RIS: Computerized Labeling Assessment Tool Services (CLAT) (IT)

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.

Estimated value

>= $250K and < $700K

Est. solicitation date

Sep 1, 2025

Anticipated award

Feb 1, 2026

• NAICS541519
• PSC541519