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Snapshot · OMB 2025 inventory · processed Oct 11, 2026
HHS · no agency ID · record R0879

Electronic translational services for regulatory documents for articles offered for import

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

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
2024-04 (month precision)Source: Apr-24
Withheld from public reporting
NoSource: a) No

Mission

Topic area
Information Technology
Operational functions
Translation and transcription Derived by keyword rules; see methodology

Problem the AI is intended to solve

FDA' Office of Information Operations (OIO) seeks to implement automated translation capabilities for foreign language documents essential to import operations. By integrating translation services directly into OIO staff workflows, the Agency can improve import screening to better serve stakeholders while maximizing staff capacity for core public health protection activities.

Expected benefits

The implemented solution automated the electronic translation of inspection/investigation and import documents, labels, industry guidance, materials related to policy and regulatory, presentations and educational records. This automation significantly reduced time spent by staff to translate documents, reduced the need to find a translator to read and understand foreign language documents, increased reliability and timeliness for enforcement actions, increased destruction of misbranded FDA regulated products at the IMFs, and increased the ability to provide regulatory materials in foreign languages.

System outputs

A translation service interface developed within an imports entry review system that utilizes Google Translate API provides the required translation of the entries entering US supply-chain. This will provide translation to the FDA imports staff without seeking external solutions and is integrated in the current system used by the consumer safety officers who are conducting investigations, import operations etc.

Technology

AI classification
Natural language processingSource: Natural Language Processing: AI that processes, interprets, and shares information in human language.
System name(s)
MLaaS
Custom-developed code
Yes
Public source code
git.fda.gov ↗

Sourcing

How it was built
Contract and in-houseSource: c) Developed with both contracting and in-house resources
Vendor (as reported)
Google Translate API / MLaaS / Azure
Vendors (standardized)
MicrosoftGoogle

A vendor is the supplier named by the agency. It does not identify the underlying model or AI technology.

Data and privacy

Involves PII
Yes
Privacy Impact Assessment
Not reported
Authorization to Operate
Yes
Demographic features
k) None of the above
Training and evaluation data
N/a
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