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| HHS/NIH | RIN: 0925-AA55 | Publication ID: Fall 2011 |
| Title: Expanded Registration and Results Reporting at ClinicalTrials.gov | |
| Abstract: The National Institutes of Health (NIH) proposes to issue new regulations that will 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, PL. 110-85). As previously announced, the agency intends to proceed with a single rulemaking to implement the expanded registry, results reporting, and adverse event information reporting requirements of the statute. The rulemaking will also consider topics that the statute requires to be addressed in regulations intended [to provide more complete results information and to enhance patient access to and understanding of the results of clinical trials] [as codified in 42 U.S.C. 282(j)(3)(D)], including whether results information should be required to be submitted for applicable clinical trials of drugs, biological products, or devices that have not been approved, licensed, or cleared by the Food and Drug Administration, and whether narrative summaries of clinical trials and their results can be included in the data bank without being misleading or promotional. These topics were the subject of discussion at the public meeting organized by NIH in April 2009, and of written public comments. The regulations will identify the trials that are subject to the registration and results reporting requirements (including adverse event reporting); the specific information and format of the information that must be submitted to ClinicalTrials.gov; deadlines for registering and reporting results; procedures for extending the deadlines or waiving the submission requirements; and procedures for agency review and public posting of submitted information. | |
| 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:
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| 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 | |
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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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