Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable

摘要

The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Guidance on Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.