0910-AC52 200310 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Submission of Standardized Electronic Study Data From Clinical Studies Evaluating Human Drugs and Biologics Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 314.50 21 CFR 601.12 21 CFR 314.94 21 USC 355 21 USC 371 42 USC 262 No NPRM 07/00/2004 Yes Businesses Undetermined No No NA Not Collected Darren Eicken 0910 Food and Drug Administration FDA 301 796-0978 301 827-8440 darren.eicken@fda.hhs.gov Room 3037, (HFD-7), Center for Drug Evaluation and Research, Building 51, Room 6206, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002