Opportunity Information: Apply for RFA HL 18 035
The Regenerative Medicine Innovation Projects (RMIP) funding opportunity (RFA HL 18 035) is a National Institutes of Health (NIH) cooperative agreement designed to help small businesses tackle practical, well-known bottlenecks that slow down or complicate the development of regenerative medicine products based on adult stem cells. It is specifically a U44 mechanism, meaning it is a cooperative agreement rather than a standard grant, and applicants should expect a more hands-on partnership style with the NIH (and coordination with the U.S. Food and Drug Administration) compared with typical research awards. The program is aimed at moving regenerative medicine technologies closer to readiness for regulatory review and eventual clinical use, while explicitly stating that clinical trials are not allowed under this opportunity.
The core purpose of the program is to support innovative, solutions-oriented projects that strengthen the evidence package needed for product development and regulatory submissions. NIH is looking for work that improves how adult stem cell-based products are characterized, manufactured, tested, and validated, especially in ways that regulators and developers rely on when deciding whether a product is consistent, safe, and likely to work. The emphasis is not simply on scientific discovery, but on applied development efforts that address real translational problems that repeatedly come up when trying to turn a regenerative medicine concept into a regulated therapeutic product.
The scope strongly favors projects that address “critical issues” for regulatory submission and product development. Examples of the kinds of topics highlighted include improved tools, methods, standards, and other applied science approaches that enable deeper and more reliable evaluation of product attributes. This includes in-depth product characterization (understanding what the product is and how it behaves), manufacturing and process development (how it is produced consistently and at appropriate quality), potency (demonstrating the product has a measurable biological activity relevant to its intended therapeutic effect), identity (confirming the product is what it is claimed to be), quality and safety (reducing variability and uncovering risks), and functional evaluation such as in vivo function and integration (how the product performs and incorporates in living systems). It also includes work that supports or improves evaluation of effectiveness in a preclinical setting, with the understanding that this is about building credible development data rather than conducting human efficacy trials.
A key feature of RMIP is its interest in late-stage preclinical research involving adult stem cells when that research is intended to generate or supplement evidence for clinical development. The opportunity explicitly mentions that studies may be conducted to support, among other goals, preparation of an Investigational New Drug (IND) application or an Investigational New Device Exemption (IDE) package. It also allows for research that supports work already being conducted under an authorized IND or IDE, as long as the proposed activities themselves remain preclinical and do not cross into clinical trial territory. In practice, this positions the program as a bridge between earlier R&D and the point where a company is ready to engage regulators with a well-supported submission package.
Eligibility is limited to small businesses, consistent with the small business research focus of the U44 mechanism. Foreign participation is tightly restricted: non-U.S. (non-domestic) entities are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined by the NIH Grants Policy Statement are not allowed. In other words, applicants need to be U.S.-based small businesses and plan to conduct the funded work without foreign components.
Administratively, the opportunity is categorized as discretionary funding and falls under health-related activity categories, with multiple CFDA numbers listed (reflecting participation across NIH Institutes and Centers). The original closing date shown is October 19, 2018, indicating this specific announcement was time-bound to that cycle. The award ceiling shown is $225,000, which suggests the program anticipated modest, targeted development efforts aimed at resolving specific translational or regulatory-relevant hurdles rather than underwriting broad platform development or large-scale preclinical programs.
Overall, RMIP is best understood as a targeted NIH-and-FDA-aligned push to improve the development toolkit for adult stem cell-based regenerative medicine products. Competitive applications would be expected to propose a clear, practical solution to a recognized development problem, show how the work will improve the ability to characterize and manufacture a product or to demonstrate potency, identity, safety, and function, and explain how the resulting data or methods will strengthen an eventual IND/IDE-oriented regulatory package without involving any clinical trial activities.Apply for RFA HL 18 035
- The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Regenerative Medicine Innovation Projects (RMIP) (U44 - Clinical Trial Not Allowed)" 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 2018-08-01.
- Applicants must submit their applications by 2018-10-19. (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 $225,000.00 in funding.
- Eligible applicants include: Small businesses.
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Regenerative Medicine Innovation Projects (RMIP) (RFA HL 18 035) - FAQs
What is the RMIP funding opportunity (RFA HL 18 035)?
RMIP (Regenerative Medicine Innovation Projects) is a National Institutes of Health (NIH) cooperative agreement funding opportunity intended to help small businesses address practical, well-known bottlenecks that slow or complicate development of regenerative medicine products based on adult stem cells.
What type of award mechanism is used for RMIP?
RMIP uses a U44 mechanism, which is a cooperative agreement rather than a standard grant. This implies a more hands-on, partnership-style relationship with NIH, and coordination with the U.S. Food and Drug Administration (FDA) compared with typical research awards.
What is the main goal of RMIP?
The program is designed to move adult stem cell-based regenerative medicine technologies closer to readiness for regulatory review and eventual clinical use by supporting applied, solutions-oriented development work that strengthens the evidence package needed for product development and regulatory submissions.
Are clinical trials allowed under RMIP?
No. The opportunity explicitly states that clinical trials are not allowed.
What kinds of problems is RMIP meant to solve?
RMIP is focused on tackling practical translational and regulatory-relevant development hurdles that repeatedly arise when attempting to turn an adult stem cell-based concept into a regulated therapeutic product. The emphasis is on applied development rather than basic scientific discovery.
What does NIH mean by projects that address "critical issues" for regulatory submission and product development?
It refers to work that directly improves the tools, methods, standards, or applied approaches used to evaluate whether a product is consistent, safe, and likely to work, in ways that matter for product development decisions and regulatory submissions.
What technical areas are emphasized in the RMIP scope?
The scope highlights improvements in product characterization, manufacturing and process development, potency, identity, quality, safety, and functional evaluation (including in vivo function and integration). These areas align with the kinds of evidence regulators and developers rely on for development and submission packages.
What is meant by "product characterization" in this opportunity?
Product characterization refers to in-depth understanding of what the adult stem cell-based product is and how it behaves, including attributes needed to support consistent development and regulatory review.
What types of manufacturing work fit RMIP?
RMIP favors manufacturing and process development work aimed at producing the product consistently and at appropriate quality, including methods and validation approaches that reduce variability and support reliable production.
Does RMIP support work on potency?
Yes. The opportunity specifically highlights potency, including demonstrating measurable biological activity relevant to the intended therapeutic effect.
Does RMIP support work on identity testing?
Yes. Identity is explicitly highlighted, including confirming the product is what it is claimed to be.
Does RMIP support work related to quality and safety?
Yes. The scope includes quality and safety, with an emphasis on reducing variability and uncovering risks that could affect product development and regulatory confidence.
What does RMIP mean by functional evaluation such as "in vivo function and integration"?
It refers to evaluating how the product performs and incorporates in living systems. This is framed as development-oriented evidence building rather than human clinical testing.
Is preclinical effectiveness work allowed?
The opportunity indicates that work supporting or improving evaluation of effectiveness in a preclinical setting can be included, as long as it is intended to build credible development data and does not involve clinical trials.
Is late-stage preclinical research specifically encouraged?
Yes. RMIP highlights interest in late-stage preclinical research involving adult stem cells when the purpose is to generate or supplement evidence for clinical development.
Can RMIP-funded studies support an IND or IDE submission?
Yes. The opportunity explicitly mentions that studies may be conducted to support preparation of an Investigational New Drug (IND) application or an Investigational New Device Exemption (IDE) package.
Can RMIP support work that relates to an authorized IND or IDE?
Yes. It allows research that supports work already being conducted under an authorized IND or IDE, provided the proposed RMIP activities themselves remain preclinical and do not become clinical trial activities.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with the small business research focus of the U44 mechanism.
Are foreign organizations eligible to apply?
No. Non-U.S. (non-domestic) entities are not eligible to apply.
Are foreign components allowed if the applicant is a U.S. organization?
No. Non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed.
What does the restriction on foreign components practically mean for applicants?
Applicants must be U.S.-based small businesses and should plan to conduct the funded work without foreign components.
What is the anticipated award ceiling for this opportunity?
The award ceiling shown is $225,000, suggesting the program anticipated modest, targeted efforts aimed at resolving specific translational or regulatory-relevant hurdles.
When was the closing date for this RMIP announcement?
The original closing date shown is October 19, 2018, indicating this specific announcement was tied to that cycle.
Is this opportunity considered discretionary funding?
Yes. Administratively, the opportunity is categorized as discretionary funding and falls under health-related activity categories.
Does RMIP involve more interaction with NIH and FDA than typical grants?
Yes. Because it is a cooperative agreement (U44), applicants should expect a more hands-on partnership style with NIH and coordination with the FDA compared with typical research awards.
How should an applicant position a competitive RMIP project, based on the description provided?
Competitive projects would be expected to propose a clear, practical solution to a recognized development problem; show how the work improves the ability to characterize and manufacture the product or demonstrate potency, identity, safety, and function; and explain how outputs will strengthen an eventual IND/IDE-oriented regulatory package without involving any clinical trial activities.
What is RMIP "not" designed to fund?
Based on the description, RMIP is not designed for clinical trials, and it is not positioned as a basic discovery program. The emphasis is on applied development work that resolves recurring translational and regulatory bottlenecks for adult stem cell-based regenerative medicine products.
What product area is the focus of RMIP?
The opportunity focuses on regenerative medicine products based on adult stem cells.
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| Funding Opportunity |
|---|
| Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Studies (Collaborative U01 Clinical Trial Not Allowed) Apply for RFA HL 18 030 Funding Number: RFA HL 18 030 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $250,000 |
| Regenerative Medicine Innovation Projects (RMIP) (UT2 - Clinical Trial Not Allowed) Apply for RFA HL 18 033 Funding Number: RFA HL 18 033 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $225,000 |
| Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required) Apply for RFA HL 18 031 Funding Number: RFA HL 18 031 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $405,000 |
| New Paradigms in Tissue Communication-from mediators to metabolic function (RC2 Clinical Trials Optional) Apply for PAR 18 886 Funding Number: PAR 18 886 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Elucidating the Role of the Autonomic Nervous System in Peripheral Metabolism and Metabolic Disease through the Application of Novel Tools and Methodologies (RC2 Clinical Trial Optional) Apply for PA 18 891 Funding Number: PA 18 891 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Elucidating the Role of the Autonomic Nervous System in Peripheral Metabolism and Metabolic Disease through the Application of Novel Tools and Methodologies (RC2 Clinical Trial Optional) Apply for PAR 18 898 Funding Number: PAR 18 898 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Human Islet Research Network - Consortium on Human Islet Biomimetics (HIRN-CHIB) (UG3/UH3 Clinical Trial Not Allowed) Apply for RFA DK 18 011 Funding Number: RFA DK 18 011 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $750,000 |
| Pilot and Feasibility Clinical and Translational Research Studies in Digestive Diseases and Nutrition (R21 Clinical Trial Optional) Apply for PA 18 903 Funding Number: PA 18 903 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $200,000 |
| Limited Competition for the Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Clinical Centers (U01 Clinical Trial Required) Apply for RFA DK 18 505 Funding Number: RFA DK 18 505 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $2,000,000 |
| Limited Competition for the Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Data Coordinating Center (U24 Clinical Trial Required) Apply for RFA DK 18 506 Funding Number: RFA DK 18 506 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $2,000,000 |
| Limited Competition for the Continuation of Cure Glomerulonephropathy (CureGN) Data Coordinating Center (U24 Clinical Trial Not Allowed) Apply for RFA DK 18 504 Funding Number: RFA DK 18 504 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $1,000,000 |
| Limited Competition for the Continuation of Cure Glomerulonephropathy (CureGN) Participating Clinical Centers (U01 Clinical Trial Not Allowed) Apply for RFA DK 18 503 Funding Number: RFA DK 18 503 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $750,000 |
| Limited Competition for the Continuation of the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network Discovery Sites (U01 Clinical Trial Not Allowed) Apply for RFA DK 18 513 Funding Number: RFA DK 18 513 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Limited Competition for the Continuation of the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network Data Coordinating Core (DCC) (U24 Clinical Trial Not Allowed) Apply for RFA DK 18 514 Funding Number: RFA DK 18 514 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Limited Competition for the Continuation of the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network Tissue and Technology Core (TATC) (U24 Clinical Trial Not Allowed) Apply for RFA DK 18 515 Funding Number: RFA DK 18 515 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Limited Competition for the Continuation of the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Research Sites (U01 Clinical Trial Not Allowed) Apply for RFA DK 18 510 Funding Number: RFA DK 18 510 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $375,000 |
| Limited Competition for the Continuation of the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Data Coordinating Center (U24 Clinical Trial Not Allowed) Apply for RFA DK 18 511 Funding Number: RFA DK 18 511 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $800,000 |
| Planning Grants for Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care (R34 Clinical Trial Required) Apply for PAR 18 924 Funding Number: PAR 18 924 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $150,000 |
| Limited Competition for the Continuation of the Childhood Liver Disease Research Network (ChiLDReN) Scientific and Data Coordinating Center (U24 Clinical Trial Optional) Apply for RFA DK 18 502 Funding Number: RFA DK 18 502 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Limited Competition for the Continuation of the Childhood Liver Disease Research Network (ChiLDReN) Clinical Centers (U01 Clinical Trial Required) Apply for RFA DK 18 501 Funding Number: RFA DK 18 501 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
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