This grant, offered by the FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER), is for the purpose of advancing the development of essential drug development tools. Specifically, it seeks to fund research for tools that have already demonstrated promise by having an accepted or reviewable Letter of Intent within CBER or CDER’s qualification programs. The primary goal is to support the continued evolution of these tools, ensuring they meet the stringent requirements for qualification. Once qualified, these innovative tools will be made publicly accessible. This initiative aims to address critical unmet needs in the broader landscape of drug development, accelerating the availability of new therapies.
Opportunity ID: 352224
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-030 |
| Funding Opportunity Title: | Drug Development Tools Research Grants (U01) Clinical Trials Optional |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 6 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Feb 06, 2024 |
| Last Updated Date: | Mar 14, 2024 |
| Original Closing Date for Applications: | May 13, 2025 |
| Current Closing Date for Applications: | May 13, 2025 |
| Archive Date: | Jun 12, 2025 |
| Estimated Total Program Funding: | $6 |
| Award Ceiling: | $500,000 |
| Award Floor: | $500,000 |
Eligibility
| Eligible Applicants: | Special district governments Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities County governments City or township governments State governments Native American tribal governments (Federally recognized) Small businesses For profit organizations other than small businesses Public and State controlled institutions of higher education Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | These grants will be used to provide funding to developers of drug development tools that have an accepted or a reviewable Letter of Intent (LOI) within a CDER/CBER’s Drug Development Tool Qualification Program and are working towards their qualification plan (QP) or full qualification package (FQP).If you received DDT research grant support from FDA-CDER/CBER in previous years, you are eligible to apply provided that you have successfully progressed to the next submission milestone (e.g., Accepted LOI to Accepted QP) and are requesting additional funding for new DDT project needs addressing different aspects of the project. |
Additional Information
| Agency Name: | Food and Drug Administration |
| 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. |
| Link to Additional Information: | RFA-FD-24-030 Funding Opportunity Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Email:terrin.brown@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| The link to the full announcement has been added. | Mar 14, 2024 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-030 |
| Funding Opportunity Title: | Drug Development Tools Research Grants (U01) Clinical Trials Optional |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 6 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Feb 06, 2024 |
| Last Updated Date: | Mar 14, 2024 |
| Original Closing Date for Applications: | May 13, 2025 |
| Current Closing Date for Applications: | May 13, 2025 |
| Archive Date: | Jun 12, 2025 |
| Estimated Total Program Funding: | $6 |
| Award Ceiling: | $500,000 |
| Award Floor: | $500,000 |
Eligibility
| Eligible Applicants: | Special district governments Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities County governments City or township governments State governments Native American tribal governments (Federally recognized) Small businesses For profit organizations other than small businesses Public and State controlled institutions of higher education Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | These grants will be used to provide funding to developers of drug development tools that have an accepted or a reviewable Letter of Intent (LOI) within a CDER/CBER’s Drug Development Tool Qualification Program and are working towards their qualification plan (QP) or full qualification package (FQP).If you received DDT research grant support from FDA-CDER/CBER in previous years, you are eligible to apply provided that you have successfully progressed to the next submission milestone (e.g., Accepted LOI to Accepted QP) and are requesting additional funding for new DDT project needs addressing different aspects of the project. |
Additional Information
| Agency Name: | Food and Drug Administration |
| 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. |
| Link to Additional Information: | RFA-FD-24-030 Funding Opportunity Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Email:terrin.brown@fda.hhs.gov |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Terrin Brown Grantor Email: terrin.brown@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | RFA-FD-24-030 | FORM H | PKG00284747 | Feb 12, 2024 | May 13, 2025 | View |
Package 1
Mandatory forms
352224 RR_SF424_5_0-5.0.pdf
352224 PHS398_CoverPageSupplement_5_0-5.0.pdf
352224 RR_OtherProjectInfo_1_4-1.4.pdf
352224 PerformanceSite_4_0-4.0.pdf
352224 RR_KeyPersonExpanded_4_0-4.0.pdf
352224 RR_Budget_3_0-3.0.pdf
352224 PHS398_ResearchPlan_5_0-5.0.pdf
352224 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
352224 RR_SubawardBudget30_3_0-3.0.pdf
352224 PHS_AssignmentRequestForm_3_0-3.0.pdf
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