OMB Individually Reported
Category Subcategory Classification - Safety Reports Bot
Low riskExact public inventory row
Description
Manual analysis and data entry of safety report submissions is time-intensive and requires staff to review scanned PDFs and determine appropriate categories.
Detailed example
To predict cat/subcat from IND submissions through the rule setup.
AI / analytics pattern
Other
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Potentially reduces manual labor in processing safety report submissions, allowing FDA staff to focus on safety analysis and regulatory decision-making rather than data entry tasks.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
Applicant submissions