*DARRTS DME & O&M, BA and Production Support New Contract
Forecast New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $3,000,000 to $7,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541511 Custom Computer Programming Services
- Points of contact
-
- CDER Acquisition Liaison cderacquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is procuring custom computer programming services for modifications, operations, and maintenance of DARRTS, a component-based enterprise application that manages drug applications and supports FDA regulatory reporting on PDUFA, GDUFA, and BsUFA performance. The contract will fund functional and interface changes and enhancements to support PDUFA VII and GDUFA III requirements and the CDER Regulatory Review Process Modernization effort, with solicitation release targeted for November 1, 2026, and award estimated for April 1, 2027.
The estimated award value ranges from $3 million to $7 million. DARRTS operates within the CDER intranet network and serves authorized FDA users through a web-based interface. Inquiries should be directed to the FDA Acquisition Liaison at cderacquisitions@fda.hhs.gov.
Forecast text
DARRTS is a component-based, multi-tier enterprise application accessed via a web-based interface. The system runs within the CDER intranet network and is only available to authorized users. DARRTS provides FDA users with the ability to receive, manage, track, and report on drug applications, delivering major advancements regarding flexibility, integration, and meeting CDER's business requirements. DARRTS helps the FDA provide better reports to Congress on a number of issues, including performance on PDUFA, GDUFA, and BsUFA. The purpose of this TO is to acquire services necessary for modifications and O&M of the DARRTS Program to support functional and interface changes, as well as enhancements to support additional PDUFA VII and GDUFA III requirements and the CDER Regulatory Review Process Modernization effort.
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