Federal Register Notice: FDA’s proposed collection of information on informed consent for in vitro diagnostic device studies using leftover human specimens not individually identifiable has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995.

FDA is also soliciting comments on the proposed collection of information associated with the guidance document entitled Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable. To view this notice, click here.