Notice Number: NOT-FD-19-002

Key Dates
Release Date: November 27, 2018

Issued by
U.S. Food and Drug Administration (FDA)

Purpose

This notice is to inform all FDA applicants and awardees that the terms below regarding Certificates of Confidentiality - 42 U.S.C. 241(d) will be incorporated for all active FDA Funding Opportunity Announcements and awards effective October 1, 2018.

Certificates of Confidentiality 42 U.S.C. 241(d)

Awardees are responsible for complying with all requirements to protect the confidentiality of identifiable, sensitive information that is collected or used in biomedical, behavioral, clinical, or other research (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs) funded wholly or in part by the Federal Government. See 42 U.S.C. 241(d). All research funded by FDA, in whole or in part, that is within the scope of these requirements is deemed to be issued a “Certificate of Confidentiality” through these Terms and Conditions. Certificates issued in this manner will not be issued as a separate document.

Awardees are expected to ensure that any investigator or institution not funded by FDA who receives a copy of identifiable, sensitive information protected by these requirements, understand they are also subject to the requirements of 42 U.S.C. 241(d). Awardees are also responsible for ensuring that any subrecipient that receives funds to carry out part of the FDA award involving a copy of identifiable, sensitive information protected by these requirements understand they are also subject to subsection 42 U.S.C. 241(d).

Inquiries

Please direct all inquiries to:

Food and Drug Administration (FDA)

Office of Acquisitions and Grants Services

Grants Management Branch

Email: [email protected]