Opportunity Information: Apply for RFA HL 17 025
Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (U54) is a National Institutes of Health (NIH) funding opportunity, issued in coordination with participating NIH Institutes and Centers and the U.S. Food and Drug Administration (FDA), that supports competing revision applications to existing, active U54 cooperative agreement awards. The core idea is to provide additional funds within a current budget period so an already-funded U54 project can expand its approved scope or research protocol in ways that accelerate clinical research in regenerative medicine, specifically work involving adult stem cells. Because this is framed as a competing revision, it is not meant for entirely new, stand-alone projects; it is intended for investigators who already hold an eligible U54 award and who can justify why an increase in support is needed now to broaden or strengthen the ongoing work.
The scientific emphasis is on practical, innovation-driven solutions to well-known bottlenecks that slow down the development of safe and effective regenerative medicine therapies. In particular, the opportunity highlights the kinds of applied research and translational activities that make a therapy more “developable” and more clearly evaluable by regulators. Applicants are expected to propose work that helps the field overcome recurring problems such as how products are manufactured consistently, how quality is defined and measured, how safety risks are identified and mitigated, and how effectiveness can be evaluated in a rigorous and decision-relevant way. The FOA explicitly signals a strong preference for projects that tackle critical product development issues that matter for regulatory submissions, reflecting FDA’s interest in improving the evidence base and technical standards that support review and oversight of regenerative medicine products.
In practical terms, the FOA points applicants toward deliverables like improved tools, methods, and standards, along with other applied science advances that strengthen understanding and evaluation of regenerative medicine products across the development pipeline. This can include better ways to characterize cell-based products, more robust release or potency testing concepts, improved approaches to assessing manufacturing variability, and clearer strategies for evaluating product quality, safety, and clinical performance. While the announcement stays high-level, the repeated focus on manufacturing and evaluation implies that projects that produce broadly usable frameworks, validated assays, standardized measurement approaches, or decision-enabling datasets are especially responsive, as long as they clearly connect back to the clinical research aims of the active U54 and meaningfully expand the approved scope.
Administratively, this opportunity is offered by the Department of Health and Human Services (HHS) through NIH as a discretionary program, using a cooperative agreement mechanism (U54). The cooperative agreement structure typically indicates substantial federal scientific or programmatic involvement compared with a standard research grant, which fits the FOA’s emphasis on coordinated, development-focused work relevant to regulatory science and real-world translation. The funding opportunity number is RFA-HL-17-025, with a creation date of April 28, 2017, and an original closing date of June 26, 2017. The award ceiling is listed as $324,500, and the program anticipated making about 6 awards, signaling a relatively targeted competition.
Eligibility is broad at the organizational level, spanning many public and private entities, including state, county, city, township, and special district governments; public and state-controlled and private institutions of higher education; independent school districts; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses, with additional eligibility details referenced in the full FOA text. Even with this wide eligibility list, the practical gatekeeping requirement is that the application must be a revision tied to an active U54 research project award that fits the program’s intent, since the funding is meant to expand an existing, already-reviewed project rather than initiate a new one.
The announcement is associated with multiple CFDA numbers (93.121, 93.173, 93.233, 93.242, 93.286, 93.350, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.856, 93.866, 93.867), reflecting the involvement of multiple NIH components and related health research authorities. Overall, the opportunity is best understood as a focused, time-bounded infusion of supplemental, competitively reviewed support for current U54 teams to push regenerative medicine clinical research forward by solving development and regulatory-relevant challenges tied to adult stem cell-based therapies, with particular attention to manufacturing, quality, safety, and effectiveness evaluation.Apply for RFA HL 17 025
- The Department of Health and Human Services, National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (U54)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.173, 93.233, 93.242, 93.286, 93.350, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.856, 93.866, 93.867.
- This funding opportunity was created on Apr 28, 2017.
- Applicants must submit their applications by Jun 26, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $324,500.00 in funding.
- The number of recipients for this funding is limited to 6 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the “Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (U54)” funding opportunity?
This opportunity is a National Institutes of Health (NIH) funding announcement, issued in coordination with participating NIH Institutes and Centers and the U.S. Food and Drug Administration (FDA). It supports competing revision applications to existing, active U54 cooperative agreement awards so current awardees can expand the approved scope or research protocol to accelerate clinical research in regenerative medicine.
What kind of application is this (new project vs. revision)?
This is a competing revision, not a mechanism for starting a brand-new, stand-alone project. The request is specifically framed as added support to broaden or strengthen an already-funded U54 project, within a current budget period, with a clear justification for why the increase is needed now.
Who is this opportunity intended for?
It is intended for investigators and teams that already hold an eligible, active U54 cooperative agreement award and want to propose an expansion of that project that remains tied to the existing award and its clinical research goals in regenerative medicine.
Can an organization apply if it does not currently have an active U54 award?
Based on the description provided, the practical gatekeeping requirement is that the application must be a revision tied to an active U54 research project award. That means entities without an eligible active U54 award would not fit the described intent of this opportunity.
What is the main scientific focus of the RMIP revision opportunity?
The scientific emphasis is on practical, innovation-driven solutions to bottlenecks that slow development of safe and effective regenerative medicine therapies, specifically work involving adult stem cells. The opportunity highlights applied research and translational activities that make therapies more developable and more clearly evaluable by regulators.
What types of problems or “bottlenecks” is the FOA trying to address?
The FOA emphasizes recurring challenges such as:
- How cell-based products are manufactured consistently
- How product quality is defined and measured
- How safety risks are identified and mitigated
- How effectiveness can be evaluated rigorously in decision-relevant ways
How does FDA relevance show up in the goals of this opportunity?
The FOA signals a strong preference for projects that tackle critical product development issues that matter for regulatory submissions. This reflects FDA interest in improving the evidence base and technical standards that support review and oversight of regenerative medicine products.
What kinds of deliverables does the FOA point applicants toward?
The announcement points toward deliverables such as improved tools, methods, standards, and other applied science advances that strengthen understanding and evaluation of regenerative medicine products across the development pipeline.
What are examples of project activities that appear responsive to this opportunity?
Examples suggested by the description include:
- Better ways to characterize cell-based products
- More robust release testing or potency testing concepts
- Improved approaches to assessing manufacturing variability
- Clearer strategies for evaluating product quality, safety, and clinical performance
Does the FOA favor any particular type of output or result?
While the announcement remains high-level, the repeated focus on manufacturing and evaluation implies a preference for outputs that are broadly usable and decision-enabling, such as validated assays, standardized measurement approaches, frameworks, or decision-enabling datasets, as long as they connect back to the clinical research aims of the active U54 and meaningfully expand the approved scope.
What does “cooperative agreement (U54)” imply for how the project is run?
The opportunity uses a U54 cooperative agreement mechanism. Cooperative agreements typically indicate substantial federal scientific or programmatic involvement compared with a standard research grant, which aligns with the FOA’s emphasis on coordinated, development-focused work relevant to regulatory science and real-world translation.
Which federal department and agencies are associated with this opportunity?
It is offered by the Department of Health and Human Services (HHS) through NIH, and is issued in coordination with participating NIH Institutes and Centers and the FDA.
What is the funding opportunity number (FOA number)?
The funding opportunity number is RFA-HL-17-025.
When was this funding opportunity created and when did it close?
The creation date is listed as April 28, 2017, and the original closing date is June 26, 2017.
What is the maximum award amount (award ceiling) listed for this opportunity?
The award ceiling is listed as $324,500.
How many awards were anticipated?
The program anticipated making about 6 awards, indicating a relatively targeted competition.
Is this a discretionary grant program?
Yes. The opportunity is described as a discretionary program offered by HHS through NIH.
What organizations are eligible to apply?
Eligibility is described as broad at the organizational level and includes many public and private entities, such as:
- State, county, city, township, and special district governments
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Independent school districts
- Federally recognized Native American tribal governments and other tribal organizations
- Public housing authorities/Indian housing authorities
- Nonprofits with and without 501(c)(3) status (other than institutions of higher education)
- For-profit organizations other than small businesses
- Small businesses
The description also notes that additional eligibility details are referenced in the full FOA text, but the practical requirement is that the application must be a revision tied to an active U54 award.
If eligibility is broad, what is the main practical requirement that determines whether you can apply?
The main practical requirement is that the submission must be a revision application linked to an existing, active U54 award that fits the program intent. The funds are meant to expand an already-reviewed project, not initiate a new one.
What disease area or NIH components does this relate to?
The description notes that multiple NIH components are involved and lists multiple CFDA numbers, reflecting the involvement of multiple NIH Institutes/Centers and related authorities. The opportunity is framed around accelerating clinical research in regenerative medicine, specifically involving adult stem cells.
What CFDA numbers are associated with this announcement?
The announcement is associated with the following CFDA numbers: 93.121, 93.173, 93.233, 93.242, 93.286, 93.350, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.856, 93.866, 93.867.
How should an applicant justify the need for additional funds?
Because it is a competing revision intended to provide additional funds within a current budget period, the application should justify why an increase in support is needed now to broaden or strengthen the ongoing U54 work in ways that accelerate clinical research in regenerative medicine and address development and regulatory-relevant challenges.
What is the overall purpose of this FOA in plain terms?
Overall, it is a focused, time-bounded opportunity for current U54 teams to receive competitively reviewed additional support to push regenerative medicine clinical research forward by solving development and regulatory-relevant challenges tied to adult stem cell-based therapies, with particular attention to manufacturing, quality, safety, and effectiveness evaluation.
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Applicants who have applied for this opportunity (RFA HL 17 025) also looked into and applied for these:
| Funding Opportunity |
|---|
| Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (R01) Apply for RFA HL 17 029 Funding Number: RFA HL 17 029 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $324,500 |
| Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (P50) Apply for RFA HL 17 032 Funding Number: RFA HL 17 032 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $324,500 |
| Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (R24) Apply for RFA HL 17 030 Funding Number: RFA HL 17 030 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $324,500 |
| Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (U01) Apply for RFA HL 17 034 Funding Number: RFA HL 17 034 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $324,500 |
| Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (P41) Apply for RFA HL 17 033 Funding Number: RFA HL 17 033 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $324,500 |
| Cystic Fibrosis Research and Translation Center (P30) Apply for RFA DK 17 007 Funding Number: RFA DK 17 007 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $750,000 |
| NIDDK Information Network Coordinating Unit: dkNET-CU (U24) Apply for RFA DK 17 010 Funding Number: RFA DK 17 010 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $635,000 |
| Limited Competition for the Continuation of the Drug Induced Liver Injury Network Data Coordinating Center (U24) Apply for RFA DK 17 510 Funding Number: RFA DK 17 510 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $900,000 |
| Limited Competition for the Continuation of the Drug Induced Liver Injury Network (DILIN) Clinical Centers (U01) Apply for RFA DK 17 509 Funding Number: RFA DK 17 509 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $250,000 |
| Chronic Kidney Disease in Children Central Biochemistry Laboratory (U24) Apply for RFA DK 17 034 Funding Number: RFA DK 17 034 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $250,000 |
| Catalyst Award in Diabetes, Endocrinology and Metabolic Diseases (DP1- Clinical Trial Not Allowed) Apply for RFA DK 17 011 Funding Number: RFA DK 17 011 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| NIDDK Partnerships with Professional Societies to Enhance Scientific Workforce Diversity and Promote Scientific Leadership (R25) Apply for RFA DK 17 015 Funding Number: RFA DK 17 015 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $135,000 |
| Diabetic Foot Consortium - Clinical Research Units (U01) Apply for RFA DK 17 014 Funding Number: RFA DK 17 014 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $275,000 |
| Lymphatics in Health and Disease in the Digestive System (R01 - Clinical Trials Not Allowed) Apply for RFA DK 17 016 Funding Number: RFA DK 17 016 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $499,999 |
| Multidisciplinary Urologic Research (KURe) Career Development Program (K12 Clinical Trial Optional) Apply for RFA DK 17 012 Funding Number: RFA DK 17 012 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $600,000 |
| George M. O'Brien Urology Cooperative Research Centers Program (U54-Clinical Trial Optional) Apply for RFA DK 17 013 Funding Number: RFA DK 17 013 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $1,000,000 |
| Silvio O. Conte Digestive Diseases Research Core Centers (P30 Clinical Trial Optional) Apply for RFA DK 18 001 Funding Number: RFA DK 18 001 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $750,000 |
| Funding For Collaborative Clinical Research In Type 1 Diabetes: Living Biobank (R01 Clinical Trial Optional) Apply for RFA DK 17 032 Funding Number: RFA DK 17 032 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $600,000 |
| Elucidating the Effect of Glycemic Excursions on Patient Well-being and Cognitive Status in People with Type 1 Diabetes (T1D) (R01 Clinical Trial Optional) Apply for RFA DK 18 003 Funding Number: RFA DK 18 003 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| Undergraduate Summer Research Education in Kidney, Urologic, and Hematologic Diseases (R25 Clinical Trial Not Allowed) Apply for RFA DK 18 006 Funding Number: RFA DK 18 006 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $125,000 |
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