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Frequently Asked Questions
Click on a category name below to display a list of questions. Can't find an answer to your question? Contact us at RMIP@nih.gov.
Q1. Why was the Regenerative Medicine Innovation Project (RMIP) launched?
Given the tremendous potential of regenerative medicine to enhance human health and treat disease, Congress included a provision in the 21st Century Cures Act — a law passed in December 2016 to accelerate medical discovery and innovation — to support a Regenerative Medicine Innovation Project (RMIP). The RMIP is one of four Innovation Projects authorized under the Act; the others are the Precision Medicine Initiative (“All of Us”), the Beau Biden Cancer Moonshot, and the BRAIN Initiative.
Q2. How much funding is available for the RMIP overall?
The 21st Century Cures Act authorizes $30 million (distributed over fiscal year (FY) 2017 through FY 2020) for the funding of clinical research to further the field of regenerative medicine (RM) using adult stem cells. Specifically, the Act authorizes $2 million in FY 2017, $10 million in each of FY 2018 and FY 2019, and $8 million in FY 2020. These funds are available subject to Congressional appropriation.
To amplify the benefit of these funds, the Cures Act requires that recipients contribute at least an equal amount of non-Federal dollars or in-kind contributions of non-Federal origin.
Q3. How long will this Innovation Project last?
Funds are authorized through FY 2020. However, by providing a catalyst for undertaking a systematic, consultative, and inclusive approach to advancing the field of regenerative medicine, the benefits of the additional support authorized by the Cures act are expected to extend beyond the funded projects and years of direct support.
Available funds/number of awards
Q4. How much money is available in FY 2018 for these awards?
Congress authorized for FY 2018 $10 million for the RMIP. NIH intends to use these funds to support clinical research projects, including clinical trials.
Q5. Six notices were issued about funding opportunities utilizing several cooperative agreement funding mechanisms (research projects, as well as small business research and development awards). Is $10 million available for each of these mechanisms?
No. The totality of funds available in FY 2018 is $10 million.
Types of awards
Q6. What funding mechanisms do these awards utilize?
Awards will utilize the following funding mechanisms:
Q7. The FOA issued in FY 2017 was for competitive revisions. Is that the type of award being used in FY 2018?
No. For FY 2018, new project grant applications are being solicited for the award mechanisms described above. Competitive supplements were awarded in FY 2017 because of the limited available monies and the compressed timeframe involved.
Q8. I see that there is a matching requirement of at least one non-federal dollar for each federal dollar awarded. The notice says that in-kind contributions can be substituted for cash. What kinds of in-kind contributions are acceptable?
Acceptable forms of in-kind contributions include personnel salary, facilities and administrative (i.e., indirect) costs, equipment, and real estate. Importantly, to be eligible, these contributions may not have been obtained with support from any federal agency.
Q9. Must we match the total award (direct and indirect costs) or just the direct costs awarded?
The 21st Century Cures Act requires that grant recipients provide non-federal contributions in “an amount not less than $1 for each $1 of Federal funds provided in the award.” Thus, NIH expects award recipients to match the total awarded amount (direct plus indirect costs). See also Q11 below.
Q10. What if we intend to contribute all of our facilities and administration expenses (indirect costs) toward the project as a form of “in kind” contribution? Must we match what would have been the total award, or just the direct cost amount?
The institution must match whatever sum was federally awarded. If the institution is forgoing all indirect cost reimbursement, and the NIH award is only for direct costs, then the institution must match the direct cost amount.
Q11. May we use revenue generated by research-related activities, such as fees charged to research participants, to fulfill the matching requirement?
No. Such revenue is considered “program income.” Program income is not an allowable source of matching dollars. Program income is gross income earned by a recipient, a consortium participant, or a contractor under a grant that was directly generated by the grant-supported activity or earned as a result of the award. Program income includes, but is not limited to, income from fees for services performed; charges for the use or rental of real property, equipment or supplies acquired under the grant; the sale of commodities or items fabricated under an award; charges for research resources; registration fees for grant-supported conferences, and license fees and royalties on patents and copyrights.
Q12. When must the matching contributions be available? All at the outset of the project? By the end of the award period? In each year that the awarded funds are drawn?
Matching contributions must be available annually in an amount at least equal to the amount of federal dollars drawn upon by the institution at the time of award. Any matching contribution paid in excess of a given year’s obligation may be credited toward the following year’s matching obligation.
Types of eligible research projects
Q13. How is “regenerative medicine” defined for the purpose of this funding opportunity?
An aim of the 21st Century Cures Act was to accelerate the development of regenerative medicine therapies, which the Act describes as including “cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products…” Research eligible for 21st Century Cures Act funding may encompass, for example, research on biologics (e.g., growth factors, cytokines) and biomaterials (e.g., ECM, scaffolds) that stimulate host adult stem cell growth, differentiation, and function or otherwise directly act upon adult stems cells to support innate host healing mechanisms, treat disease, and/or restore function.
Q14. Is basic research on stem cells eligible for these funds?
No. While basic research is an important component of regenerative medicine research, the 21st Century Cures Act requires that the RMIP funds be used “to award grants and contracts for clinical research to further the field of regenerative medicine using adult stem cells, including autologous stem cells.”
Q15. If only clinical research applications are eligible for funding under the RMIP, how is “clinical research” defined for this purpose?
Per the FOA, eligible applications will propose research that involves: (1) human subjects and/or (2) material of human origin, such as cells, tissues, and specimens.
Q16. Is research using cells from previously approved embryonic stem cell lines eligible for these funds?
No. The 21st Century Cures Act requires that these funds are to be used for regenerative medicine research using adult stem cells. For the purpose of research conducted with the RMIP funds, adult stem cells may not be derived from embryonic or fetal sources.
Q17. I see that stem cells from embryonic and fetal sources are not eligible for these awards. What about work with induced pluripotent stem cells (iPSCs)?
Research with iPSCs and their differentiated progeny is eligible for RMIP funding, provided the stem cells were not derived from embryonic or fetal cells.
Q18. Is research using neonatal stem cells eligible for these funds?
Yes. Neonatal stems cells (e.g., cells derived from foreskin) will be considered adult stem cells for the purpose of this funding opportunity since they are not derived from fetal or embryonic sources.
Q19. Is research that aims to develop products that stimulate host stem cell growth and function eligible for these competitive revisions?
Yes. Eligible projects encompass, for example, research on biologics (e.g., growth factors, cytokines) and biomaterials (e.g., ECM, scaffolds) that stimulate host adult stem cell growth, differentiation, and function or otherwise directly act upon adult stems cells to support innate host healing mechanisms, treat disease, and/or restore function.
Q20. Is work involving only animal models with animal cells eligible for these funds?
No. Research with animal models using only animal stem cells is generally not eligible because it is not “clinical research” as described in the FOAs.
Q21. Must my project involve a product that is under IND/IDE?
No. Eligible applications will propose clinical research involving adult stem cells in the context of generating or supplementing the necessary evidence for the development of a regenerative medicine clinical intervention. This may include, but is not limited to, projects generating data for submission of a pre-IND or pre-IDE package or the submission of an IND/IDE application.
Q22. I am using an autologous adult stem cell product that I do not believe is subject to IND/IDE authorization. To submit a responsive application, what is required of me in terms of obtaining confirmation from FDA on this point?
If the protocol is judged by the applicant to be exempt from an IND/IDE, the applicant should provide a written explanation. Applicants are encouraged to consult with the FDA for an authoritative opinion, when in doubt. In addition, as part of the application review process, FDA will determine whether an IND or IDE application is required for projects being considered for funding when an applicant has asserted that the project does not require an IND or IDE application.
Role of FDA
Q23. The Act states that NIH award funding “…in coordination with FDA.” How will this coordination be achieved?
As an essential partner and collaborator with NIH on the implementation of the RMIP, FDA is providing critical input on the state of regenerative medicine science, including the current knowledge gaps and technical, scientific, and operational challenges, especially with respect to regulatory science needs. NIH has worked with FDA on the development of the FOAs, as well as the design of the review crtieria and process. FDA staff may participate as observers on the initial review panels assessing the scientific merits of the applications. FDA will also provide feedback on whether an IND or IDE application is required for projects being considered for funding when an applicant has asserted that the project does not require an IND or IDE application.
Q24. What process will be used to make funding decisions on these applications?
As with all grant applications submitted to NIH, RMIP applications will undergo two levels of peer review: an initial review of the proposal’s scientific and technical merits, and a second level of review by an advisory council regarding funding and research priorities. Initial peer review of applications will be conducted by a Special Emphasis Panel. Final funding decisions will be made by NIH leadership.
Q25. Where can I get more information about this funding opportunity?
This page last reviewed on March 12, 2018