Overview
Title
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics
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ELI5 AI
The FDA wants to hear what people think about using special databases that help check if medical tests work well. They want to make sure these databases are good and safe, and need people's ideas on their plan.
Summary AI
The Food and Drug Administration (FDA) is seeking public comments on a proposal to gather information related to the use of public human genetic variant databases. These databases are used to support the clinical validity of genetic and genomic-based tests. The FDA is considering extending their guidelines and processes for recognizing these databases as trustworthy sources of scientific evidence. The deadline for submitting comments is March 26, 2021, and interested parties can access the collection of information online and share their feedback.
Abstract
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Keywords AI
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AnalysisAI
The Food and Drug Administration (FDA) has announced a proposal to collect information on the use of public human genetic variant databases, which play a crucial role in supporting the clinical validity of genetic and genomic-based diagnostic tests. The aim is to extend current guidelines to enhance the use of these databases as reliable sources of scientific evidence. The public is invited to provide feedback on this proposal by March 26, 2021, and comments can be submitted through an online platform. This commentary explores the document's content, its implications, and concerns.
General Summary
This notice from the FDA aims to improve the reliability and accessibility of genetic variant databases, which are essential for verifying the accuracy of genetic tests. Through this initiative, the FDA seeks to formalize the process by which these databases can be recognized as credible sources of evidence, supplementing the clinical validity of diagnostic tests. Specifically, the proposal underlines the procedures for database administrators to apply for such recognition and the subsequent maintenance and oversight required to keep this status.
Significant Issues and Concerns
One main concern is the estimate of five respondents per year who might apply for recognition based on the current criteria. This figure lacks clear justification or supporting data, leaving readers questioning its accuracy. Additionally, the time estimates for the application process (80 hours) and its ongoing maintenance (20 hours annually) seem significant, and the document does not sufficiently explain why such timeframes are needed.
Another issue arises from the FDA's response to public comments, particularly concerns about personally identifiable information (PII) and protected health information (PHI). The FDA clarifies that the application process does not involve submitting such information but instead focuses on the procedures for safeguarding this data in the databases. However, the explanation could be more straightforward and comprehensive to prevent misunderstanding.
Impact on the Public
For the general public, this document indicates a move towards more reliable genetic testing, which is beneficial as the results from these tests can significantly influence healthcare decisions. The public can play a role by providing feedback, contributing to a transparent and responsive regulatory process.
Impact on Specific Stakeholders
Database administrators are directly affected as they stand to benefit from gaining official recognition from the FDA, potentially improving the credibility and utility of their databases. However, the application and maintenance process presents a substantial commitment in terms of time and resource investment.
For patients and healthcare providers, the potential improvement in the reliability of genetic tests means more accurate diagnosis and treatment plans, aiding in overall healthcare quality. However, these changes will require stakeholders to stay informed about new processes and standards, ensuring they align with the FDA's updated guidelines.
In conclusion, while the FDA's initiative to enhance the usage of genetic variant databases holds promise, it is essential for the agency to address noted concerns, ensuring the effective implementation of its objectives and fostering broad stakeholder engagement.
Issues
• The document provides an estimate of five respondents per year based on the current number of databases that 'may' meet FDA recommendations for recognition and seek such recognition, which could benefit from clearer justification or data backing this estimate.
• The time estimates for completing the application (80 hours) and maintenance activities (20 hours) may need further explanation or data to justify these figures as reasonable or accurate.
• The response to the comment on concerns about PII and PHI could clarify more clearly that the application process does not include submission of PII/PHI but rather pertains to the database's procedures to protect such information.
• The language and structure of the document might be overly complex for non-expert stakeholders, which can make it difficult for them to understand the key points or actions required from them.
• The communication about the comment misunderstanding the subject could be improved to reduce ambiguity about what is being collected during the application process.