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HHS/NIH | RIN: 0925-AA55 | Publication ID: Spring 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. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
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:
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Timetable:
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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 | |
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 |