0910-AF14 200904 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 321 21 USC 331 21 USC 351 to 353 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 08/00/2009 No Organizations None No No No No Colleen Locicero 0910 Food and Drug Administration FDA 301 796-2270 301 796-9840 colleen.locicero@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Building 22, Room 4200, Silver Spring MD 20993-0002