NIH Regulations Officer

0925-AA55 201510 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 Clinical Trials Registration and Results Submission

This rule will prescribe procedures for registering and submitting summary 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). As previously announced, NIH intends to proceed with a single rulemaking to implement the expanded registry, results reporting, and adverse event information reporting requirements of the statute.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 42 CFR 3 42 U.S.C. 282(i) 42 U.S.C. 282(j) 5 U.S.C. 301 42 U.S.C. 286(a) 42 U.S.C. 241(a) 42 U.S.C. 216(b) Statutory Final 09/27/2010 No NPRM 11/21/2014 79 FR 69566 NPRM Comment Period End 02/19/2015 Final Action 05/00/2016 Undetermined Businesses None No No No No Jerry Moore NIH Regulations Officer 0925 National Institutes of Health NIH 301 496-4607 301 402-0169 jm40z@nih.gov Room 601 MSC 7669, 6011 Executive Boulevard, Suite 601-K, Rockville MD 20852