The National Institutes of Health (NIH) is offering the Regenerative Medicine Innovation Projects grant to small businesses conducting research on adult stem cell-based regenerative medicine. The grant aims to support innovative projects addressing key challenges in developing safe and effective regenerative therapies. Emphasis is placed on projects enhancing product development for regulatory approval, focusing on areas such as product characterization, manufacturing, safety, and effectiveness. The grant allows for late-stage preclinical research on adult stem cells to gather necessary evidence for clinical development, potentially for Investigational New Drug (IND) or Investigational New Device Exemption (IDE) submission. Applications are accepted until October 19, 2018.
Opportunity ID: 307791
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-18-033 |
| Funding Opportunity Title: | Regenerative Medicine Innovation Projects (RMIP) (UT2 – 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 (UT2) 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-18-033.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 | PKG00244203 | Sep 19, 2018 | Oct 19, 2018 | View |
Package 1
Mandatory forms
307791 RR_SF424_2_0-2.0.pdf
307791 PHS398_CoverPageSupplement_4_0-4.0.pdf
307791 RR_OtherProjectInfo_1_4-1.4.pdf
307791 PerformanceSite_2_0-2.0.pdf
307791 RR_KeyPersonExpanded_2_0-2.0.pdf
307791 RR_Budget_1_4-1.4.pdf
307791 RR_SubawardBudget30_1_4-1.4.pdf
307791 PHS398_ResearchPlan_4_0-4.0.pdf
307791 SBIR_STTR_Information_1_2-1.2.pdf
Optional forms
307791 PHS_AssignmentRequestForm_2_0-2.0.pdf
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