0910-AF13 200904 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Charging for Investigational Drugs Under an Investigational New Drug Application Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 312.7 and 312.8 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 356 21 USC 371 21 USC 381 to 383 21 USC 393 42 USC 262 No NPRM 12/14/2006 71 FR 75168 NPRM Comment Period End 03/14/2007 Final Action 08/00/2009 No Businesses 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