Grants Policy

What NIH Grantees Need to Know About FDAAA

Update: New HHS rule and NIH policy, effective January 18, 2017, affect all NIH-funded clinical trials. Read the summary.

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:

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

The NIH encourages registration and results reporting for all NIH-supported clinical trials, regardless of whether or not they are subject to FDAAA.

This page last updated on September 16, 2016 
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