0910-AC52 200510 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 Other Significant 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 Yes NPRM 06/00/2006 Yes Businesses None No No NA Not Collected Martha Nguyen 0910 Food and Drug Administration FDA 301 796-3601 301 847-8440 martha.nguyen@fda.hhs.gov Center for Drug Evaluation and Research, WO 51, Room 6250, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002