Drug Development Tools Research Grants (U01) Clinical Trials Optional

Active
Yes
Status
Posted
Published Date
February 12th, 2024
Close Date
May 13th, 2025
Total Funding
$6.00
Award Ceiling
$500,000.00
Award Floor
$500,000.00
Expected No. Awards
6
Opportunity No.
RFA-FD-24-030

Agency

Food and Drug Administration (HHS-FDA)

Eligible Applicants

Others

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Summary

The Food and Drug Administration (FDA) is offering Drug Development Tools Research Grants (U01) through a Cooperative Agreement funding instrument. This opportunity falls under the category of Food and Nutrition and is currently open for applications. The grants aim to support the development of drug development tools that have an accepted or reviewable Letter of Intent (LOI) within the FDA's Drug Development Tool Qualification Program. These tools are intended to fill unmet needs in drug development and will be made publicly available once qualified. The grants do not require cost sharing or matching requirements. The estimated total program funding is $6 million, with an expected number of 6 awards to be granted. The award ceiling and floor are both set at $500,000. The closing date for applications is May 13, 2025, and the archive date is June 12, 2025. Eligible applicants include developers of drug development tools who have an accepted or reviewable LOI within the FDA's Drug Development Tool Qualification Program and are working towards their qualification plan or full qualification package. Previous recipients of DDT research grant support from FDA-CDER/CBER are also eligible to apply if they have successfully progressed to the next submission milestone and are requesting additional funding for new DDT project needs addressing different aspects of the project. For more information and to apply, please visit the following link: RFA-FD-24-030 Funding Opportunity Announcement. If you have any questions, you can contact Terrin Brown, the grantor, at terrin.brown@fda.hhs.gov.

Description

The purpose of this funding opportunity announcement (FOA) is to support research to continue the development of drug development tools that have an accepted or a reviewable Letter of Intent (LOI) within a drug development tool qualification program within either CBER or CDER. The grants will be used to further the development of tools that, once qualified, will be made publicly available to fill unmet needs in drug development.

Contact Information

Attachments
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Opportunity Lifecycle

Title
Type
Grant

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