0910-AF14 200804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Expanded Access to Investigational Drugs for Treatment Use Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 312.42 21 CFR 312.300 21 CFR 312.305 21 CFR 312.310 21 CFR 312.315 21 CFR 312.320 21 USC 355 21 USC 360bbb 21 USC 371 42 USC 262 Yes NPRM 12/14/2006 71 FR 75147 NPRM Comment Period End 03/14/2007 Final Action 10/00/2008 Yes Organizations None No No Yes Not Collected Christine Rogers F. 0910 Food and Drug Administration FDA 301 796-3601 301 847-8440 christine.rogers@fda.hhs.gov Suite 3059 (HFD-7), Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 6316, Silver Spring MD 20993-0002