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HHS/NIH RIN: 0925-AA52 Publication ID: Spring 2009 
Title: Procedures for Registration of Applicable Clinical Trials in the ClinicalTrials.gov Registry 
Abstract: NIH plans to issue new regulations that will prescribe specific procedures for registering clinical trails in the expanded ClinicalTrials.gov registry, and define the information that must be provided. Required information will include descriptive information, recruitment information, location and contact information, and administrative information. The regulations will define additional information needed to comply with specific statutory requirements related to search capabilities, enforcement, posting of information related to trials of uncleared/unapproved devices, as well as to support efficient entry of valid data, link the trials in the registry database to their results, and to provide a comprehensive registry of clinical trials for the public. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 42 USC 282(i)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2009    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses, Organizations  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