrypt personally identifiable information using FIPS 140-validated solutions, and adhere to HHS and CDC policies for data confidentiality, integrity, and availability. All personnel must complete annual CDC training in information security, privacy, and records management, and the contractor must comply with HSPD-12, NIST SP 800-171 for Controlled Unclassified Information, and the Paperwork Reduction Act for human subject data collection. The performance period spans five years, beginning August 1, 2026, with four optional one-year extension periods through July 31, 2031. All work is to be performed off-site at the contractor’s facility or affiliated academic, healthcare, or research sites, with no on-site work at CDC facilities. Deliverables must be submitted electronically in editable formats such as Microsoft Word or Excel to the CDC Technical SME and Contracting Officer’s Representative, with strict milestones including a kickoff meeting within ten business days of performance start, biweekly enrollment dashboards, quarterly QA/QC reports, midterm interim datasets at six months, and final datasets due no later than thirty business days before each performance period end. The contractor is responsible for securing Institutional Review Board approvals without deviation and may be required to conduct optional tasks including neuroradiologic review, genetic and immunologic risk factor analysis, neurodevelopmental outcome assessments, and surveillance of other severe influenza complications. Proposals must be submitted by July 2, 2026, and must include documentation of Section