Notice Number: NOT-HL-18-578
Key DatesRelease Date:January 12, 2018
National Heart, Lung, and Blood Institute ( NHLBI)
National Eye Institute ( NEI)
National Institute on Aging ( NIA)
National Institute of Allergy and Infectious Diseases ( NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS)
National Institute of Biomedical Imaging and Bioengineering ( NIBIB)
National Institute on Deafness and Other Communication Disorders ( NIDCD)
National Institute on Dental and Craniofacial Research ( NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK)
National Institute of Mental Health ( NIMH)
National Institute of Neurological Disorders and Stroke ( NINDS)
National Center for Advancing Translational Sciences ( NCATS)
U.S. Food and Drug Administration ( FDA)
The National Institutes of Health (NIH) and participating NIH Institutes and Centers (ICs) and the U.S. Food and Drug Administration (FDA) intend to publish a Funding Opportunity Announcement (FOA) for new applications that will support clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. Applicants must apply and undergo peer review.
The planned FOA, known as the Regenerative Medicine Innovation Project (RMIP), will support new projects that utilize rigorous science and reproducible methods to establish proof of concept and a robust evidence base for clinical applications. In order to fulfill the mandate of advancing the field of RM more broadly, applicants will 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 product manufacturing, quality, safety, or effectiveness.
Toward these ends, the NIH will consider applications for clinical research involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including the submission of a pre-Investigational New Drug (IND) or pre-Investigational New Device Exemption (IDE) package; the submission of an IND/IDE application; or to support such research conducted under an authorized IND or IDE. Potential applicants are encouraged to review additional information on the RMIP and answers to frequently asked questions on the RMIP website. Inquiries can be sent to RMIP@nih.gov.
The FOA will utilize the U43/U44 activity code and is expected to be published in February 2018 with an application due date in May 2018.
This Notice is being provided to allow potential applicants sufficient time to develop responsive proposals, consider the requirements that are integral to this initiative, and obtain necessary matching funds (see below). Of note, this and five other Notices are being issued for a total of $28 million overall, $10 million of which is available for award in FY 2018 in order to solicit new projects for the mechanisms listed herein under Related Announcements.
Research Initiative Details
The RMIP FOA represents one step in fulfilling a new statutory provision set forth in the 21st Century Cures Act. Given the potential of RM to enhance human health and treat disease, Congress included this provision for an Innovation Project in the Act authorizing a total of $30 million for the funding of clinical research to further the field of RM using adult stem cells, including autologous cells. The Act stipulates that the NIH, in coordination with FDA, award funds contingent upon the recipient making available non-Federal contributions in an amount not less than $1 for each $1 of Federal funds provided in the award (i.e., a matching funds requirement).
The RMIP FOA is intended to support only research that involves: (1) human subjects or material of human origin, such as cells, tissues, and specimens; and (2) human stem cells that are not of embryonic or fetal origin. Applicable research on adult human stem cells 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. Funding could be used, for example, for the appropriate chemistry, manufacturing, and controls development to support the production of such products for clinical trials using good manufacturing practices (GMP). Funds may not be used for research involving human cells of embryonic or fetal origin.
This FOA will support highly meritorious clinical research projects proposing to explore and enable the development of safe and effective RM interventions. Specifically, for FY 2018 funds, in addition to being subject to the standard NIH review criteria, clinical research projects will also be assessed according to the following criteria:
Estimated Total Funding $28 million
Expected Number of Awards 5
Estimated Award Ceiling $10 million
Primary CFDA Numbers 93.837, 93.838, 93.839, 93.940, 93.233
Anticipated Eligible Organizations
Applications are not being solicited at this time.
Please direct all inquiries to: