This grant is for the purpose of accelerating the development of Digital Therapeutics (DTx) to treat Substance Use Disorders (SUDs). The National Institutes of Health (NIH) recognizes the potential of mobile, web, and other software-based platforms to deliver safe and effective treatments for SUD. The primary objective is to advance DTx through their development process, aiming for FDA authorization and widespread dissemination. Applications may focus on the pre-clinical or clinical development and testing of novel DTx, or adapting existing DTx from other indications. This initiative seeks to leverage technological advances to increase the availability of critical interventions for patients with SUDs.
Opportunity ID: 352661
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-064 |
| Funding Opportunity Title: | Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional) |
| 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: | Feb 27, 2024 |
| Last Updated Date: | May 15, 2025 |
| Original Closing Date for Applications: | Nov 19, 2026 |
| Current Closing Date for Applications: | May 23, 2025 |
| Archive Date: | Jun 22, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses City or township governments Native American tribal organizations (other than Federally recognized tribal governments) State governments County governments Special district governments Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses |
| 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: |
The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the development of Digital Therapeutics (DTx) to treat Substance Use Disorders (SUDs). Advances in technology offer unprecedented opportunities to develop clinical-grade mobile, web, or other software-based platforms designed to deliver treatments that are safe and effective for SUD. FDA authorization of DTx can play an important role in increasing the availability of treatments to patients with SUD, although there are other pathways for dissemination of this class of intervention. The primary objective of this FOA is to move DTx to their next step in the development process, with the ultimate goal of generating new, FDA authorized, disseminated treatments for SUDs. Applications may focus on the pre-clinical and/or clinical development and testing of new DTx or existing DTx developed for other indications. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-064.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-OD-25-113. | May 15, 2025 | |
| Feb 27, 2024 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-064 |
| Funding Opportunity Title: | Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional) |
| 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: | Feb 27, 2024 |
| Last Updated Date: | May 15, 2025 |
| Original Closing Date for Applications: | Nov 19, 2026 |
| Current Closing Date for Applications: | May 23, 2025 |
| Archive Date: | Jun 22, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses City or township governments Native American tribal organizations (other than Federally recognized tribal governments) State governments County governments Special district governments Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses |
| 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: |
The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the development of Digital Therapeutics (DTx) to treat Substance Use Disorders (SUDs). Advances in technology offer unprecedented opportunities to develop clinical-grade mobile, web, or other software-based platforms designed to deliver treatments that are safe and effective for SUD. FDA authorization of DTx can play an important role in increasing the availability of treatments to patients with SUD, although there are other pathways for dissemination of this class of intervention. The primary objective of this FOA is to move DTx to their next step in the development process, with the ultimate goal of generating new, FDA authorized, disseminated treatments for SUDs. Applications may focus on the pre-clinical and/or clinical development and testing of new DTx or existing DTx developed for other indications. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-064.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: | PAR-24-064 |
| Funding Opportunity Title: | Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional) |
| 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: | Feb 27, 2024 |
| Last Updated Date: | Feb 27, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Nov 19, 2026 |
| Archive Date: | Dec 25, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Private institutions of higher education Special district governments For profit organizations other than small businesses County governments Independent school districts State governments Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than 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 City or township 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: | The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the development of Digital Therapeutics (DTx) to treat Substance Use Disorders (SUDs). Advances in technology offer unprecedented opportunities to develop clinical-grade mobile, web, or other software-based platforms designed to deliver treatments that are safe and effective for SUD. FDA authorization of DTx can play an important role in increasing the availability of treatments to patients with SUD, although there are other pathways for dissemination of this class of intervention. The primary objective of this FOA is to move DTx to their next step in the development process, with the ultimate goal of generating new, FDA authorized, disseminated treatments for SUDs. Applications may focus on the pre-clinical and/or clinical development and testing of new DTx or existing DTx developed for other indications. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-064.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 352661 Full Announcement-PAR-24-064 -> PAR-24-064-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 | PKG00285081 | Feb 27, 2024 | Jan 24, 2025 | View | |
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289241 | Nov 27, 2024 | May 23, 2025 | View |
Package 1
Mandatory forms
352661 RR_SF424_5_0-5.0.pdf
352661 PHS398_CoverPageSupplement_5_0-5.0.pdf
352661 RR_OtherProjectInfo_1_4-1.4.pdf
352661 PerformanceSite_4_0-4.0.pdf
352661 RR_KeyPersonExpanded_4_0-4.0.pdf
352661 RR_Budget10_3_0-3.0.pdf
352661 PHS398_ResearchPlan_5_0-5.0.pdf
352661 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
352661 RR_SubawardBudget10_30_3_0-3.0.pdf
352661 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
352661 RR_SF424_5_0-5.0.pdf
352661 PHS398_CoverPageSupplement_5_0-5.0.pdf
352661 RR_OtherProjectInfo_1_4-1.4.pdf
352661 PerformanceSite_4_0-4.0.pdf
352661 RR_KeyPersonExpanded_4_0-4.0.pdf
352661 RR_Budget10_3_0-3.0.pdf
352661 PHS398_ResearchPlan_5_0-5.0.pdf
352661 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
352661 RR_SubawardBudget10_30_3_0-3.0.pdf
352661 PHS_AssignmentRequestForm_4_0-4.0.pdf
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