Protocol Registration System (Logo) Federal Sponsors' Logos: DHHS, NIH, FDA

PRS and U.S. Public Law 110-85

General Requirements

U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or FDAAA), Title VIII, Section 801 mandates that a "responsible party" (i.e., the sponsor or designated principal investigator) register and report results of certain "applicable clinical trials":

Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation;

Trials of Devices: Controlled trials with health outcomes of a product subject to FDA regulation (other than small feasibility studies) and pediatric postmarket surveillance studies.

"Applicable clinical trials" generally include interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the U.S, involves a drug, biologic, or device that is manufactured in the US (or its territories), or is conducted under an investigational new drug application (IND). For the complete statutory definitions and more detailed information on the agency's current thinking about their meaning, see this pdf document.

Data Submission

Investigators or Sponsors who already have PRS accounts should log into the PRS for the latest information. Others who anticipate needing to register studies in in accordance with the provisions of Section 801 of FDAAA should request a PRS account using the instructions provided under Account Application Process.

Expanded Registry

"Basic Results" Database

Additional Information

To receive occasional email announcements with information about US Public Law 110-85, join the

For specific questions or comments as this relates to the PRS, contact us at

Return to PRS Information Page

This page was last updated January 22, 2009.

U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Department of Health & Human Services
Copyright and Privacy Policy, Freedom of Information Act, Accessibility