Notice of Intent to Publish a Funding Opportunity Announcement to Support New Applications in Regenerative Medicine Innovation Projects (RMIP) (U43/U44 - Clinical Trial Not Allowed)

Notice Number: NOT-HL-18-578

Key Dates

Release Date:January 12, 2018
Estimated Publication Date of Funding Opportunity Announcement: 02/15/2018
First Estimated Application Due Date: 05/15/2018
Earliest Estimated Award Date: 09/14/2018
Earliest Estimated Start Date: 10/15/2018

Related Announcements
NOT-HL-18-573
NOT-HL-18-574
NOT-HL-18-575
NOT-HL-18-576
NOT-HL-18-577

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 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)

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 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:
 

  • Does not include a clinical trial (for clinical trial applications see NOT-HL-18-577);
  • Matching funds available at time of award;
  • Contributes to breadth/diversity of RM science;
  • Addresses critical issues relevant to clinical research and regulatory submissions including those related to product development. 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; 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 contributing to the foundational knowledge critical for product development, clinical testing, and data standards and sharing, are strongly encouraged. For example, such projects may:
 
  • Further development of standards and GMP for adult stem cell-based RM products;
  • Leverage extant cell production facilities for product preparation and qualification;
  • Promote and enhance mechanisms for data standardization, curation, integration, and sharing;
  • Contribute to a better and shared understanding of current technical and operational barriers as well as the regulatory science issues; and/or
  • Monitor stem cell function and integration in vivo.
 
Matching Requirement
The Government requires at least a 1:1 recipient cost matching for 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 $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

Small Business

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Allan Shipp
National Heart, Lung, and Blood Institute (NHLBI)
301-435-2152
RMIP@nih.gov