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

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Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The Food and Drug Administration is utilizing the Computerized Labeling Assessment Tool (CLAT) to automate the review of drug labeling, including container labels, carton labeling, prescribing information, and Instructions for Use. By leveraging AI, image processing, and computer programming, the tool compares labeling against a library of FDA regulations and standards to reduce medication errors, standardize labeling across product types, and identify unintended errors between version changes. Funding for this initiative is split between PDUFA and GDUFA to support all CDER medical products. Although the current period of performance ends on September 30, 2024, the agency intends to issue a no-cost extension through mid-October 2024 and subsequently submit a new one-year task order in early FY25. This strategy aims to ensure the delivery of a Minimum Viable Product and prevent the loss of critical project expertise, which would otherwise result in increased restart costs and operational delays.

General Info

FDA uses AI-powered CLAT tool for drug labeling review with funding through FY25.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541519 - Other Computer Related Services

Place of Performance

USA

Set-Aside

NONE

Documents

No documents available

Documents will appear here when they are available.

AI Contract Breakdown

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Organization & Contact Information

AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cder Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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.