This grant, offered by the National Institutes of Health (NIH) in coordination with the U.S. Food and Drug Administration (FDA), invites cooperative agreement applications for investigator-initiated clinical research. Its purpose is to advance the field of regenerative medicine (RM) using adult stem cells. The funding opportunity emphasizes innovative projects that address widely recognized challenges in developing safe and effective RM therapies, particularly those relevant for regulatory submissions. Key areas of focus include improving tools, methods, and applied science for in-depth product characterization, manufacturing, potency, quality, and safety. Applications are sought for late-stage preclinical studies generating evidence for clinical development, such as supporting Investigational New Drug (IND) or Investigational New Device Exemption (IDE) submissions or research conducted under existing INDs/IDEs.
Opportunity ID: 341945
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-23-019 |
| Funding Opportunity Title: | Regenerative Medicine Innovation Projects (RMIP) Investigator- Initiated Studies (Collaborative U01 Clinical Trial Not Allowed) |
| 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: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Private institutions of higher education For profit organizations other than small businesses Special district governments County governments City or township governments Public and State controlled institutions of higher education Independent school districts Native American tribal governments (Federally recognized) 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 Nonprofits having a 501(c)(3) status with the IRS, other than 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) 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, invite cooperative agreement (U01) applications to support investigator- initiated clinical research studies aimed at furthering the field of regenerative medicine (RM) 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 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 address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late-stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE. 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-23-019.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 341945 Full Announcement-RFA-HL-23-019 -> RFA-HL-23-019-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 | PKG00275649 | Sep 06, 2022 | Oct 06, 2022 | View |
Package 1
Mandatory forms
341945 RR_SF424_5_0-5.0.pdf
341945 PHS398_CoverPageSupplement_5_0-5.0.pdf
341945 RR_OtherProjectInfo_1_4-1.4.pdf
341945 PerformanceSite_4_0-4.0.pdf
341945 RR_KeyPersonExpanded_4_0-4.0.pdf
341945 PHS398_ResearchPlan_4_0-4.0.pdf
341945 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
341945 RR_Budget_3_0-3.0.pdf
341945 RR_SubawardBudget30_3_0-3.0.pdf
341945 PHS398_ModularBudget_1_2-1.2.pdf
341945 PHS_AssignmentRequestForm_3_0-3.0.pdf
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