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This grant from the FDA aims to support research in developing drug and device development tools for Substance Use Disorders. The funding will be used to create tools for submission to FDA’s qualification program, with the goal of expediting the approval and availability of innovative therapies for SUD patients. The deadline for application submission is November 14, 2022.
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Opportunity ID: 341043
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General Information
| Document Type:: | Grants Notice |
| Funding Opportunity Number:: | RFA-DA-23-020 |
| 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) (R43/R44 Clinical Trial Optional) |
| Opportunity Category:: | Discretionary |
| Opportunity Category Explanation:: | |
| Funding Instrument Type:: | |
| Category of Funding Activity:: | Education |
| Category Explanation:: | |
| Expected Number of Awards:: | |
| Assistance Listings Number(s):: | 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:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 1 | Jun 10, 2022 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | |
| Competition ID: | FORMS-G |
| Competition Title: | Use for due dates on or after January 25, 2022 |
| Opportunity Package ID: | PKG00274910 |
| Opening Date: | Oct 14, 2022 |
| Closing Date: | Nov 14, 2022 |
| Agency Contact Information:: | eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V5.0] PHS 398 Cover Page Supplement [V5.0] Research And Related Other Project Information [V1.4] Project/Performance Site Location(s) [V4.0] Research and Related Senior/Key Person Profile (Expanded) [V4.0] Research & Related Budget [V3.0] PHS 398 Research Plan [V4.0] SBIR/STTR Information [V3.0] PHS Human Subjects and Clinical Trials Information [V3.0] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V3.0] PHS Assignment Request Form [V3.0] |
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Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or after January 25, 2022 | PKG00274910 | Oct 14, 2022 | Nov 14, 2022 | View | eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ | Organization Applicants |
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