Federal Register Notice: FDA’s proposed collection of information, “Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements (Formerly: Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators and FDA Staff Humanitarian Device Exemption Regulation: Questions and Answers),” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.