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HHS/NIH RIN: 0925-AA55 Publication ID: Spring 2014 
Title: Clinical Trials Registration and Results Submission 
Abstract: This proposed rule would 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 3 
Legal Authority: 42 USC 282(i); 42 USC 282(j); 5 USC 301; 42 USC 286(a); 42 USC 241(a); 42 USC 216(b) 
Legal Deadline:
Action Source Description Date
Final  Statutory    09/27/2010 
Timetable:
Action Date FR Cite
NPRM  05/00/2014   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Jerry Moore
NIH Regulations Officer
Department of Health and Human Services
National Institutes of Health
Room 601 MSC 7669, 6011 Executive Boulevard,
Rockville, MD 20852
Phone:301 496-4606
Fax:301 402-0169
Email: jm40z@nih.gov

 
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