Category Subcategory Classification - Safety Reports Bot

Overview

Development stage

DeployedSource: c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.

High-impact designation

Not high-impactSource: c) Not high-impact

Impact justification

Not reported

Start date

2024-05 (month precision)Source: May-24

Withheld from public reporting

NoSource: a) No

Mission

Topic area

Health and Medical

Operational functions

Document processing and extraction Derived by keyword rules; see methodology

Problem the AI is intended to solve

Manual analysis and data entry of safety report submissions is time-intensive and requires staff to review scanned PDFs and determine appropriate categories.

Expected benefits

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.

System outputs

To predict cat/subcat from IND submissions through the rule setup.

Technology

AI classification

Other

System name(s)

Data Services Automation

Custom-developed code

Yes

Public source code

Not reported

Sourcing

How it was built

Contract and in-houseSource: c) Developed with both contracting and in-house resources

Vendor (as reported)

Deloitte

Vendors (standardized)

Deloitte

A vendor is the supplier named by the agency. It does not identify the underlying model or AI technology.

Data and privacy

Involves PII

No

Privacy Impact Assessment

Not reported

Authorization to Operate

Yes

Demographic features

k) None of the above

Training and evaluation data

Applicant submissions

Federal Data Catalog

Not reported

Governance

0 of 8 minimum-practice questions answered. A blank answer means the agency reported nothing; it does not mean the practice is absent.

Potential impacts and how they were identified

Not reported