FR 2025-06051

The document presents a notice from the Food and Drug Administration (FDA), exploring the possibility of changing the data format used for submitting electronic study data to two of its centers—Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research. Currently, the industry uses a format known as SAS version 5 XPORT Transport Format, but the FDA is contemplating replacing it with Dataset-JavaScript Object Notation (Dataset-JSON) version 1.1, which is based on standards from the Clinical Data Interchange Standards Consortium (CDISC). This contemplation is encapsulated in the FDA's request for comments concerning the adoption of this new format and any arising integration challenges.

General Summary of the Document

This Federal Register notice is essentially an inquiry by the FDA directed at industry professionals about transitioning to Dataset-JSON as a modern standard for electronic submissions. JSON, a common data format on the web, is lauded for its efficiency, smaller file sizes, and ease of processing compared to the existing format. Thus, Dataset-JSON is being considered as an alternative format to streamline data submission processes in alignment with modern technology trends.

Significant Issues or Concerns

A critical issue with this document is its level of technicality, which may not be clear to individuals who lack familiarity with data standards like CDISC or technical terminologies such as "XPORT Transport Format" and "Define-XML." It discusses a pilot study and technical assessments but doesn't clearly expound on potential challenges industries might face when integrating Dataset-JSON—such as cost implications or technical overhauls required for the transition.

The document also lacks detail on how the FDA plans to engage further with stakeholders, making it unclear how feedback collected will be incorporated into decision-making processes. The call for comments doesn't offer specifics on anticipated risks and benefits, leaving stakeholders with questions about what concerns or advantages they should prioritize in their feedback.

Impact on the Public

The public impact of transitioning to this new data format might not be immediately noticeable, as the changes are technical and industry-specific. However, indirectly, if the transition leads to more efficient processes in drug evaluation and biologics research, this could translate into quicker regulatory approvals and improved public health outcomes. The public may experience faster access to new therapies and drugs as a downstream effect of improved data processing within the FDA.

Impact on Specific Stakeholders

Organizations or industries familiar with JSON technology and standards like CDISC might find this transition to Dataset-JSON beneficial. They might already have in place the infrastructure or expertise needed to handle JSON data, placing them at an advantage. On the contrary, some stakeholders may face challenges, especially those heavily invested in the current SAS infrastructure, where shifts could bring financial strain or require extensive updates or training.

In the long run, technologies that facilitate quicker, more efficient data handling align with the FDA's Data Modernization Action Plan, promising a streamlined regulatory environment. This change, however, hinges on how well the transition is managed, how inclusive the FDA is of industry feedback, and how potential challenges are addressed.