FDA Submits Collection of Information for OMB Review and Clearance Under Paperwork Reduction Act

Summary

The Food and Drug Administration (FDA) has submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and clearance, as required by the Paperwork Reduction Act of 1995, to obtain guidance on informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable.