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HHS/NIH RIN: 0925-AA55 Publication ID: Fall 2016 
Title: Clinical Trials Registration and Results Submission 
Abstract:

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.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 3   
Legal Authority: 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)   
Legal Deadline:
Action Source Description Date
Final  Statutory    09/27/2010 
Timetable:
Action Date FR Cite
NPRM  11/21/2014  79 FR 69566   
NPRM Comment Period End  02/19/2015 
Final Action  09/21/2016  81 FR 64981   
Final Action Effective  01/18/2017 
Regulatory Flexibility Analysis Required: No  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, Suite 601-K,
Rockville, MD 20852
Phone:301 496-4607
Fax:301 402-0169
Email: jm40z@nih.gov