This grant is for establishing technical development centers to address the critical lack of early translational funding and technical support for new Substance Use Disorder (SUD) product developers. These centers will provide expert technical assistance, guiding researchers to advance novel pharmacotherapeutics and digital therapeutics from concept to product development readiness. Support covers target product profiles, clinical need, project planning, prototype development, proof-of-concept studies, safety assessments, and regulatory requirements. The primary purpose is to prepare principal investigators for successful future NIH funding applications, accelerating the development of crucial SUD treatments.
Opportunity ID: 354609
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-DA-25-056 |
| Funding Opportunity Title: | Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics through Training and Preclinical Support (U54 Clinical Trials Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| 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 4 |
| Posted Date: | May 30, 2024 |
| Last Updated Date: | Dec 04, 2024 |
| Original Closing Date for Applications: | Nov 13, 2024 |
| Current Closing Date for Applications: | Dec 03, 2024 |
| Archive Date: | Jan 02, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,900,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public housing authorities/Indian housing authorities County governments Special district governments Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Small businesses Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education State governments |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
There is a lack of early translational funding and technical support for new product developers to move beyond the idea stage and into the product development space. Establishing a technical development center (or centers) will assist researchers developing new digital therapeutics for SUD. These centers will provide idea developers with technical development support to prepare the PI for future funding applications (e.g. Phase I SBIR, other NIH research grants, Blueprint Neurotherapeutics or Blueprint MedTech, etc.). The technical development assistance will include support from experts in the idea to product translation activities including the following: target product profile developmentclinical need assessmentproject plan development with timeline and milestonesprototype developmentproof-of-concept study designpreliminary safety assessmentsassistance in understanding current and future regulatory requirements |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-056.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Update close date per NOT-DA-24-061. | Dec 04, 2024 | |
| Modification to close date | May 30, 2024 | |
| Modification to title | May 30, 2024 | |
| May 30, 2024 |
DISPLAYING: Synopsis 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-DA-25-056 |
| Funding Opportunity Title: | Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics through Training and Preclinical Support (U54 Clinical Trials Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| 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 4 |
| Posted Date: | May 30, 2024 |
| Last Updated Date: | Dec 04, 2024 |
| Original Closing Date for Applications: | Nov 13, 2024 |
| Current Closing Date for Applications: | Dec 03, 2024 |
| Archive Date: | Jan 02, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,900,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public housing authorities/Indian housing authorities County governments Special district governments Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Small businesses Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education State governments |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
There is a lack of early translational funding and technical support for new product developers to move beyond the idea stage and into the product development space. Establishing a technical development center (or centers) will assist researchers developing new digital therapeutics for SUD. These centers will provide idea developers with technical development support to prepare the PI for future funding applications (e.g. Phase I SBIR, other NIH research grants, Blueprint Neurotherapeutics or Blueprint MedTech, etc.). The technical development assistance will include support from experts in the idea to product translation activities including the following: target product profile developmentclinical need assessmentproject plan development with timeline and milestonesprototype developmentproof-of-concept study designpreliminary safety assessmentsassistance in understanding current and future regulatory requirements |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-056.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-DA-25-056 |
| Funding Opportunity Title: | Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics through Training and Preclinical Support (U54 Clinical Trials Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| 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 3 |
| Posted Date: | May 30, 2024 |
| Last Updated Date: | Oct 30, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Dec 06, 2024 |
| Archive Date: | Jan 05, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,900,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Special district governments For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Independent school districts Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education 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 City or township governments Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
There is a lack of early translational funding and technical support for new product developers to move beyond the idea stage and into the product development space. Establishing a technical development center (or centers) will assist researchers developing new digital therapeutics for SUD. These centers will provide idea developers with technical development support to prepare the PI for future funding applications (e.g. Phase I SBIR, other NIH research grants, Blueprint Neurotherapeutics or Blueprint MedTech, etc.). The technical development assistance will include support from experts in the idea to product translation activities including the following: target product profile developmentclinical need assessmentproject plan development with timeline and milestonesprototype developmentproof-of-concept study designpreliminary safety assessmentsassistance in understanding current and future regulatory requirements |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-056.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-DA-25-056 |
| Funding Opportunity Title: | Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics through Training and Preclinical Support (U54 Clinical Trials Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| 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 2 |
| Posted Date: | May 30, 2024 |
| Last Updated Date: | Oct 30, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Nov 13, 2024 |
| Archive Date: | Dec 19, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,900,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Special district governments For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Independent school districts Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education 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 City or township governments Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | There is a lack of early translational funding and technical support for new product developers to move beyond the idea stage and into the product development space. Establishing a technical development center (or centers) will assist researchers developing new digital therapeutics for SUD. These centers will provide idea developers with technical development support to prepare the PI for future funding applications (e.g. Phase I SBIR, other NIH research grants, Blueprint Neurotherapeutics or Blueprint MedTech, etc.). The technical development assistance will include support from experts in the idea to product translation activities including the following: target product profile developmentclinical need assessmentproject plan development with timeline and milestonesprototype developmentproof-of-concept study designpreliminary safety assessmentsassistance in understanding current and future regulatory requirements |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-056.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-DA-25-056 |
| Funding Opportunity Title: | Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics (U54 Clinical Trials Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| 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: | May 30, 2024 |
| Last Updated Date: | May 30, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Nov 13, 2024 |
| Archive Date: | Dec 19, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,900,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Special district governments For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Independent school districts Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education 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 City or township governments Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | There is a lack of early translational funding and technical support for new product developers to move beyond the idea stage and into the product development space. Establishing a technical development center (or centers) will assist researchers developing new digital therapeutics for SUD. These centers will provide idea developers with technical development support to prepare the PI for future funding applications (e.g. Phase I SBIR, other NIH research grants, Blueprint Neurotherapeutics or Blueprint MedTech, etc.). The technical development assistance will include support from experts in the idea to product translation activities including the following: target product profile development clinical need assessment project plan development with timeline and milestones prototype development proof-of-concept study design preliminary safety assessments assistance in understanding current and future regulatory requirements |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-056.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Related Documents
Folder 354609 Full Announcement-RFA-DA-25-056 -> RFA-DA-25-056-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-H | Use for due dates on or before January 24, 2025 | PKG00286768 | Oct 13, 2024 | Dec 05, 2024 | View |
Package 1
Mandatory forms
354609 RR_SF424_5_0-5.0.pdf
354609 PHS398_CoverPageSupplement_5_0-5.0.pdf
354609 RR_OtherProjectInfo_1_4-1.4.pdf
354609 PerformanceSite_4_0-4.0.pdf
354609 RR_KeyPersonExpanded_4_0-4.0.pdf
354609 PHS398_ResearchPlan_5_0-5.0.pdf
354609 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
354609 PHS_Additional_IndirectCosts_2_0-2.0.pdf
354609 PHS_AssignmentRequestForm_3_0-3.0.pdf
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