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

• Overview of FDAAA
• FDAAA and Clinical Trials Supported by NIH Grants
• Registering and Reporting Results in ClinicalTrials.gov

NIH Implementation of FDAAA

• Steps to Compliance for NIH Grantees
  • Flowchart: Identifying an “Applicable Clinical Trial” (PDF - 842 KB)
  • Flowchart: Identifying the “Responsible Party” (PDF - 177 KB)
  • At-a-glance: FDAAA requirements for NIH Grantees
• Certifying Compliance in NIH Grants and Progress Reports

Further Resources for NIH Grantees

• FAQs for NIH Grantees
• Definitions and Acronyms
• NIH Guide Notices
• Links