The National Institutes of Health (NIH), in coordination with the FDA, offers this grant as part of the Regenerative Medicine Innovation Project (RMIP) to fund investigator-initiated clinical trials. This bi-phasic cooperative agreement seeks highly innovative projects focused on developing safe and effective regenerative medicine (RM) interventions using adult stem cells. The grant prioritizes RM products ready for Phase I and beyond clinical trials, demonstrating strong scientific rationale and comprehensive operational plans. Successful applications must propose solutions to common development issues and include detailed plans for project management, participant recruitment, performance milestones, and dissemination of results. Applicants must secure an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) authorization before award, if applicable. This initiative aims to advance promising RM therapies into clinical practice.
Opportunity ID: 334718
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-22-014 |
| Funding Opportunity Title: | Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.121 — Oral Diseases and Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jul 14, 2021 |
| Last Updated Date: | Jul 14, 2021 |
| Original Closing Date for Applications: | Oct 08, 2021 |
| Current Closing Date for Applications: | Oct 08, 2021 |
| Archive Date: | Nov 13, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments County governments Independent school districts 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 State governments Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Private institutions of higher education 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; 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, are not allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications are expected to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans. Successful applicants proposing the use of adult stem cells as a clinical intervention will be asked to make available representative samples of the source stem cell and clinical-grade stem cell-derived product for in-depth and independ |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-22-014.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster 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-F | Use for due dates on or before January 24, 2022 | PKG00268184 | Sep 08, 2021 | Jan 24, 2022 | View |
Package 1
Mandatory forms
334718 RR_SF424_2_0-2.0.pdf
334718 PHS398_CoverPageSupplement_5_0-5.0.pdf
334718 RR_OtherProjectInfo_1_4-1.4.pdf
334718 PerformanceSite_2_0-2.0.pdf
334718 RR_KeyPersonExpanded_2_0-2.0.pdf
334718 RR_Budget_1_4-1.4.pdf
334718 PHS398_ResearchPlan_4_0-4.0.pdf
334718 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
334718 RR_SubawardBudget30_1_4-1.4.pdf
334718 PHS_AssignmentRequestForm_3_0-3.0.pdf
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