HHS · no agency ID · record R0869

Smart Solution for Docket Management (SSDM)

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

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: 2025-07 (month precision)Source: Jul-25
Withheld from public reporting: NoSource: a) No

Mission

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

Problem the AI is intended to solve

The AI is intended to solve the extremely labor-intensive and time consuming process of manually collating, de-duplicating, and categorizing public comments on FDA dockets.

Expected benefits

1. Significant time and resource savings: The platform aims to save the Agency a substantial number of staff hours by assisting in reducing redundant and time-consuming tasks that can take weeks to complete manually. 2. Enhanced processing capacity: The platform will enable FDA to effectively handle large-scale comment volumes. 3. Improved accuracy and quality: The AI-powered deduplication, topic modeling, and keyword flagging can potentially enhance the overall quality of comment processing while reducing human error in manual sorting.

System outputs

The AI-enabled tool provides two main outputs: 1) a line listing excel file that organizes comments into groups based on similarity/deduplication thresholds and tags them with AI-identified and SME-approved keywords and topics; and 2) a comment summary word report that provides structured analysis of themes, key performance indicators, and submitter group breakdowns to assist in regulatory decision-making.

Technology

AI classification: Generative AISource: Generative AI: AI that generates new or synthetic content (e.g., images, videos, audio, text, code).
System name(s): AWS
Custom-developed code: Yes
Public source code: Will explore making the code open source - but not there yet.

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: Public comments on various FDA dockets
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.

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