This grant, offered by the National Institutes of Health (NIH) and U.S. Food and Drug Administration (FDA), supports the crucial planning phase for clinical trials focused on regenerative medicine (RM) interventions. Specifically, it aims to enable the development of safe and effective RM treatments utilizing adult stem cells (excluding embryonic or fetal origins). Funding covers the comprehensive preparation of a clinical trial Manual of Procedures (MOP), securing essential regulatory authorizations, and establishing agreements with key partners such as cell manufacturing and data coordinating centers. Applicants may also collect preliminary data to assess feasibility. This initiative streamlines complex pre-trial processes, ensuring thorough preparation before launching studies to evaluate the safety and efficacy of new RM treatments.
Opportunity ID: 341944
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-23-020 |
| Funding Opportunity Title: | Regenerative Medicine Innovation Projects (RMIP) Clinical Trial Planning Grant (R34 – Clinical Trials Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| 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: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Small businesses Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses State governments City or township governments Independent school districts Private institutions of higher education County governments |
| 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) support the Regenerative Medicine Innovation Project (RMIP), which aims to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. Before a research team undertakes a clinical trial, it is critical to have clear delineation and documentation of the trials rationale, design, analytic techniques, protocols, and procedures in a Manual of Procedures (MOP). Additionally, there are other elements essential to the launching of a trial, such as obtaining regulatory authorizations or approvals and establishing agreements with requisite partners including cell manufacturing and production facilities, assay or cell analysis centers, and data coordinating centers. These activities are often costly and time-consuming, and they may involve collection of preliminary data to assess feasibility. Applicants may use the RMIP Clinical Trial Planning Grant to support the preparation of a clinical trial MOP and procedures necessary for implementing a clinical trial to evaluate interventions (or new treatments) that explore and enable the evaluation of the safety and/or efficacy of RM interventions using adult stem cells that are not of embryonic or fetal origin. Due to the complex nature of requirements in this FOA (e.g., 1:1 matching funds, resource sharing), applicants are strongly encouraged to communicate with the appropriate NIH Scientific/Research Contact and review online Frequently Asked Questions (FAQs) prior to submitting an application. Staff will be able to advise applicants in determining if their research meets the requirements and objectives of this FOA. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-23-020.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
Folder 341944 Full Announcement-RFA-HL-23-020 -> RFA-HL-23-020-Full-Announcement.pdf
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 | PKG00275633 | Sep 06, 2022 | Oct 06, 2022 | View |
Package 1
Mandatory forms
341944 RR_SF424_5_0-5.0.pdf
341944 PHS398_CoverPageSupplement_5_0-5.0.pdf
341944 RR_OtherProjectInfo_1_4-1.4.pdf
341944 PerformanceSite_4_0-4.0.pdf
341944 RR_KeyPersonExpanded_4_0-4.0.pdf
341944 PHS398_ResearchPlan_4_0-4.0.pdf
341944 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
341944 RR_Budget_3_0-3.0.pdf
341944 RR_SubawardBudget30_3_0-3.0.pdf
341944 PHS398_ModularBudget_1_2-1.2.pdf
341944 PHS_AssignmentRequestForm_3_0-3.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
