The National Institute of Neurological Disorders and Stroke (NINDS) is offering this grant to encourage investigator-initiated prospective observational comparative effectiveness research (CER) in clinical neurosciences. This grant is for studies that address questions within NINDS’s mission, evaluating preventive strategies, diagnostics, or interventions like drugs, devices, and therapies (surgical, behavioral, rehabilitation). The purpose is to provide cost-effective data relevant to current clinical practice. Awards begin with a UG3 planning phase (up to 2 years), focusing on scientific and operational feasibility, data collection, and recruitment strategies. Successful UG3 projects may transition to a UH3 phase (up to 5 years) to conduct the full observational study.
Opportunity ID: 358084
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-048 |
| Funding Opportunity Title: | Prospective Observational Comparative Effectiveness Research in Clinical Neurosciences (UG3/UH3 Clinical Trial Not Allowed) |
| 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: | Jan 08, 2025 |
| Last Updated Date: | Jan 08, 2025 |
| Original Closing Date for Applications: | Sep 07, 2025 |
| Current Closing Date for Applications: | Sep 07, 2025 |
| Archive Date: | Oct 13, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Independent school districts Small businesses City or township governments Public housing authorities/Indian housing authorities Private 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 announcement is to encourage grant applications for investigator-initiated prospective observational comparative effectiveness research (CER) to the National Institute of Neurological Disorders and Stroke (NINDS). The study must address questions within the mission and research interests of the NINDS and may evaluate preventive strategies, diagnostic approaches, or interventions including drugs, biologics, and devices, or surgical, behavioral, and rehabilitation therapies. Information about the mission and research interests of the NINDS can be found at the NINDS website (https://www.ninds.nih.gov/). Studies proposed should provide a cost-effective means of collecting data with a meaningful bearing on current clinical practice. Awards made under this FOA will initially support a milestone-driven planning phase (UG3) for up to 2 years, with possible transition to a observational study phase of up to five years (UH3). Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase for observational studies will permit both scientific and operational planning activities. Scientific planning activities include small-scale data collection to assess the feasibility and/or acceptability of data collection, storage, and planned analyses. Operational planning activities include, at a minimum, development of recruitment and retention strategies, case report forms, data management system and other tools for data and quality management. The UH3 phase of the award will support the conduct of investigator-initiated observational study. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-048.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 |
|---|---|---|
Related Documents
Folder 358084 Full Announcement-PAR-25-048 -> PAR-25-048-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-I | Use for due dates on or after January 25, 2025 | PKG00289952 | Jan 19, 2025 | Sep 07, 2025 | View |
Package 1
Mandatory forms
358084 RR_SF424_5_0-5.0.pdf
358084 PHS398_CoverPageSupplement_5_0-5.0.pdf
358084 RR_OtherProjectInfo_1_4-1.4.pdf
358084 PerformanceSite_4_0-4.0.pdf
358084 RR_KeyPersonExpanded_4_0-4.0.pdf
358084 RR_Budget10_3_0-3.0.pdf
358084 PHS398_ResearchPlan_5_0-5.0.pdf
358084 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
358084 RR_SubawardBudget10_30_3_0-3.0.pdf
358084 PHS_AssignmentRequestForm_4_0-4.0.pdf
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