Opportunity ID: 339577
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-142 |
| Funding Opportunity Title: | NINDS Exploratory Clinical Trials (UG3/UH3 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Apr 18, 2022 |
| Last Updated Date: | Nov 12, 2024 |
| Original Closing Date for Applications: | Mar 10, 2025 |
| Current Closing Date for Applications: | Nov 12, 2024 |
| Archive Date: | Dec 12, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments City or township governments Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities County 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 encourage grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must address questions within the mission and research interests of the NINDS and may include Phase 1 and 2 studies of drugs and biologics, feasibility studies of devices, and early studies of surgical, behavioral or rehabilitation therapies. All exploratory trials must contribute to the justification for and provide some of the data required to inform a future trial to establish efficacy (such as a Phase 3, Phase 4 or Pivotal trial). This FOA uses the UG3/UH3 mechanism. Only projects that provide satisfactory progress in the UG3 phase may move to the UH3 phase, as outlined below. For a drug, biologic or device that has not completed a Phase 1/Early Feasibility trial: The UG3 mechanism will be used to plan and execute the Phase I trial(s). If Phase 1 trials are successful, the UG3 will also include the planning phase of a Phase 2 trial. The UH3 mechanism will then support the execution of the Phase 2 clinical trial. Transition to the UH3 will depend on successfully reaching agreed upon milestones. For a drug, biologic or device that has successfully completed the Phase 1/Early Feasibility trial(s), do not use this FOA. Instead use the Companion FOA XXX. For genetic studies, do not use this FOA. Instead, use FOA XXX. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-142.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 |
|---|---|---|
| updated close date | Nov 12, 2024 | |
| Apr 18, 2022 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-142 |
| Funding Opportunity Title: | NINDS Exploratory Clinical Trials (UG3/UH3 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Apr 18, 2022 |
| Last Updated Date: | Nov 12, 2024 |
| Original Closing Date for Applications: | Mar 10, 2025 |
| Current Closing Date for Applications: | Nov 12, 2024 |
| Archive Date: | Dec 12, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments City or township governments Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities County 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 encourage grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must address questions within the mission and research interests of the NINDS and may include Phase 1 and 2 studies of drugs and biologics, feasibility studies of devices, and early studies of surgical, behavioral or rehabilitation therapies. All exploratory trials must contribute to the justification for and provide some of the data required to inform a future trial to establish efficacy (such as a Phase 3, Phase 4 or Pivotal trial). This FOA uses the UG3/UH3 mechanism. Only projects that provide satisfactory progress in the UG3 phase may move to the UH3 phase, as outlined below. For a drug, biologic or device that has not completed a Phase 1/Early Feasibility trial: The UG3 mechanism will be used to plan and execute the Phase I trial(s). If Phase 1 trials are successful, the UG3 will also include the planning phase of a Phase 2 trial. The UH3 mechanism will then support the execution of the Phase 2 clinical trial. Transition to the UH3 will depend on successfully reaching agreed upon milestones. For a drug, biologic or device that has successfully completed the Phase 1/Early Feasibility trial(s), do not use this FOA. Instead use the Companion FOA XXX. For genetic studies, do not use this FOA. Instead, use FOA XXX. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-142.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 |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-142 |
| Funding Opportunity Title: | NINDS Exploratory Clinical Trials (UG3/UH3 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 18, 2022 |
| Last Updated Date: | Apr 18, 2022 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Mar 10, 2025 |
| Archive Date: | Apr 15, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Private institutions of higher education 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 Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Native American tribal governments (Federally recognized) City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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 encourage grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must address questions within the mission and research interests of the NINDS and may include Phase 1 and 2 studies of drugs and biologics, feasibility studies of devices, and early studies of surgical, behavioral or rehabilitation therapies. All exploratory trials must contribute to the justification for and provide some of the data required to inform a future trial to establish efficacy (such as a Phase 3, Phase 4 or Pivotal trial). This FOA uses the UG3/UH3 mechanism. Only projects that provide satisfactory progress in the UG3 phase may move to the UH3 phase, as outlined below. For a drug, biologic or device that has not completed a Phase 1/Early Feasibility trial: The UG3 mechanism will be used to plan and execute the Phase I trial(s). If Phase 1 trials are successful, the UG3 will also include the planning phase of a Phase 2 trial. The UH3 mechanism will then support the execution of the Phase 2 clinical trial. Transition to the UH3 will depend on successfully reaching agreed upon milestones. For a drug, biologic or device that has successfully completed the Phase 1/Early Feasibility trial(s), do not use this FOA. Instead use the Companion FOA XXX. For genetic studies, do not use this FOA. Instead, use FOA XXX. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-142.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 |
Related Documents
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 before January 24, 2023 | PKG00273439 | May 22, 2022 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278447 | Nov 15, 2022 | Nov 23, 2024 | View |
Package 1
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Package 2
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