Publication of Notice of Proposed Rulemaking for Clinical Trials Registration and Results Submission under FDAAA


Notice Number:

NOT-OD-15-018

Key Dates

Release Date: November 19, 2014

Related Announcements

February 25, 2015 - Notice of Extension of Public Comment Period for Notice of Proposed Rulemaking for Clinical Trials Registration and Results Submission under FDAAA. See Notice NOT-OD-15-072.
NOT-OD-15-019

Issued by

National Institutes of Health (NIH)

Purpose

Today, the Department of Health and Human Services published, for a 90-day public comment period, a Notice of Proposed Rulemaking (NPRM) for Clinical Trials Registration and Results Submission under Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). The NPRM proposes requirements for submitting registration and summary results information, including adverse event information, for specified "applicable clinical trials" to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine, part of the National Institutes of Health (NIH). The NPRM provides for the expanded registry and results data bank that was established in FDAAA to enhance patient enrollment, provide a mechanism to track subsequent progress of clinical trials, provide more complete results information, and enhance patient access to and understanding of the results of clinical trials. The proposed requirements would apply to the responsible party (meaning the sponsor or designated principal investigator) for specified applicable clinical trials of drugs (including biological products) and devices (including pediatric postmarket surveillances of a device that are ordered by FDA). It applies to the private sector as well as the public sector. The Federal Register Notice is available for public inspection at: http://ofr.gov/OFRUpload/OFRData/2014-26197_PI.pdf. Public comments should be submitted electronically to Docket No. NIH-2011-0003 at www.regulations.gov.

In a separate Guide Notice NOT-OD-15-019, NIH proposes a complementary draft policy that expects clinical trial registration and results submission for all NIH-funded clinical trials, whether or not they are subject to FDAAA. NIH encourages NIH-funded investigators to comment on the draft NIH policy, in addition to the NPRM. Comments on the proposed NIH policy should be submitted electronically to clinicaltrials.disseminationpolicy@mail.nih.gov.

Inquiries

Please direct all inquiries about the NPRM to:

Jerry Sheehan
National Library of Medicine (NLM)
Telephone: 301-496-6221
Email: sheehanjr@nlm.nih.gov

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