DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

NEWS RELEASE

Released: September 21, 2020

Defense Health Program
Department of Defense Reconstructive Transplant Research Program
Funding Opportunities for Fiscal Year 2020 (FY20)

The FY20 Defense Appropriations Act provides funding to the Department of Defense Reconstructive Transplant Research Program (RTRP) to support research projects that specifically address needs in the field of vascularized composite allotransplantation (VCA). As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC). 

The RTRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY20 funding opportunity. This pre-announcement should not be construed as an obligation by the Government. The FY20 RTRP Program Announcements and General Application Instructions for the following award mechanisms will be posted on the Grants.gov website. Pre-application and application deadlines will be available when the Program Announcements are released. 

Focus Areas: Applications submitted to the FY20 RTRP Clinical Network Award Program Announcement/Funding Opportunity must address the standardization, assessment, and validation of protocols and/or standard operating procedures (SOPs) for each of the following aspects of VCA for face and hand transplantation: 

  • Patient inclusion/exclusion criteria
  • Patient education
  • Surgical procedures
  • Immunosuppression and/or immunoregulation
  • Outcome metrics
  • Quality of life measures
  • Rehabilitation
  • Patient reporting (e.g., registry)
Award Mechanism Eligibility Key Mechanism Elements Funding
Clinical Network Award Independent Investigators at or above the level of Assistant Professor (or equivalent) are eligible to be named PI.
  • To promote a major multi-institutional network of VCA Centers and associated collaborators for the purpose of standardizing clinical protocols and SOPs for face and hand transplantation, and assessing and validating those protocols and SOPs in multi-institutional clinical trials.
  • This effort will be executed through a two-phased approach in the form of a single award to the Clinical Network Coordinating Center. The Coordinating Center will serve as the Clinical Network information and planning nexus, providing administrative, operational, and data management support services to implement Clinical Network activities in a timely manner.
  • Phase 1 Objectives
    • Establish the Clinical Network
    • Develop standardized protocols and SOPs
    • Develop Clinical Trial Applications
    • Coordinate external Peer Review
    • Obtain all regulatory approvals
  • Phase 2 Objectives
    • Conduct clinical trials (one for face transplantation and one for hand transplantation)
  • Submission of a Letter of Intent is required prior to full application submission.

Phase 1:

  • Maximum funding of $3 million (M) for total costs (direct plus indirect costs).
  • Phase 1 funds will be awarded in FY20.
  • Maximum period of performance is 2 years.

Phase 2:

  • Maximum funding of $10M for total costs (direct plus indirect costs).
  • Phase 2 funds are anticipated to be awarded in FY22, pending availability of funds and successful completion of Phase I objectives.
  • Maximum period of performance is 4 years.

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcement and General Application Instructions that will be available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural Funding Opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

Submission deadlines are not available until the Program Announcement is released. For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the RTRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).


Point of Contact:

CDMRP Public Affairs
301-619-9783
usarmys.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil


Last updated Monday, September 21, 2020