What NIH Grantees Need to Know About FDAAA
This Web site provides information to help NIH applicants and grantees (recipients of extramural grants, including cooperative agreements) to understand their roles and responsibilities in relation to the Food and Drug Administration Amendments Act (FDAAA) of 2007.
The information on this site may not apply to NIH contracts or NIH intramural research.
FDAAA for NIH Grantees: The Basics
Proposed Policies and Rules:
- Proposed Rulemaking for Clinical Trials Registration and Results Submission under FDAAA
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 Federal Register Notice is available for public inspection at:Â http://ofr.gov/OFRUpload/OFRData/2014-26197_PI.pdf. Public comments should be submitted electronically by March 23, 2015 to Docket No. NIH-2011-0003 atÂ www.regulations.gov.
- Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
NIH is seeking public comments on a draft policy to promote broad and responsible dissemination of information on clinical trials funded by the NIH through registration and submission of summary results information to ClinicalTrials.gov. NIH encourages the public to provide comments on any aspect of the draft policy, described below, by March 23, 2015. Comments should be submitted electronically to the Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, via email atÂ email@example.com, mail at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, or by fax at 301-496-9839.
NIH Implementation of FDAAA
Further Resources for NIH Grantees
For Additional Information
Additional questions about compliance with the NIH implementation of FDAAA may be directed to the NIH Office of Extramural Research at OEPmailbox@mail.nih.gov.
The NIH encourages registration and results reporting for all NIH-supported clinical trials, regardless of whether or not they are subject to FDAAA.