HHS · no agency ID · record R0831

Regulatory Starting Material

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: 2023-08 (month precision)Source: Aug-23
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

FDA needs comprehensive visibility into the upstream supply chain for drug manufacturing, particularly tracking regulatory starting materials and their suppliers across approved and pending drug applications to better understand potential supply chain vulnerabilities.

Expected benefits

Assists in extracting Regulatory Starting Materials (RSMs) and their suppliers from unstructured module 3 industry submissions to help create an inventory that will illuminate the upstream supply chain and help FDA identify potential supply chain vulnerabilities.

System outputs

Support information extraction from unstructured documents

Technology

AI classification: Generative AISource: Generative AI: AI that generates new or synthetic content (e.g., images, videos, audio, text, code).
System name(s): CDEROne Analytics: FISMA-high environment
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.

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