The Food and Drug Administration (FDA) has submitted a proposed information collection to the Office of Management and Budget (OMB) for review. This collection involves FDA's expedited programs for serious and life-threatening conditions, such as fast track and breakthrough therapy designations, which are designed to speed up the development and marketing of new drugs and biologics. The FDA has issued guidance for sponsors developing these therapies, and is accepting public comments until March 22, 2021. The agency estimates significant effort will be required from participants to prepare necessary documentation, with varying hours needed depending on the type of request.
Simple Explanation
The FDA wants to make sure new medicines for serious illnesses are made faster and is asking for permission from another office to gather information about this. They also want to know what people think by March 22, 2021, but nobody has sent in comments yet.