Opportunity Information: Apply for RFA HL 18 033
The Regenerative Medicine Innovation Projects (RMIP) funding opportunity (RFA-HL-18-033) is an NIH cooperative agreement (UT2) designed to help small businesses tackle practical, well-known bottlenecks that slow down the development of safe and effective regenerative medicine therapies based on adult stem cells. The program is run by the National Institutes of Health with participation from multiple NIH Institutes and Centers, and it is coordinated with the U.S. Food and Drug Administration, which signals that the work NIH wants supported here is tightly connected to real-world regulatory expectations and the kind of evidence packages companies ultimately need for clinical development. Importantly, this UT2 notice is labeled "Clinical Trial Not Allowed," meaning the supported work is not meant to be a clinical trial; instead, it is focused on late-stage preclinical and product-enabling research that strengthens the foundation for eventual clinical studies.
At its core, RMIP is looking for innovation that directly addresses development and translational challenges for adult stem cell-based products. The emphasis is not on basic discovery, early proof-of-concept, or exploratory biology. Instead, applicants are expected to propose solutions to recognized issues that come up when moving a regenerative medicine concept toward a regulated product: how the product is characterized in depth, how it is manufactured reproducibly, how its potency and identity are defined and measured, how quality is controlled across batches, and how safety is assessed in a way that is meaningful for regulators and clinicians. The announcement highlights areas such as tools, methods, standards, and applied science approaches that improve evaluation of the product itself, including its in vivo function and integration, and the evidence needed to support claims of effectiveness. In other words, NIH is encouraging projects that make regenerative medicine development more measurable, more standardized, and more defensible when it is time to communicate with FDA.
A key theme in the opportunity is regulatory relevance. The program explicitly points applicants toward work that would be useful for regulatory submissions and regulatory decision-making. That includes generating or supplementing evidence needed for clinical development and, specifically, work that supports preparation of an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) submission. The notice also makes clear that NIH will consider late-stage preclinical studies involving adult stem cells when they are framed as the type of research that strengthens an IND/IDE package or adds to the evidence base for studies conducted under an already authorized IND or IDE. This is essentially a bridge-building program: it helps small businesses do the difficult, expensive, and highly technical preclinical and product-development work that often determines whether a regenerative medicine program can realistically move into the clinic.
From an applicant eligibility standpoint, the opportunity is limited to small businesses, consistent with its intent to accelerate commercialization-oriented development work. The eligibility rules also draw a firm boundary around foreign participation: non-U.S. (foreign) institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them in the NIH Grants Policy Statement) are not allowed. Practically, that means the work and the participating entities must stay within an allowable domestic framework, which is a common requirement for certain U.S. government funding programs, particularly those focused on product development and translational pipelines.
On the funding details provided, the award instrument is a cooperative agreement, which generally implies more substantial federal involvement than a standard grant mechanism. While the exact structure can vary by program, cooperative agreements typically involve closer coordination with NIH program staff and potentially more active project stewardship, which fits the program's translational and regulatory focus. The listed award ceiling is $225,000. The original closing date shown is October 19, 2018, and the opportunity was created on August 1, 2018. The opportunity is categorized under discretionary funding and is associated with multiple CFDA numbers spanning various NIH components, reflecting broad NIH participation and the cross-cutting nature of regenerative medicine development.
Overall, RMIP (UT2) is best understood as a targeted, product-enabling regenerative medicine program for small businesses working with adult stem cells, centered on solving the practical technical and standards-related problems that stand between promising science and a regulatory-ready therapeutic product. The strongest fit is a late-stage preclinical or translational development plan that produces rigorous, decision-grade data and/or tools that can be used in an IND/IDE context, without crossing the line into conducting a clinical trial under this specific funding opportunity.Apply for RFA HL 18 033
- The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Regenerative Medicine Innovation Projects (RMIP) (UT2 - 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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Frequently Asked Questions (FAQs): Regenerative Medicine Innovation Projects (RMIP) - RFA-HL-18-033 (UT2)
What is the RMIP funding opportunity (RFA-HL-18-033)?
RMIP (Regenerative Medicine Innovation Projects) is an NIH funding opportunity that uses a cooperative agreement mechanism (UT2) to support small businesses working on adult stem cell-based regenerative medicine products. The focus is on solving practical, well-known development bottlenecks that slow progress toward safe, effective, and regulatory-ready therapies.
What is the main goal of RMIP?
The main goal is to fund product-enabling, late-stage preclinical and translational work that makes adult stem cell-based products more measurable, standardized, reproducible, and defensible for eventual clinical development. Projects are expected to address recognized development challenges rather than early discovery science.
Who runs the RMIP program?
The program is run by the National Institutes of Health (NIH), with participation from multiple NIH Institutes and Centers.
How is the U.S. Food and Drug Administration (FDA) involved?
The opportunity is coordinated with the FDA. This signals that NIH is looking for work that aligns with real-world regulatory expectations and supports the types of evidence packages that companies ultimately need when moving toward clinical development and regulatory interactions.
Is this opportunity intended to fund clinical trials?
No. The notice is labeled "Clinical Trial Not Allowed." The supported work is not meant to be a clinical trial. Instead, it targets late-stage preclinical and product-enabling research that strengthens the foundation for eventual clinical studies.
What types of projects are a strong fit for RMIP?
Projects that directly tackle translational and development challenges for adult stem cell-based products are a strong fit. This includes practical solutions to issues that arise when moving a regenerative medicine concept toward a regulated product.
What types of work are emphasized (and what is de-emphasized)?
RMIP emphasizes applied, translational, and product-development work. It de-emphasizes basic discovery, early proof-of-concept studies, and exploratory biology that is not clearly tied to product readiness and regulatory needs.
What specific development bottlenecks does RMIP aim to address?
The opportunity highlights challenges such as deep product characterization, reproducible manufacturing, defining and measuring potency and identity, quality control across batches, and safety assessment approaches that are meaningful for regulators and clinicians.
Does RMIP support creation of tools, methods, or standards?
Yes. The announcement highlights tools, methods, standards, and applied science approaches that improve evaluation of the product, including evidence needed to support claims of effectiveness and evaluation of in vivo function and integration.
What does "regulatory relevance" mean in the context of RMIP?
Regulatory relevance means the project should generate data, tools, or approaches that would be useful for regulatory submissions and regulatory decision-making. The program is oriented toward producing decision-grade evidence and development capabilities that fit the expectations of a regulated product pathway.
Does RMIP support work related to an IND or IDE?
Yes. The notice points applicants toward work that supports preparation of an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) submission, including generating or supplementing evidence needed for clinical development.
Can RMIP fund late-stage preclinical studies involving adult stem cells?
Yes, NIH will consider late-stage preclinical studies involving adult stem cells when framed as research that strengthens an IND/IDE package or adds to the evidence base for studies conducted under an already authorized IND or IDE, without becoming a clinical trial under this notice.
What is meant by "product-enabling" research in this announcement?
"Product-enabling" research refers to development work that helps turn a regenerative medicine concept into a more standardized, reproducible, and well-characterized product candidate, including establishing assays, manufacturing controls, and safety evidence that support downstream clinical development planning.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with the program's commercialization-oriented development intent.
Are foreign (non-U.S.) institutions eligible to apply?
No. Non-U.S. (foreign) institutions are not eligible to apply.
Are non-domestic components of U.S. organizations allowed?
No. Non-domestic components of U.S. organizations are not eligible.
Are foreign components allowed in the project?
No. Foreign components (as defined by NIH in the NIH Grants Policy Statement) are not allowed for this opportunity.
What does the UT2 cooperative agreement mechanism imply?
The award uses a cooperative agreement mechanism, which generally implies more substantial federal involvement than a standard grant. In practice, this often means closer coordination with NIH program staff and more active project stewardship, matching the program's translational and regulatory focus.
What is the maximum award amount mentioned in the opportunity?
The listed award ceiling is $225,000.
What are the key dates provided?
The opportunity was created on August 1, 2018, and the original closing date shown is October 19, 2018.
What is the funding category for this opportunity?
The opportunity is categorized under discretionary funding.
What does it mean that multiple NIH Institutes and Centers participate?
Multiple NIH Institutes and Centers participating suggests the program is cross-cutting and relevant across different areas of health and translational science, consistent with the broad applicability of regenerative medicine development challenges.
How should applicants think about the "bridge" nature of RMIP?
RMIP is essentially a bridge-building program for small businesses, supporting difficult and highly technical preclinical and product-development work that can determine whether an adult stem cell-based regenerative medicine program can realistically move into the clinic.
What kind of outcomes is RMIP trying to produce?
The program is aiming for rigorous, decision-grade data and/or enabling tools and methods that make it easier to communicate with FDA and to build a credible IND/IDE-oriented evidence package, while staying out of clinical trial execution under this specific notice.
Does the opportunity relate to CFDA numbers?
Yes. The opportunity is associated with multiple CFDA numbers spanning various NIH components, reflecting broad NIH participation.
What is the core scientific/technology focus area?
The core focus is regenerative medicine therapies based on adult stem cells, with an emphasis on translational development needs tied to regulated product pathways.
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