21st Century Cures Act: Regenerative Medicine Initiative – Research Projects
Program Funding
Annual program obligations reported to SAM.gov.
Program Objective
The Regenerative Medicine Innovation Project (RMIP) was established by the 21st Century Cures Act to accelerate progress in the field by supporting clinical research on adult stem cells, while promoting scientific rigor and protecting patient safety. This initiative is a trans-NIH effort, in coordination with the Food and Drug Administration (FDA).
Regenerative medicine is an emerging area of science that holds great promise for treating and even curing a variety of injuries and diseases. Regenerative medicine includes using stem cells and other technologies—such as engineered biomaterials and gene editing—to repair or replace damaged cells, tissues, or organs. Stem cell-based approaches are under development in labs around the world, and some have already moved into clinical trials. Such progress notwithstanding, much work remains to be done toward the development of safe and effective regenerative medicine products and to realize the full potential of this field.
Eligibility
Eligible Applicants
- Unrestricted by Entity Type
The awardee will be a university, college, hospital, public agency, nonprofit research institution or for-profit organization that applies and receives a grant for support of research by a named principal investigator. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.
How to Apply
Award Procedure
Grants and cooperative agreements are funded based on scientific merit, program relevance, and program balance and are made annually. The initial grant award provides funds for the first budget period (usually 12 months) and letter Notice of Award indicates support recommended for the remainder of the project period, allocation of Federal funds by budget categories and special conditions, if any.
approximately 10 months
Program details & compliance
Description
The RMIP is one of four Innovation Projects authorized under the Cures Act; the others are the Precision Medicine Initiative (“All of Us”), the Beau Biden Cancer Moonshot, and the BRAIN Initiative.
The NIH RMIP launched following passage of the 21st Century Cures Act, which authorized $30 million over four years “for clinical research to further the field of regenerative medicine using adult stem cells.”
NIH continues to work in close collaboration with the U.S. Food and Drug Administration to implement the RMIP.
Mission Categories
Primary: Research and Development
Use of Funds
Allowed Uses
Grants and cooperative agreements may be made to eligible institutions for the support of the BRAIN Initiative. The grants and cooperative agreements may be used for personnel, consultant costs, equipment, supplies, travel, patient costs, animals, alterations and renovations, miscellaneous items, and Facilities and Administrative Costs (formerly known as indirect costs).
Required Documentation
Applications must be submitted in compliance with instructions provided with each initiative.
2 CFR 200, Subpart E - Cost Principles applies to this program.
Reporting & Compliance
Applicable 2 CFR 200 Subparts
- Subpart B — General Provisions
- Subpart C — Pre-Federal Award Requirements
- Subpart D — Post-Federal Award Requirements
- Subpart E — Cost Principles
- Subpart F — Audit Requirements