Regulatory Review Modernization Development (KASA & OGD Label Tool, Struct Rev
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
-
- 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 seeking development and maintenance services for the Knowledge-aided Assessment and Structured Application (KASA) system and the Office of Generic Drugs (OGD) Label Review Tool (LRT). Key requirements include further development of the KASA system with Drug Substance module, ATL summary, ANDA Liquid Dosage, and Integrated Assessment capabilities, as well as maintenance and enhancement of the OGD Label Review Tool, which consolidates data sources for labeling assessments through a unified user interface. The solicitation is expected to be released on January 1, 2026, with an estimated award date of June 1, 2026.
The estimated award value ranges from $7,000,000 to $13,000,000 for this base plus option years contract, which will include ongoing maintenance of the Appian deployment and implementation of new workflows, integrations, and reporting capabilities. This procurement falls under NAICS code 541519 (Other Computer Related Services) with no set-aside restrictions. Interested vendors should contact the FDA's Acquisition Liaison at cderacquisitions@fda.hhs.gov for additional information regarding this recurring contract opportunity.
Forecast text
Regulatory Review Modernization Development (KASA & OGD Label Tool, Sturctured Review) This contract is for development and maintenance of Knowledge-aided Assessment and Structured Application (KASA) system and OGD's Label Review Tool (LRT). For KASA, further development in FY22 includes Drug Substance module, ATL summary, ANDA Liquid Dosage, and Integrated Assessment. The OGD Label Review Tool (LRT) brings together data sources allowing access through a user interface for labeling assessments based on current review template used by OGD for reviews. The work includes maintenance of the new Appian deployment, and new features including new workflows, integrations, and reporting capabilities. This will be base plus option years (reoccurring)
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