Opportunity Information: Apply for RFA HL 17 023
The funding opportunity titled "Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (R43/R44)" (Funding Opportunity Number RFA-HL-17-023) is a discretionary NIH grant program that supports competing revision applications to active SBIR awards under the R43/R44 mechanisms. In practical terms, it is not a stand-alone, open-to-anyone SBIR solicitation; it is specifically for small businesses that already hold an active NIH R43 or R44 SBIR grant and want additional funds during the current budget period to expand the scope of work or modify and broaden the approved research protocol. The overall intent is to push forward clinical research efforts in regenerative medicine that rely on adult stem cells, with an emphasis on work that helps the field overcome common, well-recognized barriers to translating regenerative medicine concepts into therapies that are both safe and effective.
A central theme of this FOA is solving development and translation problems that tend to slow regenerative medicine products on their path to patients. The NIH and participating Institutes and Centers, in collaboration with the U.S. Food and Drug Administration, are looking for revisions that add meaningful, targeted activities aimed at issues that matter for real-world product development, especially issues that come up when preparing for or supporting regulatory submissions. That regulatory-facing angle is important: the opportunity is framed to encourage applied, practical advances that improve the evidence base and technical readiness of regenerative medicine products, rather than purely exploratory science that does not connect to manufacturability, control strategies, safety evaluation, or clinical performance.
The areas of interest are described broadly but point to concrete kinds of additions a revision might support. Projects may propose improved tools, methods, standards, or other forms of applied science that strengthen how regenerative medicine products are manufactured and evaluated. This can include work that improves understanding and measurement of manufacturing quality, consistency, and comparability; approaches that enhance product characterization and establish meaningful quality attributes; methods that better assess safety risks; or strategies that clarify and demonstrate effectiveness. The emphasis is on advances that make it easier to evaluate products rigorously, interpret results consistently, and generate data that can credibly support later-stage development decisions and regulatory interactions.
Eligibility is tightly limited. The eligible applicants are small businesses, and the applicant must already have an active R43/R44 SBIR award that can serve as the parent project for the competing revision. Foreign participation is expressly restricted: non-domestic (non-U.S.) entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined in the NIH Grants Policy Statement) are not allowed. These restrictions mean the proposed revision work must be structured so that all supported components fall within allowable domestic arrangements under NIH policy for this FOA.
From the source details provided, the opportunity was created on April 28, 2017, with an original closing date of June 26, 2017. The sponsoring agency is the National Institutes of Health, and the activity category falls under health-related research (with multiple CFDA numbers listed, reflecting participation across NIH components). An award ceiling and expected number of awards are not specified in the provided data, which often signals that the actual amounts and counts depend on available funds, the quality of submitted revisions, and the priorities of participating NIH Institutes and Centers.
Overall, this FOA is best understood as a mechanism for current NIH SBIR-funded regenerative medicine companies to accelerate or strengthen a running project by adding clinically relevant development work that tackles recognized bottlenecks in adult stem cell-based regenerative medicine, especially work that improves manufacturing control, product quality, safety assessment, and demonstrations of effectiveness in ways that align with regulatory expectations.Apply for RFA HL 17 023
- The 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) (R43/R44)" 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 2017-04-28.
- Applicants must submit their applications by 2017-06-26. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The funding opportunity is titled "Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (R43/R44)" and is identified as Funding Opportunity Number RFA-HL-17-023.
What type of NIH funding is this?
This is a discretionary NIH grant program that supports competing revision applications to active SBIR awards under the R43/R44 mechanisms.
Is this a stand-alone SBIR opportunity that any small business can apply to?
No. This is not a stand-alone, open-to-anyone SBIR solicitation. It is specifically for small businesses that already hold an active NIH R43 or R44 SBIR award and want to request additional funds during the current budget period by submitting a competing revision to that active "parent" award.
Who is eligible to apply?
Eligibility is tightly limited to small businesses that already have an active NIH R43/R44 SBIR award that can serve as the parent project for the competing revision.
What is meant by a "competing revision application" in this context?
In practical terms, the FOA supports requests for additional funds during the current budget period to expand the scope of work or to modify and broaden the approved research protocol of an active NIH SBIR (R43/R44) project.
What is the overall intent of the FOA?
The overall intent is to push forward clinical research efforts in regenerative medicine that rely on adult stem cells, with an emphasis on overcoming common barriers that slow translation of regenerative medicine concepts into therapies that are safe and effective.
What scientific area does this FOA focus on?
The FOA focuses on regenerative medicine clinical research efforts that rely on adult stem cells, particularly applied work that helps address development and translation challenges.
What kinds of problems is NIH trying to solve through these revisions?
A central theme is solving development and translation problems that often slow regenerative medicine products on their path to patients. The FOA emphasizes targeted activities that address real-world product development issues, especially those relevant to preparing for or supporting regulatory submissions.
How important is the regulatory angle in this opportunity?
It is a key emphasis. The opportunity is framed to encourage applied, practical advances that improve the evidence base and technical readiness of regenerative medicine products, particularly in areas that matter for regulatory interactions (for example, issues connected to manufacturability, control strategies, safety evaluation, and clinical performance).
What types of additional activities might a revision support?
Revisions may propose improved tools, methods, standards, or other forms of applied science that strengthen how regenerative medicine products are manufactured and evaluated. Examples described include work that improves understanding and measurement of manufacturing quality, consistency, and comparability; approaches that enhance product characterization and establish meaningful quality attributes; methods that better assess safety risks; and strategies that clarify and demonstrate effectiveness.
Does the FOA emphasize exploratory/basic science or applied development work?
The emphasis is on applied, practical advances that connect to product development readiness and regulatory-facing needs, rather than purely exploratory science that does not connect to manufacturability, control strategies, safety evaluation, or clinical performance.
What product-development themes are highlighted as important?
The FOA highlights themes such as manufacturing control, product quality and consistency, product characterization and meaningful quality attributes, comparability, safety risk assessment, and demonstrating effectiveness in ways that support rigorous evaluation and credible decision-making for later-stage development and regulatory interactions.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
Are any other federal agencies involved?
The FOA notes that NIH and participating Institutes and Centers are working in collaboration with the U.S. Food and Drug Administration (FDA), with an emphasis on revisions that address issues relevant to regulatory submissions and regulatory interactions.
Are foreign (non-U.S.) entities allowed to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply under this FOA.
Are non-domestic components of U.S. organizations allowed?
No. Non-domestic components of U.S. organizations are not eligible under this FOA.
Are foreign components allowed as part of the proposed project?
No. Foreign components (as defined in the NIH Grants Policy Statement) are not allowed under this FOA.
What do the foreign restrictions mean for how applicants structure the revision work?
These restrictions mean the proposed revision work must be structured so that all supported components fall within allowable domestic arrangements under NIH policy for this FOA.
When was this opportunity created?
The source details indicate it was created on April 28, 2017.
What was the original closing date?
The original closing date listed in the provided information is June 26, 2017.
What is the activity category or general research area?
The activity category falls under health-related research, and multiple CFDA numbers are listed, reflecting participation across NIH components.
Is an award ceiling specified?
No. An award ceiling is not specified in the provided data.
Is the expected number of awards specified?
No. The expected number of awards is not specified in the provided data.
What does it mean that the award ceiling and number of awards are not specified?
Based on the provided description, it often signals that actual award amounts and counts may depend on available funds, the quality of submitted revision applications, and the priorities of participating NIH Institutes and Centers.
How should applicants think about the "parent" project relationship?
This FOA is designed for competing revisions to an active NIH R43/R44 SBIR parent award. The revision is meant to add scope or broaden/modify the approved protocol of that running project, rather than propose an unrelated, independent project.
What is the main takeaway about who this FOA is for?
Overall, it is best understood as a mechanism for current NIH SBIR-funded regenerative medicine companies to accelerate or strengthen an existing project by adding clinically relevant development work that tackles recognized bottlenecks in adult stem cell-based regenerative medicine, particularly around manufacturing control, product quality, safety assessment, and demonstrating effectiveness in ways aligned with regulatory expectations.
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Applicants also applied for:
Applicants who have applied for this opportunity (RFA HL 17 023) also looked into and applied for these:
| Funding Opportunity |
|---|
| Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (R41/R42) Apply for RFA HL 17 024 Funding Number: RFA HL 17 024 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (UC4) Apply for RFA HL 17 027 Funding Number: RFA HL 17 027 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| NIDDK Central Repositories Non-renewable Sample Access (X01) Apply for PAR 17 270 Funding Number: PAR 17 270 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Therapeutic Strategies for the Converging TB/T2DM/HIV Epidemics (R01) Apply for PA 17 283 Funding Number: PA 17 283 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Administrative Supplements for Participation in the Concept to Clinic: Commercializing Innovation (C3i) Program (Admin Supp) Apply for PA 17 286 Funding Number: PA 17 286 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Psychological, Behavioral, and Neurocognitive-Focused Ancillary Studies to the Molecular Transducers of Physical Activity in Humans Consortium (MoTrPAC) (U01) Apply for RFA DK 17 009 Funding Number: RFA DK 17 009 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $3,000,000 |
| Center for Identification and Study of Individuals with Atypical Diabetes Mellitus (U54) Apply for RFA DK 17 006 Funding Number: RFA DK 17 006 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Limited Competition for the Continuation of the Chronic Renal Insufficiency Cohort Scientific and Data Coordinating Center (U24) Apply for RFA DK 17 506 Funding Number: RFA DK 17 506 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $2,250,000 |
| Limited Competition for the Continuation of the Chronic Renal Insufficiency Cohort (CRIC) Clinical Centers (U01) Apply for RFA DK 17 505 Funding Number: RFA DK 17 505 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $650,000 |
| Developmental Centers for Interdisciplinary Research in Benign Urology (P20 - Clinical Trials Not Allowed) Apply for RFA DK 17 033 Funding Number: RFA DK 17 033 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $200,000 |
| Investigator-Initiated Clinical Trials Targeting Diseases within the Mission of NIDDK (R01-Clinical Trial Required) Apply for PA 18 330 Funding Number: PA 18 330 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| NIDDK Program Projects (P01 Clinical Trial Optional) Apply for PAR 18 012 Funding Number: PAR 18 012 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $6,250,000 |
| Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01 Clinical Trial Optional) Apply for PAR 18 042 Funding Number: PAR 18 042 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Metabolic Contributions to the Neurocognitive Complications of Diabetes: Ancillary Studies (R01 Clinical Trial Optional) Apply for PAR 18 051 Funding Number: PAR 18 051 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Secondary Analyses in Obesity, Diabetes and Digestive and Kidney Diseases (R21 Clinical Trial Optional) Apply for PA 18 052 Funding Number: PA 18 052 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $200,000 |
| Pilot and Feasibility Clinical Research Grants in Kidney Diseases (R21 Clinical Trial Optional) Apply for PAR 18 100 Funding Number: PAR 18 100 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $200,000 |
| Pilot and Feasibility Clinical and Translational Research Studies in Digestive Diseases and Nutrition (R21 Clinical Trial Optional) Apply for PA 18 099 Funding Number: PA 18 099 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $200,000 |
| Pilot and Feasibility Clinical Research Grants in Urologic Disorders (R21 Clinical Trial Optional) Apply for PAR 18 101 Funding Number: PAR 18 101 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $200,000 |
| Small Grants for New Investigators to Promote Diversity in Health-Related Research (R21 Clinical Trial Optional) Apply for PAR 18 102 Funding Number: PAR 18 102 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $125,000 |
| Limited Competition: Small Grant Program for NIDDK K01/K08/K23 Recipients (R03 Clinical Trial Optional) Apply for PAR 18 103 Funding Number: PAR 18 103 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $50,000 |
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