View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
HHS/NIH | RIN: 0925-AA52 | Publication ID: Fall 2008 |
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:
|
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 |