A Health Innovation Department is offering this grant to inspire and support research aimed at advancing novel Drug Development Tools (DDTs) and Medical Device Development Tools (MDDTs). This grant is for the explicit purpose of developing tools that, once qualified through the FDA’s CDER or CDRH programs, will address critical unmet needs in Substance Use Disorder (SUD) biomedical product development. The ultimate goal is to expedite the creation and regulatory approval of innovative therapies, ensuring they reach SUD patients faster and more efficiently.
Opportunity ID: 341058
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-DA-23-019 |
| Funding Opportunity Title: | Novel Drug (DDT) and Medical Device Development Tools (MDDT) to Help Expedite Creation and Regulatory Approvals of New Therapies for Substance Use Disorders (SUD) (R41/R42 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Education Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.279 — Drug Abuse and Addiction Research Programs |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jun 10, 2022 |
| Last Updated Date: | Jun 10, 2022 |
| Original Closing Date for Applications: | Nov 14, 2022 |
| Current Closing Date for Applications: | Nov 14, 2022 |
| Archive Date: | Dec 20, 2022 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this funding opportunity announcement (FOA) is to inspire and support research to advance the drug and device development tools for ultimate submission to DDT or MDDT tool qualification program within either FDAs CDER or CDRH. The funding will be used to further the development of tools that, once qualified, will be available to fill unmet needs in SUD biomedical product development. This FOA ultimately aims to bring innovative treatments to SUD patients faster. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-23-019.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster OERWebmaster03@od.nih.gov Email: OERWebmaster03@od.nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or after January 25, 2022 | PKG00274912 | Oct 14, 2022 | Nov 14, 2022 | View |
Package 1
Mandatory forms
341058 RR_SF424_5_0-5.0.pdf
341058 PHS398_CoverPageSupplement_5_0-5.0.pdf
341058 RR_OtherProjectInfo_1_4-1.4.pdf
341058 PerformanceSite_4_0-4.0.pdf
341058 RR_KeyPersonExpanded_4_0-4.0.pdf
341058 RR_Budget_3_0-3.0.pdf
341058 RR_SubawardBudget30_3_0-3.0.pdf
341058 PHS398_ResearchPlan_4_0-4.0.pdf
341058 SBIR_STTR_Information_3_0-3.0.pdf
341058 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
341058 PHS_AssignmentRequestForm_3_0-3.0.pdf
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