Development of automation tools and data warehouse to facilitate BE assessments

Section 1: Use Case Identifiers

Use Case ID: HHS-FDA-00014

Agency: HHS

Op Div/Staff Div: FDA

Use Case Topic Area: Mission-Enabling (internal agency support)

Is the AI use case found in the below list of general commercial AI products and services?

None of the above.

Describe the AI system’s outputs.

Transform submitted PK data into a usable format so that the reviewer can perform the routine bioequivalence analysis using the authorized pre-written SAS codes. Then it exports results to a draft bioequivalence review document with the firm-submitted eCTD tables.

Stage of Development: Acquisition and/or Development

Is the AI use case rights-impacting, safety-impacting, both, or neither?

Neither

Section 2: Use Case Summary

Date Initiated: 05/2018

Date when Acquisition and/or Development began: 05/2018

Date Implemented: N/A

Date Retired: N/A

Was the AI system involved in this use case developed (or is it to be developed) under contract(s) or in-house?

Developed with both contracting and in-house resources.

Provide the Procurement Instrument Identifier(s) (PIID) of the contract(s) used.

75F40120F80605

Is this AI use case supporting a High-Impact Service Provider (HISP) public-facing service?

N/A

Does this AI use case disseminate information to the public?

N/A

How is the agency ensuring compliance with Information Quality Act guidelines, if applicable?

N/A

Does this AI use case involve personally identifiable information (PII) that is maintained by the agency?

N/A

Has the Senior Agency Official for Privacy (SAOP) assessed the privacy risks associated with this AI use case?

ongoing

Section 3: Data and Code

Do you have access to an enterprise data catalog or agency-wide data repository that enables you to identify whether or not the necessary datasets exist and are ready to develop your use case?

No

Describe any agency-owned data used to train, fine-tune, and/or evaluate performance of the model(s) used in this use case.

N/A

Is there available documentation for the model training and evaluation data that demonstrates the degree to which it is appropriate to be used in analysis or for making predictions?

Documentation is widely available

Which, if any, demographic variables does the AI use case explicitly use as model features?

N/A

Does this project include custom-developed code?

N/A

Does the agency have access to the code associated with the AI use case?

N/A

If the code is open-source, provide the link for the publicly available source code.

N/A

Section 4: AI Enablement and Infrastructure

Does this AI use case have an associated Authority to Operate (ATO) for an AI system?

Yes

System Name: CDEROne Analytics: FISMA-high environment

How long have you waited for the necessary developer tools to implement the AI use case?

Less than 6 months

For this AI use case, is the required IT infrastructure provisioned via a centralized intake form or process inside the agency?

Yes

Do you have a process in place to request access to computing resources for model training and development of the AI involved in this use case?

Yes

Has communication regarding the provisioning of your requested resources been timely?

Yes

How are existing data science tools, libraries, data products, and internally-developed AI infrastructure being re-used for the current AI use case?

Use of existing data platforms

Has information regarding the AI use case, including performance metrics and intended use of the model, been made available for review and feedback within the agency?

Limited documentation for review