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

Summary

The Food and Drug Administration (FDA) is announcing a proposed collection of information for review and clearance under the Paperwork Reduction Act of 1995, related to the use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics.