Computerized Labeling Assessment Tool (CLAT) Services

The Food and Drug Administration (FDA) intends to award a single award IDIQ to a small business as follows: 

Objective:

FDA requires a comprehensive solution to best accomplish FDA specific mission objectives to ensure the safe use of drug products by minimizing medication errors related to drug product labeling. These objectives include the following:

• Automate drug product labeling reviews

• Implement and promote operational and cost efficiencies

Scope of the Requirement

The Government requires drug product labeling review support services for prescription and nonprescription drug products, that includes:

• Develop a Computerized Labeling Assessment Tool (CLAT) that meets FDA standards (e.g., security, usability, cloud infrastructure) and can be used to perform automated labeling review activities

• Implement CLAT in FDA’s environment that meets FDA’s infrastructure and security standards

• Access and organize submitted labeling files

• Apply automated capabilities to perform labeling assessments

• Report review findings (includes analytics and data visualization tools)

• Workload and performance metrics

• Use of open source software, artificial intelligence and other novel or emerging technologies to develop CLAT

• Test, and validate CLAT

• Evaluate new or additional labeling review activities for possible automation

• Enhance or expand functionality and capabilities for automated labeling review assessments by additional FDA offices and the public

• Quality assurance, quality control, and quality improvement

• User experience and user interface design

• Integrate CLAT with other internal or external data sources