HHS · no agency ID · record R0858

SCANS Facility Role Predictor

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

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: 2024-07 (month precision)Source: Jul-24
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

The AI was used to identify facilities that are either Active Pharmaceutical Ingredient (API) or Finished Dosage Form (FDF) manufacturers that were either missed or misclassified in regulatory tracking systems.

Expected benefits

Successfully identified previously missed facilities without manually reviewing documents, improving FDA's ability to maintain comprehensive oversight of the drug manufacturing supply chain

System outputs

The output is a classification of Non-manufacturer, API, FDF, or API\FDF

Technology

AI classification: Natural language processingSource: Natural Language Processing: AI that processes, interprets, and shares information in human language.
System name(s): Not reported
Custom-developed code: Yes
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: We used 356H documents, which are vendor submitted documents describing facilities used in the production of a drug product.
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