Key Dates

Related Announcements

PAR-21-178 - Drug Development Tools Research Grants (U01) Clinical Trial Optional

Issued by

FOOD AND DRUG ADMINISTRATION (FDA)

Purpose

The purpose of this Notice is to update 

Section IV. Application and Submission Information - PHS 398 Research Plan

Specific Aims and Research Strategy: 

With a significant delay in our DDT qualification reviews at CDER due to an overall increase in the DDT Qualification Program workloads, we will accept your grant applications as long as your DDT submission (LOI or QP) is deemed reviewable by the grant deadline (May 3, 2023). If your grant application is reviewed favorability by the grant review panel with an above acceptable total score, your grant award will be deferred until  your LOI (or QP) is fully accepted by the program (with the issuance of the determination letter). Contingent upon availability of the funds to the DDT grant program and the priority of your project at that time, the grant award may be made shortly after the acceptance of your LOI (or QP). If you have a question regarding this change, please reach out to CDER-DDT Grants Contracts: CDER-DDTGrantsContracts@fda.hhs.gov.

All other aspects of this FOA remain unchanged.?

Inquiries

Please direct all inquiries to:

Shashi Malhotra

Grants Management Specialist

Office of Operations, Office of Finance Budget & Acquisitions

Office of Acquisitions and Grant Services

U.S. Food and Drug Administration

Tel: 301-402-7592

Shashi.Malhotra@fda.hhs.gov