The National Institutes of Health (NIH) and the U.S. Food and Drug Administration offer the Regenerative Medicine Innovation Projects (RMIP) grant to small businesses. This grant aims to support research studies in regenerative medicine using adult stem cells, focusing on innovative solutions for safe and effective therapies. Projects should address critical issues in product development, such as improved tools, methods, and standards, to enhance product characterization, manufacturing, and safety for regulatory submissions. Emphasis is placed on late-stage preclinical research studies involving adult stem cells to generate evidence for clinical development, including IND or IDE submissions.
Opportunity ID: 307770
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-18-035 |
| Funding Opportunity Title: | Regenerative Medicine Innovation Projects (RMIP) (U44 – 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: | 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: | $225,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: 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 cooperative agreement (U44) applications to support small business research studies 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 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. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-18-035.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 | PKG00244220 | Sep 19, 2018 | Oct 19, 2018 | View |
Package 1
Mandatory forms
307770 RR_SF424_2_0-2.0.pdf
307770 PHS398_CoverPageSupplement_4_0-4.0.pdf
307770 RR_OtherProjectInfo_1_4-1.4.pdf
307770 PerformanceSite_2_0-2.0.pdf
307770 RR_KeyPersonExpanded_2_0-2.0.pdf
307770 RR_Budget_1_4-1.4.pdf
307770 PHS398_ResearchPlan_4_0-4.0.pdf
307770 SBIR_STTR_Information_1_2-1.2.pdf
Optional forms
307770 RR_SubawardBudget30_1_4-1.4.pdf
307770 PHS_AssignmentRequestForm_2_0-2.0.pdf
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