OMB NO: 0925-0586
Burden Statement

Public reporting burden for this collection of information is estimated to average 8.0 hours per response for initial registration, 2.0 hours for each of 8 updates to the registration information during the course of the trial, 40.0 hours per response for initial results submission, 10.0 hours for two substantive updates to the results information. These estimates include the time for reviewing instructions, searching existing data sources, gathering the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0586). Do not return the completed form to this address