Notice Number: NOT-HL-19-700
Key Dates
Release Date: May 22, 2019Estimated Publication Date of Funding Opportunity Announcement: July 12, 2019
First Estimated Application Due Date: October 18, 2019
Earliest Estimated Award Date: May 25, 2020
Earliest Estimated Start Date: June 01, 2020
Related Announcements
Issued by
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 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 Neurological Disorders and Stroke ( NINDS)
National Center for Advancing Translational Sciences ( NCATS)
U.S. Food and Drug Administration ( FDA)
Purpose
The National Institutes of Health (NIH) and participating NIH Institutes and Centers (ICs) and the U.S. Food and Drug Administration (FDA) intend to reissue RFA-HL-18-031 for new applications that will support investigator-initiated clinical trials aimed at furthering the field of regenerative medicine (RM) using adult stem cells. Applicants must apply and undergo peer review.
In order to fulfill the mandate of advancing the field of RM more broadly, the reissued FOA is intended to support projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that use RM interventions and/or products that have undergone appropriate product development and preclinical studies and have demonstrated readiness to advance into clinical trials. Applicants will be encouraged to include plans for project management, subject recruitment and retention, statistical analysis, data management, performance milestones, risk assessment, scientific conduct of the trial, and dissemination of results.
Toward these ends, the NIH intends to consider applications for clinical trials involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development and supporting research conducted under an authorized IND or IDE at time of award. Potential applicants are encouraged to review additional information regarding the RMIP and answers to frequently asked questions on the Regenerative Medicine Innovation Project (RMIP) website. Inquiries can be sent to [email protected].
The reissued FOA will continue to utilize the UG3/UH3 activity code that employs a bi-phasic, milestone-driven cooperative agreement mechanism of award and is expected to be published in July 2019 with an expected application due date in October 2019.
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 notice is being issued for a total fund of $18 million with up to $15 million available for FY 2020 in order to support new projects.
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 reissued 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 stem cells to support innate host healing mechanisms, treat disease, and/or restore function.
The reissued RMIP FOA will support highly meritorious Phase I and beyond clinical trials proposing to explore and enable the development of safe and effective RM interventions. Non-clinical (animal) studies will not be supported by this FOA. Applications should present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Specifically, for FY 2020 funds, in addition to being subject to the standard NIH review criteria, clinical trials will also be assessed according to the following criteria:
- RM interventions and/or products demonstrating readiness for advancing into clinical trials and under an IND/IDE application;
- Matching funds available at time of award;
- Contributes to breadth/diversity of RM science;
- Addresses critical issues relevant to clinical research and regulatory plan/proposal including those related to overall evaluation of product quality, clinical safety, cGMP production, and effectiveness;
- Provides preliminary data, clinical and/or non-clinical studies, or information in the literature or knowledge of biological mechanisms that support the scientific rationale and need for the clinical trial to test the proposed hypothesis or intervention; and
- Will help to significantly build or advance the field of RM by contributing to fundamental knowledge as well as addressing a well-recognized challenge in clinical development including the development and evaluation of safe and effective RM products.
Applications that demonstrate potential to catalyze sustained and accelerated development of the RM field through rigorous clinical testing, and data standards and sharing are strongly encouraged. For example, such projects:
- Must make available representative samples of the source stem cell line and clinical-grade stem cell product for in-depth and independent characterization;
- Should work closely with NIH to establish common data elements, data standards, metadata requirements, controlled vocabularies, and quality control metrics for all data to ensure that the data are Findable, Accessible, Interoperable, and Reusable (FAIR);
- Should promote and enhance mechanisms for data standardization, curation, integration, and sharing;
- May utilize clinical trial network(s) to leverage infrastructure and facilitate subject recruitment and follow up as well as data sharing;
- Must make available data collected from long-term follow-up of study participants;
- May contribute to a better and shared understanding of current technical and operational barriers as well as the regulatory science issues; and
- Should monitor stem cell and stem cell-derived differentiated cell function and integration in vivo.
Matching Requirement
The Government requires at least a 1:1 recipient cost matching for all federal funds (total Direct and Indirect/Facilities & Administrative (F&A) costs) awarded in this program, as required by the 21st Century Cures Act. The Government will consider any non-federal funds, to include state and local funding (not originating from Federal funds), as well as private-sector investment, in-kind contributions, and donations from foundations provided in support of the application as qualifying for the cost matching ratio requirement. More information on the RMIP matching requirement can be found on the RMIP website.
Funding Information
Estimated Total Funding $15 million
Expected Number of Awards 5
Estimated Award Ceiling $3 million
Primary CFDA Numbers TBD
Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Applications are not being solicited at this time.
Inquiries
Please direct all inquiries to:
Joel Islam, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
[email protected]
and Human Services (HHS)
