0910-AC52 200904 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes No 21 CFR 314.50 21 CFR 601.12 21 CFR 314.94 21 CFR 314.96 21 USC 355 21 USC 371 42 USC 262 No NPRM 09/00/2009 Yes Businesses None No No Yes No 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