and FDAAA - Regulations, Policies & Guidance
U.S. Department of Health & Human Services Logo
Skip to Main Content
Grants Policy
Policy & Guidance
Compliance & Oversight
Research Involving Human Subjects
Office of Laboratory Animal Welfare (OLAW)
Animals in Research
Peer Review Policies & Practices
Intellectual Property Policy
Invention Reporting (iEdison)
NIH Public Access
Research Integrity
Global OER Resources
Glossary & Acronyms
Frequently Used Links
Question Mark - FAQs Frequently Asked Questions
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

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.