RIS: Computerized Labeling Assessment Tool Services (CLAT) (IT)
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
- 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 seeks to procure the Computerized Labeling Assessment Tool (CLAT) Services, an information technology solution that leverages computer programming, image processing, and artificial intelligence technologies to automate the review of drug labeling including container labels, carton labeling, prescribing information, and instructions for use. The tool will auto-review drug labeling against a library of FDA regulations, guidances, standards, and best practices to mitigate medication errors, increase operational and cost efficiencies, standardize labeling across therapeutic drug classes, and identify deviations between version changes. The solicitation is estimated to be released on September 1, 2025, with an estimated award date of February 1, 2026.
The estimated award value ranges from $250,000 to $700,000 under NAICS code 541519 (Other Computer Related Services), with funding split between PDUFA and GDUFA to support all CDER medical products. This is a new requirement with no set-aside designation, and the contract will support the delivery of a Minimal Viable Product with a one-year period of performance. Interested contractors should contact the FDA's Office of Acquisition Liaison at cderacquisitions@fda.hhs.gov for additional information regarding this opportunity.
Forecast text
CLAT will provide a tool for FDA Reviewers that uses computer programming, image processing, and AI technologies to replace the manual (hands on) review of drug labeling, including container labels, carton labeling, prescribing information, and Instructions for Use. CLAT will auto-review the drug labeling against a library of FDA regulations, guidance's, standards, and best practices to help mitigate medication errors, increase operational and cost efficiencies, and standardize labeling across therapeutic drug classes and product types. CLAT will identify deviations between version changes and ensure no unintended errors have been introduced. Funding Type Rationale: The fund type is split between PDUFA and GDUFA; supports all CDER medical products. Note: In FY24 OSE did not receive funding for this project. The current POP ends 9/30/2024 OSE intends to issue a NCE through mid-October 2024 and to follow-up with submitting a new task order early in FY25 with a 1-year POP to ensure Minimal Viable Product (MVP) is delivered and the investment to date is realized. The impact if not funded is that the expertise supporting this project would be lost and would require additional costs to restart and a steep learning curve, if the project was interrupted.
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