Procurement Summary
Country: USA
Summary: Completion of FDA Project - Development of a Model that Integrates Inflammation and Tissue Injury to Predict and Mitigate the Post-Acute of COVID19
Deadline: 12 Sep 2025
Other Information
Notice Type: Tender
TOT Ref.No.: 125931773
Document Ref. No.: FDA-OC-25-130611
Financier: Self Financed
Purchaser Ownership: Public
Tender Value: Refer Document
Purchaser's Detail
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Description
People infected with SARS-CoV-2 (the virus that causes COVID-19) typically recover within a few days or weeks. However some individuals have long-term effects that persist for multiple weeks, months, or even years; this is known as post-COVID conditions (PCC) or long COVID. In such cases, people experience both obvious and subtle long-term health consequences after recovering from the active infection.
While PCC occurs more frequently in people who have had severe COVID-19 illness, individuals experiencing these health consequences are not limited those who were the sickest. These effects manifest in patients across the full spectrum of COVID-19 severity and ages, including children.
At this time, it is not possible to identify patients who will develop PCC during the active phase of COVID-19 infection. If it were possible to identify patients who are more susceptible to suffering long-term health consequences of SARS-CoV-2 infection, then it may be possible to mitigate those outcomes with medical interventions. While considerable efforts have gone into understanding how COVID-19 affects the body in adults, much less is known about how COVID-19 affects children, and how those effects manifest into long-term health consequences of COVID-19 infection.
Research to develop both pediatric and adult models of PCC/long COVID was original funded by FDA Office of the Chief Scientist/Office of Regulatory and Emerging Science (OCS/ORES) in 2022. However, due to an administrative error, the contract ended prior to work completion and final reporting/analysis. Given the success of the technical approach to date and the value of preliminary data, among other factors, FDA has determined the criticality to complete the project. As such, this contract will support completion of final deliverables by the performer.
Active Contract Opportunity
Notice ID : FDA-OC-25-130611
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : FOOD AND DRUG ADMINISTRATION
Office: FDA OFFICE OF ACQ GRANT SVCS
General Information
Contract Opportunity Type: Special Notice (Original)
Original Published Date: Sep 08, 2025 03:54 pm EDT
Original Response Date: Sep 12, 2025 02:00 pm EDT
Inactive Policy: Manual
Original Inactive Date: Sep 15, 2025
Initiative:
Classification
Original Set Aside: 8(a) Sole Source (FAR 19.8)
Product Service Code: AJ12 - GENERAL SCIENCE AND TECHNOLOGY R&D SERVICES; GENERAL SCIENCE AND TECHNOLOGY; APPLIED RESEARCH
NAICS Code: 541714 - Research and Development in Biotechnology (except Nanobiotechnology)
Place of Performance: Silver Spring, MD 20993 USA
Documents
Tender Notice
Requirements-Document-FDA-OC-25-OC130611.pdf
Solicitation-Notice-of-Intent-to-SS.pdf