Completion of FDA Project – Development of a Model that Integrates Inflammation and Tissue Injury to Predict and Mitigate the Post-Acute of COVID19

The Food and Drug Administration's Office of Acquisition and Grant Services has issued a Special Notice for the completion of a critical research project focused on developing models to predict and mitigate post-acute COVID-19 conditions, also known as long COVID or post-COVID conditions (PCC). This notice announces the agency's intent to award an 8(a) sole source contract to Children's Hospital of Los Angeles (CHLA) to complete work on a project that was originally funded in 2022 but ended prematurely due to an administrative error before final deliverables could be completed. The research addresses the significant knowledge gap regarding long-term health consequences of COVID-19 infection in both adults and children, particularly the challenge of identifying which patients are most susceptible to developing these conditions during the active infection phase. The FDA has determined this project completion is critical given the success of the technical approach and value of preliminary data already generated. The contract falls under NAICS code 541714 for biotechnology research and development and PSC code AJ12 for applied research services.

The primary objective of this Special Notice is to complete the remaining tasks (7-12 out of 12 total) of the original research project, which aims to develop integrated models of inflammation and tissue injury that can predict and help mitigate long-term COVID-19 health effects in both pediatric and adult populations. Key deliverables include identifying druggable targets for preventing tissue-specific injuries, comparing inflammatory responses between children and adults, and testing interventions to restore tissue function. While the FDA intends to award this as a sole source contract to CHLA under FAR Part 6.302-1(a)(2)(ii), other organizations may submit capability statements by September 12, 2025, at 2:00 PM EST to demonstrate their ability to meet the requirements. Interested parties must email their submissions to the designated contracting officer, and the government reserves the right to compete the contract based on received responses. The contract is structured as a cost reimbursement agreement with work to be performed at CHLA's Los Angeles facility, with an expected award within approximately five days of the notice publication date.