0925-AA55 201210 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0925 National Institutes of Health NIH 0900 Department of Health and Human Services HHS Expanded Registration and Results Reporting at ClinicalTrials.gov This proposed rule would prescribe procedures for registering and reporting the results, including adverse events, of clinical trials in ClinicalTrials.gov, in accordance with section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA, Pub. L. 110-85). Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No 42 CFR 3 42 USC282(i) 42 USC 282(j) 5 USC 301 42 USC 286(a) 42 USC 241(a) 42 USC 216(b) Statutory Final 09/27/2010 No NPRM 01/00/2013 Undetermined Businesses None No No No Jerry Moore 0925 National Institutes of Health NIH 301 496-4606 301 402-0169 jm40z@nih.gov Room 601 MSC 7669, 6011 Executive Boulevard, Rockville MD 20852