DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

NEWS RELEASE

Released: July 21, 2021

Defense Health Program
Department of Defense Reconstructive Transplant Research Program
Anticipated Funding Opportunities for Fiscal Year 2021 (FY21)

The FY21 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). 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 FY21 funding opportunities. This pre-announcement should not be construed as an obligation by the government. The FY21 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. 

Applications submitted to the FY21 RTRP Investigator-Initiated Research Award must address one or more of the following focus areas:

Reduce the risks of VCA-associated immunosuppression

  • Define the unique manifestations and/or mechanisms of VCA immunogenicity
  • Develop novel approaches for achieving VCA immune tolerance
  • Develop less-toxic regimens for maintenance immunosuppression
  • Identify unique immunosuppression requirements for VCA compared to other solid organ transplants

Develop reliable non-invasive prognostic/diagnostic biomarkers methods or tools for monitoring VCA graft rejection including applications that would be suitable for point-of-care testing or home monitoring

  • Develop reliable non-invasive biomarkers for monitoring chronic VCA graft rejection in a large animal model or banked specimens and medical records
  • Identify and/or validate new peripheral biomarkers for acute and chronic rejection
  • Develop assays or devices for clinical graft monitoring utilizing validated biomarkers

Retrospective studies for VCA

  • Comparison of solid organ immunosuppression protocols and outcomes vs. VCA immunosuppression protocols and outcomes
  • Comprehensive assessment of VCAs performed to date, to include but not limited to, patient selection, immunosuppression protocols employed, long-term recipient outcomes (e.g., graft performance, chronic rejection, graft status), quality of life (e.g., physical/mental function, daily activities, social participation)
  • Assessment of frequency, duration, and severity of rejection episodes, treatment interventions to mitigate rejection episodes, and immunosuppression-related complications (e.g., infection, end organ dysfunction)
  • Assessment of VCA outcomes compared to age- and level of injury-matched prosthesis users

Applications submitted to the FY21 RTRP Advanced Technology Therapeutic Development Award must address one or more of the following focus areas:

Advance existing ex vivo tissue preservation strategies to extend the timeline between procurement and transplantation

  • Develop promising approaches and technologies for translation to the clinic, including, but not limited to, perfusion, hypothermic, high-subzero and low-subzero, or static preservation strategies.
  • Determine the extent to which VCA tissue preservation technology impacts VCA immunogenicity

Advance reliable non-invasive prognostic/diagnostic biomarkers, methods, or tools for monitoring VCA graft rejection, including applications that would be suitable for point-of-care testing or home monitoring.

  • Develop reliable non-invasive biomarkers for monitoring chronic VCA graft rejection in a large animal model or banked specimens and medical records
  • Validate peripheral biomarkers for acute and chronic rejection
  • Develop assays or devices for clinical graft monitoring utilizing validated biomarkers

Award Mechanism Eligibility Key Mechanism Elements Funding
Investigator-Initiated Research Award Independent investigators at all academic levels (or equivalent).
  • Supports studies with the potential to make an important contribution to the reconstructive transplant research field, patient care, and/or quality of life.
  • Preproposal is required; full application submission is by invitation only.
  • Applications must address at least one of the FY21 RTRP Investigator-Initiated Research Award Focus Areas.
  • Preliminary or published data are required for all focus areas except retrospective studies for VCA.
  • Multiple PI Option:
    • Supports synergistic partnerships among two to four investigators collaborating on a single application.
  • Retrospective Focus Area Single PI Option:
    • Supports retrospective studies in VCA.
  • Retrospective Focus Area Multiple PI Option:
    • Supports synergistic partnerships among two to four investigators collaborating on a single application focused on retrospective studies in VCA; multi-institutional collaborations are required.
Single PI:
  • Maximum funding of $1 million (M) for total costs (direct plus indirect costs).
  • Maximum period of performance is 3 years.

Multiple PI Option:

  • Maximum total funding of $1.5M for total costs (direct plus indirect costs).
  • Maximum period of performance is years.

Retrospective Focus Area Single PI Option:

  • Maximum funding of $250,000 for total costs (direct plus indirect costs).
  • Maximum period of performance is years.

Retrospective Focus Area Multiple PI Option:

  • Maximum funding of $375,000 for total costs (direct plus indirect costs).
  • Maximum period of performance is 2 years.
Advanced Technology Development Award Independent investigators at all academic levels (or equivalent).
  • Supports research critical for the translation of promising preclinical findings into products focused on reconstructive transplantation.
  • Applications must address at least one of the FY21 RTRP Advanced Technology Development Award Focus Areas.
  • Preproposal is required; full application submission is by invitation only.
  • Preliminary or published data are required.
  • Multiple PI Option:
    • Supports synergistic partnerships among two to four investigators collaborating on a single application; multi-institutional collaborations are encouraged.
Single PI:
  • Maximum funding of $1M for total costs (direct plus indirect costs).
  • Maximum period of performance is years.

Multiple PI Option:

  • Maximum total funding of $1.5M for total costs (direct plus indirect costs).
  • Maximum period of performance is 3 years.

It is anticipated that the Clinical Network Award will be released in FY22.

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 announcements 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 announcements are 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 Wednesday, July 21, 2021