Opportunity Information: Apply for RFA HL 17 029
Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (R01) is a one-time NIH and FDA funding opportunity (RFA-HL-17-029) designed specifically for investigators who already hold an active NIH R01 award and want to expand that existing project in a way that advances regenerative medicine using adult stem cells. The mechanism is a competing revision, meaning it is not a brand-new standalone grant. Instead, it provides additional funds during a current budget period to broaden the approved scope of work or to expand the existing research protocol. The overall goal is to push regenerative medicine toward safer, more effective, and more readily translatable therapies by tackling practical development problems that routinely slow down or complicate progress.
A central theme of the announcement is innovation aimed at well-known bottlenecks in regenerative medicine development, especially those that matter when a product is moving toward regulatory review. NIH and FDA signal that they are looking for projects that do more than generate basic scientific findings; they want work that helps solve concrete issues tied to real-world product development and eventual regulatory submissions. In practice, that means proposals should focus on improving the tools, methods, standards, and applied science needed to understand and evaluate regenerative medicine products. The announcement highlights areas such as manufacturing and production processes, quality assessment and control, safety evaluation, and evidence supporting effectiveness. The emphasis on these areas reflects a desire to strengthen the reliability, reproducibility, and interpretability of data packages used to support clinical development and regulatory decision-making.
Because the FOA is targeted at clinical research studies, applicants are expected to propose activities that directly support or enhance clinical-stage progress in adult stem cell-based regenerative medicine. The revision format implies that the proposed expansion should be clearly connected to the parent R01 project, leveraging its existing aims, resources, or infrastructure while extending what the project can accomplish. In other words, the revision should not look like an unrelated new program; it should read as a justified and logical extension that accelerates translation and addresses a recognized development gap that has broad relevance to the field.
Eligibility is broad at the institutional level, spanning many types of domestic organizations that can hold NIH awards, including state, county, and local governments; public and private institutions of higher education; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (including those other than small businesses); and small businesses, along with certain tribal governments and tribal organizations and other entities as permitted by the FOA. Even with wide organizational eligibility, the key practical constraint is that applicants must be investigators with an active R01 research project grant, since the funding is explicitly for competing revisions to ongoing R01s rather than new starts.
Administratively, the opportunity is offered by the U.S. Department of Health and Human Services through the National Institutes of Health, with participation from NIH Institutes and Centers and the U.S. Food and Drug Administration. The announcement was created on April 28, 2017, with an original closing date of June 26, 2017. The award ceiling listed is $324,500, and the program anticipated making around six awards. The funding activity falls under health-related categories and is associated with multiple CFDA listings, reflecting the cross-institute nature of regenerative medicine and the range of NIH program areas that can intersect with adult stem cell clinical development.
Taken together, this FOA is best understood as a targeted push to strengthen the development science around adult stem cell-based regenerative medicine by funding add-on work to already-funded R01 projects. The strongest-fit revisions would be those that can credibly improve how regenerative medicine products are manufactured, characterized, and evaluated for quality, safety, and effectiveness, and that produce outputs that are useful not only to the parent project but also to the broader field as it works toward clinically and regulatorily viable therapies.Apply for RFA HL 17 029
- 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) (R01)" 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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FAQs: Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (R01) - RFA-HL-17-029
What is this funding opportunity?
This is a one-time NIH and FDA funding opportunity titled "Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (R01)" (RFA-HL-17-029). It is designed to provide additional funding to expand an already-funded NIH R01 research project in ways that advance adult stem cell-based regenerative medicine.
Is this a new standalone grant or an add-on to an existing grant?
It is not a new standalone grant. The mechanism is a competing revision, meaning it provides additional funds during a current budget period to broaden the approved scope of work or expand the existing research protocol of an active parent R01 award.
Who is this opportunity intended for?
This opportunity is intended for investigators who already hold an active NIH R01 award and want to expand that existing project in a way that advances regenerative medicine using adult stem cells.
What is the overall goal of the FOA?
The overall goal is to help move regenerative medicine toward safer, more effective, and more readily translatable therapies by addressing practical development problems that often slow down or complicate progress, particularly as products move toward regulatory review.
What types of projects are NIH and FDA looking for?
NIH and FDA emphasize innovation focused on well-known bottlenecks in regenerative medicine development. The FOA highlights projects that go beyond basic scientific findings and instead solve concrete issues tied to real-world product development and eventual regulatory submissions.
What specific topic areas does the announcement emphasize?
The announcement highlights work aimed at improving tools, methods, standards, and applied science needed to understand and evaluate regenerative medicine products. Examples specifically mentioned include manufacturing and production processes, quality assessment and control, safety evaluation, and evidence supporting effectiveness.
Why is there an emphasis on manufacturing, quality, safety, and effectiveness?
The emphasis reflects a desire to strengthen the reliability, reproducibility, and interpretability of data packages that support clinical development and regulatory decision-making for adult stem cell-based regenerative medicine products.
Is this FOA focused on basic research or clinical research?
The FOA is targeted at clinical research studies. Applicants are expected to propose activities that directly support or enhance clinical-stage progress in adult stem cell-based regenerative medicine.
How should the proposed revision relate to the parent R01?
The proposed expansion should be clearly connected to the parent R01 project and should leverage its existing aims, resources, or infrastructure. The revision should read as a justified and logical extension that accelerates translation and addresses a recognized development gap with broad relevance to the field.
Can the revision be a completely unrelated new line of work?
No. The revision should not look like an unrelated new program. It should be an expansion of the existing R01 that broadens the approved scope of work or extends the current research protocol in a way that supports the FOA's regenerative medicine development goals.
What makes a revision a strong fit for this program?
Based on the announcement, strong-fit revisions would credibly improve how adult stem cell-based regenerative medicine products are manufactured, characterized, and evaluated for quality, safety, and effectiveness. They should also produce outputs useful to the parent project and relevant to the broader field as it moves toward clinically and regulatorily viable therapies.
Which agencies are involved in offering this opportunity?
The opportunity is offered by the U.S. Department of Health and Human Services through the National Institutes of Health (NIH), with participation from NIH Institutes and Centers and the U.S. Food and Drug Administration (FDA).
What is the application mechanism?
The application mechanism is a competing revision to an existing NIH R01 research project grant, providing additional funds during a current budget period.
What is the maximum award amount listed?
The award ceiling listed in the announcement is $324,500.
How many awards were anticipated?
The program anticipated making around six awards.
When was the opportunity created and when did it close?
The announcement was created on April 28, 2017, with an original closing date of June 26, 2017.
What organizations are eligible to apply?
Institutional eligibility is broad and includes many types of domestic organizations that can hold NIH awards, such as state, county, and local governments; public and private institutions of higher education; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (including those other than small businesses); small businesses; certain tribal governments and tribal organizations; and other entities as permitted by the FOA.
What is the key practical eligibility requirement for investigators?
The key practical constraint is that applicants must be investigators with an active NIH R01 research project grant, because this funding is explicitly for competing revisions to ongoing R01s rather than new starts.
Is this opportunity limited to a specific health topic area?
The funding activity falls under health-related categories and is associated with multiple CFDA listings, reflecting the cross-institute nature of regenerative medicine and the range of NIH program areas that can intersect with adult stem cell clinical development.
How does regulatory relevance factor into the FOA's priorities?
A central theme is innovation that addresses bottlenecks that matter when a product is moving toward regulatory review. The FOA signals interest in work that strengthens the types of data and evaluation methods that can support clinical development and regulatory decision-making.
What is this FOA trying to achieve for the field overall?
It is a targeted push to strengthen development science around adult stem cell-based regenerative medicine by funding add-on work to already-funded R01 projects, with an emphasis on practical advances that help the field move toward clinically and regulatorily viable therapies.
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| Funding Opportunity |
|---|
| 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 |
| Human Islet Research Enhancement Center for the Human Islet Research Network (U24 Clinical Trial Not Allowed) Apply for RFA DK 18 012 Funding Number: RFA DK 18 012 Agency: Department of Health and Human Services, National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $1,200,000 |
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