DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

NEWS RELEASE

Released: June 18, 2015

Defense Health Program
Department of Defense Reconstructive Transplantation Research
Funding Opportunities for Fiscal Year 2015 (FY15)

The FY15 Defense Appropriations Act provides $15 million (M) to the Department of Defense Reconstructive Transplantation Research (RTR) to support innovative, high-impact research in the field of reconstructive transplantation (RT), specifically vascularized composite allotransplantation (VCA)-focused research, also known as composite tissue allotransplantation (CTA). Applications to the Fiscal Year 2015 (FY15) RTR are being solicited by the U.S. Army Medical Research Acquisition Activity (USAMRAA). The executing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP).

The RTR is providing the information in this pre-announcement to allow investigators time to plan and develop applications. FY15 RTR Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in early July 2015. Pre-application and application deadlines will be available when the Program Announcements are released. This pre-announcement should not be construed as an obligation by the Government.

Focus Areas: The RTR encourages applications that specifically address the transplantation of multiple tissues such as muscle, bone, nerve, and skin, as a functional unit (e.g., a hand, or face) from a deceased donor to a recipient with a severe injury through the focus areas described below.

  • Immune system regulation
    • Understanding mechanisms of immune rejection
    • Immunomodulation approaches and mechanisms (e.g. tolerance induction, chimerism)
    • Optimizing immunosuppressive drug regimens
    • Exploiting inflammatory processes, controlling and modulating a patient's immune response to improve existing therapies and maximize outcomes (e.g. Immuno Engineering)
  • Improved access to reconstructive transplantation
    • Identify personality and psychological characteristics consistent with successful VCA outcomes.
    • Improved tissue preservation techniques or technologies to extend radius of donor procurement
    • Development of educational programs for healthcare providers to improve referrals of potential reconstructive transplantation candidates.
    • Identification of patient-driven barriers to transplantation (i.e., patient is suitable anatomically and immunologically, but declines opportunity for transplant)
    • Identification of barriers to donor offers for reconstructive transplantation, and strategies to address the same.
    • Tool to identify psychosocial factors which limit engagement and treatment adherence of reconstructive transplantation patients.
    • Identification of strategies and behavioral interventions which optimize patient engagement and adherence to prescribed course of treatment throughout the lifetime of the reconstructive transplant, in order to broaden the patient population appropriate for reconstructive transplantation.
    • Tools or techniques to identify quality of life improvement following reconstructive transplant intervention
  • Reconstructive Transplantation Rehabilitation
    • Novel rehabilitation strategies which improve reconstructive transplant function
  • Graft surveillance - Clinical monitoring
    • Non-invasive imaging technologies
    • Immune profiling e.g. gene expression, graft rejection markers, cytokine screens

Award Mechanism Eligibility Key Mechanism Elements Funding
Concept Award Independent investigators at all academic levels (or equivalent)
  • Letter of intent is required
  • Supports the exploration of a highly innovative new concept or untested theory that addresses an important problem
  • Preliminary data not allowed
  • Peer and Programmatic review are blinded to whom the applicant and submitting institution are.
  • Maximum funding of $150,000 for total costs
  • Maximum period of performance is 1 year
Discovery Award Independent investigators at or above the level of Assistant Professor (or equivalent)
  • Letter of intent is required
  • Support innovative scientific approaches to Regenerative Medicine research that may be untested but may reveal breakthroughs or new avenues. Innovation is the first review criteria.
  • Preliminary data is encouraged
  • Maximum funding of 450,000 for total costs
  • Maximum period of performance is 2 years
Translational Research Award Independent investigators at or above the level of Assistant Professor (or equivalent)
  • Preproposal is required; application submission is by invitation only.
  • Supports the development of data and model systems to complete the FDA regulatory review process and position the product for a clinical trial.
  • Animal studies encouraged;
  • Collaboration encouraged
  • Maximum funding of $1 Million in total costs
  • Maximum period of performance is 2 years
Clinical Trial Award Independent investigators at or above the level of Assistant Professor (or equivalent)
  • Preproposal is required; application submission is by invitation only.
  • A prospective accrual of patients for a study where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome
  • No preclinical studies funded through this mechanism, IND / IDE required within 60 days of award
  • Maximum funding of $3 Million in total costs
  • Maximum period of performance is 4 years

A letter of intent or pre-application is required and must be submitted through the CDMRP electronic Biomedical Research Application Portal (eBRAP) (https://eBRAP.org) prior to the letter of intent or pre-application deadline. Applications must be submitted through the federal government's single-entry portal, Grants.gov. Submission deadlines are not available until the Program Announcement is released. Requests for email notification of the Program Announcement release may be sent to help@eBRAP.org. Email notifications of funding opportunities are sent as a courtesy and should not be used as a sole source of notification; applicants should monitor Grants.gov for official postings of funding opportunities.

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 USAMRMC funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

For more information about the RTR or other CDMRP-supported programs, please visit the CDMRP website (http://cdmrp.army.mil).

Point of Contact:

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