Funding Opportunity ID: |
327425 |
Opportunity Number: |
RFA-HL-21-003 |
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: |
|
CFDA Number(s): |
93.121 93.173 93.233 93.242 93.350 93.837 93.838 93.839 93.840 93.846 93.847 93.853 93.855 93.866 93.867 |
Eligible Applicants: |
State governments County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal 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 Private institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) |
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. |
Agency Code: |
HHS-NIH11 |
Agency Name: |
Department of Health and Human Services National Institutes of Health |
Posted Date: |
Jun 02, 2020 |
Close Date: |
Oct 02, 2020 |
Last Updated Date: |
Jun 02, 2020 |
Award Ceiling: |
$0 |
Award Floor: |
$0 |
Estimated Total Program Funding: |
|
Expected Number of Awards: |
|
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 |
Version: |
8 |
Modification Comments: |
added cfda |