The National Institutes of Health (NIH), in coordination with the FDA, is offering the Regenerative Medicine Innovation Project (RMIP) grant. This bi-phasic, milestone-driven cooperative agreement supports investigator-initiated clinical trials developing safe and effective regenerative medicine (RM) interventions using adult stem cells. The grant prioritizes innovative projects solving RM therapy development challenges, particularly for products ready for Phase I and beyond clinical trials. Applicants must provide a strong scientific rationale, a comprehensive operational plan, and align with NIH’s mission and clinical trial definition. Proposals must detail project management, participant recruitment, milestones, and results dissemination. Investigational New Drug (IND) or Investigational Device Exemption (IDE) authorization is required pre-award.
Opportunity ID: 341946
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-23-017 |
| 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 07, 2022 |
| Last Updated Date: | Jul 07, 2022 |
| Original Closing Date for Applications: | Oct 06, 2022 |
| Current Closing Date for Applications: | Oct 06, 2022 |
| Archive Date: | Nov 11, 2022 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $345,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Special district governments For profit organizations other than small businesses Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education State governments Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) County governments 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; 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), seek 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 will be required 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. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-23-017.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 |
|---|---|---|
Related Documents
There are no related documents on this grant.
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 after January 25, 2022 | PKG00275650 | Sep 06, 2022 | Oct 06, 2022 | View |
Package 1
Mandatory forms
341946 RR_SF424_5_0-5.0.pdf
341946 PHS398_CoverPageSupplement_5_0-5.0.pdf
341946 RR_OtherProjectInfo_1_4-1.4.pdf
341946 PerformanceSite_4_0-4.0.pdf
341946 RR_KeyPersonExpanded_4_0-4.0.pdf
341946 RR_Budget_3_0-3.0.pdf
341946 PHS398_ResearchPlan_4_0-4.0.pdf
341946 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
341946 RR_SubawardBudget30_3_0-3.0.pdf
341946 PHS_AssignmentRequestForm_3_0-3.0.pdf
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