OMB Individually Reported
Process Large Amount of Submitted Docket Comments
Low riskExact public inventory row
Description
Deduplication of public comments, and generating draft sentiment analysis and grouping of comments
Detailed example
To provide reviewers adhoc VAERS queries.
AI / analytics pattern
Natural Language Processing: AI that processes, interprets, and shares information in human language.
Automation level / stage
b) Pilot – The use case has been deployed in a limited test or pilot capacity.
Expected benefit
To enhance the automatic process of dockets, we have created an AI/ML tool in CBER/HIVE that automatically download dockets and process them to accelerate the review of docket comments, significantly improving the efficiency and accuracy of our regulatory processes. Efficiently generate customized query outputs of VAERS queries for reviewers.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
Public comments on various FDA dockets