The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (U01) applications to support investigator-initiated clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act.
Applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness.
Toward these ends, the NIH will consider applications for late-stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE.
Due to the complex nature of requirements in this FOA (e.g., 1:1 matching funds, resource sharing), applicants are strongly encouraged to communicate with the appropriate NIH Scientific/Research Contact and review online Frequently Asked Questions (FAQs) prior to submitting an application. Staff will be able to advise applicants in determining if their research meets the requirements and objectives of this FOA.
Companion FOAs:
RFA-HL-23-017 , UG3/ UH3 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
RFA-HL-23-020 , R34 Planning Grant
Deadlines:
- Letter of Intent Due Date(s): September 2, 2022
- Application Due Date(s): October 6, 2022
RFA-HL-23-019 Expiration Date October 07, 2022
The total budget (Federal award and non-Federal matching contributions) should reflect the actual needs of the proposed project. While annual project budgets should reflect the actual costs anticipated in each year, the Federal share of this award must not exceed $250,000 in direct costs per year.
The recipient is required to provide at least a 1:1 match of the Federal funds requested (for Direct and Indirect/F&A costs) in the form of non-Federal contributions, as mandated by the 21st Century Cures Act (45 CFR 75.306).