Key Dates

Related Announcements

PAR-21-174 - The FDA's Cooperative Agreement Program for States and Territories to Implement a National Produce Safety Program (U2F) Clinical Trials Not Allowed

Issued by

FOOD AND DRUG ADMINISTRATION (FDA)

Purpose

The purpose of this Notice is to update potential new applicants and current recipients of the following changes, implemented on 10/28/2021 to Objective 7. Produce Related Event Response Planning and Implementation under PAR-21-174 "The FDA's Cooperative Agreement Program for States and Territories to Implement a National Produce Safety Program (U2F) Clinical Trials Not Allowed."

Objective 7. Produce Related Event Response Planning and Implementation Updates:

• Until further notice, Objective 7. Produce Related Event Response Planning and Implementation is on pause. New Applicants should not propose any activities under Objective 7 with their application submission.
• Recipients will not need to provide the FDA with documentation for Objectives 7a and 7b: identifying potential gaps in their capability to effectively conduct produce-related event response activities and a documented plan to identify how to address these gaps.
• Recipients must still document their produce-related event response capabilities as part of the Objective 1b Assessment document.
• A companion Notice of Funding Opportunity to provide additional funding for Recipients to address gaps in produce-related emergency response will not be made under this program.
• At this time, current Recipients may request administrative supplements for produce related event response activities, which will be assessed on a case-by-case basis.
   

Inquiries

Please direct all inquiries to:

Gordana Zuber

Food and Drug Administration

Office of Operation, Office of Finance Budget & Acquisitions

Office of Grants and Acquisition Services

Email: Gordana.Zuber@fda.hhs.gov