The National Institutes of Health, in collaboration with the U.S. Food and Drug Administration, is offering a grant opportunity for investigator-initiated clinical trials focused on advancing regenerative medicine using adult stem cells. Projects should address key challenges in developing safe and effective regenerative medicine therapies. Emphasis is placed on projects using products ready for clinical trials, with a strong scientific rationale, operational plan, and milestones. Applicants must have authorization for product administration to humans. Contacting the NIH before submission is strongly encouraged. Deadline for applications is October 19, 2018.
Opportunity ID: 307792
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-18-031 |
| Funding Opportunity Title: | Regenerative Medicine Innovation Projects (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: | Aug 01, 2018 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Oct 19, 2018 |
| Current Closing Date for Applications: | Oct 19, 2018 |
| Archive Date: | Nov 24, 2018 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $405,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public and State controlled institutions of higher education Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Small businesses State governments Native American tribal governments (Federally recognized) Independent school districts For profit organizations other than small businesses Public housing authorities/Indian housing authorities |
| 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 NIH Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite exploratory/developmental phased award cooperative agreement (UG3/UH3) applications to support investigator-initiated clinical trials (Phase I or later phase) aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that use RM products with demonstrated readiness to be advanced into clinical trials through appropriate product development and pre-clinical studies. Trials for which this FOA applies 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). This FOA utilizes a bi-phasic, milestone-driven cooperative agreement mechanism of award. This FOA seeks applications that present a strong scientific rationale for the clinical trial and a comprehensive scientific and operational plan. It is anticipated that applications will consist of plans for project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, data sharing, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) application authorization or approval, respectively, to administer the product to humans. Due to the complex nature of conducting a clinical trial, applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application. Staff will be able to assist applicants in meeting the objectives of this FOA. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-18-031.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@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 FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-E | FORMS-E | PKG00244204 | Sep 19, 2018 | Oct 19, 2018 | View |
Package 1
Mandatory forms
307792 RR_SF424_2_0-2.0.pdf
307792 PHS398_CoverPageSupplement_4_0-4.0.pdf
307792 RR_OtherProjectInfo_1_4-1.4.pdf
307792 PerformanceSite_2_0-2.0.pdf
307792 RR_KeyPersonExpanded_2_0-2.0.pdf
307792 RR_Budget_1_4-1.4.pdf
307792 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
307792 RR_SubawardBudget30_1_4-1.4.pdf
307792 PHS_AssignmentRequestForm_2_0-2.0.pdf
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