The National Institutes of Health (NIH) is offering a grant to support investigator-initiated clinical research studies focusing on regenerative medicine using adult stem cells. Projects should address key issues in developing safe and effective regenerative medicine therapies, with emphasis on product development for regulatory submissions. Areas of focus include enhancing evaluation methods, product characterization, manufacturing, safety, and effectiveness. The grant aims to support late-stage preclinical research studies involving adult stem cells to provide evidence for clinical development, including preparing for IND or IDE submissions.
Opportunity ID: 307771
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-18-030 |
| 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: | 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: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education State governments Special district governments Native American tribal governments (Federally recognized) Nonprofits having 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) Small businesses County governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) City or township governments For profit organizations other than small businesses Independent school districts |
| 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. 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-18-030.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 | PKG00244205 | Sep 19, 2018 | Oct 19, 2018 | View |
Package 1
Mandatory forms
307771 RR_SF424_2_0-2.0.pdf
307771 PHS398_CoverPageSupplement_4_0-4.0.pdf
307771 RR_OtherProjectInfo_1_4-1.4.pdf
307771 PerformanceSite_2_0-2.0.pdf
307771 RR_KeyPersonExpanded_2_0-2.0.pdf
307771 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
307771 RR_Budget_1_4-1.4.pdf
307771 RR_SubawardBudget30_1_4-1.4.pdf
307771 PHS398_ModularBudget_1_2-1.2.pdf
307771 PHS_AssignmentRequestForm_2_0-2.0.pdf
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