CDER Informatics Enterprise Service and Operation (ESO)
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $7,000,000 to $13,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541519 Other Computer Related 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 is seeking a comprehensive informatics enterprise service and operation solution for processing submission data across multiple application types (ANDA, NDA, BLA, IND, MF). The contract aims to provide a streamlined end-to-end workflow management system that can ingest submission data, route it through targeted workflow management platforms like Workfront and Appian, and ultimately archive FDA review documents in specified record management systems. The estimated solicitation release date is November 1, 2025, with an anticipated contract award on January 1, 2026.
The forecasted contract is categorized under NAICS code 541519 for Other Computer Related Services and includes $2.5 million in support of Workflow Management Operations and Maintenance (WFM O&M). The solution will need to handle various submission metadata, capture review decisions, trigger additional review processes based on different decisions, and archive documents in either on-premises (Documentum) or cloud-based record management systems. Primary points of contact include Christopher Scott, who can be reached at christopher.scott@fda.hhs.gov, representing the Food and Drug Administration.
Forecast text
Provide a streamlined end-to-end solution to ingest submission data for all application types (ANDA, NDA, BLA, IND, MF) from ASR and kick off accurate workflow processes to the targeted workflow management systems such as Workfront and Appian based on the submission metadata (eCTD backbone + application form) in the context of application/submission review phase; capture review decisions, trigger additional review process based different decision and finally archive the FDA review documents to FDA defined Record Management System such as Documentum in on-prem environment or other Record Management system selected by FDA in cloud environment. Include $2.5m in support of WFM O&M.
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