0910-AH07 201404 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Investigational New Drug Application Annual Reporting Other Significant First Time Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 312.3 21 CFR 312.33 21 USC 355(i) 21 USC 371(a) No NPRM 03/00/2015 Yes Businesses None No Yes No Peter Taschenberger A. 0910 Food and Drug Administration FDA 301 796-0018 301 847-3529 peter.taschenberger@fda.hhs.gov 10903 New Hampshire Avenue, Building 51, Room 6312, Silver Spring MD 20993