Renamed: Extracting DMF Facilities from unstructured documents Previously: DMF (Drug Master File) Facilities

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

2023-06 (month precision)Source: Jun-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 receives Drug Master File (DMF) submissions containing valuable information about manufacturing facilities, but this data exists in various document formats that require manual review to compile comprehensive facility information.

Expected benefits

Extracts facility references from Type II (Drug Substance) DMF manufacturing submissions (i.e., DMF123456 discloses that it uses Facility X for manufacturing and Facility Y for stability testing). These DMF submissions may include structured documents (3938 form) or unstructured documents (electronic Common Technical Document module 3), enabling more comprehensive oversight of the drug supply chain.

System outputs

Support information extraction from unstructured documents

Technology

AI classification

Natural language processingSource: Natural Language Processing: AI that processes, interprets, and shares information in human language.

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.

Potential impacts and how they were identified

Not reported