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.

  • 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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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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