Incidents Review Support and Records Management
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $250,000 to $700,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541990 All Other Professional, Scientific, and Technical Services
- Points of contact
-
- tbd@fda.gov
- Christopher Scott christopher.scott@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Department of Health and Human Services Food and Drug Administration's Center for Drug Evaluation and Research (CDER) Office of Compounding Quality and Compliance (OCQC) is seeking contractor support for triaging and managing incidents reports, with a focus on reviewing adverse event information from FAERS (Food and Drug Administration Adverse Event Reporting System). The estimated solicitation release date is December 1, 2025, with an anticipated contract award date of February 1, 2026, under the NAICS 541990 classification for Professional, Scientific, and Technical Services. The primary objective is to provide critical support in reviewing and cataloging incident reports, including MedWatch submissions and reports from pharmaceutical firms.
The contract will involve contractors assisting OCQC in contacting reporters and firms to gather detailed information about compounded drug-related incidents, addressing an unprecedented volume of adverse event reports. While specific award values were not disclosed, the contract aims to support ongoing efforts to prevent large-scale serious adverse events, such as the 2012 fungal meningitis outbreak that resulted in over 60 deaths and 750 infections. Key points of contact include Christopher Scott (christopher.scott@fda.hhs.gov) from the Food and Drug Administration, who can provide additional information about this procurement opportunity.
Forecast text
The CDER's Office of Compounding Quality and Compliance (OCQC) is requesting contractor support with triaging incidents report information. There is also a critical need for support for incidents to help with daily triaging. We would like to continue current contractor support that is essential for recording and cataloging information that is reviewed by the point of contact on the incidents team daily. The contractor helps to triage and address the materials that come from FAERS, including MedWatch reports and reports submitted by firms. Contracted support staff assist with incident triaging by contacting reporters or firms who submit reports to FAERS to gather information about whether the incident was related to a compounded drug and the information about the compounder of that drug. There is an unprecedented volume of adverse event/incident reports. In the past, OCQC has struggled to keep up with triaging these reports until we were able to obtain contractor support beginning in FY24. Review of incidents is one way the OCQC helps to protect the public health from potentially serious adverse events that may be related to compounded drug products such as the 2012 fungal meningitis outbreak associated with contaminated compounded drugs shipped by the New England Compounding Center to patients and healthcare providers nationwide, causing over 60 deaths and 750 cases of infection. This incident was the most significant of a long history of serious adverse events resulting from compounded drug products. Both before and since this outbreak, FDA has investigated many serious adverse events and serious product quality issues, such as contamination or potency failures, associated with sterile and non-sterile compounded drug products. It is critical the OCQC maintain this additional support needed to keep up with the increased rate of adverse event reports to help prevent large scale serious adverse events.
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