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
-
- 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 contractor to develop and maintain the Knowledge-aided Assessment and Structured Application (KASA) system and the Office of Generic Drugs (OGD) Label Review Tool (LRT). The project involves further development of the KASA system, including enhancements to the Drug Substance module, ATL summary, ANDA Liquid Dosage, and Integrated Assessment, as well as expanding the LRT's capabilities with new workflows, integrations, and reporting features. The estimated solicitation release date is April 1, 2026, with an anticipated contract award on June 1, 2026.
While specific award values are not disclosed, the contract is structured as a base contract with option years, indicating a potential multi-year engagement. The work will be performed within the Food and Drug Administration and focuses on modernizing regulatory review processes through advanced software tools. Key contacts include Christopher Scott (christopher.scott@fda.hhs.gov) from the FDA, who can provide additional information about this opportunity categorized under NAICS code 541519 for Other Computer Related Services.
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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