View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/NIH RIN: 0925-AA55 Publication ID: 2012 
Title: Expanded Registration and Results Reporting at ClinicalTrials.gov 
Abstract: 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). 
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 USC282(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  01/00/2013 
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, Suite 601-K,
Rockville, MD 20852
Phone:301 496-4607
Fax:301 402-0169
Email: jm40z@nih.gov