HHS · no agency ID · record R0843

AI Editing Tool

Department of Health and Human Services · HHS/FDA/CDER

Overview

Development stage: PilotSource: b) Pilot – The use case has been deployed in a limited test or pilot capacity.
High-impact designation: Not high-impactSource: c) Not high-impact
Impact justification: Not reported
Start date: 2025-03 (month precision)Source: Mar-25
Withheld from public reporting: NoSource: a) No

Mission

Topic area: Administrative Functions
Operational functions: No function tag matched Derived by keyword rules; see methodology

Problem the AI is intended to solve

This AI model is designed to detect style and formatting inconsistencies in FDA draft documents by comparing them against the FDA CDER Style Guide standards. It solves the problem of manual quality control inefficiencies and ensures consistent adherence to established documentation standards across all FDA CDER publications.

Expected benefits

It significantly reduces the workload for FDA editors by identifying style and formatting issues; however, human review remains essential, especially for important documents, ensuring both efficiency and quality in FDA communications.

System outputs

AI-identified style and formatting issues

Technology

AI classification: Generative AISource: Generative AI: AI that generates new or synthetic content (e.g., images, videos, audio, text, code).
System name(s): Not reported
Custom-developed code: No
Public source code: Not reported

Sourcing

How it was built: Developed in-houseSource: b) Developed in-house
Vendor (as reported): Not reported
Vendors (standardized): None on the standard list

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: No
Demographic features: k) None of the above
Training and evaluation data: CDER Style Guide
Federal Data Catalog: CDER Style Guide

Governance

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

Pre-deployment testingNo answer reported

AI impact assessmentNo answer reported

Independent reviewNo answer reported

Ongoing monitoringNo answer reported

Operator trainingNo answer reported

Fail-safeNo answer reported

Appeal processNo answer reported

User and public consultationNo answer reported

Potential impacts and how they were identified

Not reported